Transwall visualization arrangements for surgical circular staplers

[0001] The present invention relates generally to surgical staplers, and more specifically to devices for holding and / or protecting tissue near the head of a round stapler.

FIELD OF THE INVENTION [0002] For some types of surgical procedures, the use of surgical staplers has become the preferred method of tissue joining, and specially configured surgical staplers have been designed for such applications. For example, placed in the lumen of the body or round staplers for use in surgical procedures performed in the lower part of the colon after excision of the diseased part of the intestine. Round staplers useful in carrying out such procedures are described, for example, in US Patent Nos. 5,104,025; 5,205,459; 5,285,945; and 5,309,927.

[0003] A conventional, round surgical stapler consists generally and generally of an elongated shaft equipped with a proximal propelling mechanism and a distal stapler head mounted on the elongated shaft. The distal stapler head generally consists of a permanently mounted staple cartridge containing a series of staples configured as a concentric circular arrangement. The round cutting knife is mounted concentrically in the cartridge, inside the staples, for axial movement. From the center of the cartridge, in the axial direction, a movable trocar shaft extends adapted to the detachable connection of the anvil to the staples. The anvil is configured to form the staple tips as they enter the anvil. The distance between the distal plane of the staple cartridge and the staple anvil is generally controlled by an adjustment mechanism mounted at the proximal end of the stapler shaft to control the axial movement of the trocar. The tissue clamped between the staple cartridge and the staple anvil is simultaneously clamped and cut when the surgeon starts the mechanism. [0004] When performing a procedure in the lower colon using a circular stapler, part of the intestine can be laparoscopically stitched using a conventional surgical stapler introduced through a trocar. A conventional surgical stapler places several rows of staples on each side of the diseased, removed portion of the colon. The target or diseased part is cut at the same time as the adjacent part of the intestine is sutured. After removing the diseased part, the surgeon generally places the anvil of the round stapling device at the distal end of the lumen, distal to the staple line. This operation can be performed by inserting the anvil head into the input socket cut out by the surgeon in the distal light. The bottom line of staples is used to hold colon tissue on a round cartridge. This method closes both ends of the colon, the closed parts being incised and removed. Staple lines established at this intermediate stage are only temporary and facilitate the next stage of the procedure.

[0005] The anvil can sometimes be inserted rectally by placing the anvil head at the distal end of the stapler and inserting the device through the rectum. After mounting the anvil in the distal part of the intestine, the intestine is secured around the anvil shaft with a so-called "tightening" suture. The proximal part of the intestine is secured around the stapler head in a similar manner, with a tightening suture.

[0006] After securing the ends of the intestine on the appropriate elements, the surgeon using a suitable trocar sleeve can use a gripping device to grip the anvil shaft and connect it to the part of the trocar protruding inside the stapler head. The surgeon then closes the gap between the anvil and the cartridge, clamping the proximal and distal end of the intestine in the gap. The surgeon then launches the stapler by passing several rows of staples through both ends of the intestine and forming them, thereby connecting the ends of the intestine to form a passage tube. At the same time, during the introduction and forming of staples, the concentric, round blade of the knife is passed through the ends of the intestinal tissue and cuts the ends adjacent to the inner row of staples. The surgeon then withdraws the staple from the intestine and the procedure is completed.

[0007] Such procedures and devices require the surgeon to apply two astringent sutures, which increases the time required to complete the surgery.

Such procedures can also sometimes cause tissue to "build up" during the process of cutting / stitching the tissue. [0008] Various attempts have been made to attach the colon and other tissues around staplers. U.S. Patents No. 5,309,927; 6,117,148 and 7,094,247, for example, describe various configurations that generally use fasteners, fasteners, rings, springs, etc. located at a distance from the stapling device itself to fix the tissue in a fixed position. US Patent No. 5,669,918 describes a mechanism that uses a gripper-like arm to immobilize tissue on the trocar leg. Although such a device is practically independent, in practice the gripper arms may not be able to effectively hold the tissue in a given position.

[0009] There is therefore a need for devices and methods to reduce the time required to complete a surgical procedure and to address other deficiencies and challenges associated with tissue fixation in a given position when using a circular stapler configuration.

[0010] US2007 / 135803 is a document describing a colectomy device having a distal element 104 and a proximal element 106. Each of these elements has a decomposable portion 108 and a gripping mechanism 110 for gripping the colon wall. At least one of the elements may slide longitudinally relative to the body of the colonoscope 100. The colectomy device 102 also has a surgical stapler 116 and anvil 118 carried on the respective components, and such device may have a cutting device, electro-crossing device or laser device designed to cut the colon wall. The colectomy device is positioned using the fold-out parts 108 of the distal element 104 and proximal element 106 in a folded or emptied state to allow easy passage through the colon. Once positioned, the unfolding elements 108 are distributed within the colon such that the gripping mechanism 110 grips the wall of the colon. It can be said that the distal element 104 and element 106 can be folded down by any number of folding devices. The examples given include radial expansion on spokes-like support structures or radial expansion in a rotating motion until the desired expansion diameter of the element is obtained.

[0011] The discussion cited above is only intended to present some of the shortcomings that are currently in the art and should not be regarded as a denial of the scope of the claims.

BRIEF DESCRIPTION OF THE INVENTION [0012] According to one general aspect of the various non-limiting embodiments of the present invention, a surgical instrument is disclosed having an elongated shaft defining a central axis and having a distal end configured to provide functional support and seat a round staple cartridge therein. At least one detection element is functionally embedded in the elongated shaft. Each of the detection elements has a distal part, which can be placed radially, at a distance from the central axis after applying the spreading motion. A light source can be placed on the distal part of the detection element. [0013] According to another general aspect of various, non-limiting embodiments of the present invention, a surgical instrument is disclosed having a handle assembly from which an elongated shaft protrudes. The elongated shaft defines the central axis and has a distal end configured to provide functional support and seat the round staple cartridge. At least one detection element is functionally embedded in the elongated shaft. Each detection element has a distal part, which can be placed radially, at a distance from the central axis after applying a spreading motion to it. At least one pickup element is functionally embedded in the elongated shaft. Each sampling element has a distal piercing tissue that can be placed radially, at a distance from the central axis after applying a spreading motion to it.

[0014] According to yet another general aspect of various, non-limiting embodiments of the present invention, a surgical instrument is provided having a handle assembly from which an elongated shaft protrudes. The elongated shaft defines the central axis and has a distal end configured to provide functional support and seat the round staple cartridge. At least one detection element is functionally embedded in the elongated shaft. Each of the detection elements has a distal part, which can be placed radially, at a distance from the central axis after applying the spreading motion. At least one flexible knife is embedded in the elongated shaft in a manner enabling its movement. Each knife has a distal cutting portion that can extend axially from the distal end of the elongated shaft by applying axial movement to it. Each knife can selectively rotate about a central axis when a rotational movement is applied to it.

[0015] An exemplary surgical procedure for treating an organ in the form of a tube is provided. In the case of various non-limiting embodiments, the procedure involves placing the head of a round stapler of the surgical instrument in a pipe-shaped body. The treatment also includes placing at least one illuminated detection element functionally in the surgical instrument pushed into the position positioned near the wall of the organ in the form of a tube. The treatment also includes observing the light from the illuminated detection element through the organ wall to assess the position of the round stapler head inside the pipe organ.

embedded from position

BRIEF DESCRIPTION OF THE FIGURES [0016] The accompanying drawings, included in and forming part of the specification, show embodiments of the invention and together with the above general description of the invention and detailed description of the embodiments of the invention given below explain the principles of the present invention.

