HK1094666B - A surgical device - Google Patents

Abstract

A surgical device includes a first jaw and a second jaw in opposed correspondence with the first jaw. A first driver is configured to cause relative movement of the first jaw and the second jaw in a plane. The first driver is configured to engage a drive shaft rotatable about a rotation axis arrange in nonparallel, e.g., perpendicular, correspondence to the plane. The device may also include a surgical member, e.g., a cutting and stapling element, disposed within the first jaw. A second driver is configured to cause relative movement of the surgical member in a direction parallel to the plane. The second driver is configured to engage a drive shaft rotatable about a rotation axis arranged in non-parallel correspondence to the plane.

Description

Surgical instrument

This application is a divisional application of a patent application having an application date of 2003, 1/2, and an application number of 03803483.2, entitled "surgical instrument".

Cross Reference to Related Applications

The present invention claims priority from U.S. patent application No. 60/346,656, filed on 8/1/2002, the entire contents of which are incorporated herein by reference.

The present invention relates to united states patent application No. 09/510,923 filed on day 22/2/2000, united states patent application No. 09/723,715 filed on day 28/11/2000, united states patent application No. 09/836,781 filed on day 17/4/2001, united states patent application No. 09/887,789 filed on day 22/6/2001, and united states patent application No. 60/337,544 filed on day 4/12/2001, the contents of which are all incorporated herein by reference.

Technical Field

The present invention relates to a surgical instrument. In particular, the present invention relates to a clamping, cutting and stapling instrument for clamping, cutting and stapling tissue.

Background

This document includes a number of descriptions of surgical instruments. Some of these surgical instruments are described in U.S. patent No. 4,705,038 to Sjostrom et al; ams et al, U.S. Pat. No. 4,995,877; mallaby, U.S. patent No. 5,249,583; U.S. patent No. 5,395,033 to Byrne et al; tsuruta et al, U.S. patent No. 5,467,911; U.S. Pat. nos. 5,383,880, 5,518,163, 5,518,164, and 5,667,517 to Hooven; U.S. Pat. Nos. 5,653,374 to Young et al; U.S. Pat. Nos. 5,779,130 to Alesi et al; and Viola et al, U.S. patent No. 5,954,259.

One type of surgical instrument is a linear stapling instrument, which is a guillotine-type instrument for cutting and stapling a section of tissue. Fig. 1A shows an example of such an instrument described in us patent No. 3,494,533. The instrument shown in FIG. 1A includes opposed jaws that are movable parallel to each other. An array of staples is disposed within the first jaw and the second jaw has an anvil for receiving and closing the staples. A suture pusher is disposed within the first jaw and extends from the proximal end of the first jaw to the distal end of the first jaw. A drive shaft is located in the plane of movement of the first jaw and the suture pusher and is connected to the first jaw and the suture pusher. When activated, the drive shaft drives the staple pusher to simultaneously push all of the staples against the staple guides in the anvil of the second jaw.

Other examples of surgical instruments are described in U.S. patent No. 4,442,964, U.S. patent No. 4,671,445, and U.S. patent No. 5,413,267. The surgical stapler includes opposed jaws movable parallel to one another, wherein a row of staples are disposed in a first jaw and an anvil is disposed in a second jaw for receiving and closing the staples. A suture pusher is disposed within the first jaw and extends from the proximal end of the first jaw to the distal end of the first jaw. A drive shaft is located in the plane of movement of the first jaw and the staple pusher and is connected to the first jaw and the staple pusher. When activated, the drive shaft drives the staple pusher to simultaneously push all of the staples against the staple guides in the anvil of the second jaw.

Another type of surgical instrument is a linear clamping, cutting and stapling instrument, such as that described in U.S. patent No. 6,264,087. The instrument is used in surgery to cut cancerous or anomalous tissue from the gastrointestinal tract. A conventional linear clamping, cutting and stapling instrument is shown in perspective view in FIG. 1B. The instrument includes a pistol grip-type structure having an elongated shaft and a distal end. The distal end includes a pair of scissor-type clamping elements for clamping the open end of the colon closed. The anvil portion of one of the two scissor type clamping elements may move or rotate relative to the overall structure while the other clamping element remains fixed relative to the overall structure. The actuation of the scissor elements, i.e. the rotation of the anvil portion, is controlled by a clamping trigger provided at the handle. In addition to the scissor-type device, the distal end includes a suturing mechanism. The stationary clamping element of the scissors mechanism includes a staple cartridge receiving area and a mechanism for driving the staples through the clamped ends of the tissue and against the anvil portion to staple the previously opened ends. The scissor element may be integrally formed with the shaft or may be removable so that various scissors and suturing elements may be interchanged.

Typically, these surgical instruments are used in the following manner: after confirming cancerous or other abnormal tissue in the gastrointestinal tract (and after confirming the location of the cancerous tissue in the colon), the patient's abdomen is first opened, leaving the bowel exposed. The surgeon then cuts the colon tube on both sides of the cancerous tissue and sutures the two open ends of the closed bowel (the end that leads to the anus being the distal end and the end that is closest to the lower bowel being the proximal end). This temporary closure is intended to minimize contamination of the exposed abdomen with intestinal material. In particular, when the colon is positioned between the jaws of a surgical instrument, a temporary closure of the two open ends of the intestine can be achieved. By activating the first drive mechanism, the surgeon may bring the jaws together. The second drive mechanism is then activated to drive a series of sutures and a cutting blade through the clamped colon end to close and transect the end. This process is typically repeated again on the other side of the cancerous or anomalous tissue.

One problem with the aforementioned surgical instruments is that the instruments can be difficult to operate. Since these devices are typically used on the body, such as in a patient, the device should be constructed to be operable within the patient. Conventional surgical instruments, such as those shown in FIGS. 1A and 1B, are difficult to operate, especially in patients.

Disclosure of Invention

The present invention relates, according to one embodiment thereof, to a surgical instrument. The surgical instrument includes a first jaw and a second jaw opposite the first jaw. The first driver enables the first clamp and the second clamp to move relatively in a plane. The first driver is engaged with a drive shaft that is rotatable about an axis of rotation that is non-parallel, e.g., vertically disposed, with respect to the plane. The instrument further includes a surgical member disposed within the first jaw. The second driver enables relative movement of the surgical member in a direction parallel to the plane. The second driver is engaged with a drive shaft that is rotatable about an axis of rotation disposed non-parallel to the plane.

According to one embodiment of the invention, the first drive socket is configured to couple with an end of a first rotatable drive shaft disposed at an angle, such as perpendicular to a plane of the first and second jaws of the electromechanical driver, wherein the electromechanical driver rotates the first drive shaft. The first rotatable drive shaft rotates in a first direction to open the jaws and rotates in a second direction opposite the first direction to close the jaws. The first drive may include, for example, a pair of spur gears, a worm and a worm gear in rotating and meshing relationship with each other. The first driver also includes an externally threaded screw fixedly attached to one end of the worm gear and engaging an internally threaded bore of the second jaw such that relative movement between the gears causes relative movement between the first jaw and the second jaw.

As described above, the surgical instrument can also include a surgical member, such as a cutting element, e.g., a knife, and a stapling element mounted to a pusher plate disposed within the first jaw. According to this embodiment, the second driver is disposed within the first jaw. The second driver may move the surgical member in a direction parallel to the plane of motion of the first and second jaws. The second driver includes a second driver seat disposed at an angle, such as perpendicular to the plane.

According to one embodiment of the invention, the second drive socket of the second driver is configured to couple with an end of a second rotatable drive shaft disposed at an angle, such as perpendicular to a plane of the first and second jaws of the electromechanical driver, wherein the electromechanical driver rotates the second drive shaft. The second drive shaft rotates in a first direction to lower the surgical member and rotates in a second direction opposite the first direction to raise the surgical member. The second drive may include, for example, a pair of spur gears, a worm and a worm gear in rotating and meshing relationship with each other. Each of the pair of worm gears has a built-in internally threaded bore that engages a respective externally threaded screw fixedly attached to the surgical member. Rotation of the gears may cause relative movement of the surgical member.

Drawings

FIG. 1A is a side view of a conventional surgical instrument;

FIG. 1B is a perspective view of a conventional linear clamping, cutting and stapling instrument;

FIG. 2 is a perspective view of an electromechanical surgical system according to one embodiment of the present invention;

FIG. 3 is a side view of a cutting and stapling attachment in an extended position according to one embodiment of the present invention;

FIG. 4 is a side view of the cutting and stapling attachment of FIG. 3 in a retracted position;

FIG. 5 is a side view of the cutting and stapling attachment shown in FIGS. 3 and 4 in a retracted position;

FIG. 6 is a side view of the cutting and stapling attachment of FIGS. 3-5 in a retracted position;

FIG. 7 is a top view of the cutting and stapling attachment shown in FIGS. 3 and 4;

FIG. 8A is an exploded view of a cutting and stapling attachment according to one embodiment of the present invention;

FIG. 8B is an exploded view of a cutting and stapling attachment according to another embodiment of the present invention;

FIG. 9A is a perspective view of the cutting and stapling attachment shown in FIG. 8A;

FIG. 9B is a perspective view of the cutting and stapling attachment shown in FIG. 8B;

FIG. 10 is a side view, partially in cross-section, of a flexible shaft of the electromechanical surgical instrument illustrated in FIG. 2;

FIG. 11 is a cross-sectional view of the flexible shaft taken along line 11-11 of FIG. 10;

FIG. 12 is a rear elevational view of a first adapter of the flexible shaft illustrated in FIG. 10;

FIG. 13 is a front view of a second adapter of the flexible shaft of FIG. 10;

FIG. 14 is a schematic view of a motor arrangement of the electro-mechanical surgical system of FIG. 2;

FIG. 15 is a schematic view of the electro-mechanical surgical system of FIG. 2;

FIG. 16 is a schematic view of an encoder of the flexible shaft of FIG. 10;

FIG. 17 is a schematic view of a storage device of the linear clamping, cutting and stapling instrument in accordance with an embodiment of the present invention;

FIG. 18 is a schematic view of a wireless remote control unit of the electro-mechanical surgical system shown in FIG. 2;

FIG. 19 is a schematic view of a wired remote control unit of the electro-mechanical surgical system shown in FIG. 2;

FIGS. 20A through 20C illustrate a flowchart of a main operating program of steps performed during operation of a surgical instrument, according to one embodiment of the present invention;

21A-21C illustrate a flow diagram of a jaw closing sequence of the main operating sequence illustrated in FIGS. 20A-20C, according to one embodiment of the present invention;

FIGS. 22A through 22C illustrate a flow diagram of a calibration procedure of the main operating procedure illustrated in FIGS. 20A through 20C, in accordance with one embodiment of the present invention;

FIG. 23 illustrates a flow chart of a jaw opening procedure of the main operating procedure illustrated in FIGS. 20A through 20C in accordance with one embodiment of the present invention;

FIGS. 24A through 24C illustrate a flow diagram of the clamping, cutting and stapling procedure of the main operating procedure illustrated in FIGS. 20A through 20C, in accordance with one embodiment of the present invention; and

fig. 25A to 25B show a flowchart of a detection routine of the main operation flow shown in fig. 20A to 20C according to an embodiment of the present invention.

Detailed Description

One embodiment of a surgical instrument 11 according to the present invention is illustrated in fig. 3 through 7. Referring to fig. 3 and 4, one embodiment of a surgical instrument 11, such as a clamping, cutting, and stapling instrument, is shown. In this embodiment, the surgical device 11 includes a parallel split clamping arrangement having a second jaw 50 opposite a first jaw 80. The first end 50a of the second jaw 50 is mechanically coupled to the first end 80a of the first jaw 80. The opposed jaws 50 and 80 may be held parallel relative to each other. Alternatively, the opposed jaws 50 and 80 may open and close in a scissor-like manner, wherein the first end 50a of the second jaw 50 is mechanically connected to the first end 80a of the first jaw 80 by a hinge or other rotatable member, such that the first jaw 80 is rotatably coupled to the second jaw 50.

FIG. 3 illustrates the surgical device 11 in an open position, wherein the second jaw 50 and the first jaw 80 contact each other at the first ends 50a and 80a thereof. The first jaw 80 and the second jaw 50 may be held and moved in a longitudinal plane defined by the X and Y axes shown in fig. 3. A gear housing 255 is mounted to one side of the first jaw 80. The gear housing 255 includes a first drive socket 180 connected to the first driver 150, both shown schematically for clarity. The first driver 150 is connected to the first end 50a of the second jaw 50 to open and close the first jaw 80 and the second jaw 50. In addition, the gear housing 255 further includes a second driving socket 310.

FIG. 4 illustrates the surgical instrument in a closed position. In the closed position, the second jaw 50 and the first jaw 80 contact each other at both of their first ends 50a and 80a and their second ends 50b and 80 b. In the closed position, a length of tissue is clamped between the second jaw 50 and the first jaw 80.

Fig. 5 and 6 also illustrate the surgical instrument 11 in a closed position. Fig. 5 and 6 schematically show that the second drive socket 310 of the gear housing 255 is coupled to a second drive 261. A second driver 261 is coupled to the surgical element 262. The surgical element 262 may include a cutting and stapling assembly 262, although other types of surgical elements are possible.

A second driver 261 is coupled to the cutting and stapling assembly 262 to move the cutting and stapling assembly 262 from a first, retracted position, as shown in FIG. 5, to a second, extended position, as shown in FIG. 6. While two drive sockets, i.e., first drive socket 180 and second drive socket 310, and two corresponding drive shafts, i.e., first drive shaft 630 and second drive shaft 632, are shown, any suitable number of drive sockets and drive shafts may be provided. For example, a single drive shaft may be provided to drive the surgical instrument.

Fig. 7 is a top view of the surgical instrument 11 illustrated in fig. 3-6. Fig. 7 illustrates the surgical device 11 being removably or permanently connected to an electro-mechanical driver component 610. Fig. 7 illustrates a surgical device 11 including a first driver 150 coupled by a first drive shaft 630 to a first motor 680 of the device 610 through a first drive socket 180. The first actuator 150, when engaged with the device 610, operates to open and close the first jaw 80 relative to the second jaw 50. In addition, FIG. 7 illustrates the surgical device 11 as including a second driver 261 coupled by a second drive shaft 632 to a second motor 676 of the apparatus 610 via the second drive socket 310. The second driver 261, when engaged with the device 610, is operable to drive the cutting and stapling assembly 262. As shown in FIG. 7, the first drive socket 180 and the second drive socket 310 are positioned on the surgical device 11 such that the first drive shaft 630 and the second drive shaft 632 are coupled to the surgical device 11 at an angle, i.e., perpendicular to the X-Y plane shown in FIG. 3. That is, the first drive shaft 630 and the second drive shaft 632 are coupled to the surgical device 11 in the Z-axis direction as shown in fig. 7.

Fig. 8A is an exploded view of a surgical instrument 11 according to one embodiment of the present invention, and fig. 9A is a perspective view of the assembled surgical instrument 11. According to this embodiment, the second jaw 50 includes an anvil 505 that is connected to an anvil filler 509 by fasteners 527, such as rivets. The top end 5052 of the anvil 505 includes a vertically disposed internally threaded bore 5051. In addition, the anvil 505 includes a plurality of staple guides 5053 arranged in parallel along a region 5054 of the anvil 505 opposite the first jaw. The shim 520 is disposed between a plurality of suture guide structures 5053.

