Indirect end-of-cutline detection on endocutter which eliminates need for tool characterization for completion of cutline
The algorithm in endoscopic surgical staplers accurately detects the end of the cutting line using real-time force and position data, ensuring complete staple deployment and minimizing tissue damage without requiring sensors or tool characterization.
Patent Information
- Application Number
- JP2025042163
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-03-18
- Filing Date
- 2025-03-17
- Publication Date
- 2025-10-01
AI Technical Summary
Existing endoscopic surgical staplers face challenges in maximizing the cut line length and staple deployment without the need for tool characterization, as the knife and staple deployment mechanism often result in incomplete staple deployment due to the knife reaching the end of the cartridge before the full cut line is achieved, leading to potential tissue damage and incomplete stapling.
An algorithm and motor control system that utilizes proximal cutting edge and firing force information to detect the end of the cutting line without sensors or switches, predicting the end of the cut line by analyzing real-time force and position data to ensure accurate and complete staple deployment.
Ensures precise and complete cut line length and staple deployment, minimizing tissue damage and instrument wear, while avoiding the need for pre-use characterization and additional components.
Smart Images

Figure 2025143235000001_ABST
Abstract
Description
[Background technology]
[0001] In some settings, endoscopic surgical instruments may be preferred over traditional open surgical devices to minimize the size of surgical incisions and reduce postoperative recovery time and complications. To this end, some endoscopic surgical instruments may be suitable for positioning a distal end effector at a desired surgical site through a trocar cannula. These distal end effectors may engage tissue in several ways to achieve a diagnostic or therapeutic effect (e.g., endocutters (which may combine graspers, cutters, and staplers), graspers, cutters, staplers, clip appliers, access devices, drug / gene therapy delivery devices, energy delivery devices using ultrasound, RF, lasers, etc.). Endoscopic surgical instruments may include a shaft extending proximally from the end effector to a handle (or robotic attachment) portion manipulated by the clinician, or alternatively, to a robot. Such a shaft may allow insertion to a desired depth and rotation about the shaft's longitudinal axis, thereby facilitating positioning of the end effector within the patient. Positioning of the end effector may be further facilitated by including one or more articulation joints or features that allow the end effector to be selectively articulated or otherwise deflected through one or more degrees of freedom, for example, relative to the longitudinal axis of the shaft.
[0002] Examples of endoscopic surgical instruments include surgical staplers. Some such staplers, which may also be referred to as endocutters, are operable to clamp tissue layers, cut 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 further coupled to a staple-deploying sled or otherwise drives / pushes the sled directly or indirectly so that the two move together to substantially simultaneously transect and staple the clamped tissue. Such endoscopic surgical staplers may also be used in open procedures and / or other non-endoscopic procedures. By way of example only, in thoracic surgical procedures that do not use a trocar as a conduit for the stapler, a surgical stapler may be inserted through a thoracotomy, thereby between the patient's ribs, to access one or more organs. Such procedures may include the use of a stapler to cut and close blood vessels leading to an organ, such as the lungs. For example, blood vessels leading to an organ may be cut and closed by the stapler before removing the organ from the chest cavity. Of course, surgical staplers can be used in a variety of other settings and procedures.
[0003] In some procedures, it may be necessary to fire (i.e., cut and / or staple) along the tissue where more than one fire is required to complete the procedure, i.e., multiple sequential fires along a continuous path known as "marching." In procedures involving marching, the surgical stapler end effector may be placed at the surgical site, actuated to cut and staple, removed from the surgical site for installation of a new staple cartridge, and then returned to the surgical site again for another fire along the same path.
[0004] Each cartridge can physically define or otherwise transect / sever or create a cut line of a specific allowed / assigned maximum length, referred to as the cut line length, and can introduce two or more lines of staples, referred to as staple lines, of the same or varying lengths, running parallel to the cut line and with at least one staple line on either side. As shown in FIG. 9 , cartridges often define a maximum allowable nominal length of the staple line, both distally and proximally (not shown), that exceeds the maximum allowable length of the cut line by a margin, e.g., 1-5 mm, to improve hemostasis of the transected tissue. As explained above, because the knife that makes the cut and the thread that deploys the staples often move together, the length of the deployed staple line can be a function of the length of the cut line. Furthermore, because the thread acts to effectively push each staple up into the tissue as it advances, if the thread does not reach the end of the cartridge, the remaining staples may be partially, but not fully, deployed. Therefore, a maximum cut line length must typically be achieved to fully deploy all staples from the cartridge.
[0005] Therefore, when firing the stapler, it is desirable to obtain the maximum allowable cut line length, and therefore the maximum allowable staple line length, to ensure that the clamped tissue is properly transected and the staples are properly deployed.
[0006] A feature of the present disclosure is directed to enabling the endocutter to maximize the staple cartridge's allowed / allocated cut length and associated staple deployment. While various types of surgical staplers and related components have been made and used, it is believed that no one prior to the present inventors has made or used the invention described in the appended claims. [Brief explanation of the drawings]
[0007] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present 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. [Figure 1] 1 depicts a perspective view of an example of an articulating surgical stapling instrument; [Figure 2] 2 depicts a side view of the device of FIG. 1; [Figure 3] 2 depicts a perspective view of an open end effector of the instrument of FIG. 1; [Figure 4A] 4 depicts a side cross-sectional view of the end effector of FIG. 3 taken along line 4-4 of FIG. 3 with the firing beam in a proximal position. [Figure 4B] 4 depicts a side cross-sectional view of the end effector of FIG. 3 taken along line 4-4 of FIG. 3 with the firing beam in a distal position. [Figure 5] 5 depicts a cross-sectional end view of the end effector of FIG. 3 taken along line 5-5 of FIG. 3. [Figure 6] 4 depicts an exploded perspective view of the end effector of FIG. 3; [Figure 7] 4 depicts a perspective view of the end effector of FIG. 3 after being positioned in tissue and actuated once within the tissue. [Figure 8] 1 depicts a perspective view of an embodiment of a surgical stapling instrument having an end effector with a curved, resiliently deformable tip section; [Figure 9] 1 depicts a top view of the distal end of an exemplary staple cartridge showing the staple openings and cutting edge slots and cutting edges; [Figure 10] FIG. 1 shows a block diagram of a system for operating a surgical stapling instrument, according to some embodiments. [Figure 11] 11 shows a more detailed block diagram of the control circuit of FIG. 10 according to some embodiments. [Figure 12] 12 shows a flowchart depicting the operation of the control circuit of FIGS. 10 and 11 according to some embodiments. [Figure 13]12 shows a flowchart depicting an alternative operation of the control circuit of FIGS. 10 and 11, according to some embodiments. [Figure 14] 1 depicts a perspective view of a jaw of a surgical stapling instrument including a stop inserted into a pocket according to some embodiments; [Figure 15] 10 depicts a perspective view of a stop for insertion into a pocket of a jaw of a surgical stapling instrument according to some embodiments; [Figure 16] 10 depicts an exploded view of an alternative stop and lower jaw of a surgical stapling instrument according to some embodiments. [Figure 17] 17 depicts a perspective view of a distal end of an end effector of a surgical stapling instrument having the stop of FIG. 16 inserted into a pocket of a lower jaw thereof in accordance with some embodiments; [Figure 18] 10 depicts a graph of an exemplary force applied to the distal end of the drive train during transection of tissue to attempt to maintain a set displacement rate over the distance displaced thereby, according to some embodiments.
[0008] The drawings are not intended to be limiting in any manner, and it is contemplated that various embodiments of the invention may be embodied in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings, which are incorporated in and form a part of this specification, illustrate several aspects of the invention and, together with the specification, serve to explain the principles of the invention, it being understood, however, that the invention is not limited to the precise arrangements shown. DETAILED DESCRIPTION OF THE INVENTION
[0009] The following description of specific examples of the present technology should not be used for the purpose of limiting its scope. 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, by way of example, one of the best modes contemplated for carrying out the present technology. As will be understood, the technology described herein is capable of other different and obvious aspects, all without departing from the technology. Therefore, the drawings and descriptions should be regarded as illustrative in nature, and not as restrictive.
[0010] For clarity of this disclosure, the terms "proximal" and "distal" are defined herein relative to a human or robotic surgical instrument operator. The term "proximal" refers to the location of an element closer to a human or robotic surgical instrument operator and further from the surgical end effector of the surgical instrument. The term "distal" refers to the location of an element closer to a surgical end effector of the surgical instrument and further from the human or robotic surgical instrument operator. It should be noted that the terms "upper," "lower," "lateral," "transverse," "bottom," and "top" are relative terms used to provide additional clarity in the description of the figures provided below. The terms "upper," "lower," "lateral," "transverse," "bottom," and "top," therefore, are not intended to unnecessarily limit the invention(s) described herein.
[0011] Additionally, terms such as "about," "approximately," "substantially," and the like, as used herein in connection with any numerical value, range of values, and / or geometric / positional quantification, are intended to encompass the exact value referenced, as well as a suitable tolerance that enables the referenced feature or combination of features to function for the intended purpose described herein. For example, "substantially parallel" encompasses nominally parallel structures.
[0012] As used herein with respect to various embodiments of end effector jaw tips, a tip described as "angled," "bent," or "curved" includes 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, particularly configurations in which the longitudinal tip path extends distally toward the opposing jaw. Conversely, a tip described as "straight" includes tip configurations in which the longitudinal axis of the tip is substantially parallel or coaxial with the longitudinal axis of the jaw body.
[0013] 1-7 depict an example of a surgical stapling and severing instrument 10 sized for insertion into a surgical site on a patient through a trocar cannula or an incision (e.g., thoracotomy) to perform a surgical procedure. The instrument 10 in 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 trocar cannula passageway, the articulation joint 11 can be remotely articulated by an articulation control 13, as depicted in perspective in FIG. 1, such that the end effector 12 can be deflected in one or more directions / degrees of freedom at a desired angle (α), referred to as an “attitude,” from the longitudinal axis (LA) of the shaft 22. The end effector 12 of this example includes a lower jaw 16 (also referred to herein as a cartridge jaw) that includes a staple cartridge 37, and an upper jaw in the form of a pivotable anvil jaw 18. As described elsewhere herein, in robotic applications, the handle portion 20 may be replaced with a suitable adapter for coupling the instrument 10 to a robotic arm.
[0014] Unless otherwise explained, 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 variations, the anvil jaw 18 may pivot about an axis defined by a pin (or similar feature) that slidably translates along an elongated slot or channel as the anvil jaw 18 moves toward the lower jaw 16. Such translation may occur before, during, or after the pivotal movement. Thus, it should be understood that such combinations of pivotal and translational movement are encompassed by the term "pivot" and variations thereof as used herein.
[0015] The handle portion 20 includes a pistol grip 24 and a closure trigger 26. The closure trigger 26 is pivotable toward the pistol grip 24 to cause clamping or closure of the anvil jaw 18 toward the lower jaw 16 of the end effector 12. Such closure of the anvil jaw 18 may be provided through a closure tube 32 and a closure ring 33, both of which translate longitudinally relative to the handle portion 20 in response to pivoting of 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.
[0016] 2, the handle portion 20 also includes a firing trigger 28. The instrument 10 further includes a drive train or driver comprising 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 / translates longitudinal or rotational firing motion from the handle portion 20, for example, from a trigger and / or motor contained within the handle portion 20, to the firing beam 14 of the end effector 12. In some articulating instruments 10 that allow the end effector 12 to be positioned in different positions relative to the shaft 22, the drive train may further include one or more flexible components / connectors that pass through the articulation joint 11 and allow the transmission / translation of firing motion therethrough regardless of its orientation.
[0017] In a manually actuated instrument 10, firing motion is generated through actuation of a drivetrain, i.e., a firing trigger 28, which longitudinally advances / displaces the proximal end of an elongated drive member, thereby advancing / displacing the firing beam 14. In a motorized instrument, where a motor (not shown) may be located in a handle or robot, firing motion is generated through operation of a motor coupled to the drivetrain and which may be activated in response to actuation of the firing trigger 28 or other user-actuated input, and the motor is translated rotationally and / or linearly / longitudinal via the drivetrain, thereby advancing / displacing the firing beam 14.
[0018] As will be explained in more detail below, this distal translation of the firing beam 14 causes stapling and severing of tissue clamped within the end effector 12.
[0019] As shown in FIGS. 3-6 , the end effector 12 employs a firing beam 14 including a transversely oriented upper pin 38, a firing beam cap 44, a transversely oriented middle pin 46, and a distally presented knife / cutting edge 48. The upper pin 38 is positioned within a longitudinal anvil slot 42 of the anvil jaw 18 and is translatable within the longitudinal anvil slot 42. The firing beam cap 44 slidably engages the underside of the lower jaw 16 by having the firing beam 14 extend through a lower jaw slot 45 (shown in FIG. 4B ) formed through the lower jaw 16. The middle pin 46 slidably engages the upper surface of the lower jaw 16 in cooperation with the firing beam cap 44. As will be described, as the knife / cutting edge 48 advances through the cartridge slot 49, the lower portion of the cutting edge 48 engages, directly or indirectly, the sled 41 to push the sled 41 forward. As used herein, the cutting edge 48 refers to the entire cutting edge 48 assembly, including the sharp edge that travels through the cartridge slot 49 and actually engages / cuts the tissue, the upper and lower portions that engage the slots 42, 45 in the upper and lower jaws 16, 18 to guide the cutting edge 48 as it advances distally and retracts proximally, and the portion that directly or indirectly engages and pushes against the sled 41. In some embodiments, the cutting edge 48 directly engages / pushes against the sled 41. In alternative embodiments, one or more intermediate drive components may be implemented between the sled 41 and the portion of the cutting edge 48 that engages and pushes against the sled 41. In this implementation, the cutting edge 48 indirectly engages / pushes against the sled 41, i.e., the cutting edge 48 engages / pushes against one or more intermediate drive components, which in turn engages / pushes against the sled 41.
