Handheld electromechanical surgical system

Abstract

The present disclosure relates to a hand-held electromechanical surgical system. A method of operating a surgical device is disclosed, the surgical device comprising a surgical stapler reload and an anvil assembly having a head assembly movable between a non-inclined orientation and an inclined orientation for cooperating with the surgical stapler reload to form a plurality of surgical staplers, the method comprising: monitoring an axial distance of the inclined head assembly relative to the reload after the surgical device is fully primed and after the head assembly of the anvil assembly is inclined from the non-inclined orientation to the inclined orientation.

Description

[0001] This application is a divisional application of the invention patent application filed on June 5, 2018, with application number 201810576680.X and invention title "Handheld Electromechanical Surgical System".

[0002] Cross-references to related applications

[0003] This application claims the benefit and priority of U.S. Provisional Patent Application No. 62 / 517,297, filed June 9, 2017, and U.S. Provisional Patent Application No. 62 / 517,276, filed June 9, 2017, the entire disclosure of which is incorporated herein by reference. Technical Field

[0004] This disclosure relates to surgical devices. More specifically, this disclosure relates to handheld electromechanical surgical systems for performing surgical procedures. Background Technology

[0005] One type of surgical device is a circular clamping, cutting, and stapler. This device can be used in surgical procedures to reattach previously transected portions of the rectum or similar procedures. Conventional circular clamping, cutting, and staplers comprise a pistol- or linear grip-type structure with an elongated shaft extending from it and a staple cartridge supported at the distal end of said elongated shaft. In this example, the surgeon can insert the anvil assembly of the circular stapler into the patient's rectum and manipulate the anvil assembly upwards along the patient's colon toward the transected rectal portion. The surgeon can also insert the remaining portion of the circular stapler (including the cartridge assembly) through an incision toward the transected rectal portion. The anvil and cartridge assembly approach each other, and staples are ejected from the cartridge assembly toward the anvil assembly to form staples in the tissue for end-to-end anastomosis, and a ring blade is actuated to cored a portion of the clamped tissue. After achieving the end-to-end anastomosis, the circular stapler is removed from the surgical site.

[0006] Several surgical device manufacturers have developed product lines with dedicated power drive systems for operating and / or manipulating surgical devices. In many cases, surgical devices include reusable powered handle assemblies, as well as disposable staple cartridge assemblies, end effectors, or the like, which are selectively connected to the powered handle assembly before use and then disconnected from the staple cartridge assembly or end effector after use for disposal or, in some cases, sterilization for reuse.

[0007] The use of powered electric and internal mechanical surgical staplers (including those powered by smart batteries) has increased dramatically over the past few decades. Advanced technologies and information within these smart battery-powered staplers provide the ability to collect clinical data and drive design improvements to ultimately improve patient outcomes. Therefore, there is a need for improved powered electric and internal mechanical surgical staplers capable of assessing conditions affecting staple formation in order to develop smarter stapler algorithms. Summary of the Invention

[0008] The handheld electromechanical surgical system provided according to aspects of this disclosure is configured for selective connection with a surgical reloading device to actuate the surgical reloading device to perform at least one function, the surgical reloading device including a ring nail pusher for actuating its ring nail array and including a circular blade carrier for translating the ring blade independently of the nail pusher.

[0009] The surgical system provided according to this disclosure includes a handheld electromechanical surgical device, which includes a device housing and at least one rotatable drive shaft supported in and protruding therefrom.

[0010] The surgical system provided according to this disclosure includes an adapter assembly selectively connectable between a housing of a surgical device and a surgical reloading component. The adapter assembly includes: an adapter housing configured and adapted for connection to the surgical device and operatively communicating with each rotatable drive shaft of the surgical device; an external conduit having a proximal end supported by the adapter housing and a distal end configured and adapted for connection to the surgical reloading component, wherein the distal end of the external conduit is operatively communicating with each of a ring staple pusher and a circular blade carrier of the surgical reloading component; a cannula assembly supported within the external conduit, the cannula assembly including a cannula component screwably supported on the distal end of a cannula drive screw; and a first force / rotation transmission / conversion assembly for interconnecting a corresponding drive shaft of the surgical device and the cannula drive screw of the cannula assembly.

[0011] The first force / rotation transmission / conversion assembly includes: a first proximal rotation receiving component that can be connected to a corresponding rotatable drive shaft of the surgical device; and a first distal force transmission component that is connected to a cannula drive screw of the cannula assembly, the first distal force transmission component being non-rotatably connected to the first proximal rotation receiving component.

[0012] The adapter assembly includes at least a second force / rotation transmission / conversion assembly for interconnecting a corresponding drive shaft of the surgical device and a corresponding one of the annular screw pusher and the circular blade carrier of the surgical reloading unit. The second force / rotation transmission / conversion assembly includes: a second proximal rotation receiving member connectable to a corresponding rotatable drive shaft of the surgical device; and a second distal force transmission member connectable to a corresponding one of the annular screw pusher and the circular blade carrier of the surgical reloading unit, the second distal force transmission member being connected to the second proximal rotation receiving member in such a way that rotation of the second proximal rotation receiving member is converted into axial translation of the second distal force transmission member, and further into axial translation of a corresponding one of the annular screw pusher and the circular blade carrier of the surgical reloading unit.

[0013] When the cannula drive screw rotates, the cannula component of the cannula assembly can resist rotation relative to the external tube and be keyed.

[0014] The first force / rotation transmission / conversion assembly may further include: a rotatable proximal drive shaft that is non-rotatably connected to a first proximal rotation receiving member; and a rotatable distal drive shaft that non-rotatably interconnects the rotatable proximal drive shaft and the first distal force transmission member.

[0015] The rotatable distal drive shaft can be pivotally connected to each of the rotatable proximal drive shaft and the first distal force transmission component.

[0016] Rotation of the rotatable drive shaft of the surgical device associated with the first force / rotation transmission / conversion assembly can cause axial translation of the cannula component of the cannula assembly.

[0017] The surgical system may further include an anvil assembly having an annular head assembly pivotally supported on the distal end of the anvil rod assembly, wherein the anvil rod assembly is selectively connectable to the tip of the cannula component.

[0018] When the anvil assembly is connected to the cannula assembly, rotation of the rotatable drive shaft of the surgical device associated with the first force / rotation transmission / conversion assembly can cause axial translation of the annular head assembly relative to the surgical reloading assembly.

[0019] The annular head assembly can be axially translated relative to the surgical reloading assembly in any position between and in between the fully extended and fully retracted positions.

[0020] The at least second force / rotation transmission / conversion assembly may include a second force / rotation transmission / conversion assembly and a third force / rotation transmission / conversion assembly. The second force / rotation transmission / conversion assembly may be operatively associated with the annular screw pusher of the surgical reloading assembly such that actuation of the second force / rotation transmission / conversion assembly results in distal actuation of the annular screw pusher. The third force / rotation transmission / conversion assembly may be operatively associated with the circular blade carrier of the surgical reloading assembly such that actuation of the third force / rotation transmission / conversion assembly results in distal actuation of the circular blade carrier.

[0021] The second force / rotation transmission / conversion assembly may include: a gear train actuated by a second proximal rotation receiving member; a lead screw operatively connected to the gear train, wherein actuation of the gear train causes rotation of the lead screw; a driver operatively connected to the lead screw, wherein rotation of the lead screw causes axial translation of the driver; a flexible belt assembly fastened to the driver, wherein the flexible belt assembly comprises a pair of spaced-apart flexible belts; and a support base fastened to the distal ends of the pair of flexible belts.

[0022] The support base of the second force / rotation transmission / conversion assembly can be operatively associated with the annular nail pusher of the surgical reloading assembly such that actuation of the corresponding rotatable drive shaft of the surgical device results in distal actuation of the annular nail pusher of the surgical reloading assembly.

[0023] The third force / rotation transmission / conversion assembly may include: a gear train actuated by a third proximal rotation receiving member; a lead screw operatively connected to the gear train of the third force / rotation transmission / conversion assembly, wherein actuation of the gear train causes rotation of the lead screw of the third force / rotation transmission / conversion assembly; a driver operatively connected to the lead screw of the third force / rotation transmission / conversion assembly, wherein rotation of the lead screw causes axial translation of the driver of the third force / rotation transmission / conversion assembly; a flexible belt assembly fastened to the driver of the third force / rotation transmission / conversion assembly, wherein the flexible belt assembly of the third force / rotation transmission / conversion assembly comprises a pair of spaced-apart flexible belts; and a support base fastened to the distal ends of the pair of flexible belts of the third force / rotation transmission / conversion assembly.

[0024] The support base of the third force / rotational transmission / conversion assembly can be operatively associated with the circular blade carrier of the surgical reloading assembly such that actuation of the corresponding rotatable drive shaft of the surgical device results in distal actuation of the circular blade carrier of the surgical reloading assembly.

[0025] The pair of flexible strips of the third force / rotation transmission / conversion assembly can be positioned inward from the pair of flexible strips of the second force / rotation transmission / conversion assembly.

[0026] The gear train of the second force / rotation transmission / conversion assembly can be positioned close to the gear train of the third force / rotation transmission / conversion assembly.

[0027] The first force / rotation transmission / conversion assembly can extend through the gear train of the second force / rotation transmission / conversion assembly and through the gear train of the third force / rotation transmission / conversion assembly.

[0028] The gear train of each of the second and third force / rotation transmission / conversion assemblies can be a planetary gear system.

[0029] The adapter assembly may further include a strain gauge assembly supported within an external conduit, wherein the strain gauge assembly is operatively associated with a cannula component of the cannula assembly.

[0030] The strain gauge assembly can sense the axial translation of the cannula needle component.

[0031] A handheld electromechanical surgical device may include a battery, a circuit board powered by the battery, and an electrical display connected to each of the battery and the circuit board. A strain gauge assembly may be connected to the circuit board when an adapter assembly is attached to the housing of the handheld electromechanical surgical device.

[0032] The display of a handheld electromechanical surgical device can show the force applied to the cannula component, as measured by a strain gauge assembly.

[0033] The display of the handheld electromechanical surgical device can show the axial position of the cannula assembly relative to the surgical reloading component.

[0034] The display of the handheld electromechanical surgical device can show the gap distance between the annular head assembly and the surgical reloading component.

[0035] The display of the handheld electromechanical surgical device can show the activation of the annular nail array of the surgical reloading unit as the annular nail pusher advances axially.

[0036] The display of the handheld electromechanical surgical device can show the actuation of the blade of the surgical reloading unit as the circular blade carrier moves axially forward.

[0037] According to another aspect of this disclosure, an adapter assembly is provided for interconnecting a handheld surgical device and a surgical reloading component of an electromechanical surgical system. The adapter assembly includes: an adapter housing configured and adapted for connection to a handheld surgical device and operatively communicating with each rotatable drive shaft of the surgical device; an external conduit having a proximal end supported by the adapter housing and a distal end configured and adapted for connection to a surgical reloading component, wherein the distal end of the external conduit is operatively communicating with each of a ring-shaped staple pusher and a circular blade carrier of the surgical reloading component; a cannula assembly supported within the external conduit, the cannula assembly including a cannula component capable of being screwed onto the distal end of a cannula drive screw; and a first force / rotation transmission / conversion assembly for interconnecting a corresponding drive shaft of the surgical device and a cannula drive screw of the cannula assembly.

[0038] The first force / rotation transmission / conversion assembly includes: a first proximal rotation receiving component that can be connected to a corresponding rotatable drive shaft of the surgical device; and a first distal force transmission component that is connected to a cannula drive screw of the cannula assembly, the first distal force transmission component being non-rotatably connected to the first proximal rotation receiving component.

[0039] At least a second force / rotation transmission / conversion assembly is provided for interconnecting a corresponding drive shaft of the surgical apparatus and a corresponding one of the annular screw pusher and the circular blade carrier of the surgical reloading unit. The second force / rotation transmission / conversion assembly includes: a second proximal rotation receiving member connectable to a corresponding rotatable drive shaft of the surgical apparatus; and a second distal force transmission member connectable to a corresponding one of the annular screw pusher and the circular blade carrier of the surgical reloading unit, the second distal force transmission member being connected to the second proximal rotation receiving member in such a way that rotation of the second proximal rotation receiving member is converted into axial translation of the second distal force transmission member, and further into axial translation of a corresponding one of the annular screw pusher and the circular blade carrier of the surgical reloading unit.

[0040] When the cannula drive screw rotates, the cannula component of the cannula assembly can resist rotation relative to the external tube and be keyed.

[0041] The first force / rotation transmission / conversion assembly may further include: a rotatable proximal drive shaft that is non-rotatably connected to a first proximal rotation receiving member; and a rotatable distal drive shaft that non-rotatably interconnects the rotatable proximal drive shaft and the first distal force transmission member.

[0042] The rotatable distal drive shaft can be pivotally connected to each of the rotatable proximal drive shaft and the first distal force transmission component.

[0043] Rotation of the rotatable drive shaft of the surgical device associated with the first force / rotation transmission / conversion assembly can cause axial translation of the cannula component of the cannula assembly.

[0044] The adapter assembly may further include an anvil assembly having an annular head assembly pivotally supported on the distal end of the anvil rod assembly, wherein the anvil rod assembly is selectively connectable to the tip of the cannula component.

[0045] When the anvil assembly is connected to the cannula assembly, rotation of the rotatable drive shaft of the surgical device associated with the first force / rotation transmission / conversion assembly can cause axial translation of the annular head assembly relative to the surgical reloading assembly.

[0046] The ring-shaped head assembly can be axially translated relative to the attached surgical reloading assembly in and anywhere in between the fully extended and fully retracted positions.

[0047] The at least second force / rotation transmission / conversion assembly may include a second force / rotation transmission / conversion assembly and a third force / rotation transmission / conversion assembly. The second force / rotation transmission / conversion assembly may be operatively associated with the annular screw pusher of the surgical reloading assembly such that actuation of the second force / rotation transmission / conversion assembly results in distal actuation of the annular screw pusher. The third force / rotation transmission / conversion assembly may be operatively associated with the circular blade carrier of the surgical reloading assembly such that actuation of the third force / rotation transmission / conversion assembly results in distal actuation of the circular blade carrier.

[0048] The second force / rotation transmission / conversion assembly may include: a gear train actuated by a second proximal rotation receiving member; a lead screw operatively connected to the gear train, wherein actuation of the gear train causes rotation of the lead screw; a driver operatively connected to the lead screw, wherein rotation of the lead screw causes axial translation of the driver; a flexible belt assembly fastened to the driver, wherein the flexible belt assembly comprises a pair of spaced-apart flexible belts; and a support base fastened to the distal ends of the pair of flexible belts.

[0049] The support base of the second force / rotation transmission / conversion assembly can be operatively associated with the annular nail pusher of the surgical reloading assembly such that actuation of the corresponding rotatable drive shaft of the surgical device results in distal actuation of the annular nail pusher of the surgical reloading assembly.

[0050] The third force / rotation transmission / conversion assembly may include: a gear train actuated by a third proximal rotation receiving member; a lead screw operatively connected to the gear train of the third force / rotation transmission / conversion assembly, wherein actuation of the gear train causes rotation of the lead screw of the third force / rotation transmission / conversion assembly; a driver operatively connected to the lead screw of the third force / rotation transmission / conversion assembly, wherein rotation of the lead screw causes axial translation of the driver of the third force / rotation transmission / conversion assembly; a flexible belt assembly fastened to the driver of the third force / rotation transmission / conversion assembly, wherein the flexible belt assembly of the third force / rotation transmission / conversion assembly comprises a pair of spaced-apart flexible belts; and a support base fastened to the distal ends of the pair of flexible belts of the third force / rotation transmission / conversion assembly.

[0051] The support base of the third force / rotational transmission / conversion assembly can be operatively associated with the circular blade carrier of the surgical reloading assembly such that actuation of the corresponding rotatable drive shaft of the surgical device results in distal actuation of the circular blade carrier of the surgical reloading assembly.

[0052] The pair of flexible strips of the third force / rotation transmission / conversion assembly can be positioned inward from the pair of flexible strips of the second force / rotation transmission / conversion assembly.

[0053] The gear train of the second force / rotation transmission / conversion assembly can be positioned close to the gear train of the third force / rotation transmission / conversion assembly.

[0054] The first force / rotation transmission / conversion assembly can extend through the gear train of the second force / rotation transmission / conversion assembly and through the gear train of the third force / rotation transmission / conversion assembly.

[0055] The gear train of each of the second and third force / rotation transmission / conversion assemblies can be a planetary gear system.

[0056] The adapter assembly may further include a strain gauge assembly supported within an external conduit, wherein the strain gauge assembly is operatively associated with a cannula component of the cannula assembly.

[0057] The strain gauge assembly can sense the axial translation of the cannula needle component.

[0058] When the adapter assembly is connected to the surgical device, the strain gauge assembly can be connected to the circuit board of the surgical device.

[0059] The strain gauge assembly can be configured to measure the force applied to the cannula, and said force is displayed on the display of the surgical device.

[0060] The axial position of the cannula assembly relative to the surgical reloading component can be displayed on the monitor of the surgical device.

[0061] The gap distance between the annular head assembly of the anvil assembly and the surgical reloading component can be displayed on the monitor of the surgical device.

[0062] The activation of the annular nail array of the surgical reloading unit can be displayed on the monitor of the surgical device as the annular nail pusher advances axially.

[0063] The actuation of the blade of the surgical reloading unit can be displayed on the monitor of the surgical device as the circular blade carrier advances axially.

[0064] According to one embodiment of this disclosure, a surgical device includes: an adapter assembly having a first storage device; an end effector configured to be coupled to a distal portion of the adapter assembly, the end effector including a second storage device; and a handle assembly configured to be coupled to a proximal portion of the adapter assembly. The handle assembly includes: a power source; a motor coupled to the power source, the motor being configured to actuate at least one of the adapter assembly or the end effector; and a controller configured to communicate with the first and second storage devices.