The first jaw 80 includes a housing frame 506. The housing frame 506 includes a pair of internally disposed guides 5061 along which a pair of ribs 5055 of the anvil 505 may move so that the housing frame 506 may move in parallel correspondence to the anvil 505. The gear housing 255 is mounted to one side 5062 of the housing frame 506 by fasteners 533 and 534, such as screws.

A quick connect coupling 511 is mounted on the gear housing 255 and is biased by a set of springs 538. The gear housing 255 includes a first drive socket 180 and a second drive socket 310. In this embodiment, the first drive socket 180 includes a first pinion 508a having one end 5081 extending through the opening 2551 of the gear housing 255 and the other end 5082 including spur gear teeth 5083. The second drive socket 310 includes a second pinion 508b having one end 5084 extending through a second opening 2552 of the gear housing 255 and another end 5085 including spur gear teeth 5086. The memory module 501 is disposed in the gear housing 255 and includes a connector 2554 that extends through or is accessible to the opening 2553 of the gear housing 255. The memory module 501 is held in place in the gear housing 255 by an inner spacer 530 and an outer spacer 531. The memory module 501 is also biased in its position by a spring 539.

The first and second pinion gears 508a and 508b mesh with respective spur gears 529a and 529b, respectively. The first spur gear 529a includes an internal bore 5293 which is non-rotatably engaged with an end 5231 of the first worm 523 a. The second spur gear 529b includes an internal bore 5294 that is non-rotatably engaged with an end 5234 of the second worm 523 b. As shown in fig. 8A, the holes 5293 and 5294 and the ends 5231 and 5234 can be, for example, square. It will be appreciated that the apertures 5293, 5294 and ends 5231, 5234 can be of any shape and configuration that provides a non-rotatable engagement therebetween.

In this embodiment, the first worm 523a has one end 5231 which is non-rotatably engaged with the internal bore 5293 of the first spur gear 529a, and a second end 5232 which includes circumferentially-disposed threads 5233. The second worm 523b has one end 5234 engaged nonrotatably with the internal bore 5294 of the second spur gear 529b, and a second end 5235 comprising circumferentially-disposed threads 5236. The second end 5232 of the first worm 523a is disposed within the frame housing 506, and the other end 5231 of the worm 523a extends through a through-hole 5063 in the side of the frame housing 506 for engagement with the first spur gear 529a in the gear housing 255. The second end 5235 of the second worm 523b is disposed within the frame housing 506, while the other end 5234 of the worm 523b passes through a through-hole 5064 in the side of the frame housing 506 to engage the second spur gear 529b on the gear housing 255.

Also disposed within the frame housing 506 is a worm gear 522. The worm gear 522 has circumferentially disposed teeth 5221, which engage the threads 5233 of the second end 5232 of the worm 523 a. Worm gear 522 includes an internal bore 5222 through which screw 521 is disposed. The screw 521 has a head 5211 with a portion 5212 that non-rotatably engages the internal bore 5222 of the worm gear 522. The bore 5222 and the portion 5212 of the screw 521 can be complementary, and can be square, for example. The screw 521 also includes a portion 5213 of the head 5211 that extends through the washer 537 and the aperture 5351 in the shim plate 535. The screw 521 may also have external threads 5214 that engage the internally threaded bore 5051 of the anvil 505.

Disposed within the frame housing 506 are a worm gear 516 and a worm gear 517. The worm gear 516 and the worm gear 517 are located on opposite sides of the worm 523 b. In particular, the worm gear 516 includes circumferentially-disposed gear teeth 5161 that engage a first side of the worm 523b, and the worm gear 517 includes circumferentially-disposed gear teeth 5171 that engage a second side of the worm 523 b. Worm gear 516 includes a cylindrical protrusion 5162 that protrudes through an aperture 5352 in shim 535. The positioning ring 536a engages the groove 5163 of the cylindrical projection 5162 so that the worm gear 516 can rotate about its vertical central axis 5165 relative to the pad 535. Worm gear 517 includes a cylindrical protrusion 5172 that protrudes through hole 5353 in shim 535. The positioning ring 536b engages the groove 5173 on the cylindrical projection 5172 to allow the worm gear 517 to rotate relative to the shim plate 535 about its vertical central axis 5175.

The externally threaded screw 504 is disposed through the internally threaded bore 5164 of the worm gear 516. An externally threaded worm 503 is disposed through the internally threaded bore 5174 of the worm gear 517. Since the worm gears 516 and 517 are located and engaged on opposite sides of the worm 523b, the internally threaded bores 5164 and 5174 of the worm gears 516 and 517, and the externally threaded screws 504 and 503 may be provided with opposite threads to each other. In the illustrated embodiment, the internally threaded bore 5164 of the worm gear 516 may also be right-handed threaded to engage the right-handed threads of the screw 504, and the internally threaded bore 5174 of the worm gear 517 may also be left-handed threaded to engage the left-handed threads of the screw 503. Both screws 503 and 504 are fixedly coupled to the top surface 5021 of the thrust plate 502. The thrust plate 502 is positioned between opposite sides of the housing frame 506.

The staple pusher 514 is attached to the bottom surface 5022 of the thrust plate 502. The staple pusher 514 includes two parallel rows 5141 and 5142 of downwardly disposed teeth 5143, each of which corresponds to and aligns with a staple guide 5053 of the anvil 505. A cutting edge down knife 519 is disposed between the two parallel rows of downwardly disposed teeth 5143 of suture pusher 514.

Suture holder 513 is disposed below suture pusher 514. The staple holder 513 includes a cartridge (cartridge) having vertically disposed slots 5132, each of which corresponds to and aligns with a downwardly disposed tooth 5143 of the staple pusher 514 and a staple guide 5053 of the anvil 505. A suture 528 including a prong 5281 is disposed in each groove 5132. The suture holder 513 also includes a longitudinally disposed slot 5131 that extends through the suture holder 513 through which the knife 519 also passes. The suture holder 513 includes an aperture 5133 adjacent one end 5134 thereof.

The suture mounts 540 are attached to the lower parallel edges 5066 of the frame housing 506 or to the lower surface of the suture seat 513. The suture tray 540 is configured to cover the bottom surface of the suture seat 513 such that the suture 528 is retained in the suture seat 513 and foreign matter is prevented from entering through the slot 5132 of the suture seat 513 during transport of the surgical device 11. Suture carrier 540 also has a through hole 5401 with a tapered or beveled edge 5402. The suture carrier 540 also has a gripping location 5403 which is configured to be grasped by a user.

The bore 5133 of the suture holder 513, adjacent to the end 5134 of the suture holder 513, is configured to receive the end 5181 of the pin 518. The end 5181 of pin 518 is tapered so that it can be placed over the tapered edge 5402 of through hole 5401 of suture carrier 540. In this embodiment, the pin 518 is held in a substantially vertical position so as to be perpendicular to the suture mount 513. The opposite end 5184 of the pin 518 includes a centrally disposed bore 5183 for receiving a spring 524. In addition, a lever 5182 is provided at the end 5184 of the pin 518, which is perpendicularly connected to the pin 518. When the staple holder 540 is removed from the surgical instrument 11, the spring 524 biases the end 5181 of the pin 518 into the bore 5057 of the anvil 505.

The cartridge cap 515 is attached to one end 5067 of the frame housing 506, such as by welding. The latches 5151 and 5152 of the cartridge cap 515 engage the grooves 5068 of the housing frame 506. The cartridge cap 515 also includes an internally disposed aperture 5154 for receiving the pin 518. The bore 5154 of the cartridge cap 515 includes a slot 5153 in communication therewith, the slot 5153 forming a lever 5182 for guiding the pin 518. In this embodiment, the internally disposed aperture 5154 of the cartridge cap 515 does not extend through the top surface 5155 of the cartridge cap 515; but rather retains the spring 524 within an internally disposed aperture 5154. The biasing force of spring 524 pushes the end 5181 of pin 518 into aperture 5133 of staple holder 513 and secures the position of staple holder 513 such that slot 5132 can be aligned with downwardly disposed teeth 5143 of staple pusher 514 and with staple guide 5053 of anvil 505. The cartridge cap 515 is also held in place by a catch 526 that is rotatably connected to the housing frame 506 by fasteners 507. The housing top 510 is disposed between the opposing sides 5062 and 5065 of the housing frame 506 to protect the components within the housing frame 506.

The embodiment shown in FIG. 8A includes a thin, planar suture carrier 540. The suture tray 540 is configured to retain the suture 528 in the suture seat 513 when the surgical instrument is initially held in the closed position, e.g., the first jaw 80 and the second jaw 50 are in contact on opposite sides of the suture positioner 540 when the surgical instrument 11 is initially shipped to a user. This configuration of the staple tray 540 ensures that the staples 528 are in the staple seats 513 during transport and prevents damage to the staples 528 and the staple guide 5053 of the anvil 505. However, according to another embodiment of the present invention, the surgical device 11 may also be initially in an open position. FIG. 8B illustrates an exploded view of the surgical instrument 11, and FIG. 9B illustrates an assembled perspective view of the surgical instrument 11 shown in FIG. 8B, according to one embodiment of the present invention. More specifically, FIG. 8B illustrates a suture tray 525 that is configured to initially retain the surgical device 11 in an open position, e.g., with the first jaw 80 and the second jaw 50 separated as the surgical device 11 is shipped to a user.

As shown in fig. 8B, the staple tray 525 is attached to the lower parallel side 5066 of the frame housing 506 by a joint 5251 so that the staples 528 can be retained in the staple seats 513 to prevent damage to the staples 528 and to the staple guides 5053 of the anvil 505 during transport. The suture tray 525 includes a pair of guide structures 5254 disposed along side edges 5253a and 5253b that extend downwardly. The guide formation 5254 contacts the outer side 5056 of the anvil 505 so that the first jaw 80, e.g., the housing frame 506 of the surgical device 11 parallel to the second jaw 50, may be secured during shipping and handling. Thus, the guide structure 5254 can prevent misalignment of the first jaw 80 and the second jaw 50 that can occur when transporting the surgical device 11 with the first jaw 80 and the second jaw 50 in the open position.

It should be understood that while the embodiments of the present invention shown in FIGS. 3 through 9B include a stapling and cutting element in a guillotine-type arrangement, in another embodiment, the stapling and cutting element may also be movable between the proximal and distal ends of the surgical device 11. For example, in an alternative embodiment of the surgical device 11, a gear coupled to the stapling element and the cutting element and movable between the proximal and distal ends of the surgical device 11 is driven by a drive shaft that is coupled in a non-parallel relationship, such as perpendicular to the plane of motion of the first jaw 80 and the second jaw 50.

According to one embodiment of the present invention, the surgical device 11 may be used as an attachment to, or may be integrated with, an electro-mechanical surgical system, such as the electro-mechanical driver component 610. In another embodiment, the surgical instrument may be attached to or integrated with a mechanical drive device.

Fig. 2 shows a perspective view of an electromechanical driver component 610 according to the invention. Examples of such electromechanical driver components are described in the following documents, for example: U.S. patent application No. 09/723,715, U.S. patent application No. 09/836.781, and U.S. patent application No. 09/887,789, the entire disclosures of which are expressly incorporated herein by reference. The electromechanical driver component 610 may include, for example, a remote power console 612 including a housing 614 having a front panel 615. Mounted on the front panel 615 are a display device 616 and indicators 618a, 618 b. Extending from the housing 614 is a flexible shaft 620 that is removably connectable to the front panel by a first adapter 622. The distal end 624 of the flexible shaft 620 may include a second coupling 626 adapted to removably couple, for example, the surgical device 11 described above, to the distal end 624 of the flexible shaft 620. The second adapter 626 may be adapted to detachably connect with different surgical instruments or accessories. In another embodiment, the distal end 624 of the flexible shaft 620 may also be fixedly attached to or integral with a surgical instrument.

Referring to fig. 10, a side view with partial cutaway of flexible shaft 620 is shown. According to one embodiment, the flexible shaft 620 includes a tubular housing 628 that includes a coating or other sealing arrangement to form a fluid-tight seal between its internal conduit 640 and the external environment. Housing 628 may be formed of an elastomeric material that is compatible with physiological tissue and sterilizes. The housing 628 may also be made of a material that is autoclavable. First rotational drive shaft 630, second rotational drive shaft 632, first steering cable 634, second steering cable 635, third steering cable 636, fourth steering cable 637, and data transmission cable 638 may be disposed within the inner conduit of flexible shaft 620 and extend along the entire length thereof. FIG. 11 illustrates a cross-sectional view of the flexible shaft 620 taken along line 11-11 in FIG. 10, and also shows the various cables 630, 632, 634, 635, 636, 637, 638. Each distal end of steering cables 634, 635, 636, 637 is attached to distal end 624 of flexible shaft 620. Each cable 630, 632, 634, 635, 636, 637, 638 may be held within a respective housing.

The first rotational drive shaft 630 and the second rotational drive shaft 632 may form, for example, a highly flexible drive shaft, such as a braided or helical drive shaft. It will be appreciated that the highly flexible drive cable may have limited torque transmission characteristics and capabilities. It will also be appreciated that the surgical device 11 or other attachment connected to the flexible shaft 620 requires a greater torque input than is transmitted through the drive shafts 630, 632. The drive shafts 630, 632 are thus capable of transmitting relatively low torque at high speeds, which can be converted to low speed/high torque by gearing arrangements disposed at the distal and/or proximal ends of the flexible shaft 620 on the surgical instrument or attachment and/or the remote power console 612. Of course, it will be appreciated that the gear arrangement may be located anywhere along a power train between the motor on housing 614 and a surgical instrument or other attachment connected to flexible shaft 620. The gears may include, for example, spur gear arrangements, planetary gear arrangements, harmonic gear arrangements, cycloidal drives, epicyclic gear arrangements (epicyclicars), and the like.

Referring now to fig. 12, a rear end view of the first adapter 622 is shown. The first adapter 622 includes a first connector 644, a second connector 648, a third connector 652, and a fourth connector 656, each rotatably secured to the first adapter 622. Each connector 644, 648, 652, 656 includes a respective groove 646, 650, 654, 658. As shown in fig. 12, each groove 646, 650, 654, 658 may be hexagonally shaped. It will be appreciated, however, that the recesses 646, 650, 654, 658 may be of any shape and configuration suitable for non-rotatably engaging and rigidly connecting the connectors 644, 648, 652, 656 to the respective drive shafts of the motor assembly secured within the housing 612. It will be appreciated that complementary projections are also provided on the respective drive shafts of the motor arrangement so as to drive the drive elements of the flexible shaft 620. It will also be appreciated that recesses may be provided on the drive shaft and complementary protrusions may be provided on the connectors 644, 648, 652, 656. Any other connection means may be provided as long as it is capable of non-rotatably and releasably connecting to the connections 644, 648, 652, 656 and the drive shaft of the motor means.