[0020] FIG. 3 illustrates the firing beam 14 of this embodiment positioned proximally and the anvil jaw 18 pivoted to an open configuration to allow an unused staple cartridge 37 to be removably placed within the channel of the lower jaw 16. As best seen in FIGS. 5 and 6, the staple cartridge 37 of this embodiment includes a cartridge body 70 presenting an upper deck 72 and coupled to a lower cartridge tray 74. As best seen in FIG. 3, a vertical slot 49 extends longitudinally through a portion of the staple cartridge body 70. Also, as best seen in FIG. 3, three rows of staple openings 51 are formed through the upper deck 72 on each side of the vertical slot 49. As shown in FIGS. 4A-6, a wedge-shaped sled 41 and a plurality of staple drivers 43 are captured between the cartridge body 70 and the tray 74, with the wedge-shaped sled 41 positioned proximally relative to the staple drivers 43. Wedge-shaped sled 41 is movable longitudinally within staple cartridge 37, while staple driver 43 is movable vertically within staple cartridge 37. Staples 47 are also positioned within cartridge body 70 above corresponding staple drivers 43. Each staple 47 is driven vertically within cartridge body 70 by staple driver 43 to drive staple 47 out through associated staple openings 51. As best seen in FIGS. 4A and 4B, as well as FIG. 6, wedge-shaped sled 41 presents an angled cam surface that urges staple driver 43 upward as wedge-shaped sled 41 is driven distally through staple cartridge 37.
[0021] With the end effector 12 closed, by distally advancing the closure tube 32 and closure ring 33, as depicted in FIGURES 4A and 4B, a firing member in the form of the firing beam 14 is then advanced distally into engagement with the anvil jaw 18 by the upper pin 38 entering the longitudinal anvil slot 42. A pusher block 80 (shown in FIGURE 5) located at the distal end of the firing beam 14 pushes the wedge-shaped sled 41 distally as the firing beam 14 is advanced distally through the staple cartridge 37 upon firing trigger 28, or otherwise, motor actuation. During such firing, the cutting edge 48 of the firing beam 14 enters the vertical slot 49 of the staple cartridge 37, severing the tissue clamped between the staple cartridge 37 and the anvil jaw 18. As shown in FIGS. 4A and 4B, the middle pin 46 and pusher block 80 together actuate the staple cartridge 37 by entering vertical slots 49 therein, driving the wedge-shaped sled 41 upward into camming contact with the staple driver 43, which in turn drives the staple 47 outward through staple openings 51 and into contact with staple-forming pockets 53 (shown in FIG. 3) on the inner surface of the anvil jaw 18. FIG. 4B depicts the firing beam 14 fully translated distally after tissue cutting and stapling are complete. The staple-forming pockets 53 are intentionally omitted from the views of FIGS. 4A and 4B, but are shown in FIG. 3. The anvil jaw 18 is intentionally omitted from the view of FIG. 5.
[0022] FIG. 7 shows the end effector 12 actuated through one firing stroke through tissue 90. The cutting edge 48 (obscured in FIG. 7) cuts the tissue 90 while the staple driver 43 drives three alternating rows of staples 47 (staple lines) through the tissue 90 on either side of the cut line formed by the cutting edge 48. After the first firing stroke is completed, the end effector 12 is withdrawn from the patient, either before or after retracting the cutting edge 48, the spent staple cartridge 37 is replaced with a new staple cartridge 37, and the end effector 12 is then reinserted into the patient to reach the stapling site for further cutting and stapling. This process can be repeated until the desired amount and pattern of firing strokes across the tissue 90 is completed.
[0023] Instrument 10 may further be configured and operable in accordance with the teachings of any of the following references, the disclosures of which are incorporated herein by reference: U.S. Pat. No. 8,210,411, issued July 3, 2012, entitled "Motor-Driven Surgical Instrument"; U.S. Pat. No. 9,186,142, issued November 17, 2015, entitled "Surgical Instrument End Effector Articulation Drive with Pinion and Opposing Racks"; U.S. Pat. No. 9,517,065, issued December 13, 2016, entitled "Integrated Tissue Positioning and Jaw Alignment Features for Surgical Stapler"; and U.S. Pat. No. 9,622,746, issued April 18, 2017, entitled "Distal Tip Features for End Effector of Surgical Stapler." No. 9,717,497, issued August 1, 2017, entitled "Lockout Feature for Movable Cutting Member of Surgical Instrument," U.S. Patent No. 9,795,379, issued October 24, 2017, entitled "Surgical Instrument with Multi-Diameter Shaft," U.S. Patent No. 9,808,248, issued November 7, 2017, entitled "Installation Features for Surgical Instrument End Effector Cartridge," U.S. Patent No. 9,839,421, issued December 12, 2017, entitled "Jaw Closure Feature for End Effector of Surgical Instrument," U.S. Patent No. 10,092,292, issued October 9, 2018, entitled "Staple Forming Features for Surgical Stapling" "U.S. Patent No. 11,871, issued January 16, 2024, entitled ...No. 925, titled "Surgical Instruments with Dual Spherical Articulation Joint Arrangements."
[0024] In some instances, it may be desirable to provide the user with better visualization of the end effector 12. Specifically, when the end effector 12 is inserted into the surgical site, the user may rotate the shaft 22 of the instrument 10 during the procedure. As a result, the end effector 12 also rotates. As the end effector 12 rotates, it may be desirable for the user to have visual access to the surgical site. For example, the user may desire to view the interface or contact surface between the tissue 90 and the end effector 12. Because the end effector 12 may be rotated about the longitudinal axis (LA) relative to the handle portion 20, the user may view the surgical site such that the lower jaw 16 of the end effector is visible, rather than the anvil jaw 18. Alternatively, the end effector 12 may be rotated such that the anvil jaw 18 is visible to the user when the user views the end effector 12. It may be desirable to provide greater visibility of the surgical site for the user than is possible with the instrument 10 of FIG. 1 .
[0025] For example, in some surgical procedures in which fluid-carrying blood vessels are transected and stapled, it may be desirable to have visual confirmation that the anvil jaw 18 and lower jaw 16 are completely covering the vessel to be transected, so that the vessel can be completely incised and stapled in a single actuation. That is, the user may wish to avoid cutting and stapling only a portion of the vessel. Therefore, some form of visual monitoring and / or feedback may be desirable to let the user know that the end effector 12 is properly positioned within the surgical site so that the anvil jaw 18 and lower jaw 16 completely clamp the vessel. One possible method of monitoring the surgical site may include improved visualization of the area adjacent to the distal tips of the lower jaw 16 and anvil jaw 18. Furthermore, not only may visualization of the distal end of the end effector 12 be desirable, but it may also be desirable to configure the end effector 12 so that the distal end of the anvil jaw 18 is configured to urge tissue (e.g., a large blood vessel) proximally into the space between the anvil jaw 18 and the lower jaw 16 when the anvil jaw 18 closes toward the lower jaw 16.
[0026] In addition to the above, variations of the end effector 12 and instruments 10 incorporating the end effector 12 include those disclosed in U.S. Pat. No. 9,186,142, entitled "Surgical Instrument End Effector Articulation Drive with Pinion and Opposing Racks," issued November 17, 2015, the disclosure of which is incorporated herein by reference; U.S. Pat. No. 9,717,497, entitled "Lockout Feature for Movable Cutting Member of Surgical Instrument," issued August 1, 2017, the disclosure of which is incorporated herein by reference; U.S. Pat. No. 9,517,065, entitled "Integrated Tissue Positioning and Jaw Alignment Features for Surgical Stapler," issued December 13, 2016, the disclosure of which is incorporated herein by reference; and U.S. Pat. No. 9,517,065, entitled "Jaw Closure Feature for End Effector of Surgical Instrument," issued December 12, 2017, the disclosure of which is incorporated herein by reference. No. 9,839,421 entitled "Distal Tip Features for End Effector of Surgical Instrument," issued April 18, 2017, the disclosure of which is incorporated herein by reference; U.S. Pat. No. 9,622,746 entitled "Distal Tip Features for End Effector of Surgical Instrument," issued April 18, 2017, the disclosure of which is incorporated herein by reference; U.S. Pat. No. 10,092,292 entitled "Staple Forming Features for Surgical Stapling Instrument," issued October 9, 2018, the disclosure of which is incorporated herein by reference; U.S. Pat. No. 9,795 entitled "Surgical Instrument with Multi-Diameter Shaft," issued October 24, 2017, the disclosure of which is incorporated herein by reference;379, and / or U.S. Patent No. 9,808,248, entitled "Installation Features for Surgical Instrument End Effector Cartridge," issued November 7, 2017, the disclosure of which is incorporated herein by reference. Further modifications that may be incorporated into the end effector 212 are described in more detail below.
[0027] FIG. 8 illustrates another embodiment of an instrument 310 configured as a surgical stapler. The instrument 310 includes a handle portion 320 and a shaft 322. The instrument 310 has a modular configuration such that the shaft 322 is selectively detachable from and attachable to the handle portion 320. The instrument 310 is configured similarly to the instrument 10, and the operability and use of the instrument 310 are the same as those described above for the instrument 10, except for the additional feature of the instrument 310, which is its modular configuration. Due to its modular configuration, the instrument 310 provides a way to change the end effector. Such changes in the end effector can be made to replace a differently fitted end effector or to provide a different end effector configuration based on the procedure or user preference. Additionally or alternatively, features operable to provide a modular configuration of instrument 310 may be configured in accordance with at least some of the teachings of U.S. Patent No. 10,182,813, entitled "Surgical Stapling Instrument with Shaft Release, Powered Firing, and Powered Articulation," issued January 22, 2019, the disclosure of which is incorporated herein by reference. Other suitable components, features, and configurations for providing instrument 310 with a modular configuration will be apparent to those skilled in the art in view of the teachings herein. Furthermore, those skilled in the art will understand in view of the teachings herein that instrument 10 may be modified to incorporate the modular configurations shown and described with respect to instrument 310 or the other instruments incorporated herein by reference. The instrument 310 further includes a distal tip 319 that is bendable (moves when force is applied and returns to its original 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 can be discretely articulated to one or more discrete / low energy positions when force is applied and remains in the discrete positions via a retention mechanism.The tip 319 may not only provide visualization of the distal end of the end effector 12, but may also enable the end effector 12 to use the distal end of the anvil jaw 18 to urge tissue (e.g., a large blood 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.
[0028] It will be understood that the end effector 312 may be used in place of the end effector 12 shown in FIG. 1 . In some variations, the end effector 312 may be integrally formed with the shaft 22, or alternatively, may be formed separately and then combined. In some variations, the end effector 312 may be provided for use with a robotic system. In such a robotic system, the modular shaft 322 having the 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 the mechanism, i.e., motor, for actuating the firing stroke, as described above. In still other embodiments, the end effector 312 may be adapted for use with a robotic system in a manner in which the end effector 312 connects to the robotic system without necessarily connecting the entire modular shaft 322. In view of the teachings herein, other methods for incorporating an end effector having an angled, resiliently deformable anvil tip into a user-operated or robotically operated instrument will be apparent to those skilled in the art.
[0029] The disclosed embodiments are directed to ensuring that the length of the stapler / cutter cut line is maximized without having to first characterize the tool, reducing the amount of force applied to complete the cut line.
[0030] An algorithm and its implementation is disclosed that detects the end of the cutting line using proximal cutting edge and firing force information freely available from the control system of the surgical instrument 10, without requiring sensors and / or switches located within the end effector 12 to sense when the end of the firing stroke has been reached.
[0031] In one embodiment, as the cutting edge 48 moves down the slot 49 of the cartridge 37 and approaches the area proximate the end of the cut line 1804, the motor of the surgical instrument 10 decelerates to avoid hitting the end of the cut line 1806 at high speed, and a buffer begins building data values representing the real-time force / torque being applied by the motor 1808 to maintain the current displacement rate of the drive train and the corresponding current position / displacement. The buffer is an array of real-time cutting edge 48 position and real-time cutting edge 48 force, provided, for example, by the motor's encoder and torque sensor, which can then form a force versus displacement distance graph from which predicted forces can be extrapolated, as described herein. FIG. 18 depicts an exemplary force graph 1800 applied by a motor to attempt to maintain a specific displacement rate over a displacement distance that can be stored in the buffer array. As the cutting edge 48 approaches the end of the cut line 1810, a best-fit function of force and position is performed in real time on the stored array values using either a linear best-fit curve or a quadratic fit function, via interpolation and / or smoothing. This provides information about the slope of force versus position, i.e., how the firing force is trending relative to the position of the cutting edge 48, and allows that trending force to be predicted over subsequent travel increments, enabling preemptive action before or at the end of the cut line, as described herein. Then, for example, a prediction of three or more discrete horizontal axes into the future is made every processing loop time using the best-fit function to anticipate the cutting edge 48 force into the future using the prior information. This prediction then takes into account the cutting edge 48 force required to transect the tissue over the monitored distance based on tissue properties and instrument compatibility / loss, and predicts the expected cutting edge 48 force required to complete the cut line through the remaining tissue.18, as the cutting edge 48 advances, if the actual cutting edge 48 force 1802 sensed by the motor exceeds a threshold, e.g., 10%-20% of the predicted force, the algorithm signals the motor to stop, indicating that the end of the allowable cut line has been reached, i.e., a higher than predicted force has been detected, indicating the sled will push into the end of the cartridge or another physical obstruction. Thereby, the accuracy of achieving the end of the cut line with different tissue thicknesses and different end effector postures is improved, with minimal deviation, e.g., less than 0.2 mm (<0.2 mm).
