Indirect cutting line end detection in endoscopic cutter that accomplishes tool-free characterization
By optimizing the design and algorithmic control of the endoscopic cutter and accurately detecting and controlling the cutting line length, the problem of maximizing the cutting line length in the existing technology is solved, and complete suturing and cutting of the tissue is achieved.
Patent Information
- Application Number
- CN202510320220.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2024-03-18
- Filing Date
- 2025-03-18
- Publication Date
- 2025-09-19
AI Technical Summary
During the firing process of existing endoscopic surgical staplers, it is difficult to ensure the maximization of the cutting line length and the staple line length, resulting in incomplete suturing or cutting of tissues.
By optimizing the design of the endoscopic cutter, using an algorithm to detect the end of the cutting line, and combining motor control and buffer technology, we ensure that the cutting blade slows down when approaching the end of the cutting line, and accurately control the cutting line length.
It achieves precise control of the cutting line length without the need for sensors, ensuring complete suturing and cutting of tissues, and improving the efficiency and quality of surgical operations.
Smart Images

Figure CN120661197A_ABST
Abstract
Description
Background Art
[0001] In some circumstances, endoscopic surgical instruments may be preferred over traditional open surgical devices to minimize the size of the surgical incision and reduce postoperative recovery time and complications. Therefore, some endoscopic surgical instruments may be suitable for placing the distal end effector at the desired surgical site through the cannula of a trocar. These distal end effectors (e.g., endoscopic cutters (which can be combined with graspers, cutters and staplers), graspers, cutters, staplers, clip appliers, entry devices, drug / gene therapy delivery devices, energy delivery devices using ultrasound, RF, lasers, etc.) can engage tissue in a variety of ways to achieve diagnostic or therapeutic effects. The endoscopic surgical instrument may include a shaft that extends proximally from the end effector to a handle (or manipulator attachment) portion manipulated by a clinician, or alternatively to a manipulator. Such a shaft can be inserted into a desired depth and rotated around the longitudinal axis of the shaft to facilitate positioning the end effector in the patient's body. Positioning of the end effector may be further facilitated by including one or more articulation joints or features such that the end effector can be selectively articulated or otherwise deflected in one or more degrees of freedom, such as relative to the longitudinal axis of the shaft.
[0002] The example of endoscopic surgical instrument includes surgical stapler. Some such staplers (also referred to as endoscopic cutters) can operate to clamp tissue layers, cut through the clamped tissue layers, and drive staples through the tissue layers to substantially seal the cut tissue layers together near the cut ends of the tissue layers. In such instruments, the knife that performs the cutting is also directly or indirectly connected to the sliding member, or otherwise drives / propels the sliding member, which deploys staples so that the two move together to substantially simultaneously crosscut and suture the clamped tissue. Such endoscopic surgical staplers can also be used for laparotomy and / or other non-endoscopic surgeries. By way of example only, in thoracic surgery, a surgical stapler can be inserted through a thoracotomy and thus be located between the patient's ribs to reach one or more organs, and the thoracic surgery does not use a trocar as a conduit for the stapler. Such surgery may include using a stapler to cut and close blood vessels leading to an organ (such as the lungs). For example, before removing an organ from the chest cavity, a stapler can be used to cut and close blood vessels leading to the organ. Of course, surgical staplers may be used in a variety of other situations and procedures.
[0003] In some surgeries, it may be necessary to fire along the tissue (i.e., cut and / or sew), where more than one firing is required to complete the surgery. In other words, it may be necessary to perform multiple firings in sequence along a continuous path, referred to as "marching." For surgeries involving marching, the surgical stapler end effector can be placed at the surgical site, actuated to cut and sew, removed from the surgical site for installation of a new staple cartridge, and then placed back at the surgical site for the next firing along the same path.
[0004] Each cartridge physically defines or is otherwise capable of transecting / cutting or forming a cutting line of some allowed / assigned maximum length (referred to as the cutting line length) and introduces two or more rows of staples (referred to as staple lines) of equal or different lengths extending parallel to the cutting line and having at least one staple line on either side of the cutting line. Figure 9 As shown, the nail magazine generally limits the maximum allowable nominal length of the nail line to exceed the maximum allowable length of the cutting line (not shown) on both the distal and proximal sides, for example, by a margin of 1 mm to 5 mm, thereby improving the hemostasis of the transected tissue. Since the knife that performs the cutting and the slider that deploys the nails (as described above) generally move together, the length of the deployed nail line can vary with the length of the cutting line. In addition, since the slider effectively pushes each nail upward and pushes it out into the tissue as it advances, if the slider does not reach the end of the magazine, the remaining nails may be partially but not completely deployed. Therefore, it is generally necessary to achieve the maximum cutting line length in order to fully deploy all the nails from the nail magazine.
[0005] It is therefore desirable to obtain the maximum allowable cut line length, and therefore the maximum allowable length of the staple line, when firing the stapler to ensure that the clamped tissue is properly transected and the staples are properly deployed.
[0006] Features of the present invention attempt to enable an endoscopic cutter to maximize the allowed / allocated cutting line length of a staple cartridge and the associated staple deployment. Although various surgical staplers and associated components have been manufactured and used, it is believed that no one before the inventors has manufactured or used the invention described in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS
[0007] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the general description of the invention given above and the detailed description of the embodiments given below, serve to explain the principles of the invention.
[0008] Figure 1 A perspective view of an example of an articulating surgical stapling instrument is shown;
[0009] Figure 2 Depicts Figure 1 A side view of the device;
[0010] Figure 3 Depicts Figure 1 A perspective view of an open end effector in an instrument;
[0011] Figure 4A Shown Figure 3 The end effector along Figure 3 a side cross-sectional view taken along line 4-4 of FIG. 1 , wherein the firing beam is in a proximal position;
[0012] Figure 4B Shown Figure 3 The end effector along Figure 3 a side cross-sectional view taken along line 4-4 of FIG. 1 , wherein the firing beam is in a distal position;
[0013] Figure 5 Depicts Figure 3 The end effector along Figure 3 an end cross-sectional view taken along line 5-5;
[0014] Figure 6 Depicts Figure 3 An exploded perspective view of an end effector;
[0015] Figure 7 Depicts Figure 3 a perspective view of an end effector positioned at tissue and having been actuated once in the tissue;
[0016] Figure 8 depicts a perspective view of an example of a surgical stapling instrument having an end effector with a bent, elastically deformable end section;
[0017] Figure 9 depicts a top view of the distal end of an exemplary staple cartridge showing staple apertures and cutting edge slots and cutting edges;
[0018] Figure 10 shows a block diagram of a system for operating a surgical stapling instrument according to some embodiments;
[0019] Figure 11 Shown according to some embodiments Figure 10 A more detailed block diagram of the control circuit;
[0020] Figure 12 A diagram depicting a method according to some embodiments is shown. Figure 10 and Figure 11 A flow chart of the operation of the control circuit;
[0021] Figure 13 A diagram depicting a method according to some embodiments is shown. Figure 10 and Figure 11 A flowchart of an alternative operation of the control circuit;
[0022] Figure 14 depicts a perspective view of the jaws of a surgical stapling instrument including a stop inserted into a recess therein, according to some embodiments;
[0023] Figure 15 depicts a perspective view of a stop for insertion into a recess of the jaws of a surgical stapling instrument, according to some embodiments;
[0024] Figure 16 depicts an exploded view of an alternative stop and lower jaw of a surgical stapling instrument according to some embodiments;
[0025] Figure 17 Depicted is a perspective view of a distal end of an end effector of a surgical stapling instrument having a stapling insert inserted into a recess in a lower jaw thereof, according to some embodiments. Figure 16 and
[0026] Figure 18 Graph depicting exemplary forces applied at the distal end of a drive train during transection of tissue in an attempt to maintain a set displacement rate over the distance displaced thereby, according to some embodiments.
[0027] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be carried out in a variety of other ways, including those not necessarily shown in the drawings. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several aspects of the invention and, together with the description, serve to explain the principles of the invention; it should be understood, however, that the invention is not limited to the precise arrangements shown. DETAILED DESCRIPTION
[0028] The following description of certain examples of the present technology should not be used to limit the scope of the present technology. Other examples, features, aspects, embodiments, and advantages of the present technology will become apparent to those skilled in the art from the following description, which is provided by way of example, which is one of the best modes contemplated for implementing the present technology. As will be appreciated, the technology described herein is capable of other different and obvious aspects, all of which do not depart from the present technology. Accordingly, the drawings and description should be regarded as illustrative in nature and not restrictive.
[0029] For clarity of the disclosure, the terms "proximal" and "distal" are defined herein relative to a human or robotic operator of a surgical instrument. The term "proximal" refers to a position of an element that is closer to a human or robotic operator of a surgical instrument and further away from a surgical end effector of the surgical instrument. The term "distal" refers to a position of an element that is closer to a surgical end effector of a surgical instrument and further away from a human or robotic operator of the surgical instrument. In addition, the terms "upper," "lower," "lateral," "transverse," "bottom," and "top" are relative terms to provide additional clarity to the description of the figures provided below. Therefore, the terms "upper," "lower," "lateral," "transverse," "bottom," and "top" are not intended to unnecessarily limit the invention described herein.
[0030] Furthermore, the terms "about," "approximately," "substantially," and the like, as used herein in connection with any numerical value, numerical range, and / or geometric / positional quantification, are intended to encompass the exact value or quantification recited, as well as a suitable tolerance such that the recited feature or combination of features can be used for the intended purpose described herein. For example, "substantially parallel" encompasses nominally parallel structures.
[0031] As used herein in conjunction with the various examples of end effector jaw tips, a tip described as "angled," "curved," or "bent" encompasses tip configurations in which the longitudinal path (e.g., linear or arcuate) along which the tip extends is non-coaxial and non-parallel to the longitudinal axis of the jaw body; in particular, configurations in which the longitudinal tip path extends distally toward the opposing jaws. Conversely, a tip described as "straight" encompasses tip configurations in which the longitudinal axis of the tip is substantially parallel or coaxial with the longitudinal axis of the jaw body.
[0032] Figures 1 to 7 An example of a surgical stapling and severing instrument 10 is depicted, which is sized to be inserted through a trocar cannula or incision (e.g., a thoracotomy, etc.) into a surgical site of a patient to perform a surgical procedure. The instrument 10 of this example includes a handle portion 20 connected to a shaft 22, which terminates distally in an articulation joint 11, which is further coupled to an end effector 12. Once the articulation joint 11 and end effector 12 are inserted through the cannula channel of the trocar, the articulation joint 11 can be remotely articulated by an articulation control 13, as shown. Figure 1, such that the end effector 12 can be deflected in one or more directions / degrees of freedom from the longitudinal axis (LA) of the shaft 22 at a desired angle (α), referred to as a "pose." The end effector 12 of this example includes a lower jaw 16 (also referred to herein as a cartridge jaw) and an upper jaw in the form of a pivotable anvil jaw 18, the lower jaw including a staple cartridge 37. As described elsewhere herein, in robotic applications, the handle portion 20 can be replaced with a suitable adapter for coupling the instrument 10 to a robotic arm.
[0033] Unless otherwise described, the term "pivot" (and variations thereof) as used herein encompasses, but is not necessarily limited to, pivotal movement about a fixed axis. For example, in some versions, anvil jaw 18 can pivot about an axis defined by a pin (or similar feature) that slidably translates along an elongated slot or channel as anvil jaw 18 moves toward lower jaw 16. Such translation can occur before, during, or after the pivotal motion. It should therefore be understood that such combinations of pivotal and translational movement are encompassed by the term "pivot" and variations thereof as used herein.
[0034] The handle portion 20 includes a pistol grip 24 and a closure trigger 26. The closure trigger 26 is capable of pivoting toward the pistol grip 24 to cause the anvil jaw 18 to clamp or close toward the lower jaw 16 of the end effector 12. This closure of the anvil jaw 18 can be provided by a closure tube 32 and a closure ring 33, both of which translate longitudinally relative to the handle portion 20 in response to pivoting the closure trigger 26 relative to the pistol grip 24. The closure tube 32 extends along the length of the shaft 22; and the closure ring 33 is positioned distal to the articulation joint 11. The articulation joint 11 is operable to transmit / transmit longitudinal movement from the closure tube 32 to the closure ring 33.
[0035] like Figure 2 As shown, the handle portion 20 also includes a firing trigger 28. The instrument 10 also includes a drive train or driver that includes one or more driving and / or driven components, including an elongated drive member (not shown), such as a shaft, rod, or beam, extending longitudinally through the shaft 22, which transmits / transfers longitudinal or rotational firing motion from the handle portion 20 (e.g., from a trigger and / or motor included therein) to the firing beam 14 of the end effector 12. In some articulated instruments 10 that enable the end effector 12 to be set to different positions relative to the shaft 22, the drive train may also include one or more flexible components / connectors that pass through the articulation joint 11 and enable the firing motion to be transmitted / transferred therethrough regardless of its posture.
[0036] In manually actuated instruments 10, the firing motion is generated via actuation of a firing trigger 28, which longitudinally advances / displaces the drive train (i.e., the proximal end of the elongated drive member) and thereby advances / displaces the firing beam 14. In motorized instruments, in which a motor (not shown) may be located in the handle or manipulator, the firing motion is generated via operation of a motor, which is coupled to the drive train and may be activated in response to actuation of the firing trigger 28 or other input actuated by a user, with the firing motion being rotationally and / or linearly / longitudinally translated via the drive train and thereby advancing / displacing the firing beam 14.
