Apparatus for protecting adjacent structures during the insertion of a surgical instrument into a tubular organ

[0001] The invention relates generally to surgical staplers, and more particularly to devices for maintaining and / or protecting a tissue adjacent to a circular stapler head.

BACKGROUND OF THE INVENTION [0002] In certain types of surgical procedures, the use of surgical staples has become the mode of choice for joining tissue and specially configured surgical staplers as such have been developed for such applications. For example, in-line staplers or circular staplers have been developed for use in surgical procedures for the lower colon, where the lower colon portions are joined together after removal of the affected part. Circular staplers useful in carrying out such procedures are disclosed, for example, in U.S. Patent Nos. 5,104,025, 5,205,459, 5,285,945, and 5,309,927.

Generally, a standard circular stapler typically consists of an elongated shaft that has a proximal actuating mechanism and a further stapler head mounted on an elongated shaft. The further head of the stapler usually consists of a fixed staple cartridge that accommodates a plurality of staples configured in a concentric circular arrangement. The circular cutting knife is mounted in the interior of the cartridge concentrically to the staples for axial movement within it. A movable trocar shaft extends in the axial direction from the center of the cartridge, which is adapted to be attached thereto with the possibility of disconnecting the anvil of the stitching anvil. The anvil is configured to form staple finishes when they are routed to it. The distance between the distal side of the staple cartridge and the suturing anvil is usually controlled by a regulating mechanism that is mounted on the proximal end of the stapler shaft to control the axial movement of the trocar. The tissue that is clamped between the staple cartridge and the stapling anvil is simultaneously stapled and cut when the actuator is activated by the surgeon.

[0004] When performing a confluence in the lower colon using a circular stapler, a portion of the intestine can be laparoscopically stapled using a traditional surgical stapler that is inserted through the trocar. The traditional surgical stapler is used to place multiple rows of staples on each side of the affected part of the colon to be removed. The target or disease segment is simultaneously cut when the adjacent colon end is stapled. After removal of the affected section, the surgeon usually inserts an anvil of the circular stapling device until the end of the cord's lumen is removed, away from the staple line. This can be accomplished by inserting the anvil head into the inlet opening cut out at the distal end of the conductor by the surgeon. The bottom staple line is used to hold the colon tissue on a circular cartridge. Such a method makes it possible to seal both ends of the colon exclusively to cut and remove the sealed parts. The staple lines used in this intermediate step are only temporary and facilitate the next step of the procedure.

[0005] In certain situations, the anvil can be placed trans-rectally by placing the anvil head at the distal end of the stapler and inserting the device through the rectum. When the anvil was installed in the distal part of the intestine, the gut is attached around the anvil shaft using the so-called "slit" seam. The proximal part of the intestine is similarly attached around the stapler head by means of a stitching of the ear sling.

[0006] After attaching the ends of the intestine around their respective components, the surgeon may use a gripping device to engage the anvil shaft and attach it to a portion of the trocar protruding inside the stapler head by the appropriate trocar sleeve. The surgeon then closes the gap between the anvil and the cartridge, thereby clamping the proximal and distal end of the intestine in this space. The surgeon then actuates the stapler, causing several rows of staples to be inserted through both ends of the intestine and formed, thereby joining the ends and forming a tube passage. Simultaneously with the introduction and forming of the staples, the concentric annular blade of the knife is guided through the end of the intestinal tissue, cutting the ends adjacent to the inner row of staples.

[0007] Such procedures and devices require the surgeon to install two slit sockets, which extends the time required to complete the surgical procedure. In addition, such procedures can sometimes cause "wrinkling" of the tissue during the tissue cutting / stitching process.

[0008] Various attempts have been made to retain the colon and other tissues around the suturing apparatus. For example, in US patents 5,309,927; 6,117,148 and 7,094,247 disclose various configurations that substantially utilize fasteners, lashing elements, rings, springs and the like that are outside the stapling device itself to hold the tissue in place. U.S. Patent No. 5,669,918 discloses a mechanism that uses a gripper, such as an arm, to frictionally block tissue on a trocar handle. Although such a device is substantially autonomous, the gripper arms ultimately may not be able to effectively hold the tissue in place.

[0009] W02005 / 089433 describes a surgical access device that uses a sheath made of a thin walled material sheet. The material fragment is tightly wound to obtain a small diameter system that is inserted into the patient's body. The control element is connected to the shield near the innermost edge of the cover. The control element runs essentially to the closest position to the cover part. By turning the control element, the operator expands the material from metal or plastic with thin walls to obtain a larger or smaller diameter, depending on the direction of rotation. Mechanical blocking at the closer end of the guard allows selective blocking of the control element to prevent rotation and thereby blocking the diameter of the cover in place.

[0001] As a result, there is a need for devices to reduce the time required to perform a surgical operation and to solve other disadvantages and problems associated with keeping the tissue in place while using circular stapler systems.

[0011] The above discussion is intended to present only some of the disadvantages of the current solutions known in the art and should not be regarded as disclosing the scope of the claims.

SUMMARY OF THE INVENTION [0012] In accordance with a general aspect of various non-limiting embodiments of the invention, there is provided a surgical instrument comprising a protective element for protecting tissues and structures adjacent to a tubular body during a surgical operation on a portion of a tubular organ in accordance with the accompanying set of claims. In various embodiments, the protective element includes an element that can be disposed by the surgical instrument in a first configuration and extended to the second configuration such that in the second configuration the protective element can extend substantially around the perimeter of the outer tubular body.

[0013] According to a further general aspect of the various aspects of the invention there is provided a procedure that is not part of the invention for protecting tissues and structures adjacent to a tubular organ inside the abdominal cavity during manipulation and handling of surgical instruments within the target portion of the tubular organ. Various aspects include the introduction of a protective cover into the abdominal cavity adjacent to the target portion and the surrounding of the target portion of the tubular body with a protective cover. The procedure further comprises maintaining the protective cover in a position surrounding the target portion.

[0014] According to a further general aspect of the invention there is provided a surgical procedure for the treatment of a patient's colon target part that is not part of the invention. In various aspects, the procedure involves inserting an empty trocell cannula through the abdominal wall into the abdominal cavity adjacent to the colon's target portion. The procedure further includes rolling up the protective cover, rolling the shroud over the empty cannula into the abdominal cavity, and unfolding the cover. The procedure further includes placing the expanded sheath around the colon target portion such that the natural tendency for the protective cover to be wound up retains the protective cover around a circumference of the outer colon target portion.

BRIEF DESCRIPTION OF THE DRAWINGS [0015] The attached figures, which are incorporated and form a part of the description, illustrate embodiments of the invention and together with the general description of the invention shown above and the detailed description of the embodiment below serve to explain the principles of the invention.

Fig. 1 is a perspective view of a circular surgical stapling instrument in accordance with various non-limiting embodiments of the invention.

Fig. 1A shows a cross-sectional view of a part of the handle of different embodiments of the surgical stapling device according to the invention.

Fig. 2 is a cross-sectional view of a distal end portion of the longitudinal shaft of the stapling apparatus of Fig. 1.

Fig. 2A shows a partial cross-sectional view of the distal end of the longitudinal shaft with the anvil attached thereto.

Fig. 2B is a partial top view in section of the distal end of the longitudinal shaft taken along line 2B-2B in Fig. 2A.

Fig. 2C is a cross-sectional view of a portion of the handle assembly of an embodiment of the invention.

Fig. 2D is a cross-sectional view of another part of a longitudinal roller according to different embodiments of the invention.

Fig. 3 shows a view of the end of the longitudinal roller of Fig. 2.

Fig. 4 shows a partial perspective view of a distal end portion of the longitudinal roller of Figs. 2 and 3 with tissue acquisition elements and knife elements in their radially disposed positions.

Fig. 5 shows a partial cross-sectional view of a distal end of an elongated shaft with an anvil attached to it and inserted into a portion of a patient's tubular body, such as a colon.

Fig. 6 shows a further cross-sectional view of the distal end of the longitudinal roller of Fig. 5 with the anvil removed.

Fig. 7 shows a further cross-sectional view of the distal end of the longitudinal roller of Figs. 5 and 6 with a distal end of the cutter housing extending axially out of the distal side of the staple cartridge retained in the distal end of the elongated shaft.

Fig. 8 is another cross-sectional view of the distal end of the longitudinal roller of Fig. 7 with tissue acquisition elements arranged radially outside the tissue acquisition housing and the piercing portion of the colon.

Fig. 9 shows another cross-sectional view of the distal end of the longitudinal roller of Fig. 8 with tissue removal elements retracted back into the tissue treatment housing to position the pierced portion of the colon adjacent the distal side of the staple cartridge.

Fig. 10 shows a further cross-sectional view of the distal end of the longitudinal roller of Fig. 9 with knife elements disposed radially outside the chisel body and piercing a portion of the colon.

Fig. 11 shows another cross-sectional view of the distal end of the elongated shaft of Fig. 10 after the knife elements have been rotated to cut off the severed part of the colon from the diseased portion of the colon.