[0032] In an alternative embodiment, the speed of the cutting edge 48 is reduced as the cutting edge 48 moves down the cartridge 37 and approaches the distal end of the cartridge 37 (the region near the end of the cut line). The firing force and position of the cutting edge 48, as determined by the motor control circuit, are sampled, and the change in firing force (dF / dx) of the cutting edge 48 with respect to a change in position is calculated. The position and dF / dx of the cutting edge 48 are each fed into fuzzy logic sets (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 the fuzzy logic membership functions, e.g., six functions. The output of each rule is a value representing how far the rule wants the cutting edge 48 to continue or stop moving. The outputs of the fuzzy logic rules are combined to produce a single binary result: continue or stop. If the outcome is continue, the cutting edge 48 continues to move and the firing force and position are sampled and sent back through the fuzzy logic cut line algorithm. If the outcome is stop, the motor is commanded to stop.
[0033] More specifically, as described elsewhere herein, staple cartridge 37 includes slot 49 through which knife / cutting edge 48 of end effector 12 moves. Generally, this slot 49, together with cartridge body 37, defines the maximum distance that cutting edge 48 can move, and thus defines the maximum length of the cut line created by cutting edge 38. Different types of cartridges 37 may enable different cut line lengths, and for example, it may be important to ensure the maximum allowable cut line length to ensure complete severance of tissue. Additionally, as described herein, as cutting edge 48 directly or indirectly advances thread 41 of staple cartridge 37 that deploys staples 47, obtaining the maximum cut line length also ensures that distal staples 47 are properly and fully deployed and formed, and that the maximum staple line length is also achieved.
[0034] The maximum cut line length is generally less than the length of the staple line created by cartridge 37 when fired (e.g., X as shown in FIG. 9). More specifically, to ensure hemostasis of the severed tissue, it may be important for the staple line to extend distally and proximally just beyond the cut line by a small margin. As shown in FIG. 9, for example, the maximum length of the cut line is less than X mm (<X mm), e.g., 2 - 10 mm, shorter in the distal direction than the nominal staple line length X of the six parallel staple lines provided by the depicted cartridge 37. It will be appreciated that different types of cartridges 37 may be characterized by shorter or longer cut lines and / or staple lines, and / or fewer or more staple lines, and / or staple lines of different configurations.
[0035] The distance that the cutting edge 48 travels down the slot 49 controls the length of the cut line achieved, and as described elsewhere herein, the cutting edge 48 is driven by a motor located remotely, for example, in the handle 20 or robot, via a drive mechanism that extends through the shaft 22 and, if present, the articulation joint 11 to the end effector 12.
[0036] As explained below, the distance the motor advances or otherwise displaces the drive mechanism does not always result in the cutting edge 48 being advanced / displaced the same amount through the cartridge 37; for example, 1 mm of motor displacement will not result in 1 mm of movement of the cutting edge 48; this discrepancy will vary over the length of the cut line, resulting in, for example, 2-3 mm less movement of the cutting edge 48 than the driven distance / displacement.
[0037] This may be the result of compatibility / elasticity issues with one or more components of the drive mechanism / drivetrain, which may absorb, attenuate, or dissipate at least a portion of the force applied by the motor due to, for example, frictional losses or losses due to tolerances in the components, or may 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 due to, for example, the thickness or resistance or other characteristics of the tissue being cut.
[0038] Additionally, to allow for articulation of the end effector 12, some components of the drive mechanism may need to be flexible so that they pass through the articulation joint 11 and remain operable regardless of the orientation of the end effector 12. This may add flexibility to the overall drive mechanism. Furthermore, this added flexibility may vary depending on the orientation of the end effector.
[0039] Suitability may also be a function of component design, materials used, number and type of component interconnections / links, manufacturing tolerances, wear and tear from use, and the like.
[0040] To maximize the length of the cut line, it may be suggested that the motor only advance the drive mechanism, thereby advancing the cutting edge 48, until the cutting edge 48 physically cannot be advanced any further. However, motors used in endocutters are capable of delivering a significant amount of force, e.g., greater than 200 ft / lbs, to reliably cut different types of tissue. If the cutting edge 48 were simply driven with even a small portion of the available force until it collided with some physical obstruction, i.e., an over-travel end of the cartridge 37 housing, the resulting dissipation of excess force could cause unexpected movement or vibration of the instrument 10, or noise from the instrument 10, damage to the instrument 10, such as one or more components of the motor or drive mechanism, damage to the cartridge 37, such as breakage (rupture) of the cartridge 37 housing, and / or partial or complete disarticulation of the deployed end effector 12, i.e., the force of the collision could overcome the force applied by the articulation mechanism, e.g., tension cables, used to hold the end effector 12 in a particular pose and move the end effector 12. Any of these could result in disruptive user feedback, premature wear or breakage of the instrument, extension of the cut line up to or beyond the staple line, tissue damage, and / or other patient injury.
[0041] It may further be proposed to include a sensor or switch within the end effector 12 that detects when the cutting edge 48 reaches the maximum cut line distance and then causes the motor to stop advancing the drive mechanism. However, including a sensor and / or switch may complicate the design, manufacture, and / or operation of the instrument 10, requiring additional components and wiring to connect these components to the control mechanism that controls the motor, for example, via the end effector 12, articulation joint 11, shaft 22, etc. This may result in increased costs, increased points of failure, etc.
[0042] To minimize such consequences, other firing mechanisms have utilized open-loop control, which required the firing mechanism to be initially characterized or otherwise calibrated to determine, for a given attitude or other state of the instrument 10, the relationship between the distance the motor advances the drive mechanism and the resulting distance advanced by the cutting edge 48. 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.
[0043] However, characterizing the firing mechanism before each use can be inconvenient and may not produce an accurate indication of the relationship between the distance advanced by the motor and the resulting distance traveled by the cutting edge 48. For example, variations in fit caused by manufacturing variations, repeated use of the instrument, instrument orientation / configuration, and characteristics of the tissue being transected, alone or in combination, can affect accuracy.
[0044] The disclosed embodiments reach a precise location of the cutting edge 48 at the end of the cut line—for example, not too far to prevent thread disarticulation or tearing, and not too short to avoid partially formed staples—regardless of variations caused by the configuration / orientation of the instrument 10, the compatibility of its components, or the characteristics of the tissue being cut. The disclosed embodiments do not rely on correlating drive distance, compatibility, and actual travel of the cutting edge 48, or on sensors or switches within the end effector 12, or otherwise characterizing the instrument 10, to detect the end of the cut line.
[0045] Referring to FIG. 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 with a cutting edge 48 configured to be displaced a first distance, e.g., a maximum allowable cartridge 37 cut 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 seatable in one of the jaws 16, 18 and including a sled 41 and staples 47, the sled 41 configured to be displaced a second distance, e.g., a maximum sled travel distance or staple line length, from a proximal end to a distal end of the staple cartridge 37 to deploy the staples 47 into the tissue grasped by the end effector 12 along the transection. As described elsewhere herein, the second distance can extend both proximally and distally beyond the first distance such that staple deployment begins before and extends beyond the tissue transection, i.e., the cut line does not extend beyond the staple line, e.g., to promote hemostasis of the transected tissue.
[0046] The instrument 10, or otherwise the robot, further includes a motor 1004 disposed external to the end effector 12. The motor 1004 may be any suitable motor, electrically or otherwise powered by a power source (not shown), and may provide rotational or linear actuation for displacing / advancing a driver / drive train 1008 of the instrument 10. The drive train 1008 may include multiple linked driving and / or driven components, including a drive member extending longitudinally through the shaft 22 as described above, which translates the displacement and force applied by the motor 1004 to the cutting edge 48.
[0047] The instrument 10 and / or robot may further include a driver / drive train 1008 operably coupled between the motor 1004 and the cutting edge 48 and thereby operably coupled to the sled 41, the motor 1004 configured to controllably displace, e.g., advance, move, or push, a position of a proximal end of the drive train 1008 to which the motor 1004 may be mechanically / electromechanically coupled, a controllable distance, thereby displacing the cutting edge 48 and thereby directly or indirectly displacing the sled 41 to substantially simultaneously transect tissue grasped by the end effector 12 and place staples 47 along the cut on either side. In certain cases, the surgical instrument 10 may include dedicated motor drivers and / or motors for firing, closure, and / or articulation.
[0048] The instrument 10 and / or robot may further include a control circuit 1006 coupled to the motor 1004 and shown in more detail in FIG.
[0049] In the illustrated embodiment, the control circuitry 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 circuitry 1104 stores machine-executable instructions that, when executed by the processor 1102, cause the processor 1102 to implement various processes or algorithms described herein. The processor 1102 may be any one of numerous single-core or multi-core processors known in the art. The memory circuitry 1104 may include volatile 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 circuitry 1104 of the present disclosure. The control circuitry 1006 may comprise analog or digital circuitry, such as, for example, a programmable logic device (PLD), a field programmable gate array (FPGA), discrete logic, or other hardware circuitry, software, and / or firmware, or other machine-executable instructions for implementing the functions described herein. The processor 1102 may operate according to a duty cycle, which may be based on the processor's clock speed, which defines the frequency at which the processor may sample data or otherwise perform and / or repeat calculations, for example, using updated data.
[0050] In addition to the above, the control circuit 1006 is in signal communication 1014 with the motor 1004, for example, a motor driver (not shown), a feedback system (not shown), a power source (not shown) (e.g., a battery, a supercapacitor, or any other suitable energy source), and, as described, a sensor (not shown) that senses the force / torque applied by the motor 1004 to the drivetrain 1008 and its current position, or otherwise the amount the drivetrain 1008 is displaced during operation of the motor 1004.
[0051] In certain cases, the control circuit 1006 may control the motor 1004 by generating a motor set point signal 1014. The motor set point signal may be provided to a motor driver comprising one or more described circuits configured to provide a motor drive signal to the motor 1004 to drive the motor 1004, as described herein. In some embodiments, the motor 1004 may be a brushed DC electric motor. For example, the speed of the motor 1004 may be proportional to the motor drive signal. In some embodiments, the motor 1004 may be a brushless DC electric motor, and the motor drive signal may include a PWM signal provided to one or more stator windings of the motor 1004. Also, in some embodiments, the motor driver may be omitted, and the control circuit 1006 may generate the motor drive signal directly.
[0052] As described, the motor 1004 may be operated to advance / displace the drive train 1008 at a particular speed / rate with a particular force / torque. However, if the cutting edge 48 encounters resistance, or is otherwise impeded due to friction or compliance as described herein, the operation of the motor 1004 may be impeded, and the torque / force applied by the motor 1004 may fluctuate as the motor attempts to maintain the directed speed.
[0053] Thus, the control circuit 1006 controls the rate at which the motor 1004 attempts to displace the proximal end of the drivetrain 1008 and, during displacement of the proximal end of the drivetrain 1008, monitors or otherwise senses, detects, or determines the position or displacement of the proximal end of the drivetrain 1008 and the force, either linear or rotational (torque), input by the motor 1004 to the proximal end of the drivetrain 1008, such as via a torque / force sensor 1010 and a drivetrain position sensor 1012. The current torque / force being 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 of the proximal end of the drivetrain 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 drivetrain 1008. For example, the proximal end of the drivetrain 1008 may feature mechanical, optical and / or magnetic indicators applied thereto or integrated therewith that are detectable by mechanical switches, optical detectors, Hall effect sensors, or the like, to convert movement of the proximal end of the drivetrain 1008 into a signal, e.g., a digital signal from which the position or amount of that movement / displacement can be derived.
[0054] As described elsewhere herein, during displacement of at least the proximal end of the drive train 1008, one or more of the distance displaced by the cutting edge 48 or the force applied by the cutting edge 48 to the grasped tissue may vary, e.g., be smaller, compared to the distance displaced by the proximal end of the drive train 1008 or the force applied thereto by the motor 1004. This variation may depend on one or more characteristics of the grasped tissue and / or the degree of compliance of the drive train 1008. It will be appreciated that if the force on the cutting edge 48 is absorbed by the compliance of the drive train, for example, due to thick or resistant tissue, that excess force may be stored via the compliance and released when the force on the cutting edge 48 subsides, e.g., when the cutting edge 48 moves into thinner or less resistant tissue, resulting in an increase in the force applied by the cutting edge 48 compared to the force applied by the motor 1004.