Fig. 1 is a perspective view of a round surgical stapler according to various non-limiting embodiments of the present invention;

Fig. 1A is a cross-section through the handle of various embodiments of the surgical stapler in accordance with the present invention;

Fig. 2 is a cross section through the distal end of the elongated shaft of the circular stapler according to Fig. 1;

Fig. 2A is a cross section through the distal end of the elongated shaft with the anvil connected thereto;

Fig. 2B is a cross-section through the distal end of the elongated shaft taken along the line 2B-2B in Fig. 2A;

Fig. 2C is a cross section through part of the handle assembly of an embodiment of the present invention;

Fig. 2D is a cross-sectional view through another portion of the elongated shaft of various embodiments of the present invention;

Fig. 3 is an end view of the elongated shaft of Fig. 2;

Fig. 4 is a perspective view of the distal end of the elongated shaft of Figs. 2 and 3 together with the tissue sampling elements and their knives in radially positioned;

Fig. 5 is a cross section through the distal end of an elongated shaft with an anvil connected thereto, placed in a tube-like patient body such as the colon;

Fig. 6 is another cross-sectional view of the distal end of the elongated shaft of Fig. 5 with the anvil removed;

Fig. 7 is another cross-sectional view of the distal end of the elongated shaft according to Figs. 5 and 6 with the distal portion of the cutting member housing extending axially beyond the distal plane of the staple cartridge embedded in the distal end of the elongated shaft;

Fig. 8 is another cross-sectional view of the distal end of the elongated shaft of Fig. 7 with the tissue-receiving members positioned radially outside the tissue-receiving housing and piercing a portion of the colon;

Fig. 9 is another cross-sectional view of the distal end of the elongated shaft of Fig. 8 with its tissue-collecting members slid back into the tissue-receiving housing to position the pierced portion of the colon near the distal staple cartridge;

Fig. 10 is another cross-sectional view of the distal end of the elongated shaft of Fig. 9 with the knives radially positioned outside the cutting element housing and piercing another portion of the colon;

Fig. 11 is a cross-sectional view of the distal end of the elongated shaft of Fig. 10 after the knives have been rotated to separate the attached, pierced portion of the colon from the diseased portion of the colon;

Fig. 12 is a cross-sectional view of the distal end of the elongated shaft of Fig. 11 with the knives inserted back into their respective lights in the cutting element housing;

Fig. 13 is a cross-sectional view of the distal end of the elongated shaft of Fig. 12 after the anvil is attached to the distal portion of the colon and the anvil shaft is connected to a portion of the anvil assembly of the circular stapler;

Fig. 14 is a cross-sectional view of the distal end of the elongated shaft of Fig. 13 after moving the anvil near the distal plane of the staple cartridge;

Fig. 15 is a cross-sectional view of the distal end of the elongated shaft of Fig. 14 after removing the staples and moving the knife-shaped ring in the axial direction through adjacent parts of the colon;

Fig. 16 is a cross-sectional view of the distal end of the elongated shaft of Fig. 15 after stitching colon fragments together, but before removing it from the colon;

Fig. 17 is a perspective view of a round surgical stapler of various non-limiting embodiments of the present invention;

Fig. 18 is a cross-sectional view of the distal end of the elongated shaft of the round stapler of Fig. 17;

Fig. 19 is an exploded view of the pickup roller assembly and output of various non-limiting embodiments of the present invention;

Fig. 20 is a perspective view of the pickup roller of Fig. 19 with its tissue arms in a retracted position;

Fig. 21 is a cross-section through the pickup roller of Figs. 19 and 20 with its tissue arms in a set position;

Fig. 22 is a perspective view of the pickup roller of Fig. 21;

Fig. 23 is a cross-sectional view through an elongated shaft of various, non-limiting embodiments of the present invention, with an anvil attached thereto, positioned in a portion of the patient's colon;

Fig. 24 is another cross-sectional view through the elongated shaft of Fig. 23 with the anvil and withdrawal arms positioned in the proximal part of the colon adjacent to the target or diseased portion of the colon;

Fig. 25 is a top cross-sectional view of the elongated shaft of Fig. 24, viewed along line 25-25 of Fig. 24 with tissue extraction arms passing through the proximal portion of the colon;

Fig. 26 is a cross-sectional view through the elongated shaft of Figs. 24 and 25 with the target or diseased portion of the colon removed by a gripping device;

Fig. 27 is a top cross-sectional view taken along line 27-27 of Fig. 26 through the elongated shaft of Fig. 26;

Fig. 28 is a cross-sectional view through the elongated shaft after placing the anvil in the distal part of the colon and fixing the anvil on it by means of a tightening suture solution;

Fig. 29 is a cross-sectional view through the elongated shaft of Fig. 28 after the anvil has been connected to the anvil assembly and brought into contact with the staple cartridge disposed in the shaft;

Fig. 30 is a cross-sectional view through the elongated shaft of Fig. 29 after activating the staple cartridge and moving the annular cutting element through the stapled parts of the tissue;

Fig. 31 is a cross-sectional view through the elongated shaft of Fig. 30 sliding out of the colon after the stapling procedure;

Fig. 32 is a perspective view of a round surgical stapler of various non-limiting embodiments of the present invention;

Fig. 33 is a cross section through the distal end of the elongated shaft of the round stapler of Fig. 32;

Fig. 34 is a perspective view of the hook and the detection housing parts of the elongated shaft of Fig. 33 with its detection elements in the retracted position;

Fig. 35 is a perspective view of the hook and detection housing of Fig. 34 with its detection elements in an extended position;

Fig. 36 is a cross-sectional view through the distal end of the elongated shaft with its detection elements in an extended position within the colon;

Fig. 37 is a top cross-sectional view of the elongated shaft and colon of Fig. 36 along the line 3737 of Fig. 36;

Fig. 38 is a perspective view of another round surgical stapler of various non-limiting embodiments of the present invention;

Fig. 39 is a cross-sectional view through the distal end of the elongated shaft of the circular stapler of Fig. 38, disposed in the proximal part of a tube-like organ such as a colon;

Fig. 40 is an exploded view of the set of distal ends of the tissue pickup roller, output roller, and knife roller of various, non-limiting embodiments of the present invention;

Fig. 41 is a perspective view of the tissue pickup roller of Fig. 40 with its tissue arms in an retracted position;

Fig. 42 is a perspective view of the pickup roller of Fig. 41 with its tissue arms in extended positions;

Fig. 43 is a cross-sectional view through the distal end of the elongated shaft of the surgical instrument of Fig. 38 located in the proximal part of the colon with the anvil assembly removed;

Fig. 44 is a cross-sectional view through the distal end of the elongated shaft with the tissue sampling arms extended through the proximal part of the colon;

Fig. 45 is a top cross-sectional view through the distal end of the elongated shaft made along line 45-45 in Fig. 44;

Fig. 46 is a cross-sectional view through the distal end of the elongated shaft after extending the tissue withdrawal arms through the proximal part of the colon, and then moving them into the retracted position, wherein the pierced proximal part is immobilized between the tissue withdrawal arms and the tissue withdrawal roller;

Fig. 47 is a top cross-sectional view of the distal end of the elongated shaft of Fig. 46, taken along line 47-47 of Fig. 46;

Fig. 48 is a cross-section through the distal end of the elongated shaft with the diseased portion of the colon cut from the proximal part and the distal portion and removed from the colon using a conventional gripper;

Fig. 49 is a cross-sectional view through the elongated shaft after placing the anvil in the distal part of the colon and fixing the anvil on it by means of a tightening suture solution;

Fig. 50 is a cross-sectional view through the elongated shaft of Fig. 49 after the anvil has been connected to the anvil assembly and brought into contact with the staple cartridge disposed in the shaft;

Fig. 51 is a cross-sectional view through the elongated shaft of Fig. 50 after activating the staple cartridge and moving the annular cutting element through the stapled parts of the tissue;

Fig. 52 is a cross-sectional view through the elongated shaft of Fig. 51 extending from the colon after the stapling procedure;

Fig. 53 is a view of the patient & apos; s abdominal part showing various tissues and structures near the colon portion;

Fig. 54 is another partial view of the open abdomen according to Fig. 53;

Fig. 55 is another view of the abdominal cavity of Fig. 53 showing the placement of a trocar in the abdominal cavity to contain a protective sheath of an embodiment of the present invention;

Fig. 56 is another view of the abdominal cavity according to Fig. 55 with the protective cover of an embodiment removable from the trocar sleeve by means of a conventional gripper;

Fig. 57 is another abdominal view of Fig. 56 showing an exemplary method of positioning a protective sheath around the periphery of a portion of the colon being treated; and

Fig. 58 is a view of the abdominal cavity according to Fig. 57 after placing the protective sheath of the embodiment around the outer periphery of the portion of the colon being treated.

DETAILED DESCRIPTION OF THE INVENTION [0017] Some exemplary embodiments of the invention will now be described to provide a general understanding of the principles of structure, function, production and use of the devices and methods described in the text. One or more examples of such embodiments are shown in the accompanying drawings. Persons having typical skills in the art will understand that the devices specifically described in the text and illustrated in the accompanying drawings are non-limiting embodiments and the scope of the various embodiments of the present invention is defined only by the claims.

[0018] References made in the text to "various embodiments," "some embodiments," "one embodiment," "or" embodiment "or the like mean that a particular function, structure or characteristic described in a compound with an embodiment is in at least one embodiment. Thus, the appearance at various places in the text of the specification of the terms "in different embodiments", "in some embodiments", "in one embodiment" or embodiment ", or not necessarily relates to the same invention. In addition, the features, structures or characteristics may be combined in any suitable manner as part of one or more embodiments. Thus, specific functions, structures or characteristics depicted or described in connection with one embodiment may be combined without limitation, in whole or in part, with the functions, structures or characteristics of one or more embodiments. Such modifications and changes are intended to be within the scope of the present invention.