Fig. 12 shows a further cross-sectional view of the distal end of the longitudinal roller of Fig. 11 with knife elements retracted back into their respective lumens in the chisel housing.

Fig. 13 shows another cross-sectional view of the distal end of the longitudinal roller of Fig. 12 after attaching the anvil to the distal colon and joining the anvil shaft with the anvil member of the circular stapler device.

Fig. 14 is another cross-sectional view of the distal end of the elongated shaft of Fig. 13 after pulling the anvil adjacent the distal side of the staple cartridge.

Fig. 15 shows a further cross-sectional view of the distal end of the longitudinal roller of Fig. 14 after the staple has been applied and the annular knife axially advanced through the adjacent parts of the colon.

Fig. 16 shows another cross-sectional view of the distal end of the elongated shaft of Fig. 15 after the sections of the colon have been stapled together but before the shaft is withdrawn from the colon.

Fig. 17 is a perspective view of a circular surgical stapling instrument in accordance with various non-limiting embodiments of the invention.

Fig. 18 is a cross-sectional view of a distal end portion of the elongated annular shaft of the stapling apparatus of Fig. 17.

Fig. 19 is an exploded view of an assembly of shafts for acquisition and deployment according to various non-limiting embodiments of the invention.

Fig. 20 shows a partial perspective view of the acquisition roller of Fig. 19 with its tissue extraction arms in a retracted position.

Fig. 21 is a partial cross-sectional view of the acquisition roller of Figs. 19 and 20 with its tissue acquisition arms in an deployed position.

Fig. 22 is a perspective view of the acquisition roller of Fig. 21.

Fig. 23 is a cross-sectional view of a longitudinal shaft according to various non-limiting embodiments of the invention, with an anvil attached thereto and inserted into the patient's colon.

Fig. 24 is another cross-sectional view of a longitudinal roller of Fig. 23, with the anvil removed and with extraction arms disposed in a proximal portion of the colon that adheres to a target or diseased part of the colon.

Fig. 25 is a top view in cross-section of the elongated shaft of Fig. 24 taken along line 25-25 of Fig. 24, wherein the tissue extraction arms extend through the proximal portion of the colon.

Fig. 26 is a cross-sectional view of a longitudinal roller of Figs. 24 and 25, wherein the target or diseased portion of the colon has been removed using a gripping device.

Fig. 27 is a top plan view of the longitudinal roller of Fig. 26 taken along line 27-27 in Fig. 26.

Fig. 28 is a partial cross-sectional view of a longitudinal shaft after insertion of the anvil to the distal portion of the colon and secured to it by means of a slit sipe system.

Fig. 29 is a cross-sectional view of the longitudinal roller of Fig. 28 after the anvil has been connected to the anvil assembly and pulled into an opposite position with the staple cartridge present therein.

Fig. 30 is a cross-sectional view of the longitudinal roller of Fig. 29 after the staple cartridge is triggered and the annular cutting element is extended through the parts of the stapled tissue.

Fig. 31 is a cross-sectional view of the elongated shaft of Fig. 30 withdrawn from the colon after completion of the stitching procedure.

Fig. 32 is a perspective view of another circular surgical stapling instrument according to various non-limiting embodiments of the invention.

Fig. 33 is a cross-sectional view of a distal end portion of the longitudinal shaft of the stapler apparatus of Fig. 32.

Fig. 34 is a partial perspective view of a portion of the housing of the elongate engagement and detent roller of Fig. 33 with its detector means in the retracted position.

Fig. 35 is another partial perspective view of the engagement and detection housings of Fig. 34 with its detector elements in an deployed configuration.

Fig. 36 is a cross-sectional view of the distal end of the elongated shaft with its detector elements in a setting arranged inside the colon.

Fig. 37 is a top plan view in cross-section of the elongated shaft and colon of Fig. 36 taken along lines 37-37 of Fig. 36.

Fig. 38 is a perspective view of another circular stapler according to various non-limiting embodiments of the invention.

Fig. 39 is a cross-sectional view of a distal end portion of a longitudinal roll of a stapling apparatus of Fig. 38 inserted into a proximal portion of a tubular body, such as a colon,

Fig. 40 is an exploded view of a distal end portion of a tissue acquisition roll, an arranging roll, and a knife roller according to various non-limiting embodiments of the invention.

Fig. 41 is a partial perspective view of the tissue acquisition roll of Fig. 40 with its tissue extraction arms in a retracted position.

Fig. 42 is a perspective view of the acquisition roller of Fig. 41 with its tissue acquisition arms in an deployed position.

Fig. 43 is a partial cross-sectional view of a distal portion of the longitudinal shaft of the surgical instrument of Fig. 38 inserted into the proximal part of the colon with the anvil assembly removed.

Fig. 44 is a partial cross-sectional view of a distal end portion of a longitudinal shaft with tissue arms disposed in the proximal portion of the colon.

Fig. 45 is a plan view in cross-section of a distal end portion of a longitudinal roller made along line 45-45 of Fig. 44.

Fig. 46 shows a further partial cross-sectional view of a distal end portion of a longitudinal shaft after the tissue extraction arms have been disposed in the proximal part of the colon and then moved to a retracted position in which the punctured proximal portion is gripped between the tissue extraction arms and the roller. for tissue acquisition.

Fig. 47 is a plan view in cross-section of a portion of the distal end of the longitudinal roller of Figure 46 taken along lines 47-47 of Figure 46.

Fig. 48 is a partial cross-sectional view of a distal end portion of a longitudinal shaft with a diseased portion of the colon removed from the proximal part and distal portion and removed from the colon by means of conventional grippers.

Fig. 49 is a partial cross-sectional view of a longitudinal shaft after the anvil has been inserted into the distal part of the colon and attached to it by means of a slit seam system.

Fig. 50 is a cross-sectional view of the elongated shaft of Fig. 49 after the anvil has been connected to the anvil assembly and snapped into an opposite position with the staple cartridge.

Fig. 51 is a cross-sectional view of the longitudinal roller of Fig. 50 after the staple cartridge has been triggered and the annular cutting element protruded by the parts of the stitched tissue.

Fig. 52 is a cross-sectional view of a longitudinal roller of Fig. 51 withdrawn from the colon after completion of the stapling procedure.

Fig. 53 is a view of a portion of the patient's open abdominal cavity, illustrating different tissues and structures adjacent to a portion of the colon.

Fig. 54 is a further partial view of the open abdominal cavity of Fig. 53.

Fig. 55 is another view of the abdominal cavity of Fig. 53 illustrating the insertion of a trocar into the abdominal cavity to form a protective cover according to the invention.

Fig. 56 shows a further view of the abdominal cavity of Fig. 55 with a protective cover in one possible embodiment withdrawn from the tri-mite sleeve by a conventional gripping device.

Fig. 57 is a further abdominal view of Fig. 56 illustrating one method for placing a protective cover around a circumference of a portion of a collar to be treated.

Fig. 58 shows a further view of the abdominal cavity of Fig. 57 after, in one possible embodiment, the protective cover has been placed around the circumference of the outer part of the wound frame to be treated.

DETAILED DESCRIPTION [0016] Embodiments of the invention have been defined solely by the claims.

[0017] Reference herein to "various embodiments", "certain embodiments", "one embodiment" or "embodiments" or the like means that a particular feature, structure or property described in connection with an embodiment is included Accordingly, the use of the phrases "in various embodiments", "in some embodiments", "in one embodiment" or "in embodiment" or the like throughout the entire description does not necessarily refer to the same. implementation form. In addition, particular features, structures or properties may be combined in any suitable manner in one or more embodiments. Accordingly, particular features, structures or properties shown or described in connection with one embodiment may be combined, in whole or in part, with the features, structures or properties of one or more other embodiments without restriction. Such modifications and variants are intended to be within the scope of the present invention.

[0018] The terms "proximal" and "distal" are used herein with respect to the doctor operującego portion constituting a grip surgical instrument. The term "proximal" refers to the portion closest to the physician and the term "distal" refers to a portion located away from the doctor . It should also be noted that for convenience and clarity, the terms space, such as "vertical", "horizontal", "top" and "bottom" may be used herein with reference to the figures. However, the surgical tools are used in many directions, and positions, and these terms are not limiting and / or absolute.

[0019] Fig. 1 shows a circular stapler 10 in accordance with various non-limiting embodiments of the invention. In various embodiments, the circular stapler 10 comprises a handle assembly 12 that has a protruding longitudinal shaft 14 projecting thereon that defines an central axis AA. The elongated shaft assembly 14 includes a rigid outer shell 16 that has a distal end portion 17 that forms the stapler head 20. In various non-limiting embodiments, the stapler head 20 is configured to operably maintain a circular staple cartridge 30 within it. Such circular staple cartridges 30 are known in the art and may substantially retain within them one, two or more circumferentially spaced and alternating rows of staples 36. See FIGS. 2 and 3. Make the embodiments shown in FIG.