[0055] 12, 13, and 18, during displacement of the proximal end of the drivetrain 1008, the control circuit 1006 causes the motor 1004 to displace the proximal end of the drivetrain 1008 a third distance 1804, e.g., 70-74 mm, where the third distance is less than the first distance, i.e., less than the maximum cut line length, and the force input to the proximal end of the drivetrain 1008 is varied to substantially maintain a first speed, e.g., Y mm / sec, at which the motor 1004 attempts to displace the proximal end of the drivetrain 1008 (blocks 1202-1212, 1302-1306). The third distance and / or the first speed can be adjusted and varied so as not to interfere with 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 described.
[0056] Following displacement by the third distance, while the proximal end of the drive train 1008 is being displaced, control circuit 1006 causes the motor 1004 to continue to displace the proximal end of the drive train 1008 by a fourth distance 1808, e.g., 2 - 4 mm (a deviation of displacement of 72 - 78 mm), and the force input to the proximal end of the drive train 1008 varies to substantially maintain a second speed, e.g., less than Y mm / second (<Y mm / second), at which the motor 1004 attempts to displace the proximal end of the drive train 1008, and the second speed is a deceleration speed less than the first speed, e.g., 5 - 15% of the initial drive speed, etc. During this time, control circuit 1006 calculates, based on the monitored force, the predicted force required to be input to the proximal end of the drive train 1008 so as to substantially maintain the second speed 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 - 4 mm (blocks 1214 - 1238, 1308 - 1328). The calculation of the predicted force can be repeatedly executed as described, and the frequency of repetition can depend on the duty cycle of the processor 1102. Control circuit 1006 enables an adjustable displacement margin 1806 that allows the speed of motor 1004 to slow down / decelerate from the first speed to the second deceleration speed before starting the process of calculating the predicted force, e.g., over a distance from 70 - 74 mm to 1 - 4 mm, so as to allow the displacement speed to reach a steady state, e.g., such that torque values that decrease due to deceleration are excluded from subsequent calculations. It will be appreciated that the fourth distance and / or the second speed can be adjustable so as not to interfere with the surgical procedure in which the instrument 10 is being used, while the remainder of the disclosed algorithm allows sufficient remaining distance / time to calculate a suitable predicted force as described. The subsequent distance, or number of its increments, over which the required force is predicted can be implementation - dependent and can depend on the amount of time required to determine that the motor 1004 should be stopped, as well as the amount of time it actually takes to stop the advancement of the motor 1004 and the cutting edge 48.
[0057] During displacement of the proximal end of the drive train 1008, the control circuit 1006 further causes the motor 1004 to continue to displace the proximal end of the drive train 1008 (1810), varying to substantially maintain a second speed, for example, less than Y mm / second (<Y mm / second). When the motor 1004 attempts to displace the proximal end of the drive train 1008 and at the second speed, for example, over the remaining displacement of 70 - 77 mm, until it is determined (1802) that the force input to the proximal end of the drive train 1008 exceeds a threshold of the calculated predicted force, for example, more than 10% - 20% (blocks 1230 - 1236, 1308 - 1328), the control circuit 1006 stops the motor 1004 when the force input to the proximal end of the drive train 1008 exceeds the threshold. For example, if the predicted force is calculated to be 30 lbs and the monitored force exceeds 36 lbs, the motor 1004 is stopped. The speed applied by the motor 1004 can be the same or different from the speed applied to the calculation of the predicted force. Further, different thresholds can be applied to determine when to stop the motor depending on the implementation form. The threshold is calibrated to distinguish the force sensed based on encountering simply thick / more resistant tissue compared to the force sensed by the cutting edge 48, or a portion thereof, colliding with a physical obstacle at the currently applied displacement speed, for example, the physical obstacles described below, or the thread 41 stopped due to a collision with the end of the cartridge 37 or other obstacle, or an intermediate drive component therebetween. In one embodiment, the calculation of the predicted force continues until the motor 1004 is stopped.
[0058] In one embodiment, the control circuit 1006 stops the displacement, for example, by stopping or disconnecting the motor 1004, when the proximal end of the drive train 1008 is displaced beyond a maximum distance, for example, maximum mm (blocks 1238, 1326). This can be implemented as a safety mechanism and an absolute stop point and can be defined based on the type of staple cartridge 37 used with the instrument 10 and their physical dimensions, i.e., the maximum allowable movement distance of the thread 41.
[0059] Once the motor 1004 is stopped, the control circuit 1006 may activate an indicator or otherwise generate a signal indicating that the end of the cutting line has been reached. The cutting edge 48 may then be automatically or manually retracted for removal and, if desired, for subsequent firing of the instrument 10.
[0060] Once the motor 1004 is stopped, the control circuit 1006 can automatically direct the motor 1004 to reverse and retract the proximal end of the drive train 1008, thereby retracting the cutting edge 48, for example, so that the jaws 16, 18 of the end effector 12 can be opened or otherwise so that the end effector 12 can be removed from the body, e.g., so that a used staple cartridge 37 can be removed and a new staple cartridge 37 can be inserted.
[0061] The calculation of the predicted force and the determination of when to stop the motor 1004 may be implemented in different ways. For example, as shown in FIG. 12, the calculation of the predicted force may include creating an array of then-current values of monitored forces and corresponding positions (blocks 1220-1222), which may be depicted as a graph of force versus displacement distance as shown in FIG. 18, as the proximal end of the drivetrain 1008 is displaced over a fourth distance, storing the array in the memory buffer 1104 (block 1224), and fitting a linear or best-fit curve to the stored array of monitored forces and corresponding position values (block 1228), where the predicted force is calculated based on a projection of the fitted linear / curvilinear curve over one or more subsequent increments of displacement of the drivetrain 1008, allowing the control circuit 1006 to take preemptive action when the maximum cut 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 be implementation dependent. It will be appreciated that other fitting functions, such as a quadratic fitting function, may be used to determine the force trend.
[0062] In an alternative embodiment, as shown in FIG. 13 , the calculation of the predicted force includes, when the proximal end of the drivetrain 1008 is displaced a fourth distance (block 1308), determining the then current value of the monitored force and corresponding position (blocks 1310, 1312), calculating the change in the monitored force over the displaced distance (block 1314), and applying fuzzy logic to the current position and the change in the monitored force over the displaced distance; when the fuzzy logic returns a true value, the force input to the proximal end of the drivetrain 1008 is determined to exceed the calculated predicted force threshold, e.g., 10% to 20% (blocks 1316-1324).
[0063] Fuzzification takes a clean (single-valued) input and turns it into a fuzzy set—a set of values corresponding to the degree of membership for each of a set of one or more membership functions. A membership function is a function that describes the extent to which the input belongs to a fuzzy set. The maximum output of each fuzzy membership function is 1, meaning that the input is a complete part of that membership function. Fuzzy membership functions often overlap with each other, and when they do, the values of each function (corresponding to the input) should sum to 1 and represent the degree to which the input is a part of each function: 0 means the input is not a part of the function, 1 means the input is a complete part of the function, and any value in between indicates the degree to which the input is a partial part of the function.
[0064] The membership functions may be represented as overlapping graphs with the range of possible input values, e.g., 1 to 100, forming the x-axis and the degree of membership for each input value to each function, e.g., 0 to 1, plotted along the y-axis; for any given input value, the implementation-dependent degrees of membership in the defined membership functions must sum to 1. For example, a membership function may be defined to cover a lower limit, e.g., input values 1 to 49, and another membership function may be defined to cover an upper limit, e.g., input values 50 to 100, where the degree of membership in the lower limit function varies between 0 and 1 over the range of values 1 to 40, the degree of membership in the upper limit function varies between 0 and 1 over the range of values 50 to 100, etc. A third intermediate limit membership function may 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 limit function varies between 0 and 1 over the range of values 25 to 75. In this example, these three membership functions should be defined such that, for each input value, the sum of the degrees of membership in these three functions equals 1.
[0065] For example, for an input value of 35, the degree to which this input value may be part of the lower bound function may be 0.25, the degree to which this input value may be part of the middle bound function may be 0.75, and the degree to which this input value may be part of the upper bound function may be 0.00, summing to 1.
[0066] In the disclosed embodiment, each input to the control circuit 1006, i.e., the current displacement (position or x) of the proximal end of the drivetrain 1008 and the change in current force (F) being input to the proximal end of the drivetrain 1008 to maintain the current velocity at which the motor 1004 is attempting to displace the proximal end of the drivetrain 1008 as a function of the change in displacement (dF / dx), may have its own set of membership functions.
[0067] 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 used to combine fuzzy sets: and, or, and not. X and Y->x * y X or Y->x+yx * y not X->1-x
[0068] Several rules can be created using these operators. In an exemplary implementation of the disclosed embodiments, five rules are created that combine two fuzzy sets, the current displacement (x) of the proximal end of the drivetrain 1008, and the current change in force (F) being input to the proximal end of the drivetrain 1008, to maintain the current velocity at which the motor 1004 is attempting to displace the proximal end of the drivetrain 1008 as a function of the change in displacement (dF / dx). · If x is far (lower bound) or df / dx is negative (lower bound), continue. · If x is close (upper limit) and df / dx is below threshold (middle limit), continue. · If x is below the mean (mid-limit) and df / dx is below the threshold (mid-limit), continue. · Stop if x is above the mean (lower bound) and df / dx is above the threshold (upper bound). · Stop if x is close (upper limit) and df / dx is above threshold (upper limit).
[0069] Each fuzzy logic rule generates an output, and each of the outputs from the fuzzy logic rules are 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 to a precise value) to produce a single value that determines whether to continue displacing the proximal end of the drivetrain 1008, or to stop the motor 1004 and begin reverse, etc. In one implementation, defuzzification is performed using the following equation, although it will be understood that other methods of defuzzification may be used and are implementation dependent: Result = Stop > 500 * continuation where 500 is an adjustable parameter.
[0070] For example, use the following fuzzy sets: input_1(x){0.0,0.33,0.67},input_2(df / dx){0.0,0.75,0.25}
[0071] Rule Output: {continue, stop} 1: 0.0+0.0-0.0 * 0.0->0.0(continue) 2: 0.67 * 0.75->0.5025 (continued) 3: 0.33 * 0.75->0.2475 (continued) 4: 0.33 * 0.25->0.0825(stop) 5: 0.67 * 0.25->0.1675(stop)
[0072] Combining rules, i.e., combining two groups of rules into two outputs, continue and stop. Rules: 1, 2 and 3: Continuation = 0.0 + 0.5025 + 0.2475 - 0.5025 * 0.2475-0.0 * 0.5025+0.2475-0.5025* 0.2475) -> 0.6256 Rules 4 and 5: stop=0.0825+0.1675-0.0825 * 0.1675->0.1118
[0073] Combine rules into results using the formula above. Result=0.1118>500 * 0.6256->false
[0074] In this example, the result comes out as false, which means to continue displacing the proximal end of the drivetrain 1008.
[0075] In one embodiment, a physical obstruction may be provided that prevents the cutting edge 48, alone or in cooperation with the sled 41 and / or intermediate drive component, from moving further than the obstruction, i.e., beyond the maximum cut line length. In one implementation, this physical obstruction may be constituted by the distal end of the cartridge 37 itself, which obstructs the movement of the sled 41, thereby preventing further movement of the cutting edge 48, directly or indirectly via obstructed movement of the intermediate drive component, if present. The collision of the sled 41 with the end of the cartridge 37 and the resulting abrupt halt in forward movement by the cutting edge 48 may translate back through the drive train to the motor 1004, resulting in an increase in the force applied by the motor 1004, which exceeds the predicted force and stalls the motor 1004 as described.
[0076] In alternative embodiments, it may be determined that allowing the sled 41 to impact or otherwise contact the distal end of the cartridge 37 is impractical, unsafe, or otherwise does not provide sufficient translation of return force to the motor 1004, for example, because the cartridge 37 may not be adequately designed for such impact. Accordingly, a separate or designated 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 and lower jaws 16, 18. In one embodiment, this physical obstruction, which may be referred to as a bump, stop, or trigger, may be located in or across one or both of the slots 42, 45 and may be positioned on one or both of the upper and lower jaws 16, 18 to interrupt or prevent movement of the cutting edge 48, or intermediate drive component, if present, such as by obstructing movement of a portion of the cutting edge 48 therein. The location of the physical obstruction may be implementation dependent and may be selected, for example, to result in the movement of the cutting edge 48 being obstructed at the maximum cut line length allowed.
[0077] Furthermore, the physical obstruction may be configured to provide a particular response, i.e., an impulse response, a resonant response, or a ringing response, when struck or otherwise contacted by the cutting edge 48 or an intermediate drive component, and to dissipate the force as the cutting edge 48 decelerates to a stop. This particular response, when translated through the drivetrain and drivetrain 1008 back to the motor 1004, may produce a detectable response, e.g., in its frequency, magnitude, or rate of change, with respect to the variation in force applied by the motor 1004 in response thereto. For example, the physical obstruction's placement, shape, orientation, structure, stiffness / compliance, elasticity, composition, coating, treatment, and / or material, e.g., rubber, silicone, plastic, polyester, or metals of different (higher or lower) density, may be tailored to provide a desired response. Alternatively, the configuration of the physical obstruction may be tailored to absorb, dissipate, or otherwise reduce the impact force. Furthermore, the configuration of the physical obstruction may be designed in accordance with the embodiments described herein to maintain the above-described properties over multiple firings of the instrument, for example, over multiple impacts by the cutting edge 48 or intermediate drive component.
[0078] In one embodiment, a physical obstruction is formed or otherwise provided within the lower jaw 16 so as to be below the cartridge 37 and therefore not come into contact with the grasped tissue.