[0037] This distal translation of the firing beam 14 causes the tissue clamped in the end effector 12 to be stapled and severed, as will be described in greater detail below.
[0038] like Figures 3 to 6 As shown, the end effector 12 employs a firing beam 14 comprising a transversely oriented upper pin 38, a firing beam cap 44, a transversely oriented middle pin 46, and a distally located knife / cutting edge 48. The upper pin 38 is positioned within and is translatable within the longitudinal anvil slot 42 of the anvil jaw 18. The firing beam cap 44 is engaged by extending the firing beam 14 through the lower jaw slot 45 ( Figure 4B 49 and slidably engage the lower surface of the lower jaw 16, which has a lower jaw slot formed therethrough. The middle pin 46 slidably engages the top surface of the lower jaw 16, thereby cooperating with the firing beam top cover 44. As will be described, as the knife / cutting edge 48 advances through the magazine slot 49, the lower portion of the cutting edge 48 directly or indirectly engages the slider 41 to push the slider 41 forward. As used herein, the cutting edge 48 refers to the entire cutting edge 48 assembly, including the sharp edge that moves through the magazine slot 49 and actually engages / cuts tissue, as well as the upper and lower portions that engage the slots 42, 45 in the upper jaw 18 and the lower jaw 16 (which guide the cutting edge 48 as it advances distally and retracts proximally), and the portion that directly or indirectly engages and pushes the slider 41. In some embodiments, the cutting edge 48 directly engages / pushes the slider 41. In an alternative embodiment, one or more intermediate drive components may be implemented between the slider 41 and the portion of the cutting edge 48 that engages and pushes the slider 41. In this particular implementation, the cutting edge 48 engages / pushes the slider 41 indirectly, i.e., the cutting edge 48 engages / pushes the one or more intermediate drive components, which in turn engage / pushes the slider 41.
[0039] Figure 3 The firing beam 14 of the present example is shown positioned proximally, and the anvil jaw 18 is pivoted to an open configuration to allow an unspent staple cartridge 37 to be removably installed into the channel of the lower jaw 16. Figures 5 and 6As best seen in FIG, the staple cartridge 37 of this example includes a cartridge body 70 exhibiting an upper deck 72 coupled to a lower cartridge tray 74. Figure 3 As best seen in FIG, the vertical slot 49 extends longitudinally through a portion of the staple cartridge body 70. Figure 3 As best seen in FIG, three rows of nail holes 51 are formed through the upper deck 72 on each lateral side of the vertical slot 49. Figures 4A to 6 As shown, the wedge sled 41 and the plurality of staple drivers 43 are captured between the cartridge body 70 and the tray 74, with the wedge sled 41 located proximal to the staple drivers 43. The wedge sled 41 is movable longitudinally within the staple cartridge 37, while the staple drivers 43 are movable vertically within the staple cartridge 37. The staples 47 are also positioned within the cartridge body 70 above the corresponding staple drivers 43. Each staple 47 is driven vertically within the cartridge body 70 by the staple driver 43 to drive the staple 47 outward through the associated staple hole 51. Figures 4A to 4B and Figure 6 As best seen in FIG, wedge sled 41 presents an inclined cam surface that urges staple drivers 43 upwardly as wedge sled 41 is driven distally through staple cartridge 37 .
[0040] By advancing the closure tube 32 and the closure ring 33 distally so that the end effector 12 Figures 4A to 4B In the depicted closed position, the firing member in the form of the firing beam 14 is advanced distally into engagement with the anvil jaw 18 by causing the upper pin 38 to enter the longitudinal anvil slot 42. When the firing trigger 28 or motor is actuated, the pusher block 80 (located at the distal end of the firing beam 14) is actuated as the firing beam 14 is advanced distally through the staple cartridge 37. Figure 5 During such firing, the cutting edge 48 of the firing beam 14 enters the vertical slot 49 of the staple cartridge 37, thereby severing the tissue clamped between the staple cartridge 37 and the anvil jaw 18. Figures 4A to 4B As shown, the intermediate pin 46 and the push block 80 together actuate the staple cartridge 37 by entering the vertical slot 49 in the staple cartridge 37, thereby driving the wedge sled 41 into upwardly thrusting contact with the staple driver 43, which in turn drives the staples 47 outwardly through the staple holes 51 and into engagement with the staple forming pockets 53 ( Figure 3 ) to form contact. Figure 4B The firing beam 14 is depicted fully translated distally after severing and stapling tissue. Figures 4A to 4B The nail forming recess 53 is intentionally omitted in the view in FIG. Figure 3 From Figure 5 The anvil jaw 18 is intentionally omitted from the view of FIG.
[0041] Figure 7The end effector 12 is shown having been actuated through tissue 90 by a single firing stroke. Figure 7 The end effector 12 is shown in Figure 16. The end effector 12 is shown in Figure 17. The end effector 12 is shown in Figure 18. The end effector 12 is shown in Figure 19. The end effector 12 is shown in Figure 19. The end effector 12 is shown in Figure 19. The end effector 12 is shown in Figure 19. The end effector 12 is shown in Figure 19. The end effector 12 is shown in Figure 19. The end effector 12 is shown in Figure 19. The end effector 12 is shown in Figure 19. The end effector 12 is shown in Figure 19. The end effector 12 is shown in Figure 19. The end effector 12 is shown in Figure 19. The end effector 12 is shown in Figure 19. The end effector 12 is shown in Figure 19. The end effector 12 is shown in Figure 19. The end effector 12 is shown in Figure 19.
[0042] The instrument 10 may be further constructed and operated in accordance with the teachings of any of the following references, the disclosures of which are incorporated herein by reference: U.S. Patent No. 8,210,411, entitled “Motor-Driven Surgical Instrument,” issued on July 3, 2012; U.S. Patent No. 9,186,142, entitled “Surgical Instrument End Effector Articulation Drive with Pinion and Opposing Racks,” issued on November 17, 2015; U.S. Patent No. 9,517,065, entitled “Integrated Tissue Positioning and Jaw Alignment Features for Surgical Stapler,” issued on December 13, 2016; U.S. Patent No. 9,622,746, entitled “Distal Tip Features for End Effector of Surgical Instrument,” issued on April 18, 2017; and U.S. Patent No. 9,622,746, entitled “Lockout Feature for Movable Cutting Member of Surgical Instrument,” issued on August 1, 2017. U.S. Patent No. 9,717,497, entitled “Surgical Instrument”; U.S. Patent No. 9,795,379, entitled “Surgical Instrument with Multi-Diameter Shaft”, published on October 24, 2017; U.S. Patent No. 9,808,248, entitled “Installation Features for Surgical Instrument End Effector Cartridge”, published on November 7, 2017; U.S. Patent No. 9,839,421, entitled “Jaw Closure Feature for End Effector of Surgical Instrument”, published on December 12, 2017; U.S. Patent No. 10,092,292, entitled “Staple Forming Features for Surgical Stapling Instrument”, published on October 9, 2018;and / or U.S. Patent No. 11,871,925, entitled “Surgical Instruments with Dual Spherical Articulation Joint Arrangements,” issued on January 16, 2024. ;
[0043] In some cases, it may be desirable to provide the user with better visualization of the end effector 12. Specifically, after inserting the end effector 12 into the surgical site, the user may rotate the shaft 22 of the instrument 10 during the procedure. The end effector 12 is thereby also rotated. As the end effector 12 rotates, the user may wish to be able to see the surgical site. For example, the user may want to see the interface or point of contact between the tissue 90 and the end effector 12. Because the end effector 12 can be rotated about the longitudinal axis (LA) relative to the handle portion 20, the user can see the lower jaw 16 of the end effector instead of the anvil jaw 18 when viewing the surgical site. Alternatively, the end effector 12 can be rotated so that the anvil jaw 18 is visible to the user when the user is viewing the end effector 12. It may be desirable to provide the user with more than Figure 1 The instrument 10 can provide visibility of the surgical site.
[0044] For example, in the case of some surgical procedures in which vessels carrying body fluids are transected and sutured, it may be desirable to visually confirm that the anvil jaw 18 and the lower jaw 16 completely cover the vessel to be cut so that the vessel can be completely cut and sutured in a single action. In other words, the user may want to avoid a situation in which only a portion of the vessel is cut and sutured. Therefore, some visual monitoring and / or feedback means may be desired so that the user will know that the end effector 12 has been properly positioned in the surgical site so that the anvil jaw 18 and the lower jaw 16 fully clamp the vessel. A potential way to monitor the surgical site may include improving visualization of the area adjacent to the distal ends of the lower jaw 16 and the anvil jaw 18. Furthermore, not only may visualization of the distal end of the end effector 12 be desired, but it may also be desired to construct the end effector 12 so that the distal end of the anvil jaw 18 is configured to push tissue (e.g., a large vessel) proximally into the space between the anvil jaw 18 and the lower jaw 16 as the anvil jaw 18 closes toward the lower jaw 16.
[0045] In addition to the foregoing, the end effector 12 and versions of the instrument 10 incorporating the end effector 12 may be constructed and operated in accordance with at least some of the teachings of: U.S. Patent No. 9,186,142, entitled “Surgical Instrument End Effector Articulation Drive with Pinion and Opposing Racks,” issued on November 17, 2015, the disclosure of which is incorporated herein by reference; U.S. Patent No. 9,717,497, entitled “Lockout Feature for Movable Cutting Member of Surgical Instrument,” issued on August 1, 2017, the disclosure of which is incorporated herein by reference; U.S. Patent No. 9,517,065, entitled “Integrated Tissue Positioning and Jaw Alignment Features for Surgical Stapler,” issued on December 13, 2016, the disclosure of which is incorporated herein by reference; and U.S. Patent No. 9,517,065, entitled “Integrated Tissue Positioning and Jaw Alignment Features for Surgical Stapler,” issued on December 12, 2017. and / or U.S. Patent 9,839,421, entitled “Surgical Instrument with Multi-Diameter Shaft,” issued on April 18, 2017, the disclosure of which is incorporated herein by reference; U.S. Patent 9,622,746, entitled “Distal Tip Features for End Effector of Surgical Instrument,” issued on April 18, 2017, the disclosure of which is incorporated herein by reference; U.S. Patent 10,092,292, entitled “StapleForming Features for Surgical Stapling Instrument,” issued on October 9, 2018, the disclosure of which is incorporated herein by reference; U.S. Patent 9,795,379, entitled “Surgical Instrument with Multi-Diameter Shaft,” issued on October 24, 2017, the disclosure of which is incorporated herein by reference; and / or U.S. Patent 9,808,248, entitled “Installation Features for Surgical Instrument End Effector Cartridge,” issued on November 7, 2017, the disclosure of which is incorporated herein by reference.Additional modifications that may be incorporated into end effector 212 are described in greater detail below.
[0046] Figure 8 Another example of an instrument 310 configured to be capable of being used as a surgical stapler is shown. The instrument 310 includes a handle portion 320 and a shaft 322. The instrument 310 has a modular configuration so that the shaft 322 can be selectively removed from the handle portion 320 and can be attached to the handle portion. The instrument 310 is constructed similarly to the instrument 10 so that the operability and use of the instrument 310 are the same as those described above for the instrument 10, wherein the additional feature of the instrument 310 is the modular configuration. Through its modular configuration, the instrument 310 provides a method for replacing the end effector. This change can be made in the end effector to replace an otherwise worn end effector, or different end effector configurations can be provided based on the procedure or user preference. In addition to or in lieu of the foregoing, features operable to provide a modular configuration of the instrument 310 may be constructed in accordance with at least some of the teachings of U.S. Patent No. 10,182,813, issued on January 22, 2019, entitled “Surgical Stapling Instrument with Shaft Release, Powered Firing, and Powered Articulation,” the disclosure of which is incorporated herein by reference. Other suitable components, features, and configurations for providing the instrument 310 with a modular configuration will be apparent to one of ordinary skill in the art in view of the teachings herein. Furthermore, one of ordinary skill in the art will appreciate that the instrument 10 may be modified to incorporate a modular configuration, as shown and described with respect to the instrument 310 or other instruments incorporated herein by reference, in view of the teachings herein. The instrument 310 also includes a distal tip 319 that can be flexible (moves when force is applied and returns to its initial position when force is not applied), malleable (moves to a position when force is applied and remains in that position when force is not applied), or discretely articulated to one or more discrete / low-energy positions when force is applied and retained in that discrete position via a retaining mechanism. The tip 319 not only provides visualization of the distal end of the end effector 12, but also enables the end effector 12 to enable the distal end of the anvil jaw 18 to be used to push tissue (e.g., a large vessel) proximally into the space between the anvil jaw 18 and the lower jaw 16 as the anvil jaw 18 closes toward the lower jaw 16.
[0047] It should be understood that the end effector 312 may be used instead of Figure 1The end effector 12 shown. In some versions, the end effector 312 may be formed integrally with the shaft 22, or alternatively, they may form the end effector separately and then be combined. In some versions, the end effector 312 may be provided for use in a robotic system. In such a robotic system, a modular shaft 322 having an end effector 312 may be attachable to a portion of the robotic system for use, such that the handle portion 320 is replaced by a component of the robotic system that provides a mechanism (i.e., a motor) to actuate the firing stroke as described above. However, in other examples, the end effector 312 may be adapted for use with a robotic system in a manner in which the end effector 312 is connected to the robotic system without having to connect the entire modular shaft 322. Other ways of incorporating an end effector having an angled, elastically deformable anvil tip into a user-operated or robot-operated instrument will be apparent to one of ordinary skill in the art in light of the teachings herein.