[0019] The terms "proximal" and "distal" are used in the text to refer to a physician manipulating the handle of the instrument "" τ τ "in similar terms of a surgical embodiment. The term" proximal "refers to the part closest to the doctor, and the term" distal "refers to part away from the doctor. It should also be appreciated that for convenience and in the interest of clarity, spatial terms such as "vertical", "horizontal", "top" and "bottom" may be used in the text to refer to drawings. However, surgical instruments are used in many orientations and positions and are not intended to be limiting and / or absolute terms.

[0020] Fig. 1 shows a round stapler 10 according to various non-limiting embodiments of the invention. In various embodiments, the circular stapler 10 has a handle assembly 12 having an elongated shaft assembly 14 extending from the handle assembly defining a central axis AA. The elongated shaft assembly 14 has a rigid outer shell 16 having a distal end 17 forming a stapler head 20. In various, non-limiting embodiments, the stapler head 20 is configured to functionally embed in it a round staple cartridge 30. Such circular staple cartridges 30 are known in the art and one, two or more spaced along the periphery and staggered rows of staples 36 may be embedded therein alternately. See Figs. 2 and 3. The embodiment shown in Fig. 3, for example, has two rows 32, 34 staples 36. The conventional annular knife 40 is coaxially and movably mounted in the stapler head 20.

[0021] In some embodiments, the round stapler 10 also has a trigger roller assembly 50 embedded within the outer shell 16 to effect selective axial movement within the shell. See Fig. 2. The distal end 52 of the drain roller assembly 50 has an outer staple drive 54 for engaging with each of the staples 36 in the outer row 32 of staples 36 in a staple cartridge 30. The distal end 52 of the firing roller assembly 50 also has an internal staple drive member 56 intended to engage each of the staples 36 in the inner row 34 of staples 36 in the staple cartridge 30. As can also be seen, for example, in Fig. 2, the distal end 52 of the roller shaft assembly 50 has a shelf 58 configured to engage the annular knife 40. Thus, as will be discussed in more detail below, axially moving the trigger roller assembly 50 in the distal direction "DD" will cause the staples 36 to exit the staple cartridge 30, and extend the annular knife 40 in the distal direction. As can be seen in Fig. 2A, the trigger roller assembly 50 has a base 51 connected to the trigger rod 53.

[0022] In various non-limiting embodiments, the trigger rod 53 is operatively connected to a trigger 60 operably connected to the handle assembly 12. See Figures 1 and 1A. As can be seen in Figs. 1 and 1A, trigger 60 is pivotally connected to handle assembly 12 such that when trigger 60 is rotated toward handle assembly 12, the roller shaft assembly 50 is displaced in the distal direction DD. Such trigger configurations are known in the art and will therefore not be discussed in detail in the text. For example, an exemplary trigger configuration is described in US Patent Application No. US 2008/0078806 A1, entitled "Surgical stapler with a mechanical indicator showing levels of tissue compression".

[0023] As shown in Figs. 2 and 2A, various non-limiting embodiments have a pickup housing 70 coaxially mounted in the roller shaft assembly 50 and axially movable with respect to the assembly. The pickup housing 70 has a series of pickup lumens 72 in each of which a pickup member or hook 80 is mounted. As can be seen, for example, in Fig. 3, a series of three-sided pickup clearances 72 may be spaced equidistant around the perimeter of the pickup housing 70. In the non-limiting embodiment of Figure 3, a total of eight (8) pickup clearances 72 are spaced around the perimeter of the pickup housing 70 .

[0024] Each of the pickup elements or hooks 80 can be made of, for example, Nitinol, 300 or 400 series stainless steel (fully or three quarters hardened) and have a distal end 82 which, when slid out of the respective pickup lumen 72, bends radially. outwardly as shown in Fig. 4. As can also be seen for example in Fig. 4, each of the hooks 80 has a tissue hook 84 formed at the distal end 82 of the hook. As can be seen in fig. 2 and 3, for various non-limiting embodiments of the invention, a sleeve 78 is used to facilitate the assembly of the hooks 80 in their respective lumens 72.

[0025] As can be seen in Fig. 2A, each of the hooks 90 is connected to or protrudes from a pickup ring 81 having a pair of pickup rods 83 protruding therefrom.

The pickup rods 83 are connected to a hook switch 90 functionally mounted on the handle assembly 12. See Figures 1 and 2C. As the surgeon moves the hook switch 90 in the distal direction (arrow 92 in Figures 1 and 2C), the withdrawal housing 70 moves in the distal direction. Such movement of the withdrawal housing 70 causes the distal end 84 of each hook 80 to extend in a distal direction from the respective intake clearance 72. As the distal end 84 of each hook 80 extends from the withdrawal lumen 72, the natural bending action of the hook member 80 causes the end 84 to bend radially away from the central axis AA, as shown in Figure 4. The surgeon may retract the withdrawal housing 70 and hooks 80 to their initial positions (Fig. 2) by sliding the hook switch 90 in the proximal direction (arrow 94 in Figs. 1 and 2C).

[0026] As can also be seen in Figs. 2, 2A, 2D, 3 and 4, in the case of various non-limiting embodiments, the cutting element housing 100 is coaxially mounted in the receiving housing 70. The cutting element housing 100 is mounted in a manner providing selective axial relative movement relative to the receiving housing 70 and selective axial movement along the central axis AA. In the case of various embodiments of the invention, a pair of rods 101 for activating the housing protrudes from the cutting element housing 100, providing a connection with the knob 110 of the knife movably mounted on the handle assembly 12. See Figures 1 and 2D. In various non-limiting embodiments, the knife knob 110 is mounted on the handle assembly 12 so that it can move in the axial direction (shown by arrows 112, 114 in Fig. 1 and 2D) and it can also be rotated relative to the handle assembly 12 (shown by arrow 116 in Fig. 1). The rods of the housing actuator 101 are connected to the knife knob 110 such that the movement of the knife knob 110 in the axial direction displaces the cutting element housing 100 in the axial direction within the collecting housing 70, and the rotation of the knife knob 110 also causes the cutting element housing 100 to rotate about the central axis AA , which will be discussed in more detail below.

[0027] In various non-limiting embodiments of the invention, the cutting element housing 100 has at least one, and preferably a series of, knife openings 102 extending axially through the wall of the cutting element housing 100. As can be seen, for example, in Fig. 3, a series of knife clearances 102 can be arranged at an equal distance from each other around the perimeter of the cutting element housing 100. In the non-limiting embodiment of Figure 3, a total of eight (8) knife clearances 102 are equidistant around the circumference of the cutting element housing 100. As can be seen in Figs. 2 and 4, each of the knife lumens 102 has a curved portion 104 of the distal end opening radially outward.

[0028] In various, non-limiting embodiments of the invention, the flexible knife 120 is slid inside each knife lumen 102. Each flexible knife 120 has a sharpened distal end 122 and is connected to or protrudes from the knife ring 123. The pair of rods 125 that set the knife in motion are connected to the knife ring 123 by means of a sliding connection 127 that allows the knife ring 123 to rotate relative to the cylinder rods 125. See Fig. 2A. As can be seen in Fig. 2C, the knife actuator rods 125 (this view only shows one knife actuator rod 125) are connected to the knife switch 130 operably connected to the handle 12. The distal end 122 of each knife 120 is directed to allow it piercing the tissue and it may have at least one cutting edge 124 formed on it. When the knife switch 130 is moved in the distal direction (arrow 132), the knives 120 are moved distally in the knife clearance 102 so that the sharpened distal end 122 "naturally" bends or bends radially outside the curved portion 104 of the distal end 104 of the clearance 102, as shown in Fig. 4. According to use in this context, the term "natural" means that the material may be pretensioned or otherwise formed such that the distal end of the material bends or bends as it leaves the lumen. Similarly, movement of the knife switch 130 in the proximal direction (shown by arrow 134 in FIGS. 1 and 2) causes each knife 120 to slide into the knife clearance 102. For various, non-limiting embodiments, the knives 120 may be manufactured, for example, from Nitinol, 300 or 400 series stainless steel (fully or three quarters hardened).