[0020] In some implementations, the circular stapler 10 further includes a firing roller assembly 50 that is held within the outer shell 16 to selectively move the axle within it. See FIG. 2. The distal end portion 52 of the firing shaft assembly 50 has an outer portions 54 of the staple driver for engaging each of the staples 36 in the outer row 32 of staples 36 in the staple cartridge 30. In addition, the distal end portion 52 of the firing roll assembly 50 has an interior portion 56 of the staple driver, which is configured to engage each staple 36 in the inner row 34 of staples 36 inside the staple cartridge 30. As can also be seen, for example, in Fig. 2, a portion of the distal end 52 of the firing roller assembly 50 further includes a projection 58, which is configured to engage the ring knife 40. Accordingly, in the following detailed description, the axial displacement of the firing pin assembly 50 in the distal direction "DD" will direct the staples 36 out of the staple cartridge 30 and eject the ring knife 40 in the distal direction. As can be seen in FIG. 2A, the trigger-fighting assembly 50 has a base portion 51 that is connected to a firing bar 53. <

> [0021] In various non-limiting embodiments, the firing bar 53 is operably associated with a trigger trigger 60 that is operably connected to the handle assembly 12. See FIGS. 1 and 1A. As can be seen in FIGS. 1 and 1A, the firing trigger 60 is rotatably connected to the handle assembly 12 such that when the firing trigger 60 is rotated towards the handle assembly 12, the firing roll assembly 50 is advanced in the distal direction DD. Such triggering trigger configurations are known in the art and will therefore not be discussed in detail herein. For example, an exemplary trigger release configuration is disclosed in US Patent Publication No. 2008/0078806 A1,

[0022] As shown in Figs. 2 and 2A, various non-limiting embodiments include a pick-up housing 70 that is held axially within the firing roller assembly 50 and can be moved axially with respect to it. The acquisition housing 70 has in its interior a plurality of opening portions 72 for acquisition, each of which movably holds the pick-up or plugging element 80. As can be seen, for example, in FIG. 3, a plurality of tripartite acquisition lands 72 may be spaced about the same circumference around the periphery of the acquisition housing 70. In the wound and the embodiment shown in Fig. 3, all eight (8) acquisition lugs 72 are arranged at an equal distance around the circumference of the acquisition housing 70.

[0023] Each acquisition or engaging member 80 may for example be made of Nitinol, stainless steel of the 300 or 400 series (hardened entirely or in 3/4) and having a distal end portion 82 which, in the case of extending beyond its respective clearance, 72 as to obtain, bends radially outwardly as shown in Fig. 4. As can also be seen in Fig. 4, each engagement member 80 has a tissue hook 84 formed on its distal end portion 82. As can be seen in Fig. 2 and 3, in various non-limiting embodiments, the sleeve 78 is used to facilitate the installation of the hooking elements 80 in their respective lands 72.

[0024] As can be seen from Fig. 2A, each of the hooking elements 80 is connected to or protrudes from the pickup ring 81, which has a pair of rods 83 to be attached to it. The acquisition rods 83 are attached to a hooking switch 90 which is functionally retained on the handle assembly 12. See FIGS. 1 and 2C. As the surgeon moves the catch switch 90 in the distal direction (arrow 92 in FIGS. 1 and 2C), the acquisition housing 70 moves in the distal direction. Such displacement of the acquisition housing 70 causes the distal end portion 84 of each engagement element 80 to extend in a distal direction beyond its corresponding pickup clearance 72. When the distal end portion 84 of each engagement member 80 is advanced beyond the acquisition clearance 72, the natural bending action of the engagement member 80 causes the end portion 84 to bend radially from the central axis AA as shown in Fig. 4. The surgeon may retract the acquisition housing 70 and the engagement means 80 to their initial positions (Figure 2) by displacing the engagement switch 90 in the proximal direction (arrow 94 in FIGS. 1 and 2C). [0025] As can further be seen in Figures 2, 2A, 2D, 3 and 4, in various non-limiting embodiments, the cutter housing 100 is held coaxially within the acquisition housing 70. The cutter body 100 is held to selectively move axially with respect to the acquisition housing 7 and to selectively move axially along the center axis AA. In various embodiments, a pair of rods 101 actuating the housing protrudes from the cutter body 100 to be coupled to the knife knob 110, which is held movable on the handle assembly 12. See FIGS. 1 and 2D. In various non-limiting embodiments, the knife knob 110 is held on the handle assembly 12 in such a way that it can move axially (in the directions indicated by arrows 112, 114 in Fig. 1 and 2D) and can also rotate relative to the handle assembly 12 (in the direction of arrow 116 in Fig. 1). The rods actuating the housing 101 are attached to the knife knob 110 in such a way that the movement of the knife knob 110 in an axial direction moves the cutter housing 100 axially within the acquisition housing 70, and the rotation of the knife knob 110 also causes the chisel housing 100 to rotate about the center axis AA, which will be discussed in detail below. [0026] In various non-limiting embodiments, the chisel housing 100 includes at least one and preferably a plurality of lumens 102 for knives that extend axially through the wall of the chisel housing 100. As can be seen, for example, in Fig. 3, a plurality of blade clearances 102 may be arranged at an equal distance around the circumference of the cutter housing 100. In the non-limiting embodiment shown in Fig. 3, all eight (8) knife clearance 102s are arranged at an equal distance around the circumference of the cutter housing 100. As can be seen in Figures 2 and 4, each knife clearance 102 has a curved portion of distal end 104,

[0027] In various non-limiting embodiments, the flexible knife element 120 is slidably disposed within each knife clearance 102. Each flexible knife element 120 has a tapered distal end 122 and is attached to or protrudes from the knife ring 123. A pair of knife actuating bars 125 are attached to the knife ring 123 by means of a sliding connection configuration 127 that allows the knife ring 123 to rotate relative to the actuating bars 125. See FIG. 2A. As can be seen in Fig. 2C, the knife control bars 125 (only one knife actuating bar 125 is shown in this view) are attached to the knife switch 130, which is functionally attached to the handle 12. The distal end 122 of each knife element 120 is substantially tapered. .

[0028] As can also be seen from Fig. 2A, the roller assembly 50 has a post end skirt 140 that projects from the base portion 51 and extends coaxially within the chisel housing 100 for selectively axial movement therein. The various embodiments also include a partition element 141 that is secured within the outer shell 116. For ease of assembly, the outer cover 16 can include a distal segment 16 of the outer shell and a proximal segment 16 'of the outer shell, as shown in Fig. 2A. In addition, the post end skirt 142 extends from the septum 51 and supports the distal anus connector 150. The distal anvil 150 connector is connected to the distal band assembly 151. The distal band device 151 is connected to the control rod assembly 153 that connects to the adjustment knob 160, which is rotatably held on the handle assembly 12. Such anvil roller assemblies and control knob configurations are generally known. For example, the control rod assembly and the control knob can be configured as disclosed in published US Patent Application No. US 2008/0078806 A1, entitled "Surgical Stapling Instrument With Mechanical Indicator to Show Levels of Tissue Compression."

[0029] As can be seen in FIG. 2B, each of the actuation bars 101 of the housing projects through a respective arcuate slot 145 in the partition 141. The slots 145 can be sized to define / limit the amount by which the cutter housing 100 can be rotated relative to the axis. central AA. For example, in one embodiment in which all eight (8) knife elements 120 are used, the slots 145 may be sized to facilitate arcuate or rotational movement of at least approximately 45 ° - 50 ° of the cutter housing 100 about the center axis AA. The baffle 141 may further include an opening 146 to allow a further band member 151 to extend through it. In addition, each of the knife operating bars 125 extends through a corresponding opening.

147 in partition 141. Similarly, each of the rods 83 to be extracted runs through a corresponding opening

148 in bulkhead 141. See FIG. 2B.

[0030] The circular stapler 10 further comprises an anvil 170 as shown in FIG. 5. In various non-limiting embodiments, the anvil 170 includes an anvil base 171 that has in its interior a plurality of staple pockets 172 and an anvil shaft 174 that can be fastened. with the possibility of removing the anvil 150 to the distal connector. In particular, the coupling shaft 176 projects from the proximal end 175 of the anvil shaft 174 and is sized such that it can be slidably disposed in the channel 152 in the distal anvil connector 150. The anvil 170 further includes an anvil socket 178 as shown in FIGS. 5 and 13, which defines a tissue cavity 179 within.

[0031] One exemplary method of using a circular stapler 10 will be described with reference to Figs. 5-16. The various embodiments of the circular stapler 10 are particularly suitable for conducting a circular union of a tubular body, such as a colon, for example.

Referring first to FIG. 5, the stapler head 20 is inserted into the proximal portion

201 colon 200 through the patient's anus 199. In applications where the patient or the target part

202 of the colon to be removed, the stapler head 20 is placed adjacent to the part of the patient 202. See FIG. 6.

