Surgical stapling instrument and surgical loading unit therefor

Abstract

A surgical suturing instrument includes a handle assembly, a surgical loading unit, and an adapter assembly interconnecting the handle assembly and the surgical loading unit. The surgical loading unit includes a memory having instructions stored therein, which, when executed by a processor of the handle assembly, override the instructions stored in the memory of the handle assembly and implement operating parameters of the surgical loading unit, the operating parameters being unique to tissue type or a specific surgical procedure to be performed by the surgical loading unit.

Description

Technical Field

[0001] This disclosure relates to surgical suturing instruments. More particularly, this disclosure relates to intelligent loading units for surgical suturing instruments. Background Technology

[0002] Surgical suturing instruments for manipulating tissue are well known in the art and may include a handle assembly, a body portion extending distally from the handle assembly, and a surgical loading unit supported on the distal end portion of the body portion. The surgical loading unit includes a first clamp and a second clamp, which are movable relative to each other between a non-accessible position and an accessible position. In surgical suturing instruments, the first clamp is an anvil assembly, and the second clamp is a staple cartridge assembly.

[0003] Surgical suturing instruments can be pre-programmed to adjust firing speed, clamping force, etc., based on the characteristics of the tissue being treated (e.g., tissue thickness). For example, when the tissue is determined to be relatively thick, instructions stored in the handle assembly of the surgical suturing instrument may cause the handle assembly to fire suture staples from the attached surgical loading unit and / or advance the scalpel bar at a reduced speed. Summary of the Invention

[0004] According to one aspect of this disclosure, a surgical loading unit is provided for use with surgical suture instruments. The surgical loading unit includes a suture cartridge assembly; an anvil assembly operatively coupled to the suture cartridge assembly; and a memory associated with at least one of the suture cartridge assembly or the anvil assembly. The memory has instructions stored therein that, when executed, implement operating parameters of the surgical loading unit. These operating parameters are unique to tissue type or a specific surgical procedure to be performed by the surgical loading unit.

[0005] In various aspects, the operating parameters may include the suture firing speed, suture firing force, clamping speed, and / or clamping force of the surgical loading unit.

[0006] In various aspects, the launch rate may be unique to the tissue type or the specific surgical procedure to be performed by the surgical loading unit.

[0007] In various aspects, the firing force may be unique to the tissue type or the specific surgical procedure to be performed by the surgical loading unit.

[0008] In various aspects, the specific surgical procedure to be performed by the surgical loading unit may include endoscopic gastrointestinal anastomosis, tissue resection, or lesion resection.

[0009] In various aspects, the memory may have data related to the surgical loading unit stored therein.

[0010] In various aspects, the data may include the serial number of the surgical loading unit, the type of the surgical loading unit, the size of the surgical loading unit, the size of the suture staples contained in the surgical loading unit, information identifying whether the surgical loading unit has been fired, the length of the firing stroke of the surgical loading unit, and / or the maximum number of times the surgical loading unit can be used.

[0011] In all respects, when executed, the instructions stored in the memory can override the program in the corresponding adapter component or handle component. The operating parameters may differ from the operating parameters in the program.

[0012] According to another aspect of this disclosure, a surgical suturing instrument is provided, comprising a handle assembly and a surgical loading unit configured to be coupled to the handle assembly. The handle assembly includes a memory having instructions stored therein; and a processor configured to execute the instructions. The surgical loading unit includes a staple cartridge assembly; an anvil assembly operatively coupled to the staple cartridge assembly; and a memory. The memory has instructions stored therein, which, when executed by the processor of the handle assembly, override the instructions stored in the memory of the handle assembly and implement operating parameters of the surgical loading unit, the operating parameters being unique to tissue type or a specific surgical procedure to be performed by the surgical loading unit.

[0013] In various aspects, the operating parameters may include the suture firing speed, suture firing force, clamping speed, and / or clamping force of the surgical loading unit.

