RFID Identification System for Surgical Instruments
By using RFID technology in surgical systems to identify and verify the compatibility of surgical instruments and replaceable components, the problem of difficulty in ensuring compatibility of surgical instruments and components in the prior art is solved, and the safety and efficiency of surgery are improved.
Patent Information
- Application Number
- CN202080047400.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2019-06-30
- Filing Date
- 2020-06-18
- Publication Date
- 2025-03-21
- Estimated Expiration
- 2040-06-18
AI Technical Summary
Existing surgical systems are difficult to effectively identify and compatible with the relationship between surgical instruments and their replaceable components, resulting in possible incompatible use, affecting the safety and efficiency of the surgery.
Using RFID technology, RFID tags on surgical instruments and replaceable components are identified and verified through RFID scanners and controllers to ensure compatibility and prevent the instrument from performing functions when incompatible.
Accurate identification and compatibility verification between surgical instruments and replaceable components is achieved, improving the safety and efficiency of the surgery, and preventing operational errors due to incompatibility.
Smart Images

Figure CN114025685B_ABST
Abstract
Description
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS
[0002] This patent application is a non-provisional patent application claiming priority under 35 U.S.C. 119(e) to U.S. Provisional Patent Application Serial No. 62 / 868,457, filed on June 28, 2019, entitled “SURGICAL SYSTEMS WITH MULTIPLE RFID TAGS,” the entire disclosure of which is hereby incorporated by reference into this document. Background Art
[0003] The present invention relates to surgical instruments, and in various embodiments, to surgical cutting and stapling instruments and staple cartridges thereof designed for cutting and stapling tissue. In various embodiments, RFID technology can be used to identify, for example, components of surgical instruments such as staple cartridges. Examples of surgical systems using RFID technology can be found in the disclosures of U.S. Patent No. 7,959,050, entitled “ELECTRICALLY SELF-POWERED SURGICAL INSTRUMENT WITH MANUAL RELEASE,” published on June 14, 2011, and U.S. Patent Application No. 2015 / 0053743, entitled “ERROR DETECTION ARRANGEMENTS FOR SURGICAL INSTRUMENT ASSEMBLIES,” published on February 26, 2015, and both are incorporated herein by reference in their entirety. Summary of the invention
[0004] In various embodiments, a surgical suturing system is disclosed, which includes an elongated shaft, a firing drive, an end effector extending distally from the elongated shaft, an RFID scanner, and a controller communicating with the RFID scanner. The end effector includes a needle track and a replaceable needle guided by the needle track and actuated by the firing drive through a firing stroke. The replaceable needle includes a suture material attached thereto and an RFID tag including storage data. The RFID scanner receives a signal from the RFID tag including storage data. The signal indicates the storage data. The controller is configured to be able to determine the compatibility between the replaceable needle and the surgical suturing system based on the storage data received by the RFID scanner, and prevent the surgical suturing system from performing a firing stroke when the replaceable needle is not compatible with the surgical suturing system.
[0005] In various embodiments, a surgical device for applying a clamp is disclosed. The surgical device includes an elongated shaft extending from a housing; an end effector extending from the elongated shaft; a cartridge; a crimping drive; an RFID tag including a first set of information; an RFID scanner configured to receive a first signal from the RFID tag; and a controller communicating with the RFID scanner. The end effector includes a first jaw and a second jaw. The first jaw and the second jaw are movable between an open position and a closed position relative to each other. The cartridge includes a storage chamber and a plurality of clamps removably positioned within the storage chamber. The crimping drive is configured to move the first jaw and the second jaw to a closed position during a crimping stroke. During the crimping stroke, one of the plurality of clamps is crimped around tissue of the patient. The first set of information corresponds to the cartridge. The first signal includes the first set of information. The controller is configured to determine whether the cartridge is compatible with the surgical device by comparing a first set of information received by the RFID scanner with a set of compatibility data stored in a memory of the controller, allow the surgical device to perform a crimping stroke when the controller determines that the cartridge is compatible for use with the surgical device, prevent the surgical device from performing a crimping stroke when the controller cannot identify the cartridge as compatible for use with the surgical device, and prevent the surgical device from performing a crimping stroke when the RFID scanner does not receive a first signal.
[0006] In various embodiments, a surgical suturing system is disclosed, which includes a surgical instrument, a replaceable component assembly, an RFID scanner including a communication range, and a controller that communicates with the RFID scanner. The surgical instrument includes an elongated shaft, an end effector extending from the elongated shaft, and a nail magazine. The end effector includes a first jaw and a second jaw. The nail magazine is replaceably arranged in the second jaw. The nail magazine includes a magazine body, which includes a magazine platform and a nail removably positioned in the magazine body. The replaceable component assembly includes a mounting member; a replaceable component, which is configured to be able to be positioned on the magazine platform of the nail magazine; and an RFID tag, which includes a first set of data. When the replaceable component is attached to the magazine platform, the replaceable component is supported on the mounting member. The RFID scanner is configured to transmit a first signal to the RFID tag and receive a second signal from the RFID tag when the replaceable component is brought into the communication range. The second signal includes a first set of data. The controller includes a memory, which includes a second set of data. The controller is configured to determine whether a replaceable component is compatible with the surgical instrument by comparing a first set of data received by the RFID scanner with a second set of data stored in a memory of the controller, allow the surgical instrument to perform a function when the controller determines that the replaceable component is compatible for use with the surgical instrument, prevent the surgical instrument from performing a function when the controller cannot identify the replaceable component as compatible for use with the surgical instrument, and prevent the surgical instrument from performing a function when the RFID scanner fails to receive a second signal in response to the first signal. BRIEF DESCRIPTION OF THE DRAWINGS
[0007] The various features of the embodiments described herein, together with their advantages, may be understood from the following description in conjunction with the following drawings:
[0008] Figure 1 is a schematic diagram of various surgical instruments and supplementary components used with the surgical instruments;
[0009] Figure 2 is a perspective view of a package, wherein the package includes an identification feature of a supplemental component contained therein;
[0010] Figure 3 is a partial cross-sectional view of a surgical stapling instrument system including a mounting member and a supplemental component, wherein the mounting member includes an RFID tag;
[0011] Figure 4 is a representation of an RFID system for use with the surgical instruments disclosed herein;
[0012] Figure 5 is a flow chart representing a process of a controller for modifying at least one operating parameter based on an identified supplemental component;
[0013] Figure 6 is a partial perspective view of a surgical clip applier including an RFID system;
[0014] Figure 7 is a flow chart representing a process of a controller for controlling performance of a crimp stroke based on detection of an RFID tag;
[0015] Figure 8 is a flow chart representing a process of a controller for controlling performance of a crimping stroke based on monitoring of a plurality of RFID tags;
[0016] Fig. 9 is a flow chart representing a process of a controller for detecting compatibility of an attachment fixture;
[0017] Fig.10 is a flow chart representing a process of a controller for monitoring the number of fixtures remaining in a fixture bin;
[0018] Fig.11 is a partial perspective view of a surgical stapling device including an RFID system;
[0019] Fig.12 is a perspective view of a surgical instrument including a handle, a shaft, and an articulatable end effector;
[0020] Fig.13 yes Fig.12 A side view of a surgical instrument;
[0021] Fig.14 is located in Fig.12 A perspective view of a firing member and a pinion gear within the handle;
[0022] Fig.15 yes Fig.14 A perspective view of a firing member and a pinion gear and a gear reducer assembly operably engaged with the pinion gear;
[0023] Fig.16 yes Fig.12 A perspective view of the handle with portions removed to show Fig.14 The firing member and pinion, Fig.15 a gear reducer assembly and an electric motor configured to drive the firing member distally and / or proximally depending on the direction of rotation of the electric motor;
[0024] Fig.17 is a partial perspective view of a clip applier;
[0025] Fig.18 yes Fig.17A cross-sectional view of an end effector of a clip applier, comprising a removable clip cartridge, a reciprocating firing drive for sequentially advancing the clips, a receiver for receiving the clips, and a crimping drive for deforming the clips;
[0026] Fig.19 is in open configuration Fig.17 A partial cross-sectional view of a clip applier;
[0027] Fig. 20 is in a closed configuration Fig.17 A partial cross-sectional view of a clip applier;
[0028] Fig.21 It is in the unfired state Fig.18 A cross-sectional view of an end effector;
[0029] Fig. 22 yes Fig.18 sectional view of the end effector of , showing the firing drive in a partially fired state, wherein the firing member of the firing drive has advanced the clamp into the receiver;
[0030] Fig.23 yes Fig.18 A cross-sectional view of an end effector of FIG. 1 showing a firing drive engaged with a crimping drive;
[0031] Fig.24 yes Fig.18 A cross-sectional view of an end effector of , showing a crimp drive device in an at least partially fired state;
[0032] Fig.25 yes Fig.18 a perspective view of the fixture shown;
[0033] Fig.26 yes Fig.18 a front view of a bin including a plurality of clamps shown with portions of the bin removed to illustrate the clamps stored in the bin;
[0034] Fig. 27 yes Fig.26 a side view of a bin of , shown with portions removed to illustrate the clamps stored within the bin;
[0035] Fig.28 is along Fig. 27 The line 28-28 in Fig.26 A cross-sectional plan view of a warehouse;
[0036] Fig.29 is a perspective view of a surgical stapling instrument including a handle, a shaft, and an end effector;
[0037] Fig.30 yes Fig.29 A partial plan view of a surgical stapling instrument;
[0038] Fig.31 yes Fig.29 A partial plan view of a surgical stapling instrument, wherein the end effector is in an articulated state;
[0039] Fig.32 yes Fig.29 A partial perspective view of a surgical stapling instrument;
[0040] Fig.33 yes Fig.29 A partial perspective view of a surgical stapling instrument with an end effector in an articulated and rotated state;
[0041] Fig.34 is a perspective view of a surgical stapling instrument handle including a motor; and
[0042] Fig.35 is an exploded view of a suturing cartridge for use with a surgical suturing system. DETAILED DESCRIPTION
[0043] The applicant of the present application owns the following U.S. patent applications filed on the same date as the present application and each of which is incorporated herein by reference in its entirety:
[0044] Attorney Docket No. END9145USNP1 / 190235-1M entitled “METHOD FOR AUTHENTICATING THE COMPATIBILITY OF A STAPLECARTRIDGE WITH A SURGICAL INSTRUMENT”;
[0045] Attorney Docket No. END9146USNP1 / 190236, entitled “SURGICAL INSTRUMENT SYSTEM COMPRISING AN RFID SYSTEM”;
[0046] Attorney Docket No. END9147USNP1 / 190237, entitled “SURGICAL INSTRUMENT COMPRISING AN RFID SYSTEM FOR TRACKING AMOVABLE COMPONENT”;
[0047] Attorney Docket No. END9148USNP1 / 190238, entitled “SURGICAL INSTRUMENT COMPRISING AN ALIGNED RFID SENSOR”;
[0048] Attorney Docket No. END9123USNP1 / 190239 entitled “SURGICAL STAPLING SYSTEM HAVING AN INFORMATION DECRYPTIONPROTOCOL”;
[0049] Attorney Docket No. END9124USNP1 / 190240 titled “SURGICAL STAPLING SYSTEM HAVING AN INFORMATION ENCRYPTIONPROTOCOL”;
[0050] Attorney Docket No. END9125USNP1 / 190241 titled “SURGICAL STAPLING SYSTEM HAVING A LOCKOUT MECHANISM FOR ANINCOMPATIBLE CARTRIDGE”;
[0051] Attorney Docket No. END9126USNP1 / 190242, entitled “SURGICAL STAPLING SYSTEM HAVING A FRANGIBLE RFID TAG”; and
[0052] · Attorney Docket No. END9127USNP1 / 190243 entitled “PACKAGING FOR A REPLACEABLE COMPONENT OF A SURGICAL STAPLING SYSTEM”.
[0053] The applicant of the present application owns the following U.S. patent applications filed on the same date as the present application and each of which is incorporated herein by reference in its entirety:
[0054] Attorney Docket No. END9119USNP1 / 190245-1M, entitled “METHOD OF USING MULTIPLE RFID CHIPS WITH A SURGICAL ASSEMBLY”;
[0055] Attorney Docket No. END9120USNP1 / 190246, entitled “MECHANISMS FOR PROPER ANVIL ATTACHMENT SURGICAL STAPLINGHEAD ASSEMBLY”;
[0056] Attorney Docket No. END9121USNP1 / 190247, entitled “MECHANISMS FOR MOTOR CONTROL ADJUSTMENTS OF A MOTORIZED SURGICAL INSTRUMENT”;
[0057] Attorney Docket No. END9122USNP1 / 190248, entitled “SURGICAL INSTRUMENT WITH BATTERY COMPATIBILITY VERIFICATION FUNCTIONALITY”;
[0058] Attorney Docket No. END9131USNP1 / 190249, entitled “SURGICAL SYSTEM WITH RFID TAGS FOR UPDATING MOTOR ASSEMBLY PARAMETERS”;
[0059] Attorney Docket No. END9132USNP1 / 190250, entitled “SURGICAL SYSTEMS WITH MULTIPLE RFID TAGS”;
[0060] Attorney Docket No. END9149USNP1 / 190251, entitled “RFID IDENTIFICATION SYSTEMS FOR SURGICAL INSTRUMENTS”;
[0061] Attorney Docket No. END9151USNP1 / 190253, entitled “SURGICAL RFID ASSEMBLIES FOR DISPLAY AND COMMUNICATION”;
[0062] Attorney Docket No. END9152USNP1 / 190254, entitled “SURGICAL RFID ASSEMBLIES FOR COMPATIBILITY DETECTION”; and
[0063] Attorney Docket No. END9153USNP1 / 190255 titled “SURGICAL RFID ASSEMBLIES FOR INSTRUMENT OPERATIONAL SETTING CONTROL”
[0064] The applicant of this application owns the following U.S. patent applications filed on May 1, 2018, each of which is incorporated herein by reference in its entirety:
[0065] U.S. Provisional Patent Application Serial No. 62 / 665,129, entitled “SURGICAL SUTURING SYSTEMS”;
[0066] U.S. Provisional Patent Application Serial No. 62 / 665,139, entitled “SURGICAL INSTRUMENTS COMPRISING CONTROL SYSTEMS”;
[0067] U.S. Provisional Patent Application Serial No. 62 / 665,177, entitled “SURGICAL INSTRUMENTS COMPRISING HANDLE ARRANGEMENTS”;
[0068] U.S. Provisional Patent Application Serial No. 62 / 665,128, entitled “MODULAR SURGICAL INSTRUMENTS”;
[0069] U.S. Provisional Patent Application Serial No. 62 / 665,192, entitled “SURGICAL DISSECTORS”; and
[0070] · U.S. Provisional Patent Application Serial No. 62 / 665,134, entitled “SURGICAL CLIP APPLIER.”
[0071] The applicant of the present application owns the following U.S. patent applications filed on August 24, 2018, each of which is incorporated herein by reference in its entirety:
[0072] U.S. Patent Application Serial No. 16 / 112,129, entitled “SURGICAL SUTURING INSTRUMENT CONFIGURED TO MANIPULATE TISSUEUSING MECHANICAL AND ELECTRICAL POWER”;
[0073] U.S. Patent Application Serial No. 16 / 112,155, entitled “SURGICAL SUTURING INSTRUMENT COMPRISING A CAPTURE WIDTH WHICH IS LARGER THAN TROCAR DIAMETER”;
[0074] U.S. Patent Application Serial No. 16 / 112,168, entitled “SURGICAL SUTURING INSTRUMENT COMPRISING A NON-CIRCULAR NEEDLE”;
[0075] U.S. Patent Application Serial No. 16 / 112,180, entitled “ELECTRICAL POWER OUTPUT CONTROL BASED ON MECHANICAL FORCES”;
[0076] U.S. Patent Application Serial No. 16 / 112,193, entitled “REACTIVE ALGORITHM FOR SURGICAL SYSTEM”;
[0077] U.S. Patent Application Serial No. 16 / 112,099, entitled “SURGICAL INSTRUMENT COMPRISING AN ADAPTIVE ELECTRICAL SYSTEM”;
[0078] U.S. Patent Application Serial No. 16 / 112,112, entitled “CONTROL SYSTEM ARRANGEMENTS FOR A MODULAR SURGICALINSTRUMENT”;
[0079] U.S. Patent Application Serial No. 16 / 112,119, entitled “ADAPTIVE CONTROL PROGRAMS FOR A SURGICAL SYSTEM COMPRISING MORE THAN ONE TYPE OF CARTRIDGE”;
[0080] U.S. Patent Application Serial No. 16 / 112,097, entitled “SURGICAL INSTRUMENT SYSTEMS COMPRISING BATTERY ARRANGEMENTS”;
[0081] U.S. Patent Application Serial No. 16 / 112,109, entitled “SURGICAL INSTRUMENT SYSTEMS COMPRISING HANDLE ARRANGEMENTS”;
[0082] U.S. Patent Application Serial No. 16 / 112,114, entitled “SURGICAL INSTRUMENT SYSTEMS COMPRISING FEEDBACK MECHANISMS”;
[0083] U.S. Patent Application Serial No. 16 / 112,117, entitled “SURGICAL INSTRUMENT SYSTEMS COMPRISING LOCKOUT MECHANISMS”;
[0084] U.S. Patent Application Serial No. 16 / 112,095, entitled “SURGICAL INSTRUMENTS COMPRISING A LOCKABLE END EFFECTORSOCKET”;
[0085] U.S. Patent Application Serial No. 16 / 112,121, entitled “SURGICAL INSTRUMENTS COMPRISING A SHIFTING MECHANISM”;
[0086] U.S. Patent Application Serial No. 16 / 112,151, entitled “SURGICAL INSTRUMENTS COMPRISING A SYSTEM FOR ARTICULATION AND ROTATION COMPENSATION”;
[0087] U.S. Patent Application Serial No. 16 / 112,154, entitled “SURGICAL INSTRUMENTS COMPRISING A BIASED SHIFTING MECHANISM”;
[0088] U.S. Patent Application Serial No. 16 / 112,226, entitled “SURGICAL INSTRUMENTS COMPRISING AN ARTICULATION DRIVE THAT PROVIDES FOR HIGH ARTICULATION ANGLES”;
[0089] U.S. Patent Application Serial No. 16 / 112,062, entitled “SURGICAL DISSECTORS AND MANUFACTURING TECHNIQUES”;
[0090] U.S. Patent Application Serial No. 16 / 112,098, entitled “SURGICAL DISSECTORS CONFIGURED TO APPLY MECHANICAL AND ELECTRICAL ENERGY”;
[0091] U.S. Patent Application Serial No. 16 / 112,237, entitled “SURGICAL CLIP APPLIER CONFIGURED TO STORE CLIPS IN A STOREDSTATE”;
[0092] U.S. Patent Application Serial No. 16 / 112,245, entitled “SURGICAL CLIP APPLIER COMPRISING AN EMPTY CLIP CARTRIDGE LOCKOUT”;
[0093] U.S. Patent Application Serial No. 16 / 112,249, entitled “SURGICAL CLIP APPLIER COMPRISING AN AUTOMATIC CLIP FEEDING SYSTEM”;
[0094] U.S. Patent Application Serial No. 16 / 112,253, entitled “SURGICAL CLIP APPLIER COMPRISING ADAPTIVE FIRING CONTROL”; and
[0095] • U.S. Patent Application Serial No. 16 / 112,257, entitled “SURGICAL CLIP APPLIER COMPRISING ADAPTIVE CONTROL INRESPONSE TO A STRAIN GAUGE CIRCUIT.”
