Surgical stapling and cutting instrument with articulatable end effector

[0001] The present invention generally relates to endoscopic surgical instruments, including, inter alia, surgical stapling instruments that can apply rows of staples to tissue, while cutting tissue between these rows of staples, and in particular relates to improvements in joints articulated used in conjunction with surgical stapling tools with articulated end effectors.

BACKGROUND ART [0002] Endoscopic surgical instruments are often preferred over traditional open surgical devices because a smaller incision allows recovery time and complications after surgery. As a consequence, significant progress has been made in the field of endoscopic surgical instruments that are adapted to precisely place the end effector in the required surgical field by the trocar cannula. These end effectors interact with tissue in a variety of ways to achieve a diagnostic or therapeutic effect (e.g., endo-knife, gripper, knife, staplers, clamp applicator, access device, dosing device for drug / gene therapy, and an ultrasound energy device, radio frequency, laser and so on).

[0003] Known surgical staplers include an end effector that simultaneously makes an elongated incision in the tissue and applies rows of staples to opposite sides of the incision. The end effector includes a pair of cooperating jaw elements that, if the tool is intended for endoscopic or laparoscopic applications, can pass through the cannula channel. A staple cartridge having at least two transversely spaced rows of staples is placed in one of the jaw members. The second jaw member forms an anvil, having staple forming pockets, aligned with the rows of staples in the cartridge. The tool includes a plurality of reciprocating wedges that, remotely driven, pass through the holes in the staple cartridge and connect to the driving elements supporting the staples to trigger the staples to extend towards the anvil.

[0004] Examples of surgical staplers suitable for endoscopic applications are described in US Patent No. 6,905,057, Jeffrey S. Swayze and Frederick E. Shelton, IV, entitled Surgical Stapling

Instrument Incorporating a Firing Mechanism Having a Linked Rack Transmission and in US Patent No. 7,083,075, Jeffery S. Swayze, Frederick E. Shelton, IV, Kevin Ross Doll and Douglas B. Hoffman, entitled Multi-Stroke

Mechanism With Automatic End of Stroke Retractions.

[0005] Depending on the nature of the procedure, further adjustment of the end effector placement of the endoscopic surgical tool may be required. In particular, the end effector is often required to be angled with respect to the longitudinal axis of the tool shaft. The lateral or non-axial displacement of the end effector relative to the tool shaft is often referred to as "articulation displacement". Such articulation allows the physician to interact with the tissue much easier in some cases, for example at the back of the organ. In addition, the articulation can advantageously allow the endoscope to be positioned behind the end effector without being blocked by the tool shaft.

[0006] The articulation concepts of the surgical stapling and cutting tool seem to be complicated by integrating the articulation displacement control together with controlling the closing of the end effector to clamp the tissue and triggering the end effector (i.e. stapling and cutting) due to the limitations caused by the small diameter of the endoscopic tool . Generally, three control movements are transmitted through the shaft as longitudinal translational movements. For example, US Patent No. 5,673,840, Schulze et al., Discloses a harmonic-like articulation mechanism ("flexible neck") that is moved by articulation by selectively retracting one of the two connecting rods through a shaft, each rod being arranged in offset relative to each other sides of the shaft centerline. The connecting rods use a ratchet mechanism within a number of separate positions.

[0007] Another example of longitudinal control of the articulation mechanism is shown in US Patent No. 5,865,361, which includes an articulated joint displaced relative to the cam pin in such a way that the longitudinal translational pushing or pulling movement of the articulation joint results in articulation in the right direction. Similarly, US Patent No. 5,797,537 discloses a similar rod passing through the shaft and causing articulation. Further examples of surgical articulated stapling devices are disclosed in US Patent Nos. 6,250,532 and 6,644,532. [0008] Because of the commonly used types of end effector release systems, actuator assemblies for articulating the end effector often have to generate high torque values ​​to bend the release structure. This problem is compounded by the lack of space available to accommodate actuators that are large enough to generate the required forces.

[0009] To solve these problems, surgical instruments with "passive articulation joints" have been developed. For example, US Patent No. US 2007/0027469 A1, Kevin W. Smith, Matthew A. Palmer, Korey Robert Kline and Derek Dee Deville, discloses a medical device that uses a passive articulation. After actuation, the articulation joint is released to free articulated motion to allow free movement of the articulated end effector relative to the control lever depending on external forces acting on the end effector.