[0048] The disclosed embodiments are directed to ensuring that the length of a stapler / cutter's cut line is maximized without having to first characterize the tool, thereby reducing the amount of force applied to accomplish the cut line.
[0049] An algorithm and specific implementation thereof are disclosed that uses the proximal cutting edge and firing force information freely available from the control system of the surgical instrument 10 to detect the end of the cutting line, without requiring a sensor and / or switch disposed in the end effector 12 to sense when the end of the firing stroke is reached.
[0050] In one embodiment, as the cutting edge 48 travels down the slot 49 of the cartridge 37 and approaches an area near the end of the cutting line 1804, the motor of the surgical instrument 10 slows down so as not to strike the end of the cutting line at a high velocity 1806, and a buffer begins to build data values representing the real-time force / torque applied by the motor to maintain the current displacement rate and the corresponding current position / displacement of the drive train produced by the motor 1808. The buffer is an array of the real-time position of the cutting edge 48 and the real-time cutting edge 48 force provided by, for example, the motor's encoder and torque sensor, which can then form a graph of force versus displacement distance from which a predicted force can be extrapolated as described herein. Figure 18A graph 1800 depicts an exemplary force applied by the motor to attempt to maintain a particular displacement rate versus displacement distance (which may be stored in a buffer array). As the cutting blade 48 approaches the end of the cutting line 1810, a best fit function of force and position is performed on the stored array values in real time via interpolation and / or smoothing using a linear, best fit curve, or quadratic fit function. This provides information about the slope of force versus position, i.e., how the firing force is trending relative to the cutting blade 48 position, and enables projection of that trending force on subsequent travel increments, enabling preemptive action prior to or at the end of the cutting line as described herein. Thereafter, projections are made into the future using the best fit function for, for example, 3 or more discrete time horizons at each processing cycle time in order to predict the cutting blade 48 force into the future using a priori information. This projection then takes into account the cutting blade 48 force required to transect the tissue at the monitored distance based on the properties of the tissue and the compliance / loss of the instrument, and anticipates the cutting blade 48 force expected to be required to complete the cutting line through the remaining tissue. As Figure 18 As depicted, if the actual cutting blade 48 force 1802 sensed by the motor exceeds a threshold value (e.g., 10% to 20% of the expected force) as the cutting blade 48 advances, the algorithm notifies the motor that a higher-than-expected force has been detected, indicating that the end of the permitted cutting line has been reached, i.e., the slider has been pushed into the end of the cartridge or into another physical obstruction, and a stop has been requested. Thus, the accuracy of reaching the end of the cutting line is improved with minimal deviation (e.g., <0.2 mm) in situations with varying tissue thicknesses and varying end effector postures.
[0051] In an alternative embodiment, as the cutting blade 48 moves downward along the cartridge 37 and approaches the distal end of the cartridge 37 (the area near the end of the cutting line), the speed of the cutting blade 48 decreases. The firing force and position of the cutting blade 48 determined by the motor control circuit are sampled, and the change (dF / dx) of the firing force of the cutting blade 48 relative to its position change is calculated. The position and dF / dx of the cutting blade 48 are each fed into a fuzzy logic set (e.g., one set for position and one set for dF / dx). These fuzzy logic sets convert two inputs into six fuzzy logic membership functions. Fuzzy logic rules (e.g., five rules) combine the outputs of fuzzy logic membership functions (e.g., six functions). The output of each rule is a value representing how much the rule wants to continue or stop the movement of the cutting blade 48. The outputs of the fuzzy logic rules are combined to produce a single binary result: continue or stop. If the result is to continue, the cutting blade 48 continues to move, and the firing force and position are sampled and sent back through the fuzzy logic cutting line algorithm. If the result is stop, the motor is instructed to stop.
[0052] More specifically, as described elsewhere herein, the staple cartridge 37 includes a slot 49 through which the knife / cutting edge 48 of the end effector 12 travels. Generally, the slot 49, along with the cartridge body 37, will define the maximum distance that the cutting edge 48 can travel and thus define the maximum length of the cut line produced by the cutting edge 38. Different types of staple cartridges 37 can achieve different cut line lengths, and it may be important to ensure that the maximum allowable cut line length is obtained, for example, to ensure that tissue is completely transected, etc. Additionally, as described herein, since the cutting edge 48 also directly or indirectly advances the slider 41 of the deploying staple 47 of the staple cartridge 37, obtaining the maximum cut line length also ensures that the distal staple 47 is properly and fully deployed and formed, thus ensuring that the maximum staple line length is also achieved.
[0053] The maximum cut line length, the maximum cut line length is typically less than the length of the staple line produced by the staple cartridge 37 (e.g., as Figure 9 shown by X). More specifically, to ensure hemostasis of the transected tissue, it may be important for the staple line to extend a small margin beyond the cut line both distally and proximally. As Figure 9 shown, for example, the maximum length of the cut line can be <X mm, e.g., 2 mm to 10 mm, shorter distally than the nominal staple line length X of the six parallel staple lines provided by the depicted staple cartridge 37. It should be understood that different types of staple cartridges 37 can have shorter or longer cut lines and / or staple lines, and / or have fewer or more staple lines, and / or have staple lines of different configurations.
[0054] The distance that the cutting edge 48 travels along the slot 49 controls the length of the cut line achieved. And as described elsewhere herein, the cutting edge 48 is driven by a remotely located motor (e.g., located in the handle 20 or a robotic arm) via a drive mechanism that extends through the shaft 22 and the articulation joint 11 (if present) to the end effector 12.
[0055] As will be described, the distance that the motor advances the drive mechanism or otherwise displaces the drive mechanism does not always result in the cutting edge 48 advancing / shifting the same amount through the cartridge 37, e.g., a 1 mm displacement of the motor may not result in the cutting edge 48 traveling 1 mm, and this difference can vary in the length of the cut line such that the cutting edge 48 travels, for example, 2 mm to 3 mm less than the drive distance / displacement.
[0056] This may be caused by compliance / resilience issues in one or more components of the drive mechanism / drive train, which may, for example, absorb, damp or dissipate at least a portion of the force applied by the motor, such as due to friction losses or losses due to tolerances in the components, or otherwise yield, deform or compress under the load of the force applied by the motor at the proximal end of the drive mechanism and / or the resistance encountered by the cutting edge 48 at the distal end of the drive mechanism (e.g. due to the thickness or resistance or other properties of the tissue being cut).
[0057] Furthermore, to enable articulation of the end effector 12, some components of the drive mechanism may need to be flexible so as to pass through the articulation joint 11 and remain operable regardless of the posture of the end effector 12. This can increase compliance in the overall drive mechanism. Furthermore, this increased compliance can vary depending on the posture of the end effector.
[0058] Compliance may also vary with component design, materials used, number and type of component interconnections / couplings, manufacturing tolerances, wear and tear from use, and the like.
[0059] It can be suggested that in order to maximize the cutting line length, the motor only needs to advance the drive mechanism, and thereby the cutting blade 48, until the cutting blade 48 can no longer be physically advanced further. However, the motors used in endoscopic cutters can deliver significant amounts of force, for example, in excess of 200 ft / lbs, to enable reliable cutting of different types of tissue. If the cutting blade 48 were simply driven until it encountered some physical obstruction (i.e., excessive travel), such as an impact with the end of the cartridge 37 housing (even a small fraction of the available force), the dissipation of the resulting excess force could result in unintended movement or vibration of the instrument 10 or noise from the instrument, damage to the instrument 10 (such as damage to one or more components of the motor or drive mechanism), damage to the cartridge 37 (such as a fracture (rupture) of the cartridge 37 housing), and / or partial or complete disengagement of the end effector 12 from the set posture, i.e., the impact force could overcome the force applied by the articulation mechanism (e.g., tension cable) used to hold the end effector 12 in a particular posture, thereby causing the end effector 12 to move. Any of these may cause unsettling feedback to the user, premature instrument wear or breakage, extension of the cut line into or beyond the staple line, tissue damage, and / or other patient harm.
[0060] It may also be advisable to include a sensor or switch in the end effector 12 that detects when the cutting edge 48 reaches the maximum cutting line distance and then stops the motor from advancing the drive mechanism. However, including a sensor and / or switch may complicate the design, manufacture, and / or operation of the instrument 10, for example, requiring additional components and wiring to pass these components through the end effector 12, the articulation joint 11, the shaft 22, etc., and to connect them to the control mechanism that controls the motor. This may result in increased costs and an increase in points of failure, etc.
[0061] To minimize such consequences, other firing mechanisms utilize open-loop control that requires first characterizing or otherwise calibrating the firing mechanism to determine the relationship between the distance the motor advances the drive mechanism and the resulting distance the cutting edge 48 is advanced for a given pose or other condition of the instrument 10. Because open-loop control systems do not utilize feedback, this initial characterization is important to ensure that the cut line distance is maximized but not exceeded.
[0062] However, characterizing the firing mechanism before each use may be inconvenient and may not produce an accurate indication of the relationship between the distance advanced by the motor and the resulting travel distance of the cutting edge 48. For example, changes in compliance caused by manufacturing variations, repeated use of the instrument, posture / configuration of the instrument, characteristics of the tissue being transected, alone or in combination, may affect accuracy.
[0063] The disclosed embodiments achieve a precise position of the cutting edge 48 at the end of the cutting line, e.g., not too far to prevent disarticulation or breakage of the slider, and not too short to cause partially formed staples, regardless of variations caused by the configuration / posture of the instrument 10, the compliance of its components, or the nature of the tissue being cut. The disclosed embodiments do not rely on having to correlate the actuation distance, compliance, and actual movement of the cutting edge 48, or on sensors or switches in the end effector 12 or otherwise characterizing the instrument 10 to detect the end of the cutting line.
[0064] Reference Figure 10, a block diagram of a system 1002 for operating a surgical stapling instrument 10 according to some embodiments is shown, the surgical stapling instrument 10 comprising: an end effector 12 configured to grasp tissue, the end effector 12 comprising: jaws 16, 18, the jaws including a cutting edge 48 configured to be displaced a first distance, such as a maximum allowable cartridge 37 cutting line length, from a proximal end to a distal end of the jaws 16, 18 so that at least a portion of the cutting edge 48 transects tissue grasped by the end effector, the jaws 16, 18 further configured to receive a staple cartridge 37 that can be positioned in one of the jaws 16, 18 and comprises a slide 41 and staples 47, the slide 41 configured to be displaced a second distance, such as a maximum slide travel distance or staple line length, from a proximal end to a distal end of the staple cartridge 37 to deploy the staples 47 along the transect into the tissue grasped by the end effector 12. As described elsewhere herein, the second distance can extend both proximally and distally beyond the first distance such that deployment of the staples both begins before and extends beyond the transection of the tissue, i.e., the cut line does not extend beyond the staple line, for example to promote hemostasis of the transected tissue.
[0065] The instrument 10 or manipulator also includes a motor 1004 located external to the end effector 12. The motor 1004 can be any suitable motor, electrically powered or otherwise powered by a power source (not shown), and can provide rotational or linear actuation to displace / advance a driver / drive train 1008 of the instrument 10. The drive train 1008 can include a plurality of coupled driving and / or driven components, including a drive member extending longitudinally through the shaft 22 as described above, which transfers the displacement and force applied by the motor 1004 to the cutting edge 48.
[0066] The instrument 10 and / or the manipulator may further include a driver / drive train 1008 operably coupled between the motor 1004 and the cutting edge 48, and thereby coupled between the motor and the sled 41, wherein the motor 1004 is configured to controllably displace (e.g., rotationally or linearly advance, move, or push) a controllable distance of the proximal end of the drive train 1008 to which the motor 1004 is mechanically / electromechanically coupled, thereby displacing the cutting edge 48 and thereby directly or indirectly displacing the sled 41, so as to substantially simultaneously transect tissue grasped by the end effector 12 and deploy staples 47 in the tissue along the transect on either side of the transect. In some instances, the surgical instrument 10 may include dedicated motor drivers and / or motors for firing, closing, and / or articulation.
[0067] The instrument 10 and / or the manipulator may further include a control circuit 1006 coupled to the motor 1004. Figure 11 Shown in more detail in .
[0068] In the illustrated example, the control circuit 1006 is a microcontroller and includes one or more processors 1102 (e.g., microprocessors, microcontrollers) coupled to at least one memory circuit 1104. The memory circuit 1104 stores machine-executable instructions that, when executed by the processor 1102, cause the processor 1102 to implement the various processes or algorithms described herein. The processor 1102 may be any of a variety of single-core or multi-core processors known in the art. The memory circuit 1104 may include volatile storage media and non-volatile storage media. The processor 1102 may include an instruction processing unit and an arithmetic unit. The instruction processing unit may be configured to receive instructions from the memory circuit 1104 of the present disclosure. The control circuit 1006 may include analog or digital circuits (such as, for example, a programmable logic device (PLD), a field programmable gate array (FPGA), discrete logic, or other hardware circuits, software and / or firmware, or other machine-executable instructions) to perform the functions explained in this specification. The processor 1102 may operate according to a duty cycle that may be based on the processor's clock rate, defining how often the processor may sample data or otherwise perform and / or repeat calculations (eg, using updated data).