[0096] The applicant of the present application owns the following U.S. patent applications filed on October 26, 2018, each of which is incorporated herein by reference in its entirety:
[0097] U.S. Patent Application Serial No. 16 / 172,130, entitled “CLIP APPLIER COMPRISING INTERCHANGEABLE CLIP RELOADS”;
[0098] U.S. Patent Application Serial No. 16 / 172,066, entitled “CLIP APPLIER COMPRISING A MOVABLE CLIP MAGAZINE”;
[0099] U.S. Patent Application Serial No. 16 / 172,078, entitled “CLIP APPLIER COMPRISING A ROTATABLE CLIP MAGAZINE”;
[0100] U.S. Patent Application Serial No. 16 / 172,087, entitled “CLIP APPLIER COMPRISING CLIP ADVANCING SYSTEMS”;
[0101] U.S. Patent Application Serial No. 16 / 172,094, entitled “CLIP APPLIER COMPRISING A CLIP CRIMPING SYSTEM”;
[0102] U.S. Patent Application Serial No. 16 / 172,128, entitled “CLIP APPLIER COMPRISING A RECIPROCATING CLIP ADVANCING MEMBER”;
[0103] U.S. Patent Application Serial No. 16 / 172,168, entitled “CLIP APPLIER COMPRISING A MOTOR CONTROLLER”;
[0104] U.S. Patent Application Serial No. 16 / 172,164, entitled “SURGICAL SYSTEM COMPRISING A SURGICAL TOOL AND A SURGICAL HUB”; and
[0105] • U.S. Patent Application Serial No. 16 / 172,303, entitled “METHOD FOR OPERATING A POWERED ARTICULATING MULTI-CLIP APPLIER.”
[0106] The applicant of this patent application owns the following U.S. patent applications filed on December 4, 2018, the disclosures of each of these provisional patent applications are incorporated herein by reference in their entirety:
[0107] U.S. Patent Application Serial No. 16 / 209,385, entitled “METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY”;
[0108] U.S. Patent Application Serial No. 16 / 209,395, entitled “METHOD OF HUB COMMUNICATION”;
[0109] U.S. Patent Application Serial No. 16 / 209,403, entitled “METHOD OF CLOUD BASED DATA ANALYTICS FOR USE WITH THE HUB”;
[0110] U.S. Patent Application Serial No. 16 / 209,407, entitled “METHOD OF ROBOTIC HUB COMMUNICATION, DETECTION, AND CONTROL”;
[0111] U.S. Patent Application Serial No. 16 / 209,416, entitled “METHOD OF HUB COMMUNICATION, PROCESSING, DISPLAY, AND CLOUD ANALYTICS”;
[0112] U.S. Patent Application Serial No. 16 / 209,423, entitled “METHOD OF COMPRESSING TISSUE WITHIN A STAPLING DEVICE AND SIMULTANEOUSLY DISPLAYING THE LOCATION OF THE TISSUE WITHIN THE JAWS”;
[0113] U.S. Patent Application Serial No. 16 / 209,427, entitled “METHOD OF USING REINFORCED FLEXIBLE CIRCUITS WITH MULTIPLESENSORS TO OPTIMIZE PERFORMANCE OF RADIO FREQUENCY DEVICES”;
[0114] U.S. Patent Application Serial No. 16 / 209,433, entitled “METHOD OF SENSING PARTICULATE FROM SMOKE EVACUATED FROM APATIENT, ADJUSTING THE PUMP SPEED BASED ON THE SENSED INFORMATION, AND COMMUNICATING THE FUNCTIONAL PARAMETERS OF THE SYSTEM TO THE HUB”;
[0115] U.S. Patent Application Serial No. 16 / 209,447, entitled “METHOD FOR SMOKE EVACUATION FOR SURGICAL HUB”;
[0116] U.S. Patent Application Serial No. 16 / 209,453, entitled “METHOD FOR CONTROLLING SMART ENERGY DEVICES”;
[0117] U.S. Patent Application Serial No. 16 / 209,458, entitled “METHOD FOR SMART ENERGY DEVICE INFRASTRUCTURE”;
[0118] U.S. Patent Application Serial No. 16 / 209,465, entitled “METHOD FOR ADAPTIVE CONTROL SCHEMES FOR SURGICAL NETWORK CONTROL AND INTERACTION”;
[0119] U.S. Patent Application Serial No. 16 / 209,478, entitled “METHOD FOR SITUATIONAL AWARENESS FOR SURGICAL NETWORK OR SURGICAL NETWORK CONNECTED DEVICE CAPABLE OF ADJUSTING FUNCTION BASED ON ASENSED SITUATION OR USAGE”;
[0120] U.S. Patent Application Serial No. 16 / 209,490, entitled “METHOD FOR FACILITY DATA COLLECTION AND INTERPRETATION”; and
[0121] • U.S. Patent Application Serial No. 16 / 209,491, entitled “METHOD FOR CIRCULAR STAPLER CONTROL ALGORITHM ADJUSTMENT BASED ON SITUATIONAL AWARENESS.”
[0122] Before describing in detail various aspects of the surgical devices and systems, it should be noted that the application or use of the illustrative examples is not limited to the details of the construction and arrangement of the components shown in the drawings and detailed description. The illustrative examples may be implemented alone or in combination with other aspects, variations and modifications, and may be practiced or performed in a variety of ways. In addition, unless otherwise indicated, the terms and expressions used herein are selected for the convenience of the reader to describe the illustrative examples and are not for limiting purposes. Moreover, it should be understood that one or more of the aspects, expressions of aspects and / or examples described below may be combined with any one or more of the other aspects, expressions of aspects and / or examples described below.
[0123] Various surgical systems and instruments (e.g., surgical stapling instruments, surgical clip appliers, surgical stapling instruments) are described in conjunction with the present disclosure. The surgical system and / or instrument includes a radio frequency identification (RFID) system that includes one or more RFID scanners and one or more RFID tags, as will be discussed in more detail below. Examples of surgical systems using RFID technology are disclosed in U.S. Patent 7,959,050 and U.S. Patent Application 2015 / 0053743, both of which are incorporated herein by reference in their entirety.
[0124] Radio frequency identification (RFID) is used in a variety of industries to track and identify objects. RFID relies on radio waves to transmit digitally stored information from an RFID tag to an RFID reader or a receiver configured to receive the information. RFID technology uses an RFID tag (sometimes called a chip) containing electronically stored information and an RFID reader for identifying and communicating with the RFID tag. There are two different types of RFID systems - active RFID systems and passive RFID systems. An active RFID system includes an RFID tag that includes an onboard power source to broadcast its signal. An active RFID tag may include a battery within the RFID tag that allows the active RFID tag to function independently of an RFID reader. Therefore, an RFID tag in an active RFID system does not need to wait to receive a signal from an RFID reader before sending out information. Instead, an active RFID tag is free to continuously send out signals or beacons. Many commercially available active RFID systems typically operate at one of two main frequency ranges (433 MHz and 915 MHz), but any suitable frequency range may be used. Typically, an RFID tag must be within a specific distance or frequency range in order to be recognized by its corresponding RFID reader.
[0125] Passive RFID systems include RFID tags that do not include an onboard power supply, but instead receive the energy required for operation from an RFID reader. In contrast to active RFID tags, RFID tags in passive RFID systems do not actively send out signals until they are prompted. Instead, passive RFID tags wait to receive information from an RFID reader before sending out a signal. Many commercially available passive RFID systems typically operate in three frequency ranges - low frequency ("LF"), high frequency ("HF") & near field communication ("NFC"), and ultra-high frequency ("UHF"). The LF bandwidth is 125KHz-134KHz, and includes longer wavelengths with a short read range of approximately 1 cm to ten cm. The HF and NFC bandwidths are 13.56MHz, and include medium wavelengths with a typical read range of one cm to one meter. The UHF bandwidth is 865MHz-960MHz, and includes a short, high-energy wavelength of one meter, which can be converted into a long read range. As described above, any suitable frequency can be used.
[0126] There are various RFID systems including RFID tags of different sizes. However, some are more suitable for use in the field of technology where very small objects need to be tracked. For example, Hitachi Chemical Co. Ltd. is a leading manufacturer in the field of RFID technology. The ultra-small size UHF RFID tags manufactured by Hitachi Chemical Co. Ltd. are generally no larger than 1.0 mm to 13 mm, and enable communication between the RFID tag and the RFID reader to be achieved within a distance of several centimeters or more. Due to its compact nature, the Hitachi RFID tag is suitable for very small products that need to be identified. Each Hitachi RFID tag includes an antenna, an IC chip connected to the antenna, and a sealing material that seals the IC chip and the antenna. Because the Hitachi RFID tag combines the antenna and the IC chip in a single unit, the Hitachi RFID tag is very convenient to be easily attached to any small object using, for example, an adhesive or tape.
[0127] The Hitachi RFID tag includes a square stainless steel plate and a metal antenna. The antenna includes an LC resonant circuit or any other suitable circuit and is electrically connected to the board. After the board and the antenna are connected to each other, the antenna and the board are sealed in a single unit with a sealing material. The sealing material is mainly composed of epoxy resin, carbon and silicon dioxide to enhance the heat resistance of the Hitachi RFID tag. That is, the heat resistance of the RFID tag basically depends on the heat resistance of the sealing material. The sealing material has high heat resistance and can withstand temperatures as high as 250°C to 300°C for a short period of time (such as a few seconds), and can withstand heat as high as 150°C for a longer period of time. Therefore, the Hitachi RFID tag has higher heat resistance than conventional RFID tags and can operate normally even at high temperatures. Additional information about the Hitachi RFID tag can be found in, for example, U.S. Patent 9,171,244, which is incorporated herein by reference in its entirety.
[0128] During various surgical procedures, surgical instruments that include at least one replaceable component are used. Importantly, such replaceable components are replaced with functional and / or compatible components. In addition, various identification systems described in more detail herein verify the compatibility of the component with the surgical instrument and / or verify the operating state of the component, etc. For example, the controller and / or identification system can be used to, for example, ensure that the packaging containing the replaceable component has not been damaged and / or tampered with, alert the clinician whether the component is compatible with the surgical instrument, alert the clinician whether the replaceable component is expired, and / or alert the clinician whether there is a recall on a specific manufacturing batch and / or type of the replaceable component.
[0129] Identification system as described herein can be an active system or a passive system. In various embodiments, a combination of active and passive identification systems is used. Passive systems can include, for example, bar codes, two-dimensional (QR) codes and / or radio frequency identification (RFID) tags. Passive systems do not include internal power supplies, and passive systems as described herein need readers and / or scanners to send, for example, first signals such as interrogation signals.
[0130] Passive radio frequency identification (RFID) systems transmit information by using radio frequencies. Such passive RFID systems include an RFID scanner and an RFID tag without an internal power source. The RFID tag is powered by electromagnetic energy transmitted from the RFID scanner. Each RFID tag includes, for example, a chip, such as a microchip, which stores information about replaceable components and / or surgical instruments with which the replaceable components are compatible. Although the chip may contain only an identification number, in various instances, the chip may store additional information, such as manufacturing data, shipping data, and / or maintenance history. Each RFID tag includes a radio antenna that allows the RFID tag to communicate with the RFID scanner. The radio antenna extends the range in which the RFID tag can receive signals from the RFID scanner and transmit a response signal back to the RFID scanner. In a passive RFID system, the RFID scanner (which also includes its own antenna) transmits a radio signal that activates an RFID tag located within a predetermined range. The RFID scanner is configured to receive a response signal that is "bounced back" from the RFID tag, thereby allowing the RFID scanner to capture identification information representing the replaceable component. In various instances, one or more response signals include the same signal as the interrogation signal. In various instances, one or more response signals include a modified signal from the interrogation signal. In various instances, the RFID scanner is also capable of writing or encoding information directly onto the RFID tag. In any case, the RFID scanner is capable of transmitting information about replaceable components to a controller, such as a control system for a surgical instrument and / or a remote surgical system. The RFID scanner is configured to be able to read multiple RFID tags at a time because the RFID tag is activated by a radio signal. In addition, in some instances, the RFID scanner is capable of updating or rewriting the information stored on the RFID tag with the RFID scanner within the signal range. The update can be transmitted to the RFID scanner, for example, from a surgical hub or any suitable server. Various surgical hubs are described in U.S. patent application serial number 16 / 209,395, entitled "METHOD OF HUB COMMUNICATION", filed on December 4, 2018, which is incorporated herein by reference in its entirety.
[0131] Active radio frequency identification (RFID) systems also include RFID tags and RFID scanners. However, the RFID tags in active RFID systems include internal power sources. Active RFID systems utilize battery-powered RFID tags that are configured to continuously broadcast their own signals. One type of active RFID tag is generally referred to as a "beacon." Such beacon RFID tags do not wait to receive a first signal from an RFID scanner. Instead, the beacon RFID tag continuously transmits its stored information. For example, a beacon can send its information every 3-5 seconds. Another type of active RFID tag includes a transponder. In such a system, the RFID scanner first transmits a signal. Then, the RFID transponder tag sends the signal back to the RFID scanner along with the relevant information. Such RFID transponder tag systems are effective because they extend battery life when, for example, the RFID tag is out of range of the RFID scanner. In various instances, active RFID tags include onboard sensors to track environmental parameters. For example, the onboard sensors can track moisture content, temperature, and / or other data that may be relevant.
[0132] Figure 1Various surgical instruments configured to receive various supplementary components that can be replaced during surgical procedures are shown. Such surgical instruments may benefit from including at least one of the identification systems described herein, such as an RFID system. For example, a surgical stapling instrument 6100 includes a handle 6110, an elongated shaft 6120 extending from the handle 6110, and an end effector 6130 extending from the elongated shaft 6120. The end effector 6130 includes a first jaw 6132 and a second jaw 6134, wherein the second jaw 6134 is configured to receive a replaceable nail magazine 6140 therein. During a specific surgical procedure, a clinician may wish to attach various supplementary components to the end effector 6130. Such supplementary components or auxiliary materials are used to enhance the function of nails and / or supplementary nails. For example, a support or tissue thickness compensator 6165 may be attached to the first jaw 6132 and / or the second jaw 6134 to accommodate different tissue thicknesses. For example, adding the support 6165 to the end effector 6130 can help form a uniform line of staples on the patient's tissue. To facilitate attachment of the support 6165 to the end effector 6130 and / or storage, the support 6165 can be supported on the mounting member 6160. In various examples, the clinician can attach a hemostat layer 6175 to the first jaw 6132 and / or the second jaw 6134 of the end effector 6130 to promote rapid blood clotting, etc. For example, the hemostat layer 6175 can improve the seal created by the staples. To facilitate attachment of the hemostat layer 6175 to the end effector 6130 and / or storage, the hemostat layer 6175 can be supported on the mounting member 6170. In various examples, the clinician can attach a layer of adhesive 6185 to the first jaw 6132 and / or the second jaw 6134 of the end effector 6130 to promote healing of the treated tissue and / or enhance the connection between two layers of tissue. For example, the layer of adhesive 6185 can improve the seal created by the staples.To facilitate attachment of the layer of adhesive, it can be supported on the mounting member 6180.
[0133] As described in more detail herein, a first RFID tag 6162 is positioned on the mounting member 6160. The first RFID tag 6162 includes stored information, wherein the stored information includes data identifying features of a support 6165 supported on the mounting member 6160. A second RFID tag 6172 is positioned on the mounting member 6170. The second RFID tag 6172 includes stored information, wherein the stored information includes data identifying features of a hemostat layer 6175 supported on the mounting member 6170. A third RFID tag 6182 is positioned on the mounting member 6180. The third RFID tag 6182 includes stored information, wherein the stored information includes data identifying features of a layer adhesive layer 6185 supported on the mounting member 6180. The surgical stapling instrument 6100 also includes an RFID scanner 6150. As discussed in more detail herein, the RFID scanner 6150 can be positioned at any suitable location on the surgical instrument 6100 that allows the RFID scanner 6150 to communicate with the first RFID tag 6162, the second RFID tag 6172, and / or the third RFID tag 6182 while the supplemental component is being attached and / or after the supplemental component is attached to the end actuator 6130.
[0134] The surgical clip applier 6200 includes a handle 6210, an elongated shaft 6220 extending from the handle 6210, and an end effector 6230 extending from the elongated shaft 6220. The end effector 6230 includes a first jaw 6232 and a second jaw 6234, wherein at least one of the first jaw 6232 and the second jaw 6234 is movable relative to each other during the clamp crimping stroke. During a particular surgical procedure, the clinician may wish to attach various supplementary components to the end effector 6230. For example, a clamp 6260 having a first thickness may be loaded into the surgical clip applier 6200. The clamp 6260 may be loaded into the surgical clip applier 6200 separately, and / or the clamp 6260 may be loaded into the surgical clip applier 6200 as part of a clamp cartridge. For example, when the patient's tissue is thick and / or dense, the attachment of the clamp 6260 to the surgical clip applier 6200 may be beneficial. In various examples, a clinician may attach a clamp 6290 having a second thickness to the surgical clip applier 6200. In various examples, the second thickness of the clamp 6290 is less than the first thickness of the clamp 6260. For example, when the patient tissue is thin and / or fragile, the attachment of the clamp 6290 to the surgical clip applier 6200 may be beneficial. In various examples, a clinician may attach a clamp 6270 including a plurality of protrusions 6275 to the surgical clip applier 6200. The protrusions 6275 of the clamp 6270 may be used to enhance the grip between the clamp 6270 and the patient tissue and / or maintain the position of the crimping clamp 6270 on the patient tissue, etc. As shown on the clamp 6270, the protrusions 6275 may be attached to a thin clamp. For example, when the patient tissue is thin and / or fragile, it is beneficial to utilize the protrusions 6275 on the thin clamp. In various examples, a clinician may attach a clamp 6280 including a plurality of protrusions 6285 to the surgical clip applier 6200. The protrusions 6285 of the clamp 6280 may be used to enhance the grip between the clamp 6280 and the patient tissue and / or maintain the position of the crimping clamp 6280 on the patient tissue, etc. As shown on the clamp 6280, the protrusions 6285 may be attached to a thick clamp. For example, when the patient tissue is thick and / or dense, it may be beneficial to utilize the protrusions 6285 on the thick clamp.