One of the connectors 644, 648, 652, 656 is non-rotatably fixed to the first drive shaft 630, while the other of the connectors 644, 648, 652, 656 is non-rotatably fixed to the second drive shaft 632. The remaining two of the connectors 644, 648, 652, 656 engage a transmission element that is used to apply a pulling force to the steering cables 634, 635, 636, 637 so that the distal end 624 of the flexible shaft 620 can be steered. The data transfer cable 638 is electrically and logically connected to the data connector 660. The data connections 660 include, for example, electrical contacts 662 that correspond to the individual wires in the data cable 638 and are equal in number. The first adapter 622 includes a key structure 642 to properly position the first adapter 622 to a mating complementary adapter arrangement provided on one of the housings 612. The key structure 642 may be provided on either or both of the first adaptor 622 and the mating complementary adaptor means provided on the housing 612. The first adapter 622 may comprise a quick-connect type connector that engages the first adapter 622 to the housing 612 with a simple pushing action. Along with any of the connections 644, 648, 652, 656, 660, a seal is also provided so that a fluid seal may be provided between the interior of the first adaptor 622 and the external environment.

Referring to fig. 13, there is a front end view of the second adapter 626 of the flexible shaft 620. In this embodiment, the second adapter 626 includes a first connector 666 and a second connector 668, each rotatably secured to the second adapter 626 and each non-rotatably secured to the distal end of a respective one of the first and second drive shafts 630, 632. A quick-connect type fitting 664 is provided on the second adapter 626 to removably secure the instrument 11 thereto. The quick connection type joint 664 may be, for example, a rotary quick connection type joint, a bayonet (bayonet) connection type joint, or the like. A key structure 674 is provided on the second adapter 626 for properly aligning the instrument 11 with the second adapter 626. The key structure or other means of properly aligning the instrument 11 with the flexible shaft 620 may be provided on either or both of the second coupling 626 and the instrument 11. Alternatively, the quick connect type fitting may be provided on the instrument 11, as shown in FIG. 8A as a quick connect coupling 511. A data link 670 with electrical contacts 672 is also provided on the second adapter 626. Similar to the data connection 660 of the first adapter 622, the data connection 670 of the second adapter 626 includes contacts 672 electrically and logically connected to respective conductors of the data transmission cable 638 and contacts 662 of the data connection 660. Seals are also provided with the connectors 666, 668, 670 to provide a fluid seal between the interior of the second adapter 626 and the environment.

The electromechanical driver components are disposed within the housing 614 of the remote power console 612 for driving the drive shafts 630, 632 and the steering cables 634, 635, 636, 637 to operate the electromechanical driver component 610 and the surgical device 11 coupled to the second adapter 626. In the embodiment shown in fig. 14, five motors 676, 680, 684, 690, 696 are provided in the remote power console 612, each of which is operated by a power source that may be provided in the remote power console. However, it will be appreciated that any suitable number of motors may be provided, and that the motors may be operated by battery power, line current, dc power, electronically controlled dc power, and the like. It is also contemplated that the motor may also be connected to a DC power source, which in turn is connected to line current, such that the line current supplies the operating current of the motor.

Fig. 14 schematically shows one possible arrangement of the electric motor. The output shaft 678 of the first motor 676 is engaged with the first connector 644 of the first adapter 622 when the first adapter 622, and thus the flexible shaft 620, is engaged with the housing 614 to drive the first drive shaft 630 and the first connector 666 of the second adapter 626. Similarly, the output shaft 682 of the second motor 680 is engaged with the second connector 648 of the first adapter 622, whereupon the first adapter 622, and thus the flexible shaft 620, is engaged with the housing 614 to thereby drive the second drive shaft 632 and the second connector 668 of the second adapter 626. The output shaft 686 of the third motor 684 engages the third connector 652 of the first adapter 622 when the first adapter 622, and thus the flexible shaft 620, is engaged with the housing 614 to drive the first and second steering cables 634, 635 via a first pulley arrangement 688. An output shaft 692 of a fourth motor 690 engages the fourth connector 656 of the first adapter 622 when the first adapter 622, and thus the flexible shaft 620, is engaged with the housing 614 to drive the third and fourth steering cables 636, 637 via a second pulley arrangement 694. The third and fourth motors 684, 690 may be secured to a carriage 1100 that is selectively movable between a first position and a second position via an output shaft 698 of a fifth motor 696 to selectively engage and disengage the third and fourth motors 684, 690 with which the respective pulley arrangements 688, 694 are coupled such that the flexible shaft 620 may be tensioned and controlled or made limp as desired. It is contemplated that other mechanical, electrical, and/or electromechanical mechanisms and the like may be used to selectively engage and disengage the operating structure. By way of example, the motor may be arranged and configured as described in U.S. patent application No. 09/510,923, entitled "carriage assembly for controlling a core-wire mechanism in a flexible shaft," the entire contents of which are expressly incorporated herein by reference.

It is appreciated that any one or more of the motors 676, 680, 684, 690, 696 can be, for example, a high speed/low torque motor, a low speed/high torque motor, etc. As noted above, the first and second rotary drive shafts 630, 632 may be configured to transmit high speed and low torque. As such, the first and second electric motors 676, 680 can be configured as high-speed/low-torque electric motors. Alternatively, the first and second electric motors 676 and 680 can also be configured as low-speed/high-torque electric motors with a torque-reducing/speed-increasing gear arrangement disposed between the first and second electric motors 676 and 680 and one of the respective first and second rotary drive shafts 630 and 632. The torque reducing/speed increasing gear arrangement may include, for example, a spur gear arrangement, a planetary gear arrangement, a harmonic gear arrangement, a cycloidal drive arrangement, an epicyclic gear arrangement, and the like. It will be appreciated that any such gearing arrangement may be provided within the remote power console 612 or proximal end of the flexible shaft 620, such as within the first adapter 622. It will be appreciated that gearing may be provided at the distal and/or proximal ends of the first and/or second rotary drive shafts 630, 632 to prevent twisting (windrup) and damage thereof.

Referring to fig. 15, a schematic view of the electromechanical driver component 610 is shown. A controller 1122 is provided on the housing 614 of the remote power console 612 and is configured to control all functions and operations of the electromechanical driver component 610 and the linear clamping, cutting and stapling instrument 11 or other surgical instrument or attachment connected to the flexible shaft 620. A memory unit 1130 is also provided and may include memory devices such as, for example, a ROM component 1132, a RAM component 1134, and the like. The ROM element 1132 is electrically and logically connected to the controller 1122 via line 1136, and the RAM element 1134 is electrically and logically connected to the controller 1122 via line 1138. The RAM element 1134 may comprise any type of random access memory, such as magnetic memory, optical memory, magneto-optical memory, electronic memory, and the like. Similarly, ROM component 1132 may also include any type of read-only memory, such as a removable memory, e.g., a PC card or PCMCIA-type device or the like. It will be appreciated that ROM component 1132 and RAM component 1134 may be configured as a single unit or may form separate units, and that ROM component 1132 and/or RAM component 1134 may also be configured as PC-card or PCMCIA-type devices.

The controller 1122 is also connected to the front panel 615 of the housing 614, specifically to the display device 616 via line 1154 and to the indicators 618a, 618b via respective lines 1156, 1158. Lines 1116, 1118, 1124, 1126, 1128 electrically and logically connect controller 112 to first, second, third, fourth, and fifth motors 676, 680, 684, 690, 696, respectively. A wired Remote Control Unit (RCU)1150 is electrically and logically connected to the controller 1122 via line 1152. A wireless remote control unit 1148 is also provided and is connected via a wireless link 1160 to a receive/transmit unit 1146 which is also connected via a link 1144 to the transceiver 1140. The transceiver 1140 is electrically and logically connected to the controller 1122 via line 1142. The wireless link 1160 may be, for example, an optical link, such as an infrared link, a radio link, or any other form of wireless communication link.

The switch device 1186 may comprise, for example, an array of DIP switches, which may be connected to the controller 1122 via line 1188. The switch device 1186, for example, may be configured to select one of a plurality of languages used to display information and prompts on the display device 616. The information and prompts may relate to, for example, the operation and/or status of the electro-mechanical driver component 610 and/or the surgical device 11 coupled thereto.

According to an embodiment of the present invention, the first encoder 1106 may be disposed within the second coupling 626 and may be configured to respond to rotation of the first drive shaft 630 and output a signal based thereon. A second encoder 1108 is also disposed within the second coupling 626 and is configured to be responsive to rotation of the second drive shaft 632 and to output a signal in accordance therewith. The signal output by each encoder 1106, 1108 may be indicative of the rotational position of each drive shaft 630, 632 and its rotational direction. The encoders 1106, 1108 may include, for example, Hall effect devices, optics, and the like. Although the encoders 1106, 1108 are described as being disposed within the second adapter 626, it is to be understood that the encoders 1106, 1108 may be disposed at any location between the motor system and the surgical instrument 11. It is contemplated that by locating the encoders 1106, 1108 within the second coupling 626 or at the distal end of the flexible shaft 620, accurate measurements of the rotation of the drive shaft may be obtained. If the encoders 1106, 1108 are disposed at the proximal end of the flexible shaft 620, twisting of the first and second rotatable drive shafts 630, 632 may result in measurement errors.

FIG. 16 is a schematic diagram of an encoder 1106, 1108, which includes a Hall effect device. A magnet 1240 having a north pole 1242 and a south pole 1244 is non-rotatably mounted on the drive shafts 630, 632. The encoder 1106, 1108 also includes a first sensor 1246 and a second sensor 1248, which are separated by approximately 90 ° with respect to the longitudinal or rotational axis of the drive shaft 630, 632. The output of the sensors 1246, 1248 is continuous and changes its state as the polarity of the magnetic field in which it is located within its detection range changes. Thus, based on the output signals of the encoders 1106, 1108, the angular position of the drive shafts 630, 632 may be determined within a quarter of a circle, thereby allowing the rotational direction of the drive shafts 630, 632 to be determined. The output signal of each encoder 1106, 1108 is transmitted to the controller 1122 via a respective line 1110, 1112 of the data transfer cable 638. The controller 1122, by tracking the angular position and rotational direction of the drive shafts 630,632 carried by the output signals of the encoders 1106, 1108, can thereby determine the position and/or state of the components of the surgical instrument coupled to the electro-mechanical driver component 610. That is, by counting the revolutions of the drive shaft 630, 632, the controller 1122 can determine the position and/or state of the components of the surgical instrument coupled to the electromechanical driver component 610.

For example, the distance of advancement between the first and second clamps 80, 50 and the push plate 502 is a function of the rotation of each drive shaft 630, 632, which can be determined. By determining the absolute position of the second clamp 50 and the push plate 502 at a point in time, the absolute position of the first clamp 80 and the push plate 502 at any time thereafter can be determined using the relative displacement of the second clamp 50 and the push plate 502 based on the output signals of the encoders 1106, 1108, and the known screw moments of the screw 521 and the screws 503, 504. The absolute position of the second jaw 50 and the push plate 502 can be fixed and determinable when the surgical device 11 is first coupled to the flexible shaft 620. Alternatively, the position of the second clamp 50 and the push plate 502 relative to, for example, the first clamp 80 can be determined based on the output signals of the encoders 1106, 1108.

The surgical device 11 may further include a data connector 1272, as shown in FIG. 8A, that is sized and configured to electrically and logically connect to the connector 670 of the second adapter 626. In this embodiment, data connector 1272 includes contacts equal in number to the leads 672 of connector 670. The memory module 501 is electrically and logically connected to a data connector 1272. The memory module 501 may be in the form of, for example, an EEPROM, EPROM, etc., and may be loaded, for example, into the second jaw 50 of the surgical device 11.

Fig. 17 schematically shows a memory module 501. As shown in fig. 17, the data connector 1272 includes contacts 1276 that are each electrically and logically connected to the memory module 501 by respective lines 1278. The memory module 501 may be configured to store, for example, a serial number data 1180, an attachment type Identifier (ID) data 1182, and a usage data (usage data) 1184. The memory module 501 may additionally store other data. Both the serial number data 1180 and the ID data 1182 may be set as read-only data. The serial number data 1180 and/or the ID data 1182 may be stored in a read-only area of the memory module 501. In this embodiment, the serial number data 1180 may be data that is used only to identify a particular surgical instrument, while the ID data 1182 may be data that is used to identify the type of attachment, which may be, for example, other types of surgical instruments or attachments connected to the system 610. The usage data 1184 represents usage of a particular attachment, such as the number of times the first jaw 80 of the surgical instrument 11 is opened and closed, or the number of times the push plate of the surgical instrument 11 is advanced. The usage data 1184 may be stored in a read/write area in the memory module 501.

It is contemplated that an attachment, such as the surgical instrument 11, attached to the distal end 624 of the flexible shaft 620 may be designed and configured to be used only once, or may be used multiple times. The accessory may also be designed and configured to be usable a predetermined number of times. Accordingly, the usage data 1184 may be used to determine whether the surgical device 11 has been used and whether the number of uses has exceeded a predetermined maximum number of uses. As described in detail below, if an attempt is made to use the accessory after the maximum number of allowed uses has been reached, an "error" condition may result.

Referring again to fig. 15, when the surgical device 11 is initially attached to the flexible shaft 620, the controller 1122 is configured to read the ID data 1182 from the memory module 501 of the surgical device 11. The memory module 501 is electrically and logically connected to the controller 1122 via lines 1120 of the data transfer cable 638. Based on the read ID data 1182, the controller 1122 is configured to read or select from the memory unit 1130 an operating program or algorithm corresponding to the type of surgical instrument or attachment attached to the flexible shaft 620. The memory unit 1130 is configured to store operating programs or algorithms for various available types of surgical instruments or attachments, and the controller 1122 selects and/or reads the operating program or algorithm from the memory unit 1130 in accordance with the ID data read from the memory module 501 of the attached surgical instrument or attachment. As mentioned above, the memory unit 1130 includes a removable ROM component 1132 and/or RAM component 1134. Thus, the operating programs or algorithms stored in the memory unit 1130 may be updated, added, deleted, modified, or otherwise modified as desired. The operating programs or algorithms stored in the memory unit 1130 may be customized, for example, to the particular needs of a user. Data input devices, such as a keyboard, mouse, pointing device, touch screen, etc., may be connected to the memory unit 1130 through, for example, a data connection port to facilitate the customization of operating programs or algorithms. Alternatively or additionally, the operating program or algorithm may be customized and preprogrammed into the memory unit 1130, which is remote from the electro-mechanical driver component 610. It is contemplated that the serial number data 1180 and/or usage data 1184 may also be used to determine which of a plurality of operating programs or algorithms to read or select from the memory unit 1130. It will be appreciated that the operating program or algorithm may alternatively be stored in the memory module 501 of the surgical device 11 and transmitted to the controller 1122 via the data transmission cable 638. Once the appropriate operating program or algorithm is read or selected by or transmitted to the controller 1122, the controller 1122 will begin executing the operating program or algorithm in accordance with the user's operation via the wired RCU1150 and/or wireless RCU 1148. As described above, the controller 1122 is electrically and logically connected to the first, second, third, fourth, fifth motors 676, 680, 684, 690, 696 by respective lines 1116, 1118, 1124, 1126, 1128 and is configured to control the motors 676, 680, 684, 690, 696 in accordance with the operating program or algorithm read, selected or transmitted via the respective lines 1116, 1118, 1124, 1126, 1128.