[0079] In one embodiment, the physical obstruction is formed in at least one jaw 16, 18 during manufacture after the cutting edge 48 is assembled with the at least one jaw 16, 18 to facilitate assembly of the end effector 12.
[0080] In one embodiment, the physical obstruction may include a tab or other movable or bendable obstacle formed within or as part of the jaw 16, 18 that is formed out of the way to allow assembly of the cutting edge 48 with the jaw 16, 18, and that is subsequently moved, bent, or formed into an obstructing position / orientation after the cutting edge 48 is assembled with the end effector 12.
[0081] 14 depicts a perspective view of a jaw of a surgical stapling instrument including an inserted stop, according to some embodiments. In this embodiment, a pocket 1402 is machined or otherwise formed, for example, in the lower jaw 16, into which a stop / trigger / bump, such as the stop / trigger 1500 shown in FIG. 15, is inserted during manufacture, for example, after the cutting edge 48 has been assembled therewith. The stop / trigger 1500 may feature a body 1502 constructed from a material having a tailored response as described above and having a partial slot 1504 formed therein to receive the cutting edge 48, or at least a portion of the cutting edge 48 that travels down the slot 45. In one implementation, the slot 1504 may be fully or partially tapered or may otherwise have a width that is less than the width of the portion of the cutting edge 45 received thereby, and as the portion of the cutting edge 45 enters the slot 1504, the cutting edge 45 contacts the inner surface of the slot 1504 and frictional forces act to slow the cutting edge 45 prior to impact / contact with the stop 1500 and / or otherwise generate a desired detectable change in force.
[0082] 16 and 17 depict 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 pocket 1402 and stop / trigger 1500 have an hourglass shape that can compress longitudinally upon impact / contact with cutting edge 48, thereby absorbing or dissipating the impact force and / or otherwise producing a desired detectable change in force.
[0083] In one embodiment, the aforementioned surgical stapling instrument 10 further includes a handle 20 including a motor 1004 and control circuitry 1006, an articulation joint 11, and a shaft 22 extending from the handle 20 to the articulation joint 11 to which an end effector 12 is coupled, the shaft 22 including a drive train 1008, the end effector 12 including a firing beam 14 operatively coupled to the drive train 1008 and including a cutting edge 48, the articulation joint 11 enabling the end effector 12 to be articulated and maintained in one or more directions relative to a longitudinal axis of the shaft 22 through the application of a retention force. In one embodiment, the calculated predicted force threshold is determined to be less than the retention force.
[0084] In one embodiment, the aforementioned surgical stapling instrument 10 is configured to be mounted and operated by a robot.
[0085] VI. Example of Combination 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 scope of any claims that may be presented at any time in this application or any subsequent application related to this application. No disclaimer is intended. The following examples are provided merely for illustrative purposes. It is contemplated that the various teachings herein may be configured and applied in many other ways. It is also contemplated that certain features referred to in the following examples may be omitted in some variations. Accordingly, none of the aspects or features referred to below should be considered critical unless later expressly indicated otherwise by the inventors or their successors. If a claim presented in this application or a subsequent application related to this application includes additional features other than those referred to below, those additional features should not be considered added for any reasons of patentability. [Example]
[0086] A control circuit (1006) for controlling a surgical instrument (10), the surgical instrument (10) comprising an end effector (12) configured to grasp tissue, jaws (16, 18) having a cutting edge (48), the cutting edge (48) 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) sever tissue grasped by the end effector (12), the jaws (16, 18) further configured to receive a staple cartridge (37) seatable in one of the jaws (16, 18) and including a sled (41) and staples (47), the sled (41) moving in conjunction with the staple cartridge (37) to deploy the staples (47) into the tissue grasped by the end effector (12) along the transection. the surgical instrument further comprises: a motor located external to the end effector; and a drive train operatively coupled between the motor and the cutting edge and the sled, the motor configured to controllably displace the position of the proximal end of the drive train a controllable distance to displace the cutting edge and the sled so as to substantially simultaneously transect tissue grasped by the end effector and deploy staples on either side of the transection; and a control circuit configured to: A method for implementing a method for a computer-implemented program comprising: a processor and a memory coupled thereto, the memory storing computer-readable instructions that, when executed by the processor, cause the processor to: controlling the speed at which the motor (1004) attempts to displace the proximal end of the drive train (1008); During displacement of the proximal end of the drive train (1008), the location of the proximal end of the drive train (1008); and monitoring the force input by the motor (1004) to the proximal end of the drive train (1008); During displacement of the proximal end of the drive train (1008), the motor (1004) displacing the proximal end of the drivetrain (1008) a third distance less than the first distance using a force input to the proximal end of the drivetrain (1008) that varies to substantially maintain a first speed at which the motor (1004) tends to displace the proximal end of the drivetrain (1008); and continuing to displace the proximal end of the drivetrain (1008) a fourth distance using a force input to the proximal end of the drivetrain (1008) that varies to substantially maintain a second speed at which the motor (1004) attempts to displace the proximal end of the drivetrain (1008), the second speed being less than the first speed, while the control circuit (1006) calculates, based on the monitored force, a predicted force that needs to be input to the proximal end of the drivetrain (1008) to substantially maintain the second speed at which the motor (1004) attempts to displace the proximal end of the drivetrain (1008) over a subsequent further distance; and A control circuit (1006) causes the motor (1004) to continue displacing the proximal end of the drivetrain (1008) using a force input to the proximal end of the drivetrain (1008) that varies to substantially maintain a second speed at which the motor (1004) attempts to displace the proximal end of the drivetrain (1008) until it is determined that the force input to the proximal end of the drivetrain (1008) exceeds a calculated predicted force threshold. [Example]
[0087] A control circuit (1006) as described in Example 1, wherein during displacement of at least the proximal end of the drive train (1008), one or more of the distance displaced by the cutting edge (48) or the force applied to the tissue grasped by the cutting edge (48) varies compared to the distance displaced by the proximal end of the drive train (1008) or the force applied to the proximal end by the motor (1004). [Example]
[0088] The control circuit (1006) as described in Example 2, wherein the variation depends on one or more properties of the grasped tissue and / or the degree of compliance of the drive train (1008). [Example]
[0089] 4. The control circuit (1006) of any one of Examples 1 to 3, wherein the control circuit (1006) stops the displacement when the proximal end of the drive train (1008) is displaced a maximum distance. [Example]
[0090] 5. The control circuit of any one of Examples 1-4, wherein the cutting edge is physically prevented from exceeding the first distance. [Example]
[0091] The control circuit (1006) of any one of Examples 1 to 5, wherein the physical obstruction (1500) is formed in at least one jaw (16, 18) during manufacture after the cutting edge (48) is assembled with the at least one jaw (16, 18). [Example]
[0092] The control circuit (1006) of any one of Examples 1 to 6, wherein the physical obstruction (1500) is characterized by a property that results in a distinguishable change in a differently monitored force input to the proximal end of the drive train (1008) to maintain the second speed when at least a portion of the cutting edge (48) collides with, encounters, or contacts the physical obstruction (1500). [Example]
[0093] The predicted force calculation is creating an array of then-current values of the monitored forces and corresponding positions as the proximal end of the drive train (1008) is displaced through a fourth distance; storing the array in a memory buffer (1104); fitting one of a linear or best fit curve to the stored array of monitored forces and corresponding position values; The control circuit (1006) of any one of Examples 1 to 7, wherein the predicted force is calculated based on a fitted linear or best fit curve prediction over one or more subsequent increments of displacement of the drivetrain (1008). [Example]
[0094] The predicted force calculation is A control circuit (1006) as described in any one of Examples 1 to 7, which includes determining a then-current value of the monitored force and corresponding position when the proximal end of the drivetrain (1008) is displaced over a fourth distance, calculating a change in the monitored force over the displaced distance, and applying fuzzy logic to the current position and the change in the monitored force over the displaced distance, wherein when the fuzzy logic returns a true value, it is determined that the force input to the proximal end of the drivetrain (1008) exceeds the calculated predicted force threshold. [Example]
[0095] The surgical instrument (10) comprises a handle (20) and a shaft (22), the proximal end of the shaft (22) being connected to the distal end of the handle (20), the distal end of the shaft (22) being connected to the end effector (12), the motor (1004) being located within the handle (20), and the drive train (1008) being located within the shaft (22) and extending from the proximal end of the shaft (22) to the distal end of the shaft (22), a control circuit (1006) described in any one of Examples 1 to 9. [Example]
[0096] 11. The control circuit (1006) of any one of Examples 1 to 10, wherein the drive train (1008) comprises a plurality of linked components. [Example]
[0097] a handle (20) having a motor (1004) and a control circuit (1006); an articulated joint (11); a shaft (22) extending from the handle (20) to the articulation joint (11) to which the end effector (12) is coupled, the shaft (22) comprising a drive train (1008); The end effector (12) includes a firing beam (14) operably coupled to the drive train (1008) and including a cutting edge (48); A control circuit (1006) described in any one of Examples 1 to 11, wherein the articulation joint (11) enables the end effector (12) to be articulated and maintained in one or more directions relative to the longitudinal axis of the shaft through the application of a holding force. [Example]
[0098] 13. The control circuit (1006) of any one of Examples 1 to 12, wherein the calculated predicted force threshold is less than the retention force. [Example]
[0099] 14. The control circuit of any one of Examples 1 to 13, wherein the surgical stapling instrument is configured to be attached and operated by a robot. [Example]
[0100] A surgical stapling instrument (10), comprising: An end effector (12) configured to grasp tissue, an end effector (12) comprising jaws (16, 18) with cutting edges (48) configured to be displaced a first distance from a proximal end to a distal end of the jaws (16, 18) so that at least a portion of the cutting edges (48) sever tissue grasped by the end effector (12), the jaws (16, 18) being further configured to receive a staple cartridge (37) seatable in one of the jaws (16, 18) and including a sled (41) and staples (47), the sled (41) being 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) into the tissue grasped by the end effector (12) along the severance; a motor (1004) located external to the end effector (12); a drive train (1008) operatively coupled between the motor (1004) and the cutting edge (48) and the sled (41), the motor (1004) configured to controllably displace the position of a proximal end of the drive train (1008) a controllable distance to displace the cutting edge (48) and the sled (41) so as to substantially simultaneously transect tissue grasped by the end effector (12) and deploy staples (47) along the transection on either side thereof; A surgical stapling instrument (10) comprising: a control circuit (1006) according to any one of Examples 1 to 14. [Example]
[0101] A method of operating a surgical instrument (10), the surgical instrument (10) comprising an end effector (12) configured to grasp tissue, the end effector comprising jaws (16, 18) with cutting edges (48) 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 (12), the jaws (16, 18) further configured to receive a staple cartridge (37) seatable in one of the jaws (16, 18) and including a sled (41) and staples (47), the sled (41) deploying the staples (47) along the transect and into the tissue grasped by the end effector (12). the surgical instrument (10) further comprises a motor (1004) located external to the end effector (12), and a drive train (1008) operatively coupled between the motor (1004) and the cutting edge (48) and the sled (41), the motor (1004) configured to controllably displace the position of the proximal end of the drive train (1008) a controllable distance to displace the cutting edge (48) and the sled (41) so as to substantially simultaneously transect tissue grasped by the end effector (12) and deploy staples (47) on either side of the transection; controlling the speed at which the motor (1004) attempts to displace the proximal end of the drive train (1008); the location of the proximal end of the drive train (1008); monitoring the force input by the motor (1004) to the proximal end of the drive train (1008); During displacement of the proximal end of the drive train (1008), the motor (1004) displacing the proximal end of the drivetrain (1008) a third distance less than the first distance using a force input to the proximal end of the drivetrain (1008) that varies to substantially maintain a first speed at which the motor (1004) tends to displace the proximal end of the drivetrain (1008); and continuing to displace the proximal end of the drivetrain (1008) a fourth distance using a force input to the proximal end of the drivetrain (1008) that varies to substantially maintain a second speed at which the motor (1004) attempts to displace the proximal end of the drivetrain (1008), the second speed being less than the first speed, while the control circuit (1006) calculates, based on the monitored force, a predicted force that needs to be input to the proximal end of the drivetrain (1008) to substantially maintain the second speed at which the motor (1004) attempts to displace the proximal end of the drivetrain (1008) over a subsequent further distance; and and continuing to displace the proximal end of the drivetrain (1008) using a force input to the proximal end of the drivetrain (1008) that varies to substantially maintain a second speed at which the motor (1004) attempts to displace the proximal end of the drivetrain (1008) until it is determined that the force input to the proximal end of the drivetrain (1008) exceeds a calculated predicted force threshold. [Example]
[0102] The predicted force calculation is creating an array of then-current values of the monitored forces and corresponding positions as the proximal end of the drive train (1008) is displaced through a fourth distance; storing the array in a memory buffer (1104); fitting one of a linear or best fit curve to the stored array of monitored forces and corresponding position values; 17. The method of example 16, wherein the predicted force is calculated based on a best fit curve prediction over one or more fitted linear subsequent increments of displacement of the drivetrain (1008). [Example]
[0103] The predicted force calculation is The method of Example 16, comprising, when the proximal end of the drivetrain (1008) is displaced over a fourth distance, determining a then-current value of the monitored force and corresponding position, calculating a change in the monitored force over the displaced distance, and applying fuzzy logic to the current position and the change in the monitored force over the displaced distance, wherein when the fuzzy logic returns a true value, it is determined that the force input to the proximal end of the drivetrain (1008) exceeds the calculated predicted force threshold. [Example]
[0104] The method of any one of Examples 16-18, wherein the cutting edge (48) is physically prevented from exceeding the first distance. [Example]
[0105] The method of any one of Examples 16-19, further comprising forming a physical obstruction (1500) on at least one jaw (16, 18) during manufacture after the cutting edge (48) is assembled with the at least one jaw (16, 18).