[0135] As described in more detail herein, a first RFID tag 6262 is positioned on the first clamp 6260. The first RFID tag 6162 includes stored information, wherein the stored information includes data identifying features of the clamp 6260. A second RFID tag 6272 is positioned on the second clamp 6270. The second RFID tag 6272 includes stored information, wherein the stored information includes data identifying features of the second clamp 6270. A third RFID tag 6282 is positioned on the third clamp 6280. The third RFID tag 6282 includes stored information, wherein the stored information includes data identifying features of the third clamp 6280. A fourth RFID tag 6292 is positioned on the fourth clamp 6290. The fourth RFID tag 6292 includes stored information, wherein the stored information includes data identifying features of the fourth clamp 6290. The surgical clip applier 6200 also includes an RFID scanner 6250. As discussed in more detail herein, the RFID scanner 6250 can be positioned at any suitable location on the surgical instrument 6200 that allows the RFID scanner 6250 to communicate with the first RFID tag 6262, the second RFID tag 6272, the third RFID tag 6282 and / or the fourth RFID tag 6292 while the supplemental component is being attached and / or after the supplemental component is attached to the suturing device 6200.
[0136] The surgical suturing device 6300 includes a handle 6310, an elongated shaft 6320 extending from the handle 6310, and an end effector 6330 extending from the elongated shaft 6320. The end effector 6330 includes a needle track configured to receive a portion of a replaceable needle. During a specific surgical procedure, the clinician may wish to attach various supplementary components to the end effector 6330. Different knotting mechanisms and / or different suture termination elements can be used to complete the suture line instead of tying knots under laparoscopy. For example, a needle 6360 having a first thickness can be loaded into the end effector 6330. The needle 6360 includes a first end 6364 and a second end 6366. The first end 6364 includes a tip having a first sharpness. The second end 6366 includes a suture material 6365 attached thereto. For example, when the patient's tissue is thicker and / or dense, the attachment of the shaft needle 6360 to the end effector 6330 can be beneficial. In various examples, a clinician may attach a needle 6370 having a second thickness to the end effector 6330. In various examples, the second thickness of the clamp 6370 is less than the first thickness of the clamp 6360. The clamp 6370 also includes a first end 6374, which includes a tip having a second sharpness. In various examples, the second sharpness of the clamp 6370 is less than the first sharpness of the clamp 6360. The second end 6376 includes a suture material 6375 attached thereto. For example, when the patient's tissue is thick and / or dense, the attachment of the needle 6370 to the end effector 6330 may be beneficial. In various examples, a clinician may select a specific suture material to be attached to the replaceable needle. For example, the first suture material 6385 may be made of a first material, have a first length and / or have a first thickness. The first suture material 6385 may be stored in the first package 6380 before being attached to the replaceable needle. The second suture material 6395 may be made of a second material, have a second length and / or have a second thickness. The second suture material 6395 may be stored in the second package 6390 prior to being attached to the replaceable needle.
[0137] As described in more detail herein, a first RFID tag 6362 is positioned on a first replaceable needle 6360. The first RFID tag 6362 includes stored information, wherein the stored information includes data identifying characteristics of the replaceable needle 6360 and / or the suture material 6365 attached thereto. A second RFID tag 6372 is positioned on a second replaceable needle 6370. The second RFID tag 6372 includes stored information, wherein the stored information includes data identifying characteristics of the second replaceable needle 6370 and / or the suture material 6375 attached thereto. A third RFID tag 6382 is positioned on a package 6380 of a third suture material 6385. The third RFID tag 6382 includes stored information, wherein the stored information includes data identifying characteristics of the third suture material 6385. A fourth RFID tag 6392 is positioned on a package 6390 of a fourth suture material 6395. The fourth RFID tag 6392 includes stored information, wherein the stored information includes data identifying characteristics of the fourth suture material 6390. The surgical stapling device 6300 also includes an RFID scanner 6350. As discussed in more detail herein, the RFID scanner 6350 can be positioned at any suitable location on the surgical instrument 6300 that allows the RFID scanner 6350 to communicate with the first RFID tag 6362 and / or the second RFID tag 6372 while one of the replaceable needles 6360, 6370 is being positioned and / or after the replaceable needle is positioned within the needle track of the end actuator 6330 and / or with the third RFID tag 6382 and / or the fourth RFID tag 6392 when the packages 6380, 6390 are brought within a predetermined distance from the RFID scanner 6300.
[0138] Supplementary components, such as support 6165, hemostats 6175, and / or adhesives 6185, are contained within a sealed package after manufacture until the package is opened in the operating room. In various examples, the supplementary components are supported on mounting members within the package, for example, to facilitate storage and / or facilitate attachment of the supplementary components to surgical instruments. Various forms of packaging include, for example, peel-away bags, woven and / or nonwoven material wrappers, and rigid containers.
[0139] Figure 2An example of a sealed package 7000 is shown. The package 7000 shown is a peel bag. The package 7000 includes a first layer 7010 and a second layer 7020. The first layer 7010 and the second layer 7020 form a protective barrier around a hemostat layer 7175 that is configured to be attached to a surgical staple cartridge. Before the hemostat layer 7175 is attached to a surgical instrument, the hemostat layer 7175 is supported on a mounting member 7170. The mounting member 7170 includes a retaining member 7171 that is configured to receive a portion of the hemostat layer 7175 and, for example, facilitate alignment of the hemostat layer 7175. The adhesive bonds the first layer 7010 and the second layer 7020 together to form an airtight and / or fluid-tight seal and / or bag around the hemostat layer 7175. The adhesive forms a seal without creases, wrinkles, and / or gaps. For example, the seal created by the adhesive prevents contaminants from contacting the hemostat layer 7175 and / or prevents dislocation of components of the hemostat layer 7175. In various examples, the hemostat 7175 is hermetically sealed within the package 7000. In various examples, the package 7000 provides a completely fluid-tight and airtight seal.
[0140] The first layer 7010 and the second layer 7020 are made of materials such as paper with a laminated inner surface. The laminated inner surface provides a barrier to prevent contaminants from entering the sealed portion of the package 7000. In various examples, the first layer 7010 and the second layer 7020 are made of plastic. The first layer 7010 and the second layer 7020 can be made of a material with a specific transparency to allow the clinician to observe the contents of the package 7000, for example, before breaking the seal. As described above, any suitable material and / or combination of materials can be used for the first layer 7010 and / or the second layer 7020. The first layer 7010 includes a first portion positioned outside the seal, and the second layer 7020 includes a second portion positioned outside the seal. The clinician can expose the hemostatic agent 7175 of the layer seal by keeping the first portion and the second portion in a separate hand and pulling the first portion in a direction away from the second layer 7020, but any suitable opening method can be used.
[0141] Figure 2RFID system 7500 is shown as being integrated with packaging 7000. RFID system 7500 includes RFID tag 7172 and insulator 7050. RFID tag 7172 includes, for example, a chip, such as a microchip, which stores information about packaging 7000 and / or the contents of packaging 7000. In various examples, the chip includes an identification number. Such identification numbers can be assigned to the chip, so that the presence of the chip can be communicated to the RFID scanner. In various examples, the chip includes additional information, such as manufacturing data, shipping data and / or compatibility data. RFID tag 7172 also includes a radio antenna 7173, which is configured to facilitate communication between RFID tag 7172 and the RFID scanner.
[0142] The insulator 7050 is attached to the first layer 7010 of the package 7000, and the RFID tag 7172 is attached to the mounting member 7170 supporting the hemostatic agent layer 7175. When the package 7000 is in a sealed configuration, the insulator 7050 is attached to the integrated battery 7176 of the RFID tag 7172 or is otherwise connected to the integrated battery. When the package 7000 is opened, the integrated battery 7176 is activated. Before the package 7000 is opened, the interface between the insulator 7050 and the integrated battery 7176 prevents the integrated battery 7176 from providing power to the RFID tag 7172. In such an example, the RFID tag 7172 cannot transmit a signal. When the clinician destroys the seal of the package 7000 by peeling the first layer 7010 from the second layer 7020, the insulator 7050 is disconnected from the integrated battery 7176 of the RFID tag 7172 or is otherwise separated from it. When the insulator 7050 is separated from the integrated battery 7176, the circuit between the integrated battery 7176 and the RFID tag 7172 is closed, and the RFID tag 7172 is powered. Figure 2 As shown, the RFID tag 7172 begins to transmit a signal 7174 when powered on. The RFID tag 7172 is configured to transmit the signal 7174 at any suitable frequency and / or any suitable duration. For example, the RFID tag 7172 may continuously transmit the signal 7174, or the RFID tag 7172 may transmit the signal 7174 every 3 seconds to 5 seconds. The signal 7174 includes some or all of the information stored on the chip of the RFID tag 7172. In various examples, for example, the signal 7174 can be used to warn that the surgical instrument package 7000 has been tampered with during transportation and / or storage, or simply that the package 7000 has been opened.
[0143] Figure 4A block diagram of an RFID system and / or control system 7400 for a surgical stapling instrument and / or tool 7100 is shown; however, the control system 7400 may be adapted for use with alternative surgical instruments and / or tools (such as surgical clip appliers 7200 and / or surgical stapling devices 7300) described in greater detail herein. The control system 7400 includes a control circuit 1210 that may be integrated with an RFID scanner (such as an RFID scanner 7408a), or may be coupled to the RFID scanner 7408a but located separately therefrom. The control circuit 1210 may be configured to receive an input from the RFID scanner 7408a indicating information stored in an RFID tag 7406a about a supplemental component 7175 and / or information about a package 7000 of the supplemental component 7175. In various examples, the RFID system 7400 includes more than one RFID scanner 7408b-7408h and / or more than one RFID tag 7406b-7406h. The RFID scanners 7408b-7408h may be communicatively coupled such that the control circuit 1210 may receive data from the RFID scanners 7408b-7408h and then take various actions based on the read data, as described below.
[0144] In at least one example, the control circuit 1210 includes a microcontroller 1213 having a processor 1214 and a storage medium, such as a memory 1212. The memory 1212 stores program instructions for performing various processes, such as identity authentication. For example, when executed by the processor 1214, the program instructions cause the processor 1214 to verify the identity of the package 7000 and / or the supplementary component 7175 by comparing the identification information received from the RFID tags 7406a-7406h with the identification information stored in the memory 1212 in the form of, for example, an identity database or lookup table. In various examples, the memory 1212 includes a local memory of the device 7100. In other examples, the identity database or table and / or the compatibility database or table can be downloaded from a remote server. In various aspects, the device 7100 can transmit the information received from the RFID tags 7406a-7406h to a remote server that stores a database or table for remotely performing identity and / or compatibility checks.
[0145] RFID tag 7172 is configured to be able to communicate with an RFID scanner. Once insulator 7050 has been removed, the integrated battery 7176 of RFID tag 7172 allows RFID tag 7172 to transmit signal 7174 before receiving a first signal (such as an inquiry signal) from the RFID scanner. The RFID scanner includes a scanner antenna, which is configured to be able to transmit and / or receive radio signals 7174 from RFID tag 7172. In various instances, the RFID scanner has read and write capabilities. The RFID scanner is configured to be able to pass the collected information from RFID tag 7172 to the controller of the surgical instrument for further interpretation. In various instances, the controller is configured to be able to determine whether the supplementary component is compatible with a specific surgical instrument. In various instances, the controller is configured to be able to activate the locking assembly 7179 to prevent the surgical instrument from performing functions (such as nail firing strokes, suture firing strokes and / or clamp crimping strokes) together with the firing drive assembly 1163 when the controller determines that the supplementary component is not compatible with a specific surgical instrument and / or cannot be used compatibly during a specific surgical procedure. The various locking assemblies are described in more detail in the following patents: U.S. Patent 7,143,923, published on December 5, 2006, entitled "SURGICAL STAPLING INSTRUMENT HAVING A FIRING LOCKOUT FOR AN UNCLOSED ANVIL"; U.S. Patent 7,044,352, published on May 16, 2006, entitled "SURGICAL STAPLING INSTRUMENT HAVING A SINGLE LOCKOUT MECHANISM FOR PREVENTION OF FIRING"; U.S. Patent 7,000,818, published on February 21, 2006, entitled "SURGICAL STAPLING INSTRUMENT HAVING SEPARATE DISTINCTCLOSING AND FIRING SYSTEMS"; U.S. Patent 7,000,818, published on January 24, 2006, entitled "SURGICAL STAPLING INSTRUMENT HAVING A SPENT CARTRIDGE and U.S. Patent 6,978,921, entitled “SURGICAL STAPLING INSTRUMENT INCORPORATING AN E-BEAM FIRING MECHANISM”, published on December 27, 2005, the disclosures of which are incorporated herein by reference in their entirety.The RFID scanner is positioned within a predetermined range of the RFID tag 7172, which allows the RFID scanner to receive the transmission signal 7174 transmitted by the RFID tag 7172. Depending on the application, the RFID scanner can be positioned on the surgical instrument, on the contents of the package, and / or remotely located on a console (such as a remote surgical system that communicates with the surgical instrument). In addition, the controller can be located in any suitable location, such as on the surgical instrument or a remote console.
[0146] In various examples, the tag antenna of the RFID tag 7172 is damaged and / or otherwise becomes inoperable when and / or after opening the package 7000. When the tag antenna is inoperable, the RFID tag 7172 cannot transmit and / or receive communications and / or signals from the RFID scanner. In such examples, the RFID scanner is configured to receive a first signal from the RFID tag 7172 before opening the package. Once the RFID scanner receives the first signal, the controller of the surgical instrument is configured to authenticate the package 7000 and the contents of the package 7000. If the RFID scanner does not receive the first signal from the RFID tag 7172, the controller is configured to prevent the surgical instrument from performing functions with the firing drive assembly 1163. The RFID scanner fails to receive the first signal indicating that the package has been tampered with and / or the package is unreliable, etc. In various examples, the tag antenna is still operable after opening the package 7000; however, the communication range of the tag antenna is reduced. In such instances, the reduced communication range prevents the RFID tag 7172 from receiving communications from and / or transmitting communications to the RFID scanner.
[0147] In various examples, the switch is positioned between the RFID tag 7172 and the power source. When the package 7000 is in a sealed configuration and the power source cannot supply power to the RFID tag 7172, the insulator 7050 biases the switch open. In such cases, the RFID tag 7172 cannot communicate with an RFID scanner. When the package 7000 is in an unsealed configuration, the insulator 7050 separates from the RFID tag 7172 and the switch is closed. In such cases, the power source can supply power to the RFID tag 7172, and the RFID tag 7172 can communicate with an RFID scanner.
[0148] In various examples, an RFID system including an RFID tag mounted to the second layer 7020 of the package 7000 may be used. Further describing the above, the RFID tag includes an internal power source positioned on the second layer 7020 of the package 7000. An insulator similar to the insulator 7050 is attached to the package 7000, and when the package 7000 is opened, the RFID tag on the second layer 7020 is activated. The insulator is attached to the first layer 7010 of the package 7000 or is otherwise associated therewith. When the package 7000 is in a sealed configuration, the insulator 7050 is attached to the RFID tag on the second layer 7020 of the package 7000 or is otherwise connected thereto, and the circuit between the integrated power source and the RFID tag is kept open. The interface between the insulator 7050 and the RFID tag prevents the power source from activating the RFID tag, and the RFID tag cannot transmit a signal. When the clinician breaks the seal of the package 7000 by peeling off the first layer 7010, for example, the insulator 7050 is disconnected from the RFID tag or otherwise separated therefrom, and the circuit between the power source and the RFID tag is closed. At this point, the RFID tag is powered on and begins to transmit a signal.
[0149] In various examples, the RFID system 7500 also includes a repeater. The repeater receives a first communication from the RFID scanner. In various examples, the first communication from the RFID scanner powers up the repeater to a degree sufficient to enable the repeater to communicate with the RFID tag. In various examples, the repeater powers up before receiving the first communication from the RFID scanner. In any case, the repeater is configured to automatically transmit a signal to the RFID tag upon hearing or otherwise receiving the first communication from the RFID scanner. The power supply of the RFID tag powers up the RFID tag upon receiving the signal from the repeater, and the RFID tag is able to respond to the communication transmitted by the RFID scanner. In addition, the repeater is used to maintain the battery life of the RFID tag until, for example, the RFID tag is within the range of the RFID scanner.
[0150] As described in more detail herein, it is valuable for a clinician to be able to verify the compatibility of a supplemental component used with a particular surgical instrument and / or during a particular surgical procedure. For various reasons, it may also be of interest for a clinician to be able to ensure that a supplemental component has not been previously used and / or tampered with. A clinician may also wish to confirm, for example, that a supplemental component is not contaminated, that a supplemental component is intact, and / or that a supplemental component comprises an acceptable composition and / or size.
[0151] Figure 3A portion of a surgical stapling instrument 7100 is shown. As discussed in more detail elsewhere herein, the surgical stapling instrument 7100 includes an end effector 7130 extending from an elongated shaft 7120 of the surgical stapling instrument 7100. The end effector 7130 includes a first jaw 7132, wherein the first jaw 7132 is an anvil. The first jaw 7132 includes a plurality of staple forming recesses. The end effector 7130 also includes a second jaw 7134, which includes a channel configured to receive a replaceable staple cartridge 7140. The replaceable staple cartridge 7140 includes a cartridge body and a plurality of staples removably stored in the cartridge body. During the staple firing stroke 1163, the plurality of staples are driven out of the cartridge body. In order to, for example, promote rapid blood clotting of affected patient tissue during the staple firing and tissue cutting stroke 1163, the clinician may attach a hemostatic layer 7175 to the end effector 7130 before performing the staple firing stroke 1163. In various examples, the hemostatic layer 7175 is attached to the platen surface of the cartridge body. In various examples, the hemostatic layer 7175 is attached to the tissue support surface of the anvil. In any case, the hemostatic layer 7175 contacts the patient's tissue during and / or after the staple firing stroke 1163.