[0029] As can also be seen in Fig. 2A, the trigger roller assembly 50 has, at a distal end, a post 140 protruding from the base portion 51 and coaxially extending inside the housing 100 of the cutting element to provide selective axial movement within it. Various embodiments also include a septum 141 mounted in an outer shell 116. To facilitate easy assembly, the outer shell 16 may have a distal outer shell portion 16 and a proximal outer shell portion 16 'as shown in Fig. 2A. Placed at the distal end, the post 142 protrudes from the septum 51 and provides support for the distal connection of the 150 anvil. The anvil distal connection 150 is connected to the distal band assembly 151. The distal band assembly 151 is connected to the joystick assembly 153 connected to the adjustment knob 160 in turn pivotally mounted on the handle assembly 12. Such anvil shaft assemblies and control knob configurations are generally known. For example, the joystick assembly and control knob may be configured as described in US Patent Application Publication No. US 2008/0078806 A1 entitled "Surgical stapler with a mechanical indicator showing levels of tissue compression". [0030] As can be seen in Fig. 2B, each of the rods of the housing actuator 101 protrudes through the respective arcuate seats 145 in the partition 141. Sockets 145 may be sized to define / limit the rotation of the cutting element housing 100 relative to the central axis AA. For example, in one embodiment, in which a total of eight (8) knives 120 are used, the sockets 145 may be sized to facilitate rotary motion or arc movement determined by a 45 ° -50 ° angle of the cutting element housing 100 around central axis AA. The septum 141 may also have a gap 146 to allow it to project the distal web assembly 151. In addition, each of the knife actuator rods 125 passes through the respective opening 147 in the partition 141. Similarly, each of the pickup rods 83 passes through the respective slot 148 in the partition 141.

See Fig. 2B.

[0031] The circular stapler 10 also has anvil 170 shown in Fig. 5. For various, non-limiting embodiments, the anvil 170 includes the anvil base 171 having a series of staple forming pockets 172 and anvil shaft 174 coupled to the anvil remotely engaged 150. In particular, the coupling mandrel 176 protrudes from the proximal end 175 of the anvil shaft 174 and is sized so that it can be inserted into the passage 152 at the distal connection of the anvil 150. Anvil 170 also has an anvil hub 178 mounted on it as shown in Figs. 5 and 13, and which defines an empty space 179 for tissue.

[0032] One example of how to use the circular stapler 10 will be described with reference to Figs. 5-16. Various embodiments of the round stapler 10 are particularly well suited to the implementation of round anasotomosis of a tube-like organ, such as, for example, the colon. Referring first to Figure 5, the stapler head 20 is placed in the proximal part 201 of the colon 200, through the patient's anus 199. For applications where the diseased or target colon portion 202 is to be removed, the stapler head 20 is positioned near the diseased portion 202. See FIG. 6.

[0033] After the stapler head 20 has been brought into the correct position relative to the diseased portion 202, the cutting element housing 100 is displaced distally by axially moving the knife knob 110 in the distal direction (shown by arrows 112 in FIGS. 1 and 7). At this stage of the procedure, the knives 120 have not yet been extended from the respective knife clearances 102. The surgeon then moves the withdrawal housing 70 in the distal direction, moving the hook switch 90 in the distal direction (arrow 92 in Fig. 1). Movement of the withdrawal housing 70 in the distal direction causes the hooks 80 to slide out of their respective intake lumens 72 in the axial direction. When the distal ends of the hooks 80 leave their corresponding withdrawal holes 72, they naturally bend in the radial direction outwardly to connect to and puncture the proximal part 201 of the colon 200. See Fig. 8. After puncturing and connecting the hooks 80 to the proximal part 201 colon 200, the surgeon moves the hook switch 90 in the proximal direction (shown by arrow 94 in Fig. 1) to withdraw the hooks 80 into their respective take-up lumens 72 and to slide the pick-up housing 100 back to its initial position. Hooks 84 at the distal ends of the hooks 80 pull the attached proximal part 201 into the position shown in Figure 9. Thus, the connected proximal part 201 of colon 200 is stretched onto the distal plane 31 of the staple cartridge 30 and partly into the inner space 33 between the staple cartridge 30 and the cutting element housing 100.

[0034] After pulling the proximal part 201 of the colon

200 to the position shown in Fig. 9, the surgeon then extends the knives 120 from their respective knife clearances 102 by axially moving the knife knob 110 on the handle assembly 12 in the distal direction (shown by arrow 112 in Fig. 1). By moving the knife knob 110 in the distal direction, the knives 120 are pushed out of the knife clearances 102, and the curved portion 104 of each knife clearance 102 causes the knife 120 therein to extend radially outward as shown in Figure 10. The knives 120 pass through the proximal portion 201 of colon 200, proximal to the diseased portion 202 of the colon. See fig. 10. The diseased colon portion 202 can be separated from the proximal colon portion 201 by turning the knife knob 110 on the handle assembly 12 (shown by arrow 116 in FIG. 1). Turning / turning the knife knob 110 will rotate the cutting element housing 100 and the knives 120 around the central axis AA and cut the colon tissue. After cutting off the diseased part 202 from the proximal part 201 of the colon (Fig. 11), the surgeon can slide the knives 120 back into their respective knife clearances 102 by moving the knife knob 110 in the proximal direction (shown by arrow 114 in Figure 1). See fig. 12.

[0035] The sick portion 202 may be cut off from the distal colon portion 208 (Fig. 13), for example with a conventional laparoscopic tissue dissection device (not shown) inserted through a trocar sleeve extending into the abdominal cavity 601 near the diseased portion 202 The diseased colon 202 may then be removed through the trocar sleeve. The surgeon then positions the anvil 170 within the distal colon portion 206 such that the anvil shaft 174 projects from the colon distal portion 206 as shown in Figure 13.

The surgeon then binds the ends of the distal colon portion 206 around the anvil shaft 174 using a solution known in the art as "astringent suture" 220. After stitching the distal colon portion 206 around the anvil shaft 174, the anvil shaft mandrel 176 of the anvil shaft connector 174 is inserted into passage 152 in the assembly 150 anvil shaft. The coupling mandrel 176 may have dimensions so selected relative to the passage 152 to provide a frictional fit of these elements to fix the coupling mandrel 176 therein, but to allow removal of the adapter mandrel 176 from the connection at a later date.

[0036] The surgeon then pulls the anvil 170 toward the stapler head 20 (in the proximal "PD" direction) by turning the anvil control knob 160 in the proper direction until the parts 205, 210 of the colon between the anvil 170 and the staple cartridge 30 are tightened, as shown in Fig. 14. The surgeon then presses the trigger 60 to move the trigger assembly 50 axially in the distal direction "DD". As the trigger assembly 50 is displaced, the outer staple drive portion 54 and the staple drive inner portion 56 drive the staples 36 in the outer row 32 and inner row 34, respectively, by introducing them through the colon parts 205, 210 into the forming pockets 172 anvils in the base 171 anvils. The trigger roller assembly 50 also moves the annular knife 40 through the colon portion 205 to cut out portion 201. See Fig. 15. Further advancing the annular knife 40 causes colon portion 207 to be separated from colon portion 208. The surgeon then moves the anvil 170 in the "DD" distal direction to release the stapled colon portions 205, 210 from the space between the anvil base 171 and the plane 31 of the staple cartridge 30. See fig. 16. The device 10 can then be removed from the colon 200. The cut out portion 201 remains in the stapler head 20 and the cut out portion 207 remains in the tissue empty space 179 in the anvil 170 when the surgeon removes the device 10 through the patient's anus 199. The cut portions 201, 207 of colon 200 are thereby removed from the treated colon when the device is removed from it.

[0037] Fig. 17 shows another circular stapler 300 according to various non-limiting embodiments of the invention. The circular stapler 300 generally has a handle assembly 312 having an elongated shaft 314 exiting the assembly. The elongated shaft 314 may define a central AA axis. As can be seen in Figure 17, the elongated shaft 314 has a rigid outer shell 316 on which the stapler head 320 is mounted. For various, non-limiting embodiments, the stapler head 320 is configured to support the embedded circular staple cartridge 330. Such circular staple cartridges 300 are known in the art and provide in general the seating of two or more circumferentially and staggered rows of staples 36 as described above. The conventional annular knife 340 is coaxially and movably mounted in a staple cartridge 330. See fig. 18.

[0038] In some embodiments, the round stapler 300 also has a trigger roller 350 functionally embedded within the outer rigid shell 316 to effect selective axial movement within the shell as described above. See Fig. 18. The distal end 352 of the firing roller 350 has an outer staple drive portion 354 for engaging with each of the staples 36 in the outer row 32 of staples 36 in a staple cartridge 330. The distal end 352 of the firing roller 350 also has an internal staple drive portion 356 for engaging with each of the staples 36 in the inner row 34 of staples 36 in a staple cartridge 330. As can also be seen, for example, in Fig. 18, the distal end 352 of the trigger roller 350 also has a flange 358 configured to engage with the annular knife 340. Thus, as will be discussed in more detail below, axially extending the trigger roller 350 in the distal direction "DD" will cause the staples 36 to exit the staple cartridge 330 and extend the annular knife 340 in the distal direction.