[0106] The following clauses also relate to various non-exhaustive ways in which the teachings herein may be combined or applied. 1. A surgical stapling instrument (10) comprising: An end effector (12) configured to grasp tissue, an end effector (12) comprising jaws (16, 18) having cutting edges (48) configured to be displaced a first distance from a proximal end to a distal end of the jaws (16, 18) so that at least a portion of the cutting edges (48) sever tissue grasped by the end effector (12), the jaws (16, 18) being further configured to receive a staple cartridge (37) seatable in one of the jaws (16, 18) and including a sled (41) and staples (47), the sled (41) being 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) into the tissue grasped by the end effector (12) along the severance; a motor (1004) located external to the end effector (12); a drive train (1008) operatively coupled between the motor (1004) and the cutting edge (48) and the sled (41), the motor (1004) configured to controllably displace the position of a proximal end of the drive train (1008) a controllable distance to displace the cutting edge (48) and the sled (41) so as to substantially simultaneously transect tissue grasped by the end effector (12) and deploy staples (47) along the transection on either side thereof; a control circuit (1006) coupled to the motor (1004) for controlling 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): the location of the proximal end of the drive train (1008); a control circuit that monitors the force input by the motor (1004) to the proximal end of the drive train (1008); The control circuit (1006) controls the motor (1004) to: displacing the proximal end of the drivetrain (1008) a third distance less than the first distance using a force input to the proximal end of the drivetrain (1008) that varies to substantially maintain a first speed at which the motor (1004) tends to displace the proximal end of the drivetrain (1008); Following displacing the third distance, continuing to displace the proximal end of the drivetrain (1008) a fourth distance using a force input to the proximal end of the drivetrain (1008) that varies to substantially maintain a second speed at which the motor (1004) attempts to displace the proximal end of the drivetrain (1008), the second speed being less than the first speed, while the control circuit (1006) calculates, based on the monitored force, a predicted force that needs to be input to the proximal end of the drivetrain (1008) to substantially maintain the second speed at which the motor (1004) attempts to displace the proximal end of the drivetrain (1008) over a subsequent further distance; and continuing to displace the proximal end of the drive train (1008) using a force input to the proximal end of the drive train (1008) that varies so as to substantially maintain a second speed at which the motor (1004) attempts to displace the proximal end of the drive train (1008) until it is determined that the force input to the proximal end of the drive train (1008) exceeds a calculated predicted force threshold. 2. The surgical stapling instrument (10) of claim 1, wherein, during displacement of at least the proximal end of the drive train (1008), one or more of the distance displaced by the cutting edge (48) or the force applied to the tissue grasped by the cutting edge (48) varies compared to the distance displaced by the proximal end of the drive train (1008) or the force applied to the proximal end by the motor (1004). 3. The surgical stapling instrument (10) of claim 2, wherein the variation is dependent on one or more characteristics of the grasped tissue and / or the degree of compatibility of the drive train (1008). 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 been displaced a maximum distance. 5. The surgical stapling instrument (10) of claim 1, wherein the cutting edge (48) is physically prevented from exceeding a first distance. 6. The surgical stapling instrument (10) of claim 5, wherein the physical obstruction (1500) is formed in at least one jaw (16, 18) during manufacture after the cutting edge (48) is assembled with the at least one jaw (16, 18). 7. The surgical stapling instrument (10) of claim 5, wherein the physical obstruction (1500) is characterized by a property that results in a distinguishable change in a monitored force input to a proximal end of the drive train (1008) to maintain the second velocity when at least a portion of the cutting edge (48) collides with, encounters, or otherwise contacts the physical obstruction (1500). 8. Calculate the predicted force: creating an array of then-current values of the monitored forces and corresponding positions as the proximal end of the drive train (1008) is displaced through a fourth distance; storing the array in a memory buffer (1104); fitting one of a linear or best fit curve to the stored array of monitored forces and corresponding position values; 10. The surgical stapling instrument of claim 1, wherein the predicted force is calculated based on a projection of or fitted linear best fit curve over one or more subsequent increments of displacement of the drive train. 9. Calculate the predicted force: 10. The surgical stapling instrument of claim 1, further comprising: when the proximal end of the drive train is displaced a fourth distance, determining a then-current value of the monitored force and corresponding position, calculating a change in the monitored force over the displaced distance, and applying fuzzy logic to the current position and the change in the monitored force over the displaced distance, wherein when the fuzzy logic returns a true value, the force input to the proximal end of the drive train is determined to exceed the calculated predicted force threshold. 10. The surgical stapling instrument (10) of claim 1, wherein the surgical instrument (10) comprises a handle (20) and a shaft (22), the proximal end of the shaft (22) is coupled to the distal end of the handle (20), the distal end of the shaft (22) is coupled to the end effector (12), the motor (1004) is located within the handle (20), and the drive train (1008) is located within the shaft (22) and extends from the proximal end of the shaft (22) to the distal end of the shaft (22). 11. The surgical stapling instrument (10) of claim 1, wherein the drive train (1008) comprises a plurality of linked components. 12. a handle (20) having a motor (1004) and a control circuit (1006); an articulated joint (11); a shaft (22) extending from the handle (20) to the articulation joint (11) to which the end effector (12) is coupled, the shaft (22) comprising a drive train (1008); The end effector (12) includes a firing beam (14) operably coupled to the drive train (1008) and including a cutting edge (48); 10. The surgical stapling instrument of claim 1, wherein the articulation joint enables the end effector to be articulated and maintained in one or more directions relative to the longitudinal axis of the shaft through the application of a retention force. 13. The surgical stapling instrument (10) of claim 12, wherein the calculated predicted force threshold is less than the retention force. 14. The surgical stapling instrument (10) of claim 1, wherein the surgical stapling instrument (10) is configured to be mounted and operated by a robot. 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 comprising jaws (16, 18) having cutting edges (48), the cutting edges (48) 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 edges (48) sever tissue grasped by the end effector (12), the jaws (16, 18) being further configured to receive a staple cartridge (37) seatable in one of the jaws (16, 18) and including a sled (41) and staples (47), the sled (41) being configured to sever tissue grasped by the end effector (12) along the sled. the surgical instrument (10) further comprises a motor (1004) located external to the end effector (12) and a drive train (1008) operatively coupled between the motor (1004) and the cutting edge (48) and the sled (41), the motor (1004) being configured to controllably displace the position of the proximal end of the drive train (1008) a controllable distance to displace the cutting edge (48) and the sled (41) so as to substantially simultaneously transect the tissue grasped by the end effector (12) and deploy staples (47) on either side of the transect; and the control circuit (1006) A method for implementing a method for a computer-implemented program comprising: a processor and a memory coupled thereto, the memory storing computer-readable instructions that, when executed by the processor, cause the processor to: controlling the speed at which the motor (1004) attempts to displace the proximal end of the drive train (1008); During displacement of the proximal end of the drive train (1008), the location of the proximal end of the drive train (1008); and monitoring the force input by the motor (1004) to the proximal end of the drive train (1008); During displacement of the proximal end of the drive train (1008), the motor (1004) displacing the proximal end of the drivetrain (1008) a third distance less than the first distance using a force input to the proximal end of the drivetrain (1008) that varies to substantially maintain a first speed at which the motor (1004) tends to displace the proximal end of the drivetrain (1008); and continuing to displace the proximal end of the drivetrain (1008) a fourth distance using a force input to the proximal end of the drivetrain (1008) that varies to substantially maintain a second speed at which the motor (1004) attempts to displace the proximal end of the drivetrain (1008), the second speed being less than the first speed, while the control circuit (1006) calculates, based on the monitored force, a predicted force that needs to be input to the proximal end of the drivetrain (1008) to substantially maintain the second speed at which the motor (1004) attempts to displace the proximal end of the drivetrain (1008) over a subsequent further distance; and A control circuit (1006) causes the motor (1004) to continue displacing the proximal end of the drivetrain (1008) using a force input to the proximal end of the drivetrain (1008) that varies to substantially maintain a second speed at which the motor (1004) attempts to displace the proximal end of the drivetrain (1008) until it is determined that the force input to the proximal end of the drivetrain (1008) exceeds a calculated predicted force threshold. 16. Calculate the predicted force. creating an array of then-current values of the monitored forces and corresponding positions as the proximal end of the drive train (1008) is displaced through a fourth distance; storing the array in a memory buffer (1104); fitting one of a linear or best fit curve to the stored array of monitored forces and corresponding position values; 16. The control circuit (1006) of claim 15, wherein the predicted force is calculated based on a fitted linear or best fit curve prediction over one or more subsequent increments of displacement of the drivetrain (1008). 17. Calculate the predicted force. 16. The control circuit (1006) of claim 15, further comprising: when the proximal end of the drivetrain (1008) is displaced over a fourth distance, determining a then-current value of the monitored force and corresponding position, calculating a change in the monitored force over the displaced distance, and applying fuzzy logic to the current position and the change in the monitored force over the displaced distance, wherein when the fuzzy logic returns a true value, the force input to the proximal end of the drivetrain (1008) is determined to exceed the calculated predicted force threshold. 18. The control circuit (1006) of claim 15, wherein the cutting edge (48) is physically prevented from exceeding the first distance. 19. The control circuit (1006) of claim 18, wherein the physical obstruction (1500) is formed during manufacture of at least one jaw (16, 18) after the cutting edge (48) is assembled with the at least one jaw (16, 18). 20. The control circuit (1006) of claim 18, wherein the physical obstruction (1500) is characterized by a property that results in a distinguishable change in the monitored force input to the proximal end of the drive train (1008) to maintain the second speed when at least a portion of the cutting edge (48) collides with, encounters, or otherwise contacts the physical obstruction (1500). 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 comprising jaws (16, 18) having cutting edges (48), the cutting edges (48) 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 edges (48) sever tissue grasped by the end effector (12), the jaws (16, 18) further configured to receive a staple cartridge (37) seatable in one of the jaws (16, 18) and including a sled (41) and staples (47), the sled (41) extending along the sled to sever tissue grasped by the end effector (12). the surgical instrument (10) is configured to be displaced a second distance from the proximal end to the distal end of the staple cartridge (37) to deploy staples (47) within the tissue, the surgical instrument (10) further comprising: a motor (1004) located external to the end effector (12) and a drive train (1008) operatively coupled between the motor (1004) and the cutting edge (48) and the sled (41), the motor (1004) configured to controllably displace the position of the proximal end of the drive train (1008) a controllable distance to displace the cutting edge (48) and the sled (41) so as to substantially simultaneously transect tissue grasped by the end effector (12) and deploy staples (47) on either side of the transect; and the method comprises: Controlling the speed at which the motor (1004) attempts to displace the proximal end of the drive train (1008) and: the location of the proximal end of the drive train (1008); monitoring a force input by the motor (1004) to a proximal end of the drive train (1008); During displacement of the proximal end of the drive train (1008), the motor (1004) displacing the proximal end of the drivetrain (1008) a third distance less than the first distance using a force input to the proximal end of the drivetrain (1008) that varies to substantially maintain a first speed at which the motor (1004) tends to displace the proximal end of the drivetrain (1008); and continuing to displace the proximal end of the drivetrain (1008) a fourth distance using a force input to the proximal end of the drivetrain (1008) that varies to substantially maintain a second speed at which the motor (1004) attempts to displace the proximal end of the drivetrain (1008), the second speed being less than the first speed, while the control circuit (1006) calculates, based on the monitored force, a predicted force that needs to be input to the proximal end of the drivetrain (1008) to substantially maintain the second speed at which the motor (1004) attempts to displace the proximal end of the drivetrain (1008) over a subsequent further distance; and and continuing to displace the proximal end of the drivetrain (1008) using a force input to the proximal end of the drivetrain (1008) that varies to substantially maintain a second speed at which the motor (1004) attempts to displace the proximal end of the drivetrain (1008) until it is determined that the force input to the proximal end of the drivetrain (1008) exceeds a calculated predicted force threshold. 22. Calculate the predicted force. creating an array of then-current values of the monitored forces and corresponding positions as the proximal end of the drive train (1008) is displaced through a fourth distance; storing the array in a memory buffer (1104); fitting one of a linear or best fit curve to the stored array of monitored forces and corresponding position values; 22. The method of claim 21, wherein the predicted force is calculated based on a fitted linear or best fit curve prediction over one or more subsequent increments of displacement of the drivetrain (1008). 23. Calculate the predicted force. 22. The method of claim 21, further comprising: when the proximal end of the drivetrain (1008) is displaced a fourth distance, determining a then-current value of the monitored force and corresponding position; calculating a change in the monitored force over the displaced distance; and applying fuzzy logic to the current position and the change in the monitored force over the displaced distance; wherein when the fuzzy logic returns a true value, the force input to the proximal end of the drivetrain (1008) is determined to exceed the calculated predicted force threshold. 24. The method of claim 21, wherein the cutting edge (48) is physically prevented from exceeding the first distance. 25. The method of claim 23, further comprising forming a physical obstruction (1500) on at least one jaw (16, 18) during manufacture after the cutting edge (48) is assembled with the at least one jaw (16, 18).