[0010] US Patent Publication No. US 2005/0006431 discloses a surgical stapling and cutting tool suitable in particular for endoscopic use that articulates the end effector by having a gear articulated mechanism that converts the rotational motion of a portion of the handle.

[0011] The European Patent published under the number EP 1 769 758 discloses a method and apparatus for activating and / or articulating a rotary stapler. In one embodiment, the rotary stapler has an elongated shaft with a stapling device attached thereto.

An electrically expandable and retractable trigger, such as an electroactive polymeric trigger, can be used to rotatably or angularly adjust the position of the stapling apparatus relative to the elongated shaft by supplying energy to the electroactive polymeric trigger.

[0012] US Patent Publication No. US 2006/049229 discloses a surgical stapling device in particular an endoscopic procedure kit. The device includes a handle assembly and an elongated body extending further from the handle assembly. The distal end of the elongated body is adapted to engage the disposable loading unit. A control rod having a proximal end operatively connected to a handle assembly including a distal end extending through the elongated body. The closing member of the control rod is provided to prevent the control rod from moving until full protection of the disposable loading unit into the elongated body of the stapling device.

[0013] European patent publication number EP 1639008 discloses a surgical instrument in particular adapted for endoscopic use that articulates the end effector by incorporating an articulation transfer mechanism that is proximal controlled.

[0014] Although the aforementioned medical device with a passive articulation system effectively solves the various problems that can be encountered with active articulation systems, there is still a need for medical devices with improved passive articulation systems.

SUMMARY OF THE INVENTION [0015] The present invention provides a surgical instrument as defined in the appended claim 1 and a method for processing a surgical instrument as defined in the appended claim 3.

BRIEF DESCRIPTION OF THE FIGURES [0019] The accompanying drawings, which are incorporated and form part of the present description, illustrate embodiments of the invention and together with the general description of the invention set forth above and the detailed description of the embodiments set forth below, serve to explain the various principles of the present invention.

Fig. 1 is a perspective view of a surgical stapling and cutting tool according to various embodiments of the present invention.

Fig. 2 is an exploded perspective view of the elongated shaft assembly and the articulation mechanism of the surgical stapling and cutting tool of Fig. 1.

Fig. 3 is an exploded perspective view of the distal parts of the surgical tool of the stapling and cutting tool of Fig. 1. Fig. 4 is a cross-sectional elevational view of an articulation according to one aspect of the present disclosure.

Fig. 5 is a perspective view of a dog bone connector that can be used in various aspects of the present disclosure.

Fig. 6 is a cross-sectional elevational view of an articulation joint according to another aspect of the present disclosure.

Fig. 7 is a top view of the articulation joint of Fig. 6 showing the position of certain components in a schematic form.

Fig. 8 is a cross-sectional elevational view of an articulation joint according to another aspect of the present disclosure.

Fig. 9 is a top view of the articulation joint of Fig. 8 showing the position of certain components in a schematic form.

Fig. 10 is a cross-sectional elevational view of an articulation joint according to another aspect of the present disclosure.

Fig. 11 is a top view of the articulation joint of Fig. 10 showing the position of certain components in a schematic form.

Fig. 12 is a cross-sectional elevational view of the articulation joint of the present invention.

Fig. 13 is a top view of the articulation joint of Fig. 12, showing the position of certain components in a schematic form.

Fig. 14 is a cross-sectional elevational view of an articulation joint according to another aspect of the present disclosure.

Fig. 15 is a top view of the articulation joint of Fig. 6 showing the location of certain components in a schematic form.

DETAILED DESCRIPTION [0017] In the drawings, in which similar reference numerals refer to similar components in several views, Fig. 1 shows a surgical tool which in illustrative versions is in particular a surgical stapling and cutting tool in which some unique benefits of the present invention. In particular, the surgical stapling and cutting tool 10 is sized to allow, in a non-articulated state, as shown in Figure 1, through the truss cannula corridor to the patient's surgical site (not shown) to perform a surgical procedure. The end effector, shown in the exemplary version as the staple application unit 20, is attached distally to the shaft portion 16 by means of articulation 100. After the staple application assembly 20 is introduced through the trocar cannula passageway, the physician can move the staple application assembly 20 to the required articulation by "passively" dragging the staple application assembly 20 to contact the organ or other body part or other medical tool for external use forces against the staple application unit 20 to cause its articulation, as discussed in detail below. This angular position may be beneficial when trying to reach the tissue at the required angle to perform cutting and stapling, reaching the tissue in case of other obstruction by other organs and tissue, and / or allow the endoscope to be positioned behind and aligned with the staple application unit in to confirm the location.