Referring now to FIG. 18, a diagram of a wireless RCU1148 is shown. The wireless RCU includes a steering controller 1300 having a plurality of switches 1302, 1304, 1306, 1308 arranged under a four-way rocker 1310. Switches 1302, 1304 operate via rocker 1310, and the operation of first and second steering cables 634, 635 is controlled via third motor 684. Similarly, switches 1306, 1308 are operated by rocker 1310, and the operation of third and fourth steering cables 636, 637 is controlled by fourth motor 392. It will be appreciated that the rocker 1310 and switches 1302, 1304, 1306, 1308 are arranged so that operation of the switches 1302, 1304 steers the flexible shaft 620 in the north-south direction and operation of the switches 1306, 1308 steers the flexible shaft 620 in the east-west direction. North and south, here, east and west, are based on a relative coordinate system. Alternatively, a digital joystick, analog joystick, or the like may be provided in place of rocker 1310 and switches 1302, 1304, 1306, 1308. A potentiometer or any other type of actuator may be used in place of rocker 1310 and switches 1302, 1304, 1306, 1308.

The wireless RCU1148 further includes a steering engage/disengage switch 1312, the operation of which controls the operation of the fifth motor 696 for selective engagement and disengagement with the steering mechanism. Wireless RCU1148 also includes a two-way rocker 1314 having first and second switches 1316, 1318 operable thereby. The operation of these switches 1316, 1318 may control certain functions of the electro-mechanical driver component 610, and any surgical instrument or attachment, such as the surgical instrument 11 attached to the flexible shaft 620, in accordance with an operating program or algorithm corresponding to the attached instrument 11. For example, operation of the two-way rocker 1314 may control the opening and closing of the first jaw 80 and the second jaw 50 of the surgical device 11. The wireless RCU1148 may also be provided with other switches 1320, the operation of which may further control the operation of the electro-mechanical driver component 610 and the attachment attached to the flexible shaft 620 in accordance with an operating program or algorithm corresponding to the attached instrument. For example, operation of the switch 1320 may initiate advancement of the push plate 502 of the surgical instrument 11.

The wireless RCU1148 also includes a controller 1322, which is electrically and logically connected to the switches 1302, 1304, 1306, 1308 via line 1324, to the switches 1316, 1318 via line 1326, to the switch 1312 via line 1328, and to the switch 1320 via line 1330. The wireless RCU1148 may include indicators 618a ', 618b ' that correspond to the indicators 618a, 618b of the front panel 615, and a display device 616 ' that corresponds to the display device 616 of the front panel 615. If provided, the indicators 618a ', 618b ' are electrically and logically connected to the controller 1322 via respective lines 1332, 1334, and the display device 616 ' is electrically and logically connected to the controller 1322 via line 1336. The controller 1322 is electrically and logically connected to a transceiver 1338 via line 1340, and the transceiver 1338 is electrically and logically connected to a receiver/transmitter 1342 via line 1344. A power source, such as a battery, is also provided within the wireless RCU1148 to provide power thereto. In this manner, the wireless RCU1148 may control the operation of the electro-mechanical driver component 610 and the instrument 11 coupled to the flexible shaft 620 via the wireless link 1160.

The wireless RCU1148 may include a switch 1346 connected to the controller 1322 via line 1348. Operation of the switch 1346 may transmit data signals to the transmitter/receiver 1146 via the wireless link 1160. The data signal includes identification data that identifies only the wireless RCU 1148. This identification data is used by controller 1122 to prevent unauthorized operation of electro-mechanical driver component 610 and to prevent another wireless RCU from interfering with the operation of electro-mechanical driver component 610. Each subsequent communication between the wireless RCU1148 and the electromechanical surgical instrument 610 includes identification data. In this manner, the controller 1122 can distinguish between wireless RCUs and, therefore, only allow a signal identifying the wireless RCU1148 to control the operation of the electro-mechanical driver component 610 and the instrument 11 coupled to the flexible shaft 620.

Based on the position of the various components of the instrument attached to the flexible shaft 620 (as determined from the output signals of the encoders 1106, 1108), the controller 1122 may selectively activate or deactivate the electro-mechanical driver component 610 as defined by the operating program or algorithm corresponding to the attached instrument. For example, for the surgical device 11, the activation function controlled by operation of the switch 1320 is not available unless the space or gap between the second jaw 50 and the first jaw 80 is determined to be within an acceptable range.

Referring now to FIG. 19, therein is shown a schematic diagram of a wired RCU 1150. In this embodiment, the wired RCU1150 includes substantially the same control elements as the wireless RCU1148, and further description of these elements will be omitted. Similar elements are indicated in fig. 19 with additional superscripts. It is contemplated that the functions of the electromechanical driver component 610 and the accessories, such as the surgical device 11, attached to the flexible shaft 620 can be controlled by the wired RCU1150 and/or the wireless RCU 1148. By way of example, the wired RCU1150 may be used to control the function of the electromechanical driver component 610 and the accessories connected to the flexible shaft 620 in the event of a battery failure of the wireless RCU 1148.

As described above, the front panel 615 of the housing 614 includes the display device 616 and the indicators 618a, 618 b. The display device 616 may include an alpha-numeric display (alpha-numeric display) device, such as an LCD display device. The display device 616 may also include an audio output device, such as a speaker, buzzer, etc. The display device 616 is operated and controlled by the controller 1122 in accordance with an operating program or algorithm corresponding to an attachment, such as the surgical device 11, attached to the flexible shaft 620. If no surgical instrument or attachment is so connected, a default operating program or algorithm may be read or selected by or transmitted to the controller 1122 to control the operation of the display device 616, as well as other aspects and functions of the electro-mechanical driver component 610. If the surgical device 11 is coupled to the flexible shaft 620, the display device 616 may display, for example, data indicative of the gap between the second jaw 50 and the first jaw 80 as determined from the output signals of the encoders 1106, 1108, as described above.

Similarly, the indicators 618a, 618b may be operated and controlled by the controller 1122 in accordance with an operating program or algorithm corresponding to the attachment 11, such as the surgical device 11, attached to the flexible shaft 620. The indicators 618a and/or 618b may include an audio output device, such as a speaker, buzzer, etc., and/or a visual indicator device, such as an LED, light (lamp), light window (light), etc. If the surgical device 11 is coupled to the flexible shaft 620, the indicator 618a may indicate, for example, that the electromechanical driver component 610 is in an "on" state, and the indicator 618b may indicate, for example, whether the gap between the second jaw 50 and the first jaw 80 is within an acceptable range. It will be appreciated that although only two indicators 618a, 618b are depicted, any number of additional indicators may be provided as necessary. Additionally, it is contemplated that although only a single display 616 is depicted, any number of displays may be additionally provided as desired.

The display 616 'and indicators 618 a', 618b 'of the wired RCU1150, and the display 616 "and indicators 618 a", 618b "of the wireless RCU1148 operate and control similarly via the respective controllers 1322, 1322' in accordance with the operating program or algorithm of the instrument attached to the flexible shaft 620.

As described above, the surgical instrument 11 may be configured to clamp, cut, and secure a section of tissue. The operation of the instrument 11 will now be described in connection with the removal of cancerous or anomalous sections of tissue of a patient's bowel, which are but one type of tissue and one type of surgical procedure to be performed using the surgical instrument 11. Generally, in operation, after cancerous or anomalous tissue within the gastrointestinal tract is located, the abdomen of the patient is first opened to expose the bowel. Upon a remote action provided by the electro-mechanical driver component 610, the first and second jaws 50, 80 of the surgical device 11 are advanced to an open position by the first driver. As described above, the surgical device may be initially maintained in the open position, thereby eliminating the need to first advance the surgical device 11 to the open position. The bowel tube immediately to the side of the cancerous tissue is placed between the open first jaw 80 and the second jaw 50. By remote actuation, the first driver is engaged in the opposite direction, and the first jaw 80 is brought into proximity with the second jaw 50, clamping intestinal tissue therebetween. Once the bowel is firmly clamped, the second driver is engaged which causes the pusher plate (with the suture pusher and knife mounted thereon) to move between a first position shown in FIG. 5 and a second position shown in FIG. 6, thereby cutting and stapling the bowel. The second driver is then engaged in the opposite direction so that the staple pusher and knife return to the first position shown in FIG. 5, and the first driver is then engaged to drive the first jaw 80 and the second jaw 50 of the surgical device 11 back to the open position. These steps are repeated on the other side of the cancerous tissue, so that intestinal tissue with the cancerous tissue can be excised, which is stapled at both ends to avoid the flow of intestinal material within the open abdomen.

More specifically, according to an embodiment of the present invention, the surgical device 11 is coupled to the attachment adapter 626 of the electro-mechanical driver component 610 such that the first drive socket 180 engages the first drive shaft 630 of the electro-mechanical driver component 610 and the second drive aperture 310 engages the second drive shaft 632 of the electro-mechanical driver component 610. The pinion 508a is rotated by rotation of the first drive socket 180, which in turn is rotated by rotation of the corresponding drive shaft 630 of the electromechanical driver component 610. The clockwise or counterclockwise rotation of the pinion 508a depends on the direction of rotation of the motor 680. The pinion 508b is rotated by rotation of the second drive socket 310, which in turn is rotated by rotation of the corresponding drive shaft 632 of the electromechanical driver component 610. The clockwise or counterclockwise rotation of the pinion 508b depends on the direction of rotation of the motor 676.

When the surgical device 11 is in the initial closed position as shown in FIG. 4, the first motor 680 is operated to place the surgical device in the open position. In particular, the first motor 680 corresponding to the first drive shaft 630 is activated and the first drive shaft is engaged with the first drive socket 180, thereby causing the pinion 508a to rotate in a first rotational direction, e.g., counterclockwise. Since the circumferentially-disposed gear teeth 5083 of the pinion 508a are meshed with the circumferentially-disposed gear teeth 5291 of the spur gear 529a, rotation of the pinion 508a causes the spur gear to rotate in a first, e.g., clockwise, direction, which is opposite to the direction of rotation of the pinion 508 a. The internal bore 5293 of the first spur gear 529a is engaged with the end 5231 of the first worm 523a, thereby causing the first worm 523a to rotate in the same direction as the first spur gear 529a, i.e., in a clockwise direction. The threads 5233 of the worm 523a engage the gear teeth 5221 of the worm gear 522, thereby causing the worm gear 522 to rotate in a first, e.g., counter-clockwise (as viewed from the top), rotational direction. The internal bore 5222 of the worm gear 522 engages the portion 5212 of the head 5211 of the screw 521, thereby causing the screw 521 to rotate in a first, e.g., counter-clockwise (as viewed from the top), rotational direction. The external threads 5214 of the screw 521 engage the threads of the internally threaded bore 5051 of the anvil 505, thereby causing the anvil 505 to move in a downward direction, i.e., away from the frame housing 506. In this way, the second jaw 50 is opened in a continuous manner. In the illustrated embodiment, the second jaw opens in parallel alignment with the first jaw 80, e.g., in a plane, and begins to separate from the first jaw 80. The motor continues to operate in this manner, eventually placing the surgical device 11 in an open state, as shown in FIG. 3, with a space between the first jaw 80 and the second jaw 50.

Next, the suture mounts 540 attached to the lower parallel edges 5066 of the frame housing 506, or to the lower surface of the suture seat 513, are removed. According to one embodiment, the suture mount is configured to pull end 5181 of pin 518 out of through-hole 5401 of suture tray 540 by pulling upward on lever 5182 of pin 518. The grasping portion 5403 of the suture tray 540 can be grasped so that the suture tray 540 can be pulled away from the surgical device 11. Next, a length of tissue is placed between the first jaw 80 and the second jaw 50. With the staple holder 540 removed from the surgical instrument 11 and the length of tissue disposed between the first jaw 80 and the second jaw 50, the end 5181 of the pin 518 is inserted into the bore 5057 of the anvil 505 and is held in the inserted position against the bias of the spring 524 so that the length of tissue is always disposed between the jaws.

The first motor 680 is operated in the reverse direction to place the surgical instrument in the closed position. Specifically, the first motor 680, which corresponds to the first drive shaft 630, is activated and the first drive shaft engages the first drive socket 180, thereby causing the pinion 508a to rotate in a second rotational direction, e.g., clockwise. Since the circumferentially-disposed gear teeth 5083 of the pinion 508a are meshed with the circumferentially-disposed gear teeth 5291 of the spur gear 529a, rotation of the pinion 508a causes the spur gear 529a to rotate in a second, e.g., counter-clockwise, direction, i.e., opposite the direction of rotation of the pinion 508 a. The internal bore 5293 of the first spur gear 529a is engaged with the end 5231 of the first worm gear 523a, such that the rotation of the first spur gear 529a causes the first worm 523a to rotate in the same rotational direction as the first spur gear 529a, i.e., in a counterclockwise direction. The threads 5233 of the worm 523a are engaged with the gear teeth 5221 of the worm gear 522, such that rotation of the first worm 523a causes the worm gear 522 to rotate in a second, i.e., clockwise (as viewed from the top), direction. The internal bore 5222 of the worm gear 522 is engaged with the portion 5212 of the head 5211 of the screw 521, and thus, rotation of the worm gear 522 causes the screw 521 to rotate in a second, i.e., clockwise (as viewed from the top), direction. The external thread 5214 of the screw 521 is engaged with the thread of the internally threaded hole 5051 of the anvil 505, and thus, the anvil 505 is moved in an upward direction, i.e., toward the frame housing 506, by the rotation of the screw 521. In this way, the second jaw 50 is closed in a continuous manner and is proximate to the first jaw 80. Continued operation of the motor in this manner will eventually bring the surgical device 11 into a closed state, as shown in FIG. 4, wherein the tissue is clamped between the first jaw 80 and the second jaw 50. In this closed condition, the section of tissue stapled and cut is clamped between the pair of parallel disposed edges 5253a and 5253b of the staple holder 513 and the region 5054 of the anvil 505.

To begin the stapling and cutting procedure, the second motor 676 is actuated to move the pusher plate 502 from a first raised position, e.g., a retracted position, to a second lowered position, e.g., an extended position. Specifically, the second motor 676 corresponding to the second drive shaft 632 starts to be started. The second drive shaft 632 is engaged with the second drive socket 310 such that the second drive shaft 632 rotates in a first direction, e.g., counterclockwise, causing the pinion 508b to rotate in a first rotational direction, i.e., counterclockwise. The circumferentially-disposed gear teeth 5086 of the pinion 508b are engaged with the circumferentially-disposed gear teeth 5292 of the spur gear 529b, and rotation of the pinion 508b causes the spur gear 529b to rotate in a first direction, e.g., clockwise, opposite the direction of rotation of the pinion 508 b. The internal bore 5294 of the spur gear 529b is engaged with the end 5234 of the second worm 523b, such that the rotation of the spur gear 529b causes the second worm 523b to rotate in the same rotational, e.g., clockwise, direction as the second spur gear 529 b. The threads 5236 of the worm 523b are engaged with the worm gear teeth 5161 of the worm gear 516, such that rotation of the second worm 523b causes the worm gear 516 to rotate in a first direction, such as counterclockwise (as viewed from the top). The threads of the internally threaded bore 5164 of the worm gear 516 engage the threads of the screw 504. Because the threaded rod 504 is non-rotatably coupled to the push plate 502, the threaded rod 504 and the push plate 502 move together in a downward direction. Meanwhile, the thread 5236 of the worm 523b is engaged with the gear teeth 5171 of the worm gear 517, and thus rotation of the worm 523b causes the worm gear 517 to first rotate in a clockwise direction (as viewed from the top). The threads of the internally threaded bore 5174 of the worm gear 517 engage the threads of the screw 503. Since the screw 503 is non-rotatably coupled to the push plate 502, the screw 503 moves in a downward direction together with the push plate 502. Thus, the pusher plate 502 moves downward in a continuous manner, as do the staple pushers 514 and knife 519 mounted to the bottom surface 5022 of the pusher plate 502.