After inserting the stapler head 20 to the desired position relative to the diseased part 202, the cutter chassis 100 is advanced in the distal direction by axially extending the knife knob 110 in the distal direction (indicated by arrows 112 in Figures 1 and 7). At this stage of the procedure, the knife elements 120 have not been extended beyond their respective blade clearances 102. The surgeon then extends the housing 70 for acquisition in the distal direction by moving the engagement switch 90 in the distal direction (arrow 92 in Figure 1). The displacement of the backward facing housing 70 causes axial movement of the catch elements 80 beyond their respective pickups 72 for acquisition. When the further ends of the hooking elements 80 leave their respective lumens 72 for acquisition, naturally bend radially outward to engage and pierce the proximal portion 201 of the colon 200. See FIG. 8. After piercing and being hooked by the catch means 80 of the proximal portion 201 of the colon 200, the surgeon moves the catch switch 90 in the proximal direction (indicated by arrow 94 on FIG. 1) to retract hooking elements 80 to their respective acquisition clearances 72 and to retract housing 100 for recovering back to its initial position. The hooks 84 at the distal ends of the catch elements 80 draw the latched proximal portion 201 to the position shown in Fig. 9.

[0033] After the attached proximal portion 201 of the colon 200 has been pulled into the position shown in Fig. 9, the surgeon then extends the knife elements 120 from their respective lumens 102 by axially extending the knife knob 110 on the handle assembly 12 in the distal direction (indicated by the arrow 112 in Fig. 1). By moving the knife knob 110 towards the distal side, the knife elements 120 extend beyond their knife clearance 102, and the curved portion 104 of each knife lumbar 102 causes the knife element 120 within it to move radially outward, as shown in FIG. 10. The knife elements 120 extend through the proximal portion 201 of the colon 200, which is closer to the sick part of the colon 202. See FIG. 10. The sick part of the colon 202 can then be cut off from the proximal portion of the colon 201 by rotating the knife knob 110 on the handle assembly 12 (in the direction indicated by the arrow 116 in Figure 1). The rotary movement / actuation of the knife knob 110 will cause rotation of the cutter housing 100 and the knife elements 120 about the center axis AA and the intersection of colon tissue. After the sick part 202 has been cut off from the proximal portion of the colon 201 (Figure 11), the surgeon may retract the knife elements 120 back to their respective knife clearance 102 by moving the knife knob 110 closer (indicated by the arrow 114 in Fig. 1). See FIG. 12. The rotary movement / actuation of the knife knob 110 will cause rotation of the cutter housing 100 and the knife elements 120 about the center axis AA and the intersection of colon tissue. After the sick part 202 has been cut off from the proximal portion of the colon 201 (Figure 11), the surgeon may retract the knife elements 120 back to their respective knife clearance 102 by moving the knife knob 110 closer (indicated by the arrow 114 in Fig. 1). See FIG. 12. The rotary movement / actuation of the knife knob 110 will cause rotation of the cutter housing 100 and the knife elements 120 about the center axis AA and the intersection of colon tissue. After the sick part 202 has been cut off from the proximal portion of the colon 201 (Figure 11), the surgeon may retract the knife elements 120 back to their respective knife clearance 102 by moving the knife knob 110 closer (indicated by the arrow 114 in Fig. 1). See FIG. 12.

[0034] The sick part 202 can be cut off from the distal part of the colon 208 (figure 13), e.g. by means of a traditional laparoscopic tissue cutting device (not shown), which can be inserted through the trocar sleeve that runs into the abdominal cavity 601, which adjoins the sick part 202. The sick part of the colon 202 can then be removed by the trocar sleeve. The surgeon then sets the anvil 170 inside the distal portion of the colon 206 so that the anvil shaft 174 projects beyond the distal portion of the colon 206, as shown in Figure 13. The surgeon then establishes the end of the distal portion of the colon 206 around the anvil shaft 174 using the state known from the state of the anvil. the "mantle suture" technique 220. After the distal portion of the colon 206 is sutured around the anvil shaft 174,

[0035] The surgeon then draws the anvil 170 towards the stapler head 20 (in the proximal direction "PD") by rotating the anvil control knob 160 in a desired direction until the parts of the colon 205, 210 are clamped between the anvil 170 and the staple cartridge 30. as shown in Fig. 14. The surgeon then actuates the firing trigger 60 to extend the axial firing shaft assembly 50 in the distal direction "DD". When the release roller assembly 50 is extended in the distal direction, the outer staple driver portion 54 and the staple driver inner part 56 serve to direct staples 36 located respectively in the outer row 32 and in the inner row 34 through the colon portions 205, 210 into mold pockets 172 anvil in the anvil base 171. The roller assembly 50 also extends the annular collar 40 through a portion of the colon 205 to cut part 201 therefrom. See FIG. 15. Further ejection of the ring knife 40 causes the colon portion 207 to be cut off from the colon portion 208. The surgeon then moves the anvil 170 distal "DD "To release stapled parts of the colon 205, 210 between the base of the anvil 171 and the surface 31 of the staple cartridge 30. See FIG. 16. The apparatus 10 can then be removed from the colon 200. The cut portion 201 remains in the stapler head 20 and the severed portion 207 remains in the anvil tissue cavity 179 as the surgeon withdraws the device 10 out through the patient's anus. As a result, the dissected parts 201, 207 of the colon 200 are removed from the colon subjected to surgery when the device is withdrawn from it.

[0036] Fig. 17 shows a further circular stapler 300 in accordance with various non-limiting embodiments of the invention. The circular stapler 300 generally comprises a handle assembly 312 that has an elongate shaft 314 extending therefrom. The elongated shaft 314 can define the central axis AA. As can be seen in Figure 17, the longitudinal shaft 314 includes a rigid outer sheath 316 that holds the stapler head 320. In various non-limiting embodiments, the stapler head 320 is configured to hold a circular staple cartridge 330 within it. Such circular staple cartridges 330 are known in the art and may substantially retain within them one, two or more circumferentially-spaced and alternating rows of staples 36, as described above. The traditional ring knife 340 is held coaxially and movably in the staple cartridge 330. See FIG. 18.

[0037] In some implementations, the circular stapler 300 further includes a firing roller 350 that is operably retained within the rigid outer shell 316 for selectively axially moving there- in its interior as described above. See FIG. 18. The distal end portion 352 of the firing shaft 350 has an outer tab portion 354 of the staple driver drive portion of each of the staples 36 in the outer row 32 of staples in the staple cartridge 330. In addition, the distal end portion 352 of the firing shaft 350 has an inner portion 356 of the staple driver configured to engage each of the staples 36 in the inner row 34 of staples 36 inside the staple cartridge 330. As can also be seen, for example, in Fig. 18,

[0038] In various non-limiting embodiments, the firing shaft 350 connects to a trigger trigger 360 that is operably connected to the handle assembly 312. As can be seen in Figure 17, the trigger trigger 360 is rotatably connected to the handle assembly 312 such that when the trigger trigger 360 is rotated towards the handle assembly 312, the firing shaft 350 is moved in the distal direction DD. As mentioned before, such triggering trigger configurations are known in the art and will therefore not be discussed in detail herein.

[0039] As can be seen in Fig. 18, various non-limiting embodiments also include an arranging roller 370 that is held coaxially and rotationally within the tissue acquisition roller 380, which is held non-rotatably within the elongated shaft 316. The proximal end of the arranging shaft 370 connects functionally with the tissue pick-up knob 310, which is rotatably held on the handle assembly 312. The placement roller 370 connects to the tissue dial 310 as described above with respect to the knife knob 110. Thus, the rotation / actuation of the tissue pick-up knob 310 on the handle assembly 312 will result in a rotational movement of the distribution roller 370 within the roller 380 for tissue acquisition about the central axis AA. In particular and with reference to Fig. 19, in various embodiments, the distal end 372 of the arranging shaft 370 protrudes through the opening 382 in the acquisition roller 380 and has a drive gear 374 attached thereto. The further end 384 of the acquisition roller 380 is configured to functionally maintain the at least two tissue acquisition elements 400. tissue. In the non-limiting embodiment shown in Figure 19, all four of the tissue arms 400 are rotatably attached to the distal end 384 of the roller 380 for tissue acquisition through the respective pins 386 such that each tissue arm 400 rotates about the corresponding "acquisition" axis BB which is substantially parallel to the central axis AA. See figures 21 and 23.

[0040] As can be seen in Figures 19 and 22, each tissue arm 400 has a body portion 402 that can be made of, for example, stainless steel (300 or 400 series), titanium, titanium-alloy composite, ceramic and the like, and be driven a toothed wheel 404 attached to it or formed thereon. The driven gear 404 of each tissue arm 400 is held movable within a respective cavity 388 of the arm formed in the distal end 384 of the tissue acquisition roll 380. Each driven gear 404 is in mesh with the drive gear 374 on the setting roller 370. As a result, the rotational movement of the positioning roller 370 will result in the rotation of the tissue arms 400 from the retracted position shown in FIG.