[0065] According to one aspect of the above embodiments, the controller is operatively coupled to the motor and configured to calibrate the motor while at least one of the adapter assembly or the end effector is actuated by the motor.

[0066] According to another aspect of the above embodiments, the controller is configured to read and write data on the first and second storage devices. The data may include usage counts.

[0067] According to another aspect of the above embodiments, the controller is configured to write recovery code to a second storage device.

[0068] According to one aspect of the above embodiments, the handle assembly includes a memory accessible by a controller. The controller can be configured to write recovery code to the memory.

[0069] According to another aspect of the above embodiments, at least one of the adapter assembly or the handle assembly can be replaced during the surgical procedure, and at least one of the adapter assembly or the handle assembly is configured to continue the surgical procedure based on the recovery code.

[0070] According to another embodiment of this disclosure, a surgical device includes: a handle assembly having a power source; a motor coupled to the power source; and a controller configured to control the motor. The surgical device further includes: an adapter assembly configured to selectively connect to the handle assembly; a reloading member configured to selectively connect to a distal portion of the adapter assembly, the reloading member including a plurality of fasteners; and an anvil assembly capable of selectively connecting to the distal portion of the adapter assembly. The anvil assembly is movable relative to the reloading member, wherein the controller is configured to control the motor to move the anvil at a first speed for a first segment and at a second speed for a second segment to compress tissue between the anvil and the reloading member, the second speed being slower than the first speed.

[0071] According to one aspect of the above embodiments, the adapter assembly includes a strain gauge configured to measure strain.

[0072] According to another aspect of the above embodiments, the controller is further configured to determine whether the anvil assembly is disconnected from the adapter assembly based on the strain measured during the second segment.

[0073] According to another aspect of the above embodiments, the controller is further configured to move the anvil at a variable speed during the third segment.

[0074] According to another aspect of the above embodiments, the controller is further configured to determine the predicted clamping force based on a plurality of measured strain values.

[0075] According to one aspect of the above embodiments, the controller is further configured to calculate the predicted clamping force from the plurality of measured strain values ​​using a second-order predictive filter.

[0076] According to another aspect of the above embodiments, the controller is further configured to adjust the variable speed based on a comparison between the predicted clamping force and the target clamping force.

[0077] According to another aspect of the above embodiments, the controller is further configured to calculate the set speed during the third segment based on the difference between the target clamping force and the predicted clamping force.

[0078] According to another embodiment of this disclosure, a surgical device includes: a handle assembly having: a power source; at least one motor coupled to the power source; and a controller configured to control the motor. The surgical device further includes: an adapter assembly configured to be selectively coupled to the handle assembly, the adapter assembly including a strain gauge configured to measure strain; and a reloading member configured to be selectively coupled to a distal portion of the adapter assembly. The reloading member includes: a plurality of fasteners; a ring nail pusher for ejecting a plurality of nails; and an anvil assembly selectively coupled to the distal portion of the adapter assembly, the anvil assembly being movable relative to the reloading member; wherein the controller is configured to control the motor to move the ring nail pusher based on measured strain.

[0079] According to one aspect of the above embodiments, the controller is configured to compare the measured strain with the minimum and maximum engagement forces during the movement of the ring nail pusher.

[0080] According to another aspect of the above embodiments, the controller is configured to determine the presence of the plurality of fasteners based on the measured strain being lower than the minimum engagement force.

[0081] According to another aspect of the above embodiments, the controller is configured to stop the motor in response to the measured strain exceeding the maximum engagement force.

[0082] According to another aspect of the above embodiments, the reloading member further includes a circular blade capable of moving independently relative to the nail pusher.

[0083] According to one aspect of the above embodiments, the controller is configured to control the motor to move the circular blade based on the measured strain.

[0084] According to another aspect of the above embodiments, the controller is configured to compare the measured strain with the target cutting force and the maximum cutting force during the movement of the circular blade.

[0085] According to another aspect of the above embodiments, the controller is configured to determine whether the tissue has been cut based on the measured strain being equal to or exceeding the target cutting force.

[0086] According to one embodiment of the above embodiments, a method of using a surgical device includes: attaching an adapter assembly to a handle assembly, the adapter assembly including a storage device and the handle assembly including a motor, a memory, and a controller; having the controller perform an operational step to control the motor to actuate at least one component of the adapter assembly; and registering an error state associated with the operational step. The method further includes: writing recovery code into the storage device and the memory; replacing at least one of the adapter assembly or the handle assembly based on the error state; and continuing the operational step based on the recovery code read from at least one of the storage device or the memory.

[0087] According to one aspect of the above embodiments, the method further includes connecting a reloading member comprising a plurality of fasteners to a distal portion of the adapter assembly.

[0088] According to another aspect of the above embodiments, the method further includes connecting the anvil assembly to the distal portion of the adapter assembly.

[0089] According to another aspect of the above embodiments, the method further includes displaying a recovery procedure for continuing the operation process on a display of the handle assembly.

[0090] According to another embodiment of this disclosure, a method of using a surgical device includes: attaching an adapter assembly to a handle assembly; performing a surgical procedure using the handle assembly and the adapter assembly; immediately replacing at least one of the adapter assembly or the handle assembly upon encountering an error in at least one of the adapter assembly or the handle assembly; and continuing the surgical procedure. Attached Figure Description

[0091] Embodiments of this disclosure are described herein with reference to the accompanying drawings, in which:

[0092] Figure 1 This is a perspective view of a handheld surgical device and adapter assembly according to an embodiment of the present disclosure, illustrating its connection with an end effector or reloading device;

[0093] Figure 2 yes Figure 1 Front perspective view of the handle assembly of the surgical device;

[0094] Figure 3 yes Figure 2 A front perspective view of the handle assembly with some parts separated;

[0095] Figure 4 yes Figure 2 Rear perspective view of the handle assembly with some parts separated;

[0096] Figure 5The illustration shows a perspective view of the handle assembly being inserted into the outer housing assembly according to the present disclosure;

[0097] Figure 6 This is a perspective view illustrating a handle assembly inserted into the proximal half section of an outer housing assembly according to the present disclosure;

[0098] Figure 7 This is a side front view of the outer casing with the outer shell in the open position;

[0099] Figure 8 This is a front perspective view of the outer casing shown in the open position;

[0100] Figure 9 This is a front perspective view of the outer housing with the insertion guide removed and in a partially opened condition;

[0101] Figure 10 This is the rear perspective view of the inserted guide component;

[0102] Figure 11 This is the front perspective view of the inserted guide;

[0103] Figure 12 This is a front perspective view of the power handle with the internal rear housing separated.

[0104] Figure 13 This is a rear perspective view of the power handle with the internal rear cover removed;

[0105] Figure 14 This is a perspective view of the core assembly of the power handle;

[0106] Figure 15 yes Figure 14 Front perspective view of the motor assembly and control assembly of the core assembly of the power handle;

[0107] Figure 16 yes Figure 15 Rear perspective view of the motor assembly and control assembly with parts separated;

[0108] Figure 17 yes Figure 2 A longitudinal cross-sectional view of the handle assembly;

[0109] Figure 18 yes Figure 17 A magnified view of the indicated detail area;

[0110] Figure 19 Is it through Figure 17 Cross-sectional view of the handle assembly obtained from 19-19;

[0111] Figure 20 yes Figure 1 Front perspective view of the adapter assembly;

[0112] Figure 21 yes Figure 1 and 20 Rear perspective view of the adapter assembly;

[0113] Figure 22 This is a perspective view illustrating the connection between the adapter assembly and the handle assembly;

[0114] Figure 23 This is a perspective view of the adapter assembly, illustrating the reloading component fastened to its distal end;

[0115] Figure 24 This is a perspective view of the adapter assembly secured to the far end without reloading.

[0116] Figure 25 This is a perspective view of the adapter assembly, partially shown in shaded lines, illustrating its first force / rotation transmission / conversion assembly;

[0117] Figure 26 yes Figure 25 Perspective view of the first force / rotation transmission / conversion assembly;

[0118] Figure 27 yes Figure 25 A longitudinal cross-sectional view of the first rotatable proximal drive shaft, the first rotatable distal drive shaft, and the connecting component of the first force / rotation transmission / conversion assembly;

[0119] Figure 28 yes Figure 25 A perspective view of the cannula assembly of the first force / rotation transmission / conversion assembly, in which the parts have been separated;

[0120] Figure 29 yes Figure 25 A perspective view of the distal portion of the first force / rotation transmission / conversion assembly, illustrating its support block;

[0121] Figure 30 yes Figure 25 A perspective view of the distal portion of the first force / rotation transmission / conversion assembly, with its support block shown in shading;

[0122] Figure 31 Is it through Figure 29 The cross-sectional view obtained from section 31-31;

[0123] Figure 32 Is it through Figure 29 The cross-sectional view obtained from 32-32;

[0124] Figure 33 Is it through Figure 32 The cross-sectional view obtained from section 33-33;

[0125] Figure 34 This is a perspective view of the adapter assembly, partially shown in shaded lines, illustrating its second force / rotation transmission / conversion assembly;

[0126] Figure 35 yes Figure 34 Perspective view of the second force / rotation transmission / conversion assembly;

[0127] Figure 36 yes Figure 35 A magnified view of the indicated detail area;

[0128] Figure 37 yes Figure 34 A perspective view of the planetary gear set and pin drive of the second force / rotation transmission / conversion assembly, in which the parts have been separated;

[0129] Figure 38 Is it through Figure 24 The cross-sectional view obtained from 38-38;

[0130] Figure 39 This is a perspective view of the adapter assembly, partially shown in shaded lines, illustrating its third force / rotation transmission / conversion assembly;

[0131] Figure 40 yes Figure 39 Perspective view of the third force / rotation transmission / conversion assembly;

[0132] Figure 41 yes Figure 40 A magnified view of the indicated detail area;

[0133] Figure 42 yes Figure 39 A perspective view of the planetary gear set and the tool driver, in which the parts have been separated, of the third force / rotation transmission / conversion assembly;

[0134] Figure 43 This is a perspective view of the distal portion of the adapter assembly;

[0135] Figure 44 This is another perspective view of the distal portion of the adapter assembly, where some parts have been separated.

[0136] Figure 45 This is a rear perspective view of the internal components of the distal portion of the adapter assembly;

[0137] Figure 46 yes Figure 45 A magnified view of the indicated detail area;

[0138] Figure 47 This is a front perspective view of the internal components of the distal portion of the adapter assembly;

[0139] Figure 48 yes Figure 47 A magnified view of the indicated detail area;

[0140] Figure 49 yes Figures 45-48 A front perspective view of the internal components of the more distal portion of the adapter assembly;

[0141] Figure 50 yes Figure 49 A front perspective view of the internal components of the more distal part of the adapter assembly, where some parts have been separated;

[0142] Figure 51 yes Figures 45-50 A perspective view of the distal portion of the adapter assembly, in which some parts have been separated;

[0143] Figure 52 yes Figures 45-51 A perspective view of the distal portion of the adapter assembly, illustrating its electrical assembly;

[0144] Figure 53 This is a perspective view of the electrical assembly of the adapter assembly disclosed herein;

[0145] Figure 54 yes Figures 52-53 A perspective view of the strain gauge assembly of the electrical assembly;

[0146] Figure 55 Is it through Figure 54 The cross-sectional view obtained at 55-55;

[0147] Figure 56 yes Figure 49 and 50 The diagram shows a longitudinal cross-sectional view of the more distal portion of the adapter assembly.

[0148] Figure 57 This is a longitudinal cross-sectional view of the knob assembly of the adapter assembly disclosed herein;

[0149] Figure 58 This is a perspective view of the rotating assembly of the knob assembly;

[0150] Figure 59 yes Figure 58 Longitudinal cross-sectional view of the rotating assembly;

[0151] Figure 60 yes Figure 58 A perspective cross-sectional view of the separated parts of a rotating assembly;

[0152] Figure 61 This is a perspective view of the rotating assembly, illustrating its operation;

[0153] Figure 62 This is a rear perspective view of the adapter assembly, illustrating the rotation of the rotating assembly and shaft assembly relative to their drive coupling assembly;

[0154] Figure 63 This is a rear perspective view of the adapter assembly, showing the adapter assembly in its unrotated position;

[0155] Figure 64 Is it through Figure 63 The cross-sectional view obtained from 64-64;

[0156] Figure 65 Is it through Figure 63 The cross-sectional view obtained from 64-64 illustrates the rotation of the rotating assembly and the shaft assembly relative to the drive coupling assembly;

[0157] Figure 66 This is a perspective view of a reloaded component according to this disclosure, in which some parts have been separated;

[0158] Figure 67 yes Figure 66 A longitudinal cross-sectional view of the assembled and reloaded component;

[0159] Figure 68 yes Figures 66-67 A perspective view of the electrical connector of the reloading component;

[0160] Figure 69 Is it through Figure 68 The cross-sectional view obtained from 69-69;

[0161] Figure 70 yes Figures 66-69 The rear perspective view of the reloading component illustrates the release ring and retaining ring that have separated from it;

[0162] Figure 71 It is a longitudinal cross-sectional view of the reloading component aligned with and separated from the more distal portion of the adapter assembly.

[0163] Figure 72 It is a longitudinal cross-sectional view of the reloading component that is aligned with and connected to the more distal portion of the adapter assembly.

[0164] Figure 73 This is a front perspective view of the anvil assembly disclosed herein;

[0165] Figure 74 yes Figure 73 Rear perspective view of the anvil assembly;

[0166] Figure 75 yes Figure 73 and 74 A perspective view of the anvil assembly with its parts separated;

[0167] Figure 76 This is a rear perspective view of the reloading part and the more distal portion of the adapter assembly, illustrating the connection of the flushing tube to it;

[0168] Figure 77 This is a rear perspective view of the reloading part and the more distal portion of the adapter assembly, showing the flushing tube separated from it;

[0169] Figure 78 yes Figure 77 A magnified view of the indicated detail area;

[0170] Figure 79 This is a perspective view of the flushing tube;

[0171] Figure 80 yes Figure 79 A magnified view of the indicated detail area;

[0172] Figure 81 yes Figure 79 A magnified view of the indicated detail area;

[0173] Figure 82A -F illustrates an embodiment of the present disclosure for operation Figure 1 A flowchart of a method for using a handheld surgical device;

[0174] Figure 83 The illustration shows an embodiment of the present disclosure in which... Figure 1 A schematic diagram showing the travel distance and speed of the anvil assembly and corresponding motor during the clamping process performed by the handheld surgical device;

[0175] Figure 84 The illustrations are based on embodiments of the present disclosure and show the situation in which... Figure 1 A schematic diagram showing the travel distance and speed of the driver and corresponding motor during the stapling procedure performed by the handheld surgical device;

[0176] Figure 85 The illustrations are based on embodiments of the present disclosure and show the situation in which... Figure 1 A schematic diagram showing the travel distance and speed of the blade assembly and corresponding motor during the cutting process performed by the handheld surgical device;

[0177] Figure 86 The illustration shows an embodiment of the present disclosure. Figure 1 A flowchart of a method for executing a controlled tissue compression algorithm using a handheld surgical device;

[0178] Figure 87A-B illustrates an embodiment of the present disclosure by Figure 1 A flowchart of a method for executing a stapling algorithm using a handheld surgical device;

[0179] Figure 88A -B illustrates an embodiment of the present disclosure by Figure 1 A flowchart of the cutting algorithm performed by a handheld surgical device; and

[0180] Figure 89 This is a schematic diagram of a handheld surgical device, adapter assembly, and reloading device according to embodiments of the present disclosure. Detailed Implementation

[0181] Embodiments of the currently disclosed surgical apparatus and adapter assemblies for the surgical apparatus and / or handle assembly are described in detail with reference to the accompanying drawings, in which similar reference numerals denote the same or corresponding elements in each of the various figures. As used herein, the term "distal" refers to the portion of the adapter assembly or surgical apparatus or its components further away from the user, while the term "proximal" refers to the portion of the adapter assembly or surgical apparatus or its components closer to the user.

[0182] The surgical device according to an embodiment of the present disclosure is a handheld surgical device in the form of a powered electromechanical handle assembly, the assembly being configured to selectively attach a plurality of different reloading members via a plurality of respective adapter assemblies, each of the reloading members being configured to be actuated and manipulated by the powered electromechanical handle assembly.

[0183] The surgical device includes a handle assembly 100 configured to selectively connect with an adapter assembly 200, which in turn is configured to selectively connect with a selected reload 400 (one of a plurality of reloads) configured to perform surgical action on the patient's tissues.

[0184] like Figure 1-11 As described herein, the handle assembly 100 includes a power handle 101 and an outer housing 10 configured to selectively receive and close the power handle 101. The outer housing 10 includes a distal half-section 10a and a proximal half-section 10b, the proximal half-section being pivotally connected to the distal half-section 10a via hinges 16 positioned along the upper edges of the distal half-section 10a and the proximal half-section 10b. When engaged, the distal half-section 10a and the proximal half-section 10b define a housing cavity 10c therein, within which the power handle 101 is selectively located.

[0185] The distal half-section 10a and the proximal half-section 10b of the housing 10 are divided along a plane that traverses the longitudinal axis “X” of the adapter assembly 200.

[0186] Each of the distal half-section 10a and proximal half-section 10b of the housing 10 includes a corresponding upper housing portion 12a, 12b and a corresponding lower housing portion 14a, 14b. The lower housing portions 14a, 14b define a snap-on closure feature 18 for selectively fastening the lower housing portions 14a, 14b to each other and for maintaining the housing 10 in a closed condition. The housing 10 includes right and left snap-on closure features 18a for further fastening the distal half-section 10a and proximal half-section 10b of the housing 10 to each other.

[0187] The distal half-section 10a of the housing 10 defines a connection portion 20 configured to receive a corresponding drive coupling assembly 210 of the adapter assembly 200. Specifically, the distal half-section 10a of the housing 10 has a recess 20 that receives a portion of the drive coupling assembly 210 of the adapter assembly 200 when the adapter assembly 200 is engaged with the handle assembly 100.