As suture pusher 514 is lowered, downwardly disposed teeth 5143 of suture pusher 514 are advanced through slots 5132 of suture seat 513. The staples 528, which are initially disposed in the slots 5132 of the staple holder 513, are pushed downwardly out of the lower openings of the slots 5132 and through the clamped tissue until the tips 5281 of the staples 528 contact the corresponding staple guides 5053 of the anvil 505. The suture guide 5053 bends and closes the tip 5281 of the suture 528, thereby allowing the tissue to be sutured. At the same time, the knife 519, which is mounted to the bottom surface 5022 of the push plate 502, passes through the longitudinally disposed slot 5131 of the staple holder 513 until the knife contacts the knife pad 520 of the anvil 505, whereby the clamped tissue can be excised.

Upon completion of the stapling and excising procedure, the second motor 676 is actuated to move the pusher plate 502 from the second downward position to the first upward position. Specifically, the second motor 676 is activated corresponding to the second drive shaft 632, which corresponds to the second drive socket 310. Rotation of the second drive shaft 632 causes the pinion 508b to rotate in a second direction, such as a clockwise direction. The teeth 5086 of the pinion 508b are engaged with the gear teeth 5292 of the spur gear 529b, such that rotation of the pinion 508b causes the spur gear 529b to rotate in a second, e.g., counter-clockwise, direction. The internal bore 5294 of the spur gear 529b is engaged with the end 5234 of the second worm 523b, such that the rotation of the spur gear 529b causes the second worm 523b to rotate in a second, e.g., counter-clockwise, direction of rotation. The threads 5236 of the worm 523b are engaged with the circumferentially-disposed gear teeth 5161 of the worm gear 516, such that rotation of the worm 523b causes rotation of the worm gear 516 in a second, e.g., clockwise (as viewed from the top), direction. The threads of the internally threaded bore 5164 of the worm gear 516 engage the threads of the threaded rod 504, and because the threaded rod 504 is non-rotatably coupled to the thrust plate 502, the threaded rod 504 and thrust plate 502 move together in an upward direction. At the same time, the threads 5236 of the worm 523b are engaged with the gear teeth 5171 of the worm gear 517, such that rotation of the worm 523b causes the worm gear 517 to rotate in a second, e.g., counter-clockwise (as viewed from the top) direction. The threads of the internally threaded bore 5174 of the worm gear 517 engage the threads of the screw 503, and because the screw 503 is non-rotatably coupled to the thrust plate 502, the screw 503 moves in an upward direction along with the thrust plate 502. In this manner, the push plate 502 is raised in a continuous manner, and the staple pusher 514 and knife 519 mounted to the bottom surface of the push plate 502 are likewise raised in a continuous manner to their initial retracted positions.

After completing the cutting and stapling of the tissue and returning the knife 519 to the retracted position, the first motor 680 is activated to place the surgical instrument in the open position. Specifically, the first motor corresponding to the first driving shaft 630 is started. The first drive shaft 630 engages the first drive socket 180 such that rotation of the first drive shaft 630 causes the pinion 508a to rotate in a first rotational direction, e.g., counterclockwise. The teeth 5083 of the pinion 508a engage the gear teeth 5291 of the spur gear 529a, such that rotation of the pinion 508a causes the spur gear to rotate in a first, e.g., clockwise, direction. The internal bore 5293 of the first spur gear 529a is engaged with the end 5231 of the first worm 523a, such that the rotation of the first spur gear 529a causes the first worm 523a to rotate in the same direction as the first spur gear 529a, e.g., in a clockwise direction. The threads 5233 of the worm 523a engage the gear teeth 5221 of the worm gear 522, such that rotation of the worm 523a causes the worm gear 522 to rotate in a first direction, e.g., clockwise (as viewed from the top). The internal bore 5222 of the worm gear 522 engages the portion 5212 of the head 5211 of the screw 521, such that rotation of the worm gear 522 causes the screw 521 to rotate in a first direction, e.g., counter-clockwise (as viewed from the top). The external threads 5214 of the screw 521 engage the internally threaded bore 5051 of the anvil 505 such that rotation of the screw 521 causes the anvil 505 to move in a downward direction, e.g., away from the frame housing 506. In this manner, the second jaw 50 is separated from the first jaw 80 until the surgical device 11 is in the open position, as shown in FIG. 3, with a space between the first jaw 80 and the second jaw 50.

Thereafter, the surgical device 11 is separated from the electromechanical driver component and replaced with another surgical device 11 so that the same clamping, cutting, and stapling procedures can be performed on different tissue portions, such as on opposite sides of abnormal or cancerous tissue. Once the second end of the intestine is also clamped, cut, and stapled, the surgical device 11 may also be separated from the electromechanical driver component 610. The operator may also discard the accessory or sterilize it for reuse, if necessary.

It is noted that a calibration procedure should be performed prior to activation of the surgical device 11. This procedure is described in U.S. provisional application No. 60/337,544, filed on 4.12.2001, entitled "calibration of surgical instruments", the contents of which are incorporated herein by reference.

According to the embodiment of the invention shown in fig. 8A and 8B, the surgical device 11 may be of a non-reloadable type, e.g., where the operator cannot remove the suture holder 513 from the housing 506 and reload the surgical device 11 with a subsequent row of sutures 523, thereby failing to reuse the surgical device 11 with the same or other patient or to reuse the surgical device to perform the same or other procedure. Thus, after the surgical device 11 is activated to staple a section of tissue with the staples 528 in the staple holder 513, the surgical device 11 cannot be activated again to staple another section of tissue with a new set of staples 528 or a new staple holder 513. The surgical device 11 is configured to be non-reloadable, thereby reducing the risk of contamination or infection, since the surgical device 11 cannot be used intentionally or unintentionally on two different patients, nor can it be reused on the same patient. However, the surgical device 11 may also be of a reloading type, according to one embodiment of the invention. For example, in this embodiment, the surgical device 11 may be configured such that certain components thereof may be removable from the surgical device 11 so as to be replaceable with respect to the surgical device 11. For example, according to one embodiment of the present invention, the cartridge cap 515, the pin 518, the suture pusher 514 with the knife 519 attached thereto, and the suture holder 513 with the suture tray 540 attached thereto form a replaceable cartridge (cartridge) that can be removably attached to the housing 506 so as to be removed from the housing 506 after use for replacement with another cartridge. The replaceable cartridge may be removed when the upper jaw 80 and the lower jaw 50 are in the fully open position to prevent inadvertent removal of the cartridge when the upper jaw 80 and the lower jaw 50 are clamping, cutting and stapling a section of tissue. In the embodiment shown in fig. 8A and 8B, a rail 5091 is included on the anvil filler 509 that engages the rail groove 5135 of the staple holder 513 when the upper jaw 80 and the lower jaw 50 are not in the fully open position, and that does not engage the rail groove when the upper jaw 80 and the lower jaw 50 are in the fully open position, thereby enabling the staple holder 513 and other components of the replaceable cartridge to be slidably removed from the housing 506 for replacement. In an alternative embodiment, the suture holder 513 may be slid into and out of the housing 506 such that, after a first set of sutures 528 is used, a user may slide into the housing 506 a new suture holder 513 having a new set of sutures 528. Alternatively, after the first set of sutures 528 in the suture holder 513 has been used, the operator may replace the sutures 528 in the same suture holder 513, thereby reusing the same suture holder 513. The pin 518 may be retracted from the aperture 5133 of the suture holder 513 such that the cartridge cap 515 may be removably or removably coupled to the housing 506.

According to another embodiment of the present invention, the surgical device 11 may also be configured to have limited reloadability. For example, the surgical device 11 may be configured to allow only one replacement of the suture holder 513, such that only two clamping, cutting, and stapling operations are allowed for the same patient, e.g., on opposite sides of cancerous tissue, but the replacement of the suture holder 513 is not allowed more than twice.

In another embodiment of the present invention, the surgical device 11 may also be configured to hold two sets of sutures 528 in the suture holder 513, a first set for one side of the tissue cancerous portion and a second set for the other side of the tissue cancerous portion. It should be appreciated that the surgical device 11 may be configured for any number of uses, the usage of which may be determined based on the usage data 1184. That is, the memory module 501 may be used to store data indicative of the number of reloads of the surgical device 11. Thus, according to the operating program, the electro-mechanical driver component 610 may limit the number of reloads of the surgical device 11 based on the usage information stored in the memory module 501.

The operation of the reloading type surgical instrument 11 is similar to the operation of the non-reloading type surgical instrument 11 as described above. However, the reloadability of the surgical device 11 allows the operator to perform additional steps during operation of the surgical device 11. For example, once the surgical device 11 is initially in the open position, the operator may access the suture holder 513, and may also check to determine whether the suture 528 is ready and/or to determine whether it is necessary to replace the suture holder 513 with a more suitable suture holder 513. Similarly, once the clamping, cutting, and stapling operations have been performed and one set of staples 518 is in use, the operator may again access the staple holder 513 to replace the staple holder 513 with another staple holder 513 or insert another set of staples 518 into the same staple holder 513.

According to the embodiment of the present invention illustrated in fig. 8A and 8B, the surgical device 11 may be configured to operate in a plurality of operating ranges. This feature has the following advantages: the surgical instrument 11 is well suited for use when the tissue portions have different thicknesses. For example, according to one embodiment of the present invention, the surgical device 11 can be configured such that the distance between the upper jaw 80 and the lower jaw 50 can be changed when the surgical device 11 is in the closed position, or the position of the push plate 535 relative to the upper jaw 80 can be changed when the push plate 535 is in the fully extended position. According to one embodiment, the surgical device 11 may be of the reloadable type, such that two or more different sizes of suture seats 513 may be used, such as suture seats 513 of different thicknesses or suture seats that accommodate sutures 518 of different lengths. In this embodiment, the operator may choose to use one of two or more different suture mounts 513 having different sized sutures 528 disposed therein. The suture holder 513 may include a memory module that is readable by the controller 1122 so that the controller 1122, upon identifying the suture holder 513, may identify whether it includes a suture suitable for suturing a corresponding thickness of tissue. The controller 1122 may then control the first drive shaft 630 during operation such that the distance between the upper jaw 80 and the lower jaw 50 corresponds to the thickness of tissue to be cut and stapled by the staples 523 when the surgical device 11 is moved to the closed position. Similarly, the controller 1122 can control the second drive shaft 632 such that, when moved to the extended position, the push plate 535, suture pusher 514, and knife 519 are positioned to correspond with the thickness of tissue to be cut and stapled by the staples 523.

In accordance with another embodiment of the present invention, different sizes of non-reloading surgical instruments 11 may also be used, each size of the non-reloading surgical instruments 11 corresponding to a different thickness of tissue to be cut and stapled. In this embodiment, the memory module 501 of the surgical device 11 includes data that is readable by the controller 1122 to enable the controller 1122 to identify the surgical device 11 corresponding to a particular thickness of tissue to be cut and stapled.

In another embodiment of the present invention, the controller 1122 is configured to provide more than one operating range for the same set of stitches 523. For example, the controller 1122 may be configured to allow the operator to select settings corresponding to different thicknesses of tissue to be resected or stapled. For example, according to one embodiment, the controller 1122 is configured to actuate the first drive shaft 630 to close the upper jaw 80 to a first position opposite the lower jaw 50 to clamp the portion of tissue disposed therebetween. The operator can then select whether to activate the second drive shaft 632 to cut and staple tissue, or whether to again activate the first drive shaft 630 to close the upper jaw 80 to a second position opposite the lower jaw 50. This embodiment has the following advantages: the operator need not preselect the particular size of the surgical device 11 or a replaceable cartridge for the surgical device 11 before the tissue to be excised and stapled is exposed and its thickness is determined. This arrangement may prevent the operator from pre-selecting the wrong size or keeping a list of more than one available size.

The surgical device 11 may also be configured to automatically calibrate when connected to the electro-mechanical driver component 610. For example, the controller 1122 may be configured to open or close the surgical device 11 prior to operation in order to determine a fully open or fully closed position of the surgical device 11. According to one embodiment, the surgical device 11 and the electro-mechanical driver component 610 are configured to perform an automatic calibration procedure that is independent of the presence and thickness of the suture mount 540 by employing a mechanical hard-stop (hard-stop) calibration component. As mentioned above, an embodiment of a calibration procedure for a surgical instrument is described in U.S. provisional patent application No. 60/337,544, the contents of which are incorporated herein by reference.

Fig. 20A to 20C show a flowchart of a main operating program for operating the surgical device 11, according to an embodiment of the present invention. The main operating program is executed by controller 1122 in accordance with an embodiment of the present invention, although it is understood that other or additional controllers, electronic devices, etc. may be configured to perform some or all of the steps of the flowchart. Referring to FIG. 20A, in step 2002, a host operating program is initialized. This step 2002 may include, for example, the step of obtaining an operating program from the memory unit 1130 or from the memory module 501 of the surgical device 11, as described above. In step 2004, clearing the "DLU Current" (DLU OLD) flag, "DLU Ready" (DLU READY) flag, "DLU Start" (DUL FIRED) flag, and "Axis detect" (SHAFT TEST) flag in each respective memory location in RAM 1134. The term "DLU" refers to the surgical instrument 11 or other device or attachment connected to the electro-mechanical driver component 610 or to the surgical instrument 11 or other device or attachment. In step 2006, the end positions of the motors/tools, such as the motors 676, 680 that drive the surgical instrument 11, are initialized. According to one embodiment of the invention, the end position of the knife 519 is initialized at 0mm and the end position of the anvil 505 is initialized at 1.5 mm. In step 2008, the serial number of the surgical device 11, such as the ID data 1182 stored in the memory module 501 of the surgical device 11, is read from the memory module 501 and saved. According to one embodiment of the present invention, if reading and saving the serial number of the surgical device 11 fails, step 2008 will be repeated a predetermined number of times within a predetermined time period, or at predetermined time intervals. The predetermined number of times may be, for example, three times, and the predetermined period of time may be, for example, 100 ms. An error condition may be determined if reading and saving the serial number of the surgical instrument fails, either initially or after a predetermined number of retries, in which case operation ends as described below.

In step 2010, it is determined whether the ID data 1182 was successfully read and/or whether the ID data 1182 is valid. If it is determined in step 2010 that the ID data 1182 has not been successfully read and/or that the ID data 1182 is invalid, then in step 2012 control returns to a core program, e.g., a basic operating program for the electromechanical driver component 610. If it is determined in step 2010 that the ID data 1182 has been successfully read in step 2008 and/or that the read ID data 1182 is valid, then in step 2014, the "DLU New" feature bits of RAM 1134 are read. In step 2016, a determination is made as to whether the DLU New feature bit was successfully read and/or whether the DLU New feature bit is valid. If it is determined in step 2016 that the "DLU New" feature bit was not successfully read and/or that the feature bit is invalid, then control passes to step 2012, where control returns to the core routine. If it is determined in step 2016 that the DLU NEW feature bit has been successfully read and/or valid, then control passes to step 2018.