[0152] As described above, the hemostat layer 7175 is sealed within the package prior to attachment to the surgical instrument. Within the package, the hemostat layer 7175 is part of a mounting assembly that is configured to facilitate storage and attachment of the hemostat layer 7175. The mounting assembly includes a mounting member 7170. In various examples, the mounting member 7170 provides a physical barrier between the packaging layer and the hemostat layer 7175 and prevents the packaging layer from contacting the hemostat layer 7175. For example, the mounting member 7170 prevents the hemostat layer 7175 from bonding and / or otherwise adhering to one or both of the packaging layers. The hemostat layer 7175 is positioned within the mounting member 7170 between openings defined by the side walls 7177, 7188 of the mounting member 7170. The mounting member 7170 includes a retaining member 7171 that receives a portion of the hemostat layer 7175. The retaining member 7171 maintains the alignment of the hemostat layer 7175 and secures the hemostat layer 7175 to the mounting member 7170. The mounting member 7170 also provides a surface for the clinician to hold while aligning the hemostat layer 7175 for attachment to the end effector 7130 of the surgical instrument. The surface provided by the mounting member 7170 allows the clinician to attach the hemostat layer 7175 to the end effector 7130 without having to touch or otherwise contact the hemostat layer 7175.
[0153] The mounting member 7170 also includes an RFID tag 7172. The RFID tag 7172 includes, for example, a chip, such as a microchip, that stores information about the mounting member 7170 and / or the hemostat layer 7175. In various examples, a set of stored information stored on the RFID chip includes data identifying the type of supplemental component supported by the mounting member 7170. In the illustrated embodiment, the mounting member 7170 supports the hemostat layer 7175. However, the mounting member 7170 may support any suitable form of supplemental component, such as a tissue thickness compensator and / or an adhesive. Figure 3 As shown, the RFID tag 7172 is mounted to the side wall 7178 of the mounting member 7170. However, the RFID tag 7172 can be embedded within the mounting member 7170 and / or attached to the mounting member by any suitable method. In various examples, the RFID tag 7172 can be positioned on the hemostat layer 7175.
[0154] The RFID tag 7172 in the mounting member 7170 provides a locking device 7179 for the surgical instrument. For example, if the information stored on the RFID tag 7172 is not received by the controller of the surgical instrument, the surgical instrument will not perform functions (such as nail firing strokes and / or jaw closing strokes) with the firing drive assembly 1163. In various examples, when the RFID tag 7172 is still communicating with the RFID scanner 7150 after the hemostat layer 7175 has been attached to the end effector 7130, the surgical instrument will not perform functions with the firing drive assembly 1163. Such a locking device 7179 prevents the surgical instrument from performing functions with the firing drive assembly 1163 when the mounting member 7170 is still attached to the hemostat layer 7175 and / or the hemostat layer 7175 has been improperly attached to the end effector 7130.
[0155] As mentioned in more detail herein, the surgical stapling instrument 7100 includes an RFID scanner 7150 configured to be able to communicate with a nearby RFID tag. The RFID scanner 7150 includes a scanner antenna configured to be able to transmit a radio signal. The radio signal activates the RFID tag positioned within a predetermined range of the RFID scanner 7150. Then, the RFID scanner 7150 receives one or more response signals "bounced back" from the RFID tag. In various instances, one or more response signals include the same signal as the interrogation signal. In various instances, one or more response signals include a modified signal from the interrogation signal. In various instances, the RFID scanner 7150 has read and write capabilities. Then, the RFID scanner 7150 is able to pass the collected information from the RFID tag to the controller for further interpretation. The controller may be positioned in the surgical instrument, on the remote console, or in any suitable location. The RFID scanner 7150 and / or the controller may include a stored set of information corresponding to a surgical stapling assembly that is compatible with a specific surgical instrument and / or can be compatible for use during a specific surgical procedure.
[0156] More specifically, the surgical system includes an RFID scanner 7150 that is configured to interact with an RFID tag 7172 attached to a mounting member 7170. The RFID scanner 7150 may be present in various locations. For example, the RFID scanner 7150 may be held by a staple cartridge 7140. In various instances, the RFID scanner is powered by a battery and / or power source of the surgical instrument. In the illustrated embodiment, the RFID scanner 7150 is positioned on the second jaw 7134 of the end effector 7130; however, the RFID scanner 7150 may be located at an alternative location within the surgical system and / or any other suitable location that will allow communication between the RFID tag 7172 and the RFID scanner 7150 when the mounting member 7170 is within a predetermined range of the end effector 7130. The RFID scanner 7150 and / or the RFID tag 7172 are powered so that the signals emitted by them can only be detected within a limited radius. That is, when the mounting member 7170 is removed from the hemostat layer 7175 after the hemostat layer 7175 is attached to the end actuator 7130, the RFID tag 7172 is unable to communicate with the RFID scanner 7150.
[0157] In various examples, the end effector 7130 includes an RFID scanner positioned on the distal end of the end effector 7130. The RFID tag is held by the rear wall 7177 of the mounting member 7170. During the correct attachment of the supplemental component 7175 to the end effector 7130, the distal end of the end effector 7130 is close to, aligned with, and / or in contact with the rear wall 7177 of the mounting member 7170. In various examples, when the end effector 7130 is close to and / or in contact with the rear wall 7177, the distance spanned by the communication range of the RFID scanner only covers the RFID tag of the rear wall 7177 of the mounting member 7170. Such a communication range allows the RFID tag to communicate with the RFID scanner only when the supplemental component 7175 is fully aligned with the end effector 7130. The communication between the RFID tag and the RFID scanner can alert the clinician that the supplemental component 7175 is fully aligned with the end effector 7130 and can perform functions with the firing drive assembly 1163 of the surgical instrument. For example, if the RFID scanner does not receive communication from the RFID tag, the supplemental component 7175 may be misaligned and / or not fully attached to the end effector 7130, which may result in, for example, the formation of an uneven nail line. In various instances, for example, a controller of a surgical instrument prevents the surgical instrument from performing a function (such as a nail firing stroke) with the firing drive assembly 1163. In various instances, if the RFID scanner continues to receive communication from the RFID tag when the clinician believes that the supplemental component 7175 is attached to the end effector, the controller is configured to prevent the function of the firing drive assembly 1163 with the surgical instrument. Continued communication indicates that the mounting member 7170 is still attached to the supplemental component 7175. In such cases, the loss of communication indicates that the mounting member 7170 has been removed and / or moved out of the communication distance with the end effector 7130 and / or the supplemental component 7175.
[0158] If the mounting member 7170 does not include an RFID tag and / or the RFID tag 7172 includes information that is not compatible with the surgical instrument, the supplementary component verification system of the surgical instrument will not allow the surgical instrument to perform a function (such as a nail firing stroke or a jaw closing stroke) with the firing drive assembly 1163. If the RFID scanner 7150 receives a response to an interrogation signal that is not found in a set of stored compatible supplementary components, the controller of the surgical instrument is programmed to communicate the error to the clinician. Similarly, if the RFID scanner 7150 does not receive a response to the interrogation signal, the controller of the surgical instrument is programmed to be able to communicate the error to the clinician. In various instances, the detection of an error by the controller may make the surgical instrument inoperable for use with a specific supplementary component. In various instances, the detected error may prevent the surgical instrument from performing a nail firing stroke, a jaw closing stroke, and / or a tissue cutting stroke. In various instances, the surgical instrument also includes a manual override that can be activated to allow the clinician to override any system locking device 7179 and utilize the operating function of the surgical instrument in an emergency. As described above, the controller is configured to be able to alert the clinician that an error has been detected through the indicator 1209. Such alerts can be transmitted through various forms of feedback (including, for example, tactile, acoustic and / or visual feedback). In at least one instance, the feedback includes audio feedback, and the surgical instrument may include, for example, a speaker that emits a sound such as a buzzer when an error is detected. In some instances, the feedback includes visual feedback, and the surgical instrument may include, for example, a light emitting diode (LED) that flashes when an error is detected. In various instances, the feedback includes tactile feedback, and the surgical instrument may include an electric motor 1160 that includes an eccentric element that vibrates when an error is detected. The alert can be specific or general. For example, the alert may specifically state that the RFID tag 7172 on the mounting member 7170 cannot be detected, or the alert may specifically state that the RFID tag 7172 includes information indicating that the supplementary component 7175 is incompatible and / or defective.
[0159] In various examples, the controller can be configured to select and / or modify various operating parameters based on identifying the hemostat layer 7175 using the information stored on the RFID tag 7172. Such identification can include the material that constitutes the hemostat layer 7175 and / or the thickness of the hemostat layer 7175, etc. After identifying the hemostat layer 7175, the controller can be configured to use modified operating parameters to allow the surgical instrument to perform the desired function with the firing drive assembly 1163.
[0160] For example, Figure 5An exemplary process 6400 of the control circuit 1210 is shown. As described above, the control circuit 1210 is configured to receive 6410 information stored on an RFID tag 7172 corresponding to a supplemental component, such as a hemostat layer 7175. Using the received information, the control circuit 1210 is configured to identify 6420 a characteristic of the supplemental component 7175 using the received information. The control circuit 1210 is configured to select 6430 one or more appropriate operating parameters corresponding to the identified characteristic of the supplemental component 7175. The control circuit 1210 is configured to direct 6440 a firing assembly to perform a function, such as a staple firing stroke, using the selected operating parameters.
[0161] In various examples, and as described above, the RFID tag 7172 can include an integrated power source and be activated when the package 7000 is opened. In such examples, the RFID tag 7172 can continuously transmit the stored set of information, and the RFID tag 7172 does not need to wait for an interrogation signal from the RFID scanner 7300 to transmit the stored set of information.
[0162] Figure 6 A portion of a surgical clip applier 7200 is shown. As discussed in more detail herein, the surgical clip applier 7200 includes an end effector 7230. The end effector 7230 includes a first jaw 7232 and a second jaw 7234. At least one of the first jaw and the second jaw can move toward each other during the crimping stroke. The surgical clip applier 7200 also includes at least one clamp. In various examples, the surgical clip applier 7200 is configured to receive a bin including a plurality of clamps. In other examples, the surgical clip applier 7200 is configured to receive one clamp at a time. Each clamp is configured to be able to crimp around the patient tissue T one at a time during the crimping stroke.
[0163] The surgical clip applier 7200 is configured to receive a clip cartridge including a first clip 7260 and a second clip 7260'. The first clip 7260 includes a first RFID tag 7262. The first RFID tag 7262 includes, for example, a chip, such as a microchip, which stores information about the surgical clip applier 7200, the first clip 7260, and / or the cartridge attached to the surgical clip applier 7200. In various examples, a set of stored information stored on the RFID chip includes data identifying the type of clip 7260 and / or clip cartridge attached to the surgical instrument 7200. Figure 6As shown, the first RFID tag 7262 is mounted to the outer surface of the first clamp 7260. The first RFID tag 7262 is positioned on the outer surface of the first clamp 7260 so that when the first clamp 7260 is crimped, the first RFID tag 7262 does not contact the patient tissue T. For example, such placement can minimize damage and / or trauma to the patient tissue T. The first RFID tag 7262 is positioned on a portion of the first clamp 7260 that is not bent during the crimping stroke. For example, such placement avoids damaging the first RFID tag 7262 during the crimping stroke. That is, the first RFID tag 7262 can be embedded in the first clamp 7260 and / or attached to the first clamp by any suitable method and / or at any suitable location.
[0164] The first RFID tag 7262 on the first clamp 7260 provides, for example, a locking device for a surgical instrument, such as the locking device 7179. For example, if the information stored on the RFID tag 7262 is not received by the controller of the surgical instrument, the clip applier will not perform a function (such as a crimping stroke on the first clamp 7260) with the firing drive assembly 1163. In various examples, when the first RFID tag 7262 is still communicating with the RFID scanner 7250 after the crimping stroke has been performed on the first clamp 7260, the surgical instrument will not perform a function with the firing drive assembly 1163. As described in more detail herein, continued communication between the first RFID tag 7262 and the RFID scanner 7250 after the crimping stroke has been performed on the first clamp 7260 indicates, among other things, that the clip applier is positioned too close to the formed first clamp 7260. In various examples, the clip applier can alert the clinician of the detected position of the clip applier relative to the formed first clamp 7260 to prevent, for example, the clip applier from applying the clamps too close together.
[0165] For example, Figure 7 A process 6700 of the control circuit 1210 is shown. The control circuit 1210 is configured to detect 6710 the presence of a first clamp after performing a crimping stroke on the first clamp. If the controller receives 6720 a communication and / or signal from a first RFID tag supported by the first clamp via an RFID scanner, the controller is configured to prevent 6730 the surgical instrument 7200 from performing a crimping stroke on a second clamp. If the controller fails to receive 6740 a communication and / or signal from a first RFID tag supported by the first clamp via an RFID scanner, the controller is configured to allow 6750 the surgical instrument 7200 to perform a crimping stroke on the second clamp.
[0166] Figure 8An additional process 6600 of the control circuit 1210 is shown. The control circuit 1210 is configured to detect the presence of a first RFID tag supported by the first clamp 6610. If the control circuit 1210 fails to receive a communication from the first RFID tag 6620 via the RFID scanner, the controller is configured to prevent the surgical instrument 7200 from performing a function 6630, such as a crimping stroke, on the first clamp. The control circuit 1210 continues to detect the presence of the first RFID tag 6610 until the controller receives a communication from the first RFID tag 6640. Upon receiving a communication from the first RFID tag 6640 via the RFID scanner, the control circuit 1210 is configured to allow the surgical instrument 7200 to perform a crimping stroke on the first clamp. After performing a crimping stroke on the first clamp, if the controller continues to receive communications from the first RFID tag 6660, the controller is configured to prevent the surgical instrument 7200 from performing a crimping stroke on the second clamp 6670. After performing a crimping stroke on the first clamp, if the controller no longer receives communications from the first RFID tag 6680, the controller is configured to allow the surgical instrument 7200 to perform a crimping stroke on the second clamp 6690.
[0167] As mentioned in more detail herein, the surgical clip applier 7200 includes an RFID scanner 7250 configured to communicate with a nearby RFID tag. The RFID scanner 7250 includes a scanner antenna configured to transmit a radio signal. The radio signal activates an RFID tag located within a predetermined range of the RFID scanner 7250. The RFID scanner 7250 then receives one or more response signals that "bounce back" from the RFID tag. In various instances, the one or more response signals include the same signal as the interrogation signal. In various instances, the one or more response signals include a modified signal from the interrogation signal. In various instances, the RFID scanner 7250 has read and write capabilities. The RFID scanner 7250 then can pass the collected information from the RFID tag to the controller for further interpretation. The controller may be located in the surgical instrument 7200, on a remote console, or in any suitable location. The RFID scanner 7250 and / or the controller may include a stored set of compatibility information corresponding to a clamp cartridge and / or clamp that is compatible with a particular surgical instrument and / or can be used compatibly during a particular surgical procedure.
[0168] More specifically, the surgical system 7200 includes an RFID scanner 7250 that is configured to interact with an RFID tag 7262 attached to a first clamp 7262. The RFID scanner 7250 may be present in various locations. In the illustrated embodiment, the RFID scanner 7250 is positioned on the second jaw 7234 of the end effector 7230; however, the RFID scanner 7250 may be located at an alternative location within the surgical system 7200 and / or any other suitable location that will allow communication between the first RFID tag 7262 and the RFID scanner 7250. The RFID scanner 7250 and / or the first RFID tag 7262 are powered so that the signals emitted by them can only be detected within a communication range 7252 defined by a limited radius. That is, when the surgical clip applier 7200 moves away from the patient tissue T when the first clamp 7260 is applied, the first RFID tag 7262 cannot communicate with the RFID scanner 7250. In such a case, the RFID tag 7262 moves outside the communication range 7252 of the RFID scanner 7250. When the RFID tag 7262 is positioned outside the communication range 7252, the RFID tag 7262 cannot transmit and / or receive signals from the RFID scanner 7250.
[0169] If the first fixture 7260 does not include an RFID tag and / or the first RFID tag 7262 includes information that is not compatible with the surgical instrument 7200, the supplementary component verification system of the surgical instrument 7200 will not be able to allow the surgical instrument to perform functions (such as crimping strokes) with the firing drive assembly 1163. If the RFID scanner 7250 receives a response to an interrogation signal that is not found in a set of stored compatible supplementary components, the controller of the surgical instrument is programmed to communicate the error to the clinician. Similarly, if the RFID scanner 7250 does not receive a response to the interrogation signal, the controller of the surgical instrument is programmed to be able to communicate the error to the clinician. In various instances, the detection of an error by the controller may render the surgical instrument inoperable for use with a particular fixture bin and / or fixture 7260. In various instances, the detected error may prevent the surgical instrument from performing a fixture application and / or crimping stroke. In various instances, the surgical instrument also includes a manual override that can be activated to allow the clinician to override any system lockout device 7179 and utilize the operating functions of the surgical instrument in an emergency. As described above, the controller is configured to be able to alert the clinician that an error has been detected via the indicator 1209. Such alerts may be transmitted via various forms of feedback, including, for example, tactile, acoustic, and / or visual feedback. Alerts may be specific or general. For example, the alert may specify that the first RFID tag 7262 on the first fixture 7260 cannot be detected, or the alert may specify that the first RFID tag 7262 includes information indicating that the fixture compartment and / or fixture 7260 is incompatible and / or defective.