[0041] In various embodiments, the body portion 402 of each tissue arm 400 may further include a tissue piercing tip 406 formed thereon or otherwise secured thereto. Furthermore, the arm knife 408, which has a cutting edge 410 formed thereon, is attached to or otherwise formed on the body portion 402 of each tissue arm 400. In various embodiments, the arm knife 408 may be made of, for example, stainless steel (300 or 400 series), titanium-steel composite, ceramic and the like, and may be attached to the body portion 402 of the respective tissue arm 400 using, depending from material, welding or any other appropriate method of attachment. In preferred embodiments, if the arm knife 408 is made of any of the materials defined above, it may be desirable to cure such material. For example, a Rockwell material hardness value of 38-52 may be desirable. In alternative embodiments, the arm can be made of a thin element that can have a sharp edge. From the following detailed description it will be understood that the blade acts more like a shears than a knife because it cuts in a closed form, which means that it cuts the tissue as it approaches 421. As can also be seen in FIG. 19, the shear plate 420 is attached to the distal end 382 of the arm shaft 380 by means of threaded fastening elements 422 that extend to the threaded holes 424 of the fastener in the arm shaft 380. Also in various embodiments, a plurality of tissue-gathering pins 426 are spaced about the circumference of the tissue-building roller 380 and protrude therefrom radially. The outer edge 421 of the shearing plate 420 cooperates with the cutting edges 410 on the tissue arms 400 to shear tissue that is pulled between these edges 410, 421 when the tissue arms 400 are moved to their retracted position.

[0042] In some embodiments, the distal end post 442 projects from a portion of the firing roller 350 that coaxially extends within the arranging shaft 370 to selectively move the axial within it. The post-stop post 442 retains within its distal anus connector 450 that is connected to the adjustment knob 460, which is rotatably held on the handle assembly 312 in accordance with various methods discussed above. [0043] The circular stapler 300 further comprises an anvil 470 as shown in Fig. 18. In various non-limiting embodiments, the anvil 470 includes an anvil base 471 that has in its interior a series of staple forming pockets 472. The anvil base 471 may further define a shearing edge 473 to facilitate shearing of the tissue through the ring knife 340. The anvil 470 further includes an incontinent shaft 474 that is attachable to the distal anvil 450 connector. In particular, the coupling shaft 476 protrudes from the proximal end 475 of the anvil shaft 474 and is sized to be slidable in the channel 452 in the anvil peg assembly 450. See FIG. 23. The anvil assembly 470 may further include an anvil adapter 478 that serves to defining the tissue cavity 479, as shown in FIGS. 18 and 23. As can also be seen in FIG. 18, the disk-like assembly 401 is sized to extend into the aperture 475 in the anvil base 471. which is attached with the possibility of removing the anvil 450 to the distal connector. In particular, the coupling shaft 476 protrudes from the proximal end 475 of the anvil shaft 474 and is sized to be slidable in the channel 452 in the anvil peg assembly 450. See FIG. 23. The anvil assembly 470 may further include an anvil adapter 478 that serves to defining the tissue cavity 479, as shown in FIGS. 18 and 23. As can also be seen in FIG. 18, the disk-like assembly 401 is sized to extend into the aperture 475 in the anvil base 471. which is attached with the possibility of removing the anvil 450 to the distal connector. In particular, the coupling shaft 476 protrudes from the proximal end 475 of the anvil shaft 474 and is sized to be slidable in the channel 452 in the anvil peg assembly 450. See FIG. 23. The anvil assembly 470 may further include an anvil adapter 478 that serves to defining the tissue cavity 479, as shown in FIGS. 18 and 23. As can also be seen in FIG. 18, the disk-like assembly 401 is sized to extend into the aperture 475 in the anvil base 471.

[0044] One example of methods for using a circular stapler 300 will be described with reference to Figs. 23-31. The various embodiments of the circular stapler 300 are particularly suitable for conducting a circular union of a tubular body, such as for example a colon 200. Referring first to FIG. 23, the stapler head 320 is inserted into the proximal portion 201 of the colon 200 through the patient's anus. In cases in which the sick or target portion 202 of the colon 200 is to be removed, the stapler head 320 is placed in the area where the sick part 202 is to be cut away from the proximal portion 201.

After the stapler head 320 is correctly positioned within the colon, the tissue arms 400 may be arranged radially by rotating the knob 310 to acquire tissue in the first direction (indicated by the arrow 311 in Figure 17), which also causes the setting roller 370 to rotate. The rotation of the positioning roller 370 in the first direction also causes the drive gear wheel 374 to rotate, which is meshed with the driven gear portions 404 of each tissue arm 400. Thus, the rotational movement of the drive gear 374 in the first direction causes radial disposition of the tissue arms 400. When the tissue arms 400 are radially disposed, the tissue piercing ends 406 pierce the proximal portion 201 of the colon 200. See Figs. 24 and 25. as the tissue arms 400 will be arranged in such a way that their tissue piercing ends 406 pierce the proximal 201 part of the colon 200, the surgeon can then turn the tissue selecting knob 310 in the second direction (indicated by the arrow 313 in Figure 17) to move the tissue arms 400 to the retracted position. When the tissue arms 400 are retracted, they collect the pierced proximal part of the colon 201

200 and pull it inwardly towards the tissue-producing roller 380. When the colon is collected

201 is pulled between the shear plate 420 and the tissue extraction arms 201 that the colon 200 that is caught between the outer edge 421 of the shear plate 420 and the cutting edges 410 on the tissue arms 400 is cut from the sick part 202 of the colon 200. Retraction of the tissue arms 400 causes the 201 colon part 201 to be studded onto the pins 426 for holding the tissue and retaining thereon as shown in Fig. 26.

202 of the colon 200 may be cut off from the distal portion of colon 208 using a traditional laparoscopic tissue cutting device (not shown) inserted through a trocell sleeve inserted into the abdominal cavity 601. After the sick part 202 is cut off from the distal portion of the colon 208, the affected part 202 may be removed by the trocell sleeve (not shown) using a conventional gripping device 600. See Fig. 26.

The surgeon may then set the anvil 170 within the distal portion 208 of the colon 200 so that the coupling shaft 476 of the anvil shaft anvil shaft 474 projects beyond the distal portion 208 of the colon 200, as shown in Figure 28. The surgeon then establishes the end of the distal portion colon 208 around the anvil shaft 474 using the prior art "mantle staple" 220. After the distal portion of the colon 208 is sutured around the anvil shaft 474, the anvil shaft 476 engaging shaft 474 is introduced into the channel 452 in the anvil shaft assembly 450. The coupling shaft 476 can be sized with respect to the channel 152 to define a pressure between them to hold the coupling stem 176 in the channel, but to allow the coupling stem 176 to be removed from the channel at a later time.See Fig. 28.

The surgeon may then move the anvil 470 in the distal direction "DD" to release the stapled parts of the collar 205, 210 from between the anvil 470 and the stapler head 320. The apparatus 300 can then be removed from the colon 200. See Figure 31. The cut-off portions 201, 207 of the colon 200 remain in the head 320 of the stapler and anvil 470, respectively, as the surgeon retracts the device 300 out through the patient's anus. Thus, the cut-off portions 201, 207 of the cap 200 are removed from the surgical vessel as the apparatus 300 is withdrawn from it. 207 of the bin 200 are respectively in the head 320 of the stapler and anvil 470 as the surgeon withdraws the device 300 out through the patient's anus. Thus, the cut-off portions 201, 207 of the cap 200 are removed from the surgical vessel as the apparatus 300 is withdrawn from it. 207 of the bin 200 are respectively in the head 320 of the stapler and anvil 470 as the surgeon withdraws the device 300 out through the patient's anus. Thus, the cut-off portions 201, 207 of the cap 200 are removed from the surgical vessel as the apparatus 300 is withdrawn from it.