[0039] In various, non-limiting embodiments, the trigger shaft 350 is connected to the trigger 360 operably connected to the handle assembly 312. As can be seen in Fig. 17, the trigger 360 is pivotally connected to the handle assembly 312 such that when the trigger 360 is rotated towards the handle assembly 312, the trigger shaft 350 is moved in the distal direction DD. According to the above discussion, such trigger configurations are known in the art and will not be discussed in more detail in the text.

[0040] As shown in Fig. 18, various, non-limiting embodiments, also have an output roller 370 coaxially and rotatably mounted in a tissue pickup roller 380, mounted in a non-rotatable manner in the elongated shaft 316. Proximal end of the output roller 370 is operably connected to a tissue receiving knob 310 pivotally mounted on the handle assembly 312. The output shaft 370 is connected to the tissue intake knob 310 in the manner described above with respect to the knife knob 110. Thus, rotation / use of the tissue intake knob 310 on the handle assembly 312 will cause the output shaft 370 in the tissue intake shaft 380 to rotate about the central axis AA. More specifically and with reference to Fig. 19, in various embodiments, the distal end 372 of the output shaft 370 projects through the opening 382 in the pickup shaft 380 and is connected to the transmission gear 374. The distal end 384 of the pickup roller 380 is configured to operatively seat at least two pickup elements on it. tissue or arms 400 tissue. In the case of a non-limiting example of the embodiment shown in fig. 19, a total of four tissue arms 400 are pivotally attached to the distal end 384 of the tissue intake roller 380 by means of respective pins 386 so that each of the tissue arms 400 pivots about a respective BB "pickup" axis parallel to the central AA axis. See Figures 21 and 23.

[0041] As can be seen in FIGS. 19 and 22, each tissue arm 400 has a body 402 that can be made of, for example, stainless steel (300 or 400 series), a titanium-steel composite or ceramic material, etc. and combined a gear 404 may be formed with it or molded thereon. The driven gear 404 of each tissue arm 400 is movably mounted in a respective hollow space 388 of the arm formed at the distal end 384 of the tissue intake roller 380. Each transmission meshes with the transmission gear 374 on the output shaft 370. By turning the output shaft 370, the tissue arms 400 rotate from the retracted position shown in Fig. 20 to the derived position shown in Fig. 22. As can be seen in Fig. 20 and 22, in the case of various embodiments, each of the tissue arms 400 has an arc shape such that when the tissue arms 400 are in the retracted position shown in Fig. 20, they mate to form a circular, disk-like assembly 401 at the distal end of the tissue intake roller 380.

[0042] In various embodiments, the body 402 of each tissue arm 400 also has a tip 406 piercing tissue formed thereon or otherwise connected thereto. In addition, an arm knife 408 having a cutting edge 410 is connected to or otherwise formed on the body 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), or of a titanium-steel composite or ceramic material, etc., and may be connected to the body 402 of the respective tissue arm 400, in depending on the material, using welding or other suitable joining method. In preferred embodiments, if the arm knife 408 is made of any of the metal materials defined above, it may be advantageous to harden such material. For example, it may be desirable to obtain hardness values ​​of 38-52 on the Rockwell scale. In the alternative embodiments, the arm can be made with a thin characteristic which can be ground to a thin edge. As can be appreciated from the continuation of the detailed description given above, the blade operates in a manner characteristic of the scissors rather than the knife during its closing, so that it cuts the tissue when 408 closes on the element 421. As can also be seen in Fig. 19, the cutting plate 420 is connected to the distal end 382 of the arm shaft 380 by means of threaded fasteners 422 within the threaded fasteners 424 in the arm shaft 380. Also, in the case of various embodiments, a series of tissue receiving pins 426 are disposed around the periphery of the tissue sampling roller 380 and protrude radially from said shaft. The outer edge 421 of the cutting plate 420 cooperates with the cutting edges 410 of the tissue arms 400 to cut off the tissue being pulled between these edges 410, 421 as the tissue arms 400 move into their retracted position.

[0043] In some embodiments, the distal end post 442 projects from a portion of the trigger shaft 350 arranged coaxially inside the output shaft 370 to effect axial movement. The distal end post 442 provides seating of the anvil distal connecting member 450 coupled to the adjustment knob 460 pivotally mounted on the handle assembly 312 in the various ways described above.

[0044] The circular stapler 300 also has anvil 470 shown in Fig. 18. For various non-limiting embodiments of the invention, anvil 470 has an anvil base 471 having a series of staple forming pockets 472. The anvil base 471 can also define a cutting edge 473 to facilitate tissue cutting with an annular knife 340. Anvil 470 also has an anvil shaft 474 connected to the anvil's distal connecting element 450 detachably. In particular, the coupling mandrel 476 protrudes from the proximal end 475 of the anvil shaft 474 and has a size that allows it to be inserted into the passage 452 in the anvil shaft assembly 450. See Fig. 23. The anvil assembly 470 also has an anvil hub 478 mounted thereon defining a tissue empty space 479 in the anvil as shown in Figs. 18 and 23. As can also be seen, for example, in Fig. 18, the disk-like assembly 401 has dimensions that allow it to be inserted into the opening 475 in the base of the anvil 471.

[0045] One example of how to use the circular stapler 300 will be described with reference to Figs. 23.-31. Various embodiments of the round stapler 300 are particularly well suited to the implementation of round anasotomosis of a tube-like organ, such as, for example, colon 200. Referring first to Figure 23, the stapler head 320 is inserted through the anus 199 of the patient into the proximal part 201 of colon 200. When diseased or target 202 colon portion 200 is to be removed, the stapler head 320 is positioned where the diseased portion 202 is to be removed from the proximal portion 201.

[0046] Once the stapler head 320 has been properly positioned inside the colon, the tissue arms 400 can be displaced radially by turning the tissue intake knob 310 in the first direction (indicated by arrow 311 in Fig. 17), which also causes the output shaft 370 to rotate. Rotation of the output shaft 370 to the first direction also rotates the drive gear 374 which meshes with the parts 404 of the driven gear of each of the tissue arms 400. The rotation of the 374 transmission in the first direction thus leads the tissue arms 400 in the radial direction. When the tissue arms 400 extend radially, their tissue piercing tips 406 pierce the proximal part 201 of colon 200. See Figures 24 and 25. After extending the tissue arms 400 so that their tissue piercing tips 406 pierce the proximal part 201 of the colon 200, the surgeon can rotate the tissue extraction knob 310 in the second direction (indicated by arrow 313 in Fig. 17) to move the tissue arms 400 to the retracted position. As the tissue arms 400 are inserted, they collect the pierced proximal part 201 of the colon 200 and pull it inward toward the tissue withdrawal roller 380. When the collected colon portion 201 is pulled between the cutting plate 420 and the tissue arms, colon portion 201 captured between the outer edge 421 of the cutting plate 420 and the cutting edges 410 on the arms 400 of the tissue is cut off from the diseased portion 202 of the colon 200. Insertion of the arms 400 causes tissue that colon portion 201 200 is nailed to and attached to tissue fastening pins 426, as shown in Fig. 26. Diseased portion 202 of colon 200 can then be cut off from the distal portion of colon 208 using a conventional laparoscopic tissue dissection device (not shown) inserted into the trocar sleeve positioned in abdominal cavity 601. After dissection of diseased portion 202 from distal portion 208 of the colon, diseased portion 202 can be removed through a trocar sleeve (not shown) using a conventional gripper

600. See fig. 26.

[0047] The surgeon then positions the anvil 170 inside the distal colon portion 208 so that the anvil shaft 476 extends from the distal colon shaft 208 200 as shown in Fig. 28. The surgeon then binds the ends of the distal colon portion 208 around the anvil shaft 474 using a solution known in the art as "astringent seam" 220. After stitching the distal colon portion 208 around the anvil shaft 474, the anvil shaft connector 476 is pushed into passage 452 in the anvil shaft assembly 450. The spindle 476 of the coupling has dimensions sized for passage 452 that a frictional connection is created to secure the coupling plunger 176, but at the same time to allow the removal of the plunger plunger 176 at a later date. See fig. 28.