[0170] For example, Fig. 9A process 6500 is shown in which the control circuit 1210 determines the reliability and / or compatibility of the clamp and / or clamp cartridge attached to the surgical instrument 7200. In an instance where each clamp includes an RFID tag, the control circuit 1210 is configured to be able to detect the presence of a first RFID tag supported by the first clamp 6510 through an RFID scanner. If the RFID scanner fails to receive a communication from the first RFID tag, the RFID scanner cannot pass the communication to the control circuit 1210. In such an instance, the control circuit 1210 fails to receive the information stored on the first RFID tag 6520, and the control circuit 1210 prevents the surgical instrument 7200 from performing a crimping stroke on the first clamp 6530. The reason why the RFID scanner fails to detect the first RFID tag may be various circumstances, such as an unreliable clamp, a defective clamp, and / or an improperly aligned clamp, etc. If the RFID scanner receives a communication from the first RFID tag, the RFID scanner is configured to be able to transmit the received information to the control circuit 1210. The control circuit 1210 determines whether the first clamp is compatible 6550 for use with the surgical instrument 7200 and / or is compatible for use during a surgical procedure. If the control circuit 1210 determines that the first clamp is compatible for use, the control circuit 1210 allows the surgical instrument 7200 to perform a function 6560, such as a crimping stroke, on the first clamp. If the control circuit 1210 determines that the first clamp is compatible for use, the control circuit 1210 prevents the surgical instrument 7200 from performing a function 6570.
[0171] In various examples, the controller can modify various operating parameters based on identifying the clamp cartridge and / or the clamp 7260 using the information stored on the RFID tag 7262. Such identification can include the material constituting the first clamp 7260, the number of clamps 7260 remaining in the clamp cartridge, the size of the clamp 7260, and / or the thickness of the first clamp 7260, etc. After identifying the first clamp 7260, the controller is configured to allow the surgical instrument to perform the desired function with the firing drive assembly 1163 using the modified operating parameters.
[0172] As described above, the RFID scanner 7250 includes a communication range 7252 that spans a distance D from the RFID scanner 7250. When the first RFID tag 7262 on the first fixture 7260 is less than the distance D from the RFID scanner 7250, the RFID scanner 7250 can transmit a signal to the first RFID tag 7262 and receive a signal 7265 from the first RFID tag. As described above, Figure 6The surgical clip applier 7200 shown also includes a second clamp 7260', which includes a second RFID tag 7260'. The second RFID tag 7260' includes an RFID chip and a tag antenna, and the second RFID tag 7260' is similar in function and structure to the first RFID tag 7260. When the RFID scanner 7250 receives signals from both the first RFID tag 7260 and the second RFID tag 7260', the controller of the surgical clip applier 7200 is configured to alert the clinician. For example, such an alert may notify the clinician that the surgical clip applier 7200 is about to crimp the second clamp 7260' at a position too close to the first forming clamp 7260. The controller may then prevent the clip applier 7200 from performing a crimping stroke on the second clamp 7260' until the RFID scanner 7250 is unable to send and / or receive communications and / or signals from the first RFID tag 7262 on the first clamp 7260.
[0173] In various instances, the information stored on the first RFID tag 7262 is a first serial number specific to the first fixture 7260, and the information stored on the second RFID tag 7262' is a second serial number specific to the second fixture 7260'. For example, based on the information received by the RFID scanner 7250, the controller can monitor the compatibility and / or reliability of each individual fixture 7260, 7260' with the surgical clip applier 7200. In various instances, the controller can also maintain a count of the number of fixtures remaining in the loaded fixture bin. In such instances, the controller is configured to alert the clinician of the number of fixtures remaining in the fixture bin so that the clinician can prepare a new fixture bin for attachment to the clip applier 7200.
[0174] For example, Fig.10 A process 6800 of the control circuit 1210 is shown. The control circuit 1210 is configured to be able to identify features of a fixture bin 6810 attached to a surgical instrument 7200. Using the identified features, the control circuit 1210 is configured to be able to determine the number of fixtures stored and / or remaining in the fixture bin 6820. The control circuit 1210 is configured to be able to update a count of the number of fixtures 6830 stored and / or remaining in the fixture bin after each crimping stroke. The control circuit 1210 is also configured to be able to alert a clinician 6840 when a predetermined number of fixtures remain in the fixture bin. For example, the clinician may be alerted when only one fixture remains in the fixture bin. In various instances, the clinician may be continuously alerted of the fixture count.
[0175] In various examples, individual surgical clip appliers (such as clip appliers 6200 and 7200) are configured to be interchangeable with various configurations of clamps and / or clamp cartridges. For example, the clamps may include different sizes, different strengths, different restraints, and / or different material compositions. In addition, the end effector 6230 may be removably attached to the elongated shaft 6220 to allow different end effector configurations to be attached to the clip applier 6200. Such modularity requires that the controller of the clip applier implement different operating parameters for each type of attached clamp, attached clamp cartridge, and / or attached end effector.
[0176] The surgical clip applier 7200 also includes an electric motor 1160 and a driver 1161, which is configured to control the operation of the motor 1160, including the flow of electrical energy from a power source. The controller changes and / or modifies the parameters of the electric motor 1160 through a motor control program. The motor control program is configured to determine appropriate operating parameters based on information received by an RFID scanner. The motor control program can compare the information received from the RFID tag with a lookup table and / or database stored in a memory (such as memory 1212). Such a lookup table and / or database may include recommended operating parameters for the motor control program to implement based on the detected attached components. For example, the operating parameters that can be adjusted based on the identification of the identified replaceable components include the overall motor rate, the loading force applied to the clamp by the jaws of the end effector during the crimping stroke, the duration of the crimping stroke, the crimping rate, and / or the duration of the jaws of the end effector remaining in the closed configuration when the crimping stroke is completed. For example, such operating parameters should be changed based on the attached clamp to ensure proper clamp closure without cutting patient tissue.
[0177] In various examples, the motor control program is configured to be able to set a maximum load threshold based on information received from an RFID tag positioned on an attached clamp and / or clamp compartment. In such examples, when the maximum load threshold is exceeded, the motor control program prevents the clip applier 7200 from performing a crimping stroke by blocking the ability of the power supply to power the electric motor 1160. In various examples, the motor control program is configured to be able to prevent the clip applier 7200 from performing function 1163 when other thresholds are exceeded, such as handling loads and / or elongated shaft torsion loads, etc. The motor control program may prevent the power supply from providing power to the electric motor 1160 after the crimping stroke is completed but before the jaws of the end effector are opened. Such a pause in the supply of power to the motor 1160 allows the jaws to hold the crimped clamp in place for a predetermined amount of time. In various examples, the clip applier 7200 includes a locking member that holds the jaws in a closed configuration when power is no longer supplied to the motor 1160. Such a locking member prevents the jaws from returning to an open configuration when power is no longer supplied to the motor 1160. In various examples, the control program is configured to enable the power source to supply a minimum amount of power to the motor 1160 after the crimping stroke is completed, wherein the minimum amount of power is sufficient to maintain the jaws in the closed configuration.
[0178] For example, the ability of the end effector 7230 to be interchangeably attached to the elongated shaft of the clip applier 7200 requires the instrument controller to change and / or otherwise adjust the length of the advancement member that must be translated to separate the individual clamps from the clamps stored in the clamp magazine to the crimping position. The controller is configured to account for the difference in the distance between the first jaw and the second jaw of the modular end effector 7330 to properly crimp the clamps. For example, the operating parameters should also be modified based on the attached clamps to compensate for the rebound and / or other responses of the clamps based on the material composition of the clamps and the patient's tissue. The ability of the controller of the clip applier 7200 to determine the identification of the clamp material and / or size, the clamp magazine side and configuration, and / or the end effector configuration and / or capability allows the control system to adapt appropriately by setting a maximum threshold limit and / or rate and / or speed, etc., for executing the crimping stroke.
[0179] Fig.11 A portion of a surgical stapling device 7300 is shown. As discussed in more detail herein, the surgical stapling device 7300 includes an end effector 7330. The end effector 7330 includes a needle track 7335 configured to guide a replaceable needle 7360. The replaceable needle 7360 includes a first end 7364 that includes a tip configured to pierce patient tissue. The replaceable needle 7360 includes a second end 7366, wherein the second end 7366 includes a suture material 7365 attached thereto. The replaceable needle 7360 is guided by the needle track 7335 and actuated by the firing drive through a firing stroke.
[0180] As described above, the needle track 7335 of the end effector 7330 is configured to receive a replaceable needle 7360. The replaceable needle 7360 includes an RFID tag 7362. The RFID tag 7362 includes, for example, a chip, such as a microchip, which stores information about the surgical stapling device 7300, the replaceable needle 7360, and / or the suture material 7365 attached to the replaceable needle 7360. In various examples, the set of information stored on the RFID chip includes data identifying the size of the needle 7360 positioned in the needle track 7335, the material constituting the needle 7360, and / or the material constituting the suture material 7365. Fig.11 As shown, the RFID tag 7362 is molded into the replaceable needle 7360. The RFID tag 7362 is molded into the replaceable needle 7360 to allow the needle 7362 to travel through the needle track 7335, for example, without interruption. In addition, the RFID tag 7362 is molded into the replaceable needle 7360 to allow the needle 7362 to travel through the patient tissue T in a smooth path. In other words, the RFID tag 7362 does not get stuck during the firing stroke and / or require additional force to fire the replaceable needle through the patient tissue and / or the needle track 7335 during the firing stroke. That is, the RFID tag 7362 can be embedded in and / or attached to the replaceable needle 7360 by any suitable method and / or at any suitable location.
[0181] The RFID tag 7362 on the replaceable needle 7360 provides a locking device 7179 for the surgical instrument 7300. For example, if the information stored on the RFID tag 7362 is not received by the controller of the surgical instrument, the suturing device 7300 will not perform a function (such as a nail firing stroke) with the firing drive assembly 1163. As mentioned in more detail herein, the surgical suturing device 7300 includes an RFID scanner 7350 configured to be able to communicate with a nearby RFID tag. The RFID scanner 7350 includes a scanner antenna configured to be able to transmit a radio signal. The radio signal activates an RFID tag positioned within a predetermined range of the RFID scanner 7350. Then, the RFID scanner 7350 receives one or more response signals "bounced back" from the RFID tag. In various instances, the one or more response signals include the same signal as the interrogation signal. In various instances, the one or more response signals include a modified signal from the interrogation signal. In various instances, the RFID scanner 7350 has read and write capabilities. The RFID scanner 7350 can then communicate the collected information from the RFID tag to the controller for further interpretation. The controller can be located in the surgical instrument 7300, on a remote control console, or in any suitable location. The RFID scanner 7350 and / or the controller can include a stored set of compatibility information corresponding to replaceable needles and / or suture materials that are compatible with a particular surgical instrument and / or that are compatible for use during a particular surgical procedure.
[0182] More specifically, the surgical system 7300 includes an RFID scanner 7350 that is configured to interact with an RFID tag 7362 attached to a replaceable needle 7360. The RFID scanner 7350 may be present in various locations. In the illustrated embodiment, the RFID scanner 7350 is positioned on the distal end of the end effector 7330; more specifically, when the replaceable needle 7360 is properly positioned in the needle track 7335, the RFID scanner 7350 is positioned at the first end of the needle track 7335 adjacent to the second end 7366 of the replaceable needle 7360; however, the RFID scanner 7350 may be located at an alternative location within the surgical system 7300 and / or any other suitable location that will allow communication between the RFID tag 7362 and the RFID scanner 7350. The RFID scanner 7350 and / or the RFID tag 7362 are powered so that the signals emitted by them can only be detected within a limited radius.
[0183] If the replaceable needle 7360 does not include an RFID tag and / or the RFID tag 7362 includes information that is not compatible with the surgical instrument 7300, the supplementary component verification system and / or controller of the surgical instrument 7300 will prevent the surgical instrument from performing functions (such as crimping strokes) with the firing drive assembly 1163. If the RFID scanner 7350 receives a response to an interrogation signal that is not found in a set of stored compatible supplementary components, the controller of the surgical instrument is programmed to communicate the error to the clinician. Similarly, if the RFID scanner 7350 does not receive a response to the interrogation signal, the controller of the surgical instrument is programmed to be able to communicate the error to the clinician. In various instances, the detection of an error by the controller may prevent the surgical instrument from being used with a particular replaceable needle 7360. In various instances, the detected error may prevent the surgical instrument from performing a firing stroke. In various instances, the surgical instrument also includes a manual override that can be activated to allow the clinician to override any system lockout device 7179 and utilize the operating functions of the surgical instrument in an emergency. As described above, the controller is configured to be able to alert the clinician that an error has been detected via the indicator 1209. Such alerts may be transmitted via various forms of feedback, including, for example, tactile, acoustic, and / or visual feedback. Alerts may be specific or general. For example, the alert may specify that the RFID tag 7362 on the replaceable needle 7360 could not be detected, or the alert may specify that the RFID tag 7362 includes information indicating that the needle 7360 and / or suture material 7365 is incompatible and / or defective.
[0184] In various examples, the controller can modify various operating parameters based on identifying the replaceable needle 7360 and / or suture material 7365 using the information stored on the RFID tag 7362. Such identification can include the material constituting the needle 7360 and / or suture material 7365, the length of the suture material 7365, and / or the thickness of the replaceable needle 7360 and / or suture material 7365, etc. After identifying the characteristics of the replaceable needle 7360, the controller is configured to use modified operating parameters to allow the surgical instrument to perform the desired function with the firing drive assembly 1163.
[0185] The embodiments disclosed herein are configured for use with surgical clip appliers and systems, such as those disclosed in U.S. Patent Application Serial No. 14 / 200,111, now U.S. Patent No. 9,629,629, entitled “CONTROL SYSTEMS FOR SURGICALINSTRUMENTS.” Fig.12 and Fig.13A motor driven surgical cutting and fastening instrument 12310 is shown. This illustrated embodiment shows an endoscopic instrument, and generally speaking, the instrument 12310 is described herein as an endoscopic surgical cutting and fastening instrument; however, it should be noted that the present invention is not limited thereto, and according to other embodiments, any instrument disclosed herein may include a non-endoscopic surgical cutting and fastening instrument. Fig.12 and Fig.13 The surgical instrument 12310 shown in the drawings includes a handle 12306, a shaft 12308, and an end effector 12312 connected to the shaft 12308. In various embodiments, the end effector 12312 can be articulated relative to the shaft 12308 about an articulation joint 12314. Various devices for articulating the end effector 12312 and / or devices for allowing the end effector 12312 to be articulated relative to the shaft 12308 are disclosed in the following U.S. Patents: U.S. Patent 7,753,245, entitled "SURGICAL STAPLING INSTRUMENTS", issued on July 13, 2010, and U.S. Patent 7,670,334, entitled "SURGICAL INSTRUMENT HAVING AN ARTICULATING END EFFECTOR", issued on March 2, 2010, the entire disclosures of which are incorporated herein by reference. Various other devices for articulating the end effector 12312 are discussed in more detail below. Similar to the above, the end effector 12312 is configured to function as a surgical stapler for clamping, cutting and / or stapling tissue, but in other embodiments, different types of end effectors may be used, such as end effectors for other types of surgical devices such as graspers, cutters, staplers, clip appliers, access devices, drug / gene therapy devices, ultrasound, RF and / or laser devices. Several RF devices can be found in U.S. Patent No. 5,403,312, entitled "ELECTROSURGICAL HEMOSTATIC DEVICE", issued on April 4, 1995, and U.S. Patent Application Serial No. 12 / 031,573, entitled "SURGICAL CUTTING AND FASTENING INSTRUMENT HAVING RF ELECTRODES", filed on February 14, 2008, the complete disclosures of which are incorporated herein by reference in their entirety.
[0186] For example, the end effector 12312 may include, among other things, a staple channel 12322 and a pivotally translatable clamping member, such as an anvil 12324. The handle 12306 of the instrument 12310 may include a closing trigger 12318 and a firing trigger 12320 for actuating the end effector 12312. It should be understood that instruments having end effectors related to different surgical tasks may have different numbers or types of triggers or other suitable controls for operating the end effector 12312. The handle 12306 may include a downwardly extending pistol grip 12326, toward which the clinician pivotally pulls the closing trigger 12318 to clamp or close the anvil 12324 toward the staple channel 12322 of the end effector 12312, thereby clamping tissue positioned between the anvil 12324 and the channel 12322. In other embodiments, different types of clamping members may be used in addition to or in place of the anvil 12324. The handle 12306 may further include a lock which may be configured to releasably retain the closure trigger 12318 in its closed position. Further details regarding embodiments of exemplary closure systems for closing (or clamping) the anvil 12324 of the end actuator 12312 by retracting the closure trigger 12318 are provided in the following U.S. patents: U.S. Patent 7,000,818, entitled "SURGICAL STAPLING INSTRUMENT HAVING SEPARATE DISTINCTCLOSING AND FIRING SYSTEMS," issued on February 21, 2006; U.S. Patent 7,422,139, entitled "MOTOR-DRIVEN SURGICAL CUTTING AND FASTENING INSTRUMENT WITH TACTILE POSITION FEEDBACK," issued on September 9, 2008; and U.S. Patent 7,422,139, entitled "ELECTRO-MECHANICAL SURGICAL INSTRUMENT WITH CLOSURE SYSTEM AND ANVIL ALIGNMENT," issued on December 16, 2008. COMPONENTS", the entire disclosures of which are incorporated herein by reference.
[0187] Once the clinician is satisfied with the positioning of the end effector 12312, the clinician can withdraw the closure trigger 12318 back to the fully closed locked position close to the pistol grip 12326. The firing trigger 12320 can then be actuated or fired. In at least one such embodiment, the firing trigger 12320 can be located further outboard of the closure trigger 12318, wherein the closing of the closure trigger 12318 can move or rotate the firing trigger 12320 toward the pistol grip 12326 so that the operator can access the firing trigger 12320 with one hand. Thereafter, the operator can pivotally withdraw the firing trigger 12320 toward the pistol grip 12312 to clamp and sever the clamped tissue in the end effector 12312. Thereafter, the firing trigger 12320 can return to its unactuated or unfired position after the clinician relaxes or releases the force applied to the firing trigger 12320. When pressed, the release button on the handle 12306 can release the locking closure trigger 12318. The release button can be implemented in various forms, such as disclosed in published U.S. Patent Application Publication No. 2007 / 0175955, entitled "SURGICAL CUTTING AND FASTENING INSTRUMENT WITH CLOSURE TRIGGER LOCKING MECHANISM," filed on January 31, 2006, the entire disclosure of which is incorporated herein by reference in its entirety.