[0014] In various aspects, the launch rate may be unique to the tissue type or the specific surgical procedure to be performed by the surgical loading unit.

[0015] In various aspects, the firing force may be unique to the tissue type or the specific surgical procedure to be performed by the surgical loading unit.

[0016] In various aspects, the specific surgical procedure to be performed by the surgical loading unit may include endoscopic gastrointestinal anastomosis, tissue resection, or lesion resection.

[0017] In various aspects, the memory of the surgical loading unit may have data related to the surgical loading unit stored therein.

[0018] In various aspects, the data may include the serial number of the surgical loading unit, the type of the surgical loading unit, the size of the surgical loading unit, the size of the suture staple, information identifying whether the surgical loading unit has been launched, the length of the launch stroke of the surgical loading unit, and / or the maximum number of times the surgical loading unit can be used.

[0019] In various aspects, the surgical suturing instrument may further include an adapter assembly configured to interconnect the surgical loading unit and the handle assembly.

[0020] In various respects, the instructions stored in the memory of the surgical loading unit can alter the operation of the adapter assembly.

[0021] According to another aspect of this disclosure, a method for modifying the operation of a surgical suture instrument is provided. The method includes transferring instructions from a memory of a surgical loading unit to a processor of an adapter assembly or an electrified handle assembly of the surgical suture instrument; and overwriting instructions stored in the memory of the handle assembly or the adapter assembly with the instructions from the memory of the surgical loading unit. The instructions from the memory of the surgical loading unit guide the processor to adapt the operation of the adapter assembly or the handle assembly from a preset operating mode to a unique operating mode.

[0022] In various aspects, the unique operating mode can adjust the way the handle assembly or the adapter assembly performs the function of the surgical loading unit.

[0023] In various aspects, the unique operating mode may correspond to a unique tissue type or a specific surgical procedure to be performed by the surgical loading unit.

[0024] Further details and aspects of exemplary embodiments of the present disclosure are described in more detail below with reference to the accompanying drawings. Attached Figure Description

[0025] This document describes embodiments of the present disclosure with reference to the accompanying drawings, in which:

[0026] Figure 1 This is a perspective view of an embodiment of a surgical suturing instrument according to the present disclosure;

[0027] Figure 2 yes Figure 1 A surgical side perspective view of the surgical suture instrument shown.

[0028] Figure 3 yes Figure 2 A side perspective view of the surgical loading unit, showing the suture cartridge assembly of the surgical loading unit in a disassembled state; and

[0029] Figure 4 This shows the operation. Figure 1 A flowchart of an exemplary method for using a surgical suturing instrument. Detailed Implementation

[0030] Embodiments of the disclosed surgical suturing instrument and its surgical loading unit are described in detail with reference to the accompanying drawings, wherein in each of the several views, the same reference numerals denote the same or corresponding elements. As used herein, the term "distal" refers to the portion of the surgical suturing instrument or its component closest to the patient, while the term "proximal" refers to the portion of the surgical suturing instrument or its component distant from the patient.

[0031] As will be described in detail below, a surgical loading unit for use in a surgical suture instrument is provided. The surgical loading unit includes an anvil assembly; a staple cartridge assembly pivotally coupled to the anvil assembly; and a memory. The memory has instructions stored therein, which are unique to the type of tissue for which the surgical loading unit is intended or the type of surgical procedure for which the surgical loading unit is intended. The memory is configured to transfer instructions from the surgical loading unit to a processor in a handle assembly of the surgical suture instrument. The instructions instruct the processor to override a program stored in the handle assembly, such that the processor performs multiple functions of the surgical loading unit in a manner specified by the instructions stored in the memory of the surgical loading unit. Other features and benefits of the disclosed surgical suture instrument will be described in further detail below.