[0188] The connecting portion 20 of the distal half-section 10a defines a pair of axially extending guide rails 20a, 20b that project radially inward from their inner surfaces. The guide rails 20a, 20b facilitate rotational orientation of the adapter assembly 200 relative to the handle assembly 100 when the adapter assembly 200 is engaged with the handle assembly 100.

[0189] The connecting portion 20 of the distal half-section 10a defines three openings 22a, 22b, and 22c formed in its distally facing surface and arranged in a common plane or line. The connecting portion 20 of the distal half-section 10a also defines an elongated slot 24 (for accommodating connector 66, see [link]) also formed in its distally facing surface. Figure 3 ).

[0190] The connecting portion 20 of the distal half-segment 10a further defines the concave connecting feature 26 formed in its surface (see Figure 2 The concave connection feature 26 selectively engages with the convex connection feature of the adapter assembly 200, as will be described in more detail below.

[0191] The distal half-section 10a of the housing 10 supports a dual-state switching control button 30 facing the distal side. The dual-state switching control button 30 can be actuated immediately in the left, right, up, and down directions after applying stress or pressure to it.

[0192] The distal half-section 10a of the housing 10 supports a pair of control buttons 32a, 32b on the right side (see...) Figure 3 ) and a pair of control buttons 34a and 34b on the left (see Figure 2The right-side control buttons 32a and 32b and the left-side control buttons 34a and 34b can be actuated immediately upon application of stress or pressure.

[0193] The proximal half section 10b of the housing 10 supports the right-side start button 36a (see...). Figure 3 ) and the left-side start button 36b (see Figure 2 The right-side start button 36a and the left-side start button 36b can be actuated immediately upon application of stress or pressure.

[0194] The distal half-section 10a and proximal half-section 10b of the housing 10 are made of polycarbonate and are clear or transparent or can be overmolded.

[0195] See Figure 5-11 The handle assembly 100 includes an insertion guide 50, which is configured and shaped to be placed on the distal edge 10d of the proximal half-section 10b. Figure 3 and 9 The insertion guide 50 includes a body portion 52 that defines a central opening therein, and a hand / finger gripping protrusion 54 extending from the bottom of the body portion 52.

[0196] In use, when the main body portion 52 of the insertion guide 50 is placed on the distal edge 10d of the proximal half-section 10b, the central opening of the insertion guide 50 provides access to the housing cavity 10c of the housing 10 for inserting the non-sterile powered handle 101 of the handle assembly 100 into the proximal half-section 10b of the sterile housing 10.

[0197] See Figure 2-4 The housing 10 includes a sterile barrier plate assembly 60 selectively supported in the distal half-section 10a. Specifically, the sterile barrier plate assembly 60 is positioned behind the connecting portion 20 of the distal half-section 10a and within the housing cavity 10c of the housing 10. The plate assembly 60 includes a plate 62 rotatably supporting three connecting shafts 64a, 64b, 64c. Each connecting shaft 64a, 64b, 64c extends from an opposite side of the plate 62 and has a three-lobed transverse cross-sectional profile. When the sterile barrier plate assembly 60 is positioned within the housing cavity 10c of the housing 10, each connecting shaft 64a, 64b, 64c extends through a corresponding orifice 22b, 22c, 22a of the connecting portion 20 of the distal half-section 10a.

[0198] The plate assembly 60 further includes an electrical connector 66 supported on a plate 62. The electrical connector 66 extends from opposite sides of the plate 62. When the sterile barrier plate assembly 60 is disposed within the housing cavity 10c of the housing housing 10, each connecting shaft 64a, 64b, 64c extends through corresponding orifices 22a, 22b, 22c of the connecting portion 20 of the distal half-segment 10a of the housing housing 10. The electrical connector 66 includes a chip and defines a plurality of contact paths, each of which includes an electrical conduit for extending an electrical connection across the plate 62.

[0199] When the plate assembly 60 is placed within the housing cavity 10c of the housing 10, the distal ends of the connecting shafts 64a, 64b, 64c and the distal end of the through connector 66 are placed or positioned within the connecting portion 20 of the distal half section 10a of the housing 10, and electrically and / or mechanically engage the corresponding features of the adapter assembly 200, as will be described in more detail below.

[0200] In operation, with the new and / or sterile housing 10 in an open configuration (e.g., distal half-segment 10a separated from proximal half-segment 10b around hinge 16) and the insertion guide 50 in place against the distal edge 10d of the proximal half-segment 10b of the housing 10, the power handle 101 is inserted through the central opening of the insertion guide 50 and into the housing cavity 10c of the housing 10. With the power handle 101 inserted into the housing cavity 10c of the housing 10, the insertion guide 50 is removed from the proximal half-segment 10b, and the distal half-segment 10a is pivoted around hinge 16 to a closed configuration for the housing 10. In the closed configuration, the snap-on closure feature 18 of the lower housing portion 14a of the distal half-segment 10a engages the snap-on closure feature 18 of the lower housing portion 14b of the proximal half-segment 10b. Furthermore, the right and left snap closure features 18a engage to further maintain the housing 10 in a closed configuration.

[0201] During operation, after the surgical procedure, the latch closure feature 18 of the lower housing portion 14a of the distal half-section 10a disengages from the latch closure feature 18 of the lower housing portion 14b of the proximal half-section 10b, and the right and left latch closure features 18a disengage, allowing the distal half-section 10a to pivot about the hinge 16 away from the proximal half-section 10b to open the housing shell 10. With the housing shell 10 open, the power handle 101 is removed from the housing cavity 10c of the housing shell 10 (specifically from the proximal half-section 10b of the housing shell 10), and the housing shell 10 is discarded.

[0202] The power handle 101 will then be sterilized and cleaned. The power handle 101 will not be submerged or sterilized.

[0203] refer to Figure 3-6 and Figure 12-19 The handle assembly 100 includes a power handle 101. The power handle 101 includes an inner handle housing 110 having a lower housing portion 104 and an upper housing portion 108 extending from and / or supported thereon. The lower housing portion 104 and the upper housing portion 108 are divided into a distal half-section 110a and a proximal half-section 110b connectable to the distal half-section 110a via a plurality of fasteners. When engaged, the distal half-section 110a and the proximal half-section 110b define the inner handle housing 110 having an inner housing cavity 110c in which the power supply core assembly 106 is located.

[0204] The power supply core assembly 106 is configured to control various operations of the handle assembly 100, as will be described in additional details below.

[0205] The distal half-section 110a of the inner handle housing 110 defines a distal opening 111a therein, which is configured and adapted to support the control plate 160 of the power supply core assembly 106. When the power handle 101 is placed inside the housing 10, the control plate 160 of the power handle 101 abuts against the rear surface of the plate 62 of the sterile barrier plate assembly 60 of the housing 10.

[0206] See Figure 12 The distal half-section 110a of the inner handle housing 110 supports a distal dual-state switching control interface 130 that is operably aligned with the distal dual-state switching control button 30 of the housing housing 10. In use, when the power handle 101 is placed inside the housing housing 10, the actuation of the dual-state switching control button 30 applies force to the dual-state switching control interface 130.

[0207] The distal half-section 110a of the inner handle housing 110 also supports a pair of control ports 132a, 132b on the right and a pair of control ports 134a, 134b on the left. In use, when the power handle 101 is placed inside the housing 10, actuation of one of the pair of control buttons 32a, 32b on the right or the pair of control buttons 34a, 34b on the left of the distal half-section 10a of the housing 10 applies force to the corresponding one of the pair of control ports 132a, 132b on the right or the pair of control ports 134a, 134b on the left of the distal half-section 110a of the inner handle housing 110.

[0208] During use, the control button 30, the right start button 36a or the left start button 36b, the right pair of control interfaces 132a, 132b and the left pair of control interfaces 134a, 134b of the distal half section 110a of the internal handle housing 110 will be deactivated or inoperable unless the housing housing 10 has been verified.

[0209] The proximal half-section 110b of the inner handle housing 110 defines the right control port 136a and the left control port 136b. In use, when the power handle 101 is placed inside the housing 10, actuation of either the right start button 36a or the left start button 36b of the proximal half-section 10b of the housing 10 extends either the right start button 36a or the left start button 36b into and across the right control port 136a or the left control port 136b of the proximal half-section 110b of the inner handle housing 110.

[0210] See Figure 12-19 The internal handle housing 110 provides a housing in which the power supply core assembly 106 is located. The power supply core assembly 106 includes a battery circuit 140, a controller circuit board 142, and a rechargeable battery 144 configured to supply power to any of the electrical components of the handle assembly 100. The controller circuit board 142 includes a motor controller circuit board 142a, a main controller circuit board 142b, and a first ribbon cable 142c interconnecting the motor controller circuit board 142a and the main controller circuit board 142b.

[0211] The power supply core assembly 106 further includes a display screen 146 supported on the main controller circuit board 142b. The display screen 146 is provided through a clear or transparent window 110d in the proximal half-section 110b of the internal handle housing 110 (see...). Figure 12 and 17 )visible.

[0212] The power supply core assembly 106 further includes a first motor 152, a second motor 154, and a third motor 156, each electrically connected to a controller circuit board 142 and a battery 144. Motors 152, 154, and 156 are positioned between the motor controller circuit board 142a and the main controller circuit board 142b. Each motor 152, 154, and 156 includes a corresponding motor shaft 152a, 154a, and 156a extending therefrom. Each motor shaft 152a, 154a, and 156a has a three-lobed lateral cross-sectional profile for transmitting rotational force or torque.

[0213] Each motor 152, 154, and 156 is controlled by a corresponding motor controller. The motor controller is mounted on motor controller board 142a and is an A3930 / 31K motor driver from Allegro Microsystems, Inc. The A3930 / 31K motor driver is designed to control 3-phase brushless DC (BLDC) motors, such as motors 152, 154, and 156, using N-channel external power MOSFETs. Each of the motor controllers is connected to a main controller mounted on main controller board 142b. The main controller is also connected to a memory, which is also mounted on main controller board 142b. The main controller is an ARM Cortex M4 processor from Freescale Semiconductor, Inc., containing 1024 kilobytes of internal flash memory. The main controller communicates with the motor controllers via an FPGA, which provides control logic signals (e.g., coasting, braking, etc.). The motor controller's control logic then uses fixed-frequency pulse-width modulation (PWM) to output the corresponding power supply signals to its respective motor 152, 154, and 156.

[0214] Each motor 152, 154, 156 is supported on a motor bracket 148 such that the motor shafts 152a, 154a, 156a are rotatably mounted in corresponding openings within the motor bracket 148. For example... Figure 16 and 19 As illustrated, motor bracket 148 rotatably supports three rotatable drive connector sleeves 152b, 154b, and 156b, which are keyed to the corresponding motor shafts 152a, 154a, and 156a of motors 152, 154, and 156. When the power handle 101 is positioned within the housing 10, the drive connector sleeves 152b, 154b, and 156b non-rotatably receive the proximal ends of the corresponding connecting shafts 64a, 64b, and 64c of the plate assembly 60 of the housing 10. Each drive connector sleeve 152b, 154b, and 156b is spring-biased away from its corresponding motor 152, 154, and 156.

[0215] Motor shafts 152a, 154a, and 156a drive the shafts and / or gear assemblies of adapter assembly 200 by rotating the corresponding motors 152, 154, and 156 to perform various operations of handle assembly 100. Specifically, motors 152, 154, and 156 of power assembly core assembly 106 are configured to drive the shafts and / or gear assemblies of adapter assembly 200 to: selectively extend / retract the cannula needle assembly 270 of adapter assembly 200, open / close reloading member 400 (when anvil assembly 510 is connected to cannula needle assembly 270 of cannula needle assembly 270), activate the annular array of pins of reloading member 400, and activate the annular blade 444 of reloading member 400.

[0216] The motor bracket 148 also supports an electrical socket 149. The electrical socket 149 is electrically connected to the main controller circuit board 142b via a second ribbon cable 142d. The electrical socket 149 defines a plurality of electrical slots for receiving corresponding electrical contacts or blades extending from the through connector 66 of the board assembly 60 of the housing 10.

[0217] In use, when the adapter assembly 200 is fitted into the handle assembly 100, each of the connecting shafts 64a, 64b, and 64c of the plate assembly 60 of the housing 10 of the handle assembly 100 is connected to the corresponding rotatable connector sleeves 218, 222, and 220 of the adapter assembly 200 (see...). Figure 22 In this respect, the interfaces between the first connecting shaft 64a and the first connector sleeve 218, the interfaces between the second connecting shaft 64b and the second connector sleeve 222, and the interfaces between the third connecting shaft 64c and the third connector sleeve 220 are keyed, such that rotation of each of the connecting shafts 64a, 64b, and 64c of the handle assembly 100 causes corresponding rotation of the corresponding connector sleeves 218, 222, and 220 of the adapter assembly 200.

[0218] The engagement of the connecting shafts 64a, 64b, 64c of the handle assembly 100 with the connector sleeves 218, 222, 220 of the adapter assembly 200 allows for the independent transmission of rotational force via each of the three corresponding connector interfaces. The connecting shafts 64a, 64b, 64c of the handle assembly 100 are configured to rotate independently by the corresponding motors 152, 154, 156.

[0219] Because each of the connecting shafts 64a, 64b, 64c of the handle assembly 100 has a keyed and / or substantially non-rotatable interface with the corresponding connector sleeves 218, 222, 220 of the adapter assembly 200, rotational force is selectively transmitted from the motors 152, 154, 156 of the handle assembly 100 to the adapter assembly 200 when the adapter assembly 200 is connected to the handle assembly 100.

[0220] The selective rotation of the connecting shafts 64a, 64b, and 64c of the handle assembly 100 allows the handle assembly 100 to selectively actuate different functions of the reloading member 400. As will be discussed in more detail below, the selective and independent rotation of the first connecting shaft 64a of the handle assembly 100 corresponds to the selective and independent extension / retraction of the cannula needle component 274 of the adapter assembly 200 and / or the selective and independent opening / closing of the reloading member 400 (when the anvil assembly 510 is connected to the cannula needle component 274). Furthermore, the selective and independent rotation of the third connecting shaft 64c of the handle assembly 100 corresponds to the selective and independent actuation of the annular array of pins in the reloading member 400. Additionally, the selective and independent rotation of the second connecting shaft 64b of the handle assembly 100 corresponds to the selective and independent actuation of the annular blade 444 of the reloading member 400.

[0221] See Figure 12-19 The power supply core assembly 106 further includes a switch assembly 170 supported within the distal half-section 110a of the inner handle housing 110, located below and aligned with the dual-state switching control interface 130, a pair of right-side control interfaces 132a, 132b, and a pair of left-side control interfaces 134a, 134b. The switch assembly 170 includes a first set of four push-button switches 172a-172d arranged around the guide rod 30a of the dual-state switching control button 30 on the outer housing 10 when the power handle 101 is positioned within the outer housing 10. The switch assembly 170 also includes a second pair of push-button switches 174a, 174b located below the pair of right-side control interfaces 132a, 132b on the distal half-section 110a of the inner handle housing 110 when the power handle 101 is positioned within the outer housing 10. The switch assembly 170 further includes a third pair of push-button switches 176a, 176b located below a pair of control interfaces 134a, 134b on the left side of the distal half-section 110a of the inner handle housing 110 when the power handle 101 is located inside the outer housing housing 10.

[0222] The power supply core assembly 106 includes a single right-side push-button switch 178a located below the right-side control port 136a of the proximal half-section 110b of the inner handle housing 110, and a single left-side push-button switch 178b located below the left-side control port 136b of the proximal half-section 110b of the inner handle housing 110. Push-button switches 178a and 178b are supported on the controller circuit board 142. When the power handle 101 is housed within the outer housing 10, push-button switches 178a and 178b are located below the right-side start button 36a and the left-side start button 36b of the proximal half-section 10b of the housing 10.

[0223] Actuation of the push-button switch 172c of the power handle 101 corresponding to the downward actuation of the dual-state switching control button 30 causes the controller circuit board 142 to provide an appropriate signal to the motor 152 to activate, retract the cannula needle part 274 of the adapter assembly 200 and / or close the handle assembly 100 (e.g., relative to the reloading member 400, approaching the anvil assembly 510).

[0224] Actuation of the push-button switch 172a of the power handle 170 corresponding to the upward actuation of the dual-state switching control button 30 causes the controller circuit board 142 to be activated, the cannula needle component 274 of the adapter assembly 200 to be advanced, and / or the handle assembly 100 to be opened (e.g., the anvil assembly 510 is separated relative to the reloading member 400).

[0225] Actuation of the start switch 178a or 178b of the power handle 101 corresponding to the actuation of the right or left control buttons 36a, 36b causes the controller circuit board 142 to provide appropriate signals to the motors 154 and 156 to activate, actuate the pins of the reloading member 400 when appropriate, and then advance (e.g., actuate) and retract the ring blade 444 of the reloading member 400.

[0226] The actuation of switches 174a, 174b (via the user's right thumb) or switches 176a, 176b (via the user's left thumb) of the switch assembly 170 corresponding to the actuation of the right pair of control buttons 32a, 32b or the left pair of control buttons 34a, 34b causes the controller circuit board 142 to provide appropriate signals to the motor 152 to activate, advance or retract the cannula pin component 274 of the adapter assembly 200.

[0227] See Figure 12 and 14The power supply core assembly 106 of the handle assembly 100 includes a USB connector 180 supported on a main controller circuit board 142b of the controller circuit board 142. The USB connector 180 can be accessed via the control board 160 of the power supply core assembly 106. When the power handle 101 is housed within the outer housing 10, the USB connector 180 is covered by the plate 62 of the sterile barrier plate assembly 60 of the housing 10.

[0228] like Figure 1 and Figure 20-65 As described herein, the handle assembly 100 is configured for selective connection with the adapter assembly 200, and the adapter assembly 200 is configured for selective connection with the reloading member 400.