[0069] In addition to the above, the control circuit 1006 is in signal communication 1014 with the motor 1004 (e.g., with a motor driver (not shown), a feedback system (not shown), a power source (not shown) (e.g., a battery, an ultracapacitor, or any other suitable energy source), and a sensor (not shown)), as described, which senses the force / torque applied by the motor 1004 to the drive train 1008 and the current position of the drive train, or otherwise, the amount the drive train 1008 has displaced during operation of the motor 1004.
[0070] In some examples, the control circuit 1006 can control the motor 1004 by generating a motor setpoint signal 1014. The motor setpoint signal can be provided to a motor driver, which includes one or more circuits configured to provide a motor drive signal to the motor 1004 to drive the motor 1004, as described herein. In some examples, the motor 1004 can be a brushed DC electric motor. For example, the speed of the motor 1004 can be proportional to the motor drive signal. In some examples, the motor 1004 can be a brushless DC electric motor, and the motor drive signal can include a PWM signal provided to one or more stator windings of the motor 1004. Furthermore, in some examples, the motor driver can be omitted, and the control circuit 1006 can directly generate the motor drive signal.
[0071] As described, the motor 1004 can be operated to advance / displace the drive train 1008 at a specific rate / speed with a specific force / torque. However, as the cutting edge 48 encounters resistance, or otherwise due to friction or compliance as described herein, the operation of the motor 1004 may be hindered, causing the torque / force applied by the motor 1004 to vary as the motor attempts to maintain the specified speed.
[0072] Thus, the control circuit 1006 controls the rate at which the motor 1004 attempts to displace the proximal end of the drive train 1008, and during the displacement of the proximal end of the drive train 1008, monitors or otherwise senses, detects, or determines, such as via torque / force 1010 and drive train position 1012 sensors: the position or displacement amount of the proximal end of the drive train 1008; and the linear or rotational force (torque) input to the proximal end of the drive train 1008 by the motor 1004. The current torque / force applied by the motor 1004 may be provided by a motor 1004 encoder, a motor driver, or other sensor coupled to the motor 1004 or its output (e.g., a drive shaft / rotor). The current position or displacement amount of the proximal end of the drive train 1008 may be determined via mechanical, electromechanical, optical, and / or magnetic sensors that detect the movement or current position of the proximal end of the drive train 1008. For example, the proximal end of the drive train 1008 can feature mechanical, optical and / or magnetic indicators applied thereto or integrated therewith that are detectable, such as by a mechanical switch, optical detector or Hall effect sensor, to convert movement of the proximal end of the drive train 1008 into a signal, such as a digital signal, from which the position or amount of movement / displacement of the drive train can be derived.
[0073] As described elsewhere herein, at least during displacement of the proximal end of the drive train 1008, one or more of the distance the cutting edge 48 is displaced or the force applied by the cutting edge 48 to the grasped tissue varies, e.g., can be less, than the distance the proximal end of the drive train 1008 is displaced or the force applied to the drive train by the motor 1004. This variation can depend on one or more properties of the grasped tissue and / or the degree of compliance of the drive train 1008. It should be understood that in situations where the force on the cutting edge 48 is absorbed by the compliance of the drive train, such as due to thick or resistive tissue, the excess force can be stored via the compliance and released when the force on the cutting edge 48 decreases (e.g., as the cutting edge 48 moves into thinner or less resistive tissue), thereby resulting in an increase in the force applied by the cutting edge 48 compared to the force applied by the motor 1004.
[0074] like Figure 12 、 Figure 13 and Figure 18As shown, during the displacement of the proximal end of the drive train 1008, the control circuit 1006 causes the motor 1004 to: displace the proximal end of the drive train 1008 a third distance 1804 (e.g., 70 mm to 74 mm) with a force input to the proximal end of the drive train 1008, the third distance being less than the first distance (i.e., less than the maximum cutting line length), and the force varying so as to substantially maintain a first rate (e.g., Y mm / second) at which the motor 1004 attempts to displace the proximal end of the drive train 1008 (blocks 1202 to 1212, 1302 to 1306). The third distance and / or the first rate may be adjustable and variable so as not to impede the surgical procedure in which the instrument 10 is being used, while allowing sufficient remaining distance / time for the remainder of the disclosed algorithm to calculate a suitable predicted force, as will be described.
[0075] After displacing the third distance, during the displacement of the proximal end of the drive train 1008, the control circuit 1006 causes the motor 1004 to: continue to displace the proximal end of the drive train 1008 a fourth distance 1808, e.g., 2 mm to 4 mm (a displacement of 72 mm to 78 mm), with a force that varies so as to substantially maintain a second rate (e.g., <Y mm / second) at which the motor 1004 attempts to displace the proximal end of the drive train 1008, the second rate being a deceleration rate that is less than the first rate, such as 5% to 15% of the initial drive rate, during which the control circuit 1006 calculates a predicted force that needs to be input to the proximal end of the drive train 1008 so as to substantially maintain the second rate at which the motor 1004 attempts to displace the proximal end of the drive train 1008 over a subsequent further distance (e.g., the next 1 mm to 4 mm) (blocks 1214 to 1238, 1308 to 1328). As will be described, the calculation of the predicted force may be performed repeatedly, and the frequency of repetition may depend on the duty cycle of the processor 1102. It should be understood that the control circuit 1006 may allow, for example, an adjustable displacement margin 1806 over a 1 mm to 4 mm distance from 70 mm to 74 mm, over which the rate of the motor 1004 is allowed to slow down / decelerate from the first rate to the second deceleration rate before the process of calculating the predicted force begins, so as to allow the displacement rate to reach a steady state, e.g., such that the drop in torque value due to deceleration is excluded from subsequent calculations. The fourth distance and / or the second rate may be adjustable so as not to impede the surgical procedure in which the instrument 10 is being used, while allowing sufficient remaining distance / time for the remainder of the disclosed algorithm to calculate a suitable predicted force, as will be described. The number of subsequent distances or increments over which the required force is predicted may depend on the particular implementation and on the amount of time determined to be required to stop the motor 1004 and the amount of time actually taken to stop the advancement of the motor 1004 and the cutting edge 48.
[0076] During the displacement of the proximal end of the drive train 1008, the control circuit 1006 also causes the motor 1004 to continue to displace the proximal end of the drive train 1008 with the force input to the proximal end of the drive train 1008, the force varying so as to substantially maintain a second rate at which the motor 1004 attempts to displace the proximal end of the drive train 1008, such as <Y mm / sec, until, for example, over a remaining displacement of 70 mm to 77 mm, the force input to the proximal end of the drive train 1008 is determined to exceed a threshold of the calculated predicted force (blocks 1230 to 1236, 1308 to 1328) 1802, such as by 10% to 20%, at which time the control circuit 1006 causes the motor 1004 to stop. For example, if the predicted force is calculated as 30 lbs and the monitored force exceeds 36 lbs, the motor 1004 is stopped. The rate applied by the motor 1004 may be the same as or different from the rate applied by the calculation of the predicted force. Additionally, depending on the particular implementation, different thresholds may be applied to determine when to stop the motor. The threshold may be calibrated so as to distinguish a force sensed based on only encountering thicker / more resistant tissue compared to a force sensed by impacting a cutting edge 48 or a portion thereof, or a slider 41, or an intermediate drive component between the two, of a physical obstruction (such as the physical obstructions described below) with the currently applied displacement rate, which itself stops due to impact with an end of the cartridge 37 or other obstruction. In one embodiment, the calculation of the predicted force continues until the motor 1004 stops.
[0077] In one embodiment, when the proximal end of the drive train 1008 has been displaced a maximum distance (e.g., >max mm), the control circuit 1006 causes the displacement to stop (blocks 1238, 1326), such as by stopping or disconnecting the motor 1004. This may be implemented as a safety mechanism and an absolute stop point and may be defined based on the type of cartridge 37 that can be used with the instrument 10 and their physical dimensions (i.e., the maximum allowable travel distance of the slider 41).
[0078] Once the motor 1004 has stopped, the control circuit 1006 can activate an indicator or otherwise generate a signal indicating that the end of the cutting line has been reached. Then, the cutting edge 48 can be retracted automatically or manually for removal and, if desired, subsequent firing of the instrument 10.
[0079] Once the motor 1004 has stopped, the control circuit 1006 can automatically direct the motor 1004 to reverse and retract the proximal end of the drive train 1008 and, thereby, retract the cutting edge 48 so that, for example, the jaws 16, 18 of the end effector 12 can be opened or otherwise the end effector 12 can be removed from the body, such as so that a used cartridge 37 can be removed and a new cartridge 37 can be inserted.
[0080] The calculation of the expected force and the determination of when to stop the motor 1004 can be implemented in different ways. Figure 12 As shown, calculation of the expected force may include creating an array of current values of the monitored forces and corresponding positions as the proximal end of the drive train 1008 is displaced over a fourth distance, such as Figure 18 As shown, the array can be plotted as a graph of force versus displacement distance (blocks 1220 to 1222); the array is stored in the memory buffer 1104 (block 1224); a linear fit curve or a best fit curve is fitted to the stored array of monitored force and corresponding position values (block 1228); and a predicted force is calculated based on the projection of the fitted linear / curve onto one or more subsequent displacement increments of the drive train 1008, thereby enabling the control circuit 1006 to take proactive action when the maximum cutting line length is approached and / or achieved (block 1230). The number of values stored in the array may depend on the displacement distance over which the values are calculated, the sampling frequency or duty cycle of the processor 1102 (e.g., 2 kHz), the capacity of the memory 1104, and / or the desired accuracy of the predicted force values, which may depend on the specific implementation. It should be understood that other fitting functions may be used to determine the force trend, such as a quadratic fit function.
[0081] In an alternative embodiment, as Figure 13 As shown, the calculation of the expected force includes: as the proximal end of the drive system 1008 shifts over a fourth distance (box 1308), determining the current values of the monitored force and the corresponding position (boxes 1310, 1312), calculating the change in the monitored force over the distance of the shift (box 1314), and applying fuzzy logic to the current position and the change in the monitored force over the distance of the shift, wherein when the fuzzy logic returns a true value, the force input to the proximal end of the drive system 1008 is determined to exceed a threshold value of the calculated expected force, for example 10% to 20% (boxes 1316 to 1324).
[0082] Fuzzification takes a clear (single-valued) input and converts it into a fuzzy set (a set of values corresponding to the degree of membership of each membership function in a set of one or more membership functions). A membership function is a function that describes the extent to which an input belongs to a fuzzy set. The maximum output of each fuzzy membership function is 1, meaning that the input is completely part of that membership function. Fuzzy membership functions often overlap with each other, and when they overlap, the value of each function (corresponding to the input) should sum to 1 and represent the extent to which the input is part of each function, where 0 means that the input is not part of the function, 1 means that the input is completely part of the function, and any value in between indicates the extent to which the input is partially part of the function.
[0083] The membership functions can be represented as overlay graphs, where the range of possible input values forms the x-axis (e.g., 1 to 100), and the degree of membership of each input value to each function (e.g., 0 to 1) is plotted along the y-axis, where for any given input value, the implementation-dependent memberships in the defined membership functions must sum to 1. For example, one membership function can be defined to cover a lower bound, e.g., input values 1 to 49, and another membership function can be defined to cover an upper bound, e.g., input values 50 to 100, where the degree of membership in the lower bound function varies between 0 and 1 over the range of values 1 to 40, and the degree of membership in the upper bound function varies between 0 and 1 over the range of values 50 to 100, etc. A third intermediate bound membership function can be further defined to cover or otherwise overlap an intermediate range of input values (e.g., input values 25 to 75), where the degree of membership in the intermediate bound function varies between 0 and 1 over the range of values 25 to 75. In this example, the three membership functions must be defined so that for each input value, the sum of the membership degrees in the three functions adds up to 1.
[0084] For example, for an input value of 35, the extent to which the input value is part of the lower limit function may be 0.25, the extent to which the input value is part of the middle limit function may be 0.75, and the extent to which the input value is part of the upper limit function may be 0.00, for a total of 1.
[0085] In the disclosed embodiment, each input to the control circuit 1006 can have its own set of membership functions, where the inputs are the current displacement of the proximal end of the drive train 1008 (position or x) and the current force (F) input to the proximal end of the drive train 1008 to maintain the current rate at which the motor 1004 attempts to displace the proximal end of the drive train 1008 as a function of the change in displacement (dF / dx).
[0086] A fuzzy logic rule base describes how to combine fuzzy sets to generate an output fuzzy set. As an example, assume there are two inputs to a system, and each input has three fuzzy membership functions as described above. In this example, a rule base is created that describes the output for different combinations of the two fuzzy sets. Fuzzy logic has three operators for combining fuzzy sets: AND, OR, and NOT:
[0087] X and Y -> x*y
[0088] X or Y -> x+y – x*y
[0089] Not X->1-x
[0090] Several rules can be created using these operators. In an exemplary implementation of the disclosed embodiment, five rules are created to combine two fuzzy sets, the current displacement of the proximal end of the drive train 1008 (x) and the change in the current force (F) input to the proximal end of the drive train 1008 to maintain the current rate at which the motor 1004 attempts to displace the proximal end of the drive train 1008 as a function of the change in displacement (dF / dx):
[0091] If x is far (lower bound) or df / dx is negative (lower bound), continue.