[0107] VII. et al. It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein can be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Thus, the above teachings, expressions, embodiments, examples, etc. should not be considered in isolation from one another. Various suitable ways in which the teachings herein can be combined will be readily apparent to those skilled in the art in light of the teachings herein. Such modifications and variations are intended to be within the scope of the claims.
[0108] Additionally, any one or more of the teachings herein may be incorporated into U.S. patent application Ser. No. 63 / 467,622, filed May 19, 2023, entitled "Surgical Stapler Cartridge Having Intermediate Raised Tissue Engagement Protrusions," U.S. patent application Ser. No. 63 / 467,623, filed May 19, 2023, entitled "Surgical Stapler Cartridge Having Tissue Engagement Protrusions with Enlarged Engagement Surface," U.S. patent application Ser. No. 63 / 467,648, filed May 19, 2023, entitled "Surgical Stapler Cartridge Having Raised Surface to Promote Buttress Adhesion," U.S. patent application Ser. No. 63 / 467,648, filed May 19, 2023, entitled "Surgical Stapler Cartridge Having Cartridge Retention," U.S. patent application Ser. No. 63 / 467,648, filed May 19, 2023, No. 63 / 467,469, filed May 19, 2023, entitled "Surgical Staple Anvil Having Staple Forming Pockets with Laterally Varying Orientations," U.S. Patent Application No. 63 / 459,739, filed May 19, 2023, entitled "Surgical Staple Anvil With Discretely Positionable Distal Tip," U.S. Patent Application No. 63 / 467,656, filed May 19, 2023, and / or U.S. Patent Application No. 63 / 467,615, filed May 19, 2023, entitled "Incompatible Staple Cartridge Use Prevention Features for Surgical Staple."
[0109] Additionally, any one or more of the teachings herein may be combined with any one or more of the teachings disclosed in U.S. Patent Application No. 63 / 459,739, entitled "Surgical Staple Anvil Having Staple Forming Pockets with Laterally Varying Orientations," filed April 17, 2023. The disclosure of each of these U.S. patent applications is incorporated herein by reference in its entirety.
[0110] Additionally, any one or more of the teachings herein may be combined with any one or more of the teachings disclosed in U.S. Patent No. 11,304,697, entitled "Surgical Stapler with Deflectable Distal Tip," issued on April 19, 2022, the disclosure of which is incorporated herein by reference in its entirety; any one or more of the teachings disclosed in U.S. Patent No. 11,317,912, entitled "Surgical Stapler with Rotatable Distal Tip," issued on May 3, 2022, the disclosure of which is incorporated herein by reference in its entirety; and / or any one or more of the teachings disclosed in U.S. Patent No. 11,439,391, entitled "Surgical Stapler with Toggling Distal Tip," issued on September 13, 2022, the disclosure of which is incorporated herein by reference in its entirety.
[0111] It should be understood that all or part of any patent, publication, or other disclosure referred to as being incorporated herein by reference is incorporated herein only to the extent that the incorporated material does not contradict existing definitions, opinions, or other disclosures set forth in this disclosure. As such, and to the extent necessary, the disclosure explicitly set forth herein shall prevail over any conflicting statements incorporated herein by reference. Any material, or portions thereof, that is referred to as being incorporated herein by reference but that contradicts current definitions, opinions, or other disclosures set forth herein shall be incorporated only to the extent that no conflict arises between the incorporated material and the current disclosures.
[0112] Variations of the above devices may be applied not only to traditional medical procedures and surgeries performed by medical professionals, but also to robotic-assisted medical procedures 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 Intuitive Surgical, Inc., Sunnyvale, California.
[0113] Variations of the devices described above may be designed to be disposed of after a single use, or they may be designed to be used multiple times. Variations, in either or both cases, may be reconditioned for reuse after at least one use. Reconditioning may include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular parts, and subsequent reassembly. Specifically, some device variations may be disassembled and any number of particular portions or parts of the device may be selectively replaced or removed in any combination. Upon cleaning and / or replacement of particular parts, some device variations may be reassembled for subsequent use at a reconditioning facility or by a user immediately prior to a procedure. Those skilled in the art will appreciate that reconditioning of a device can utilize a variety of techniques for disassembly, cleaning / replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
[0114] By way of example only, the variations described herein may be sterilized before and / or after treatment. In one sterilization technique, the device is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and device may then be placed in a radiation field that can penetrate the container, such as gamma radiation, X-rays, or a high-energy electron beam. The radiation may kill bacteria on the device and in the container. The sterilized device may then be stored in the sterile container for later use. The device may also be sterilized using any other technique known in the art, including, but not limited to, beta or gamma radiation, ethylene oxide, or steam.
[0115] While various embodiments of the present invention have been shown and described, further adaptations of 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. While some of such possible modifications have been mentioned, other modifications will be apparent to those skilled in the art. For example, the examples, embodiments, geometries, materials, dimensions, proportions, steps, etc. discussed above are illustrative and not required. Accordingly, it will be understood that the scope of the present invention should be considered in terms of the following claims, and is not limited to the details of structure and operation shown and described in this specification and drawings.
[0116] [Embodiment] (1) A surgical stapling instrument comprising: an end effector configured to grasp tissue, an end effector comprising jaws having 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 the tissue grasped by the end effector, the jaws further configured to receive a staple cartridge seatable in one of the jaws and including a thread and staples, the thread configured to be displaced a second distance from the proximal end to the distal end of the staple cartridge to deploy the staples along the transect and into the tissue grasped by the end effector; a motor located external to the end effector; a drive train operatively coupled between the motor and the cutting edge and the sled, the motor configured to controllably displace a position of a proximal end of the drive train 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 on either side along the transect; a control circuit coupled to the motor for controlling a rate at which the motor attempts to displace the proximal end of the drive train, the control circuit controlling the rate at which the motor attempts to displace the proximal end of the drive train during displacement of the proximal end of the drive train; the position of the proximal end of the drivetrain; and a control circuit that monitors a force input by the motor to the proximal end of the drive train; The control circuitry controls the motor during displacement of the proximal end of the drive train to: displacing the proximal end of the drivetrain a third distance less than the first distance with a force input to the proximal end of the drivetrain that varies to substantially maintain a first speed at which the motor tends to displace the proximal end of the drivetrain; subsequent to displacing the third distance, continuing to displace the proximal end of the drivetrain a fourth distance with a force input to the proximal end of the drivetrain varying to substantially maintain a second speed at which the motor will displace the proximal end of the drivetrain, the second speed being less than the first speed, while the control circuit calculates, based on the monitored force, a predicted force that needs to be input to the proximal end of the drivetrain to substantially maintain the second speed at which the motor will displace the proximal end of the drivetrain over a subsequent further distance; continuing to displace the proximal end of the drive train with a force input to the proximal end of the drive train varied to substantially maintain the second speed at which the motor attempts to displace the proximal end of the drive train until it is determined that the force input to the proximal end of the drive train exceeds the calculated predicted force threshold. (2) The surgical stapling instrument of claim 1, wherein, during displacement of at least the proximal end of the drive train, one or more of the distance displaced by the cutting edge or the force applied by the cutting edge to the grasped tissue varies compared to the distance displaced by the proximal end of the drive train or the force applied to the proximal end by the motor. (3) A surgical stapling instrument according to embodiment 2, wherein the variation depends on one or more characteristics of the grasped tissue and / or the degree of compatibility of the drive train. (4) The surgical stapling instrument of claim 1, wherein the control circuit stops the displacement when the proximal end of the drive train is displaced a maximum distance. (5) The surgical stapling instrument of claim 1, wherein the cutting edge is physically prevented from exceeding the first distance.
[0117] (6) The surgical stapling instrument of claim 5, wherein the physical obstruction is formed in the at least one jaw during manufacture after the cutting edge is assembled with the at least one jaw. (7) The surgical stapling instrument of claim 5, wherein the physical obstruction is characterized by a property that results in a distinguishable change in the monitored force input to the proximal end of the drive train to maintain the second velocity when at least a portion of the cutting edge contacts the physical obstruction. (8) The calculation of the predicted force is creating an array of then-current values of the monitored forces and the corresponding positions as the proximal end of the drivetrain is displaced through the fourth distance; and storing said array in a memory buffer; fitting one of a linear or best fit curve to the stored array of monitored forces and corresponding position values; 2. The surgical stapling instrument of claim 1, wherein the predicted force is calculated based on a projection of the fitted linear or best fit curve over one or more subsequent increments of displacement of the drive train. (9) The calculation of the predicted force is 2. The surgical stapling instrument of claim 1, further comprising: when the proximal end of the drive train is displaced over the fourth distance, determining the then-current value of the monitored force and corresponding position, calculating the change in the monitored force over the displaced distance, and applying fuzzy logic to the current position and the change in the monitored force over the displaced distance; and when the fuzzy logic returns a true value, the force input to the proximal end of the drive train is determined to exceed the calculated predicted force threshold. (10) A surgical stapling instrument according to embodiment 1, wherein the surgical instrument comprises a handle and a shaft, the proximal end of the shaft being connected to the distal end of the handle, the distal end of the shaft being connected to the end effector, the motor being located within the handle, and the drive train being located within the shaft and extending from the proximal end of the shaft to the distal end of the shaft.
[0118] (11) The surgical stapling instrument of claim 1, wherein the drive train comprises a plurality of linked components. (12) A handle having the motor and the control circuit; An articulated joint; a shaft extending from the handle to the articulation joint to which the end effector is coupled, the shaft comprising the drive train; the end effector comprising a firing beam operatively coupled to the drive train and comprising the cutting edge; A surgical stapling instrument as described in embodiment 1, wherein the articulation joint allows the end effector to be articulated and maintained in one or more directions relative to the longitudinal axis of the shaft through the application of a holding force. (13) The surgical stapling instrument of claim 12, wherein the calculated predicted force threshold is less than the retention force. (14) The surgical stapling instrument of claim 1, wherein the surgical stapling instrument is configured to be mounted and operated by a robot. (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 with 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 the tissue grasped by the end effector, the jaws further configured to receive a staple cartridge seatable in one of the jaws and including a thread and staples, the thread being adapted to insert the staple into the tissue grasped by the end effector along the transecting portion. the surgical instrument is configured to be displaced a second distance from a proximal end to a distal end of the staple cartridge to deploy staples, the surgical instrument further comprising: a motor located external to the end effector; and a drive train operatively coupled between the motor, the cutting edge, and the sled, the motor configured to controllably displace the position of the proximal end of the drive train 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 on either side of the transecting portion; and the control circuitry a processor and a memory coupled thereto, the memory storing computer readable instructions that, 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; During displacement of the proximal end of the drive train: the position of the proximal end of the drivetrain; a force input by the motor to the proximal end of the drive train; During displacement of the proximal end of the drive train, the motor displacing the proximal end of the drivetrain a third distance less than the first distance with a force input to the proximal end of the drivetrain varying to substantially maintain a first speed at which the motor tends to displace the proximal end of the drivetrain; subsequent to displacing the third distance, continuing to displace the proximal end of the drivetrain a fourth distance with a force input to the proximal end of the drivetrain varying to substantially maintain a second speed at which the motor will displace the proximal end of the drivetrain, the second speed being less than the first speed, 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 drivetrain to substantially maintain the second speed at which the motor will displace the proximal end of the drivetrain over subsequent further distances; and continuing to displace the proximal end of the drivetrain with a force input to the proximal end of the drivetrain that varies to substantially maintain the second speed at which the motor attempts to displace the proximal end of the drivetrain until it is determined that the force input to the proximal end of the drivetrain exceeds the calculated predicted force threshold.
[0119] (16) The calculation of the predicted force is creating an array of then-current values of the monitored forces and the corresponding positions as the proximal end of the drivetrain is displaced through the fourth distance; and storing said array in a memory buffer; fitting one of a linear or best fit curve to the stored array of monitored forces and corresponding position values; 16. The control circuit of claim 15, wherein the predicted force is calculated based on a prediction of the fitted linear or best fit curve over one or more subsequent increments of displacement of the drivetrain. (17) The calculation of the predicted force is 16. The control circuit of claim 15, further comprising: when the proximal end of the drivetrain is displaced over the fourth distance, determining the then-current value of the monitored force and corresponding position, calculating a change in the monitored force over the displaced distance, and applying fuzzy logic to the current position and the change in the monitored force over the displaced distance; and when the fuzzy logic returns a true value, determining that the force input to the proximal end of the drivetrain exceeds the calculated predicted force threshold. (18) The control circuit of embodiment 15, wherein the cutting edge is physically prevented from exceeding the first distance. (19) The control circuit of claim 18, wherein the physical obstruction is formed in the at least one jaw during manufacturing after the cutting edge is assembled with the at least one jaw. (20) The control circuit of claim 18, wherein the physical obstruction is characterized by a property that results in a distinguishable change in the monitored force input to the proximal end of the drive train to maintain the second velocity when at least a portion of the cutting edge contacts the physical obstruction.