[0229] The adapter assembly 200 is configured to convert rotation of the connecting shafts 64a, 64b, 64c of the handle assembly 100 into axial translation, said axial translation including advance / retract the cannula needle component 274 of the adapter assembly 200, open / close the handle assembly 100 (when the anvil assembly 510 is connected to the cannula needle component 274), actuate the pin of the reloading member 400, and actuate the annular blade 444 of the reloading member 400, as shown. Figure 22 As illustrated in the figure, and will be described in more detail below.

[0230] The adapter assembly 200 includes a first drive transmission / conversion assembly for interconnecting a first connecting shaft 64a of the handle assembly 100 and an anvil assembly 510, wherein the first drive transmission / conversion assembly converts and transmits rotation of the first connecting shaft 64a of the handle assembly 100 to axial translation of the cannula part 274 of the cannula assembly 270, and then to the anvil assembly 510 connected to the cannula part 274 to open / close the handle assembly 100.

[0231] The adapter assembly 200 includes a second drive transmission / conversion assembly for interconnecting the third connecting shaft 64c of the handle assembly 100 and the second axially translatable drive component of the reloading member 400, wherein the second drive transmission / conversion assembly converts and transmits rotation of the third connecting shaft 64c of the handle assembly 100 to axial translation of the outer flexible belt assembly 255 of the adapter assembly 200, and to the drive adapter 432 of the nail driver assembly 430 of the reloading member 400 to actuate nails from the nail magazine 420 of the reloading member 400 and against the anvil assembly 510.

[0232] The adapter assembly 200 includes a third drive transmission / conversion assembly for interconnecting the second connecting shaft 64b of the handle assembly 100 and the third axially translatable drive member of the reloading member 400, wherein the third drive transmission / conversion assembly converts and transmits the rotation of the second connecting shaft 64b of the handle assembly 100 to the axial translation of the internal flexible belt assembly 265 of the adapter assembly 200, and then to the knife assembly 440 of the reloading member 400 to abut against the anvil assembly 510 to activate the annular knife 444.

[0233] Now refer to Figure 20-24 The adapter assembly 200 includes an outer knob housing 202 and an outer conduit 206 extending from the distal end of the knob housing 202. The knob housing 202 and the outer conduit 206 are configured and sized to accommodate components of the adapter assembly 200. The knob housing 202 includes a drive coupling assembly 210, which is configured and adapted to connect to a connection portion 108 of the handle housing 102 of the handle assembly 100.

[0234] The adapter assembly 200 is configured to convert rotation of any one of the first, second, or third connecting shafts 64a, 64b, 64c of the handle assembly 100 into axial translation for operating the cannula assembly 270, the anvil assembly 510, and / or the nail driver assembly 430 or the knife assembly 440 of the reloading unit 400, as will be described in more detail below.

[0235] like Figures 57-61 As described herein, the adapter assembly 200 includes a proximal inner housing component 204 housed within the knob housing 202. The inner housing component 204 rotatably supports a first rotatable proximal drive shaft 212, a second rotatable proximal drive shaft 214, and a third rotatable proximal drive shaft 216 therein. Each proximal drive shaft 212, 214, 216 acts as a rotation receiving component to receive rotational forces from corresponding connecting shafts 64a, 64c, and 64b of the handle assembly 100, as described in more detail below.

[0236] As briefly described above, the drive coupling assembly 210 of the adapter assembly 200 is also configured to rotatably support first, second, and third connector sleeves 218, 222, and 220, which are arranged in a common plane or line. Each of the connector sleeves 218, 220, and 222 is configured to mate with the corresponding first, second, and third coupling shafts 64a, 64c, and 64b of the handle assembly 100, as described above. Each of the connector sleeves 218, 220, and 222 is further configured to mate with the proximal ends of the corresponding first, second, and third proximal drive shafts 212, 214, and 216 of the adapter assembly 200.

[0237] like Figure 26 , 34 As illustrated in Figures 35 and 40, the drive coupling assembly 210 of the adapter assembly 200 further includes first, second, and third biasing members 224, 226, and 228 disposed distal to the respective first, second, and third connector sleeves 218, 222, and 220. Each of the biasing members 224, 226, and 228 is disposed around the respective first, second, and third rotatable proximal drive shafts 212, 216, and 214. The biasing members 224, 226, and 228 act on the respective connector sleeves 218, 222, and 220 to help maintain distal engagement of the connector sleeves 218, 222, and 220 with the respective coupling shafts 64a, 64b, and 64c of the handle assembly 100 when the adapter assembly 200 is connected to the handle assembly 100.

[0238] Specifically, the first, second, and third biasing components 224, 226, and 228 are used to bias the corresponding connector sleeves 218, 222, and 220 in the proximal direction. In this way, during the connection from the handle assembly 100 to the adapter assembly 200, if the first, second, and / or third connector sleeves 218, 222, and / or 220 are not aligned with the connecting shafts 64a, 64b, and 64c of the handle assembly 100, then the first, second, and / or third biasing components 224, 226, and / or 228 are compressed. Therefore, when the handle assembly 100 is operated, the connecting shafts 64a, 64c, and 64b of the handle assembly 100 will rotate, and the first, second, and / or third biasing components 224, 228, and / or 226 will cause the corresponding first, second, and / or third connector sleeves 218, 220, and / or 222 to slide back proximally, thereby effectively connecting the connecting shafts 64a, 64c, and 64b of the handle assembly 100 to the first, second, and / or third proximal drive shafts 212, 214, and 216 of the drive coupling assembly 210.

[0239] As briefly mentioned above, the adapter assembly 200 includes first, second, and third force / rotation transmission / conversion assemblies 240, 250, and 260 respectively housed within the inner housing component 204 and the outer conduit 206. Each force / rotation transmission / conversion assembly 240, 250, and 260 is configured and adapted to transmit or convert the rotation of the first, second, and third connecting shafts 64a, 64c, and 64b of the handle assembly 100 into axial translation to enable operation of the cannula needle assembly 270 of the adapter assembly 200 and the nail driver assembly 430 or knife assembly 440 of the reloading member 400.

[0240] like Figure 25-28As shown, the first force / rotation transmission / conversion assembly 240 includes a first rotatable proximal drive shaft 212, a second rotatable proximal drive shaft 281, a rotatable distal drive shaft 282, and a coupling member 286 as described above, each of which is supported within the inner housing member 204, the drive coupling assembly 210, and / or the external conduit 206 of the adapter assembly 200. The first force / rotation transmission / conversion assembly 240 is used to extend / retract the cannula member 274 of the cannula assembly 270 of the adapter assembly 200, and to open / close the handle assembly 100 (when the anvil assembly 510 is connected to the cannula member 274).

[0241] The first rotatable proximal drive shaft 212 includes a non-circular or molded proximal portion configured for connection with a first connector 218 connected to a corresponding first connecting shaft 64a of the handle assembly 100. The first rotatable proximal drive shaft 212 includes a non-circular recess formed therein, configured to be keyed to a corresponding complementary molded proximal portion 281a of the second rotatable proximal drive shaft 281. The second rotatable proximal drive shaft 281 includes a distal portion 281b defining an oversized recess therein, the recess being configured to receive the proximal portion 282a of the first rotatable distal drive shaft 282. The proximal portion 282a of the first rotatable distal drive shaft 282 is pivotally secured to the recess in the distal portion 281b of the second rotatable proximal drive shaft 281 by a pin 283a, the pin being received through the oversized recess in the distal portion 281b of the second rotatable proximal drive shaft 281.

[0242] The first rotatable distal drive shaft 282 includes a proximal portion 282a and a distal portion 282b pivotally secured within a recess in a connecting member 286. The distal portion 282b of the first rotatable distal drive shaft 282 is pivotally secured within a recess in the proximal end of the connecting member 286 by a pin 283b, which is received through the recess in the proximal end portion of the connecting member 286. The proximal and distal portions 282a and 282b of the first rotatable distal drive shaft 282 respectively define oversized openings for receiving the pins 283a and 283b.

[0243] The connecting member 286 includes a proximal end 286a defining a recess 286c for receiving a distal portion 282b of a first rotatable distal drive shaft 282, and a distal end 286b defining a recess 286d for operably receiving a non-circular guide rod 276c on the proximal end 276a of the drive screw 276 of the cannula assembly 270.

[0244] The first force / rotation transmission / conversion assembly 240 further includes a cannula assembly 270 removably supported in the distal end of the outer conduit 206. The cannula assembly 270 includes an outer housing 272, a cannula member 274 slidably disposed within the tubular outer housing 272, and a drive screw 276 operably received within the cannula member 274 for axial movement of the cannula member 274 relative to the tubular housing 272. Specifically, the cannula member 274 includes a proximal end 274a having an internally threaded portion that engages a threaded distal portion 276b of the drive screw 276. The cannula member 274 further includes at least one longitudinally extending flat portion formed in its outer surface, which mates with a corresponding flat portion formed in the tubular housing 272 to suppress rotation of the cannula member 274 relative to the tubular housing 272 when the drive screw 276 rotates. The distal end 274b of the cannula needle component 274 is configured to selectively engage the anvil assembly 510. Figures 73-75 ).

[0245] The tubular housing 272 of the cannula assembly 270 is axially and rotatably secured within the outer conduit 206 of the adapter assembly 200. The tubular housing 272 defines a pair of radially opposed and radially oriented openings 272a, which are configured and sized to cooperate with a pair of locking pins 275c of the cannula assembly release mechanism 275. (Reference) Figures 29-33 The adapter assembly 200 includes a support block 292 fixedly disposed within an external conduit 206. The support block 292 is positioned proximal to the connector sleeve 290 and proximal to the strain sensor 320a of the strain gauge assembly 320, as described in more detail below. The locking pin 275c extends through the support block 292 and into the tubular housing 272 of the cannula assembly 270 to connect the cannula assembly 270 to the adapter assembly 200.

[0246] like Figures 29-33 As described, the cannula assembly release mechanism 275 includes a release button 275a pivotally supported on a support block 292 and within an external conduit 206. The release button 275a is spring-biased to a locked / extended condition. The cannula assembly release mechanism 275 further includes a spring clip 275b connected to the release button 275a, wherein the spring clip 275b includes a pair of legs extending through the support block 292 and across the cannula assembly 270. Each of the legs of the spring clip 275b extends via a corresponding locking pin 275c, which is slidably disposed within a corresponding radial opening 272a in the tubular housing 272 and a radial opening 292a in the support block 292 (see [link to documentation]). Figure 31 ).

[0247] During use, when the release button 275a is pressed (e.g., in the radially inward direction), Figure 33 When the release button 275a is activated, the spring clip 275b moves laterally relative to the cannula assembly 270. During this lateral movement, the legs of the spring clip 275b translate via the locking pins 275c such that the gooseneck in each leg cams and pushes the locking pins 275c radially outward. Each of the locking pins 275c is pushed radially outward a distance sufficient to completely disengage from the corresponding opening 272a of the tubular housing 272. With the locking pins 275c free and completely disengaged from the tubular housing 272, the cannula assembly 270 can be axially removed from the distal end of the external conduit 206 of the adapter assembly 200.

[0248] During operation, when the first rotatable proximal drive shaft 212 is rotated, the rotation of the first connector sleeve 218, due to the rotation of the first connecting shaft 64a of the handle assembly 100, causes the second rotatable distal drive shaft 281 to rotate. The rotation of the second rotatable distal drive shaft 281 causes the first rotatable distal drive shaft 282 to rotate simultaneously. The rotation of the first rotatable distal drive shaft 282 causes the connecting member 286 to rotate simultaneously, which in turn causes the drive screw 276 of the cannula assembly 270 to rotate simultaneously. When the drive screw 276 is within and rotates relative to the cannula member 274, the engagement of the internal threaded portion of the cannula member 274 with the threaded distal portion 276b of the drive screw 276 causes axial translation of the cannula member 274 within the tubular housing 272 of the cannula assembly 270. Specifically, rotation of the drive screw 276 in the first direction causes axial translation of the cannula assembly 274 in the first direction (e.g., extension of the cannula assembly 270 of the handle assembly 100), and rotation of the drive screw 276 in the second direction causes axial translation of the cannula assembly 274 in the second direction (e.g., retraction of the cannula assembly 270 of the handle assembly 100).

[0249] When the anvil assembly 510 is connected to the cannula needle assembly 274, as will be described in detail below, axial translation of the cannula needle assembly 274 in a first direction causes the reloading member 400 to open, and axial translation of the cannula needle assembly 274 in a second direction causes the reloading member 400 to close.

[0250] The force during the closure of the actuation or cannula needle component 274 or the reloading component 400 can be measured by the strain sensor 320a of the strain gauge assembly 320 so that:

[0251] - Determine the presence and proper engagement of the cannula assembly 270 in the adapter assembly 200;

[0252] - Determine the presence of the anvil assembly 510 during calibration;

[0253] - Identify the misalignment between the rack of the cannula needle assembly 274 and the longitudinally extending ridge 416 of the reloading member 400;

[0254] - Determine the re-clamping of the previously laid-out anvil assembly 510;

[0255] - Determine the presence of an obstacle during the clamping or closing of the reloading component 400;

[0256] - Determine the presence of the anvil assembly 510 and its connection with the cannula needle assembly 274;

[0257] - Monitor and control the compression of the tissues placed within the reloading unit 400;

[0258] - Monitor the relaxation of the tissue held within the reloading component 400 over time;

[0259] - Monitor and control the activation of the nail from the reloading component 400;

[0260] - Detect the presence of nails in the reloading component 400;

[0261] - Monitor the force during the initiation and formation of the nail as it is being ejected from the reloading unit 400;

[0262] - Optimize nail formation (e.g., nail crimping height) for different symptoms of the tissue when nails are being ejected from the reloading unit 400;

[0263] - Monitor and control the activation of the ring cutter 444 of the reloading unit 400;

[0264] - Monitor and control the completion of the initiation and cutting procedures; and

[0265] - Monitor maximum power output and control the starting and cutting processes to prevent exceeding the predetermined maximum power output.

[0266] During operation, the strain sensor 320a of the strain gauge assembly 320 of the adapter assembly 200 measures and monitors the retraction of the cannula assembly 274, as described above. During the closure of the reloading member 400, if and when the head assembly 512 of the anvil assembly 510 contacts tissue, an obstacle, the cartridge 420, or the like, a generally distal reaction force is applied to the head assembly 512. This distal reaction force is transmitted from the head assembly 512 to the center rod assembly 514 of the anvil assembly 510, which in turn is transmitted to the cannula assembly 270. The cannula assembly 270 then transmits the distal reaction force to the pin 275c of the cannula assembly release mechanism 275, which in turn transmits the reaction force to the support block 292. The support block 292 then transmits the distal reaction force to the strain sensor 320a of the strain gauge assembly 320.

[0267] The strain sensor 320a of the strain gauge assembly 320 is a device configured to measure the strain (dimensionless) on an object to which it is adhered, such that when the object deforms, the metal foil of the strain sensor 320a also deforms, thereby causing a change in its resistance, which is then used to calculate the load experienced by the cannula assembly 270.

[0268] The strain sensor 320a of the strain gauge assembly 320 then transmits the signal to the main controller circuit board 142b of the power supply core assembly 106 of the handle assembly 100. Graphics are then displayed on the display screen 146 of the power supply core assembly 106 of the handle assembly 100 to provide the user with real-time information related to the activation status of the handle assembly 100.

[0269] See Figures 34-38 The second force / rotation transmission / conversion assembly 250 of the adapter assembly 200 includes a second proximal drive shaft 214, a first connecting shaft 251, a planetary gear set 252, a nail guide screw 253, and a nail driver 254, each of which is supported within the inner housing component 204, the drive coupling assembly 210, and / or the outer conduit 206 of the adapter assembly 200. The second force / rotation transmission / conversion assembly 250 is used to actuate the nail of the reloading member 400 for abutment formation of the anvil assembly 510.

[0270] The second rotatable proximal drive shaft 214 includes a non-circular or molded proximal portion configured for connection with a second connector or coupling 220 connected to a corresponding second coupling shaft 64c of the handle assembly 100. The second rotatable proximal drive shaft 214 further includes a distal portion 214b having a spur gear non-rotatably connected thereto.

[0271] The first connecting shaft 251 of the second force / rotation transmission / conversion assembly 250 includes a proximal portion 251a having a spur gear non-rotatably connected thereto, and a distal portion 251b having a spur gear non-rotatably connected thereto. The spur gear at the proximal portion 251a of the first connecting shaft 251 meshes with a spur gear at the distal portion 214b of the second rotatable proximal drive shaft 214.

[0272] The planetary gear set 252 of the second force / rotation transmission / conversion assembly 250 includes a first hollow sun gear 252a, a first set of planetary gears 252b, a ring gear 252c, a second set of planetary gears 252d, and a second hollow sun gear 252e. The first sun gear 252a meshes with a spur gear at the distal portion 251b of the first connecting shaft 251. The first set of planetary gears 252b is inserted between and meshes with the first sun gear 252a and the ring gear 252c. The second set of planetary gears 252d is inserted between and meshes with the second sun gear 252e and the ring gear 252c. The ring gear 252c is non-rotatably supported in the external conduit 206 of the adapter assembly 200.

[0273] The planetary gear set 252 of the second force / rotation transmission / conversion assembly 250 includes a washer 252f, which is disposed within the ring gear 252c and between the first set of planetary gears 252b and the second set of planetary gears 252d. The first set of planetary gears 252b is radially rotatably supported around the washer 252f, and the second sun gear 252e is non-rotatably connected to the center of the washer 252f.

[0274] The second force / rotation transmission / conversion assembly 250 includes a lead screw 253 comprising a proximal flange 253a and a distal threaded portion 253b extending from the flange 253a. The lead screw 253 defines a cavity 253c therethrough. A second set of planetary gears 252d is radially rotatably supported around the proximal flange 253a of the lead screw 253.