[0018] The surgical stapling and cutting tool 10 may include a handle portion 22 proximal to the tool portion 12 to provide position, articulation, closing and firing movements relative thereto. The handle portion 22 may include a pistol grip 24 in which it is rotatably pulled and in a proximal direction a closing trigger 26 to tighten or close the staple application assembly 20. The trigger 28 may be located further outside the closing trigger 26 and may be pivotally pulled by a physician to staple and cut the tissue clamped in the staple application unit 20. Then the closure release button 30 is pressed to release the clamped trigger 26 and thus the cut and stapled ends of the clamped tissue. The handle portion 22 also includes a rotary knob for moving along the longitudinal shaft 16 to rotate the shaft 16 and the staple application assembly 20 about the longitudinal axis of the shaft 16. The handle portion 22 also includes a release retracting handle 34 to assist in retracting the firing mechanism (not shown in Fig. 1) when combined in such a way that staple application assembly 20 may open at a later time.

[0019] It should be noted that the terms "proximal" and "distal" are used herein to refer to a physician holding the tool holder. As a result, the staple application assembly 20 is distal to the proximal portion 22 of the handle. In addition, it should be noted that for convenience and clarity, spatial terms such as 'vertical' and 'horizontal' are used in this document to refer to drawings. However, surgical instruments are used in many directions and positions, and these terms are not limiting or absolute.

[0020] An exemplary portion 22 of the multi-jump handle for the surgical stapling and cutting tool 10 of Figs. 1-2 is described in detail in the following pending and also pending US patent applications with additional elements and variations as described herein:

(1) US Patent Publication No. US 2006 / 0289602A1, Kenneth S. Wales and Eugene L. Timperman, entitled "Surgical Instrument With

Articulating Shaft With Double Pivot Closure And Single

Pivot Frame Portion ";

(2) US Patent Publication No. US 2006 / 0190029A1, Kenneth S. Wales, entitled "Surgical Instrument With Laterally Moved Shaft Actuator Coupled to Pivoting Articulation Joint";

(3) US Patent Publication No. US 2006/0190031 A1, Kenneth S. Wales and Cad P. Boudreaux, entitled "Surgical Instrument With Articulating Shaft With Rigid Firing Bar Supports";

(4) US Patent Publication No. 20050070958 A1, Swayze and Shelton IV, entitled "Surgical Stapling Instrument Incorporating a Multistroke Firing Position Indicator and Retraction Mechanism".

[0021] Although part 22 of the multi-jump handle preferably supports applications with high trigger forces over a long distance, applications in accordance with the present invention may include one trigger stroke, such as described in pending and pending US Patent No. 7,000,818, entitled "Surgical Stapling Instrument Having Separate Distinct Closing and Firing Systems", Frederick E. Shelton IV, Michael E. Setser and Brian J. Hemmelgarn.

[0022] In Figs. 2 and 3, the tool portion 12 may preferably include a plurality of actuating movements among longitudinal rotation, articulation, closing and triggering within a small diameter suitable for endoscopic and laparoscopic procedures. The staple application assembly 20 ("end effector") has a pair of axially opposed jaws shown as an elongated channel 40 with an anvil 42 attached axially (Figs. 1 and 3). Closing and clamping of the anvil 42 on the longitudinal channel 40 is accomplished by longitudinally supporting the longitudinal channel 40 using the frame assembly 44 (Fig. 2) pivotally attached to the handle portion 22 on which the double assembly 46 of the rotary closing sleeve moves longitudinally to apply closing movements and opening against the anvil 42, even when the articulated staple application assembly is moved.