[0188] Further describing the above, the end effector 12312 may include a cutting instrument, such as a knife, for example, for cutting the tissue clamped in the end effector 12312 when the firing trigger 12320 is retracted by the user. In addition, further describing the above, the end effector 12312 may also include a device for, for example, fastening the tissue cut by the cutting instrument, such as a nail, an RF electrode and / or an adhesive. A drive shaft capable of longitudinal movement within the shaft 12308 of the instrument 12310 can drive / actuate the fastening device in the cutting instrument and the end effector 12312. An electric motor located in the handle 12306 of the instrument 12310 can be used to drive the drive shaft, as further described herein. In various embodiments, the motor can be, for example, a DC brushed drive motor with a maximum speed of about 25,000 RPM. In other embodiments, the motor can include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. For example, a battery (or "power source" or "power pack") such as a lithium-ion battery may be disposed in the pistol grip portion 12326 of the handle 12306 adjacent to the motor, wherein the battery may supply power to the motor via the motor control circuit. According to various embodiments, multiple battery cells connected in series may be used as a power source to power the motor. In addition, the power source may be replaceable and / or rechargeable.
[0189] As described above, the electric motor in the handle 12306 of the instrument 12310 can be operably engaged with a longitudinally movable drive member positioned within the shaft 12308. Referring now to Figures 14 to 16 , the electric motor 12342 can be mounted to and positioned within the pistol grip portion 12326 of the handle 12306. The electric motor 12342 may include a rotatable shaft that is operably coupled to a gear reducer assembly 12370, wherein the gear reducer assembly 12370 may include, among other things, a housing 12374 and an output pinion 12372. In certain embodiments, the output pinion 12372 may be directly operably engaged with a drive member 12382 capable of longitudinal movement, or may alternatively be operably engaged with the drive member 12382 via one or more intermediate gears 12386. In at least one such embodiment, the intermediate gear 12386 may be meshingly engaged with a collection or rack of drive teeth 12384 defined in the drive member 12382. In use, the electric motor 12342 may be distally (indicated by arrow D( Fig. 9 ) and / or proximally (indicated by arrow D ( Fig.10 ) indicates) driving the drive member, which depends on the direction in which the electric motor 12342 rotates the intermediate gear 12386. In use, the voltage polarity provided by the battery can operate the electric motor 12342 in a clockwise direction, wherein the voltage polarity applied by the battery to the electric motor can be reversed to operate the electric motor 12342 in a counterclockwise direction. The handle 12306 may include a switch that can be configured to reverse the polarity applied by the battery to the electric motor 12342. The handle 12306 may also include a sensor 12330 configured to detect the position of the drive member 12382 and / or the direction in which the drive member 12382 moves.
[0190] The embodiments disclosed herein are configured for use with surgical clip appliers and systems, such as those disclosed in U.S. Patent Application Serial No. 16 / 112,237, filed on August 24, 2018, entitled "SURGICAL CLIP APPLIER CONFIGURED TO STORE CLIPS IN A STORED STATE," now U.S. Patent Application Publication No. 2019 / 0125347, which is incorporated herein by reference in its entirety. See Fig.17 , a surgical instrument such as clip applier 13100, for example, can be configured to apply one or more clips to tissue located within a surgical site of a patient. Fig.25In general, clip applier 13100 can be structured and arranged to position clamp 13140 relative to tissue so as to compress tissue within clamp 13140. Clip applier 13100 can be configured to deform clamp 13140, for example, Fig.19 and Fig. 20 As shown, and as further described in more detail below. Each clamp 13140 may include a base 13142 and opposing legs 13144 extending from the base 13142. For example, the base 13142 and the legs 13144 may include any suitable shape, and may define a substantially U-shaped configuration and / or a substantially V-shaped configuration. The base 13142 may include an angled portion 13141 that is connected together by a joint 13143. When in use, the legs 13144 of the clamp 13140 may be positioned on opposite sides of the tissue, wherein the legs 13144 may be pushed toward each other, thereby compressing the tissue positioned between the legs 13144. The joint 13143 may be configured to allow the angled portion 13141 of the base 13142 and the legs 13144 extending therefrom to deform inwardly. In various circumstances, the clamp 13140 can be configured to yield or plastically deform when the clamp 13140 is sufficiently compressed, although a certain amount of elastic deformation or rebound can occur within the deformed clamp 13140.
[0191] See now Fig.17 and Fig.18 , the clip applier 13100 may include a shaft 13110, an end effector 13120, and a replaceable clip cartridge or magazine 13130. Figure 26 to Figure 28 , the fixture bin 13130 may include a housing 13132 and a plurality of fixtures 13140 positioned within the housing 13132. The housing 13132 may define a storage chamber 13134 in which the fixtures 13140 may be stacked. The storage chamber 13134 may include a side wall that extends around or at least substantially around the perimeter of the fixtures 13140. Again, see Fig.25, each clamp 13140 may include opposing surfaces, such as a top surface 13145 and a bottom surface 13146 located on opposite sides of the clamp 13140, wherein the top surface 13145 of the clamp 13140 may be positioned against the bottom surface 13146 of an adjacent clamp 13140 when the clamps 13140 are stacked in the housing 13132, and wherein the bottom surface 13146 of the clamp 13140 may be positioned against the top surface 13145 of another adjacent clamp 13140. In various circumstances, the bottom surface 13146 of the clamp 13140 may face downward toward one or more support frames or platforms 13135 defined in the housing 13132, and the top surface 13145 of the clamp 13140 may face upward away from the support frames 13135. In some cases, the top surface 13145 and the bottom surface 13146 of the clamp 13140 can be the same, or at least substantially the same, while in other cases, the top surface 13145 and the bottom surface 13146 can be different. For example, Figure 26 to Figure 28 13140; however, other embodiments are contemplated in which the stack of clamps 13140 may include more than five clamps 13140 or less than five clamps 13140. In any case, the clamp cartridge 13130 may also include at least one biasing member, such as biasing member 13136, which is positioned, for example, intermediate the housing 13132 and the top clamp 13140 in the stack of clamps 13140. As described in more detail below, the biasing member 13136 may be configured to bias the bottom clamp 13140 in the stack of clamps 13140, or more specifically, the bottom surface 13146 of the bottom clamp 13140, against a support frame 13135 defined in the housing 13132. The biasing member 13136 may include a spring, and / or any suitable compressive elastic element, for example, which may be configured to apply a biasing force to the clamps 13140, or at least to the top clamp 13140, which is transmitted downward through the stack of clamps 13140.
[0192] When the clamp 13140 is positioned against the support frame 13135 as described above, the clamp 13140 can be supported in a firing position, wherein the clamp 13140 can be advanced and ejected from the cartridge 13130. In various cases, the support frame 13135 can define at least a portion of the firing chamber 13149, wherein the clamp 13140 can be sequentially positioned in the firing position. In some cases, the firing chamber 13149 can be completely defined within the cartridge 13130, or in other cases, the firing chamber 13149 can be defined within and / or between the shaft 13110 and the cartridge 13130. In any event, as further described in greater detail below, the clip applier 13100 can include a firing drive that can advance a firing member into the cartridge 13130 and urge the clamp 13140 from its firing position, in which it is positioned against the support frame 13135, to a fired position in which it is received within the end actuator 13120 of the clip applier 13100. Figure 26 to Figure 28 , the housing 13132 of the cartridge 13130 may include a proximal opening or window 13133 that may be aligned, or at least substantially aligned, with the support frame 13135 such that a firing member may enter the cartridge 13130 through the proximal opening 13133 and push the clamp 13140 distally out of the cartridge 13130. In at least one such embodiment, for example, the housing 13132 may also include a distal or discharge opening or window 13137 that may also be aligned with the support frame 13135 such that the clamp 13140 may be pushed or fired distally along a firing axis 13139 that extends through the proximal opening 13133, the firing chamber 13149, and the distal opening 13137.
[0193] To push the clamp 13140 out of the cartridge 13130, further to the above description, the firing member of the firing drive can be pushed into the cartridge housing 13132 and, in various cases, into the firing chamber 13149. As further disclosed in greater detail below, the firing member can pass completely through the cartridge 13130 to push the clamp 13140 into its fired position within the end effector 13120. After the clamp 13140 positioned in the firing chamber 13149 has been advanced distally by the firing member, as described above, the firing member can be sufficiently retracted so that the biasing member 13136 can position another clamp 13140 against the support frame 13135. In various cases, the biasing member 13136 can bias the clamp 13140 against the firing member, while the firing member is positioned within the housing 13132. Such clamps 13140 can be referred to as queued clamps. After the firing member has been sufficiently retracted and has slid out from under the queue clamp 13140, the biasing member 13136 can bias the clamp 13140 against the support frame 13135, in which case the next stroke of the reciprocating firing member is staged. Fig.18 and Figure 26 to Figure 28 , for example, the cartridge 13130 can be configured to supply the clamps 13140 to the firing chamber 13149 along a predetermined path, such as a supply axis 13138. The supply axis 13138 can be transverse to the firing axis 13139, such that the clamps 13140 are fed into the firing chamber 13149 in a direction that is different from the direction in which the firing member passes through the firing chamber 13149. In at least one such embodiment, for example, the supply axis 13138 can be perpendicular or at least substantially perpendicular to the firing axis 13139.
[0194] See again Fig.18 For example, the shaft 13110 may include a magazine hole or cartridge hole 13131, which may be sized and configured to receive the fixture magazine 13130 therein. The magazine hole 13131 may be sized and configured so that the housing 13132 of the magazine 13130 is tightly received within the magazine hole 13131. The side walls defining the magazine hole 13131 may limit or at least substantially limit the lateral movement of the magazine 13130 relative to the shaft 13110. The shaft 13110 and / or the magazine 13130 may also include one or more locks that may be configured to releasably retain the magazine 13130 in the magazine hole 13131. Fig.18 As shown, the cartridge 13130 can be loaded into the cartridge aperture 13131 along an axis that, in at least one embodiment, is parallel to or co-linear with the supply axis 13138. Fig.18 As shown, the shaft 13110 may further include a pad or seat 13118 extending from a sidewall 13111 of the shaft 13110, wherein the pad 13118 may be configured to be received within and / or engage with the housing 13132 of the cartridge 13130. The pad 13118 may be sized and configured to be snugly received within a groove 13148 defined in the cartridge housing such that the pad 13118 may limit or at least substantially limit lateral movement of the cartridge 13130 relative to the shaft 13110. The pad 13118 may be sized and configured to align the cartridge 13130 within the shaft 13110 and / or support the cartridge housing 13132.
[0195] Once the fixture cartridge 13130 has been positioned and seated within the axial bore 13131, now refer to Fig.21 and Fig. 22, the firing drive 13160 of the clip applier 13100 can be actuated to advance the clamp 13140 from the clamp magazine 13130 as described above. The firing drive 13160 may include, for example, a rotational drive input such as a drive screw 13161, and a replaceable firing nut 13163 operably engaged with the drive screw 13161. The drive screw 13161 may include at least one drive thread 13162 that may be threadedly engaged with a threaded hole extending through the firing nut 13163. In various embodiments, the clip applier 13100 may also include, for example, an electric motor operably coupled to the drive screw 13161. In various examples, for example, the drive screw 13161 may be operably coupled to a motor of a surgical instrument system including a handheld instrument or a robotic arm. In any case, the movement of the firing nut 13163 within the shaft 13110 can be constrained such that when the motor rotates the drive screw 13161 about the longitudinal axis 13164, the firing nut 13163 moves along the longitudinal axis 13164. For example, when the motor rotates the drive screw 13161 in a first direction, the drive screw 13161 can push the firing nut 13163 distally toward the end effector 13120, such as Fig. 22 When the motor rotates the drive screw 13161 in a direction opposite to the first direction, the drive screw 13161 can cause the firing nut 13163 to retract proximally away from the end effector 13120. The shaft 13110 may include one or more bearings that may be configured to rotatably support the drive screw 13161. For example, the bearing 13159 may be configured to rotatably support the distal end of the drive screw 13161, such as Fig.21 and Fig. 22 shown.
[0196] The firing drive 13160 may further include a firing member 13165 extending from the firing nut 13163 which may be advanced distally and retracted proximally by the firing nut 13163 as further described in greater detail below. Fig.21 and Fig. 22 The reader will note that the firing nut 13163 and the firing member 13165 have been removed from Fig.21 The proximal unfired position shown is advanced to Fig. 22 13165 has advanced the clamp 13140 from the clamp cartridge 13130 into the end effector 13120. Fig.21 , the clamp magazine 13130 is shown to include a plurality of clamps 13140 stored therein, wherein one of the clamps 13140 is positioned in a firing position, as described above. Fig.21 and Fig. 22As shown, the firing member 13165 may include a distal portion 13166 that can be advanced into the nail magazine 13130 along the firing axis 13167 and engage the clamp 13140 positioned in the firing position when the firing member 13165 and the firing nut 13163 are advanced distally. In some cases, the firing member 13165 may include a linear member, while in other cases, for example, the distal end 13166 of the firing member 13165 may extend upward from the firing member 13165. Further describing the above, the firing member 13165 can push the clamp 13140 distally out of the clamp magazine 13130 along the firing axis 13167 and push it into the receiving cavity 13122 defined in the end actuator 13120.
[0197] In various cases, the firing member 13165 can be attached to and extend distally from the firing nut 13163, while in other cases, the firing member 13165 and the firing nut 13163 can be operably connected to each other by a firing actuator 13168. The firing actuator 13168 can be pivotally mounted to the firing member 13165 at a pivot 13169 and can include a distal arm 13170a and a proximal arm 13170b that can engage with a longitudinal slot 13113 defined in a housing 13112 of the shaft 13110. In at least one such embodiment, each of the arms 13170a, 13170b can include a protrusion extending therefrom, such as protrusions 13171a and 13171b, respectively, which can be configured to slide within the longitudinal slot 13113. Further describing the above, the firing nut 13163 may also include a firing pin 13172 extending therefrom which can be configured to engage the distal arm 13170a to advance the actuator 13168 and the firing member 13165 distally, as described above. Fig.21 and Fig. 22 13165, the firing nut 13163 can be pushed distally by the drive screw 13161, wherein the firing pin 13172 positioned between the distal arm 13170a and the proximal arm 13170b can contact the distal arm 13170a and drive the actuator 13168 and the firing member 13165 distally. When the actuator 13168 is pushed distally, since one or both of the protrusions 13171a and 13171b that can prevent sliding in the shaft slot 13113 from moving laterally relative to the longitudinal shaft slot 13113, the actuator 13168 can be prevented from rotating about the pivot pin 13169 until the actuator 13168 reaches the end of the shaft slot 13113. Fig. 22 The location shown in .
[0198] Further describing the above, for example, once the clamp 13140 is positioned within the receiving cavity 13122, the crimping drive 13180 can deform the clamp 13140. Now referring to Fig.19 and Fig. 20 , the end effector 13120 of the clip applier 13100 may further include a first jaw 13123a and a second jaw 13123b, wherein the first jaw 13123a and the second jaw 13123b may at least partially define a receiving chamber 13122. Fig.19 and Fig. 20 As shown, the first jaw 13123a may include a first channel 13124a and the second jaw 13123b may include a second channel 13124b, each of which may be configured to receive and support at least a portion of the clamp 13140 therein. The first jaw 13123a may be pivotally coupled to the frame 13111 of the shaft 13110 via a pin 13125a, and the second jaw 13123b may be pivotally coupled to the frame 13111 via a pin 13125b. When in use, the crimping drive 13180 may be configured to rotate the first jaw 13123a toward the second jaw 13123b and / or rotate the second jaw 13123b toward the first jaw 13123a to compress the clamp 13140 positioned therebetween. In at least one such embodiment, the crimping drive device 13180 can include a cam actuator 13181 that can engage a first cam surface 13126a defined on the first jaw 13123a with a second cam surface 13126b on the second jaw 13123b to pivot the first jaw 13123a and the second jaw 13123b toward each other. The cam actuator 13181 can include a collar that at least partially surrounds the first jaw 13123a and the second jaw 13123b. In at least one such embodiment, the collar can include an inner cam surface 13182 that can be contoured to contact the cam surfaces 13126a, 13126b of the jaws 13123a, 13123b and drive them inwardly toward each other. In various circumstances, the clamp 13140 positioned within the receiving chamber 13122 defined in the end effector 13120 can be positioned relative to the tissue prior to actuating the crimping drive 13180. In some circumstances, the crimping drive 13180 can be at least partially actuated prior to positioning the clamp 13140 relative to the tissue so as to at least partially compress the clamp 13140. In certain instances, the size and configuration of the clamp 13140 and the receiving chamber 13122 can be set so that when the end effector 13120 is in its unactuated state, the clamp 13140 can be biased or bent inwardly, such as Fig.19In various examples, the crimping first jaw 13123a and the second jaw 13123b can be actuated to elastically crimp and / or permanently crimp the clamp 13140 positioned therebetween.
[0199] Further describing the above, the firing nut 13163 can be configured to actuate the crimping drive 13180. More specifically, referring now to Fig.23 , the crimp drive 13180 may include a crimp actuator 13188 operably coupled to the cam actuator 13181, wherein the crimp actuator 13188 can be selectively engaged by the firing nut 13163 when the firing nut 13163 is advanced distally as described above. In at least one such embodiment, the firing nut 13163 may also include a second firing pin such as the firing pin 13184 extending therefrom, which can engage the crimp actuator 13188 when the firing nut 13163 advances the firing actuator 13168. See again Fig.23 , the crimping actuator 13188 is positioned in an unactuated position, and, when the firing nut 13163 is sufficiently advanced to engage the distal arm 13190a of the crimping actuator 13188, the firing nut 13163 can rotate the crimping actuator 13188 upward into the position as shown in FIG. Fig.24 As shown in the actuation position. Fig.24As shown, for example, the distal arm 13190a and the proximal arm 13190b can each include a protrusion extending therefrom, such as protrusions 13191a and 13191b, respectively, which can be positioned within a second longitudinal slot, such as slot 13115, defined in the shaft 13110. As the crimp actuator 13188 is rotated upward about the pivot 13189 from its unactuated position, the protrusions 13191a and 13191b can move from the proximal curved end 13116 of the longitudinal slot 13115 into a portion of the substantially linear longitudinal slot 13115. Similar to the above, the sidewalls of the longitudinal slot 13115 can be configured to constrain the movement of the crimp actuator 13188 along the longitudinal path, and once the crimp actuator 13188 has been rotated upward into the at least partially actuated position, the sidewalls can be configured to limit or prevent rotation of the crimp actuator 13188, as described above. As the reader will appreciate, the firing pin 13172 of the firing drive 13160 and the firing pin 13184 of the crimping drive 13180 both extend from the firing nut 13163. For ease of illustration, the firing pin 13172 and the firing pin 13184 are shown extending from the same side of the firing nut 13163; however, it is contemplated that the firing pin 13172 may extend from a first lateral side of the firing nut 13163, while the firing pin 13184 may extend from the other lateral side of the firing nut 13163. In such a case, the firing actuator 13168 may be positioned next to the first lateral side of the drive screw 13161, and the crimping actuator 13188 may be positioned next to the opposite lateral side of the drive screw 13161. Accordingly, the longitudinal slot 13113 can be defined in a first lateral side of the shaft housing 13112 , while the longitudinal slot 13115 can be defined in an opposite lateral side of the shaft housing 13112 .