[0048] The surgeon then pulls the anvil 470 toward the stapler head 420 (in the proximal "PD" direction) by turning the anvil control knob 460 in the proper direction until tightening portions 205, 210 of the colon 200 between the anvil 470 and the staple cartridge 330, as shown in Fig. 29. The surgeon then presses trigger 360 to move the trigger 360 axially, and extends the trigger shaft 350 in the distal direction "DD". As the trigger shaft 350 moves distally, the staple drive parts 354, 356 lead the staples 36 through the parts 205, 210 of the colon 200 and insert them into the forming pockets 472 of the anvils in the anvil 470. The trigger roller 350 also moves the annular knife 340 through the parts 205 , 210 of the colon to separate parts 201, 207 from them, respectively. The surgeon may then move the anvil 470 in the "DD" distal direction to release the stapled colon portions 205, 210 from the space between the anvil 470 and the stapler head 320. The device 300 can then be removed from the colon 200. See FIG. 31. The cut portions 201, 207 of the colon 200 remain in the stapler head 320 and the anvil 470, respectively, when the surgeon removes the device 300 through the patient's rectum. The cut portions 201, 207 of colon 200 are thereby removed from the treated colon when the device 300 is removed therefrom.

[0049] Round staplers are generally inserted through the rectum, not from the side of the pelvis adjacent to the abdominal cavity. This method of insertion makes it difficult for the surgeon to visualize the tumor necessary to determine the tumor boundaries and boundary edges relative to the position of the distal incision to make sure that the stapler head is correctly positioned in the colon before starting the incision. FIG. 3237 show a circular stapler 700 according to various non-limiting embodiments of the invention that can provide feedback to the surgeon during the placement process. Round stapler 700 generally has a handle assembly 712 having an elongated shaft assembly 714 protruding from the assembly. The elongated shaft assembly 714 may define a central AA axis. As can be seen in fig. 32, the elongated shaft assembly 714 has a rigid outer shell 716 having a distal end on which the stapler head 720 is mounted. In various non-limiting embodiments, the stapler head 720 is configured to functionally embed a circular staple cartridge 30 therein. Such round staple cartridges 730 are known in the art and can generally contain one, two or more spaced along the perimeter and alternately along the perimeter of the staple rows. In the non-limiting embodiment of Figure 33, two rows 732, 734 of staples 36 are embedded in staple cartridge 730. Conventional annular knife 740 is coaxially and movably mounted in stapler head 720.

[0050] The circular stapler 700 also has a trigger shaft 750 operatively mounted inside the outer, rigid shell 716 to perform selective axial movement within the shell. See Fig. 33. The distal end 752 of the release roller 750 has an outer portion 754 of a staple drive member capable of engaging each of staples 36 of the outer row 732 of staples 36 in a staple cartridge 730. The distal end 752 of the trigger roller assembly 750 also has an inner portion 756 of the staple driver to be combined with each of the staples 36 in the inner row 734 of staples 36 in a staple cartridge 730. As can also be seen, for example, in Fig. 33, the distal end 752 of the trigger roller 750 also has a flange 758 configured to engage with the annular knife 740. Thus, as will be discussed in more detail below, axially extending the trigger roller 750 in the "DD" distal direction will result in the staples 36 being moved out of the staple cartridge 730 and the annular knife 740 being extended in the distal direction.

[0051] In various, non-limiting embodiments, the trigger shaft 750 is connected to a trigger 60 operably connected to the handle assembly 712.

As can be seen in Fig. 32, trigger 60 is pivotally connected to handle assembly 712, such that when trigger 60 is rotated toward handle assembly 712, trigger shaft 750 is displaced in distal direction DD as discussed above.

[0052] As shown in Fig. 33, various non-limiting embodiments of the invention have a hook and detection housing 770 mounted coaxially inside the trigger shaft 750 and able to move axially in it. The detection hook and housing 770 has a number of 772 hook clearances, in each of which a pickup hook 780 is mounted. As can be seen in Fig. 34, for example, a series of three-sided hook clearances 772 may be arranged equidistantly around the perimeter of the hook and the detection housing 770. For example, in the non-limiting embodiment of Figure 34, a total of eight (8) hook lumens 772 are equidistant around the perimeter of the hook and the detection housing 770. Each of the 780 hooks can be made of, for example, Nitinol, 300 or 400 series stainless steel (fully or three-quarters hardened), etc. and has a 782 distal end, which, when slid out of the appropriate 772 clearance, bends or bends naturally and radially outward as described above. As with other embodiments, each of the procurement hooks 780 has a tissue hook 784 formed at the distal end 782 of the hook. As can be seen in Figs. 33 and 34, for various non-limiting embodiments of the invention, the detection hook and housing 770 has a sleeve

778 hook for easy assembly of the pickup hooks 780 in their respective clearances 772.

[0053] For various, non-limiting embodiments, the proximal end of the hook and the detection housing 770 may be operably connected to the hook switch 790 operatively mounted on the handle 712. See Fig. 32. When the surgeon moves the hook switch 790 in the distal direction (arrow) 792 in Fig. 32), the detection hook and housing 770 move in a distal direction. Each pickup hook 780 is also slid out in the distal direction from the corresponding hook clearance 772 as described above. The surgeon can slide the hooks 780 to their initial positions by moving the hook switch 790 in the proximal direction (shown by arrow 794 in Fig. 32).

[0054] A series of flexible detection elements 781 are also embedded in the detection hook and housing 770. In particular, the detection hook 770 also has a series of detection gaps 774. For example, in the non-limiting embodiment of Figure 34, a total of eight (8) detection gaps 774 are equidistant around the circumference of the hook and the detection housing 770. In the case of one non-limiting embodiment, each of the detection elements 781 may be manufactured, for example, of polyethylene, nylon, nitrile, titanium, etc., and has a distal end 783 which when slid from the appropriate clearance 774 naturally bends or bends radially outwardly as shown in Fig. 35. A blunt or rounded bumper 785 can also be positioned at the distal end of each detection element 781. In one embodiment, the bumper may be made of, for example, sanoprene, isoprene, natural rubber, polypropylene, polyethylene, nylon, etc. In other embodiments, the 785 bumper may have a light source or a light-emitting diode (LED). In these embodiments, a conductor providing connection to lighting 785 may come out of the battery located in the handle assembly 712 or from another energy source through the lumen of the detection element 781.

[0055] In various non-limiting embodiments, the proximal end of each detection element 770 may be connected to the detection knob 791 operatively mounted on the handle assembly 712. See Fig. 32. When the surgeon rotates the detection knob 790 in the first direction (arrow 793 in Fig. 32), the detection elements 781 extend distally from their respective lumens, in the radial direction away from the central axis AA, to the extended position (Fig. 36 ). In the case of various embodiments, for example, all detection elements 781 may be connected to a round sleeve (not shown), slidably mounted inside the outer shell 716. The round sleeve may also have a gear gear associated with it, meshed with the gear (not shown) located on the underside of the detection knob 791. By turning the detection knob 791 in one direction, the sleeve moves in the distal direction, thereby extending all detection elements 781. When the surgeon rotates the detection knob 791 in a second direction (arrow 795 in Fig. 32), the detection elements 781 are pushed back into their respective detection gaps 774 into a folded position.

See fig. 34. It is also possible to use other switches and drive configurations selectively extending and retracting the detection elements without departing from the scope of the present invention as defined in the claims.

[0056] As can also be seen in Fig. 33, in various non-limiting embodiments, the cutting element housing 800 is coaxially mounted in the hook and the detection housing 770. The cutting element housing 800 is seated in a manner that ensures selective relative movement in the axial direction relative to the detection hook and housing 770, and selective movement in the axial direction along the central axis AA. The cutting element housing 800 is connected to the knife knob 810 movably mounted on the handle assembly 712. See Fig. 32. In various non-limiting embodiments, the knife knob 810 is mounted on the handle assembly 712 so that it can move in the axial direction (shown by arrows 812, 814 in Fig. 32) and can also be rotated relative to handle assembly 712 (shown by arrow 816 in Fig. 32). The cutting element housing 800 can be connected to the knife knob 810 in the various ways described above so that the movement of the knife knob in the axial direction causes the cutting element housing 800 to move axially within the hook and the detection housing 770, and the rotation of the knife knob 810 also rotates the knife housing 800 cutting around the central axis AA.

[0057] In various non-limiting embodiments of the invention, the cutting element housing 800 has a series of knife apertures 802 extending axially through the wall of the cutting element housing 800.

As discussed above with respect to other embodiments, a series of knife clearances 802 may be evenly distributed around the perimeter of the cutting element housing 800. For example, in the non-limiting embodiment, a total of eight (8) knife apertures 802 may be evenly distributed around the circumference of the cutting member housing 800. As can be seen in fig. 33, each of the knife clearances 802 has a curved distal end 804 opening radially outward.