[0092] • If x is near (upper limit) and df / dx is below threshold (middle limit), continue.
[0093] • If x is mean (mid limit) and df / dx is below threshold (mid limit), continue.
[0094] • If x is the mean (middle limit) and df / dx is above the threshold (upper limit), stop.
[0095] • If x is near (upper bound) and df / dx is above threshold (upper bound), then stop.
[0096] Each fuzzy logic rule will generate an output, and each of the outputs from the fuzzy logic rules is then combined using OR logic. This current rule base creates another fuzzy set with two membership functions: continue and stop. This fuzzy set is then defuzzified (converted into exact values) to generate a single value that determines whether to continue displacing the proximal end of the drive train 1008 or to stop the motor 1004, begin retraction, etc. In one specific implementation, defuzzification is performed using the following equation, but it should be understood that other methods of defuzzification may be used depending on the specific implementation:
[0097] Result = Stop > 500 * Continue
[0098] Where 500 is an adjustable parameter.
[0099] For example, using the following fuzzy sets:
[0100] Input_1(x){0.0,0.33,0.67}, Input_2(df / dx){0.0,0.75,0.25}
[0101] Rule output: {continue, stop}
[0102] 1: 0.0+0.0–0.0*0.0->0.0 (continue)
[0103] 2: 0.67*0.75->0.5025 (continued)
[0104] 3: 0.33*0.75->0.2475 (continued)
[0105] 4: 0.33*0.25->0.0825 (stop)
[0106] 5: 0.67*0.25->0.1675 (stop)
[0107] Combine the rules, that is, combine the two sets of rules into two outputs, continue and stop:
[0108] Rules: 1, 2, and 3:
[0109] continue
[0110] =0.0+0.5025+0.2475–0.5025*0.2475–0.0*0.5025+0.2475–0.5025*0.2475)-
[0111] >0.6256
[0112] Rules: 4 and 5:
[0113] Stop = 0.0825 + 0.1675 – 0.0825 * 0.1675 -> 0.1118
[0114] Use the above equation to combine the rules into a result:
[0115] Result = 0.1118 > 500 * 0.6256 -> False
[0116] In this example, the result ends in false, which means that the proximal end of the drive train 1008 continues to be displaced.
[0117] In one embodiment, a physical obstruction can be provided that prevents the cutting edge 48 from moving further than the obstacle, i.e., exceeding the maximum cutting line length, either alone or in conjunction with the slide 41 and / or the intermediate drive component. In one specific implementation, the physical obstruction can be constituted by the distal end of the cartridge 37 itself, which directly or indirectly, via the obstructed movement of the intermediate drive component (when present), obstructs the movement of the slide 41 and thereby obstructs further movement of the cutting edge 48. The impact of the slide 41 with the end of the cartridge 37 and the resulting sudden stop in the advancement of the cutting edge 48 can be transferred back through the drive train and to the motor 1004, thereby causing an increase in the force applied by the motor 1004 that exceeds the expected force and causes the motor 1004 to stop as described.
[0118] In an alternative embodiment, allowing the slider 41 to impact or otherwise contact the distal end of the cartridge 37 may be determined to be impractical, unsafe, or otherwise not result in sufficient force being transferred back to the motor 1004, for example, because the cartridge 37 may not be fully designed for such impact. Therefore, a separate or specified physical obstruction, such as a stop or bump, may be provided. This physical obstruction may be formed in or otherwise added to one or both of the upper jaw 18 and the lower jaw 16. In one embodiment, the physical obstruction, which may be referred to as a bump, stop, or trigger, may be placed in one or both of the upper jaw 18 and the lower jaw 16 to interrupt or prevent the advancement of the cutting edge 48 or the intermediate drive component (if present), such as by being placed in one or both of the slots 42, 45 or across one or both to obstruct the movement of a portion of the cutting edge 48 therein. The location of the physical obstruction may be implementation dependent and selected so that, for example, the movement of the cutting edge 48 is obstructed at the maximum allowed cutting line length.
[0119] In addition, physical obstruction can be configured to provide specific response when being impacted by cutting edge 48 or intermediate drive component or otherwise contacting with this cutting edge or intermediate drive component, i.e. pulse, resonance or ringing response, and dissipates its force as cutting edge 48 slows down to stop.When being transferred back to motor 1004 by drive train and drive train 1008, this specific response can produce the detectable response about the change of the force applied in response to this by motor 1004, for example, in frequency, amplitude or its rate of change.For example, the placement, shape, orientation, structure, rigidity / compliance, elasticity, composition, coating, processing and / or material (for example rubber, silicone, plastics, polyester or the metal of different (higher or lower) density) of physical obstruction can be adjusted to provide expected response.Alternatively, the configuration of physical obstruction can be adjusted to absorb, dissipate or otherwise reduce impact force.In addition, according to embodiments as herein described, the configuration of physical obstruction can be designed to keep above-mentioned property in the multiple percussion of instrument (for example, in the multiple impacts of cutting edge 48 or intermediate drive component).
[0120] In one embodiment, a physical obstruction is formed or otherwise provided in lower jaw 16 so as to be below cartridge 37 and therefore not in contact with the tissue being grasped.
[0121] In one embodiment, a physical obstruction is formed in at least one jaw 16 , 18 to facilitate assembly of the end effector 12 during manufacturing after the cutting edge 48 has been assembled with the at least one jaw 16 , 18 .
[0122] In one embodiment, the physical obstruction may include a tab or other movable or bendable obstruction formed in or as part of the jaws 16, 18 in a non-obstructive manner to allow the cutting blade 48 to be assembled with the jaws, and the tab or other movable or bendable obstruction is subsequently moved, bent, or formed into an obstructing position / orientation after the cutting blade 48 has been assembled with the end effector 12.
[0123] Figure 14 A perspective view of the jaws of a surgical stapling instrument according to some embodiments is depicted, the jaws including a stop inserted therein. In this embodiment, a dimple 1402 is machined or otherwise formed in, for example, the lower jaw 16, and the stop / trigger / bump (such as Figure 15 The stopper / trigger 1500 is shown inserted into the recess. The stopper / trigger 1500 can be characterized by a body 1502 constructed of a material having a tuned response as described above and having a partial slot 1504 formed therein for receiving the cutting edge 48, or at least the portion thereof that travels along the slot 45. In one embodiment, the slot 1504 can be fully or partially tapered, or otherwise have a width that is less than the width of the portion of the cutting edge 45 to be received by the slot, wherein as the portion of the cutting edge 45 enters the slot 1504, the cutting edge 45 contacts the inner surface of the slot 1504, wherein friction acts to decelerate the cutting edge 45 prior to impact / contact with the stopper 1500, and / or otherwise produce a desired detectable force change.
[0124] Figure 16 and Figure 17 Depicted are exploded and assembled views of an alternative stop / trigger 1500 and lower jaw 16 of surgical stapling instrument 10 according to some embodiments. In this embodiment, machined dimple 1402 and stop / trigger 1500 have an hourglass shape that can compress in the longitudinal direction upon impact / contact with cutting edge 48, thereby absorbing or dissipating the impact force, and / or otherwise generating a desired detectable force change.
[0125] In one embodiment, the aforementioned surgical stapling instrument 10 further comprises: a handle 20 comprising a motor 1004 and a control circuit 1006; an articulation joint 11; a shaft 22 extending from the handle 20 to the articulation joint 11, to which the end effector 12 is coupled, wherein the shaft 22 comprises a drive train 1008; and wherein the end effector 12 comprises a firing beam 14 operably coupled to the drive train 1008 and comprising a cutting edge 48; and wherein the articulation joint 11 allows the end effector 12 to be articulated and retained in one or more directions relative to the longitudinal axis of the shaft 22 via application of a retaining force. In one embodiment, the calculated expected force threshold is determined to be less than the retaining force.
[0126] In one embodiment, the aforementioned surgical stapling instrument 10 is configured to be attachable and operable by a robot.
[0127] VI. Combination Examples
[0128] The following examples relate to various non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to limit the coverage of any claims that may be provided at any time in this patent application or subsequent submissions of this patent application. It is not intended to make a disclaimer. The following examples are provided for illustrative purposes only. It is envisioned that the various teachings herein may be arranged and applied in a variety of other ways. It is also envisioned that some variations may omit certain features mentioned in the following examples. Therefore, any of the aspects or features mentioned below should not be considered decisive unless otherwise expressly indicated as such by the inventor or a successor with an interest in the inventor at a later date. If any claim set forth in this patent application or subsequent submissions related to this patent application includes additional features other than those mentioned below, these additional features should not be assumed to be added for any reason related to patentability.
[0129] Example 1
[0130] A control circuit (1006) for controlling a surgical instrument (10), the surgical instrument (10) comprising an end effector (12) configured to grasp tissue, the end effector (12) comprising jaws (16, 18), the jaws comprising a cutting edge (48), the cutting edge being configured to be displaced a first distance from a proximal end to a distal end of the jaws (16, 18) such that at least a portion of the cutting edge (48) transects tissue grasped by the end effector, the jaws (16, 18) further being configured to receive a staple cartridge (37) which is positionable in one of the jaws (16, 18) and comprising a slide (41) and a staple (47), the slide (41) being configured to be displaced a second distance from a proximal end to a distal end of the staple cartridge (37). The surgical instrument (10) further comprises a motor (1004) external to the end effector (12) and a drive train (1008) operably coupled between the motor (1004) and the cutting blade (48) and the slide (41), wherein the motor (1004) is configured to controllably shift the position of the proximal end of the drive train (1008) by a controllable distance to shift the cutting blade (48) and the slide (41) so as to substantially simultaneously transect the tissue grasped by the end effector (12) and deploy the staples (47) in the tissue along the transection on either side of the transection, the control circuit (1006) comprising:
[0131] A processor and a memory coupled to the processor, the memory storing computer-readable instructions, which, when executed by the processor, cause the processor to:
[0132] controlling the rate at which the motor (1004) attempts to displace the proximal end of the drive train (1008); and
[0133] Monitoring during displacement of the proximal end of the drive train (1008):
[0134] the position of the proximal end of the drive train (1008); and the force input by the motor (1004) to the proximal end of the drive train (1008); and
[0135] During displacement of the proximal end of the drive train (1008), the motor (1004) is caused to:
[0136] displacing the proximal end of the drive train (1008) by a third distance less than the first distance using a force input to the proximal end of the drive train (1008), the force being varied so as to substantially maintain the first rate at which the motor (1004) attempts to displace the proximal end of the drive train (1008);
[0137] After shifting the third distance, the proximal end of the drive train (1008) is continuously shifted a fourth distance by a force input to the proximal end of the drive train (1008), the force being varied so as to substantially maintain a second rate at which the motor (1004) attempts to shift the proximal end of the drive train (1008), the second rate being less than the first rate, during which the control circuit (1006) calculates an expected force that needs to be input to the proximal end of the drive train (1008) based on the monitored force in order to substantially maintain the proximal end of the drive train (1008). the second rate at which the motor (1004) attempts to displace the proximal end of the drive train (1008) over a subsequent further distance; and continuing to displace the proximal end of the drive train (1008) with a force input to the proximal end of the drive train (1008), the force varying so as to substantially maintain the second rate at which the motor (1004) attempts to displace the proximal end of the drive train (1008) until the force input to the proximal end of the drive train (1008) is determined to exceed the calculated expected force threshold.
[0138] Example 2
[0139] A control circuit (1006) according to embodiment 1, wherein, at least during the displacement of the proximal end of the drive train (1008), one or more of the distance the cutting blade (48) is displaced or the force applied by the cutting blade (48) to the grasped tissue changes compared to the distance the proximal end of the drive train (1008) is displaced or the force applied to the drive train by the motor (1004).
[0140] Example 3
[0141] The control circuit (1006) of embodiment 2, wherein the variation is dependent on one or more properties of the grasped tissue and / or a degree of compliance of the drive train (1008).
[0142] Example 4
[0143] A control circuit (1006) according to any one of embodiments 1 to 3, wherein when the proximal end of the drive train (1008) has displaced a maximum distance, the control circuit (1006) causes the displacement to stop.
[0144] Example 5
[0145] The control circuit (1006) of any one of embodiments 1 to 4, wherein the cutting edge (48) is physically obstructed beyond the first distance.
[0146] Example 6
[0147] A control circuit (1006) according to any one of embodiments 1 to 5, wherein a physical obstruction (1500) is formed in at least one jaw (16, 18) after the cutting blade (48) has been assembled with at least one jaw (16, 18) during manufacturing.
[0148] Example 7
[0149] A control circuit (1006) according to any one of embodiments 1 to 6, wherein the physical obstruction (1500) is characterized by the following property: when at least a portion of the cutting blade (48) impacts, encounters or otherwise contacts the physical obstruction (1500), the property causes a distinguishable change in the monitored force input to the proximal end of the drive system (1008) to maintain the second rate.