[0023] With reference in particular to Fig. 2, the frame assembly 44 may include one part 48 of the axial frame (which is proximal) which proximal end is connected to a rotary knob 32 with a right half of the cover 50 thereon in Fig. 2. It should be noted that the proximal end of the closing sleeve assembly 46, in particular the straight closing tube 52, surrounds the proximal end of the frame portion 48, further moving inwardly to the handle portion 22 to connect to the closing components (not shown) that move the assembly longitudinally 46 closing sleeve. The round lip 54 at the proximal end of the straight closing tube 52 provides a rotatable engagement with such components. The hooking components of the rotary knob 32 pass through the longitudinal slot 56 in the proximal part of the straight closing tube 52 to engage the opening 58 located closer to the part 48 of the frame. The longitudinal slot 56 is long enough to allow closing longitudinal movement of the closing sleeve assembly 46 at different rotational angles determined by the rotary knob 32 relative to the closing sleeve assembly 46 and the frame portion 48.

[0024] The elongate shaft 16 assists the firing movement by receiving the firing rod 60 which rotatably engages the firing components of the handle portion 22 (not shown). The firing rod 60 enters the proximal opening 62 along the longitudinal center line of the frame portion 48. The distal portion of the frame portion 48 includes a slot 64 of the firing rod along its bottom portion that connects to the proximal opening 62. The firing rod 66 travels longitudinally in the gap 64 of the firing rod and includes an upwardly projecting proximal pin 68 that engages the distal end 70 of the firing rod 60.

[0025] With particular reference to Fig. 3, the articulation connection 100 may comprise a distal section 116 of the closing tube, which may be constructed in the manner shown for increased manufacturing capabilities and may include a short closing tube 146, which is attached to the articulated mounting flange 148 , which may include proximal flaps 126, 128 axial. Similarly, the straight closing tube 52 may be constructed of a long proximal portion 150 of the closing tube that attaches to the rear attachment flange 152, which may include distal protrusions 119, 120 axial. The horseshoe-shaped hole 118 in the short tube 146 is intended to engage the upwardly projecting element

154 the anvil, which is slightly closer to the transverse pivot pins 156 that engage the pivot recesses 158 inside the longitudinal channel 40. See Fig. 3.

[0026] In various aspects, the firing rod 66 may terminate further in the beam E 165, which includes upper guide pins 166 that enter into the anvil slot 168 of the anvil 42 to verify and assist in keeping the anvil 42 closed during staple forming and cut. See fig. 3. The distance between the longitudinal channel 40 and the anvil 42 can further be maintained by the E 165 beam, by moving the central pins 170 along the top surface of the longitudinal channel 40, when the lower foot 172 moves in the opposite direction along the bottom surface of the longitudinal channel 40, guided through the longitudinal opening 174 in the longitudinal channel 40. In the distance, the cutting surface 176 of the E 165 beam, which is between the upper guide pins 166 and the central pin 170, cuts the clamped tissue, while the E beam moves the removable cartridge with staples 178 by moving the 180 wedge sleds further, which causes that the staple drive elements 182 move upward using the cam mechanism, by directing staples 184 out of the upwardly open staple holes 186 in the staple cartridge body 188, forming them on the bottom surface 190 for forming anvil staples 42. The staple cartridge tray 192 surrounds from below other components of the staple cartridge 178 to hold them in place . The staple cartridge tray 192 includes an upwardly open slot 194 that covers the elongate hole 174 in the longitudinal channel 40, so that the center pins 170 pass inside the staple cartridge tray 192. One form of end effector or staple application unit that can be used has been described in detail in the pending and patent pending US Patent Publication No. 20070084897 A1, entitled "Articulating Surgical Stapling Instrument Incorporating a Two-Piece E-Beam Firing Mechanism ", Frederick E. Shelton IV and others.

[0027] In Figs. 2-4, the articulation joint 100 may advantageously comprise the dual rotary closing sleeve assembly 46 described above. One example configuration of these mechanisms and their operation will now be described in more detail. For example, in various aspects, the distal end 49 of the proximal part 48 of the frame may be provided with a downwardly concave bottom surface 200 that is adapted to receive a correspondingly shaped convex surface 204 on the distal member 114 of the frame. One skilled in the art will be aware that in an alternative aspect a concave surface may be provided on the distal member 114 of the frame and a convex surface may be formed on the proximal part 48 of the frame without departing from the scope of the present disclosure.