[0120] (21) A method of operating a surgical instrument, the surgical instrument comprising: an end effector configured to grasp tissue, the end effector comprising jaws with 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 the tissue grasped by the end effector, the jaws further configured to receive a staple cartridge seatable in one of the jaws and including a thread and staples, the thread being adapted to drive the staples along the transecting portion 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 operatively coupled between the motor, the cutting edge, and the sled, the motor configured to controllably displace the position of the proximal end of the drive train 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 on either side of the transect; controlling the rate at which the motor attempts to displace the proximal end of the drive train; below: the position of the proximal end of the drivetrain; monitoring a force input by the motor to the proximal end of the drive train; During displacement of the proximal end of the drive train, the motor displacing the proximal end of the drivetrain a third distance less than the first distance with a force input to the proximal end of the drivetrain varying to substantially maintain a first speed at which the motor tends to displace the proximal end of the drivetrain; subsequent to attempting to displace the third distance, continuing to displace the proximal end of the drivetrain a fourth distance with a force input to the proximal end of the drivetrain varying to substantially maintain a second speed at which the motor attempts to displace the proximal end of the drivetrain, the second speed being less than the first speed, while the control circuit calculates, based on the monitored force, a predicted force that needs to be input to the proximal end of the drivetrain to substantially maintain the second speed at which the motor attempts to displace the proximal end of the drivetrain over a subsequent further distance; and and continuing to displace the proximal end of the drivetrain with a force input to the proximal end of the drivetrain that varies to substantially maintain the second speed at which the motor attempts to displace the proximal end of the drivetrain until it is determined that the force input to the proximal end of the drivetrain exceeds the calculated predicted force threshold. (22) The calculation of the predicted force is creating an array of then-current values of the monitored forces and the corresponding positions as the proximal end of the drivetrain is displaced through the fourth distance; and storing said array in a memory buffer; fitting one of a linear or best fit curve to the stored array of monitored forces and corresponding position values; 22. The method of claim 21, wherein the predicted force is calculated based on a projection of the fitted linear or best fit curve over one or more subsequent increments of displacement of the drivetrain. (23) The calculation of the predicted force is 22. The method of claim 21, comprising: when the proximal end of the drivetrain is displaced over the fourth distance, determining the then current value of the monitored force and corresponding position; calculating a change in the monitored force over the displaced distance; and applying fuzzy logic to the current position and the change in the monitored force over the displaced distance; wherein when the fuzzy logic returns a true value, the force input to the proximal end of the drivetrain is determined to exceed the calculated predicted force threshold. (24) The method of embodiment 21, wherein the cutting edge is physically prevented from exceeding the first distance. 25. The method of claim 23, further comprising forming the physical obstruction in the at least one jaw during manufacture after the cutting edge is assembled with the at least one jaw.
Claims
1. 1. A surgical stapling instrument comprising: an end effector configured to grasp tissue, an end effector comprising jaws having 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 the tissue grasped by the end effector, the jaws further configured to receive a staple cartridge seatable in one of the jaws and including a thread and staples, the thread being configured to be displaced a second distance from the proximal end to the distal end of the staple cartridge to deploy the staples along the transect and into the tissue grasped by the end effector; a motor located external to the end effector; a drive train operatively coupled between the motor and the cutting edge and the sled, the motor configured to controllably displace a position of a proximal end of the drive train 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 on either side along the transect; a control circuit coupled to the motor for controlling a rate at which the motor attempts to displace the proximal end of the drive train, the control circuit controlling the rate at which the motor attempts to displace the proximal end of the drive train during displacement of the proximal end of the drive train; the position of the proximal end of the drivetrain; and a control circuit that monitors a force input by the motor to the proximal end of the drive train; The control circuitry controls the motor during displacement of the proximal end of the drive train to: displacing the proximal end of the drivetrain a third distance less than the first distance with a force input to the proximal end of the drivetrain that varies to substantially maintain a first speed at which the motor tends to displace the proximal end of the drivetrain; subsequent to displacing the third distance, continuing to displace the proximal end of the drivetrain a fourth distance with a force input to the proximal end of the drivetrain varying to substantially maintain a second speed at which the motor will displace the proximal end of the drivetrain, the second speed being less than the first speed, while the control circuit calculates, based on the monitored force, a predicted force that needs to be input to the proximal end of the drivetrain to substantially maintain the second speed at which the motor will displace the proximal end of the drivetrain over a subsequent further distance; continuing to displace the proximal end of the drive train with a force input to the proximal end of the drive train varied to substantially maintain the second speed at which the motor attempts to displace the proximal end of the drive train until it is determined that the force input to the proximal end of the drive train exceeds the calculated predicted force threshold.
2. 10. The surgical stapling instrument of claim 1, wherein, during displacement of at least the proximal end of the drive train, one or more of a distance displaced by the cutting edge or a force applied by the cutting edge to the grasped tissue varies as compared to a distance displaced by the proximal end of the drive train or a force applied to the proximal end by the motor.
3. The surgical stapling instrument of claim 2 , wherein the variation is dependent on one or more characteristics of the clamped tissue and / or a degree of compliance of the drive train.
4. The surgical stapling instrument of claim 1 , wherein the control circuitry stops the displacement of the proximal end of the drive train when the proximal end is displaced a maximum distance.
5. The surgical stapling instrument of claim 1 , wherein the cutting edge is physically prevented from exceeding the first distance.
6. The surgical stapling instrument of claim 5, wherein the physical obstruction is formed in the at least one jaw during manufacture after the cutting edge is assembled with the at least one jaw.
7. 6. The surgical stapling instrument of claim 5, wherein the physical obstruction is characterized by a property that results in a distinct change in the monitored force input to the proximal end of the drive train to maintain the second velocity when at least a portion of the cutting edge contacts the physical obstruction.
8. The calculation of the predicted force may be creating an array of then-current values of the monitored forces and the corresponding positions as the proximal end of the drivetrain is displaced through the fourth distance; and storing said array in a memory buffer; fitting one of a linear or best fit curve to the stored array of monitored forces and corresponding position values; The surgical stapling instrument of claim 1 , wherein the predicted force is calculated based on a projection of the fitted linear or best fit curve over one or more subsequent increments of displacement of the drive train.
9. The calculation of the predicted force may be 2. The surgical stapling instrument of claim 1, further comprising: determining the then current value of the monitored force and corresponding position when the proximal end of the drive train is displaced over the fourth distance; calculating a change in the monitored force over the displaced distance; and applying fuzzy logic to the current position and the change in the monitored force over the displaced distance; wherein when the fuzzy logic returns a value of true, the force input to the proximal end of the drive train is determined to exceed the calculated predicted force threshold.
10. 2. The surgical stapling instrument of claim 1, wherein the surgical instrument comprises a handle and a shaft, a proximal end of the shaft coupled to a distal end of the handle, the distal end of the shaft coupled to the end effector, the motor located within the handle, and the drive train located within the shaft and extending from the proximal end of the shaft to the distal end of the shaft.
11. The surgical stapling instrument of claim 1 , wherein the drive train comprises a plurality of linked components.
12. a handle including the motor and the control circuit; An articulated joint; a shaft extending from the handle to the articulation joint to which the end effector is coupled, the shaft comprising the drive train; the end effector comprising a firing beam operatively coupled to the drive train and comprising the cutting edge; The surgical stapling instrument of claim 1, wherein the articulation joint enables the end effector to be articulated and maintained in one or more directions relative to a longitudinal axis of the shaft through the application of a holding force.
13. The surgical stapling instrument of claim 12, wherein the calculated predicted force threshold is less than the retention force.
14. The surgical stapling instrument of claim 1 , wherein the surgical stapling instrument is configured to be mounted and operated by a robot.
15. 1. A control circuit for controlling a surgical instrument, the surgical instrument comprising: an end effector configured to grasp tissue, the end effector comprising jaws with 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 the tissue grasped by the end effector, the jaws further configured to receive a staple cartridge seatable in one of the jaws and including a thread and staples, the thread being adapted to insert the staple into the tissue grasped by the end effector along the transecting portion. the surgical instrument is configured to be displaced a second distance from a proximal end to a distal end of the staple cartridge to deploy staples, the surgical instrument further comprising: a motor located external to the end effector; and a drive train operatively coupled between the motor, the cutting edge, and the sled, the motor configured to controllably displace the position of the proximal end of the drive train 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 on either side of the transecting portion; and the control circuitry a processor and a memory coupled thereto, the memory storing computer readable instructions that, 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; During displacement of the proximal end of the drive train: the position of the proximal end of the drivetrain; a force input by the motor to the proximal end of the drive train; During displacement of the proximal end of the drive train, the motor displacing the proximal end of the drivetrain a third distance less than the first distance with a force input to the proximal end of the drivetrain varying to substantially maintain a first speed at which the motor tends to displace the proximal end of the drivetrain; following displacing the third distance, continuing to displace the proximal end of the drivetrain a fourth distance with a force input to the proximal end of the drivetrain varying to substantially maintain a second speed at which the motor attempts to displace the proximal end of the drivetrain, the second speed being less than the first speed, 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 drivetrain to substantially maintain the second speed at which the motor attempts to displace the proximal end of the drivetrain over subsequent further distances; and continuing to displace the proximal end of the drivetrain with a force input to the proximal end of the drivetrain that varies to substantially maintain the second speed at which the motor attempts to displace the proximal end of the drivetrain until it is determined that the force input to the proximal end of the drivetrain exceeds the calculated predicted force threshold.
16. The calculation of the predicted force may be creating an array of then-current values of the monitored forces and the corresponding positions as the proximal end of the drivetrain is displaced through the fourth distance; and storing said array in a memory buffer; fitting one of a linear or best fit curve to the stored array of monitored forces and corresponding position values; The control circuit of claim 15 , wherein the predicted force is calculated based on a projection of the fitted linear or best fit curve over one or more subsequent increments of displacement of the drivetrain.
17. The calculation of the predicted force may be 16. The control circuit of claim 15, further comprising: determining the then current value of the monitored force and corresponding position when the proximal end of the drivetrain is displaced over the fourth distance; calculating a change in the monitored force over the displaced distance; and applying fuzzy logic to the current position and the change in the monitored force over the displaced distance; wherein when the fuzzy logic returns a value of true, the force input to the proximal end of the drivetrain is determined to exceed the calculated predicted force threshold.
18. The control circuit of claim 15 , wherein the cutting edge is physically prevented from exceeding the first distance.
19. 20. The control circuit of claim 18, wherein the physical obstruction is formed in the at least one jaw during manufacture after the cutting edge is assembled with the at least one jaw.
20. 20. The control circuit of claim 18, wherein the physical obstruction is characterized by a property that results in a distinguishable change in the monitored force input to the proximal end of the drive train to maintain the second velocity when at least a portion of the cutting edge contacts the physical obstruction.
21. 1. A method of operating a surgical instrument, the surgical instrument comprising: an end effector configured to grasp tissue, the end effector comprising jaws with 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 the tissue grasped by the end effector, the jaws further configured to receive a staple cartridge seatable in one of the jaws and including a thread and staples, the thread driving the staples along the transect and 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 operatively coupled between the motor, the cutting edge, and the sled, the motor configured to controllably displace the position of the proximal end of the drive train 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 on either side of the transect; the method further comprising: controlling the rate at which the motor attempts to displace the proximal end of the drive train; below: the position of the proximal end of the drivetrain; monitoring a force input by the motor to the proximal end of the drive train; During displacement of the proximal end of the drive train, the motor displacing the proximal end of the drivetrain a third distance less than the first distance with a force input to the proximal end of the drivetrain varying to substantially maintain a first speed at which the motor tends to displace the proximal end of the drivetrain; subsequent to attempting to displace the third distance, continuing to displace the proximal end of the drivetrain a fourth distance with a force input to the proximal end of the drivetrain varying to substantially maintain a second speed at which the motor attempts to displace the proximal end of the drivetrain, the second speed being less than the first speed, while the control circuit calculates, based on the monitored force, a predicted force that needs to be input to the proximal end of the drivetrain to substantially maintain the second speed at which the motor attempts to displace the proximal end of the drivetrain over a subsequent further distance; and and continuing to displace the proximal end of the drivetrain with a force input to the proximal end of the drivetrain that varies to substantially maintain the second speed at which the motor attempts to displace the proximal end of the drivetrain until it is determined that the force input to the proximal end of the drivetrain exceeds the calculated predicted force threshold.
22. The calculation of the predicted force may be creating an array of then-current values of the monitored forces and the corresponding positions as the proximal end of the drivetrain is displaced through the fourth distance; and storing said array in a memory buffer; fitting one of a linear or best fit curve to the stored array of monitored forces and corresponding position values; 22. The method of claim 21, wherein the predicted force is calculated based on a projection of the fitted linear or best fit curve over one or more subsequent increments of displacement of the drivetrain.
23. The calculation of the predicted force may be 22. The method of claim 21, comprising: determining the then current value of the monitored force and corresponding position when the proximal end of the drivetrain is displaced over the fourth distance; calculating a change in the monitored force over the displaced distance; and applying fuzzy logic to the current position and the change in the monitored force over the displaced distance; wherein when the fuzzy logic returns a value of true, the force input to the proximal end of the drivetrain is determined to exceed the calculated predicted force threshold.
24. 22. The method of claim 21, wherein the cutting edge is physically prevented from exceeding the first distance.
25. 24. The method of claim 23, further comprising forming the physical obstruction in the at least one jaw during manufacture after the cutting edge is assembled with the at least one jaw.