[0150] Example 8
[0151] The control circuit (1006) of any one of embodiments 1 to 7, wherein the calculation of the predicted force comprises:
[0152] creating an array of current values of monitored forces and corresponding positions as the proximal end of the drive train (1008) is displaced over the fourth distance;
[0153] storing the array in a storage buffer (1104);
[0154] fitting one of a linear fit curve or a best fit curve to the stored array of monitored force and corresponding position values; and
[0155] The predicted force is calculated based on a projection of the fitted linear fit curve or best fit curve onto one or more subsequent displacement increments of the drive train (1008).
[0156] Example 9
[0157] The control circuit (1006) of any one of embodiments 1 to 7, wherein the calculation of the predicted force comprises:
[0158] As the proximal end of the drive system (1008) shifts over the fourth distance, the current values of the monitored force and corresponding position are determined, the change in the monitored force over the shifted distance is calculated, and fuzzy logic is applied to the current position and the change in the monitored force over the shifted distance, wherein when the fuzzy logic returns a true value, the force input to the proximal end of the drive system (1008) is determined to exceed a threshold of the calculated expected force.
[0159] Example 10
[0160] A control circuit (1006) according to any one of Examples 1 to 9, wherein the surgical instrument (10) includes a handle (20) and a shaft (22), the proximal end of the shaft (22) being coupled to the distal end of the handle (20), the distal end of the shaft (22) being coupled to the end actuator (12), wherein the motor (1004) is located in the handle (20) and the drive train (1008) is located in the shaft (22) and extends from the proximal end of the shaft (22) to the distal end of the shaft (22).
[0161] Example 11
[0162] The control circuit (1006) of any one of embodiments 1 to 10, wherein the drive train (1008) comprises a plurality of coupled components.
[0163] Example 12
[0164] The control circuit (1006) according to any one of embodiments 1 to 11, further comprising:
[0165] a handle (20) comprising a motor (1004) and a control circuit (1006);
[0166] articulation joints (11);
[0167] a shaft (22) extending from the handle (20) to an articulation joint (11) to which the end effector (12) is coupled, wherein the shaft (22) includes the drive train (1008); and
[0168] wherein the end effector (12) includes a firing beam (14) operably coupled to the drive train (1008) and including the cutting edge (48); and
[0169] The articulation joint (11) allows the end effector (12) to be articulated and retained in one or more directions relative to the longitudinal axis of the shaft via application of a retaining force.
[0170] Example 13
[0171] The control circuit (1006) of any one of embodiments 1 to 12, wherein the threshold value of the calculated expected force is less than the holding force.
[0172] Example 14
[0173] A control circuit (1006) according to any one of embodiments 1 to 13, wherein the surgical stapling instrument (10) is configured to be attachable and operable by a robot.
[0174] Example 15
[0175] A surgical suturing instrument (10) comprising:
[0176] An end effector (12) configured to grasp tissue.
[0177] The end effector (12) comprises:
[0178] Jaws (16, 18), the jaws including a cutting edge (48), the cutting edge being configured to be displaced a first distance from a proximal end to a distal end of the jaws (16, 18) such that at least a portion of the cutting edge (48) transects tissue grasped by the end effector, the jaws (16, 18) being further configured to receive a staple cartridge (37) that is positionable in one of the jaws (16, 18) and includes a slide (41) and staples (47), the slide (41) being configured to be displaced a second distance from a proximal end to a distal end of the staple cartridge (37) to insert the staples (47)
[0179] deploying along a transection into the tissue grasped by the end effector (12);
[0180] a motor (1004) located external to the end effector (12);
[0181] and
[0182] A drive train (1008) operably coupled to the motor (1004)
[0183] Between the cutting edge (48) and the slide (41), wherein the motor (1004)
[0184] being configured to controllably shift the position of the proximal end of the drive train (1008) a controllable distance to shift the cutting edge (48) and the slider (41) so as to substantially simultaneously transect the tissue grasped by the end effector (12) and deploy the staples (47) in the tissue along the transection on either side of the transection; and
[0185] The control circuit (1006) according to any one of embodiments 1 to 14.
[0186] Example 16
[0187] A method of operating a surgical instrument (10), the surgical instrument (10) comprising an end effector (12) configured to grasp tissue, the end effector (12) comprising jaws (16, 18), the jaws comprising a cutting edge (48), the cutting edge configured to be displaced a first distance from a proximal end to a distal end of the jaws (16, 18) such that at least a portion of the cutting edge (48) transects tissue grasped by the end effector, the jaws (16, 18) further configured to receive a staple cartridge (37), the staple cartridge being positionable in one of the jaws (16, 18) and comprising a slide (41) and staples (47), the slide (41) configured to be displaced a second distance from a proximal end to a distal end of the staple cartridge (37) , to deploy the staples (47) along a transection into the tissue grasped by the end effector (12), the surgical instrument (10) further comprising a motor (1004) external to the end effector (12) and a drive train (1008) operably coupled between the motor (1004) and the cutting edge (48) and the slide (41), wherein the motor (1004) is configured to controllably shift the position of a proximal end of the drive train (1008) by a controllable distance to shift the cutting edge (48) and the slide (41) so as to substantially simultaneously transect the tissue grasped by the end effector (12) and deploy the staples (47) in the tissue along the transection on either side of the transection, the method comprising:
[0188] Controlling the motor (1004) attempts to cause the proximal end of the drive train (1008) to
[0189] the rate of displacement of the
[0190] monitor:
[0191] the position of the proximal end of the drive train (1008); and the force input by the motor (1004) to the proximal end of the drive train (1008); and
[0192] During displacement of the proximal end of the drive train (1008), the horse
[0193] Da (1004):
[0194] displacing the proximal end of the drive train (1008) by a third distance less than the first distance using a force input to the proximal end of the drive train (1008), the force being varied so as to substantially maintain the first rate at which the motor (1004) attempts to displace the proximal end of the drive train (1008);
[0195] After attempting to displace the third distance, continuing to displace the proximal end of the drive train (1008) a fourth distance using a force input to the proximal end of the drive train (1008), the force varying so as to substantially maintain the motor (1004)
[0196] attempting to displace the proximal end of the drive train (1008) at a second rate, the second rate being less than the first rate, during which the control circuit (1006)
[0197] calculating, based on the monitored force, an expected force that needs to be input to the proximal end of the drive train (1008) in order to substantially maintain the second rate at which the motor (1004) attempts to displace the proximal end of the drive train (1008) over a subsequent further distance; and
[0198] The proximal end of the drive train (1008) continues to be displaced by a force input to the proximal end of the drive train (1008), the force varying so as to substantially maintain the second rate at which the motor (1004) attempts to displace the proximal end of the drive train (1008) until the force input to the proximal end of the drive train (1008) is determined to exceed the calculated expected force threshold.
[0199] Example 17
[0200] The method of embodiment 16, wherein the calculating of the predicted force comprises:
[0201] creating an array of current values of monitored forces and corresponding positions as the proximal end of the drive train (1008) is displaced over the fourth distance;
[0202] storing the array in a storage buffer (1104);
[0203] fitting one of a linear fit curve or a best fit curve to the stored array of monitored force and corresponding position values; and
[0204] The predicted force is calculated based on a projection of the fitted linear fit curve or best fit curve onto one or more subsequent displacement increments of the drive train (1008).
[0205] Example 18
[0206] The method of embodiment 16, wherein the calculating of the predicted force comprises:
[0207] As the proximal end of the drive system (1008) shifts over the fourth distance, the current values of the monitored force and corresponding position are determined, the change in the monitored force over the shifted distance is calculated, and fuzzy logic is applied to the current position and the change in the monitored force over the shifted distance, wherein when the fuzzy logic returns a true value, the force input to the proximal end of the drive system (1008) is determined to exceed a threshold of the calculated expected force.
[0208] Example 19
[0209] The method of any one of embodiments 16 to 18, wherein the cutting edge (48) is physically obstructed beyond the first distance.
[0210] Example 20
[0211] The method of any one of embodiments 16 to 19 further includes forming a physical obstruction (1500) in the at least one jaw (16, 18) after the cutting edge (48) has been assembled with the at least one jaw (16, 18) during manufacturing.
[0212] The following clauses also refer to the various non-exhaustive ways in which the teachings herein may be combined or applied.
[0213] 1. A surgical suturing instrument (10), comprising:
[0214] An end effector (12) configured to grasp tissue, the end effector (12) comprising:
[0215] Jaws (16, 18), the jaws including a cutting edge (48), the cutting edge being configured to be displaced a first distance from a proximal end to a distal end of the jaws (16, 18) such that at least a portion of the cutting edge (48) transects tissue grasped by the end effector, the jaws (16, 18) being further configured to receive a staple cartridge (37) that is positionable in the jaws (16, 18)
[0216] and includes a slide (41) and a nail (47), wherein the slide (41)
[0217] The nail cartridge (37) is configured to be displaced a second distance from the proximal end to the distal end thereof to deploy the nail (47) along the transverse section to the distal end of the nail cartridge (37).
[0218] (12) in the grasped tissue;
[0219] a motor (1004) located external to the end effector (12); and
[0220] A drive train (1008) operably coupled to the motor (1004)
[0221] Between the cutting edge (48) and the slide (41), wherein the motor (1004)
[0222] configured to controllably displace the position of the proximal end of the drive train (1008) by a controllable distance to displace the cutting edge (48) and the slider (41) so as to substantially simultaneously transect the tissue grasped by the end effector (12) and deploy the staples (47) in the tissue along the transection on either side of the transection;
[0223] a control circuit (1006) coupled to the motor (1004) and controlling the rate at which the motor (1004) attempts to displace the proximal end of the drive train (1008), and monitoring during displacement of the proximal end of the drive train (1008):
[0224] the position of the proximal end of the drive train (1008); and the force input by the motor (1004) to the proximal end of the drive train (1008); and
[0225] wherein during displacement of the proximal end of the drive train (1008), the
[0226] The control circuit (1006) causes the motor (1004) to:
[0227] displacing the proximal end of the drive train (1008) by a third distance less than the first distance using a force input to the proximal end of the drive train (1008), the force being varied so as to substantially maintain the first rate at which the motor (1004) attempts to displace the proximal end of the drive train (1008);
[0228] After displacing the third distance, continuing to displace the proximal end of the drive train (1008) by a force input to the proximal end of the drive train (1008), the force varying so as to substantially maintain a second rate at which the motor (1004) attempts to displace the proximal end of the drive train (1008), the second rate being less than the first rate, during which the control circuit (1006) calculates, based on the monitored force, a predicted force that needs to be input to the proximal end of the drive train (1008) in order to substantially maintain the second rate at which the motor (1004) attempts to displace the proximal end of the drive train (1008) over a subsequent further distance; and
[0229] The proximal end of the drive train (1008) continues to be displaced by a force input to the proximal end of the drive train (1008), the force varying so as to substantially maintain the second rate at which the motor (1004) attempts to displace the proximal end of the drive train (1008) until the force input to the proximal end of the drive train (1008) is determined to exceed the calculated expected force threshold.
[0230] 2. A surgical stapling instrument (10) according to claim 1, wherein, at least during the displacement of the proximal end of the drive train (1008), one or more of the distance the cutting blade (48) is displaced or the force applied by the cutting blade (48) to the grasped tissue changes compared to the distance the proximal end of the drive train (1008) is displaced or the force applied to the drive train by the motor (1004).
[0231] 3. The surgical stapling instrument (10) of claim 2, wherein the variation is dependent upon one or more properties of the grasped tissue and / or a degree of compliance of the drive train (1008).
[0232] 4. The surgical stapling instrument (10) of claim 1, wherein the control circuit (1006) stops the displacement when the proximal end of the drive train (1008) has displaced a maximum distance.
[0233] 5. The surgical stapling instrument (10) according to claim 1, wherein the cutting edge (48)
[0234] is physically obstructed beyond said first distance.
[0235] 6. The surgical stapling instrument (10) of claim 5, wherein a physical obstruction (1500) is formed in the at least one jaw (16, 18) after the cutting edge (48) has been assembled with the at least one jaw (16, 18) during manufacturing.
[0236] 7. A surgical stapling instrument (10) according to claim 5, wherein the physical obstruction (1500) is characterized by the following properties: when at least a portion of the cutting edge (48) impacts, encounters or otherwise contacts the physical obstruction (1500), the property causes a distinguishable change in the monitored force input to the proximal end of the drive system (1008) to maintain the second rate.
[0237] 8. The surgical stapling instrument (10) of claim 1, wherein the calculation of the predicted force comprises:
[0238] creating an array of current values of monitored forces and corresponding positions as the proximal end of the drive train (1008) is displaced over the fourth distance;
[0239] storing the array in a storage buffer (1104);
[0240] fitting one of a linear fit curve or a best fit curve to the stored array of monitored force and corresponding position values; and
[0241] Wherein the linear fitting curve or the best fitting curve based on the fitting is
[0242] 9. The surgical stapling instrument (10) according to claim 1, wherein the calculation of the predicted force comprises:
[0243] As the proximal end of the drive system (1008) shifts over the fourth distance, the current values of the monitored force and corresponding position are determined, the change in the monitored force over the shifted distance is calculated, and fuzzy logic is applied to the current position and the change in the monitored force over the shifted distance, wherein when the fuzzy logic returns a true value, the force input to the proximal end of the drive system (1008) is determined to exceed a threshold of the calculated expected force.