[0058] For various, non-limiting embodiments of the invention, the flexible knife 820 is inserted into each knife lumen 802. Each flexible knife 820 has a sharpened distal end 822 and a proximal end (not shown) connected to the knife switch 830 functionally mounted on handle 712 in the various ways described above. See fig. 32. The distal end 822 may be directed so as to allow it to pierce the tissue, and it may have at least one cutting edge formed thereon. When the knife switch 830 is moved in the distal direction (arrow 832), the knives 820 are moved distally in the knife clearance 802 so that the sharpened distal end 822 naturally bends or bends radially outside the curved distal end 804 of the clearance 802 as described above. Similarly, movement of the knife switch 830 in the proximal direction (shown by arrow 834 in Fig. 32) causes each knife 820 to slide into the respective knife clearance 802. In various non-limiting embodiments, the 820 knives may be manufactured, for example, from Nitinol, 300 or 400 series stainless steel (fully or three quarters hardened).

[0059] As can also be seen in Fig. 33, various non-limiting embodiments may also have an anvil shaft assembly 840 coaxially mounted in the cutting element housing 800 for axial movement within the housing. The anvil shaft assembly 840 may have a distal end post 842 protruding from the drain shaft portion 750. In the distal end post 842, anvil distal connector 850 is protruding distally from the distal end post 842. The anvil shaft assembly 840 has a proximal end connected to an adjustment knob 760 pivotally mounted on the handle assembly 712 as discussed above for other embodiments. The circular stapler 700 also has anvil 170 shown in Fig. 32.

[0060] An exemplary method of using the circular stapler 700 will now be described. To begin the procedure, the surgeon inserts the elongated shaft 714 through the patient's rectum 199 into the proximal part 201 of the colon 200. The surgeon can then extend the detection elements 781 as shown in Figures 36 and 37 to "fine-adjust" the stapler head 720. This effect can be realized by turning the detection knob 791 in the right direction. When the bumpers 785 are radially pressed into the wall of the colon portion 201, they form recognizable bulges or deflections 203, or outwardly projecting irregular shapes, and provide the surgeon with the ability to visually observe the position of the stapler head 720. These identifiable characteristics differ from the actual anatomy of the colon wall. Blunt or rounded tabs do not penetrate or damage the colon wall. Such protrusions 203 allow the surgeon to position the stapler head 720 relative to the tumor or diseased portion 202 of the colon. If one or more bumpers 785 have a light source, the surgeon can view it through the wall of the colon as shown in Fig. 37.

[0061] After the surgeon sets the stapler head 720 in the desired position in the proximal part 201 of the colon 200, the surgeon can then slide the detection elements 781 into the hook and the detection housing 770 by turning the detection knob 791 in the opposite direction in which it was rotated to eject 781 detection elements. The withdrawal hooks 780 can then be extended so that they pierce and engage with adjacent parts of the proximal colon wall 201. In alternative embodiments, the surgeon may, however, choose to hold the detection elements 781 in their extended positions as shown in Figure 37. If this choice is made, the detection elements 781 may cause some "loop tension" in the colon wall, which may facilitate collection and piercing the proximal intestinal wall 201 through withdrawal hooks 780.

[0062] For the pickup hooks 780 to engage with and penetrate the proximal colon 201, the surgeon moves the hook and detection housing 770 in the distal direction, moving the hook switch 790 in the distal direction (arrow 792 in Fig. 32). The movement of the hook and the detection housing 770 in the distal direction causes the pickup hooks 780 to extend out of their respective clearance 772 in the axial direction. When the distal ends of the retrieving hooks 780 leave their respective clearances 772 hooks, they move radially outward to engage with and puncture the proximal colon wall 201. See Fig. 37. After piercing and engaging the hooks 780 with adjacent parts of the proximal colon wall 201, the surgeon moves the hook switch 790 in the proximal direction [0063] (shown by arrow 794 in Fig. 32) to withdraw withdrawal hooks 780 to their respective clearances 772 hooks and to slide the hook and detection housing 770 back to its initial position. Hooks 784 at the distal ends of the withdrawal hooks 780 pull the attached portions of the proximal colon wall 201 into a position similar to that in Fig. 9. After the proximal part 201 colon is pulled into the position shown in Fig. 9, the surgeon may then complete the procedure by performing the same steps described above for the round stapler 10.

[0064] Fig. 38 shows another circular stapler 900 according to various non-limiting embodiments of the invention. The circular stapler 900 generally has a handle assembly 912 having an elongated shaft 914 exiting the assembly. The elongated shaft 914 may define the central axis AA. As can be seen in Fig. 38, the elongated shaft 914 has a rigid outer casing 916 having a stapler head 920 located at the distal end 917 of the casing. In various non-limiting embodiments, the stapler head 920 is configured to be able to seat a circular staple cartridge 930. Such round staple cartridges 930 are known in the art and provide in general the seating of one, two or more than two circumferentially spaced and staggered rows of staples 36 as described above.

The conventional annular knife 940 is coaxially and movably mounted in the stapler head 920. See fig. 39.

[0065] The circular stapler 900 also has a drain shaft 950 embedded within the outer, rigid shell 916 to perform selective axial movement within the shell. See Fig. 39. The distal end 952 of the drain roller 950 has an outer staple drive portion 954 for engaging with each of the staples 36 in the outer row 32 of staples 36 in a staple cartridge 930. The distal end 952 of the drain roller 950 also has an internal staple drive portion 956 for connecting to each of the staples 36 in the inner row 34 of staples 36 in a staple cartridge 930. As can also be seen, for example, in Fig. 39, the distal end 952 of the trigger roller 950 also has a flange 958 configured to engage with the annular knife 940. Thus, as will be discussed in more detail below, axially extending the trigger roller 950 in the "DD" distal direction will result in the staples 36 being moved out of the staple cartridge 930 and the annular knife 940 being extended in the distal direction.

[0066] In various, non-limiting embodiments, the trigger roller 950 may be connected to a trigger 960 operably connected to the handle assembly 912. See Fig. 38. As can be seen in Fig. 38, trigger 960 can be pivotally connected to handle assembly 912 such that when trigger 960 is rotated toward handle assembly 912, trigger shaft 950 is displaced in distal direction DD. According to the above discussion, such trigger configurations are known in the art and will not be discussed in more detail in the text.

[0067] As shown in Fig. 39, variously non-limiting embodiments may also have a hollow output roller 970 coaxially mounted in a hollow tissue intake shaft 980. The proximal end of the output shaft 970 is operably connected to the arm output knob 910 pivotally mounted on the handle assembly 912 in the various ways described above. Thus, turning the arm output knob 910 on the handle assembly 912 will cause the output shaft 970 to rotate about the central axis AA. More specifically and with reference to Fig. 40, in various embodiments, the distal end 972 of the output shaft 970 projects through the opening 982 in the tissue intake shaft 980 and is connected to the transmission 974. The distal end 984 of the take-up roller 980 is configured to operatively seat at least one tissue take-up member or arm 1000. It is preferred to use two or more tissue arms 1000. In the non-limiting embodiment of Fig. 40, a total of four tissue arms 1000 are pivotally attached to the distal end 984 of the tissue receiving roller 980 by means of respective pins 986.

[0068] Each tissue arm 1000 may have a body 1002 which may, for example, be made of stainless steel (300 or 400 series), titanium, titanium-steel composite, ceramic material, etc., and may be connected to it or a gear formed thereon 1004. The gear 1004 of each tissue arm 1000 is movably mounted in a respective void space 988 of the arm formed at the distal end 984 of the tissue intake roller 980. Each transmission 1004 meshes with the transmission 974 on the output shaft 970. By turning the output shaft 970, the tissue arms 1000 will rotate from the retracted position shown in Fig. 41 to the derived position shown in Fig. 42. In various embodiments, the body 1002 of each tissue arm 1000 may also have a tip 1006 piercing tissue formed on it or otherwise connected to it.

[0069] In various embodiments, the knife shaft 1010 is coaxially arranged in the output shaft 970 and is connected to the knife knob 1020 (Fig. 38) pivotally mounted on the handle assembly 912 so that the rotation of the knife knob 1020 causes the knife shaft 1010 to rotate . The knife shaft 1010 also has a distal end 1012 protruding from the distal ends 972, 984 of the lead-out roller 970 and the tissue-receiving roller 980, respectively. See fig. 40. Knife 1030 can be releasably connected to the distal end 1012 of the knife shaft 1010, for example by means of pins 1032 or other suitable fasteners. In various embodiments, knife 1030 may be flat and have tissue piercing points 1031, 1033 formed opposite each other as shown in Fig. 40.

[0070] As can also be seen in Fig. 39, various non-limiting embodiments may also have an anvil shaft assembly 440 having a distal end post protruding from a portion of the discharge shaft 950 arranged coaxially inside the output shaft 970 for axial movement. The distal end post 442 provides seating of the anvil distal connecting member 450 coupled to the adjustment knob 460 pivotally mounted on the handle assembly 312 in the various ways described above.