[0048] Circular stapling devices are usually inserted through the anus, rather than from the ventral side of the pelvis. This method of insertion makes it difficult for the surgeon to recognize the tumor, the required margins of the tumor, and the margin margins with respect to the further cutting position, to ensure that the stapler head is correctly positioned in the collar before commencing the cutting. Figs. 32-37 illustrate a circular stapler 700 according to various non-limiting embodiments of the invention that can provide feedback to the surgeon during the insertion process. The circular stapler 700 generally comprises a handle assembly 712 that has an elongate shaft assembly 714 protruding therefrom. The longitudinal struggle assembly 714 can define the central axis AA. As can be seen in Fig. 32, the longitudinal roller assembly 714 includes a rigid outer shell 716 that has a distal end portion that holds the stapler head 720. In various non-limiting embodiments, the stapler head 720 is configured to operably hold the circular cartridge 730 with staples in its interior. Such circular staple cartridges 730 are known in the art and may substantially retain within them one, two or more than two circumferentially staple rows of staples. In the non-limiting embodiment shown in FIG. 33, the staple cartridge 730 holds two rows of 732, 734 staples 36 in its interior. The conventional ring knife 740 is held coaxially and movably in the stapler head 720. which holds the stapler head 720. In various non-limiting embodiments, the stapler head 720 is configured to operably hold the circular cartridge 730 with staples in its interior. Such circular staple cartridges 730 are known in the art and may substantially retain within them one, two or more than two circumferentially staple rows of staples. In the non-limiting embodiment shown in FIG. 33, the staple cartridge 730 holds two rows of 732, 734 staples 36 in its interior. The conventional ring knife 740 is held coaxially and movably in the stapler head 720. which holds the stapler head 720. In various non-limiting embodiments, the stapler head 720 is configured to operably hold the circular cartridge 730 with staples in its interior. Such circular staple cartridges 730 are known in the art and may substantially retain within them one, two or more than two circumferentially staple rows of staples. In the non-limiting embodiment shown in FIG. 33, the staple cartridge 730 holds two rows of 732, 734 staples 36 in its interior. The conventional ring knife 740 is held coaxially and movably in the stapler head 720. In various non-limiting embodiments, the stapler head 720 is configured to operably hold the circular cartridge 730 with staples in its interior. Such circular staple cartridges 730 are known in the art and may substantially retain within them one, two or more than two circumferentially staple rows of staples. In the non-limiting embodiment shown in FIG. 33, the staple cartridge 730 holds two rows of 732, 734 staples 36 in its interior. The conventional ring knife 740 is held coaxially and movably in the stapler head 720. In various non-limiting embodiments, the stapler head 720 is configured to operably hold the circular cartridge 730 with staples in its interior. Such circular staple cartridges 730 are known in the art and may substantially retain within them one, two or more than two circumferentially staple rows of staples. In the non-limiting embodiment shown in FIG. 33, the staple cartridge 730 holds two rows of 732, 734 staples 36 in its interior. The conventional ring knife 740 is held coaxially and movably in the stapler head 720.

[0049] The circular stapler 700 further comprises a firing roller 750 that is functionally retained within the rigid outer shell 716 for selective axial movement therein. See FIG. 33. The distal end portion 752 of the firing shaft 750 has an outer portion 754 of the staple driver for engaging each of the staples 36 in the outer row 732 of staples 36 in the staple cartridge 730. In addition, the distal end portion 752 of the firing shaft assembly 750 includes an inner staple driver portion 756 that is configured to engage each staple 36 in the inner row 734 of staples 36 within the staple cartridge 730. As can also be seen, for example, in Fig. 33, a portion of the distal end 752 of the firing shaft 750 further has a flange portion 758,

[0050] In various non-limiting embodiments, the firing shaft 750 connects to a trigger trigger 760 that is operatively connected to the handle assembly 712. As can be seen in Figure 32, the firing trigger 760 is rotatably connected to the handle assembly 712 such that when the firing trigger 760 is rotated towards the handle assembly 712, the firing shaft 750 is moved in the distal direction DD in the manner discussed above.

[0051] As can be seen in Fig. 33, various non-limiting embodiments comprise a detenting and detecting housing 770 that is held coaxially within the firing shaft 750 and can be moved axially within it. The housing 770 detaching and detecting it has in its interior a plurality of hooks 772, each of which holds with the possibility of displacing the catch element 780 for its acquisition. As can be seen, for example, in Fig. 34, a plurality of three-way lumens 772 may be arranged at an equal distance around the periphery of the catching and detecting housing 770. For example, in a non-severe wound (ie, the embodiment shown in FIG. 34 all eight (8) detent apertures 772 are arranged at an equal distance around the perimeter of the detent housing 770. Each engagement member 780 may be made of, for example, Nitinol, stainless steel series 300 or 400 (hardened entirely or in 3/4) and the like, and may have a distal end portion 782 which, in the case of extending beyond its respective coupling clearance 772, naturally bends radially outward in accordance with the methods described above. As with other embodiments, each catching member 780 may have a tissue hook 784 formed at its distal end 782. As can be seen in Figures 33 and 34,

[0052] In various non-limiting embodiments, the proximal end portion of the engagement and detection housings 770 may operably connect to the catch switch 790 that is operatively held on the holder 712. See Fig. 32. When the surgeon moves the catch switch 790 in the distal direction (arrow 792). in Fig. 32) the detent and detent housing 770 moves in the distal direction. In addition, each catching member 780 is advanced in the distal direction beyond its corresponding hook clearance 772 in the manner described above. The surgeon may retract the engagement means 780 to their initial positions by moving the engagement switch 790 in the proximal direction (arrow 794 in Fig. 32).

There are also a plurality of flexible detecting elements 781 within the detenting and detecting housing 770. In particular, a plurality of lugs 774 for the detecting means are also provided in the detent and detent housing 770. For example, in the non-limiting embodiment shown in Fig. 34, all eight (8) laps 774 for the detector elements are arranged at an equal distance around the circumference of the detent and detent housing 770. In one non-limiting embodiment, each detector element 781 may be made of, for example, polyethylene, nylon, Nitinol, titanium and the like, and may have a distal end portion 783 which, if disposed outside its corresponding lumen 774 for detecting elements, in a natural manner, it bends radially outwardly as shown in Fig. 35. Furthermore, at the distal end of each detector element 781 there may be a substantially blunt or rounded reflector 785. In one embodiment, the reflector may be made of, for example, a Sanoprene material, from isoprene. , natural rubber, polypropylene, polyethylene, nylon and the like. In other embodiments, the reflector 785 may include a light source or an LED (light emitting diode). In these embodiments, the conduit may run from the battery in the holder assembly 712 or other energy source through the clearance in the detector element 781 to the light source 785. In one embodiment, the reflector may be made, for example, of a Sanoprene material, of isoprene, natural rubber, polypropylene, polyethylene, nylon and the like. In other embodiments, the reflector 785 may include a light source or an LED (light emitting diode). In these embodiments, the conduit may run from the battery in the holder assembly 712 or other energy source through the clearance in the detector element 781 to the light source 785. In one embodiment, the reflector may be made, for example, of a Sanoprene material, of isoprene, natural rubber, polypropylene, polyethylene, nylon and the like. In other embodiments, the reflector 785 may include a light source or an LED (light emitting diode). In these embodiments, the conduit may run from the battery in the holder assembly 712 or other energy source through the clearance in the detector element 781 to the light source 785.

[0054] In various non-limiting embodiments, the proximal end portion of each detecting element 770 may engage the detection knob 791 that is functionally held on the handle assembly 712. See Fig. 32. When the surgeon rotates the detection dial 791 in the first direction (arrow 793 on Fig. 32), the detector elements 781 move in a distal direction beyond their respective lumens in the radial direction away from the central axis A ~ A to the arranged positions (Fig. 36). In various embodiments, for example, all of the detecting elements 781 can be attached to a circular sleeve (not shown), which is held slidable inside the outer shell 716. The circular sleeve can furthermore have a toothed rack attached thereto. which is inserted in the toothed wheel (not shown) on the bottom side of the detection knob 791. The rotational movement of the detection knob 791 in one direction causes the sleeve to move distally and thus pulls out all of the detecting elements 781. When the surgeon rotates the detection knob 791 in in the second direction (arrow 795 in Fig. 32), the detector elements 781 are attracted back to their respective detection lands 774 into the retracted position. See FIG. 34. Other switches and drive systems may also be used to selectively extract and retract detection means without departing from the concept and scope of the present invention. Rotation of the detection knob 791 in one direction causes displacement of the sleeve in the distal direction and thus pulls out all of the detecting elements 781. As the surgeon rotates the detection knob 791 in the second direction (arrow 795 in Fig. 32), the detector elements 781 are attracted back to their respective detection clearances 774 to the retracted position. See FIG. 34. Other switches and drive systems may also be used to selectively extract and retract detection means without departing from the concept and scope of the present invention. Rotation of the detection knob 791 in one direction causes displacement of the sleeve in the distal direction and thus pulls out all of the detecting elements 781. As the surgeon rotates the detection knob 791 in the second direction (arrow 795 in Fig. 32), the detector elements 781 are attracted back to their respective detection clearances 774 to the retracted position. See FIG. 34. Other switches and drive systems may also be used to selectively extract and retract detection means without departing from the concept and scope of the present invention. the detecting elements 781 are attracted back to their respective detection lands 774 to the retracted position. See FIG. 34. Other switches and drive systems may also be used to selectively extract and retract detection means without departing from the concept and scope of the present invention. the detecting elements 781 are attracted back to their respective detection lands 774 to the retracted position. See FIG. 34. Other switches and drive systems may also be used to selectively extract and retract detection means without departing from the concept and scope of the present invention.

[0055] As can also be seen in Fig. 33, in various non-limiting embodiments, the cutter housing 800 is held coaxially within the catching and sensing housing 770. The chisel housing 800 is held for selective axial movement relative to the detent and detent housing 770 and for selective axial movement along the center axis AA. The cutter body 800 connects to the knife knob 810, which is held movable on the handle assembly 712. See Fig. 32. In various non-limiting embodiments, the knife knob 810 is held on the handle assembly 712 so that it can move axially ( in the directions indicated by arrows 812, 814 in FIG. 32) and can also be rotated relative to the handle assembly 712 (in the direction of arrow 816 in Fig. 32). The cutter body 800 may be attached to the knife knob 810 in various ways described above, which means that moving the knife knob 810 axially moves the chisel housing 800 axially within the detent and detent housing 770, and the rotary movement of the knife knob 810 also causes rotation of the knife. housing 800 of the cutter about the center axis AA.