[0028] This configuration of the connection 100 facilitates axial displacement of the distal frame member 114 relative to the proximal frame portion 48 about the rotation axis, usually referred to as the AA axis in Fig. 4, which means that distal frame element 114 (and staple application assembly 20) it can generally rotate around the axis AA on the "PP" plane, on which the proximal part 48 of the frame is also located. As can be seen in Figure 4, the AA axis is substantially perpendicular to the plane PP. In other words, such a configuration of the concave and convex surfaces 200, 204 limits the rotational movement of the distal frame member 114 about the axis of rotation AA with respect to the proximal part 48 of the frame within the common rotation plane PP. As a result, such a configuration of the connection does not allow the further element 114 of the pivoting frame on a plane that is substantially different from the plane on which the proximal part 48 of the frame is located. However, this configuration allows relatively easy axial and rotational movement of the staple application unit. When the closing sleeve assembly 46 is moved distally to rotate the anvil 42 to the closed position, the straight closing tube 52 moves distally around the proximal part 48 of the frame, and the articulated distal section 116 of the closing tube moves distally along the articulated distal member 114 frames as a result of pushing through connectors 134, 140 axial. Double pins 136, 138 and 142, 144 axial on connectors 134, 140, respectively, facilitate attachment to the straight closing tube 52 and the articulated distal portion of the closing tube 116 when they are pushed towards the further closing position when the device is articulated (not shown) .

[0029] In various aspects, the dog bone fastener 160 may be used and configured to provide support for the firing rod 66, which may have a flexible structure. The frame portion 48 may also include a frame knife slot (not shown) that runs along the bottom of the frame 48 and a further knife slot (not shown) that runs along the bottom of the distal frame member 114 for slidingly placing the firing rod 66 therein (not shown). The bone-shaped connector 160 for the dog may be pivotally connected at the proximal end 157 of the pin and connected with the possibility of displacement at the distal end 159 of the pin and include left and right transverse guides 1818, 1820 defining between them the gap 1822 leading for the sliding corridor of the firing rod 66 ( Fig. 5). In effect, to bridge the gap between the frame portion 48 and the distal frame member 114, the fixed bone swivel connector 160 is pivotally attached to the frame portion 48 and slidably attached to distal frame member 114. A proximal pin 157 of the dog bone swivel connector 160 is rotatably arranged in an opening 1824 in the frame portion 48, allowing the dog bone swivel connector 160 to rotate within it. A distal pin 159 extends from the dog bone swivel connector 160 and is slidably positioned in the gap 1826 in the distal member 114 of the frame. The articulation of the staple application assembly 20 at an angle such as 45 degrees from the longitudinal axis causes the dog bone swivel connector 160 to rotate in the hole 1824 at its proximal pin 157, and the distal pin 157 moves in the gap 1826 at its distal end 1814 to bend firing rod 66 to two distant angles, which are half the angle of the staple application assembly 20.

[0030] The further frame member 114 may pivot relative to the proximal frame portion 48 about the axis of rotation AA due to the configuration of the concave and convex surface. One skilled in the art will be aware that in various aspects the friction between surfaces 200 and 204 will serve to keep the distal frame member 114 (and staple application unit 20) in an articulated position relative to the proximal part 48 of the frame, and additional clamping configurations may be used to apply compressive forces to them to keep these components in the required articulated position. The end effector can be articulated by applying articulation force relative to it by attracting the end effector to contact a part of the patient's body or another tool that can also be introduced into the patient's body.

[0031] Figs. 6 and 7 show another articulation 300 that can be used in connection with various aspects of the present invention. Such an aspect may be substantially the same in construction as the aspect described above except for the following differences. For example, in this aspect, the proximal end 115 of the distal frame member 114 may have two arches 310, 312 formed therein to receive respective pins 320, 322 formed at the distal end 49 of the proximal frame portion 48. As a result, the distal frame member 114 is limited to pivoting relative to the frame parts 48 by moving pins 320, 322 in their respective slots 310, 312 about the axis of rotation BB, which extends through the center 311 between the arc slots 310, 312. The axis of rotation BB may be substantially perpendicular to the longitudinal axis LL of the proximal part 48 of the frame. This connection configuration can also be used to limit the rotational displacement of the distal frame member 114 about the rotation axis BB in such a way that the distal frame member 114 is substantially maintained in a common rotation plane PP with the proximal part 48 of the frame. One skilled in the art will be aware that in alternative aspects, arches 310, 312 may be provided at the distal end 49 of the proximal part 48 of the frame, and pins 320, 322 may be provided at the distal member 114 of the frame without departing from the scope of the present disclosure. In other aspects, the distal frame member 114 and proximal frame portion 48 may have one arc gap and one pin, the bolt being positioned so that it can be slidably inserted into the gap in another part.