[0275] The nail driver 254 of the second force / rotation transmission / conversion assembly 250 includes a central threaded cavity 254a extending therethrough, and the central threaded cavity is configured and sized to support the distal threaded portion 253b of the nail guide screw 253 therein. The nail driver 254 includes a pair of protrusions 254b projecting radially from its outer surface, and the protrusions are configured for connection to the outer flexible band assembly 255 of the adapter assembly 200, as will be described in more detail below.

[0276] Now see Figure 34 , 35In conjunction with 43-51, the second force / rotation transmission / conversion assembly 250 of the adapter assembly 200 includes an external flexible band assembly 255 fastened to the nail driver 254. The external flexible band assembly 255 includes first and second flexible bands 255a and 255b, which are laterally spaced and connected at their proximal ends to a support ring 255c and at their distal ends to the proximal end of a support base 255d. Each of the first and second flexible bands 255a and 255b is attached to both the support ring 255c and the support base 255d.

[0277] The external flexible band assembly 255 further includes first and second connecting extensions 255e and 255f extending proximally from the support ring 255c. The first and second connecting extensions 255e and 255f are configured to operatively connect the external flexible band assembly 255 to the nail driver 254 of the second force / rotation transmission / conversion assembly 250. Specifically, each of the first and second connecting extensions 255e and 255f is defined to receive an opening of a corresponding protrusion 254b of the nail driver 254. The protrusion 254b of the nail driver 254, received within the opening of the corresponding first and second connecting extensions 255e and 255f, secures the external flexible band assembly 255 to the nail driver 254 of the second force / rotation transmission / conversion assembly 250.

[0278] The driver adapter 432 of the nail driver assembly 430, which is supported by a base 255d extending distally from the flexible strips 255a and 255b and configured to selectively contact the reloading member 400.

[0279] The flexible belts 255a and 255b are made of semi-hard stainless steel 301 and are configured to transmit axial driving force along a bending path.

[0280] The second force / rotation transmission / conversion assembly 250 and the external flexible belt assembly 255 are configured to receive, through them, the first rotatable proximal drive shaft 212, the first rotatable distal drive shaft 282, and the cannula assembly 270 of the first force / rotation transmission / conversion assembly 240. Specifically, the first rotatable proximal drive shaft 212 is non-rotatably connected to the second rotatable proximal drive shaft 281, which is rotatably housed within and passes through the first hollow sun gear 252a, the second hollow sun gear 252e, the pin guide screw 253, and the pin driver 254 of the first planetary gear set 252.

[0281] The second force / rotation transmission / conversion assembly 250 and the outer flexible belt assembly 255 are also configured to receive the third force / rotation transmission / conversion assembly 260 therethrough. Specifically, as described below, the inner flexible belt assembly 265 is slidably disposed within and through the outer flexible belt assembly 255.

[0282] The first rotatable distal drive shaft 282 of the first force / rotation transmission / conversion assembly 240 is rotatably mounted within the support base 255d of the outer flexible belt assembly 255, while the cannula needle component 274 of the cannula needle assembly 270 of the first force / rotation transmission / conversion assembly 240 is slidably mounted within the support base 255d of the outer flexible belt assembly 255.

[0283] The outer flexible belt assembly 255 is also configured to receive the inner flexible belt assembly 265 therethrough.

[0284] During operation, when the second rotatable proximal drive shaft 214 rotates due to the rotation of the second connector sleeve 220, the rotation of the second connecting shaft 64c of the handle assembly 100 causes the first connecting shaft 251 to rotate, which in turn causes the first hollow sun gear 252a to rotate. The rotation of the first hollow sun gear 252a causes the first set of planetary gears 252b to rotate simultaneously, which in turn causes the washer 252f to cause the second hollow sun gear 252e to rotate simultaneously. The rotation of the second hollow sun gear 252e causes the second set of planetary gears 252d to rotate simultaneously, which in turn causes the pin guide screw 253 to rotate simultaneously. When the pin guide screw 253 rotates, it causes the pin driver 254 to translate axially, which in turn causes the outer flexible belt assembly 255 to translate axially. When the external flexible belt assembly 255 translates axially, the support base 255d presses against the driver adapter 432 of the nail driver assembly 430 of the reloading member 400 to advance the driver 434 distally and abut against the anvil assembly 510 to actuate the nail "S" of the reloading member 400. Figure 67 This is used to form the "S" in the underlying tissue.

[0285] See Figures 39-42 In sections 45-51, the third force / rotation transmission / conversion assembly 260 of the adapter assembly 200 includes a third proximal drive shaft 216, a second connecting shaft 261, a planetary gear set 262, a tool guide screw 263, and a tool driver 264, each of which is supported within the inner housing component 204, the drive connection assembly 210, and / or the outer conduit 206 of the adapter assembly 200. The third force / rotation transmission / conversion assembly 260 is used to actuate the tool of the reloading member 400.

[0286] The third rotatable proximal drive shaft 216 includes a non-circular or molded proximal portion configured for connection with a third connector or coupling 222 connected to a corresponding third connecting shaft 64b of the handle assembly 100. The third rotatable proximal drive shaft 216 further includes a distal portion 216b having a spur gear non-rotatably connected thereto.

[0287] The second connecting shaft 261 of the third force / rotation transmission / conversion assembly 260 includes a proximal portion 261a having a spur gear non-rotatably connected thereto, and a distal portion 261b having a spur gear non-rotatably connected thereto. The spur gear at the proximal portion 261a of the second connecting shaft 261 meshes with a spur gear at the distal portion 216b of the third rotatable proximal drive shaft 216.

[0288] The planetary gear set 262 of the third force / rotation transmission / conversion assembly 260 includes a first hollow sun gear 262a, a first set of planetary gears 262b, a ring gear 262c, a second set of planetary gears 262d, and a second hollow sun gear 262e. The first sun gear 262a is non-rotatably supported on the distal portion of a hollow shaft 269. The hollow shaft 269 includes a spur gear 269a non-rotatably supported on its proximal end. The spur gear 269a of the hollow shaft 269 meshes with a spur gear at the distal portion 261b of a second connecting shaft 261. The first set of planetary gears 262b is inserted between and meshes with the first sun gear 262a and the ring gear 262c. The second set of planetary gears 262d is inserted between and meshes with the second sun gear 262e and the ring gear 262c. The ring gear 262c is non-rotatably supported in the external conduit 206 of the adapter assembly 200.

[0289] The planetary gear set 262 of the third force / rotation transmission / conversion assembly 260 includes a washer 262f, which is disposed within the ring gear 262c and between the first set of planetary gears 262b and the second set of planetary gears 262d. The first set of planetary gears 262b is rotatably supported radially around the washer 262f, and the second sun gear 262e is non-rotatably connected to the center of the washer 262f.

[0290] The second force / rotation transmission / conversion assembly 260 includes a guide screw 263 comprising a proximal flange 263a and a distal threaded portion 263b extending from the flange 263a. The guide screw 263 defines a cavity 263c therethrough. A second set of planetary gears 262d is radially rotatably supported around the proximal flange 263a of the guide screw 263.

[0291] The tool driver 264 of the second force / rotation transmission / conversion assembly 260 includes a central threaded cavity 264a extending therethrough, and the central threaded cavity is configured and sized to support the distal threaded portion 263b of the tool guide screw 263 therein. The tool driver 264 includes a pair of protrusions 264b projecting radially from its outer surface, and the protrusions are configured for connection to the internal flexible band assembly 265 of the adapter assembly 200, as will be described in more detail below.

[0292] Now see Figures 39-42 The third force / rotation transmission / conversion assembly 260 of the adapter assembly 200 includes an internal flexible band assembly 265 fastened to the knife driver 264. The internal flexible band assembly 265 includes first and second flexible bands 265a and 265b, which are laterally spaced and connected at their proximal ends to a support ring 265c and at their distal ends to a proximal end of a support base 265d. Each of the first and second flexible bands 265a and 265b is attached to both the support ring 265c and the support base 265d. The internal flexible band assembly 265 is configured to receive, via it, a first rotatable proximal drive shaft 212, a first rotatable distal drive shaft 282, and a cannula assembly 270 of the first force / rotation transmission / conversion assembly 240.

[0293] The internal flexible band assembly 265 further includes first and second connecting extensions 265e and 265f extending proximally from the support ring 265c. The first and second connecting extensions 265e and 265f are configured to operatively connect the internal flexible band assembly 265 to the blade driver 264 of the third force / rotation transmission / conversion assembly 260. Specifically, each of the first and second connecting extensions 265e and 265f is defined to receive an opening of a corresponding protrusion 264b of the blade driver 264. The protrusion 264b of the blade driver 264, received within the openings of the corresponding first and second connecting extensions 265e and 265f, secures the internal flexible band assembly 265 to the blade driver 264 of the third force / rotation transmission / conversion assembly 260.

[0294] The support base 265d extends distally from the flexible strips 265a and 265b and is configured to connect with the blade carrier 442 of the blade assembly 440 of the reloading member 400.

[0295] The flexible belts 265a and 265b are made of semi-hard stainless steel 301 and are configured to transmit axial driving force along a bending path.

[0296] The third force / rotation transmission / conversion assembly 260 and the internal flexible belt assembly 265 are configured to receive, through them, the first rotatable proximal drive shaft 212, the first rotatable distal drive shaft 282, and the cannula assembly 270 of the first force / rotation transmission / conversion assembly 240. Specifically, the first rotatable proximal drive shaft 212 is rotatably disposed within and passes through the hollow shaft 269, the first hollow sun gear 262a of the first planetary gear set 262, the second hollow sun gear 262e of the planetary gear set 262, the tool guide screw 263, and the tool driver 264.

[0297] The first rotatable distal drive shaft 282 of the first force / rotation transmission / conversion assembly 240 is also rotatably mounted within the support base 265d of the inner flexible belt assembly 265, while the cannula needle component 274 of the cannula needle assembly 270 of the first force / rotation transmission / conversion assembly 240 is slidably mounted within the support base 265d of the inner flexible belt assembly 265.

[0298] During operation, when the third rotatable proximal drive shaft 216 rotates due to the rotation of the third connector sleeve 222, the rotation of the third connecting shaft 64b of the handle assembly 100 causes the second connecting shaft 261 to rotate, which in turn causes the hollow shaft 269 to rotate. The rotation of the hollow shaft 269 causes the first set of planetary gears 262b to rotate simultaneously, which in turn causes the washer 262f to rotate the second hollow sun gear 262e. The rotation of the second hollow sun gear 262e causes the second set of planetary gears 262d to rotate simultaneously, which in turn causes the tool guide screw 263 to rotate. When the tool guide screw 263 rotates, it causes the tool driver 264 to translate axially, which in turn causes the internal flexible belt assembly 265 to translate axially. When the internal flexible band assembly 265 is axially translated, the support base 265d presses against the blade carrier 442 of the reloading member 400 to push the blade carrier 442 distally and abuts against the anvil assembly 510 to activate the annular blade 444 of the reloading member 400 for cutting tissue held in the reloading member 400.

[0299] Now refer to Figure 21-24 The adapter assembly 200 includes an outer conduit 206 extending from the knob housing 202. As mentioned above, the outer conduit 206 is configured to support the first, second, and third force / rotation transmission / conversion assemblies 240, 250, and 260, respectively. The adapter assembly 200 further includes a frame assembly 230 supported within the outer conduit 206. The frame assembly 230 is configured to support and guide the flexible strips 255a and 255b of the outer flexible strip assembly 255 and the flexible strips 265a and 265b of the inner flexible strip assembly 265 as the flexible strips 255a, 255b are axially translated through the outer conduit 206.

[0300] The frame assembly 230 includes first and second proximal spacers 232a, 232b and first and second distal spacers 234a, 234b. When fastened together, the first and second proximal spacers 232a, 232b define a pair of internal longitudinal slots 234c for slidably receiving the first and second flexible bands 265a, 265b of the inner flexible band assembly 265, and a pair of external longitudinal slots 234d for slidably receiving the first and second flexible bands 255a, 255b of the outer flexible band assembly 255. The first and second proximal spacers 232a, 232b further define longitudinal passages therethrough for receiving the first force / rotation transmission / conversion assembly 240 and the cannula assembly 270.

[0301] The first and second distal spacers 234a and 234b define a pair of internal slots 234c for slidably receiving the first and second flexible strips 265a and 265b of the internal flexible strip assembly 265, and a pair of external slots 234d for slidably receiving the first and second flexible strips 255a and 255b of the external flexible strip assembly 255. The first and second distal spacers 234a and 234b further define longitudinal passages therethrough for receiving the first force / rotation transmission / conversion assembly 240 and the cannula assembly 270.

[0302] The first and second proximal spacers 232a, 232b and the first and second distal spacers 234a, 234b are made of plastic to reduce friction with the flexible strips 255a, 255b of the outer flexible strip assembly 255 and the flexible strips 265a, 265b of the inner flexible strip assembly 265.

[0303] Now see Figure 44-50 The frame assembly 230 further includes a sealing member 235. The sealing member 235 seals the outer conduit 206, the corresponding inner and outer flexible strip assemblies 255 and 265 (inner and outer flexible strips 255a, 255b and 265a, 265b), the cannula assembly 270, and the wiring extending therethrough. In this manner, the sealing member 235 operates to provide a fluid-impermeable seal between the distal and proximal ends of the outer conduit 206.

[0304] The adapter assembly 200 further includes a connector sleeve 290 fixedly supported at the distal end of the external conduit 206. The connector sleeve 290 is configured to selectively fasten the fastening reload member 400 to the adapter assembly 200, as will be described in more detail below. The connector sleeve 290 is also configured to be positioned around the distal ends of the external and internal flexible assemblies 255, 265 and the cannula assembly 270. Specifically, the proximal end of the connector sleeve 290 is received within and securely attached to the distal end of the external conduit 206 and configured to engage the strain gauge assembly 320 of the adapter assembly 200, and the distal end of the connector sleeve 290 is configured to selectively engage the proximal end of the reload member 400.

[0305] Now see Figures 52-55 60 and 69, adapter assembly 200 includes an electrical assembly 310 disposed therein and configured for electrical connection with and between the handle assembly 100 and the reloading unit 400. Electrical assembly 310 allows calibration and communication information (e.g., identification information, life cycle information, system information, force information) to reach the main controller circuit board 142b of the power supply core assembly 106 via the electrical socket 149 of the power supply core assembly 106 of the handle assembly 100.

[0306] Electrical assembly 310 includes a proximal pin connector assembly 312, a proximal wire harness assembly 314 in the form of a ribbon cable, a distal wire harness assembly 316 in the form of a ribbon cable, a strain gauge assembly 320, and a distal electrical connector 322.

[0307] The proximal pin connector assembly 312 of the electrical assembly 310 is supported within the inner housing component 204 of the knob housing 202 and the drive coupling assembly 210. The proximal pin connector assembly 312 includes a plurality of electrical contact blades 312a supported on a circuit board 312b, which provide electrical connection to a through connector 66 of the plate assembly 60 of the outer housing 10 of the handle assembly 100. A proximal wiring harness assembly 314 is electrically connected to the circuit board 312b of the proximal pin connector assembly 312. Figure 53 and 54 ).

[0308] The strain gauge assembly 320 is electrically connected to the proximal pin connector assembly 312 via proximal and distal wiring harness assemblies 314, 316. The strain gauge assembly 320 includes a strain sensor 320a supported within an external conduit 206 of the adapter assembly 200. The strain sensor 320a is electrically connected to the distal wiring harness assembly 316 via a sensor flexible cable 320b. The strain sensor 320a defines a lumen therethrough through which a cannula assembly 270 extends.

[0309] like Figures 29-33 As described, the cannula assembly 270 of the first force / rotation transmission / conversion assembly 240 extends through the strain sensor 320a of the strain gauge assembly 320. The strain gauge assembly 320 provides closed-loop feedback to the actuation / clamping loads represented by the first, second, and third force / rotation transmission / conversion assemblies 240, 250, and 260, respectively.

[0310] The strain sensor 320a of the strain gauge assembly 320 is supported in the external conduit 206 and inserted between the connector sleeve 290 and the support block 292. The support block 292 includes a raised flange 292b extending distally therefrom and contacting the strain sensor 320a (see [link to documentation]). Figure 29 ).

[0311] Now see Figures 53-55 As mentioned above, electrical assembly 310 includes a distal electrical connector 322 supported in connector sleeve 290. The distal electrical connector 322 is configured to selectively mechanically and electrically connect to chip assembly 460 of reload 400 when reload 400 is connected to adapter assembly 200.

[0312] The distal electrical connector 322 includes a plug portion 322a, first and second conductors 323a and 323b, and first and second contact portions 324a and 324b electrically connected to the respective first and second conductors 323a and 323b. The plug portion 322a includes a pair of arms 322b and 322c that respectively support the first and second contact portions 324a and 324b. The arms 322b and 322c are sized and dimensioned to be received within a cavity 461a of the chip assembly 460 and around the circuit board assembly 464 of the reload 400 when the reload 400 is connected to the adapter assembly 200.

[0313] The first and second contact portions 324a, 324b of the remote electrical connector 322 are configured to engage the corresponding contact portion 464b of the circuit board assembly 464 of the chip assembly 460 of the reload 400 when the reload 400 is connected to the adapter assembly 200.

[0314] Now see Figures 57-65 The adapter assembly 200 includes a rotating assembly 330 configured to allow rotation of the adapter assembly 200 relative to the handle assembly 100. Specifically, the outer knob housing 202 and the outer conduit 206 of the adapter assembly 200 are rotatable relative to the drive coupling assembly 210 of the adapter assembly 200.