[0071] The circular stapler 900 also has anvil 470 shown in Fig. 39. In various non-limiting embodiments of the invention, anvil 470 has an anvil base 471 having a series of staple forming pockets 472. The anvil base 471 may also define a cutting edge 473 to facilitate tissue cutting with a ring knife 940. The anvil 470 may also have an anvil shaft 474 connected to the anvil distal connecting member 450 in such a way that it can be detached. In particular, the coupling mandrel 476 projects from the proximal end 475 of the anvil shaft 474 and has a size that allows it to be inserted into the passage 452 in the anvil shaft assembly 450. Anvil 470 may also have an anvil hub 478 mounted thereon defining an empty space 479 of tissue in the anvil as shown in Fig. 39.

[0072] One example of how to use the circular stapler 900 will be described with reference to Figs. 39 and 4351. Referring first to Fig. 39, the stapler head 920 is placed in a tube-like body, such as colon 200, through the anus of the patient 199 . The stapler head 920 is located in the proximal colon portion 201 200 adjacent the colon diseased portion 202. Thus, the tissue arms 1000 are extended radially by turning the arm output knob 910 in the first direction (indicated by arrow 911 in Fig. 38), which also causes the output shaft 970 to rotate. Rotation of the output shaft 970 in the first direction also causes the drive gear 974 to rotate meshes with parts 1004 of the driven gear of each of the arms 1000 of tissue. By rotating the 974 transmission in the first direction, the tissue arms 1000 extend in the radial direction. While the tissue arms 1000 are extending radially, their tissue piercing tips 1006 pierce the proximal part 201 of colon 200. See Figures 44 and 45. The surgeon can then turn the knob 910 bringing the arm out in the opposite or second direction (indicated by arrow 913 in Fig. 38 ) to slide the tissue arms 1000 into the retracted position (Fig. 20). As the tissue arms 1000 are inserted, the pierced proximal portion 201 of colon 200 is transferred on the arms 1000 of tissue such that the portion 201 is collected between tissue arms 1000 and arm shaft 980 adjacent to and facing the staple cartridge 930. The surgeon may thus turn the knife knob 1020 so as to rotate the knife 1030 and cut off the diseased portion 202 of the colon 200 from the proximal part 201. Sick part 202 may be cut off from the proximal part 208 of the colon using a conventional laparoscopic cutting apparatus (not shown) inserted through the trocar sleeve (not shown) placed in abdominal cavity 601. After cutting off the sick part 202 from the proximal part 201 of the colon 200 and the distal part 208, the sick part 202 can be removed through the trocar sleeve using a conventional gripper 600. See Fig. 48.

[0073] The surgeon may then position the anvil 470 inside the distal colon portion 208 so that the connecting pin 476 of the anvil shaft 474 projects from the distal colon portion 208 200 as shown in Fig. 49. The surgeon may then tie the end of the distal colon portion 208 around the shaft 474 anvils using a solution known in the art as "astringent seam" 220. After stitching the distal colon 208 around the anvil shaft 474, the anvil shaft connector 476 is inserted into the passage 452 in the anvil shaft assembly 450. The spindle 476 of the coupling may be sized to pass 452 such that these elements are frictionally connected to secure the coupling spindle 476, but at the same time to allow removal of the coupling spindle 476 at a later date. See fig. 49.

[0074] The surgeon then pulls the anvil 470 toward the stapler head 920 (in the proximal "PD" direction) by turning the anvil control knob 460 in the right direction until clamping parts 205, 210 of the colon 200 between anvil 470 and staple cartridge 9, as shown in Fig. 50. The surgeon then presses the trigger 960 to move the trigger roller 950 axially in the "DD" distal direction. As the discharging roller 950 is moved distally, portion 954 of the staple driver exits the staples 36 through portions 205, 210 of the colon 200 and insert them into the anvil forming pockets 472 in the anvil base 471. Trigger shaft 950 also moves the annular knife 940 to cut off colon parts 201, 207, respectively, colon parts 205, 210. The surgeon may then move the anvil 470 in the distal direction "DD" to release the stapled colon parts 205, 210 from the space between the anvil 470 and the stapler head 920. The device 900 can then be removed from the colon 200. See Fig. 51. The cut parts 207 are caught in the anvil cavity 479, and the cut part 201 is secured between the anvil arms 1000 and arm shaft 980. The cut portions 201, 207 of colon 200 are thereby removed from the operated colon when the instrument 900 is removed from it. [0075] When the surgeon performs the above-described procedures or other similar procedures in this area of ​​the body, care should be taken not to accidentally damage near soft tissues and bone structures. Figures 52 and 53 show some of the adjacent bone tissue and structures located near colon 200. In Fig. 52, peritoneal 1100 has been cut to show, for example, anal sphincter 1101, sacro-tumor ligament 1102, sciatic tumor 1104, sciatic-rectal pit 1106, levator muscle 1180 and third sacral vertebra 1110. Fig. 3 also shows the perianal pit 1112, genital cross-fold 1114, catheter 1116, vas deferens 1118, bladder 1120, perithelial pit 1122 and trans-bladder folds 1124. The surgeon must also be careful not to damage muscles, nerves, blood vessels, and arteries running along the inner peritoneal wall 1100 while accessing the resected portion of colon 200.

[0076] Figs. 54-57 show the use of the protective cover 1200, which is not a limiting embodiment of the present invention. In various embodiments, the sheath 1200 may be manufactured, for example, from Kevlar, polyethylene, nylon, etc., and compressed in a manner that gives it a natural tendency to curl into a spiral. See fig. 55. In various embodiments, measurement or reference indicators 1202 may be placed on the sheath 1200 to assist the surgeon in positioning the functional part of the surgical instrument (e.g., the stapling head of a round stapler) and to avoid accidental damage to adjacent nerves, blood vessels and tissues . In yet other embodiments, the sheath 1200 may be made of a magnetic field sensitive tape that would allow magnetic attraction to the functional part of the device to protect adjacent anatomical structures and tissues, for example against parts of the device that can damage adjacent tissues, muscles, bones , nerves, etc. in the event of accidental contact with parts of the device. In further alternative embodiments, the cover 1200 may have a ring or a magnetically interacting element attracted to the stapler head. Due to this solution, at least part of the shield 1200 can be a magnetic shield or otherwise have a magnetic material connected to it.

[0077] The sheath 1200 may be installed through cannula 1252 of a conventional trocar 1250 inserted laparoscopically

<td>through the wall</td><td>cavity</td><td>abdominal</td><td>down</td><td>abdominal cavity in</td><td>way</td>

<td>presented</td><td>on</td><td>FIG.</td><td> 54.</td><td>Conventional</td><td>grasper</td>

<td>laparoscopic</td><td> 600</td><td>maybe</td><td>be</td><td>used in</td><td>way</td>

<td>presented</td><td>in fig</td><td>. 54 and 55</td><td colspan="2">to remove the cover</td><td>1200 z</td>

trocar cannula 1252. The surgeon may then wrap the unwrapped sheath 1200 around the colon 200 using conventional grippers 600 as shown in Fig. 56. Fig. 57 shows the sheath 1200 wrapped around the colon 200 and before starting to introduce the round surgical instrument into the colon. The sheath's natural tendency to curl into a spiral allows it to be attached in a spiral around the colon 200.

[0078] The sheath 1200 according to the present invention can be effectively used to protect adjacent tissues and organs during use of any of the described embodiments. See, for example, Figs. 5-16, 23-31, 36, 39, and 43-51, where sheath 1200 is installed around colon 200 in the manner described above. Non-limiting embodiments of the sheath 1200 can also be effectively used with conventional round staplers and similar devices without departing from the scope of the present invention as defined in the claims. In the case of implementations of the device using light sources on detection elements or the like, the cover 1200 may be made, for example, of a photosensitive film which would change the color of the part of the cover 1200 in areas adjacent to the illuminated detection elements. See, for example, the non-limiting embodiment shown in Fig. 36.

[0079] Various embodiments of the present invention represent a significant improvement over circular stapling solutions known in the art and related operations. Although several embodiments of the invention have been described in the text, it should be obvious to those having ordinary skill in the art that various modifications, changes, and adaptations of these embodiments are possible to achieve some or all of the benefits of the invention. For example, according to various embodiments, one element may be replaced by several elements, and several elements may be replaced by one element to perform a specific function or functions. Therefore, this application is intended to cover all such modifications, changes and adaptations without departing from the scope of the invention described in the claims.

[0080] The protected invention should therefore not be interpreted as limited to the specific embodiments described. The embodiments should therefore be regarded as illustrative rather than limiting.