[0032] Also in these aspects, to bridge the gap between the frame portion 48 and the distal frame member 114, the fixed bone swivel dog connector 160 can be pivotally attached to the frame portion 48 and slidably attached to the further frame member 114. A proximal pin 157 of the dog bone swivel connector 160 is rotatably arranged in an opening 1824 in the frame portion 48, allowing the dog bone swivel connector 160 to rotate within it. A distal pin 159 extends from the dog bone connector 160 and is slidably positioned in the gap 1826 in the distal member 114 of the frame. The articulation of the staple application assembly 20 at an angle such as 45 degrees from the longitudinal axis causes the dog bone swivel connector 160 to rotate in the hole 1824 at its proximal pin 157, and the distal pin 157 moves in the gap 1826 at its distal end 1814 to bend firing rod 66 to two distant angles, which are half the angle of the staple application assembly 20. In various aspects, a harmonica-shaped sleeve or sheath 350 made of elastomeric or polymeric material may be positioned over the shaft at the articulation to prevent dirt and liquids from entering the joint. See fig. 6. The end effector can be articulated by applying articulation force relative to it by attracting the end effector to contact a part of the patient's body or another tool that can also be introduced into the patient's body.

[0033] Figs. 8 and 9 show another articulation connection 400 that can be used in connection with various aspects of the present invention. Such an aspect may be substantially the same in construction as the embodiments described above except for the following differences. For example, this aspect may use a pair of substantially rigid connecting rods 410, 420 to rotatably connect to each other frame member 114 and frame parts 48. As can be seen, for example, in Fig. 8, the lower connecting rod 410 may have a distal portion 414 of the pin protruding from its distal end 412, which is constructed so that it can be placed in the first hole 260 in the distal member 114 of the frame. The further frame member 114 may also be provided with an undercut portion 262 to receive rotational displacement of the distal end 412 of the lower rod 410 around the first axis of rotation CC defined by the distal pin 414 and the hole 262. As can be seen in Figure 8, the proximal end 416 of the lower connecting rod 410 may have a proximal pin 418 protruding therefrom, which is constructed in such a way that it can be placed inside the opening 264 in the distal end 49 of the frame parts 48.

The proximal pin 418 and hole 264 also serve to define the second axis of rotation DD.

[0034] As indicated above, this aspect may further include an upper connecting rod 420 that has a distal end 422 and a proximal end 426. The distal pin 424 protrudes from the distal end 422 and is constructed so that it can be inserted into the second hole 266 in the further element 114 of the frame. Pin 424 and hole 266 are used to define the third axis of rotation EE. The proximal pin 428 protrudes from the proximal end 426 of the upper connecting rod 420 and is constructed in such a way that it can be inserted into the second hole 268 in the distal end 49 of the frame parts 48. The proximal pin 428 and hole 268 are used to determine the fourth axis of rotation FF. As can be seen in Figure 8, the first axis CC, the second axis DD, the third axis EE, as well as the fourth axis FF can be substantially transverse and perpendicular to the longitudinal axis LL of the proximal part 48 of the frame. As can also be seen in Figure 9, at least one of the pins 424, 428 extends along the longitudinal axis LL.

[0035] Also in this aspect, to bridge the gap between the frame portion 48 and the distal frame member 114, the fixed bone swivel dog connector 160 can be pivotally attached to the frame portion 48 and slidably attached to the further frame member 114. A proximal pin 157 of the dog bone swivel connector 160 is rotatably arranged in an opening 1824 in the frame portion 48, allowing the dog bone swivel connector 160 to rotate within it. A distal pin 159 extends from the dog bone connector 160 and is slidably inserted into the gap 1826 in the distal member of the frame 114. As can be seen in Fig. 8, the lower connecting rod 410 extends along the lower GG plane, and the upper connecting rod 420 extends along the upper HH plane, which is not coplanar with the lower GG plane. This configuration allows the connecting rods 410, 420 to be rotated to an axially aligned position in which the shaft 16 can be inserted through the trocar passage (Fig. 1) and to other axially misaligned articulated positions (Fig. 9). In various aspects, a harmonica-shaped sleeve 450 made of an elastomeric or polymeric material may be positioned above the shaft at the articulated joint 400 to prevent contaminants and fluids from entering the joint. See fig. 9. The end effector can be articulated by applying articulation force relative to it by attracting the end effector to contact a part of the patient's body or another tool that can also be introduced into the patient's body.