[0056] In various non-limiting embodiments, the cutter housing 800 includes a plurality of lumens 802 for knives that extend axially through the wall of the chisel housing 800. In accordance with the above description and with respect to other embodiments, a plurality of knife clearance 802 can be arranged at an equal distance around the circumference of the cutter housing 800. For example, in a non-limiting embodiment, all eight (8) lumens 802 of the knives may be spaced about the circumference of the chisel 800 enclosure. As can be seen in Fig. 33, each knife clearance 802 has a curved portion of the distal end 804 that opens radially outwards.

[0057] In various non-limiting embodiments, the knife elastic element 820 is disposed displaceably within each knife clearance 802. Each knife elastic element 820 has a tapered distal end 822 and a proximal end (not shown) that connects to a knife switch 830 that is operably attached to the handle 712 in various ways described above. See FIG. 32. The distal end 822 can be substantially pointed to allow tissue to pierce it, and can have at least one cutting edge formed thereon. When the knife switch 830 is moved in the distal direction (arrow 832), the knife elements 820 are moved in a distal direction inside the knife lugs 802 in such a way, that the further ending 822 ended sharply naturally bends radially beyond the curved portion of the distal end 804 of the lumen 802, as described above. Likewise, displacement of knife switch 830 in a proximal direction (indicated by arrow 834 in Fig. 32) brings the knife elements 820 back to their respective knife clearance 802. In various non-limiting embodiments, the knife elements 820 may be made of, for example, Nitinol, a 300 or 400 series stainless steel (hardened in whole or in 3/4).

[0058] As can also be seen in Figure 33, various non-limiting embodiments may further comprise anvil shaft assembly 840 that is held coaxially within the chassis cutter 800 to selectively move axially within it. The anvil roller assembly 840 may include a distal end post 842 that protrudes from a portion of the firing roller 750. The post end post 842 holds a distal anvil connector 850 in its interior that protrudes distally from the post end post 842. The anvil roller assembly 840 has a proximal end portion that connects to the adjusting knob 760, which is held rotatable on the handle assembly 712, as discussed above with reference to other non-limiting embodiments.

Basically blunt or rounded fenders do not penetrate or damage the colon wall. Such humps 203 allow the surgeon to position the stapler head 720 relative to the tumor or diseased colon portion 202. If one or more of the reflectors 785 include light sources, the surgeon can observe them through the colon wall, as shown in Fig. 37.

After the surgeon has placed the stapler head 720 at the desired location within the proximal portion 201 of the colon 200, the surgeon may then retract the detection means 781 to the engagement and detection housing 770 by rotating the detection knob 791 in a direction that is opposite to the direction in which the items detecting 781 have been ejected. Attachment engagement members 780 may then be advanced to pierce and reach adjacent portions of the proximal wall of colon 201. However, in alternative embodiments, the surgeon may decide to keep detector elements 781 in their extended position as shown in Figure 37. detecting 781 may generate some "peripheral stress" in the wall of the colon,

[0061] In order to cause the hooks 780 to engage and pierce the proximal portion of the colon 201, the surgeon projects the catch hook 770 and detent further by displacing the catch switch 790 in the distal direction (arrow 792 in Fig. 32). The displacement of the detent housing 770 and detecting it in the distal direction causes the axial movement of the engagement means 780 to acquire beyond their respective acquisition clearances 772. After the distal ends of the hooking elements 780 have lowered their respective lands 772, these elements move radially outward to engage and pierce the adjacent parts of the proximal wall of the colon 201. See FIG. 37. After piercing and engaging by the hook members 780 of the adjacent portions of the proximal wall of the colon 201, the surgeon moves the catch switch 790 in the proximal direction (indicated by arrow 794 in Fig. 32) to retract the catching means 780 to their respective lands 772 and retract the housing. 770 catching and detecting back to its initial position. The hooks 784 at the distal ends of the catching members 780 attract the hooked portions of the proximal wall of the colon 201 to a position similar to the position shown in FIG. 9. After pulling the proximal portion of the colon 201 to the position shown in FIG. 9,

[0062] Fig. 38 shows a further circular stapler 900 in accordance with various non-limiting embodiments of the invention. The circular stapler 900 generally comprises a handle assembly 912 that has an elongate shaft 914 extending therefrom. The elongated shaft 914 can define the central axis AA. As can be seen in Figure 38, the longitudinal roller 914 includes a rigid outer shell 916 that has a stapler head 920 at its distal end 917. In various non-limiting embodiments, the stapler head 920 is configured to operably hold the circular staple cartridge 930 in its staple position. interior. Such circular staple cartridges 930 are known in the art and may substantially retain within them one, two or more than two circumferentially and alternately rows of staples 36, as described above. The traditional ring knife 940 is held coaxially and can be moved in the stapler head 920. See Fig. 39.

[0063] The circular stapler 900 further includes a firing roller 950 that is held within the rigid outer shell 916 for selective axial movement therein. See FIG. 39. The distal end portion 952 of the firing shaft 950 has an outer staple driver portion 954 for engaging each of the staples 36 in the outer row 32 of staples 36 in the staple cartridge 930. Further, the distal end portion 952 of the firing shaft 950 has an inner portion of staple driver 956 configured to engage each of the staples 36 in the inner row 34 of staples 36 inside the staple cartridge 930. As can also be seen, for example, in Fig. 39, the distal end portion 952 of the firing pin 950 further has a flange portion 958,

[0064] In various non-limiting embodiments, the firing roll 950 can communicate with a release trigger 960 that is operably connected to the handle assembly 912. See FIG. 38. As can be seen in FIG. 38, the firing trigger 960 can be pivotally connected to the handle assembly. 912 in such a way that when the firing trigger 960 is rotated towards the handle assembly 912, the firing shaft 950 is moved in the distal direction DD. As mentioned earlier, such triggering trigger configurations are known in the art, and thus will not be discussed in detail herein.

[0065] As shown in Fig. 39, various non-limiting embodiments may also include a hollow distribution roller 970 that is held coaxially within the hollow tissue-gathering roll 980. The proximal end of the arranging roll 970 is operatively attached to the handwheel 910, which is rotatably held on the handle assembly 912 in accordance with the various methods described above. Thus, the rotary movement of the arm distributor 910 on the handle assembly 912 will result in a rotational movement of the distribution shaft 970 about the center axis AA. In particular and with reference to Fig. 40, in various embodiments, the distal end 972 of the placement roller 970 projects through the opening 982 in the tissue acquisition roll 980 and has a drive gear 974 attached thereto. The distal end 984 of the tissue acquisition roll 980 is configured to functionally retain the at least one tissue acquisition member; arm 1000. It is preferred to use two or more tissue arms 1000. In the non-limiting embodiment shown in FIG. 40, all of the four tissue arms 1000 are rotatably attached to the distal end 984 of the roller 980 for tissue acquisition through the appropriate pins 986. The use of two or more tissue arms 1000 is preferred. In the non-limiting embodiment shown in FIG. 40, all of the four tissue arms 1000 are rotatably attached to the distal end 984 of the roller 980 for tissue acquisition through the appropriate pins 986. The use of two or more tissue arms 1000 is preferred. In the non-limiting embodiment shown in FIG. 40, all of the four tissue arms 1000 are rotatably attached to the distal end 984 of the roller 980 for tissue acquisition through the appropriate pins 986.

[0066] Each tissue arm 1000 may have a body portion 1002 that may be made of, for example, stainless steel (300 or 400 series), titanium, titanium-steel composite, ceramic and the like, and have a toothed wheel drive 1004 attached thereto or formed on it. The driven gear 1004 of each tissue arm 1000 is held movable within a respective arm cavity 988 formed at the distal end 984 of the tissue acquisition roll 980. Each driven gear 1004 is in mesh with the drive gear 974 on the distribution roller 970. As a result, the rotational movement of the distribution shaft 970 will result in a rotational arrangement of the tissue arms 1000 from the retracted position shown in Fig. 41 to the deployed position shown in Fig.

[0067] In various embodiments, the knife shaft 1010 is positioned coaxially within the arranging shaft 970 and connects to the knife knob 1020 (Figure 38) rotatably supported on the handle assembly 912 so that the rotary movement of the knife knob 1020 results in the rotation of the roller 1010. knife. The knife shaft 1010 further has a distal end 1012 that protrudes beyond the distal end 972, 984 of the arranging roller 970 and the tissue collecting roll 980, respectively. See FIG. 40. The knife 1030 can be attached to the distal end 1012 of the knife shaft 1010, e.g. by means of pins 1032 or other suitable fastening elements. In various embodiments, the knife 1030 may be substantially flat and may have tissue piercing points 1031, 1033 formed against it,

[0068] As can also be seen in Fig. 39, various non-limiting embodiments may further include anvil shaft assembly 440 that includes a distal end post 442 that protrudes from a portion of the firing roller 950 that coaxially extends inside the arranging shaft 970 for selective axial movement. inside him. The post-stop post 442 retains within its distal anus connector 450 that is connected to the adjustment knob 460, which is rotatably held on the handle assembly 312 in accordance with various methods discussed above.