In step 2018, it is determined whether the surgical instrument 11 is NEW based on the DLU NEW flag. If it is determined in step 2018 that the surgical instrument 11 is new, the control routine proceeds to step 2026. In step 2026, an auto-zero operation is performed on the surgical instrument 11, and the control program advances to step 2028. The auto-zero routine in step 2026 will be explained below in conjunction with the flowcharts shown in fig. 22A to 22C. If in step 2018 it is determined that the surgical instrument 11 is not new, the control routine proceeds to step 2020 where the display device 616 of the electromechanical driver component 610 indicates that the surgical instrument 11 was determined not to be new in step 2018. For example, in step 2020, the display device 616 may flash quickly and/or emit an audible sound signal. In step 2022, information such as "connect new DLU" is displayed on the display device 616. In step 2024, the "DLU original" feature bit of a storage device, such as RAM 1134, is set, thereby eliminating all functions except the power on function. In addition, the "DLU axis" and "auto-zero" feature bits of the memory devices, such as RAM 1134, are set to cancel the startup axis test function and the auto-zero function. In step 2028, the "DLU check (check)" timer, the "start button" timer, and the "start button" counter are reset.

After the execution of step 2028 is completed, the control routine proceeds to the steps shown in the flowchart of fig. 20B. In step 2030, it is determined whether the main motor power of the electro-mechanical driver section 610 is cut off. If it is determined in step 2030 that the main motor power has been cut off, the control program proceeds to step 2032 where information such as "error 010-view operator manual" is displayed on the display unit 616. At step 2034, an indication signal is provided, such as repeatedly sending an audible signal, such as once per second, until the electromechanical driver component 610 shuts off power. If it is determined in step 2030 that the main motor power is not cut, the remote control apparatus reads data in step 2036. In step 2040, it is determined whether or not a "DLU source" flag is set in, for example, the RAM 1134. If the "DLU original" feature bit is set, control proceeds to step 2054. If it is determined in step 2040 that the "DLU original" feature bit has not been set, then the control routine advances to step 2042 where a determination is made as to whether the "start" key, such as switch 1320 of wireless RCU1148 or switch 1320' of wired RCU1150, has been pressed. If it is determined in step 2042 that the "start" key has been pressed, the control routine advances to step 2044 where a start operation is performed. This startup operation will be described later, which is shown in fig. 24A to 24C. If it is determined in step 2042 that the "start" key has not been pressed, control proceeds to step 2046.

In step 2046, a determination is made as to whether a "close" key, such as switch 1320 of wireless RCU1148 or switch 1320' of wired RCU1150, has been pressed. If it is determined in step 2046 that the "close" key has been pressed, the control routine proceeds to step 2048 where a closing operation as shown in FIGS. 21A to 21C is performed. If it is determined in step 2046 that the "close" key has not been pressed, the control program advances to step 2054 where a determination is made as to whether the "open" key, such as the switch 1320 of the wireless RCU1148 or the switch 1320' of the wired RCU1150, has been pressed. If it is determined in step 2054 that the "open" key has been pressed, the control routine proceeds to step 2056 where an open operation is performed as shown in FIG. 23. If it is determined in step 2054 that the "open" key has not been pressed, control proceeds to step 2058.

In step 2058, a determination is made as to whether any other key, such as any key of wireless RCU1148 or wired RCU1150, has been pressed. If it is determined in step 2058 that a key has been pressed, control proceeds to step 2064. If it is determined in step 2058 that no key has been pressed, control proceeds to step 2060. In step 2060, a determination is made as to whether the start button timer has exceeded a predetermined period of time, such as 10 seconds. If it is determined in step 2060 that the start button timer did exceed the predetermined time period, the start button timer and counter are reset in step 2062. The control routine then advances to step 2064 where a determination is made as to whether the start button counter has a value of "1". If, in step 2064, it is determined that the start button counter has a value of "1", the control routine advances to step 2066 where the display of the anvil gap is resumed on the display device 616. After execution of step 2066 is complete, control proceeds to step 2050 where the start button counter is reset. Thereafter, in step 2052, a kernel program (kernel) is called in order to check for manipulation or disengagement of the key and the procedure is performed.

After step 2044, step 2052 or step 2060 is executed, and the control routine advances to the step shown in fig. 20C. In step 2068, a determination is made as to whether the DLU detection timer value is greater than or equal to a predetermined value, such as 100 ms. If it is determined in step 2068 that the DLU check timer has no value greater than or equal to the predetermined value, control proceeds to step 2082. If it is determined in step 2068 that the DLU check timer value is greater than or equal to the predetermined value, then in step 2070, the DLU check timer is reset. In step 2072, the DLU sequence number is read. In step 2074, it is determined whether the DLU sequence number can be read. If it is determined in step 2074 that the DLU sequence number cannot be read, then the "DLU Current" feature bit in RAM 1134 is cleared. If it is determined in step 2074 that the DLU's serial number can be read, then the DLU's current feature bit is set in step 2078.

In step 2080, a determination is made as to whether the serial number of the surgical device 11 has changed. If it is determined in step 2080 that the serial number has not been changed, the control program proceeds to step 2082, where an IDLE program is invoked. After that, control returns to step 2030. If the serial number is not changed, as determined in step 2080, the serial number is stored in a temporary storage location, as determined in step 2084. In step 2086, the serial number of the surgical instrument 11 is read. In step 2088, a determination is made as to whether the DLU serial number can be read. If it is determined in step 2082 that the DLU serial number cannot be read, control proceeds to step 2082 where an IDLE program is invoked. If it is determined in step 2088 that the DLU serial number can be read, then in step 2090 a comparison step is performed for the DLU serial number with the serial number stored in the temporary storage location. If it is determined in step 2090 that the comparison between the DLU serial number and the serial number stored in the temporary storage location was not successful, control passes to step 2082 where an IDLE procedure is invoked. If it is determined in step 2090 that the comparison of the DLU serial number to the serial number stored in the temporary memory location was successful, then in step 2092, the serial number of the surgical device 11 is read. At step 2094, a determination is made as to whether the DLU serial number can be read. If it is determined in step 2094 that the DLU serial number cannot be read, control passes to step 2082 where an IDLE process is invoked. If it is determined in step 2094 that the DLU serial number can be read, then in step 2096, a comparison step is performed for the DLU serial number with the serial number stored in the temporary storage location. If it is determined in step 2096 that the comparison between the DLU serial number and the serial number stored in the temporary storage location was not successful, control passes to step 2082 where an IDLE procedure is invoked. If it is determined in step 2096 that the comparison between the DLU sequence number and the sequence number stored in the temporary storage location was successful, then in step 2098, control returns to the core program.

Figures 21A through 21C illustrate a jaw closing procedure for closing the jaws when the surgical device 11 is coupled to the electromechanical driver component 610. Although the closing procedure may be performed by the controller 1122 as described above, it will be appreciated that other controllers, motorized devices, etc. may be used to perform some or all of the steps shown in fig. 21A through 21C, in accordance with an embodiment of the present invention.

Referring to FIG. 21A, in step 2101, the clamp closing procedure is initialized. In step 2104, it is determined whether the surgical instrument 11 has been auto-zeroed, e.g., whether an auto-zero operation has been performed or performed thereon. If it is determined in step 2104 that the surgical instrument 11 is not auto-zeroed, then an auto-zero operation is performed in step 2106. The flow diagrams of fig. 22A through 22C illustrate one embodiment of auto-zeroing. Then, in step 2108, all keys of a remote device, such as wireless RCU1148 or wired RCU1150, are awaited for release. In step 2110, control returns to the main operating program of fig. 20A through 20C. If it is determined in step 2104 that the surgical device 11 has been auto-zeroed, the control program advances to step 2112, where it is determined whether the flexible shaft 620 has been inspected. If it is determined in step 2112 that the flexible shaft 620 is not detected, in step 2114, a shaft detection procedure is performed. Fig. 25A to 25B show one embodiment of the axis detection program. If it is determined in step 2116 that the axis detection performed in step 2114 was not successful, the control program proceeds to step 2108. As described above, in step 2108, release of all keys of the remote device is awaited, and in step 2110, control returns to the main operating program.

If it is determined in step 2112 that the flexible shaft 620 is not detected, or if it is determined in step 2116 that the shaft detection of the flexible shaft is unsuccessful, the control program proceeds to step 2118 in which the surgical instrument 11 is labeled: is no longer new. For example, in step 2118, data is written in the memory module 501 to indicate that the surgical instrument 11 is no longer new. In step 2120, a determination is made as to whether the marking step 2118 was successful. If it is determined in step 2120 that the flagging step 2118 was unsuccessful, then control proceeds to step 2122 where information such as "replace DLU" is displayed on display device 616. In step 2124, an audio sound signal is emitted. In step 2126, the release of all keys of remote device 1148 or 1150 is awaited. Then, in step 2128, control returns to the main operating program shown in fig. 20A to 20C.

If it is determined in step 2120 that the marking routine performed in step 2118 was successful, control proceeds to step 2130. In step 2130, a value corresponding to the current position of the anvil 505 is obtained and a determination is made in step 2132 as to whether the value corresponding to the current position of the anvil 505 is greater than a value referred to as the "anvil gap green range". This "anvil gap green range" may be stored into a storage location such as storage unit 1130. If it is determined in step 2132 that the value corresponding to the current position of the anvil 505 is greater than the "anvil gap green range" reference value, then in step 2134 a message such as "anvil closed" is displayed, such as on display device 616, and the message (msg) flag is set to a value of "0". If it is determined in step 2132 that the value corresponding to the current position of the anvil 505 is not greater than the "anvil gap green range" reference value, then a determination is made in step 2136 as to whether the value corresponding to the current position of the anvil 505 is greater than a "anvil gap blue range" value, referred to as a reference. If it is determined in step 2136 that the value corresponding to the current position of the anvil 505 is greater than the "anvil gap blue range" reference value, then in step 2140, a message, such as "green OK", is displayed, such as on display device 616, and the message flag is set to a "1" value. If it is determined in step 2136 that the value corresponding to the current position of the anvil 505 is not greater than the "anvil gap blue range" reference value, then in step 2138 a message, such as "blue OK", is displayed, such as on display device 616, and the message flag is set to a value of "2". In this manner, the information displayed on the display device 616 may provide an indication to the user whether the gap between the first jaw 80 and the second jaw 50 is in a range such as "green" (the tissue portion is in the first predetermined thickness range) or "blue" (the tissue portion is in the second predetermined thickness range). According to one embodiment of the invention, the "green" range corresponds to a tissue portion thickness in the range of between about 1.5mm and 2.0mm, and the "blue" range corresponds to a tissue portion thickness in the range of less than about 1.5 mm. After either of steps 2138 and 2140 have been executed, control proceeds to step 2142 where the graphical gap display is updated, for example, on the display device 616. After the execution of step 2134 or 2142 is completed, the control routine proceeds to step 2144 shown in fig. 21B.

Referring to the flow chart of FIG. 21B, in step 2144, it is determined whether the gap between the first jaw 80 and the second jaw 50 is greater than a predetermined value referred to as a "minimum anvil gap," which may be stored in a storage location such as in the storage unit 1130. If it is determined at step 2144 that the gap between the first jaw 80 and the second jaw 50 is not greater than the "minimum anvil gap" predetermined value, then the control routine advances to step 2186 in the flowchart of FIG. 21C. If it is determined in step 2144 that the gap between the first jaw 80 and the second jaw 50 is greater than the "minimum anvil gap" predetermined value, the control routine advances to step 2146. In step 2146, the value for speed is set to a value referred to as "closing speed", the value for torque is set to a value referred to as "closing torque", and the value for position is set to a value referred to as "closing position", all of which may be stored in a storage location such as storage unit 1130. In step 2148, movement of the jaws of the surgical instrument 11 is initiated and a stall timer (stall timer) is reset. In step 2150, a determination is made as to whether the "close" key is released. If it is determined in step 2150 that the "close" key is released, control proceeds to step 2186 shown in the flowchart of FIG. 21. If it is determined in step 2150 that the close key has not been released, the control routine proceeds to step 2152 where it is determined whether the stall timer value is greater than a predetermined value called "closed stall", which may be stored in a memory location such as memory location 1130. If it is determined in step 2152 that the value of the stall timer is greater than the predetermined "closed stall" value, then in step 2154 it is determined whether the value corresponding to the gap between the first jaw 80 and the second jaw 50 of the surgical instrument 11 is referred to as a "maximum anvil gap" value, which may be stored in a memory location such as memory unit 1130. If it is determined in step 2154 that the value corresponding to the gap between the first jaw 80 and the second jaw 50 of the surgical instrument 11 is less than or equal to the value referred to as the "maximum anvil gap," then the control routine advances to step 2186, which is illustrated in the flowchart of FIG. 21C. If it is determined in step 2154 that the value corresponding to the gap between the first jaw 80 and the second jaw 50 of the surgical device 11 is not less than or equal to the value referred to as the "maximum anvil gap," then in step 2156, a message such as "failure to close" is displayed on, for example, the display device 616. In step 2158, the audio sound signal is transmitted, and the control program proceeds to step 2186 shown in fig. 21C.

Referring back to step 2152, if the stall timer value is not greater than the predetermined "closed stall" reference value in step 2152, control proceeds to step 2160 where a current anvil position is obtained. In step 2162, a determination is made as to whether the position of the anvil 505 has changed. If it is determined in step 2162 that the position of the anvil 505 has changed, then in step 2164, the last known position of the anvil 505 is updated and the stall timer is reset. If it is determined in step 2162 that the position of the anvil 505 has not changed, the control routine advances to step 2166. In step 2166, a determination is made as to whether the current position of the anvil 505 is less than or equal to a value, referred to as the "anvil gap green range," which is stored in a memory location, such as memory unit 1130. If it is determined in step 2166 that the current position of the anvil 505 is less than or equal to the value referred to as the "anvil gap green range", then the control routine advances to step 2168, where it is determined whether the current position of the anvil 505 is less than or equal to a value referred to as the "minimum anvil gap", which may be stored in a memory location, such as memory unit 1130. If it is determined in step 2168 that the current position of the anvil 505 is less than or equal to the predetermined value, referred to as the "minimum anvil gap", then the control routine advances to step 2186, which is illustrated in the flowchart of FIG. 21C. If it is determined in step 2168 that the current position of the anvil 505 is not less than or equal to the predetermined value, referred to as the "minimum anvil gap", then in step 2170, it is determined whether the jaws of the surgical instrument 11 have completed moving. If it is determined at step 2170 that the first jaw 80 and the second jaw 50 of the surgical device 11 have completed moving, the control program advances to step 2186, which is illustrated in the flowchart of FIG. 21C. If it is determined in step 2170 that the first jaw 80 and the second jaw 50 of the surgical device 11 have not completed movement, the control routine returns to step 2150.