[0244] 10. A surgical stapling instrument (10) according to claim 1, wherein the surgical instrument (10) includes a handle (20) and a shaft (22), the proximal end of the shaft (22) is connected to the distal end of the handle (20), and the distal end of the shaft (22) is connected to the end actuator (12), wherein the motor (1004) is located in the handle (20) and the drive system (1008) is located in the shaft (22) and extends from the proximal end of the shaft (22) to the distal end of the shaft (22).
[0245] 11. The surgical stapling instrument (10) according to claim 1, wherein the drive train (1008)
[0246] Consists of multiple connected parts.
[0247] 12. The surgical stapling instrument (10) according to claim 1, further comprising:
[0248] a handle (20) comprising a motor (1004) and a control circuit (1006);
[0249] articulation joints (11);
[0250] a shaft (22) extending from the handle (20) to an articulation joint (11) to which the end effector (12) is coupled, wherein the shaft (22) includes the drive train (1008); and
[0251] wherein the end effector (12) includes a firing beam (14) operably coupled to the drive train (1008) and including the cutting edge (48); and
[0252] and
[0253] The articulation joint (11) allows the end effector (12) to be articulated and retained in one or more directions relative to the longitudinal axis of the shaft via application of a retaining force.
[0254] 13. The surgical stapling instrument (10) of claim 12, wherein the threshold value of the calculated expected force is less than the holding force.
[0255] 14. The surgical stapling instrument (10) according to claim 1, wherein the surgical stapling instrument (10) is configured to be attached and operated by a robot.
[0256] 15. A control circuit (1006) for controlling a surgical instrument (10), the surgical instrument (10) comprising an end effector (12) configured to grasp tissue, the end effector (12) comprising jaws (16, 18), the jaws comprising a cutting blade (48), the cutting blade being configured to be displaced a first distance from a proximal end to a distal end of the jaws (16, 18) such that at least a portion of the cutting blade (48) transects tissue grasped by the end effector, the jaws (16, 18) being further configured to receive a staple cartridge (37) which is positionable in one of the jaws (16, 18) and comprising a slide (41) and a staple (47), the slide (41) being configured to be displaced a first distance from a proximal end to a distal end of the staple cartridge (37) The surgical instrument (10) further comprises a motor (1004) located outside the end effector (12) and a drive train (1008) operably coupled between the motor (1004) and the cutting edge (48) and the slide (41), wherein the motor (1004) is configured to controllably shift the position of the proximal end of the drive train (1008) by a controllable distance to shift the cutting edge (48) and the slide (41) so as to substantially simultaneously transect the tissue grasped by the end effector (12) and deploy the staples (47) in the tissue along the transection on either side of the transection, the control circuit (1006) comprising:
[0257] A processor and a memory coupled to the processor, the memory storing computer-readable instructions, which, when executed by the processor, cause the processor to:
[0258] Controlling the motor (1004) attempts to cause the drive train (1008) to
[0259] the rate of proximal end displacement; and
[0260] Monitoring during displacement of the proximal end of the drive train (1008):
[0261] the position of the proximal end of the drive train (1008); and the force input by the motor (1004) to the proximal end of the drive train (1008); and
[0262] During displacement of the proximal end of the drive train (1008), the motor (1004) is caused to:
[0263] The proximal end of the drive train (1008) is displaced a third distance by a force input to the proximal end of the drive train (1008), the third distance being less than the first distance, the force being varied so as to substantially maintain the motor (1004) attempting to displace the proximal end of the drive train (1008) by the third distance.
[0264] One rate;
[0265] After displacing the third distance, continuing to displace the proximal end of the drive train (1008) by a force input to the proximal end of the drive train (1008), the force varying so as to substantially maintain a second rate at which the motor (1004) attempts to displace the proximal end of the drive train (1008), the second rate being less than the first rate, during which the control circuit (1006) calculates, based on the monitored force, a predicted force that needs to be input to the proximal end of the drive train (1008) in order to substantially maintain the second rate at which the motor (1004) attempts to displace the proximal end of the drive train (1008) over a subsequent further distance; and
[0266] The proximal end of the drive train (1008) continues to be displaced by a force input to the proximal end of the drive train (1008), the force varying so as to substantially maintain the second rate at which the motor (1004) attempts to displace the proximal end of the drive train (1008) until the force input to the proximal end of the drive train (1008) is determined to exceed the calculated expected force threshold.
[0267] 16. The control circuit (1006) of claim 15, wherein the calculation of the predicted force comprises:
[0268] creating an array of current values of monitored forces and corresponding positions as the proximal end of the drive train (1008) is displaced over the fourth distance;
[0269] storing the array in a storage buffer (1104);
[0270] fitting one of a linear fit curve or a best fit curve to the stored array of monitored force and corresponding position values; and
[0271] Wherein the linear fitting curve or the best fitting curve based on the fitting is
[0272] 17. The control circuit (1006) of claim 15, wherein the calculation of the predicted force comprises:
[0273] As the proximal end of the drive system (1008) shifts over the fourth distance, the current values of the monitored force and corresponding position are determined, the change in the monitored force over the shifted distance is calculated, and fuzzy logic is applied to the current position and the change in the monitored force over the shifted distance, wherein when the fuzzy logic returns a true value, the force input to the proximal end of the drive system (1008) is determined to exceed a threshold of the calculated expected force.
[0274] 18. The control circuit (1006) of claim 15, wherein the cutting edge (48)
[0275] is physically obstructed beyond said first distance.
[0276] 19. The control circuit (1006) of claim 18, wherein the physical obstruction (1500) is formed in the at least one jaw (16, 18) after the cutting edge (48) has been assembled with the at least one jaw (16, 18) during manufacturing.
[0277] 20. A control circuit (1006) according to claim 18, wherein the physical obstruction (1500) is characterized by the following property: when at least a portion of the cutting edge (48) impacts, encounters or otherwise contacts the physical obstruction (1500), the property causes a distinguishable change in the monitored force input to the proximal end of the drive system (1008) to maintain the second rate.
[0278] 21. A method of operating a surgical instrument (10), the surgical instrument (10) comprising an end effector (12) configured to grasp tissue, the end effector (12) comprising jaws (16, 18), the jaws comprising a cutting edge (48), the cutting edge being configured to be displaced a first distance from a proximal end to a distal end of the jaws (16, 18) such that at least a portion of the cutting edge (48) transects tissue grasped by the end effector, the jaws (16, 18) being further configured to receive a staple cartridge (37), the staples The cartridge is capable of being positioned in one of the jaws (16, 18) and includes a slide (41) and a staple (47), the slide (41) being configured to be displaceable a second distance from a proximal end to a distal end of the staple cartridge (37) to deploy the staple (47) along a transverse cut into the tissue grasped by the end effector (12), the surgical instrument (10) further comprising a motor (1004) located outside the end effector (12) and a motor operably coupled to the motor (1004) and the cutting blade (48) and the slide (41).
[0279] wherein the motor (1004) is configured to controllably displace the position of the proximal end of the drive train (1008) by a controllable distance to displace the cutting edge (48) and the slider (41) so as to substantially simultaneously transect the tissue grasped by the end effector (12) and deploy the staples (47) in the tissue along the transection on either side of the transection, the method comprising:
[0280] controlling the rate at which the motor (1004) attempts to displace the proximal end of the drive train (1008); and
[0281] monitor:
[0282] the position of the proximal end of the drive train (1008); and the force input by the motor (1004) to the proximal end of the drive train (1008); and
[0283] During displacement of the proximal end of the drive train (1008), the
[0284] Motor (1004):
[0285] displacing the proximal end of the drive train (1008) by a third distance less than the first distance using a force input to the proximal end of the drive train (1008), the force being varied so as to substantially maintain the first rate at which the motor (1004) attempts to displace the proximal end of the drive train (1008);
[0286] continuing to displace the proximal end of the drive train (1008) by a fourth distance using a force input to the proximal end of the drive train (1008) after attempting to displace the third distance, the force varying so as to substantially maintain a second rate at which the motor (1004) attempts to displace the proximal end of the drive train (1008), the second rate being less than the first rate, during which the control circuit (1006) calculates, based on the monitored force, an expected force that needs to be input to the proximal end of the drive train (1008) in order to substantially maintain the second rate at which the motor (1004) attempts to displace the proximal end of the drive train (1008) over a subsequent further distance; and
[0287] The proximal end of the drive train (1008) continues to be displaced by a force input to the proximal end of the drive train (1008), the force varying so as to substantially maintain the second rate at which the motor (1004) attempts to displace the proximal end of the drive train (1008) until the force input to the proximal end of the drive train (1008) is determined to exceed the calculated expected force threshold.
[0288] 22. The method of claim 21 , wherein calculating the predicted force comprises:
[0289] creating an array of current values of monitored forces and corresponding positions as the proximal end of the drive train (1008) is displaced over the fourth distance;
[0290] storing the array in a storage buffer (1104);
[0291] fitting one of a linear fit curve or a best fit curve to the stored array of monitored force and corresponding position values; and
[0292] Wherein the linear fitting curve or the best fitting curve based on the fitting is
[0293] 23. The method of claim 21 , wherein the calculation of the predicted force comprises:
[0294] As the proximal end of the drive system (1008) shifts over the fourth distance, the current values of the monitored force and corresponding position are determined, the change in the monitored force over the shifted distance is calculated, and fuzzy logic is applied to the current position and the change in the monitored force over the shifted distance, wherein when the fuzzy logic returns a true value, the force input to the proximal end of the drive system (1008) is determined to exceed a threshold of the calculated expected force.
[0295] 24. The method of claim 21, wherein the cutting edge (48) is physically obstructed beyond the first distance.
[0296] 25. The method of claim 23, further comprising forming a
[0297] Having been assembled with at least one jaw (16, 18), a physical obstruction (1500) is formed in the at least one jaw (16, 18).
[0298] VII. Miscellaneous
[0299] It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Therefore, the above teachings, expressions, embodiments, examples, etc. should not be considered in isolation from each other. Based on the teachings herein, various suitable ways in which the teachings herein can be combined will be apparent to those of ordinary skill in the art. Such modifications and variations are intended to be included within the scope of the claims.
[0300] In addition, any one or more of the teachings herein may be combined with any one or more of the teachings disclosed in the following patent applications: U.S. Patent Application No. 63 / 467,622, filed on May 19, 2023, entitled “Surgical Stapler Cartridge Having Intermediate Raised Tissue Engagement Protrusions”; U.S. Patent Application No. 63 / 467,623, filed on May 19, 2023, entitled “Surgical Stapler CartridgeHaving Tissue Engagement Protrusions with Enlarged Engagement Surface”; U.S. Patent Application No. 63 / 467,648, filed on May 19, 2023, entitled “Surgical Stapler CartridgeHaving Raised Surface to Promote Buttress Adhesion”; U.S. Patent Application No. 63 / 467,650, filed on May 19, 2023, entitled “Surgical Stapler CartridgeHaving CartridgeRetention U.S. patent application No. 63 / 467,469, filed on May 19, 2023, entitled “Surgical Stapler Anvil Having Staple Forming Pockets with Laterally Varying Orientations”; U.S. patent application No. 63 / 459,739, filed on May 19, 2023, entitled “Surgical Stapler With Discretely Positionable Distal Tip”; and / or U.S. patent application No. 63 / 467,656, filed on May 19, 2023, entitled “Surgical Stapler With Discretely Positionable Distal Tip”; and / or U.S. patent application No. 63 / 467,615, filed on May 19, 2023, entitled “Incompatible Staple Cartridge Use Prevention Features for Surgical Stapler.”
[0301] In addition, any one or more of the teachings herein may be combined with any one or more of the teachings disclosed in the following patent application: U.S. Patent Application No. 63 / 459,739, entitled “Surgical Stapler Anvil Having Staple Forming Pockets with Laterally Varying Orientations,” filed on April 17, 2023. The disclosures of each of these U.S. patent applications are incorporated herein by reference in their entirety.
[0302] In addition, any one or more of the teachings herein may be combined with any one or more of the teachings disclosed in the following patent applications: U.S. Patent No. 11,304,697, entitled “Surgical Stapler with Deflectable Distal Tip,” published on April 19, 2022, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 11,317,912, entitled “Surgical Stapler with Rotatable Distal Tip,” published on May 3, 2022, the disclosure of which is incorporated herein by reference in its entirety; and / or U.S. Patent No. 11,439,391, entitled “Surgical Stapler with Toggling Distal Tip,” published on September 13, 2022, the disclosure of which is incorporated herein by reference in its entirety.
[0303] It should be understood that any patent, patent publication, or other public material, whether in whole or in part, allegedly incorporated herein by reference is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other public materials set forth in this disclosure. Accordingly, and to the extent necessary, the disclosure expressly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, allegedly incorporated herein that conflicts with existing definitions, statements, or other public materials set forth herein will be incorporated only to the extent that no conflict arises between the incorporated material and the existing public materials.
[0304] The versions of the devices described above may be applied to traditional medical treatments and surgeries performed by medical professionals, as well as robotic-assisted medical treatments and surgeries. By way of example only, the various teachings herein may be readily incorporated into robotic surgical systems, such as those offered by Auris Health, Inc. (Redwood City, CA) or by Intuitive Surgical, Inc. (Sunnyvale, California).