[0032] Figure 1 An embodiment of the disclosed surgical suturing instrument 10 is shown. The surgical suturing instrument 10 includes an electrified handle assembly 12, an adapter assembly 14, and a surgical loading unit 100. The handle assembly 12 and the adapter assembly 14 are configured to influence the operation of the loading unit 100. The handle assembly 12 is configured to selectively connect with the adapter assembly 14, and conversely, the adapter assembly 14 is configured to selectively connect with the separately used loading unit (“SULU’s”) 100. The handle assembly 12 includes: a processor 2 for influencing the operation of a drive motor (not shown) in the handle assembly 12; and a memory 4 having instructions stored therein or programs to be executed by the processor 2.

[0033] Although the loading unit 100 is shown and described as being selectively fastened to the adapter assembly 14 of the surgical suture instrument 10, it is foreseeable that in embodiments where the surgical suture instrument 10 does not have an adapter assembly, the loading unit 100 may be supported on the axis of the handle assembly 12.

[0034] For a detailed description of the structure and function of the handle assembly 12 and the adapter assembly 14, please refer to the commonly owned U.S. Patent No. 9,055,943 and U.S. Patent Application Publication No. 2016 / 0310134, the entire contents of each of which are incorporated herein by reference. Details regarding the operation of the loading unit 100 can be found in U.S. Patent Application Publication No. 2016 / 0249929, the entire contents of which are incorporated herein by reference.

[0035] Figures 1 to 3 A surgical loading unit 100 is shown, comprising a proximal body portion 102 and an end effector assembly 104. A mounting assembly 106 is fastened to the end effector assembly 104 and pivotally coupled to the proximal body portion 102 of the loading unit 100 to pivotally fasten the end effector assembly 104 to the proximal body portion 102. Although the end effector assembly 104 is shown and described as operable by a surgical handle assembly 12 ( Figure 1 However, it is foreseeable that the end effector assembly 104 can also be operatively coupled to surgical robotic instruments.

[0036] The end effector assembly 104 includes a first clamping member (e.g., anvil assembly 108) and a second clamping member (e.g., suture cartridge assembly 110), which are movable relative to each other between an approach configuration and an unfolded or open configuration. The cartridge assembly 110 typically includes a base 112 ( Figure 3 The base 112 includes a disposable suture clip body 122 configured for removable reception within a base 112. The base 112 has a proximal end portion pivotally coupled to a proximal end portion of an anvil assembly 108. In an embodiment, the proximal end portion of the base 112 may be indirectly pivotally coupled to the anvil assembly 108. The base 112 defines an elongated channel 114 therein. Figure 3 The elongated channel is sized to removably accommodate the suture staple cartridge body 122.

[0037] The staple cartridge body 122 has a tissue contact surface 116 that defines multiple rows of staple holding grooves. Figure 2 The suture cartridge body 122 supports a plurality of sutures (not shown). The loading unit includes: a launching member configured to interact with a slider having a wedge; and a pusher having a corresponding cam surface to discharge the sutures through corresponding suture holding slots formed in the tissue contact surface 116. The launching member moves through the suture cartridge body 122 to sequentially discharge multiple rows of sutures. The suture cartridge assembly 110 may further include a transport wedge 124. Figure 3The transport wedge is configured to hold the suture staple within the suture staple holding groove of the tissue contact surface 116 of the suture staple cartridge body 122 and to prevent actuation of the end effector assembly 104 prior to removal of the transport wedge 124.

[0038] The surgical loading unit 100 includes a memory 130 disposed within the proximal body portion 102. Figure 2 In various aspects, the memory 130 may be located at any other suitable location on the surgical loading unit 100, such as within or on the anvil assembly 108 or the suture cartridge assembly 110. The memory 130 is configured to transmit the presence of the surgical loading unit 100 and one or more operating parameters of the surgical loading unit 100 to the handle assembly 12 via electrical contact or wireless connection (e.g., near-field communication) when the surgical loading unit 100 is engaged with the adapter assembly 14.