[0200] Further describing the above, the cam actuator 13181 can be operably coupled to the crimping actuator 13188 so that when the crimping actuator 13188 is pushed distally by the firing nut 13163, the cam actuator 13181 can be pushed distally, such as Fig.24As shown, until the distal protrusion 13191a extending from the distal arm 13190a reaches the distal end 13117 of the longitudinal slot 13115. In such a distal position, the cam actuator 13181 can be in a fully advanced position and the clamp 13140 positioned in the receiving chamber 13122 can be in a fully deformed or crimped configuration. The cam actuator 13181 can then be retracted and the end actuator 13120 can be opened again. More specifically, the drive screw 13161 can be rotated in the opposite direction to move the firing nut 13163 toward the proximal side and retract the cam actuator 13181, wherein, in some instances, the end actuator 13120 may also include a biasing member, which can be configured to move the first jaw 13123 and the second jaw 13123b from Fig. 20 The closed or fired position shown is biased into Fig.19 The open or unfired position is shown in FIG.
[0201] The embodiments disclosed herein are configured to be used with surgical stapling instruments and systems disclosed in the following applications: such as U.S. patent application serial number 16 / 112,168, entitled “SURGICAL SUTURING INSTRUMENT COMPRISING A NON-CIRCULAR NEEDLE”, filed on August 24, 2018, now U.S. patent application publication 2019 / 0125336; U.S. patent application serial number 13 / 832,786, entitled “CIRCULAR NEEDLE APPLIER WITH OFFSET NEEDLE AND CARRIERTRACKS”, now U.S. Patent Application 9,398,905; U.S. patent application serial number 14 / 721,244, entitled “SURGICAL NEEDLE WITH RECESSED FEATURES”, now U.S. patent application publication 2016 / 0345958; and ... DRIVE”, now U.S. Patent Application Serial No. 14 / 740,724, now U.S. Patent Application Publication No. 2016 / 0367243, which are incorporated herein by reference in their entirety.The embodiments discussed herein may also be used with the apparatus, systems, and methods disclosed in the following applications: U.S. Patent Application Serial No. 15 / 908,021, filed on February 28, 2018, entitled “SURGICAL INSTRUMENT WITH REMOTE RELEASE”; U.S. Patent Application Serial No. 15 / 908,012, filed on February 28, 2018, entitled “SURGICAL INSTRUMENT HAVING DUAL ROTATABLE MEMBERS TO EFFECT DIFFERENT TYPES OF END EFFECTORMOVEMENT”; U.S. Patent Application Serial No. 15 / 908,040, filed on February 28, 2018, entitled “SURGICALINSTRUMENT WITH ROTARY DRIVE SELECTIVELY ACTUATING MULTIPLE END EFFECTORFUNCTIONS”; U.S. Patent Application Serial No. 15 / 908,051, filed on February 28, 2018, entitled “SURGICALINSTRUMENT WITH ROTARY DRIVE SELECTIVELY ACTUATING No. 15 / 908,057, entitled "MULTIPLE END EFFECTOR FUNCTIONS" filed on February 28, 2018; No. 15 / 908,058, entitled "SURGICALINSTRUMENT WITH MODULAR POWER SOURCES" filed on February 28, 2018; and No. 15 / 908,143, entitled "SURGICAL INSTRUMENT WITH SENSOR AND / OR CONTROL SYSTEMS" filed on February 28, 2018, all of which are incorporated herein by reference in their entirety. In general, these surgical stapling instruments include, among other things, a shaft, an end effector attached to the shaft, and a drive system positioned within the shaft to transmit motion from the source motion to the end effector. The motion source may include a manually driven actuator, an electric motor, and / or a robotic surgical system. The end effector includes a main body portion, a needle track defined within the main body portion, and a needle driver configured to drive the needle through a rotational firing stroke. The needle is configured to be guided by the needle track through its rotational firing stroke within the main body. In various examples, the needle driver is similar to a needle driver of a ratchet system. In at least one example, the needle driver is configured to drive the needle through a first half of the rotational firing stroke, which places the needle in a switching position in which the tissue piercing end of the needle has passed through the target tissue and re-entered the main body of the end effector.At this point, the needle driver can return to its initial position to pick up the tissue puncture end of the needle and drive the needle through the second half of its rotation firing stroke. Once the needle driver pulls the needle through the second half of its rotation firing stroke, the needle driver then returns to its initial unfired position to catch the needle for another rotation firing stroke. The drive system can be driven by one or more motors and / or a manually driven actuation system. The needle includes, for example, suture material attached thereto, such as a thread. Suture material is configured to be pulled through tissue, for example, when the needle is advanced through its rotation firing stroke, to seal tissue and / or attach tissue to another structure.
[0202] Figure 29 to Figure 33 A surgical stapling instrument 94000 configured to sew patient tissue is shown. The surgical stapling instrument 94000 includes a handle 94100, a shaft 94200 extending distally from the handle 94100, and an end effector 94300 attached to the shaft 94200 by means of an articulation joint 94210. The handle 94100 includes a firing trigger 94110 configured to drive a firing drive of the surgical stapling instrument 94000, a first rotary actuator 94120 configured to enable the end effector 94300 to articulate around an articulation axis AA defined by the articulation joint 94210, and a second rotary actuator 94130 configured to enable the end effector 94300 to rotate around a longitudinal axis LA defined by the end effector 94300. The surgical stapling instrument 94000 also includes a flushing port 94140. Examples of surgical suturing devices, systems, and methods are disclosed in the following patents: U.S. patent application serial number 13 / 832,786, entitled “CIRCULAR NEEDLE APPLIER WITH OFFSET NEEDLE AND CARRIER TRACKS,” now U.S. Patent No. 9,398,905; U.S. patent application serial number 14 / 721,244, entitled “SURGICAL NEEDLE WITH RECESSED FEATURES,” now U.S. Patent Application Publication No. 2016 / 0345958; and U.S. patent application serial number 14 / 740,724, entitled “SUTURING INSTRUMENT WITH MOTORIZED NEEDLE DRIVE,” now U.S. Patent Application Publication No. 2016 / 0367243, the entirety of which are incorporated herein by reference.
[0203] Fig.34A handle assembly 95200 operable to use a surgical stapling instrument is shown. The handle assembly 95200 is connected to the proximal end of the shaft. The handle assembly 95200 includes a motor 95202 and a transmission assembly 95210. The motor 95202 is configured to enable the end effector to articulate by a needle driver actuating the needle of the surgical stapling end effector, and to rotate the end effector by the transmission assembly 95210. The transmission assembly 95210 is converted between three states, for example, by a double-acting solenoid, so as to allow the motor 95202 to be used to actuate the needle of the surgical stapling end effector, to articulate the end effector and / or to rotate the end effector. In at least one embodiment, for example, the handle assembly 95200 can take the form of a robot interface or housing including gears, pulleys and / or servo mechanisms. This arrangement can be used with a robotic surgical system.
[0204] Fig.35 A suture cartridge 93590 is shown that includes a lower body 93581, an upper body 93582, and a needle cover 93583. The cartridge 93590 also includes a drive system that includes a needle driver 93586, a rotational input 93594, and a connector 93585 that connects the needle driver 93586 and the rotational input 93594. The needle driver 93586, the rotational input 93594, and the connector 93585 are captured between the lower body 93581 and the upper body 93582. For example, the needle driver 93586, the connector 93585, and the rotational input 93594 are configured to be actuated by a motor drive system, a manually driven handheld system, and / or a robotic system to drive the needle 93570 through a needle firing stroke. The lower body 93581 and the upper body 93582 are attached to each other using any suitable technique, such as welding, pins, adhesives, etc. to form a cartridge body. The needle 93570 includes a front end 93571 configured to pierce tissue, a rear end 93572, and a length of suture 93573 extending from the rear end 93572 and attached to the rear end. The needle 93570 is configured to be able to rotate in a circular path defined by a needle track 93584. The needle track 93584 is defined in the cartridge body. The needle 93570 is configured to be able to exit one of the first arm 95393A and the second arm 95393B of the cartridge body during the needle firing stroke and enter the other of the first arm 95393A and the second arm 95393B. The recessed feature 93574 is provided so that the needle driver 93586 can engage the needle 93570 with a ratchet-like motion and drive the needle through the needle firing stroke. The needle 93570 is positioned between the needle track 93584 and the needle cover 93583. The suture cartridge 93590 also includes a retaining frame 93587 that is configured to slide on the cartridge body to attach the needle cover 93583 to the lower body 93581.
[0205] Various aspects of the subject matter described herein are illustrated in the following examples.
[0206] Example set 1.
[0207] Embodiment 1. A surgical device for applying a clamp, wherein the surgical device includes an elongated shaft extending from a housing; an end effector extending from the elongated shaft; a cartridge; a crimping drive; an RFID tag including stored data; an RFID scanner configured to send an interrogation signal to the RFID tag and receive a first signal from the RFID tag in response to the interrogation signal; and a controller in communication with the RFID scanner. The end effector includes a first jaw and a second jaw, wherein the first jaw and the second jaw are movable between an open position and a closed position relative to each other. The cartridge includes a storage chamber and a plurality of clamps removably positioned within the storage chamber. The crimping drive is configured to move the first jaw and the second jaw to a closed position during a crimping stroke, wherein during the crimping stroke, one of the plurality of clamps is crimped around tissue of a patient. The stored data on the RFID tag relates to an identification feature of at least one of the plurality of clamps within the cartridge. The first signal includes the stored data on the RFID tag. The controller is configured to compare the stored data received by the RFID scanner with a set of compatibility data stored in a memory of the controller and to change an operating parameter of the surgical device based on the stored data received by the RFID scanner.
[0208] Example 2. A surgical device according to Example 1, wherein the controller is further configured to allow the surgical device to perform a crimping stroke using altered operating parameters when the controller determines that the cartridge is compatible for use with the surgical device.
[0209] Example 3. A surgical device according to Example 1 or 2, wherein the controller is further configured to prevent the surgical device from performing a crimping stroke when the controller is unable to identify the cartridge as compatible for use with the surgical device.
[0210] Embodiment 4. A surgical device according to any one of embodiments 1 to 3, wherein the controller is configured to be able to change the operating parameters of the surgical device based on the stored data received by the RFID scanner and a set of compatibility data stored in the memory.
[0211] Embodiment 5. A surgical device according to any one of embodiments 1 to 4, wherein the stored data on the RFID tag includes a plurality of clamps accommodated in the bin.
[0212] Embodiment 6. A surgical device according to any one of embodiments 1 to 5, wherein the stored data on the RFID tag includes the type of material constituting the plurality of clamps within the bin.
[0213] Embodiment 7. A surgical device according to any one of embodiments 1 to 6, wherein the stored data on the RFID tag includes the dimensions of a plurality of clamps positioned within the bin.
[0214] Example 8. A surgical device according to any one of Examples 1 to 7, wherein the operating parameter is a maximum load threshold.
[0215] Example 9. A surgical device according to any one of Examples 1 to 7, wherein the operating parameter is a locking load threshold, wherein if the locking load threshold is exceeded, the controller prevents the surgical device from performing a crimping stroke.
[0216] Example 10. A surgical device according to any one of Examples 1 to 9, further comprising an electric motor and a power source, wherein the power source supplies power to the electric motor, and wherein the controller is configured to be able to change the power supplied to the electric motor based on stored data received by the RFID scanner.
[0217] Embodiment 11. A surgical device according to any one of embodiments 1 to 10, wherein the RFID tag is positioned on the cartridge.
[0218] Embodiment 12. A surgical device according to any one of embodiments 1 to 10, wherein the RFID tag is positioned on one of the plurality of clamps.
[0219] Example 13. A surgical device according to Example 12, wherein the RFID tag is positioned on a portion of the clamp that is not bent during the crimping stroke.
[0220] Embodiment 14. A surgical device for applying a clamp, wherein the surgical device comprises an elongated shaft extending from a housing; an end effector extending from the elongated shaft; a clamp comprising an RFID tag; a crimping drive; an RFID scanner; and a controller in communication with the RFID scanner. The end effector comprises a first jaw and a second jaw, wherein the first jaw is movable between an open position and a closed position relative to the second jaw. The RFID tag comprises stored data, wherein the stored data on the RFID tag represents the clamp. The crimping drive is configured to move the first jaw and the second jaw to a closed position during a crimping stroke, wherein the clamp is crimped around tissue of a patient during the crimping stroke. The RFID scanner is configured to receive the stored data on the RFID tag. The controller is configured to determine whether the clamp is compatible for use with the surgical device by comparing stored data received by the RFID scanner with a set of compatibility data, allowing the surgical device to perform a function when the controller determines that the clamp is compatible for use with the surgical device, and preventing the surgical device from performing a function when the controller determines that the clamp is not compatible for use with the surgical device.
[0221] Embodiment 15. A surgical device according to embodiment 14, wherein when the stored data received by the RFID scanner is not found within the set of compatibility data, the controller determines that the clamp is not compatible for use with the surgical device.
[0222] Embodiment 16. A surgical device according to embodiment 14 or 15, wherein when the RFID scanner fails to receive the stored data on the RFID tag, the controller determines that the clamp is not compatible for use with the surgical device.
[0223] Example 17. A surgical device according to any one of Examples 14 to 16, further comprising an electric motor and a power supply, wherein the power supply is configured to supply power to the electric motor, and wherein the controller is configured to change an operating condition of the electric motor based on stored data received from the RFID tag.
[0224] Embodiment 18. A surgical device according to any one of Embodiments 14 to 17, wherein the RFID tag is positioned on a portion of the clamp that is not bent during the crimping stroke.
[0225] Embodiment 19. A surgical device according to any one of embodiments 14 to 17, wherein the clamp includes an inner surface and an outer surface, wherein the inner surface contacts the patient's tissue after the crimping stroke, and wherein the RFID tag is positioned on the outer surface of the clamp.
[0226] Embodiment 20. A surgical device for applying a clamp, wherein the surgical device includes an elongated shaft extending from a housing; an end effector extending from the elongated shaft; a cartridge; a crimping drive; an RFID tag including stored data; an RFID scanner configured to communicate with the RFID tag; and a controller communicating with the RFID scanner. The end effector includes a first jaw and a second jaw, wherein the first jaw and the second jaw are movable relative to each other between an open position and a closed position. The cartridge includes a storage chamber and a plurality of clamps removably positioned within the storage chamber. The crimping drive is configured to move the first jaw and the second jaw to a closed position during a crimping stroke, wherein during the crimping stroke, one of the plurality of clamps is crimped around tissue of a patient. The stored data on the RFID tag relates to identification features of the plurality of clamps within the cartridge. The RFID scanner is configured to receive the stored data from the RFID tag. The controller is configured to compare the stored data received by the RFID scanner with a set of reliability data, allowing the surgical device to perform a crimping stroke when the controller determines that the multiple clamps are reliable, and preventing the surgical device from performing a crimping stroke when the controller determines that the multiple clamps are unreliable.
[0227] Example set 2.
[0228] Embodiment 1. A surgical suturing system, comprising an elongated shaft, a firing drive, and an end effector extending distally from the elongated shaft, wherein the end effector comprises a needle track and a replaceable needle guided by the needle track and actuated by the firing drive through a firing stroke, wherein the replaceable needle comprises a suture material attached thereto and an RFID tag comprising stored data. The surgical suturing system further comprises an RFID scanner, wherein the RFID scanner receives a signal from the RFID tag comprising stored data, and wherein the signal indicates the stored data. The surgical suturing system further comprises a controller that communicates with the RFID scanner, wherein the controller is configured to be able to determine the compatibility between the replaceable needle and the surgical suturing system based on the stored data received by the RFID scanner, and to prevent the surgical suturing system from performing a firing stroke when the replaceable needle is not compatible with the surgical suturing system.
[0229] Example 2. The surgical stapling system of Example 1, wherein the controller is further configured to prevent the surgical stapling system from executing a firing stroke when the RFID scanner fails to receive a signal from the RFID tag.
[0230] Embodiment 3. The surgical suturing system of embodiment 1 or 2, wherein the RFID scanner has both reading and writing capabilities.
[0231] Embodiment 4. A surgical suturing system according to any one of embodiments 1 to 3, wherein the RFID tag is positioned on a replaceable needle.
[0232] Embodiment 5. A surgical suturing system according to any one of embodiments 1 to 3, wherein the RFID tag is positioned on the suturing material.
[0233] Embodiment 6. A surgical stapling system according to any one of embodiments 1 to 5, wherein the RFID tag includes an integrated battery.
[0234] Example 7. A surgical suturing system according to Example 6, wherein the replaceable needle is stored in a package before being attached to the surgical suturing system, wherein the package includes a first layer and a second layer, wherein the first layer and the second layer form a seal around the replaceable needle, and wherein the RFID tag is positioned on the package.
[0235] Example 8. The surgical suturing system of Example 7 further comprises an insulator attached to the second layer, the insulator electrically decoupling the integrated battery from the RFID tag, wherein the RFID tag is attached to the first layer of the package, wherein the insulator detaches from the integrated battery when the first layer is removed from the second layer, and wherein when the insulator detaches from the integrated battery, the RFID tag becomes active and transmits stored data.
[0236] Embodiment 9. A surgical device for applying a clamp, wherein the surgical device includes an elongated shaft extending from a housing; an end effector extending from the elongated shaft; a cartridge; a crimping drive; an RFID tag including a first set of information; an RFID scanner configured to receive a first signal from the RFID tag; and a controller communicating with the RFID scanner. The end effector includes a first jaw and a second jaw, wherein the first jaw and the second jaw are movable between an open position and a closed position relative to each other. The cartridge includes a storage chamber and a plurality of clamps removably positioned within the storage chamber. The crimping drive is configured to move the first jaw and the second jaw to a closed position during a crimping stroke, wherein during the crimping stroke, one of the plurality of clamps is crimped around tissue of a patient. The first set of information corresponds to the cartridge. The first signal includes the first set of information. The controller is configured to determine whether the cartridge is compatible with the surgical device by comparing a first set of information received by the RFID scanner with a set of compatibility data stored in a memory of the controller, allow the surgical device to perform a crimping stroke when the controller determines that the cartridge is compatible for use with the surgical device, prevent the surgical device from performing a crimping stroke when the controller cannot identify the cartridge as compatible for use with the surgical device, and prevent the surgical device from performing a crimping stroke when the RFID scanner does not receive a first signal.