[0036] Figs. 10 and 11 show a further articulation joint 500 that can be used in connection with various aspects of the present invention. Such an aspect may be substantially the same in structure as the aspects described above except for the following differences. For example, such an aspect may use a series of 510 flexible locking recesses 512 to axially and rotatably interconnect further frame member 114 and proximal frame portion 48. As can be seen, for example, in Fig. 10, the proximal end of a series of flexible locking recesses may be attached to the distal end 49 of the proximal part 48 of the frame. The distal end 514 of the series 510 may be attached to the proximal end 115 of the distal frame element 114. The tensioning cord 520 can be used in such a way that it extends from a part of the handle (not shown) through the proximal section 150 of the closing tube and is connected to the frame element 114. When tension is applied to the cable 520, the recesses 512 lock to keep the recesses 512 in a substantially locked position. To place the staple application assembly 20 in its proper position, tension is released on the cable 520 to thereby allow an external force to be applied to the staple application assembly 20 to allow it to be articulated and / or rotatable to the desired position. After the staple application assembly 20 has been placed in the required position, the tension of the cable 520 is applied again to keep the locking recesses 512 in position.

[0037] Also in this aspect, to bridge the gap between the proximal part 48 of the frame and the distal part 114 of the frame, the rotatable bone bone connector 160 for the fixed wall can be pivotally attached to the proximal part 48 of the frame and slidably attached to distal frame 114 . A proximal pin 157 of the dog bone swivel connector 160 is rotatably arranged in an aperture 1824 in the proximal part 48 of the frame, allowing the dog bone swivel connector 160 to rotate within it. A distal pin 159 extends from the dog bone connector 160 and is slidably positioned in slot 1826 in distal frame member 114. In various embodiments, a harmonica-shaped sleeve 550 made of an elastomeric or polymeric material may be positioned above the shaft at the articulation to prevent dirt and liquids from entering the joint. See fig. 10. The end effector can be articulated by applying articulation force relative to it by attracting the end effector to contact a part of the patient's body or another tool that can also be introduced into the patient's body.

[0038] Figs. 12 and 13 show another articulated joint 600 that can be used in conjunction with various embodiments of the present invention. Such an embodiment may be substantially the same in construction as the embodiments described above except for the following differences. For example, in this embodiment, the first array of planetary gear teeth 610 may be formed on at least part of the circumference of the proximal end 115 of the distal frame member 114. Similarly, a second series of teeth 620 of the planetary gear is formed on at least part of the periphery of the distal end 49 of the frame part 114. Teeth 610 are held in constant engagement with the teeth 620 by means of a rotational rod 630 that rotatably connects the proximal end 115 of the frame element 114 to the distal end 49 parts of the 48 frame. As can be seen in fig. 12, the distal portion 634 of the pin protrudes from the distal end 632 of the pivot rod 630 and is designed to be rotatably placed in an aperture 260 formed in the bottom side of the distal frame member 114. The frame member 114 may also have an undercut area 262 formed therein to receive rotational displacement of the rotational rod 630. Similarly, the proximal end 636 of the pivot rod 630 has a proximal portion 638 of the pin that projects from it and is of such a size that it can be rotatably placed in the hole 640 in the proximal part 48 of the frame. The undercut area 642 may further be provided at the distal end 49 of the proximal frame portion 48 to receive the rotational movement of the rotational rod 630.