Referring back to step 2166, if it is determined that the current position of the anvil 505 is greater than a value referred to as the "anvil gap green range", then the control routine proceeds to step 2172, where it is determined whether the current position of the anvil 505 is greater than a value referred to as the "anvil gap blue range", which may be stored in a memory location such as memory unit 1130. If it is determined in step 2172 that the current position of the anvil 505 is greater than the value referred to as the "blue range of anvil gap", then the control routine proceeds to step 2174 where it is determined if the value of the information characteristic bit is "1". If it is determined in step 2174 that the value of the information characteristic bit is not "1", then in step 2176 the controller 1122 sets the value of the information characteristic bit to "1" and displays information such as "green OK" on, for example, the display device 616 indicating that the user may use a "green" cartridge corresponding to the particular thickness of tissue to be sutured. After step 2176 is complete, or if the value of the information feature bit is determined to be "1" in step 2174, then control passes to step 2178.

If it is determined in step 2172 that the current position of the anvil 505 is not greater than a value referred to as the "anvil gap blue range", which may be stored in a storage location such as storage unit 1130, then in step 2180, a determination is made as to whether the value of the information characteristic bit is "2". If it is determined in step 2180 that the value of the informative feature bit is not "2", then in step 2182, the value of the informative feature bit is set to "2" and information such as "blue OK" is displayed on, for example, display device 616 indicating that the user may use a "blue" cartridge corresponding to a particular thickness of tissue to be sutured. After step 2182 is completed, or after the value of the information flag is determined to be "2" in step 2180, control proceeds to step 2178. In step 2178, the image gap display, for example, on display device 616, is updated. In step 2184, the "in range" display, e.g., light emitting diode, is turned on and the "DLU enable" flag in RAM 1134 of memory unit 1130 is set. Thereafter, the control routine proceeds to step 2168.

After steps 2158, 2168, or 2170 are performed, control proceeds to step 2186, where the motor driving the anvil 505, e.g., motor 680, is turned off. At step 2188, a determination is made as to whether the value corresponding to the current gap state is less than or equal to a predetermined value referred to as the "maximum anvil gap," which may be stored in a storage location such as storage unit 1130. if at step 2188 it is determined that the value corresponding to the gap is less than or equal to the predetermined value stored in the storage location referred to as the "maximum anvil gap," the control routine proceeds to step 2192 where the graphical gap display on display device 616 is updated. If it is determined in step 2188 that the value corresponding to the gap is not less than or equal to the predetermined value referred to as the "maximum anvil gap," then in step 2190, release of all keys of the remote device is awaited and control returns to the main operating program illustrated in FIGS. 20A through 20C in step 2194.

Figures 22A through 22C illustrate one embodiment of an auto-zero procedure for performing the auto-zero function of the surgical instrument 11 when the surgical instrument is coupled to the electro-mechanical driver component 610. Although the zeroing procedure may be performed by the controller 1122 as described above according to one embodiment of the present invention, it is understood that other controllers, electronic devices, etc. may be configured to perform some or all of the steps shown in fig. 22A-22C. Referring to fig. 22A, in step 2202, an auto-zero procedure is initialized. In step 2204, release of all keys of the remote device is awaited. In step 2206, information, such as the "calibrate" word, is displayed, such as on display device 616. In step 2208, the "ready to start" feature bit and the "auto zero OK" feature bit are reset. In step 2210, the current position of the anvil 505 is set to a value, referred to as an "auto-zero position," which may be stored in a storage location, such as storage unit 1130. In step 2212, the torque is set to a value referred to as "auto-zero torque," which may be stored in a storage location such as storage unit 1130. In step 2214, the speed is set to a value called "auto-zero speed," which may be stored in a storage location such as storage unit 1130. In step 2216, the destination location is set to a value of "0". In step 2218, a motor, such as motor 680, corresponding to the anvil 505 is signaled to begin moving the anvil 505, thereby closing the jaws of the surgical instrument 11. In step 2220, the stall timer and the last position are reset. The control program then executes the steps shown in the flowchart of fig. 22B.

In step 2222, a determination is made as to whether the stall timer value is greater than a value known as "auto-zero stall," which may be stored in a storage location such as storage unit 1130. If it is determined in step 2222 that the value of the stall timer is greater than the predetermined value, referred to as "auto-zero stall", the control routine proceeds to step 2242, where the motor corresponding to the anvil 505, such as motor 680, is turned off. If it is determined in step 2222 that the value of the stall timer is not greater than the predetermined value, referred to as "auto-zero stall", the control routine advances to step 2224 where a determination is made as to whether the current position of the anvil 505 is equal to the last position. If it is determined in step 2224 that the current position of the anvil 505 is not equal to the last position, then in step 2226, the stall timer and the last position are reset. If it is determined in step 2224 that the current position of the anvil 505 is equal to the last position, the control routine proceeds to step 2228 where a determination is made as to whether any of the keys of a remote device, such as the wireless RCU1148 or the wired RCU1150, has been pressed. If it is determined in step 2228 that any key of the remote device has been pressed, then in step 2230, the stall timer and last position are reset. In step 2232, the anvil 505 is opened a predetermined distance, referred to as "anvil backup," a value of which may be stored in a storage location, such as storage unit 1130, or until the value of the stall timer exceeds a value referred to as "auto-zero stall," or a multiple thereof, such as a multiple of the "auto-zero stall" value. In step 2232, a motor, such as motor 680, corresponding to the anvil 505 is turned off. In step 2234, an audio sound signal is emitted and a message such as "press close key to recalibrate" is displayed, for example, on display device 616. In step 2236, release of all keys of the remote device is awaited, and in step 2238 control returns to the main operating program, such as the main operating program shown in fig. 20A to 20C.

If, in step 2228, it is determined that no keys of the remote device have been depressed, the control program advances to step 2240 where it is determined whether movement of the clamp is complete. If it is determined in step 2240 that the movement of the clamp is not complete, control returns to step 2222. If it is determined in step 2240 that the jaw movement is complete, the control routine proceeds to step 2242 where the motor driving the anvil 505, such as motor 680, is turned off. In step 2244, both the distal position value and the proximal position value are set to 1.5 mm.

The control routine then proceeds to the step shown in fig. 22C. In step 2246, the stall timer and the last position are reset in storage. In step 2248, the speed is set to a predetermined value, referred to as the "opening speed," which may be stored in a storage location such as storage unit 1130. In step 2250, the destination position is set to a predetermined value, referred to as the "open destination position," which may be stored in a storage location, such as the storage unit 1130, and causes the jaws of the surgical device 11 to begin to move. In step 2252, a determination is made as to whether the stall timer value is greater than a predetermined value, referred to as "auto-zero stall", or a multiple thereof, such as a multiple of the "auto-zero stall" value. If it is determined in step 2252 that the value of the stall timer is not greater than the predetermined value, referred to as "auto-zero stall", then a determination is made in step 2254 as to whether the current position of the anvil 505 is equal to its last position. If it is determined in step 2254 that the current position of the anvil 505 is not equal to its last position, then in step 2256 the stall timer and last position are reset. If at step 2254 it is determined that the current position of the anvil 505 is equal to the last position, then the control routine continues to step 2258 where a determination is made as to whether any of the keys of the remote device, such as the wireless RCU1148 or the wired RCU1150, has been pressed. If it is determined that the remote device key is pressed, the motor, e.g., motor 680, driving the anvil 505 is turned off in step 2268. In step 2270, a beep or other audio signal is sent to the user and information such as "press close to recalibrate" is displayed, for example, on display device 616. In step 2272, the release of all keys of the remote device is awaited, and in step 2274, control returns to the main operating program as shown in fig. 20A through 20C.

If it is determined at step 2258 that a key of the remote device, such as either of the wireless RCU1148 or the wired RCU1150, has not been pressed, a determination is made at step 2260 as to whether movement of the jaws of the surgical instrument 11 is complete. If in step 2260 it is determined that the movement of the clamp is not complete, control returns to step 2252. If it is determined in step 2260 that the jaws of the surgical instrument 11 have completed moving, then in step 2262, the anvil motor, e.g., motor 680, is turned off and an audio signal is emitted or a message, e.g., a "ready" word, is displayed on the display device 616. In step 2264, the "auto zero OK" feature bit is set and the release of all keys of the remote device is awaited. In step 2266, control returns to the main operating program as shown in FIGS. 20A through 20C.

FIG. 23 illustrates an embodiment of an open clamp procedure for opening the surgical device 11 when the surgical device is coupled to the electro-mechanical driver component 610. While the above-described operations are performed by controller 1122 in accordance with one embodiment of the present invention as described above, it will be appreciated that other controllers, electronics, etc., may be used to perform some or all of the steps of the open clamp procedure. Referring to FIG. 23, at step 2300, the open clamp procedure is initiated. In step 2302, the "in-range" display, such as a light emitting diode, is turned off and the "DLU ready" feature bit in memory is cleared. In step 2304, a determination is made as to whether an "auto-zero" feature bit is set in memory. If it is determined in step 2304 that the "auto zero" feature bit is not set in memory, then in step 2306, information such as "press close key to recalibrate" typeface is displayed on the display device 616. At step 2308, an audio signal (audio signal) or sound (chime) is sent to the user. At step 2310, the release of all keys of the remote device is awaited. Thereafter, in step 2312, control returns to the main operation routine shown in fig. 20A to 20C.

If it is determined at step 2304 that the "auto zero" feature bit has been set, then at step 2314 the anvil torque is set to a certain value referred to as "opening torque" which may be stored in a memory location such as memory unit 1130. At step 2316, the speed is set to a predetermined value referred to as the "opening speed," which may be stored in a storage location such as storage unit 1130. At step 2318, the purpose of the clamp is set to the fully released position. In step 2320, information in the form of "anvil open" is displayed, such as on display device 616. In step 2324, the information characteristic bits in memory are cleared. In step 2326, a determination is made as to whether the "open" key of the remote device is released. If it is determined in step 2326 that the "open" key is released, the control program proceeds to step 2328 where the anvil motor, such as motor 680, is turned off and the release of all keys of the remote device is awaited. At step 2330, the control program returns to the main operating program as shown in fig. 20A through 20C.

If it is determined in step 2326 that the "open" key has not been released, an anvil clearance value, such as the clearance value between the first jaw 80 and the second jaw 50 of the surgical instrument 11, is obtained in step 2332. In step 2334, a determination is made as to whether the gap is greater than a value referred to as the "anvil fully open gap," which may be stored in a storage location such as storage unit 1130. If it is determined in step 2334 that the gap is greater than the value referred to as the "anvil fully open gap," then a determination is made in step 2336 whether the information flag is set. If it is determined in step 2336 that the message flag is not set, then the message flag is set in step 2338 and a message in the form of "anvil fully open" is displayed, for example, on display device 616. Control then proceeds to step 2340. Similarly, if it is determined in step 2334 that the gap is not greater than the value referred to as the "anvil fully open gap", or if it is determined in step 2336 that the message flag is not set, then control passes to step 2340. In step 2340, a determination is made as to whether movement of the jaws of the surgical device 11 is complete. If it is determined in step 2340 that the movement of the clamp is not complete, control returns to step 2326. If it is determined in step 2340 that movement of the jaws of the surgical device 11 is complete, the control routine proceeds to step 2328. As described above, in step 2328, anvil motor 505, such as motor 680, is turned off and waits for the release of all keys of the remote device. Control returns to the main operating program as shown in fig. 20A through 20C in step 2330.

FIG. 24A illustrates a suture initiation sequence for cutting and stapling a section of tissue clamped between upper and lower jaws of a surgical instrument 11 when the surgical instrument is coupled to the electro-mechanical driver component 610. Although the above-described operations are performed by the controller 1122 in accordance with one embodiment of the present invention, as described above, it should be appreciated that other controllers, electronics, and the like may be configured to perform some or all of the steps of the suture initiation procedure. Referring to fig. 24A, in step 2400, the suture start-up procedure is initialized. In step 2402, it is determined whether the "auto zero OK" feature bit is set, and if it is determined in step 2402 that the "auto zero OK" feature bit is not set, then in step 2404, an error message such as "press close key to recalibrate" is displayed on the display device 616. If it is determined that the "auto zero OK" feature bit is set, control proceeds to step 2406. In step 2406, a determination is made as to whether the "DLU ready" feature bit is set. If it is determined in step 2406 that the "DLU ready" flag is not set, then in step 2408, an error message, such as the "out of range" word, is displayed on, for example, display device 616. If it is determined in step 2406 that the "DLU ready" feature bit is set, control proceeds to step 2410. In step 2410, it is determined whether the "DLU Start" feature bit is set. If it is determined in step 2410 that the "DLU activated" feature bit is set, then it is determined in step 2412 that an error condition has occurred and an error message in the form of "no stitching" is displayed on the display device 616. If it is determined in step 2410 that the "DLU enable" feature bit is not set, control passes to step 2422. Upon completion of steps 2404, 2408, or 2412, control proceeds to step 2414 where the start button count is reset. In step 2416, an audio sound is emitted. In step 2418, the release of all keys is awaited. In step 2420, control returns to the main operating program as shown in FIGS. 20A through 20C.

If, as described above, it is determined in step 2410 that the "DLU enable" feature bit has not been set, control passes to step 2422. In step 2422, the start button count is incremented. At step 2424, it is determined whether the start button was first pressed. If it is determined at step 2424 that the start button was first pressed, at step 2426, information such as the "start button ready" word is displayed on the display device 616. In step 2428, the start button timer is reset. After step 2428 is complete, control returns to step 2418 as described above. If it is determined at step 2424 that the start button was not pressed for the first time, then at step 2430, information such as the "start" word is displayed on, for example, display device 616. In step 2432, the usage count is decremented and the "DLU enable" feature bit is set. According to one embodiment of the invention, control retries a predetermined number of times, such as three times, within a predetermined time interval, such as 100ms, to decrease the usage count.

Control then proceeds to step 2434 as shown in FIG. 24B. At step 2434, a start motor speed is set, for example the speed of a motor that starts the seam, such as motor 676. Additionally, at step 2434, a torque limit is set. At step 2436, the firing motor position is set to a preset value, referred to as the "firing position," which may be stored in a memory location, such as memory unit 1130, and causes the jaws of the surgical device 11 to begin to move. At step 2438, the last known position is set to a value of "0". Additionally, in step 2438, the start and stall timers are reset and the error flag is cleared. In step 2440, a determination is made as to whether the start or stall timer has expired. If it is determined in step 2440 that the start or stall timer has expired, then in step 2452 the first motor, such as motor 676, is stopped. In step 2454, an error message, such as the "startup sequence is not sufficient" word, is displayed, such as on display device 616. In step 2456, a sound or other audio signal is emitted and the out-of-error flag is set. Thereafter, control proceeds to step 2458.

If it is determined in step 2440 that the start or stall timer has not expired, control proceeds to step 2442. In step 2442, a determination is made as to whether the starter motor, such as motor 676, has completed its motion. If it is determined in step 2442 that the starter motor, such as motor 676, has completed its motion, the control routine proceeds to step 2452, as described above. If it is determined in step 2442 that the starter motor, such as motor 676, is not completing its motion, then the control routine advances to step 2444. In step 2444, it is determined whether the current position of the anvil 505 corresponds to the last position of the anvil 505. If it is determined in step 2444 that the current position of the anvil 505 does not correspond to the last position of the anvil 505, then in step 2446, the last position of the anvil 505 is set to correspond to the current position of the anvil 505 and the stall timer is reset. After step 2446 is completed, or after step 2444 determines that the current position of the anvil 505 corresponds to the last position of the anvil 505, the control routine advances to step 2448. At step 2448, a determination is made as to whether the knife, e.g., knife 519, has reached its destination position, e.g., a fully extended position. If it is determined in step 2448 that the knife has not reached its destination, control returns to step 2440. If, at step 2448, it is determined that the knife has reached its destination, then, at step 2450, the controller 1122 stops starting the motor, such as motor 676.