[0237] Example 10. A surgical device according to Example 9, wherein the RFID tag is positioned on the cartridge.
[0238] Example 11. A surgical device according to Example 9, wherein the RFID tag is positioned on a first clamp from the plurality of clamps, and the second RFID tag is positioned on a second clamp from the plurality of clamps, and wherein the second RFID tag includes a second set of information.
[0239] Example 12. The surgical device of Example 11, wherein the controller is configured to prevent the crimping stroke when the RFID scanner receives a first signal from the RFID tag and a second signal from the second RFID tag.
[0240] Example 13. A surgical device according to Example 11, wherein the RFID scanner includes a communication range, wherein the RFID scanner can communicate only with RFID tags located within the communication range, and wherein the controller is configured to prevent a crimping stroke when the RFID scanner receives signals from more than one RFID tag.
[0241] Example 14. A surgical device according to any one of Examples 9 to 13, further comprising an electric motor and a power supply, wherein the power supply is configured to supply power to the electric motor, and wherein the controller is configured to change operating parameters of the electric motor based on a first set of information received by the RFID scanner.
[0242] Embodiment 15. A surgical stapling system, comprising a surgical instrument, a replaceable component assembly, an RFID scanner including a communication range, and a controller in communication with the RFID scanner. The surgical instrument comprises an elongated shaft; an end effector extending from the elongated shaft, wherein the end effector comprises a first jaw and a second jaw; and a staple cartridge, which is replaceably disposed in the second jaw, wherein the staple cartridge comprises a cartridge body, the cartridge body comprising a cartridge plate and staples removably positioned in the cartridge body. The replaceable component assembly comprises a mounting member; a replaceable component, the replaceable component being configured to be positionable on a cartridge plate of the staple cartridge, wherein when the replaceable component is attached to the cartridge plate, the replaceable component is supported on the mounting member; and an RFID tag, the RFID tag comprising a first set of data. The RFID scanner is configured to transmit a first signal to the RFID tag and receive a second signal from the RFID tag when the replaceable component is brought into the communication range, wherein the second signal comprises the first set of data. The controller includes a memory including a second set of data, wherein the controller is configured to determine whether a replaceable component is compatible with the surgical instrument by comparing the first set of data received by the RFID scanner with the second set of data stored in the memory of the controller, allow the surgical instrument to perform a function when the controller determines that the replaceable component is compatible for use with the surgical instrument, prevent the surgical instrument from performing a function when the controller cannot identify the replaceable component as compatible for use with the surgical instrument, and prevent the surgical instrument from performing a function when the RFID scanner fails to receive a second signal in response to the first signal.
[0243] Example 16. A surgical stapling system according to Example 15, wherein the mounting member includes a rear wall, wherein the RFID tag is positioned on the rear wall, and wherein the RFID scanner is positioned on the distal end of the end actuator.
[0244] Example 17. The surgical stapling system of Example 16, wherein the RFID tag is within the communication range of the RFID scanner when the end effector and the replaceable component are aligned.
[0245] Example 18. A surgical suturing system according to any one of Examples 15 to 17, wherein the function includes a staple firing stroke.
[0246] Example 19. A surgical stapling system according to any one of Examples 15 to 18, wherein the replaceable component includes a tissue thickness compensator.
[0247] Example 20. A surgical suturing system according to any one of Examples 15 to 19, further comprising a motor and a power supply configured to supply power to the motor, wherein the controller is configured to change operating parameters of the motor based on a first set of data received by the RFID scanner.
[0248] Although multiple forms have been illustrated and described, it is not the intention of the applicant to restrict or limit the scope of the appended claims to such details. Without departing from the scope of the present disclosure, many modifications, variations, changes, substitutions, combinations and equivalents to these forms can be realized, and those skilled in the art will think of many modifications, variations, changes, substitutions, combinations and equivalents to these forms. In addition, alternatively, the structure of each element associated with the described form can be described as a device for providing the function performed by the element. In addition, in the case of disclosing materials for certain parts, other materials can also be used. Therefore, it should be understood that the above-mentioned specific embodiments and the appended claims are intended to cover all such modifications, combinations and variations within the scope of the forms disclosed by the present invention. The appended claims are intended to cover all such modifications, variations, changes, substitutions, modifications and equivalents.
[0249] The above specific embodiments have been described in various forms of devices and / or methods using block diagrams, flow charts and / or examples. As long as such block diagrams, flow charts and / or examples contain one or more functions and / or operations, those skilled in the art will understand that each function and / or operation in such block diagrams, flow charts and / or examples can be implemented individually and / or collectively by a variety of hardware, software, firmware or any combination thereof. Those skilled in the art will recognize that some aspects of the forms disclosed herein can be implemented equivalently in integrated circuits as one or more computer programs running on one or more computers (e.g., as one or more programs running on one or more computer systems), as one or more programs running on one or more processors (e.g., as one or more programs running on one or more microprocessors), as firmware, or as any combination thereof, in whole or in part, and according to the present disclosure, designing circuit systems and / or writing software and / or hardware codes will be within the technical scope of those skilled in the art. In addition, those skilled in the art will recognize that the mechanisms of the subject matter described herein can be distributed as one or more program products in a variety of forms, and the illustrative forms of the subject matter described herein are applicable, regardless of the specific type of signal-bearing medium used to actually distribute.
[0250] Instructions for programming logic to perform various disclosed aspects may be stored in a memory in the system, such as a dynamic random access memory (DRAM), a cache, a flash memory, or other memory. In addition, the instructions may be distributed via a network or by other computer-readable media. Therefore, a machine-readable medium may include any mechanism for storing or transmitting information in a machine (e.g., computer) readable form, but is not limited to a floppy disk, an optical disk, a compact disk read-only memory (CD-ROM), and a magneto-optical disk, a read-only memory (ROM), a random access memory (RAM), an erasable programmable read-only memory (EPROM), an electrically erasable programmable read-only memory (EEPROM), a magnetic card or an optical card, a flash memory, or a tangible, machine-readable storage device used when transmitting information on the Internet via an electrical signal, an optical signal, an acoustic signal, or other form of propagation signal (e.g., a carrier wave, an infrared signal, a digital signal, etc.). Therefore, a non-transitory computer-readable medium includes any type of tangible machine-readable medium suitable for storing or transmitting electronic instructions or information in a machine (e.g., computer) readable form.
[0251] As used in any aspect of this document, the term "control circuitry" may refer to, for example, hardwired circuitry, programmable circuitry (e.g., a computer processor including one or more separate instruction processing cores, a processing unit, a processor, a microcontroller, a microcontroller unit, a controller, a digital signal processor (DSP), a programmable logic device (PLD), a programmable logic array (PLA), a field programmable gate array (FPGA)), state machine circuitry, firmware that stores instructions executed by the programmable circuitry, and any combination thereof. The control circuitry may be implemented collectively or individually as circuitry that forms part of a larger system, such as an integrated circuit (IC), an application specific integrated circuit (ASIC), a system on a chip (SoC), a desktop computer, a laptop computer, a tablet computer, a server, a smart phone, etc. Thus, as used herein, "control circuitry" includes, but is not limited to, electronic circuitry having at least one discrete circuit, electronic circuitry having at least one integrated circuit, electronic circuitry having at least one application specific integrated circuit, electronic circuitry forming a general purpose computing device configured by a computer program (e.g., a general purpose computer configured by a computer program to at least partially implement the methods and / or devices described herein, or a microprocessor configured by a computer program to at least partially implement the methods and / or devices described herein), electronic circuitry forming a memory device (e.g., forming a random access memory), and / or electronic circuitry forming a communication device (e.g., a modem, a communication switch, or an optoelectronic device). Those skilled in the art will recognize that the subject matter described herein may be implemented in analog or digital form, or some combination thereof.
[0252] As used in any aspect of this document, the term "logic" may refer to an application, software, firmware, and / or circuitry configured to perform any of the aforementioned operations. Software may be embodied as a software package, code, instructions, instruction sets, and / or data recorded on a non-transitory computer-readable storage medium. Firmware may be embodied as code, instructions, instruction sets, and / or data hard-coded (e.g., non-volatile) in a memory device.
[0253] As used in any aspect of this document, the terms "component," "system," "module" and the like may refer to a computer-related entity, hardware, a combination of hardware and software, software, or software in execution.
[0254] As used herein in any aspect, an "algorithm" refers to a self-consistent sequence of steps leading to a desired result, wherein "steps" refer to manipulations of physical quantities and / or logical states, which may (but need not) take the form of electrical or magnetic signals capable of being stored, transferred, combined, compared, and otherwise manipulated. References to such signals are often made to bits, values, elements, symbols, characters, terms, numbers, and the like. These and similar terms may be associated with the appropriate physical quantities and are merely convenient labels applied to such quantities and / or states.
[0255] The network may include a packet switching network. The communication devices may be able to communicate with each other using the selected packet switching network communication protocol. An exemplary communication protocol may include an Ethernet communication protocol that may allow communication using a transmission control protocol / Internet protocol (TCP / IP). The Ethernet protocol may comply with or be compatible with the Ethernet standard entitled "IEEE 802.3 Standard" issued by the Institute of Electrical and Electronics Engineers (IEEE) in December 2008 and / or a higher version of this standard. Alternatively or additionally, the communication devices may be able to communicate with each other using an X.25 communication protocol. The X.25 communication protocol may comply with or be compatible with the standard issued by the International Telecommunication Union Telecommunication Standardization Sector (ITU-T). Alternatively or additionally, the communication devices may be able to communicate with each other using a frame relay communication protocol. The frame relay communication protocol may comply with or be compatible with the standard issued by the International Telegraph and Telephone Consultative Committee (CCITT) and / or the American National Standards Institute (ANSI). Alternatively or additionally, the transceivers may be able to communicate with each other using an asynchronous transfer mode (ATM) communication protocol. The ATM communication protocol may conform to or be compatible with the ATM standard entitled "ATM-MPLS Network Interworking 2.0" published by the ATM Forum in August 2001 and / or later versions of the standard. Of course, different and / or later developed connection-oriented network communication protocols are also contemplated herein.
[0256] In various aspects, the microprocessor of the control circuit according to the present disclosure can be any single-core or multi-core processor, such as those known under the trade name ARM Cortex produced by Texas Instruments. In one aspect, the microcontroller 461 can be a LM4F230H5QR ARM Cortex-M4F processor core available from, for example, Texas Instruments, which includes 256KB of single-cycle flash or other non-volatile memory (up to 40MHz) on-chip memory, a pre-fetch buffer for improving performance above 40MHz, 32KB of single-cycle SRAM, a CPU loaded with Internal ROM for software, 2KB electrical EEPROM, one or more PWM modules, one or more QEI analog, one or more 12-bit ADC with 12 analog input channels, details of which can be found in the product data sheet.
[0257] Unless otherwise expressly indicated in the above disclosure, it is understood that discussions using terms such as "processing," "computing," "calculating," "determining," and "displaying" in the above disclosure refer to the actions and processes of a computer system or similar electronic computing device that manipulates data represented as physical (electronic) quantities within the computer system's registers and memories and transforms it into other data similarly represented as physical quantities within the computer system's memories or registers or other such information storage, transmission, or display devices.
[0258] One or more components may be referred to herein as "configured to be able to", "configurable to be able to", "operable / operably", "suitable / adaptable to", "able to", "conformable / conform to", etc. Those skilled in the art will recognize that, unless the context indicates otherwise, "configured to be able to" may generally cover components in an active state and / or components in an inactive state and / or components in a standby state.
[0259] The terms "proximal" and "distal" are used herein relative to a clinician manipulating the housing portion of a surgical instrument. The term "proximal" refers to the portion closest to the clinician, and the term "distal" refers to the portion positioned away from the clinician. It should also be understood that for brevity and clarity, spatial terms such as "vertical," "horizontal," "upper," and "lower" may be used herein in conjunction with the accompanying drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and / or absolute.
[0260] Those skilled in the art will recognize that, in general, the terms used herein, and in particular in the appended claims (e.g., the body of the appended claims), are generally intended to be "open" terms (e.g., the term "including" should be interpreted as "including but not limited to", the term "having" should be interpreted as "having at least", the term "comprising" should be interpreted as "including but not limited to", etc.). Those skilled in the art will also understand that if a specific number of an introduced claim recitation is intended, such intent will be explicitly stated in the claim, and in the absence of such recitation, no such intent is present. For example, to aid understanding, the following appended claims may contain use of the introductory phrases "at least one" and "one or more" to introduce claims. However, the use of such phrases should not be construed as implying that the introduction of a claim recitation by the indefinite article "a" or "an" limits any particular claim containing such introduced claim recitation to claims containing only one such recitation, even when the same claim includes the introductory phrases "one or more" or "at least one" and an indefinite article such as "a" or "an" (e.g., "a" and / or "an" should generally be interpreted as meaning "at least one" or "one or more"); this also applies to the use of definite articles used to introduce claim recitations.
[0261] In addition, even if a specific number of claim recitations is explicitly recited, those skilled in the art will recognize that such recitation should generally be interpreted to mean at least the recited number (e.g., a bare recitation of "two recitations" without other modifiers generally means at least two recitations, or two or more recitations). In addition, in those cases where a convention similar to "at least one of A, B, and C, etc." is used, generally, such construction is intended to have the meaning that those skilled in the art will understand the convention (e.g., "a system having at least one of A, B, and C" will include, but is not limited to, systems having only A, only B, only C, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). In those cases where a convention similar to "at least one of A, B, or C, etc." is used, generally, such construction is intended to have the meaning that those skilled in the art will understand the convention (e.g., "a system having at least one of A, B, or C" will include, but is not limited to, systems having only A, only B, only C, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). Those skilled in the art will also understand that, generally, unless the context indicates otherwise, transitional words and / or phrases presenting two or more alternative terms in the detailed description, claims, or drawings should be understood to include the possibility of including one of the terms, any one of the terms, or both of the terms. For example, the phrase "A or B" will generally be understood to include the possibility of "A" or "B" or "A and B".
[0262] For the appended claims, those skilled in the art will appreciate that the operations described therein may generally be performed in any order. In addition, although various operational flow charts are presented in one or more sequences, it should be understood that the various operations may be performed in other orders than the order shown, or the various operations may be performed simultaneously. Unless the context otherwise dictates, examples of such alternative orderings may include overlapping, interleaved, interrupted, reordered, incremental, preparatory, supplementary, simultaneous, reverse, or other altered orderings. In addition, unless the context otherwise dictates, terms such as "responsive to," "related to," or other past tense adjectives are generally not intended to exclude such variants.
[0263] It is worth mentioning that any reference to "one aspect", "an aspect", "an example", or "an example" means that the specific features, structures, or characteristics described in conjunction with the aspect are included in at least one aspect. Therefore, the phrases "in one aspect", "in an aspect", "in an example", or "in an example" appearing in various places throughout the specification do not necessarily refer to the same aspect. In addition, specific features, structures, or characteristics may be combined in any suitable manner in one or more aspects.
[0264] Any patent application, patent, non-patent publication or other public material referred to in this specification and / or listed in any Application Data Sheet is incorporated herein by reference to the extent that the incorporated material is inconsistent herewith. Therefore, and to the extent necessary, the disclosure explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material or portion thereof that is allegedly incorporated herein by reference but conflicts with existing definitions, statements or other public material set forth herein will be incorporated only to the extent that there is no conflict between the incorporated material and the existing public material.
[0265] In summary, many of the benefits resulting from the use of the concepts described herein have been described. For purposes of illustration and description, one or more of the above specific embodiments have been provided. These specific embodiments are not intended to be exhaustive or limited to the precise forms disclosed by the invention. The invention may be modified or varied in accordance with the above teachings. The one or more forms selected and described are intended to illustrate the principles and practical applications so that one of ordinary skill in the art can utilize various forms and various modifications suitable for the intended specific use. The claims submitted herewith are intended to define the full scope.
Claims
1. A surgical suturing system, comprising: Slender shaft; A firing drive device; an end effector extending distally from the elongated shaft, wherein the end effector comprises: needle track; and a replaceable needle guided by the needle track and actuated through a firing stroke by the firing drive, wherein the replaceable needle comprises: a suture material attached to the replaceable needle; and An RFID tag, the RFID tag comprising stored data; an RFID scanner, wherein the RFID scanner receives a signal from the RFID tag including the stored data, and wherein the signal is indicative of the stored data; and a controller in communication with the RFID scanner, wherein the controller is configured to: determining compatibility between the replaceable needle and the surgical stapling system based on the stored data received by the RFID scanner; and Preventing the surgical stapling system from executing the firing stroke when the replaceable needle is not compatible with the surgical stapling system.
2. The surgical stapling system according to claim 1, wherein: The controller is further configured to prevent the surgical stapling system from executing the firing stroke when the RFID scanner fails to receive the signal from the RFID tag.
3. The surgical stapling system according to claim 1, wherein: The RFID scanner includes read capability and write capability.
4. The surgical stapling system according to claim 1, wherein: The RFID tag is positioned on the replaceable needle.
5. The surgical stapling system according to claim 1, wherein: The RFID tag is positioned on the suture material.
6. The surgical stapling system according to claim 1, wherein: The RFID tag includes an integrated battery.
7. The surgical stapling system according to claim 6, wherein: The replaceable needle is stored in a package prior to attachment to the surgical stapling system, wherein the package comprises a first layer and a second layer, wherein the first layer and the second layer form a seal around the replaceable needle, and wherein the RFID tag is positioned on the package.
8. The surgical suturing system of claim 7, further comprising an insulator attached to the second layer, the insulator electrically decoupling the integrated battery from the RFID tag, wherein the RFID tag is attached to the first layer of the package, wherein the insulator detaches from the integrated battery when the first layer is removed from the second layer, and wherein when the insulator detaches from the integrated battery, the RFID tag becomes active and transmits the stored data.
Citation Information
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