[0039] Memory 130 may contain an EEPROM, EPROM, or any suitable non-transitory memory chip storing a program or instruction set for the operation of surgical loading unit 100. Such a program may store operating parameters of surgical loading unit 100, such as firing parameters required for successfully applying staples or clips to tissue. The firing parameters stored in memory 130 may include staple firing speed of surgical loading unit 100, staple firing force of surgical loading unit 100, clamping speed of end effector assembly 104 of surgical loading unit 100, and / or clamping force of end effector assembly 104 of surgical loading unit 100. Other operating parameters may be stored in memory 130 of surgical loading unit 100, such as tissue thickness indication or blade retraction speed. Software updates or revisions may also be stored in memory 130 to allow modification or complete redesign of memory 4 stored in handle assembly 12. Figure 1 The software in ).

[0040] This disclosure provides a plurality of surgical loading units 100, each configured for use on a specific type of tissue (e.g., liver, lung, heart, gastrointestinal tract, etc.) and / or during a specific type of surgical procedure (e.g., hepatectomy, gastrointestinal anastomosis, lesion resection). Thus, each of the loading units 100 has a discrete set of operating parameters unique to the type of tissue on which the selected loading unit 100 is to be used and / or the type of surgical procedure to be performed by the surgical loading unit 100. The operating parameters can override operating parameters stored in a program in a handle assembly 12, such that when a selected loading unit 100 is coupled to the handle assembly 12, a preset program in the handle assembly 12 for operating the surgical loading unit is overridden and directed to execute the operating parameters stored in the memory 130 of the selected surgical loading unit 100. It is conceivable that while each of the loading units 100 has unique operating parameters stored therein, the surgical loading units 100 may have identical structural components.

[0041] The memory 130 of the surgical loading unit 100 can also be configured to provide data about the surgical loading unit 100 to the processor 2 of the handle assembly 12 in response to electromechanically coupling the surgical loading unit 100 to the handle assembly 12. The data may include the serial number of the surgical loading unit 100, the type of the surgical loading unit 100, the size of the surgical loading unit 100, the size of the suture used in the surgical loading unit 100, information identifying whether the surgical loading unit 100 has been fired, the maximum number of uses of the surgical loading unit 100, the length of the firing stroke of the surgical loading unit 100, and at least one combination thereof. Knowing the length of the firing stroke of the surgical loading unit 100 allows the processor 2 to determine when to stop firing the surgical loading unit 100. The firing stroke may include the length of the suture thread, the cutting line of the scalpel (if the instrument has a cutting line), or simply the end of the desired stroke for the firing member.

[0042] During operation, a specific surgical loading unit 100 is selected based on the type of surgical procedure to be performed and / or the type of tissue being operated on. For example, if the surgical procedure involves liver resection, a surgical loading unit 100 with operating parameters suitable for removing liver tissue is selected. Because liver tissue is highly vascularized and thick, the surgical loading unit 100 for liver resection can be pre-programmed with instructions that, when executed, result in a rapid and constant suture firing rate regardless of the sensed tissue thickness. If another type of tissue or surgical procedure is to be performed, a loading unit equipped with appropriate operating parameters will be selected instead of the surgical loading unit 100 for liver resection.

[0043] Connect the selected surgical loading unit 100 to the adapter assembly 14 ( Figure 1 When modifying the operation of surgical suture instrument 10, in particular, refer to... Figure 4 In step 200, instructions or programs are loaded from the memory 130 of the surgical loading unit 100. Figure 2 ) transmits to the processor 2 of the electrically powered handle assembly 12 ( Figure 1 In step 202, the program stored in the memory 4 of the handle assembly 12 is overwritten with instructions from the memory 130 of the surgical loading unit 100. Without overwriting from instructions from the surgical loading unit 100, when executed by the processor 2, the program of the handle assembly 12 will cause the surgical suture instrument 10 to automatically and dynamically adjust its firing speed based on sensed tissue thickness.