[0315] The rotary assembly 330 includes a locking button 332 operably supported on the outer knob housing 202. As will be described in further detail below, when the rotary assembly 330 is in the unlocked configuration, the outer knob housing 202 and the outer conduit 206 are rotatable relative to the drive coupling assembly 210 along the longitudinal axis of the adapter assembly 200. When the rotary assembly 330 is in the locked configuration, the outer knob housing 202 and the outer conduit 206 are rotated securely relative to the drive coupling assembly 210. Specifically, in the case where the outer conduit 206 has a curved profile, rotation of the outer knob housing 202 and the outer conduit 206 about the longitudinal axis of the adapter assembly 200 causes the handle assembly 100 to be positioned in various orientations relative to the adapter assembly 200, providing clinicians with increased flexibility in manipulating surgical instruments at the target surgical site.

[0316] The locking button 332 of the rotary assembly 330 is configured to operatively engage the inner housing component 204 of the adapter assembly 200. The inner housing component 204 is a generally cylindrical component defining a pair of longitudinal openings therethrough for receiving at least portions of the first and second force / rotation transmission / conversion assemblies 240, 250. The inner housing component 204 includes proximal and distal annular flanges 204a, 204b and further defines proximal and distal external annular recesses. The proximal annular recess of the inner housing component 204 receives the internal annular flange of the outer knob housing 202 to rotatably secure the outer knob housing 202 to the inner housing component 204.

[0317] Still referencing Figures 57-65 The distal annular flange 204b and distal annular groove of the inner housing component 204 engage with the rotary assembly 330 of the adapter assembly 200 to secure the outer knob housing 202 to a fixed rotational orientation relative to the inner housing component 204. Specifically, the distal annular flange 204b of the inner housing component 204 defines first, second, and third radial cutouts 204c, 204d, and 204e of the locking shoe 334 of the locking button 332 of the rotary assembly 330. The first and third cutouts 204c and 204e are opposite to each other, and the second cutout 204d is oriented perpendicular to the first and third cutouts 204c and 204e.

[0318] See Figures 60-61The outer knob housing 202 has a truncated conical profile and includes a plurality of ridges configured for operably engaging by a clinician. The outer knob housing 202 defines a radial opening for operably supporting a lock button 332. The opening in the outer knob housing 202 is positioned to align or be aligned with a distal annular groove of the inner housing component 204 such that the lock button 332 of the rotary assembly 330 can be received in the distal annular groove and selectively received within each of the first, second, and third cutouts 204c, 204d, and 204e in the distal annular flange 204b of the inner housing component 204.

[0319] As mentioned above, the rotating assembly 330 of the adapter assembly 200 includes a locking button 332 operably supported in an opening in the outer knob housing 202 and configured to actuate the rotating assembly 330. The rotating assembly 330 further includes a locking shoe 334 disposed between the outer knob housing 202 and the inner housing component 204 and axially slidable relative to the locking button 332 and the inner housing component 204. A biasing member 336 is inserted between the locking button 332 and the locking shoe 334 to push the locking button 332 to a locked position, wherein the locking shoe 334 is disposed within one of the first, second, and third cutouts 204c, 204d, and 204e in the distal annular flange 204b of the inner housing component 204.

[0320] The locking button 332 is configured for operable engagement by a clinician. The locking button component 332 defines an angled cam slot 332a formed therein for receiving a cam pin or boss 334a of the locking shoe 334. A biasing component 336 biases the locking button 332 and the locking shoe 334 away from each other and pushes the locking shoe 334 into contact with the distal annular flange 204b of the inner housing component 204, and when the locking shoe 334 is aligned with one of the first, second, and third cutouts 204c, 204d, and 204e in the distal annular flange 204b, it enters one of the first, second, and third cutouts 204c, 204d, and 204e in the distal annular flange 204b.

[0321] As mentioned above, the locking shoe 334 is configured to be selectively received within one of the first, second, and third radial cutouts 204c, 204d, and 204e in the distal annular flange 204b of the inner housing component 204. Specifically, the locking shoe 334 includes or defines a shoulder 334a projecting from its surface for reception within one of the first, second, and third radial cutouts 204c, 204d, and 204e in the distal annular flange 204b when the shoulder 334a is aligned with one of the first, second, and third radial cutouts 204c, 204d, and 204e in the distal annular flange 204b and the locking button 332 is not pressed. When the shoulder 334a of the lock boot 334 leaves any of the first, second, and third radial cutouts 204c, 204d, and 204e in the distal annular flange 204b (e.g., the rotary assembly 330 is in the unlocked condition), the outer knob housing 202 rotates freely relative to the inner housing component 204, and thus the adapter assembly 200 rotates freely relative to the handle assembly 100.

[0322] We will continue to refer to Figures 57-65 Describe the operation of the rotating assembly 330. First, refer to... Figure 58 , 59 61 and 64, the rotating assembly 330 is shown in the locked condition. Specifically, in the locked condition, the shoulder 334a of the locking shoe 334 is received within a first cutout 204c in the distal annular flange 204a of the inner housing component 204. Furthermore, in the locked condition, the locking button 332 of the rotating mechanism 330 is radially outwardly biased by the biasing member 336.

[0323] When the lock button 332 of the rotating assembly 330 is pressed, as Figure 64 As indicated by arrow "A", the lock button 332 moves radially inward against the biasing member 336. During this radial inward movement, the locking shoe 334 slides axially against the biasing member 336 in the distal direction. This axial sliding of the locking shoe 334 causes its shoulder 334a to move from the first radial cutout 204c of the distal annular flange 204b of the inner housing member 204, thus placing the rotary assembly 330 in the unlocked condition and allowing the outer knob housing 202 to rotate freely relative to the inner housing member 204. Figure 62 The middle part is indicated by the arrow "B".

[0324] Now refer to Figure 65Once the rotary assembly 330 is in the unlocked condition, the outer knob housing 202 can rotate relative to the inner housing component 204. Release of the lock button 332 allows the biasing component 336 to bias the lock button 332 to its initial position. Similarly, the biasing component 336 biases the locking shoe 334 to its initial position. When the locking shoe 334 is realigned with one of the first, second, and third radial cutouts 204c, 204d, and 204e of the distal annular flange 204b of the inner housing component 204, the shoulder 334a of the locking shoe 334 is freely received within the corresponding first, second, and third cutouts 204c, 204d, and 204e due to the rotation of the outer knob housing 202 relative to the inner housing component 204, and causes the outer knob housing 202 to rotate and lock relative to the inner housing component 204 of the adapter assembly 200 and the drive coupling assembly 210.

[0325] The rotating assembly 330 can be used throughout the surgical procedure to rotate the handle assembly 100 and the adapter assembly 200 relative to each other.

[0326] During rotation of the outer knob housing 202 relative to the inner housing component 204 of the adapter assembly 200 and the drive coupling assembly 210, the proximal drive shafts 212, 214, and 216 are supported in the drive coupling assembly 210, and the first connecting shaft 251 of the second force / rotation transmission / conversion assembly 250, the second connecting shaft 261 of the third force / rotation transmission / conversion assembly 260, and the second rotatable proximal drive shaft 281 of the first force / rotation transmission / conversion assembly 240 are supported in the inner housing component 204. Therefore, the angular orientations of the proximal drive shaft 212 relative to the second rotatable proximal drive shaft 281, the proximal drive shaft 216 relative to the second connecting shaft 261, and the proximal drive shaft 214 relative to the first connecting shaft 251 change relative to each other.

[0327] like Figures 57-59 As seen, the adapter assembly 200 further includes an attachment / disengagement button 342 supported thereon. Specifically, the button 342 is supported on the drive coupling assembly 210 of the adapter assembly 200 and biased to an unactuated condition by the biasing member 344. The button 342 includes a lip or protrusion 342a formed therewith, which is configured to latch onto a corresponding lip or protrusion 20a defined along the recess 20 of the connection portion 108 of the handle housing 102 of the handle assembly 100. Figure 18Behind the handle assembly 100. In use, when the adapter assembly 200 is connected to the handle assembly 100, the lip 342a of the button 342 is positioned behind the lip 108b of the connecting portion 108 of the handle housing 102 of the handle assembly 100, so that the adapter assembly 200 and the handle assembly 100 are fastened and held together. To allow the adapter assembly 200 and the handle assembly 100 to disconnect from each other, the button 342 is pressed or actuated against the biasing member 344, so that the lip 342a of the button 342 disengages from the lip 108b of the connecting portion 108 of the handle housing 102 of the handle assembly 100.

[0328] like Figure 1 and 66 As described in -80, the reloading member 400 is configured to be operably connected to the adapter assembly 200 and configured to activate and form a ring array of surgical staples and a ring that cuts through tissue.

[0329] The reloading unit 400 includes a shipping cap assembly (not shown) that is selectively received on the distal end 402 of the reloading unit 400 and can be used to facilitate insertion of the reloading unit 400 into the target surgical site and maintain the staples "S" within the staple cartridge 420 of the reloading unit 400. Figure 67 The shipping cover assembly 401 is also used to prevent the nail driver assembly 430 of the reload 400 from attaching to the adapter assembly 200 before and during attachment. Figure 66 ) and the knife assembly 440 of the reloading component 400 ( Figure 66 (Premature advancement)

[0330] Now see Figure 66-72 The reloading unit 400 includes a housing 410 having a proximal portion 410a and a distal portion 410b, a staple cartridge 420 fixedly fastened to the distal portion 410b of the housing 410, a staple driver assembly 430 operably received within the housing 410, a blade assembly 440 operably received within the housing 410, a bushing member 450 received within the proximal portion 410a of the housing 410, and a chip assembly 460 mounted around the bushing member 450.

[0331] The housing 410 of the reloading member 400 includes an outer cylindrical portion 412 and an inner cylindrical portion 414. Multiple ribs (not shown) interconnect the outer and inner cylindrical portions 412 and 414. The outer cylindrical portion 412 and the inner cylindrical portion 414 of the reloading member 400 are coaxial and define a recess 412a therebetween. Figure 67 The recess is configured to operably receive the nail driver assembly 430 and the knife assembly 440. The inner cylindrical portion 412 of the reloading member 400 includes a plurality of longitudinally extending ridges 416 projecting from its inner surface. Figure 67 The ridge is configured for radial alignment (e.g., timing) of the anvil assembly 510 and the reloading member 400 during the fastening process. As will be described in further detail below, the proximal end 416a of the longitudinal ridge 416 is configured to facilitate selective fastening of the shipping cover assembly 401 and the reloading member 400. Annular ridge 418 ( Figure 67 It is formed on the outer surface of the inner cylindrical portion 412 and is configured to help hold the tool assembly 440 in the retracted position.

[0332] The staple cartridge 420 of the reloading component 400 is securely fastened to the distal end 410b of the housing 410 and includes a plurality of staple recesses 421 formed therein, the staple recesses being configured to selectively retain staples “S”.

[0333] Continue to refer to Figure 66-72 The nail driver assembly 430 of the reloading unit 400 includes a driver adapter 432 and a driver 434. The proximal end 432a of the driver adapter 432 is configured to selectively contact and abut against the support base 255d of the outer flexible band assembly 255 of the second force / rotation transmission / conversion assembly 250 of the adapter assembly 200. In operation, during distal advance of the outer flexible band assembly 255, as described above, the support base 255d of the outer flexible band assembly 255 contacts the proximal end 432a of the driver adapter 432 to advance the driver adapter 432 and the driver 434 from a first or proximal position to a second or distal position. The driver 434 includes a plurality of driver components 436 aligned with the nail recess 421 of the nail cartridge 420 for contact with the nail "S". Therefore, advance of the driver 434 relative to the nail cartridge 420 causes the ejection of the nail "S" from the nail cartridge 420.

[0334] See also Figure 66-72 The blade assembly 440 of the reloading unit 400 includes a blade carrier 442 and a circular blade 444 fastened around the distal end 442b of the blade carrier 442. The proximal end 442a of the blade carrier 442 is configured for operable connection with the support base 265d of the inner flexible band assembly 265 of the third force / rotation transmission / conversion assembly 260 of the adapter assembly 200. In operation, during distal advance of the inner flexible band assembly 265, as described above, the support base 265d of the inner flexible band assembly 265 connects with the proximal end 442a of the blade carrier 442 to advance the blade carrier 442 and the circular blade 444 from a first or proximal position to a second or advanced position to cause cutting of tissue disposed between the staple cartridge 420 and the anvil assembly 510.

[0335] The distal end 452b of the bushing component 450 is secured to the proximal end 414a of the inner cylindrical portion 414 of the housing 410 by a plurality of ridges 452c formed on the distal end 452b of the bushing component 450.

[0336] The chip assembly 460 includes a housing 461 from which an annular flange 462 extends. The annular flange 462 extends perpendicular to the longitudinal axis of the housing 461. The annular flange 462 is configured to be received around the distal end 452b of the bushing member 450.

[0337] Chip assembly 460 includes a circuit board assembly 464 secured within a cavity 461a of housing 461. Circuit board assembly 464 includes a circuit board 464a, a pair of contact members 464b, and a chip 464c. A first end of circuit board 464a supports chip 464c, and a second end of circuit board 464a supports the first and second contact members 464b. Chip 464c is a writable / erasable memory chip. Chip 464c contains stored information including: lot number, pin size, lumen size, firing count, manufacturing stroke offset, excess force index, shipment cover assembly presence, and demonstration mode. Chip 464c includes write capability, allowing handle assembly 100 to encode chip 464c for use with reload 400 to prevent reuse of empty, used, or fired reloads.

[0338] The proximal end 410a of the housing 410 is configured for selective connection to the connector sleeve 290 of the adapter assembly 200. Specifically, the outer cylindrical portion 412 of the housing 410 terminates in a proximal cylindrical flange 412a, the inner diameter of which is larger than the diameter of the distal portion 290a of the connector sleeve 290 of the adapter assembly 200. Furthermore, the outer diameter of the proximal end 432a of the driver adapter 432 is smaller than the diameter of the distal portion 290a of the connector sleeve 290.

[0339] The reloading member 400 includes a compressible release ring 413 supported on a flange 412a of the outer cylindrical portion 412 of the housing 410. The release ring 413 has a generally oval profile, including a relative major axis and a relative minor axis. In operation, when a radially inward force acts along the major axis of the release ring 413 (as by…), Figure 70 (As indicated by arrow "A1"), the release ring 413 flexes radially outward along its minor axis (as indicated by...). Figure 70 (The arrow "A2" indicates this).

[0340] The release ring 413 includes a ramp feature 413a that projects radially inward and is positioned generally along the short axis of the release ring 413. The ramp feature 413a of the release ring 413 extends through a window 412b in a flange 412a defined in the outer cylindrical portion 412 of the housing 410. The ramp feature 413a of the release ring 413 projects radially inward sufficiently to be selectively received in a window 290b defined in the distal portion 290a of the connector sleeve 290.

[0341] The reloading member 400 includes an outer cylindrical portion 412 connected to the housing 410 and a retaining ring 415 configured to help retain the release ring 413 on the outer cylindrical portion 412 of the housing 410.

[0342] For radial alignment and timing of the reloading member 400 and the adapter assembly 200, the reloading member 400 includes longitudinally extending ribs 412c that project radially inward from the outer cylindrical portion 412 of the housing 410, the ribs being configured for slidably receiving in a longitudinally extending slot 290c defined in the distal portion 290a of the connector sleeve 290.

[0343] To connect the reloading member 400 to the adapter assembly 200, the ribs 412c of the reloading member 400 are radially aligned with the longitudinally extending slots 290c of the connector sleeve 290 of the adapter assembly 200. The reloading member 400 and the adapter assembly 200 then approach each other axially until the distal portion 290a of the connector sleeve 290 is received within the flange 412a of the outer cylindrical portion 412 of the housing 410 and until the ramp feature 413a of the release ring 413 is received in the window 290b of the connector sleeve 290. The reloading member 400 and the adapter assembly 200 are thus locked together.

[0344] When the reload 400 is connected to the adapter assembly 200, the distal electrical connector 322 of the adapter assembly 200 is mechanically and electrically connected to the chip assembly 460 of the reload 400.

[0345] In order to disconnect the reload 400 and the adapter assembly 200 from each other, the release ring 413 is pressed along its long axis (in the direction of arrow "A1") to remove the ramp feature 413a of the release ring 413 from the window 290b of the connector sleeve 290, and thus allow the reload 400 and the adapter assembly 200 to be axially separated from each other.

[0346] Now for reference Figures 71-75 It provides an anvil assembly 510 and is configured for selective connection to the cannula needle component 274 of the adapter assembly 200 and for cooperation with the reloading component 400.

[0347] The anvil assembly 510 includes a head assembly 512 and a center rod assembly 514. The head assembly 512 includes a post 516, a housing 518, a cutting ring 522, a cutting ring cover 523, an anvil plate 524, a spacer or washer 525, a cam latching component 526, and a retainer component 527. The post 516 is centrally positioned within the housing 518.

[0348] Still referencing Figures 73-75 The anvil plate 524 is supported in the outer annular recess 528 of the housing 518 and includes a plurality of nail recesses 530 formed therein and configured to receive and form nails.

[0349] The cutting ring 522 includes a post 516 within an inner annular recess surrounding the housing 518, with a central opening positioned between the post 516 and the outer annular recess 528. The cutting ring 522 is formed of polyethylene. A cutting ring cap 523 is fastened to the outward-facing or proximal surface of the cutting ring 522.

[0350] A retainer component 527 is positioned within an inner annular recess between the cutting ring 522 and the rear wall of the housing 518. The retainer component 527 is annular and includes a plurality of deformable protrusions that engage the rear surface of the cutting ring 522. The retainer component 527 prevents the cutting ring 522 from moving or being pushed into the inner annular recess of the housing 518 until a predetermined force sufficient to deform the protrusions is applied to the cutting ring 522. When the predetermined force is reached, for example, during tissue cutting, the cutting ring 522 is pushed into the inner annular recess 536 and compresses the retainer component.

[0351] Return to Figure 75 The anvil center rod assembly 514 includes a center rod 552, a plunger 554, and a plunger spring 556. The first end of the center rod 552 includes a pair of arms 159 defining a cavity 159a. A pivot member 562 is provided to pivotally secure the post 516 to the center rod 552, such that the anvil head assembly 512 is pivotally mounted to the anvil center rod assembly 514.