[0039] Also in this embodiment, in order to bridge the gap between the proximal part 48 of the frame and the distal part 114 of the frame, the rotatable bone shaped connector 160 for a fixed wall dog can be pivotally attached to the proximal part 48 of the frame and slidably attached to the distal element 114 frame. The proximal pin 157 of the dog bone swivel connector 160 is rotatably arranged in an aperture 1824 in the proximal portion 48 of the frame, allowing the dog bone swivel connector 160 to rotate within it. A distal pin 159 extends from the dog bone connector 160 and is slidably positioned in slot 1826 in the distal frame of element 114. In various embodiments, the harmonica-shaped sleeve 650 made of elastomeric or polymeric material may be positioned above the shaft at the articulation to prevent dirt and liquids from entering the joint. See Fig. 12. [0040] Figs. 14 and 15 show another articulation 700 that can be used in connection with various aspects of the present invention. Such an aspect may be substantially the same in construction as the aspect described above except for the following differences. For example, in this aspect, the distal end 49 of the proximal part 48 of the frame has been formed as a projection 710 running in a distal direction. In various aspects, distal projection 710 has a first transverse side 712 and a second transverse side 714. Similarly, the proximal end 115 of the distal frame member 114 has also been formed as a projection 720 that runs proximately in a position opposite to the distal projection 710. The proximal projection 720 has a main transverse side 722 which corresponds to the first transverse side 712 running in the distal projection 710. The proximal protrusion 720 further has a secondary transverse side 724 which corresponds to the second transverse side 714 of the distal protrusion 710.

[0041] In this aspect, the flexible connection 700 may further comprise a first elastic band 730 that has a proximal end 732 attached to the first transverse side 712 extending toward the distal projection 710 and a distal end 734 attached to the secondary transverse side 724 extending towards the proximal projection 720 . This aspect may further include a second elastic band 740 that has a proximal end 742 attached to the second transverse side 714 extending toward the distal projection 710 and a distal end 744 that is attached to the main transverse side 722 extending towards the proximal projection 720. In various aspects, the first elastic band 730 and the second elastic band 740 may be made of spring steel or other suitable elastic materials, and may be attached to projections 710, 720, respectively, by means of appropriate fasteners such as screws, a binder and the like. As can be seen in Fig. 14, the first elastic band has a first notch 736 and the second elastic band 740 has a second notch 746 to allow spacing of the 730 bands,

740 as shown in Fig. 15.

[0042] Also in this aspect, in order to bridge the gap between the proximal part 48 of the frame and the distal part 114 of the frame, the rotatable bone-shaped dog connector 160 can be pivotally attached to the proximal part 48 of the frame and slidably attached to the frame element 114. A proximal pin 157 of the dog bone swivel connector 160 is rotatably arranged in an aperture 1824 in the proximal part 48 of the frame, allowing the dog bone swivel connector 160 to rotate within it. A distal pin 159 extends from the dog bone swivel connector 160 and is slidably positioned in a slot 1826 in the distal frame of element 114. In various aspects, a harmonica-shaped sleeve 750 made of an elastomeric or polymeric material may be positioned above the shaft at the articulation to prevent contaminants and fluids from entering the joint. See fig. 14. The end effector can be articulated by applying articulation force relative to it by attracting the end effector to contact a part of the patient's body or another tool that can also be introduced into the patient's body.

[0043] Although several aspects of the invention have been described herein, it will be apparent to those skilled in the art that various modifications, changes, and adaptations of these aspects are possible, with some or all of the benefits of the invention. For example, in accordance with various aspects, a single component may be replaced by multiple components, and multiple components may be replaced by a single component to perform a specific function or functions. The present application is intended to cover all such modifications, changes and adaptations without departing from the scope of the disclosed invention as defined in the appended claims.

[0044] The devices disclosed herein may be designed to be removed after one use, or may be designed to be used repeatedly. In any case, however, the device may be regenerated for reuse after at least one use. Regeneration can include any combination of the steps to disassemble the device, clean or replace individual components, and then reassemble. In particular, the device can be dismantled, and any number of individual components or parts of the device can be selectively replaced or removed in any combination. After cleaning and / or replacing individual parts, the device can be reused for further use in a regeneration facility or by a surgical team immediately prior to surgery. Those skilled in the art will be aware that device regeneration may involve a number of different techniques for dismantling, cleaning / replacing components, and reassembly. The use of such techniques as well as the resulting refurbished device is within the scope of this application.

[0045] Preferably the invention described herein will be prepared before surgery. First a new or used tool is obtained and cleaned if necessary. The tool can then be sterilized. According to one sterilization technique, the tool is placed in a closed and sealed package, such as a bag made of plastic or TYVEK®. The packaging and the tool are then placed in a radiation field that can penetrate the packaging, such as gamma radiation, X-rays or electrons with increased energy. Radiation destroys bacteria found on the tool and in the packaging. The sterilized tool can then be stored in sterile packaging. The sealed package allows the tool to remain sterile until it is opened in a medical facility.

25913 / EP / 16

EP1997440