[0305] The devices of the types described above can be designed to be discarded after a single use, or they can be designed to be reusable. In either case or both cases, these types can be repaired for reuse after at least one use. Repair can include any combination of the following steps: disassembling the device, then cleaning or replacing specific parts and subsequently reassembling. Specifically, some types of devices can be disassembled, and any number of specific parts or parts of the device can be selectively replaced or removed in any combination. When cleaning and / or replacing specific parts, some types of the device can be reassembled at a repair facility or reassembled by the user before surgery is about to be performed for subsequent use. Those skilled in the art will appreciate that the repair of the device can utilize a variety of techniques to disassemble, clean / replace, and reassemble. The use of such technology and the resulting repair device are all within the scope of this application.
[0306] By way of example only, the devices described herein can be sterilized before and / or after the procedure. In one sterilization technique, the device is placed in a closed and sealed container, such as a plastic bag or a TYVEK bag. The container and device can then be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation can kill bacteria on the device and in the container. The sterilized device can then be stored in a sterile container for later use. The device can also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.
[0307] Various embodiments of the present invention have been shown and described, and further improvements to the methods and systems described herein may be achieved by appropriate modifications by those skilled in the art without departing from the scope of the present invention. Several such possible modifications have been mentioned, and other modifications will be apparent to those skilled in the art. For example, the examples, embodiments, geometries, materials, dimensions, ratios, steps, etc. discussed above are illustrative and not required. Accordingly, the scope of the present invention should be considered in light of the following claims and should be understood not to be limited to the details of construction and operation shown and described in the specification and drawings.
Claims
1. A surgical suturing instrument comprising: An end effector configured to grasp tissue, the end effector comprising: jaws comprising a cutting edge configured to be displaced a first distance from a proximal end to a distal end of the jaws such that at least a portion of the cutting edge transects tissue grasped by the end effector, the jaws further configured to receive a staple cartridge positionable in one of the jaws and comprising a sled and staples, the sled configured to be displaced a second distance from a proximal end to a distal end of the staple cartridge to deploy the staples along the transect into the tissue grasped by the end effector; a motor located external to the end effector; and a drive train operably coupled between the motor and the cutting edge and the sled, wherein the motor is configured to controllably displace a position of a proximal end of the drive train by a controllable distance to displace the cutting edge and the sled so as to substantially simultaneously transect the tissue grasped by the end effector and deploy the staples in the tissue along the transection and on either side of the transection; a control circuit coupled to the motor and controlling the rate at which the motor attempts to displace the proximal end of the drive train, and monitoring during displacement of the proximal end of the drive train: the location of the proximal end of the drive train; and a force input by the motor to the proximal end of the drive train; and wherein, during displacement of the proximal end of the drive train, the control circuit causes the motor to: displacing the proximal end of the drive train by a third distance less than the first distance using a force input to the proximal end of the drive train, the force being varied so as to substantially maintain a first rate at which the motor attempts to displace the proximal end of the drive train; continuing to displace the proximal end of the drive train a fourth distance after displacing the third distance using a force input to the proximal end of the drive train that varies so as to substantially maintain a second rate at which the motor attempts to displace the proximal end of the drive train, the second rate being less than the first rate, during which the control circuit calculates, based on the monitored force, a predicted force that needs to be input to the proximal end of the drive train in order to substantially maintain the second rate at which the motor attempts to displace the proximal end of the drive train over a subsequent further distance; and Continue to displace the proximal end of the drive train with a force input to the proximal end of the drive train, the force varying so as to substantially maintain the second rate at which the motor attempts to displace the proximal end of the drive train until the force input to the proximal end of the drive train is determined to exceed the calculated expected force threshold.
2. The surgical stapling instrument according to claim 1, wherein: At least during displacement of the proximal end of the drive train, one or more of the distance the cutting edge is displaced or the force applied by the cutting edge to the grasped tissue changes compared to the distance the proximal end of the drive train is displaced or the force applied to the drive train by the motor.
3. The surgical stapling instrument according to claim 2, wherein: The variation depends on one or more properties of the grasped tissue and / or the degree of compliance of the drive train.
4. The surgical stapling instrument according to claim 1, wherein: The control circuit stops the displacement when the proximal end of the drive train has displaced a maximum distance.
5. The surgical stapling instrument according to claim 1, wherein: The cutting edge is physically obstructed beyond the first distance.
6. The surgical stapling instrument according to claim 5, wherein: A physical obstruction is formed in the at least one jaw during manufacturing after the cutting edge has been assembled with the at least one jaw.
7. The surgical stapling instrument according to claim 5, wherein: The physical obstruction is characterized by a property that, when at least a portion of the cutting edge comes into contact with the physical obstruction, causes a distinguishable change in a monitored force input to the proximal end of the drive train to maintain the second rate.
8. The surgical stapling instrument according to claim 1, wherein: The calculation of the estimated force includes: creating an array of current values of monitored forces and corresponding positions as the proximal end of the drive train is displaced over the fourth distance; storing the array in a storage buffer; fitting one of a linear fit curve or a best fit curve to the stored array of monitored force and corresponding position values; and The predicted force is calculated based on a projection of a fitted linear fit curve or a best fit curve onto one or more subsequent displacement increments of the drive train.
9. The surgical stapling instrument according to claim 1, wherein: The calculation of the estimated force includes: As the proximal end of the drive system shifts over the fourth distance, the current values of the monitored force and corresponding position are determined, the change in the monitored force over the distance of displacement is calculated, and fuzzy logic is applied to the current position and the change in the monitored force over the distance of displacement, wherein when the fuzzy logic returns a true value, the force input to the proximal end of the drive system is determined to exceed a threshold of the calculated expected force.
10. The surgical stapling instrument according to claim 1, wherein: The surgical instrument includes a handle and a shaft, wherein the proximal end of the shaft is connected to the distal end of the handle, and the distal end of the shaft is connected to the end actuator, wherein the motor is located in the handle and the drive system is located in the shaft and extends from the proximal end of the shaft to the distal end of the shaft.
11. The surgical stapling instrument according to claim 1, wherein: The drive train includes a plurality of coupled components.
12. The surgical stapling instrument according to claim 1, further comprising: a handle, the handle including the motor and the control circuit; articulated joints; a shaft extending from the handle to the articulation joint to which the end effector is coupled, wherein the shaft includes the drive train; and wherein the end effector includes a firing beam operably coupled to the drive train and including the cutting edge; and Wherein the articulation joint allows the end effector to be articulated and retained in one or more directions relative to the longitudinal axis of the shaft via application of a retaining force.
13. The surgical stapling instrument according to claim 12, wherein: The threshold value of the calculated expected force is less than the holding force.
14. The surgical stapling instrument according to claim 1, wherein: The surgical stapling instrument is configured to be attached and manipulated by a robotic arm.
15. A control circuit for controlling a surgical instrument, the surgical instrument comprising an end effector configured to grasp tissue, the end effector comprising jaws, the jaws comprising a cutting edge, the cutting edge configured to be displaced a first distance from a proximal end to a distal end of the jaws so that at least a portion of the cutting edge transects tissue grasped by the end effector, the jaws further configured to receive a staple cartridge, the staple cartridge being positionable in one of the jaws and comprising a slide and staples, the slide configured to be displaced a second distance from a proximal end to a distal end of the staple cartridge wherein the proximal end of the drive train is controlled to move the cutting edge and the sled such that the staples are deployed along the transection into the tissue grasped by the end effector, the surgical instrument further comprising a motor located external to the end effector and a drive train operably coupled between the motor, the cutting edge, and the sled, wherein the motor is configured to controllably shift the position of the proximal end of the drive train a controllable distance to shift the cutting edge and the sled so as to substantially simultaneously transect the tissue grasped by the end effector and deploy the staples in the tissue along the transection on either side of the transection, the control circuit comprising: A processor and a memory coupled to the processor, the memory storing computer-readable instructions, which, when executed by the processor, cause the processor to: controlling the rate at which the motor attempts to displace the proximal end of the drive train; and During displacement of the proximal end of the drive train, monitoring: the position of the proximal end of the drive train; and a force input by the motor to the proximal end of the drive train; as well as During displacement of the proximal end of the drive train, causing the motor to: displacing the proximal end of the drive train by a third distance less than the first distance using a force input to the proximal end of the drive train, the force being varied so as to substantially maintain a first rate at which the motor attempts to displace the proximal end of the drive train; continuing to displace the proximal end of the drive train a fourth distance after displacing the third distance using a force input to the proximal end of the drive train, the force varying so as to substantially maintain a second rate at which the motor attempts to displace the proximal end of the drive train, the second rate being less than the first rate, during which the control circuit calculates, based on the monitored force, a predicted force that needs to be input to the proximal end of the drive train in order to substantially maintain the second rate at which the motor attempts to displace the proximal end of the drive train over a subsequent further distance; as well as Continue to displace the proximal end of the drive train with a force input to the proximal end of the drive train, the force varying so as to substantially maintain the second rate at which the motor attempts to displace the proximal end of the drive train until the force input to the proximal end of the drive train is determined to exceed the calculated expected force threshold.
16. The control circuit according to claim 15, wherein: The calculation of the estimated force includes: creating an array of current values of monitored forces and corresponding positions as the proximal end of the drive train is displaced over the fourth distance; storing the array in a storage buffer; fitting one of a linear fit curve or a best fit curve to the stored array of monitored force and corresponding position values; and The predicted force is calculated based on a projection of a fitted linear fit curve or a best fit curve onto one or more subsequent displacement increments of the drive train.
17. The control circuit according to claim 15, wherein: The calculation of the estimated force includes: As the proximal end of the drive system shifts over the fourth distance, the current values of the monitored force and corresponding position are determined, the change in the monitored force over the distance of displacement is calculated, and fuzzy logic is applied to the current position and the change in the monitored force over the distance of displacement, wherein when the fuzzy logic returns a true value, the force input to the proximal end of the drive system is determined to exceed a threshold of the calculated expected force.
18. The control circuit according to claim 15, wherein: The cutting edge is physically obstructed beyond the first distance.
19. The control circuit according to claim 18, wherein: A physical obstruction is formed in the at least one jaw during manufacturing after the cutting edge has been assembled with the at least one jaw.
20. The control circuit according to claim 18, wherein: The physical obstruction is characterized by a property that, when at least a portion of the cutting edge comes into contact with the physical obstruction, causes a distinguishable change in a monitored force input to the proximal end of the drive train to maintain the second rate.
21. A method of operating a surgical instrument, the surgical instrument comprising an end effector configured to grasp tissue, the end effector comprising jaws, the jaws comprising a cutting edge, the cutting edge configured to be displaced a first distance from a proximal end to a distal end of the jaws such that at least a portion of the cutting edge transects tissue grasped by the end effector, the jaws further configured to receive a staple cartridge, the staple cartridge being positionable in one of the jaws and comprising a slide and staples, the slide configured to be displaced a second distance from a proximal end to a distal end of the staple cartridge , to deploy the staples into the tissue grasped by the end effector along a transection, the surgical instrument further comprising a motor located external to the end effector and a drive train operably coupled between the motor and the cutting edge and the sled, wherein the motor is configured to controllably shift the position of a proximal end of the drive train a controllable distance to shift the cutting edge and the sled so as to substantially simultaneously transect the tissue grasped by the end effector and deploy the staples into the tissue along the transection on either side of the transection, the method comprising: controlling the rate at which the motor attempts to displace the proximal end of the drive train; as well as monitor: the position of the proximal end of the drive train; and a force input by the motor to the proximal end of the drive train; as well as During displacement of the proximal end of the drive train, causing the motor to: displacing the proximal end of the drive train by a third distance less than the first distance using a force input to the proximal end of the drive train, the force being varied so as to substantially maintain a first rate at which the motor attempts to displace the proximal end of the drive train; continuing to displace the proximal end of the drive train a fourth distance after attempting to displace the third distance using a force input to the proximal end of the drive train, the force varying to substantially maintain a second rate at which the motor attempts to displace the proximal end of the drive train, the second rate being less than the first rate, during which the control circuit calculates, based on the monitored force, a predicted force that needs to be input to the proximal end of the drive train to substantially maintain the second rate at which the motor attempts to displace the proximal end of the drive train a subsequent further distance; as well as Continue to displace the proximal end of the drive train with a force input to the proximal end of the drive train, the force varying so as to substantially maintain the second rate at which the motor attempts to displace the proximal end of the drive train until the force input to the proximal end of the drive train is determined to exceed the calculated expected force threshold.
22. The method according to claim 21, wherein The calculation of the estimated force includes: creating an array of current values of monitored forces and corresponding positions as the proximal end of the drive train is displaced over the fourth distance; storing the array in a storage buffer; fitting one of a linear fit curve or a best fit curve to the stored array of monitored force and corresponding position values; and The predicted force is calculated based on a projection of a fitted linear fit curve or a best fit curve onto one or more subsequent displacement increments of the drive train.
23. The method according to claim 21, wherein The calculation of the estimated force includes: As the proximal end of the drive system shifts over the fourth distance, the current values of the monitored force and corresponding position are determined, the change in the monitored force over the distance of displacement is calculated, and fuzzy logic is applied to the current position and the change in the monitored force over the distance of displacement, wherein when the fuzzy logic returns a true value, the force input to the proximal end of the drive system is determined to exceed a threshold of the calculated expected force.
24. The method according to claim 21, wherein The cutting edge is physically obstructed beyond the first distance.
25. The method of claim 23, further comprising forming a physical obstruction in the at least one jaw after the cutting edge has been assembled with the at least one jaw during manufacturing.
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