[0352] The cam latching member 526 is pivotally mounted within a transverse slot of the post 516 of the housing 518 and around the pivot member 562. The cam latching member 526 has an external cam profile that allows the plunger 554 to move forward when the cam latching member 526 rotates clockwise and allows the plunger 554 to retract when the cam latching member rotates counterclockwise.

[0353] A plunger 554 is slidably positioned in a cavity formed in a first end of a center rod 552. The plunger 554 includes engaging fingers offset from the pivot axis of the anvil head assembly 512 and biased to engage an edge of the cam latch 526. The engagement of the plunger 554 fingers with the edge of the cam latch 526 abuts against the inner periphery of the cutting ring 522, pressing a leading portion of the edge of the cam latch 526 to push the anvil head assembly 512 to an operable or non-tilted position on the center rod 552.

[0354] The anvil head assembly 512 can tilt relative to the anvil center rod assembly 514 in a pre-start tilt position. This tilting of the anvil head assembly 512 relative to the anvil center rod assembly 514 causes the main body of the cam latch member 526 to engage the fingers 166 of the plunger 554. As the cam latch member 526 rotates with the tilt of the anvil head assembly 512, the plunger 554 retracts via the orifice in the anvil center rod assembly 514, thereby compressing the spring 556. In this way, the fingers 566 of the plunger 554 are offset distally against the main body of the cam latch member 526.

[0355] See Figures 74-75 The second end of the center rod 552 includes an aperture 580 defined by a plurality of flexible arms 582. The proximal end of each of the flexible arms 582 includes an inner shoulder sized to releasably engage the shoulder of the cannula 274 of the cannula assembly 270 of the adapter assembly 200 to secure the anvil assembly 510 to the adapter assembly 200. A plurality of racks 586 are formed around the center rod 552. The racks 586 are used to align and / or time the anvil assembly 510 with the staple cartridge 420 of the reloading member 400.

[0356] Now see Figure 76-81 The reloading unit 400 is configured to selectively and optionally connect to an external flushing source via a flushing tube 590. The flushing tube 590 is configured to deliver air or saline solution to the anastomosis site for leakage testing, for improved insertion, or for flushing the rectal stump.

[0357] The flushing tube 590 has a proximal Luer fitting 591 at its proximal end 590a, configured to connect to a syringe (not shown), and a distal fitting 592 at its distal end 590b, configured to selectively snap-fit ​​into a port 410c of the housing 410 of the reloading member 400. The distal fitting 592 includes a pair of resilient fingers 592a configured to engage a corresponding shoulder 410d defined in the port 410c of the housing 410.

[0358] See Figure 89A schematic diagram of the power handle 101, the circular adapter assembly 200, and the reloading unit 400 is shown. For simplicity, only one of the motors 152, 154, and 156 is shown, namely motor 152. Motor 152 is connected to battery 144. In embodiments, motor 152 can be connected to any suitable power source configured to provide electrical power to motor 152, such as an AC / DC transformer.

[0359] Battery 144 and motor 152 are connected to a motor controller circuit board 142a with a motor controller 143, which controls the operation of motor 152, including the flow of electrical energy from battery 144 to motor 152. Main controller circuit board 142b ( Figure 12 and 13 The system includes a main controller 147 that controls the power handle 101. The motor controller 143 includes multiple sensors 408a, 408b, ... 408n configured to measure the operating states of the motor 152 and the battery 144. Sensors 408a-n may include voltage sensors, current sensors, temperature sensors, telemetry sensors, optical sensors, and combinations thereof. Sensors 408a-408n can measure the voltage, current, and other electrical properties of the electrical energy supplied by the battery 144. Sensors 408a-408n can also measure angular velocity (e.g., rotational speed) as revolutions per minute (RPM), torque, temperature, current draw, and other operating properties of the motor 152. Angular velocity can be determined by measuring the rotation of the motor 152 or a drive shaft (not shown) connected to and rotatable by the motor 152. The position of various axially movable drive shafts can also be determined by using various linear sensors disposed in or near the shaft, or by extrapolating the position from RPM measurements. In one embodiment, torque can be calculated based on the regulated current drawn by motor 152 at a constant RPM. In another embodiment, motor controller 143 and / or main controller 147 can measure time and process the aforementioned values ​​that vary over time, including, for example, integration and / or differentiation, to determine the rate of change of the measured values. Main controller 147 is also configured to determine the travel distance of various components of the circular adapter assembly 200 and / or reloading assembly 400 by counting the revolutions of motors 152, 154, and 156.

[0360] Motor controller 143 is coupled to main controller 147, which includes multiple inputs and outputs for interfacing with motor controller 143. Specifically, main controller 147 receives measured sensor signals from motor controller 143 regarding the operating state of motor 152 and battery 144, and outputs control signals to motor controller 143 to control the operation of motor 152 based on sensor readings and specific algorithm instructions, discussed in more detail below. Main controller 147 is also configured to accept multiple user inputs from a user interface (e.g., a switch, button, touchscreen, etc. coupled to main controller 147).

[0361] The main controller 147 is also coupled to a memory 141 disposed on a main controller circuit board 142b. The memory 141 may contain volatile (e.g., RAM) and non-volatile storage devices configured to store data, including software instructions for operating the power handle 101. The main controller 147 is also coupled to the strain gauge 320 of the circular adapter assembly 200 via a wired or wireless connection and is configured to receive strain measurements from the strain gauge 320 used during operation of the power handle 101.

[0362] The reload unit 400 includes a storage device 405 (e.g., chip 464c). The circular adapter assembly 200 also includes a storage device 407. Storage devices 405 and 407 include a non-volatile storage medium (e.g., EEPROM) configured to store any data relating to the reload unit 400 and the circular adapter assembly 200, respectively, including, but not limited to, usage counts, identification information, model number, serial number, pin size, stroke length, maximum power, minimum actuation power, factory calibration data, and similar data. In embodiments, the data may be encrypted and can only be decrypted by a device with an appropriate key (e.g., the main controller 147). The data may also be used by the main controller 147 to verify the circular adapter assembly 200 and / or the reload unit 400. Storage devices 405 and 407 may be configured in read-only or read / write modes, allowing the main controller 147 to read and write data to storage devices 405 and 407.

[0363] The following text is for reference only. Figure 82A -F describes the operation of the handle assembly 100, the circular adapter assembly 200, and the reloading assembly 400, the figure of which shows a flowchart of the operation process. Special Reference Figure 82A The power handle 101 is removed from the charger (not shown) and activated. Upon activation, the power handle 101 immediately performs a self-test, and if the self-test passes, the power handle 101 displays an animation on the display screen 146 illustrating how the power handle 101 should be inserted into the housing 10.

[0364] After the power handle 101 is inserted into the housing 10, the power handle 101 verifies its proper insertion into the housing 10 by establishing communication with an electrical connector 66 having a chip (not shown) disposed therein. The chip within the electrical connector 66 stores a usage counter, which the power handle 101 uses to confirm that the housing 10 has not been previously used. The data stored on the chip (e.g., the usage count) is encrypted and verified by the power handle 101, which then determines whether the usage count stored on the chip exceeds a threshold (e.g., whether the housing 10 has been previously used).

[0365] See Figure 82B After the power handle 101 is enclosed within the housing 10 to form the handle assembly 100, the adapter assembly 200 is attached to the handle assembly 100. Following attachment of the circular adapter assembly 200, the handle assembly 100 initially verifies and confirms its connection by establishing communication with the storage device 407 of the circular adapter assembly 200. Data stored on the storage device 407 (e.g., usage counts) is encrypted and verified by the power handle 101, which then determines whether the usage counts stored on the storage device 407 exceed a threshold (e.g., whether the adapter assembly 200 has been previously used). The power handle 101 then performs inspection checks (e.g., end-of-life checks, missing cannula component 274, etc.) and calibrates the circular adapter assembly 200 after the handle assembly 100 confirms attachment of the cannula component 274.

[0366] After calibrating the circular adapter assembly 200, the unused reload unit 400 with the shipping cover assembly 401 is attached to the circular adapter assembly 200. The handle assembly 100 verifies the attachment of the circular reload unit 400 to the circular adapter assembly 200 by establishing communication with the storage device 405 of the circular reload unit 400. (Reference) Figure 82C The power handle 101 also verifies the storage device 405 and confirms that the circular reload unit 400 has not been previously activated by checking the usage count. After the circular reload unit 400 is used, the handle assembly 100 adjusts and encodes the usage count. If the circular reload unit 400 has been previously used, the handle assembly 100 displays an error indicating this condition on the display screen 146.

[0367] The power handle 101 also performs calibration with respect to the reload unit 400 attached to the circular adapter assembly 200 to determine the starting hard stop position. The main controller 147 calculates the distance traveled by the motors 152, 154, and 156 to determine the hard stop. The main controller 147 also uses the travel distance during calibration to confirm that the reload unit 400 is not used. Therefore, if the travel distance is determined to be higher than a predetermined hard stop threshold, the main controller 147 confirms that the nail was previously ejected from the reload unit 400 and marks the reload unit 400 as used if it was not previously properly marked. Once the anvil assembly 510 is attached, the main controller 147 performs another calibration.

[0368] Continue to refer to Figure 82C After attaching the circular reloading unit 400 and confirming that it is unused and has been verified, the handle assembly 100 immediately prompts the user to spray the shipping cap assembly 401 by prompting the user to press the dual-state switching control button 30. This prompt is displayed as an animation on the display screen 146, featuring a flashing arrow pointing to the dual-state switching control button 30. The user presses the upper portion of the dual-state switching control button 30, which activates the automatic extension (and retraction) of the cannula needle component 274 until the shipping cap assembly 401 is sprayed, at which point the shipping cap spraying process is complete and the handle assembly 100 is now ready for use.

[0369] In this embodiment, the circular adapter assembly 200 also operates with respect to the reloading assembly 400 with a disposable transanal / abdominal inserter. Once the reloading assembly 400 with the inserter is attached, the handle assembly 100 displays a ready screen. This allows the user to more easily insert the circular adapter assembly 200 together with the reloading assembly 400 through the abdominal incision. Thus, when the dual-state switching control button 30 is pressed, a prompt to eject the inserter is displayed, similar to the animation of the ejection loading cap assembly 401. The user presses the upper portion of the dual-state switching control button 30, which activates the automatic extension (and retraction) of the cannula assembly 274 until the inserter is ejected, at which point the inserter ejection process is complete.

[0370] Continue to refer to Figure 82CAfter the transport cap assembly 401 or the introducer is removed, the user begins the surgical procedure, which includes preparing the target tissue area and positioning the circular adapter assembly 200 in the colon, rectum, or upper gastrointestinal region until the cannula component 274 is sufficiently extended to allow tissue puncture. The user presses the dual-state toggle control button 30 to extend the cannula component 274 until it punctures the tissue. An animation illustrating the extension process is displayed on the display screen 146 as the cannula component 274 extends. Additionally, the distance traveled by the cannula component 274 is displayed as a scale, and the direction of movement of the cannula component 274 is indicated by arrows. The cannula component 274 extends until it reaches the maximum extension distance indicated on the display screen 146.

[0371] See Figure 82C -D and 86, which illustrate the flowchart of the clamping process, show that after the extension of the cannula component 274, the anvil assembly 510 (already positioned by the surgeon) is attached to the cannula component 274, and the user initiates the clamping process of the tissue inserted between the circular reloading member 400 and the anvil assembly 510 by pressing the bottom of the dual-state switching control button 30. The clamping process is also displayed as an animation on the display screen 146, but as a reversal of the animation of the extension of the cannula component 274, for example, highlighting arrows indicating the retraction direction.

[0372] During clamping, the anvil assembly 510 retracts toward the circular reloading member 400 until it reaches a fully compressed position, i.e., the position where the anvil assembly 510 is fully compressed between the anvil assembly 510 and the reloading member 400. The full compression distance varies for each of the different types of reloading members (e.g., the distance is approximately 29 mm for a 25 mm reloading member). Simultaneously with clamping, the strain gauge assembly 320 continuously provides measurements of the force imparted to the first rotational transmission assembly 240 as it moves the anvil assembly 510 to the main controller.

[0373] See Figure 83 The diagram schematically illustrates the travel distance and speed of the anvil assembly 510 as it retracts from the first motor 152. The anvil assembly 510 initially retracts from the fully open position marker 600 at a first speed for a first segment from the fully open position marker 600 to the first distance marker 602. Subsequently, the anvil assembly 510 traverses a second distance from the first distance marker 602 to the second distance marker 604 at a second speed slower than the first speed. As the anvil assembly 510 traverses the second segment, the main controller 147 continuously checks whether the measured force is within predefined parameters to determine whether the force measured before reaching the initial compression distance exceeds a high force threshold limit. Figure 83 and 86This measurement is used to detect misalignment between the rack 586 of the cannula assembly 274 and the longitudinally extending ridge 416 of the reloading member 400. If the force exceeds a high-force threshold, the power handle 101 temporarily reverses the rotational transmission assembly 240 to retract the anvil assembly in an attempt to correct the misalignment of the rack 586. The main controller 147 then re-attempts to continue clamping until the third distance marker 604 is reached. If the third distance marker 604 is not reached within a predetermined time period, the main controller 147 then issues an error, including an alarm on the display screen 146 prompting the user to check the anvil assembly 510. After any obstruction has been checked and cleared, the user can then restart the clamping process.

[0374] Once the anvil assembly 510 reaches the third distance marker 604 at the end of the second segment, the power handle 101 performs a rotation check to verify the position of the anvil assembly 510. The main controller then initiates a controlled tissue compression (“CTC”) algorithm, which changes the clamping speed during tissue compression without exceeding the target compression force.

[0375] CTC utilizes a second-order predictive force filter to account for both slowly changing and rapidly changing forces imparted to the tissue during compression. As the predicted force approaches the target force, the clamping speed is reduced to prevent overshoot. When the measured force reaches the target force but the clamping gap has not yet been achieved, clamping is stopped to allow tissue relaxation. During tissue relaxation, CTC restarts after the measured force drops below the target clamping force. The force applied to the tissue is derived by the main controller 147 from strain measurements in the strain gauge assembly 320.

[0376] During CTC, the user continues to press the dual-state switching control button 30 to continue operating the handle assembly 100. The controller initiates CTC at the third distance marker 604, which corresponds to the distance at which the anvil assembly 510 begins to compress the tissue against the nail guide of the circular reloading member 400 during the remainder of the clamping process. During the third segment of CTC, the movement of the anvil assembly 510 from the third distance marker 604 to the fourth distance marker 606, which corresponds to the fully compressed position of the anvil assembly 510. CTC continues until the anvil assembly 510 reaches the fourth distance marker 606. If no force is detected during clamping, the handle assembly 100 identifies the anvil assembly 510 as missing and issues an error.

[0377] CTC operates for a predetermined time period, namely a first time period, and an optional second time period. During the execution of CTC, the main controller monitors the force applied to the first rotary transmission assembly 240 as it moves the anvil assembly 510 based on the strain measured by the strain gauge assembly 320, until the measured force approaches the target clamping force.

[0378] During CTC execution, the main controller 147 determines whether the measured force is close to the target clamping force by calculating a predicted clamping force using a second-order predictive filter. The target clamping force can be any suitable threshold from about 100 pounds to about 200 pounds; in this embodiment, the target clamping force can be approximately 150 pounds. The CTC calculates the predicted clamping force and compares it to the target clamping force. The main controller samples multiple strain gauge values ​​at a predetermined frequency (e.g., every 1 millisecond) during a predetermined sampling time period. The main controller 147 then uses the first plurality of strain gauge samples obtained during the sampling time period to calculate filtered strain gauge values. The main controller 147 stores the plurality of filtered strain gauge values ​​and uses three strain gauge samples to predict the target clamping force. Specifically, the main controller 147 initially calculates a first difference between the first two (e.g., first and second) filtered strain gauge values, which provides a first-order comparison. More specifically, the main controller 147 then calculates a second difference between the subsequent two filtered strain gauge values ​​(e.g., second and third values). In this embodiment, the subsequent filtered strain gauge value can be any other subsequent value, rather than including the second value used to calculate the first difference. The first difference is then divided by the second difference to obtain a percentage of the difference. The main controller determines the target clamping force based on a predicted strain change, calculated by multiplying the first difference by a percentage of the difference and a value representing the future period of strain extrapolation. The predicted strain change is then added to the current filtered strain gauge value to determine a predicted strain value corresponding to the predicted clamping force.

[0379] If the predicted clamping force is higher than the target force, the PWM voltage driving the motor 152 that drives the first rotary transmission assembly 240 is set to zero. The force is continuously monitored, and once the force drops below the target threshold, the speed of the motor 152 is set to an updated speed to continue the clamping process. This process is repeated until the fourth distance marker 606 is reached.

[0380] The target speed is calculated by the main controller 147 based on the strain ratio. The strain ratio is calculated by subtracting the determined strain value from the target clamping force and dividing the difference by the target clamping force. The strain ratio is then used to determine the speed offset by multiplying the difference between the maximum and minimum speeds of the motor 152 by the strain ratio. The speed offset is then added to the minimum speed of the motor 152 to determine the target speed. The target speed is used to control the motor 152 in response to a predetermined deviation of the motor from the currently set speed (e.g., if the motor 152 deviates by approximately 50 rpm). Additionally, for example, if the current speed of the motor 152 is zero after predicting that the clamping force is close to the target force, the motor 152 is set to the newly calculated target speed. This allows for changes in the speed of the motor 152 while maintaining the required force on the tissue during clamping.