After either step 2450 or 2456 is complete, control proceeds to step 2458. At step 2458, the "in range" display, such as the LEDs, is turned off and the "DLU ready" flag is cleared. At step 2460, the current limit is set to the full limit. At step 2462, the anvil 505 is initially moved back to its initial position. At step 2464, the last known position is set to "0" and the loop and stall timers are reset. In step 2466, as shown in FIG. 24C, it is determined whether the cycle timer is greater than a predetermined value, referred to as "time start," which may be stored in a storage location, such as storage unit 1130. If it is determined in step 2466 that the cycle timer is greater than a predetermined value, referred to as "timer start", then in step 2468, a determination is made as to whether the error flag bit is set. If it is determined in step 2468 that the error flag is not set, then in step 2470, an error message, such as the "start-up sequence not sufficient" word, is displayed, such as on display device 616. After step 2472 is complete, or if it is determined in step 2468 that the error flag is not set, control proceeds to step 2482.

If it is determined in step 2466 that the cycle timer is not greater than a predetermined value, referred to as "timer started", then in step 2474 it is determined whether the stall timer is greater than a predetermined value, referred to as "timed stall", which may be stored in a storage location, such as storage unit 1130, or may be stored as a multiple, such as a multiple of the "timed stall" value. If it is determined in step 2474 that the stall timer is greater than the predetermined value, referred to as "timed stall," control proceeds to step 2468, as described above. If it is determined in step 2474 that the stall timer is not greater than the predetermined value, referred to as "timed stall," then control proceeds to step 2476. In step 2476, a determination is made as to whether the current position of the anvil 505 is the same as the last position of the anvil 505. If it is determined in step 2476 that the current position of the anvil 505 is the same as the last position of the anvil 505, then in step 2478, the last position of the anvil 505 is set to be the same as the current position of the anvil 505 and the stall timer is reset. After step 2478 is completed, or after it is determined in step 2476 that the current position of the anvil 505 is the same as the last position of the anvil 505, the control routine advances to step 2480. In step 2480, a determination is made as to whether the knife, e.g., knife 519, is fully retracted. If it is determined in step 2480 that the knife is not fully retracted, control returns to step 2466. If it is determined in step 2480 that the knife has been fully retracted, or after steps 2468 or 2472 have been performed as described above, then in step 2482, the motor is stopped, such as motor 676. In step 2484, a determination is made as to whether an error flag bit is set in memory. If in step 2484 it is determined that the error flag bit is set in memory, then the control routine proceeds to step 2488 and returns to the main operating routine. If it is determined in step 2484 that the error flag is not set, a message, such as the word "start complete," is displayed, such as on display device 616. Thereafter, in step 2488, control returns to the main operating program.

Fig. 25A shows an axis detection routine corresponding to axis detection for the electromechanical driver component 610. Although the axis detection routine is executed by the controller 1122 in accordance with one embodiment of the present invention as described above, it should be appreciated that other controllers, electronic devices, etc. may be configured to perform some or all of the steps of the axis detection routine. Referring to fig. 25A, in step 2500, the axis detection program is initialized. In step 2502, the torque, speed, and position of a knife motor, such as motor 676, are set to jog a corresponding rotatable drive shaft, such as rotatable drive shaft 632. At step 2504, wait for a predetermined period of time, referred to as "start detect time exceeded," which may be stored in a storage location such as storage unit 1130 or wait for blade 519 to complete its movement. In step 2506, it is determined whether a time period called "start detection time exceeded" has expired. If it is determined in step 2506 that the predetermined period of time called "start detection time exceeded" has expired, then in step 2508, information in the form of, for example, "error 006-see operator manual" is displayed on, for example, display device 616. At step 2510, an audible signal is emitted periodically, for example, once per second, until power to the electromechanical driver component 610 is cut off.

If it is determined in step 2506 that the predetermined period of time, referred to as the "start detect time exceeded," has not yet expired, then in step 2512 a predetermined period of time, referred to as the "start stop time," is waited for, which may be stored in a storage location, such as storage unit 1130, to ensure that the knife 519 completes its movement. In step 2514, a determination is made as to whether the distal position is less than a predetermined position, referred to as the "start detect position," the value of which may be stored in a memory location such as memory unit 1130. If it is determined in step 2514 that the distal end position is not less than the predetermined position, referred to as the "start detection position", then it is determined in step 2516 that an error condition has occurred and an error message, such as the word "replace flexible shaft", is displayed on, for example, display device 616. In step 2518, an audio sound is sounded and an error flag is set. After step 2518 is complete, or if it is determined in step 2514 that the distal end position is less than the "start detection position," control proceeds to step 2520. At step 2520, the distal position is set to an initial, or home, position. In step 2522, a predetermined period of time, referred to as "start detect time exceeded", is waited for, either to be stored in a storage location such as storage unit 1130 or to wait for the blade to complete its movement. At step 2524, a determination is made as to whether a predetermined time period, referred to as "startup detection time exceeded," has expired. If it is determined in step 2524 that the predetermined period of time, referred to as "activation detection time exceeded", has expired, then in step 2526, information in the form of "error 006-see operator manual" is displayed, as on display device 616. At step 2528, an audible signal is emitted until power to the electromechanical driver component 610 is cut off. If it is determined at step 2524 that the time has not expired, then a determination is made at step 2530 as to whether the error flag bit is set, as shown in the flow chart of FIG. 25B. If the error flag is set in step 2530, then the release of all keys of the remote device is awaited in step 2536. Thereafter, in step 2538, control returns to the main operating program in step 2538. If it is determined in step 2530 that the error flag is not set, then in step 2532, a spindle test flag is set to "1". Thereafter, in step 2534, control returns to the main operating program as shown in FIGS. 20A through 20C.

One problem with conventional surgical instruments is that they may limit the angle of approach of the instrument during use. As mentioned above, conventional surgical instruments typically use an instrument shaft that is perpendicular to the tissue portions to be cut and stapled. When used on the body, such as a patient, the conventional instrument will be limited to a single angle of approach to cut and staple a section of tissue.

In contrast, the surgical instrument 11 of the present invention does not limit the approach angle at which the device is used. As previously mentioned, the surgical device 11 according to embodiments of the present invention includes drive shafts 630 and 632 that are coupled to the first jaw 80 at an angle, for example, perpendicular to the plane of movement of the first jaw 80 relative to the second jaw 50. Thus, when the surgical device 11 is used on the body, such as in a patient, the surgical device 11 is not limited to a single angle of approach. Conversely, multiple angles of approach may be employed, which may allow the operator to more efficiently use the surgical instrument on various tissue portions.

Another problem with conventional surgical instruments is that the instruments are difficult to maneuver within the patient. For example, when using conventional surgical instruments to clamp or staple tissue portions that are not easily manipulated, there is a need for the surgical instruments to be flexible in their operation. For example, where a portion of gastrointestinal tissue is located adjacent to the anal stump, that portion of tissue cannot be removed in advance or during the surgical procedure. Conventional surgical instruments cannot be used at this location because the angle of approach required by the operator interferes with the patient's pelvis.

In contrast, the surgical device 11 according to embodiments of the present invention is much less difficult to manipulate within a patient. For example, where a portion of gastrointestinal tissue is located adjacent to the anal stump, the surgical instrument 11 may be located at the very end of the gastrointestinal tissue closest to the anus. Thus, configuring the drive shafts 630 and 632 at an angle, e.g., perpendicularly, relative to the plane of movement of the first jaw 80 relative to the second jaw 50 may improve the operational flexibility of the surgical device 11 within the patient.

The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims (44)

1. A surgical instrument, comprising:

a first clamp;

a second clamp opposite the first clamp;

a first driver for causing relative movement of the first and second jaws in a plane, the first driver being engaged with a first rotatable drive shaft rotatable about an axis of rotation disposed non-parallel to the plane.

2. The apparatus of claim 1, further comprising:

a surgical member disposed within the first jaw; and

a second driver for relatively moving the surgical member in a direction parallel to the plane, the second driver being engaged with a second rotatable drive shaft rotatable about an axis of rotation disposed non-parallel to the plane.

3. The instrument of claim 2, wherein the surgical member comprises a cutting element.

4. The apparatus of claim 2, wherein the surgical member comprises a stapling element.

5. The device of claim 2, wherein the surgical member includes a pusher plate having the cutting element and the stapling element mounted thereon.

6. The device of claim 1, further comprising an electromechanical driver to rotate the first rotatable drive shaft.

7. The device of claim 1, wherein an axis of rotation of the first rotatable drive shaft is perpendicular to the plane in which the first and second jaws move.

8. The device of claim 1, wherein the first rotatable drive shaft rotates in a first direction to extend the jaws and rotates in a second direction opposite the first direction to close the jaws.

9. The device according to claim 1, wherein the first driver includes at least two spur gears, a worm and a worm gear in rotating and meshing relationship with each other, and an externally threaded screw fixedly connected to one end of the worm gear and engaged with an internally threaded bore of the second jaw, rotation of the gears causing relative movement of the first and second jaws.

10. The device of claim 2, further comprising an electromechanical driver to rotate the second rotatable drive shaft.

11. The device of claim 2, wherein an axis of rotation of the second rotatable drive shaft is perpendicular to the plane in which the first and second jaws move.

12. The device of claim 11, wherein the second rotatable drive shaft rotates in a first direction to extend the surgical member and rotates in a second direction opposite the first direction to retract the surgical member.

13. The instrument of claim 2 wherein said second driver comprises two spur gears and a worm in rotating and meshing relationship with each other, and a pair of additional worm gears each having a centrally disposed internally threaded bore for engagement with a respective one of a pair of externally threaded screws fixedly attached to said surgical member, rotation of said gears causing relative movement of said surgical members.

14. The device of claim 2, further comprising an electromechanical driver including a first rotary drive shaft for driving the first driver and a second rotary drive shaft for driving the second driver.

15. The device according to claim 14, wherein the electromechanical driver further comprises at least one motor arrangement for driving each of the first and second rotatable drive shafts.

16. The device according to claim 15, wherein the electromechanical driver includes a first motor means for driving the first rotatable drive shaft and a second motor means for driving the second rotatable drive shaft.

17. A surgical instrument, comprising:

a first rotary drive shaft rotatable about a rotation axis;

a first clamp;

a second clamp opposite the first clamp; and

a first driver for causing relative movement of the first and second jaws in a plane and in response to rotation of the first rotatable drive shaft, the plane being disposed non-parallel to the axis of rotation.

18. The apparatus of claim 17, further comprising:

a surgical member disposed within the first jaw, an

A second driver for relatively moving the surgical member in a direction parallel to the plane, the second driver being engaged with a second rotary drive shaft that rotates about a rotational axis disposed non-parallel to the plane.

19. The instrument of claim 18, wherein the surgical member comprises a cutting element.

20. The apparatus of claim 18, wherein the surgical member comprises a stapling element.

21. The device according to claim 18, wherein the surgical member includes a pusher plate, the cutting element and the stapling element being mounted on the pusher plate.

22. The device of claim 17, further comprising an electromechanical driver to rotate the first rotatable drive shaft.

23. The device of claim 17, wherein an axis of rotation of the first rotatable drive shaft is perpendicular to the plane in which the first and second jaws move.

24. The device of claim 23, wherein the first rotatable drive shaft rotates in a first direction to extend the jaws and rotates in a second direction opposite the first direction to close the jaws.

25. The instrument of claim 17 wherein the first driver comprises at least two spur gears, a worm and a worm gear in rotating and meshing relationship with each other, and an externally threaded screw fixedly connected to one end of the worm gear and engaged with an internally threaded bore of the second jaw, rotation of the gears causing relative movement of the first and second jaws.

26. The device of claim 18, further comprising an electromechanical driver to rotate the second rotatable drive shaft.

27. The device of claim 26, wherein an axis of rotation of the second rotatable drive shaft is perpendicular to the plane in which the first and second jaws move.

28. The device of claim 27, wherein the second rotatable drive shaft rotates in a first direction to extend the surgical member and rotates in a second direction opposite the first direction to retract the surgical member.

29. The instrument defined in claim 18 wherein said second driver includes at least two spur gears and a worm in rotating and meshing relationship with one another, and a pair of additional worm gears each having a centrally disposed internally threaded bore for respectively engaging a respective one of a pair of externally threaded screws fixedly connected to said surgical member, rotation of said gears causing relative movement of said surgical members.

30. The device of claim 18, further comprising an electromechanical driver including a first rotary drive shaft for driving the first driver and a second rotary drive shaft for driving the second driver.

31. The device according to claim 30, wherein the electromechanical driver further comprises at least one motor arrangement for driving each of the first and second rotatable drive shafts.

32. The device according to claim 31, wherein the electromechanical driver includes a first motor means for driving the first rotatable drive shaft and a second motor means for driving the second rotatable drive shaft.

33. The apparatus according to claim 31 further comprising a control system for controlling said motor means.

34. The apparatus of claim 33, wherein the control system is disposed within a housing.

35. The apparatus according to claim 34, further comprising a remote control unit in communication with said control system for controlling said motor means via said control system.

36. The apparatus of claim 35, wherein the remote control unit comprises at least one of a wired remote control unit and a wireless remote control unit.

37. The device of claim 33, further comprising a sensor corresponding to the first rotatable drive shaft, the sensor outputting a signal in response to and in accordance with rotation of the first rotatable drive shaft.

38. The device of claim 37, wherein the control system determines at least one of a rotational position and a rotational direction of the first rotatable drive shaft based on the output signal of the sensor.

39. The apparatus of claim 33, wherein the control system comprises a first memory unit.

40. The device of claim 39 wherein the first memory unit is adapted to store a plurality of operating programs, at least one of the operating programs corresponding to cutting and stapling elements coupled to an end of an elongate shaft.

41. The instrument of claim 40 wherein the control system is configured to identify a surgical device coupled to the distal end of the elongate shaft as a cutting and stapling instrument, wherein the cutting and stapling element is one of a plurality of types of surgical devices coupled to the distal end of the elongate shaft, the control system being configured to retrieve the operating program based on the cutting and stapling element being one of read and selected from the first memory unit.

42. The instrument of claim 41 wherein the control system identifies the cutting and stapling instrument as the type of surgical device attached to the elongated shaft based on data read from a second memory unit disposed within the cutting and stapling instrument.

43. The instrument of claim 42, further comprising a data cable disposed within the elongate shaft, the data cable logically and electrically connected to the control system and logically and electrically connected to the second memory unit.

44. A surgical instrument, comprising:

an electric motor;

a first rotary drive shaft that rotates about a rotation axis by the motor;

a first clamp;

a second clamp opposite the first clamp; and

a first driver for moving the first and second jaws relative to each other in a plane and in response to rotation of the first rotatable drive shaft, the plane and the axis of rotation being non-parallel.