[0044] In step 204, the instruction guidance processor 2 of the surgical loading unit's memory changes the operation of the adapter assembly 14 or the handle assembly 12 from a preset operating mode to a unique operating mode. The unique operating mode adjusts how the handle assembly 12 or the adapter assembly 14 performs the functions of the surgical loading unit 100. For example, when the surgical loading unit 100 for liver resection is attached to the adapter assembly 14, the instruction guidance processor 2 from the surgical loading unit 100 fires the suture staples into the liver tissue at a constant and rapid rate, rather than adjusting the firing rate based on tissue thickness to minimize bleeding during the surgical procedure.

[0045] Although adapter assembly 14 and surgical loading unit 100 have been described, different adapter assemblies configured for use with different surgical loading units and / or different surgical loading units configured for use with adapter assembly 14 can also be used with handle assembly 12. Suitable surgical loading units configured for use with adapter assembly 14 and / or other adapter assemblies that can be used with energized handle assembly 12 include surgical loading units configured for performing endoscopic gastrointestinal anastomosis (EGIA) procedures (e.g., surgical loading unit 100 or multipurpose loading unit (“MULU”) (not shown)), surgical loading units configured for performing end-to-end anastomosis (EEA) procedures, transverse suture loading units, and curved loading units.

[0046] Those skilled in the art will understand that the apparatuses and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments. It is anticipated that elements and features shown or described in connection with one exemplary embodiment may be combined with elements and features of another exemplary embodiment without departing from the scope of this disclosure. Similarly, those skilled in the art will understand further features and advantages of this disclosure based on the embodiments described above. Accordingly, this disclosure is not limited to what has been specifically shown and described, except as indicated by the appended claims.

Claims

1. A surgical loading unit for use with a surgical suture instrument, the surgical loading unit comprising: Stitching staple cartridge assembly; An anvil assembly, which is operatively connected to the staple cartridge assembly; as well as A memory associated with at least one of the staple cartridge assembly or the anvil assembly, the memory having instructions stored therein, which, when executed, guide the processor to adapt the operation of the adapter assembly or handle assembly from a preset operating mode to a unique operating mode, wherein the preset operating mode includes automatically adjusting the staple firing rate of the surgical loading unit based on sensed tissue thickness, and the unique operating mode includes setting a constant staple firing rate of the surgical loading unit.

2. The surgical loading unit according to claim 1, wherein the memory further comprises data related to the surgical loading unit stored therein.

3. The surgical loading unit according to claim 2, wherein the data includes at least one of the following: serial number of the surgical loading unit, type of the surgical loading unit, size of the surgical loading unit, size of the suture staple contained in the surgical loading unit, information identifying whether the surgical loading unit has been fired, length of the firing stroke of the surgical loading unit, or maximum number of uses of the surgical loading unit.

4. A surgical suturing instrument, comprising: The handle assembly includes: A memory containing instructions stored therein; and A processor configured to execute the instructions; and A surgical loading unit configured to be coupled to the handle assembly, the surgical loading unit comprising: Stitching staple cartridge assembly; Anvil assembly, operably coupled to the staple cartridge assembly; and The memory has instructions stored therein, which, when executed by the processor of the handle assembly, override the instructions stored in the memory of the handle assembly and guide the processor to adapt the operation of the adapter assembly or the handle assembly from a preset operating mode to a unique operating mode, wherein the preset operating mode includes automatically adjusting the suture firing speed of the surgical loading unit based on sensed tissue thickness, and the unique operating mode includes setting a constant suture firing speed of the surgical loading unit.

5. The surgical suturing instrument of claim 4, wherein the memory of the surgical loading unit further comprises data related to the surgical loading unit stored therein.

6. The surgical suturing instrument of claim 5, wherein the data includes at least one of the following: serial number of the surgical loading unit, type of the surgical loading unit, size of the surgical loading unit, size of the suture staple, information identifying whether the surgical loading unit has been fired, length of the firing stroke of the surgical loading unit, or maximum number of uses of the surgical loading unit.

7. The surgical suturing instrument of claim 4, further comprising an adapter assembly configured to interconnect the surgical loading unit and the handle assembly.

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