[0381] The target clamping force is fixed in the first time cycle. When encountering thick tissue, if the clamping gap cannot be reached within the first time cycle (e.g., reaching the fourth distance marker 606), clamping stops and the operator is notified via the display screen. If the operator chooses to continue clamping, the CTC continues operation in the second time cycle, during which the target clamping force is increased until it reaches its maximum force. During the second cycle, the clamping movement distance is monitored to determine whether the anvil assembly 510 moves in response to the incremental force increase. Subsequently, the clamping distance is periodically monitored for any minimum movement. If no minimum movement is detected, the target force is dynamically increased proportionally based on the difference between the current clamping position and the fourth distance marker 606. If a maximum force higher than the target clamping force is detected, all clamping stops. Additionally, if clamping is not achieved within the second time cycle, the CTC issues an alarm. This may include instructing the user on the display screen 146 to check for obstructions at the clamping site. If no obstructions are found, the user can continue the clamping process. If clamping is not completed, for example, when the second time cycle expires and / or the maximum force limit is reached, another alarm is triggered, instructing the user to check the tissue thickness and restart the clamping process using the larger reload 400.

[0382] See Figure 82C -D and 86, once CTC begins, display screen 146 displays the CTC user interface after the main controller 147 confirms the presence of the anvil assembly 510 based on the detection of minimum force. Specifically, the distance scale on display screen 146 is replaced by a gauge illustrating the force being applied to the tissue, and the cannula is replaced by the anvil and the tissue being compressed. The progress of clamping is also displayed up to the fourth distance marker 606. Thus, as the anvil assembly 510 moves to compress the tissue under CTC, the gauge, anvil animation, and the distance traveled by the anvil assembly 510 are continuously updated to provide real-time feedback on the progress of CTC.

[0383] During CTC, the strain gauge assembly 320 continuously provides measurements of the force applied to the first rotary transmission assembly 510 as the first rotary transmission assembly 240 moves the anvil assembly 510 to the main controller. The force measured by the strain gauge assembly 320 is represented by a gauge on the display screen 146, divided into three zones: zone 1 displays the force from 0% to 50% of the target clamping force, zone 2 displays the force from 51% to 100%, and zone 3 displays the maximum force exceeding the target clamping force. A high-force attention graphic is displayed on the screen for zone 3. Regardless of the high force in zone 3, the user needs to perform a second activation of the dual-state switching to confirm clamping.

[0384] The user can then press the dual-state switching control button 30 to re-clamp, which will move the anvil assembly 510 until the force reaches the maximum force limit in zone 3. This allows for further compression of the tissue in certain situations, such as when the user deems it necessary based on tissue thickness. Once the CTC algorithm is complete and the tissue is compressed, the handle assembly 100 activates an LED and emits an audible tone indicating this status, and continuously displays a CTC screen indicating 100% compression on the display screen 146 until the fastening process begins. A pre-start calibration is performed before the start of the fastening process.

[0385] See Figure 82D and 87A -B, To initiate the fastening process, the user presses one of the safety buttons 36a or 36b on the power handle 101. This button acts as a safety catch and holds the dual-state switching control button 30, allowing fastening to begin. Upon activation of the safety button 36a or 36b, a second rotational calibration check is immediately performed. The display screen 146 transitions to a fastening process display, including a circle illustrating the circular fit, a progress bar, and a fastener icon. The fastening process screen remains displayed until the user initiates, exits, or releases the clamp. At the start of the fastening process, the LED begins flashing and an audio tone is played. The LED continues flashing throughout the entire duration of the fastening and cutting process.

[0386] To initiate the nailing process, the user presses the dual-state switching control button 30, which moves the second rotary transmission assembly 250 to convert rotation into linear motion and eject and form the nail from the circular reloading member 400. Specifically, during the initiation process, the second motor 152 uses the second rotary transmission assembly 250 to propel the driver 434. The force applied to the second rotary transmission assembly 250 is monitored by the strain gauge assembly 320. The process is considered complete once the second rotary transmission assembly 250 reaches a hard stop corresponding to the force threshold and detected by the strain gauge assembly 320. This indicates that the nail has been successfully ejected and deformed against the anvil assembly 510.

[0387] See Figure 84 The diagram schematically illustrates the travel distance and speed of the second motor 154 as it propels the driver 434. The driver 434 initially advances from a first position marker 608 (e.g., a hard stop) at a first speed for a first segment, and from the first distance marker 608 to a second distance marker 610. From the second distance marker 610, the driver 434 advances at a second speed, slower than the first speed, until it reaches a third distance marker 612 to spray nails.

[0388] During the first segment, the second motor 154 propels the driver 434 until the driver 434 contacts the pin to initiate operation. The main controller 147 also writes to the storage devices 405 and 407 of the reload unit 400 and the circular adapter assembly 200. Specifically, the main controller 147 marks the reload unit 400 as "used" in storage device 405 and increments the usage count in storage device 407 of the circular adapter assembly 200.

[0389] After reaching the second distance marker 610, the second motor 154 is operated at a second, slower speed to eject nails from the reloading unit 400. (Reference) Figure 87B During the second segment, as the staple is ejected from the reloading unit 400 to fasten the tissue, the main controller 147 continuously monitors the strain measured by the strain gauge assembly 320 and determines whether the force corresponding to the measured strain is between the minimum and maximum fastening force. The fastening force range can be stored in the storage device 405 of the reloading unit 400 and is used by the main controller 147 during the fastening process. Determining whether the measured force is below the minimum fastening force is used to verify the presence of the staple in the reloading unit 400. Additionally, a low force can also indicate a malfunction of the strain gauge 320. If the measured force is below the minimum fastening force, the main controller 147 signals the second motor 154 to retract the drive 434 to the second distance marker 610. The main controller 147 also displays the process on the display 146, instructing the user to exit the fastening process and retract the anvil assembly 510. After removing the anvil assembly 510, the user can replace the circular adapter assembly 200 and the reloading assembly 400 and restart the fastening process.

[0390] If the measured force exceeds the maximum fastening force of approximately 500 lbs, the main controller 147 stops the second motor 154 and displays the process on the display 146, instructing the user to exit the fastening process. However, the user can still continue the fastening process by pressing the dual-state switching control button 30, thus limiting the detection.

[0391] If the second motor 154 reaches the third distance marker 612 associated with the stapled tissue and the strain measured during this movement is within the minimum and maximum staple force limits, then the main controller 147 determines that the stapled process has been successfully completed. Subsequently, the second motor 154 retracts the drive 434 back to the fourth distance marker 614 to release pressure on the tissue and then retracts back to the second distance marker 610, and then the cutting process begins.

[0392] The main controller 147 is also configured to consider the compression of the outer flexible belt assembly 255 during the fastening process, which can result in a nonlinear relationship between the motor position, as determined by the main controller 147, and the position of the components of the circular adapter assembly 200. The main controller 147 is configured to use a second-order mapping of force changes that cause the difference to resolve the discrepancy between the calculated positions of the motors 152, 154, and 156 and the actual positions of the components of the circular adapter assembly 200. The force changes are based on strain measurements from the strain gauge assembly 320. Specifically, the main controller 147 maintains a count of failed rotations of the motors 152, 154, and 156 based on the force applied to the components of the circular adapter assembly 200, i.e., rotations that do not cause movement of the components of the circular adapter assembly 200, for example, due to compression. The main controller 147 accumulates the total failed rotations whenever the applied force changes by a predetermined amount, for example, about 5 lbs. The motor position is then adjusted based on the total accumulated failed rotation value to determine whether the target position has been reached.

[0393] See Figure 82D The animation illustrates the progress of the staple formation through a matching, initiation progress bar, and staple formation animation. Specifically, the animation illustrates the staple legs penetrating the tissue and then forming concentric staple lines. Once the staple formation is complete, the outer circumference is displayed in green. The staple icon also shows the initially unformed staple, followed by the staple legs curling inward. The progress bar is divided into two segments, the first segment indicating the staple formation process and the second segment indicating the cutting process. Therefore, as the staple formation is in progress, the progress bar continues to fill until it reaches its midpoint.

[0394] See Figure 82E and 88A -B, After the fastening process is completed, the power handle 101 automatically begins the cutting process. During the cutting process, the third motor 154 uses the third rotary transmission assembly 260 to advance the cutter assembly 440. The force applied to the third rotary transmission assembly 260 is monitored by the strain gauge assembly 320. Once the third rotary transmission assembly 260 reaches a hard stop corresponding to the force threshold and detected by the strain gauge assembly 320, or reaches its maximum position, the process is considered complete. This indicates that the cutter assembly 320 has cut through the fastened tissue.

[0395] See Figure 85 The diagram schematically illustrates the travel distance and speed of the third motor 156 as it advances the blade assembly 440. The blade assembly 440 initially advances from the first position marker 616 at a first speed for a first segment, from the first distance marker 616 to the second distance marker 618. From the second distance marker 618, the blade assembly 440 advances at a second speed, slower than the first speed, until it reaches the third distance marker 620 to cut the stapled tissue.

[0396] During the first segment, the third motor 156 advances the blade assembly 440 until it contacts the stapled tissue. After reaching the second distance marker 618, the third motor 154 operates at a second, slower speed to cut the stapled tissue. See also Figure 88A -B, During the second segment, as the blade assembly 440 advances to cut the tissue, the main controller 147 continuously monitors the strain measured by the strain gauge assembly 320 and determines whether the force corresponding to the measured strain is between the target cutting force and the maximum cutting force. The target cutting force and the maximum cutting force can be stored in the storage device 405 of the reloading unit 400 and are used by the main controller 147 during the cutting process. If the target cutting force is not reached during the cutting process, indicating improper cutting, the main controller 147 signals the third motor 156 to retract the blade assembly 440, thereby allowing the user to open the reloading unit 400 and stop the cutting process. The main controller 147 also displays the process on the display 146, instructing the user to exit the cutting process and retract the anvil assembly 510. After removing the anvil assembly 510, the user can replace the circular adapter assembly 200 and the reloading unit 400 and restart the stapling process. If the measured force is higher than the maximum cutting force, the main controller 147 stops the third motor 156 and displays the process on the display 146, instructing the user to exit the cutting process.

[0397] If the blade assembly 440, which is being moved by the third motor 156, reaches the third distance marker 620 associated with the tissue being cut, and the strain measured during this movement is within the target and maximum cutting force limits, then the main controller 147 determines that the stapling process has been successfully completed. Subsequently, the third motor 154 retracts the blade assembly 440 back to the first distance marker 616.

[0398] Each of the distance markers 600-620 is stored in memory 141 and / or storage device 405 and is used by the main controller 147 to control the operation of the power handle 101 to actuate various components of the circular adapter assembly 200. As mentioned above, the distance markers 600-620 may differ for different types of reloaders, taking into account factors such as nail size and reload diameter. Furthermore, the distance markers 600-620 are set according to a hard stop determined during the calibration process described above.

[0399] See Figure 82EThe cutting process is illustrated through the same user interface, except that the nail icon is grayed out and the knife icon is highlighted. During the cutting process, the knife icon is animated in motion, and the progress bar moves to the right from its midpoint. Additionally, once the cutting process is complete, the inner circumference of the circle is displayed in green. During the cutting process, the force applied to the third rotational transmission assembly 260 is monitored by the strain gauge assembly 320 to ensure that it does not exceed the maximum force limit. Once the third rotational transmission assembly 260 reaches a hard stop or force threshold detected by the strain gauge assembly 320, the process is considered complete. This indicates that the knife has successfully cut the tissue. The completion of the cutting process is indicated by another tone, and the LED stops flashing and remains lit.

[0400] See Figure 82F After the stapling and cutting processes are completed, the user initiates the release process by pressing the top of the dual-state switching control button 30 to release the anvil assembly 510 from the cannula assembly 274. Upon pressing the dual-state switching control button 30, the cannula assembly 274 automatically extends distally, moving the anvil assembly 510 away from the reloading member 400 and releasing the tissue to a preset anvil tilt distance. The release process is illustrated on the display screen 146. Specifically, the release animation shows the anvil assembly 510 moving distally and the head assembly 512 tilting. Additionally, the display screen 146 displays a lock icon to indicate that the anvil assembly 510 is secured to the cannula assembly 274. Once the anvil assembly 510 has moved away from the circular reloading member 400 to its tilt distance, the display screen 146 shows the anvil assembly 510 in its extended state, with the head assembly 512 tilted. This indicates that the user can remove the circular adapter assembly 200 from the patient. The LED then turns off. Once the circular adapter assembly 200 is removed, the user can then unlock the anvil assembly 510 from the cannula assembly 274 by pressing one of the left or right control buttons 32a, 32b, 34a, 34b on the power handle 101 for a predetermined time period (e.g., 3 seconds or longer). A display screen 146 shows which button on the power handle 101 needs to be pressed to unlock the anvil assembly 510. When the user presses one of the control buttons 32a, 32b, 34a, 34b, the display screen 146 displays a countdown (e.g., 3, 2, 1) and the lock icon is indicated as unlocked. At this point, the anvil assembly 510 is unlocked and can be removed. The user can then remove the reload 400 and the severed tissue from the excision procedure. The circular adapter assembly 200 is also detached from the handle assembly 100 and cleaned and sterilized for later reuse. The housing 10 is opened and discarded, from which the power handle 101 is removed for reuse.

[0401] The powered stapler according to the invention is also configured to enter a recovery state during clamping, staplering, and cutting operations if any of the components, such as the power handle 101, the circular adapter assembly 200, the circular reloading member 400, and / or the anvil assembly 510, encounter an error. The recovery state is a software state executed by the main controller 147, which guides the user to correct and / or troubleshoot the error and allows the user to resume any of the clamping, staplering, and cutting operations once the error has been corrected.

[0402] At the beginning of each operation step (e.g., clamping, engaging, starting, etc.), the main controller 147 writes the recovery code associated with the operation step to the storage device 407 of the circular adapter assembly 200. Thus, at the beginning of the program, the storage device 407 stores initialization recovery code indicating that the circular adapter assembly 200 has not yet been used. However, as the circular adapter assembly 200 is used throughout the program, i.e., as it progresses through the different steps described above, the corresponding recovery code is written to the storage device 407. Additionally, the main controller 147 writes the corresponding recovery state to the memory 141. In either instance, this allows either the adapter assembly 200 and / or the power handle 101 to be replaced depending on the error state, since both components store the last recovery state locally, i.e., in storage device 407 or memory 141, respectively.

[0403] See the demonstration of the recovery procedure during the fastening process. Figure 87A And showcasing the recovery procedure during the cutting process. Figure 88A During the procedure, instances may occur where the power handle 101 identifies a defect in one or more of the components of the power handle 101, the circular adapter assembly 200, and / or the reloading element 400. These recovery procedures are illustrative, and similar procedures are also envisioned to be implemented in other operational steps of the power handle 101, such as clamping steps. The recovery procedure may include, but is not limited to, attaching a new power handle 101 to the adapter assembly 200 inserted into the patient, thereby replacing the adapter assembly 200 and / or the reloading element 400.

[0404] When the adapter assembly 200 is attached to the power handle 101, the power handle 101 reads a recovery code from the storage device 407 to determine the state of the adapter assembly 200. The recovery code is written when the adapter assembly 200 was previously detached from the power handle 101. As described above, at the beginning of the procedure, the recovery code indicates the initial state, which guides the power handle 101 to initiate a process, such as calibration. If the adapter assembly 200 detaches during a process such as clamping, fastening, or cutting, the corresponding recovery code provides an entry point to return to the main flow after the recovery procedure has been performed. This allows the operator to continue the surgical procedure from the point where the adapter assembly 200 was originally detached.

[0405] Similarly, in the case where the power handle 101 is being replaced, the new power handle 101 is configured to read the recovery state from the adapter assembly 200. This allows the new power handle 101 to continue the operation of the previous power handle 101. Therefore, during any of the operation steps such as clamping, fastening, and cutting, the adapter assembly 200 can remain in the corresponding configuration, such as clamping or fastening, and can continue operation after the new power handle 101 is attached.

[0406] It should be understood that various modifications can be made to the embodiments of the currently disclosed adapter assembly. Therefore, the above description should not be construed as limiting, but merely as illustrative of the embodiments. Those skilled in the art will envision other modifications within the scope and spirit of this disclosure.

Claims

1. A surgical apparatus comprising a surgical stapler reloading member, a controller, and an anvil assembly, the anvil assembly having a head assembly movable between a non-tilting direction and an tilting direction for cooperating with the surgical stapler reloading member to form a plurality of surgical staples, the controller being configured to: After the surgical device is fully activated, and after the head assembly of the anvil assembly tilts from the non-tilting direction to the tilting direction, the axial distance of the tilted head assembly relative to the reloading member is monitored.

2. The surgical apparatus of claim 1, wherein the controller is further configured to monitor forces acting on the anvil assembly as the anvil assembly translates toward the reloading member.

3. The surgical apparatus of claim 2, wherein the controller is further configured to stop the axial translation of the anvil assembly when the force acting on the anvil assembly exceeds a predetermined threshold.

4. The surgical apparatus of claim 2, wherein the controller is further configured to monitor forces acting on the tilted head assembly of the anvil assembly as the tilted head assembly translates toward the reloading member.

5. The surgical apparatus of claim 4, wherein the controller is further configured to stop the translation of the tilted head assembly toward the reloading member when the force acting on the tilted head assembly exceeds a predetermined threshold.

6. The surgical apparatus of claim 5, wherein the controller is further configured to determine, based on an increase in the force being monitored during axial translation of the anvil assembly, that tissue is being captured between the tilted head assembly and the reloading member.

7. The surgical apparatus of claim 5, wherein the controller is further configured to activate an alarm when the force acting on the anvil assembly exceeds the predetermined threshold.

8. The surgical device according to claim 4, wherein: The reloading member is circular and includes a tissue contact surface defining a plane of the reloading member, the plane of which is orthogonal to the axis of translation of the anvil assembly; and The head assembly of the anvil assembly is circular and includes a tissue contact surface defining a plane of the anvil head, the plane of the anvil head being: When the head assembly is in the non-tilting direction, it is parallel to the plane of the reloading component; and When the head assembly is in the tilt direction, it forms an angle with respect to the plane of the reloading component. The controller is further configured to monitor when the outer radial edge of the head assembly comes into close contact with the tissue contact surface of the reloading member while the head assembly is in the tilt direction.

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