[0069] The circular stapler 900 further comprises an anvil 470 as shown in Fig. 39. In various non-limiting embodiments, the anvil 470 includes an anvil base 471 that has in its interior a series of staple forming pockets 472. The anvil base 471 may further define a shearing edge 473 to facilitate shearing of the tissue through the annular knife 940. The anvil 470 may further include an incontinent shaft 474 that can be removably attached to the distal anvil 450 connector. In particular, the coupling shaft 476 protrudes from the proximal end 475 of the anvil shaft 474 and is sized to be slidable in the channel 452 in the anvil shaft assembly 450. The anvil 470 may further include an anvil adapter 478 that identifies the tissue cavity 479,

One exemplary method of using a circular stapler 900, which is not part of the invention, will be described with reference to Figures 39 and 43-51. Referring first to FIG. 39, the stapler head 920 is inserted into a tubular body such as a colon 200 through a patient's anus 199. The stapler head 920 is located in the proximal portion 201 of the colon 200, adjacent to the diseased portion 202. Next, the arms 1000 for tissue acquisition are radially positioned by rotating the knob 910 for deploying the arms in the first direction (indicated by the arrow 911 in Fig. 38), which also causes the setting shaft 970 to rotate. The rotation of the positioning shaft 970 in the first direction also causes the drive gear to rotate. 974, which is meshing with the driven parts of the gear 1004 of each tissue extraction arm 1000. Thus, the rotational movement of the drive gear 974 in the first direction causes the radial deployment of the tissue extraction arms 1000. When the tissue extraction arms 1000 are radially deployed, the tissue piercing ends 1006 pierce the proximal portion 201 of the colon 200. See FIGS. 44 and 45. The surgeon may then rotate the shoulder positioning knob 910 in the opposite or the second direction (indicated by arrow 913 on the fig) 38) for retracting arms 1000 for tissue acquisition into their retracted position (Figure 20). When the tissue extraction arms 1000 are retracted, the punctured proximal portion 201 of the colon 200 is discharged through the arms 1000 for tissue acquisition in such a way, that part 201 is collected between the tissue extraction arms 1000 and the arm shaft 980 in a position opposite to the staple cartridge 930. The surgeon can then turn the knife knob 1020 to cause the knife 1030 to rotate and cut away the diseased portion 202 of the colon 200 from the proximal portion of the colon 201. The diseased portion 202 can be cut off from the distal colon portion 208 using a traditional laparoscopic tissue cutter (not shown) inserted by the trocar sleeve (not shown) placed in the abdominal cavity 601. After the sick portion 202 is cut off from the proximal portion 201 of the colon 200 and distal portion 208, the diseased portion 202 can be removed through the trocell sleeve using a traditional gripping device 600. . See FIG. 48.

The surgeon may then set the anvil 470 within the distal portion 208 of the colon 200 so that the coupling shaft 476 of the anvil shaft roll shaft 474 projects beyond the distal portion 208 of the colon 200, as shown in Figure 49. The surgeon can then tie the end of further parts of the colon 208 around the anvil shaft 474 using the prior art "fascia stitch" 220. After sewing the distal portion of the colon around the anvil shaft 474, the coupling shaft 476 of the inc shaft 444 is inserted into the duct 452 in the anvil peg assembly 450. Coupling shaft 476 it may be of such size in relation to channel 452 that establishes a pressure therebetween to maintain the coupling stem 476 in the channel, but allowing removal of the coupling stem 476 from the channel at a later time. See Fig. 49.

The surgeon then draws the anvil 470 toward the stapler head 920 (in the proximal direction "PD") by rotating the anvil control knob 460 in a proper direction until the colon part 205, 210 is clamped between the anvil 470 and the staple cartridge 930. as shown in Fig. 50. The surgeon then actuates the firing trigger 960 to extend the axial firing shaft 950 in the distal direction "DD". When the firing roll 950 is extended in the distal direction, a portion of the staple driver 954 serves to direct the staples 36 through the colon portions 205, 210 to the staple forming pocket 472 in the anvil base 471. The firing roll 950 also extends the ring cutter 940 to cut off a portion of the colon 201, 207 from a portion of the colon 205, 210 respectively. and the cut portion 201 is held between the tissue extraction arms 1000 and the arm shaft 980. Thus, the cut-off portions 201, 207 of the colon 200 are removed from the colon surgically treated when the device 900 is withdrawn from it. and the cut portion 201 is held between the tissue extraction arms 1000 and the arm shaft 980. Thus, the cut-off portions 201, 207 of the colon 200 are removed from the colon surgically treated when the device 900 is withdrawn from it.

[0073] When a surgeon performs the above-described procedures or other related procedures in this area of ​​the body, he must take care to avoid inadvertent damage to adherent soft tissues and bone structures. Fig. 52 and 53 show some of the adjoining tissue and bone structures that are located near the colon 200. In Figure 52 the peritoneum 1100 has been cut to represent, for example, anal sphincter 1101, cruciate lobe 1102, sciatica 1104, sciatica -rective 1106, levator anihege muscle 1108, and the third sacral vertebral circle 1110. Fig. 53 further shows the analvial recess 1112, the sacral-genitain fold 1114,catheter 1116, vas 1118, urinary bladder 1120, perifollicular sac 1122, and intravesical folds 1124. The surgeon must also be careful not to damage the muscles, nerves, blood vessels and arteries along the inner peritoneal wall 1100 while accessing the dissected portion of the colon. 200.

[0074] Figures 54-57 show the use of a protective cover 1200 according to a non-limiting aspect of the invention. In various aspects, sheath 1200 may be manufactured, for example, from Kevlar, polyethylene, nylon and the like, and compressed so as to give it a natural tendency to curl into a spiral. See Fig. 55. In various aspects, measurement or reference indicators 1202 may be provided on the sheath 1200 to provide the surgeon with assistance when positioning the functional part of the surgical instrument (e.g., the stapling head of the circular stapler) and to avoid accidental damage to adjacent nerves, blood vessels. and tissues. In further aspects, the sheath 1200 may be produced from a magnetic-field sensitive tape, which would allow magnetic attraction to the functional part of the device to protect neighboring anatomical structures and tissues, e.g. against instrument parts that can damage adjacent tissues, muscles, bones, nerves and the like, during accidental contact of a portion of the device with them. In further alternative aspects, the skirt 1200 may have a ring or magnetically interacting portion that is drawn to the head of the stapler. As a result, at least a portion of the sheath 1200 may be a magnetic shield or otherwise have magnetic material attached thereto. In further alternative aspects, the skirt 1200 may have a ring or magnetically interacting portion that is drawn to the head of the stapler. As a result, at least a portion of the sheath 1200 may be a magnetic shield or otherwise have magnetic material attached thereto. In further alternative aspects, the skirt 1200 may have a ring or magnetically interacting portion that is drawn to the head of the stapler. As a result, at least a portion of the sheath 1200 may be a magnetic shield or otherwise have magnetic material attached thereto.

The sheath 1200 can be installed through the cannula 1252 of the traditional trocar 1250 inserted laparoscopically through the abdominal wall into the abdominal cavity as shown in Fig. 54. The traditional laparoscopic gripping device 600 can be used as shown in Figures 54 and 55 in to remove the sheath 1200 from the trocar canula 1252. The surgeon may then wrap the unconcealed sheath 1200 around colon 200 using conventional grippers 600 as shown in Fig. 56. Fig. 57 shows the sheath 1200 after it is wrapped around the colon 200 and prior to the introduction of the colon wrap ring device. The natural tendency of the sheath to curl into the spiral allows it to be kept in a spiral around the colon 200.

[0076] The sheathing 1200 of the invention can be effectively used to protect neighboring tissues and organs during the use of any of the described embodiments. See, for example, Figures 5-16, 23-31, 36, 39 and 43-51, where the sheath 1200 is installed around the colon 200 in the manner described above. In addition, non-limiting embodiments of the sheath 1200 can also be effectively used with traditional circular stapling devices and similar devices without departing from the scope of the present invention. In embodiments of the device using light sources on detector elements or the like, the sheath 1200 is e.g. made of a photosensitive film that will change the color of the sheath portion 1200 in areas adjacent to the illuminated detector elements.

[007] The various embodiments of the invention represent a significant improvement over previous configurations of circular staplers and related procedures. Although several embodiments of the invention have been described herein, it will be apparent to those skilled in the art that various modifications, variations, and adaptations to these embodiments are possible, with some or all of the advantages of the invention. For example, in accordance with various embodiments, a single component may be replaced by a plurality of components, and a plurality of components may be replaced with one component to perform a specific function and some functions. This application is intended to cover all such modifications,

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