stapling cartridge assembly and circular stapling instrument

专利摘要:
INSTRUMENT FOR CIRCULAR STAPLING WITH A SEPARATION WASHER FIXING ELEMENT. The present invention relates to a stapling cartridge assembly for a circular stapling instrument that includes a housing, a staple driver and a blade. The clamp driver can be received inside the compartment and configured to move within said compartment, from a pre-firing position to a post-firing position. The blade can be attached to the staple driver. The blade includes a cutting edge and a separating washer fixing element to connect securely to a separating washer when the clamp driver is moved from the pre-trigger position to the post-trigger position.
公开号:BR102012001794B1
申请号:R102012001794-6
申请日:2012-01-26
公开日:2021-02-02
发明作者:Anil K. Nalagatla；Michael L. Kruszynski；Thomas E. Adams
申请人:Ethicon Endo-Surgery, Inc.；
IPC主号:

专利说明:

DESCRIPTION FIELD
[001] The present description relates in general to a fixing element of the separating washer of a blade of a circular stapler. BACKGROUND OF THE INVENTION
[002] Circular stapling instruments are well known in the surgical art for bowel surgery. An example of such a device is the Endopath ILS ECS 25 endoscopic curved intraluminal stapler produced by Ethicon Endo Surgery Inc. There are many patents for circular staplers, for example, US patent No. 4,207,898 to Becht, US patent No. 4,351,466 to Noiles, US patent No. 5,292,053 to Bilotti et al. and US Patent No. 5,344,059 to Green et. al.
[003] Typically, instruments for circular stapling are designed to be used once, during which cutting and stapling are completed, and then discarded. The annular blade used for tissue cutting is advanced during cutting and then retracted back into the device after use, thus protecting the edge of the annular blade. However, the instrument for circular stapling may be inadvertently reused a second time if it is not immediately discarded after the first use. Sometimes, reusable circular stapling instruments can leave the annular blade in an advanced position after use. This can present a danger to the user in relation to a sharp and exposed edge. Some reusable circular stapling instruments use only friction to retain a solid element for cutting over the edge of the annular blade, covering it. This is not a reliable means of covering the exposed edge of the annular blade, since in some cases the cover may separate from the edge of the annular blade, exposing the edge of the annular blade.
[004] An apparatus for an instrument for circular stapling, as well as a method for its use, is necessary to reduce one or more problems of the instruments for circular stapling of prior art. SUMMARY
[005] The present description is defined by the claims and nothing in this section should be taken as a limitation on the claims.
[006] In one aspect, a set of stapling cartridge for an instrument for circular stapling is presented. The stapling cartridge assembly comprises a compartment, a staple driver and a blade. The clamp driver can be received inside the compartment and configured to move within said compartment, from a pre-firing position to a post-firing position. The blade can be attached to the staple driver. The blade comprises a cutting edge and a separating washer fixing element to connect securely to a separating washer when the clamp driver is moved from the pre-trigger position to the post-trigger position.
[007] In another aspect, an instrument for circular stapling is presented. The instrument for circular stapling comprises a compartment, a staple driver, an anvil set and a blade. The clamp actuator is arranged inside the compartment and can be moved, inside it, from a pre-firing position to a post-firing position. The anvil assembly comprises a separation washer assembly attached to an anvil base surface. The anvil assembly can be moved from an open position away from the compartment to a closed position adjacent to the compartment. The blade is attached to the staple driver. The blade comprises a fixing element for the separating washer. When the clamp driver is in the pre-trigger position, the separation washer is not cut by the blade and the separation washer fixing element is not attached to the separation washer. When the clamp driver is in the post-firing position and the anvil assembly is in the closed position, the blade cuts the separation washer and the separation washer fixture securely connects to the cut-off separation washer.
[008] In an additional aspect, a method is presented for locking a blade to a separation washer of an instrument for circular stapling. In one step, an instrument for circular stapling is presented. The instrument for circular stapling shown comprises a compartment, a staple trigger, an anvil set and a blade. The clamp driver is movably arranged inside the compartment. The anvil assembly comprises a separating washer fixed to an anvil base surface. The blade is attached to the staple driver. In another step, the anvil assembly is moved from an open position away from the compartment to a closed position adjacent to the compartment. In an additional step, the clamp actuator is moved from a pre-firing position, in which the blade did not cut the separating washer and in which a blade separating washer fixing element was not attached to the separation, for a firing position in which the blade cuts the separation washer and the blade separation washer fixing element securely attaches to the cut separation washer. BRIEF DESCRIPTION OF THE DRAWINGS
[009] The present description can be better understood with reference to the drawings and description below. The components in the figures are not necessarily to scale, instead, the emphasis is placed on illustrating the principles of the description.
[0010] Figure 1 illustrates a perspective view of a reusable circular stapling instrument that has an open set architecture, according to a preferred modality;
[0011] Figure 2 illustrates a perspective view of the reusable circular stapling instrument of figure 1 with the instrument in the open position with an anvil set separate from the rest of the reusable circular stapling instrument;
[0012] Figure 3 shows an exploded perspective view of a cable and stem assembly of the reusable circular stapling instrument of figure 1;
[0013] Figure 3A illustrates a cross-sectional view through line 3A-3A of a portion of an anvil reciprocating adjustment rod of the reusable circular stapling instrument of figure 3;
[0014] Figure 3B illustrates a cross-sectional view through line 3B-3B of another portion of the anvil reciprocating adjustment rod of the reusable circular stapling instrument of figure 3;
[0015] Figure 4 illustrates an exploded perspective view of a staple refill set of the reusable circular stapling instrument of figure 1;
[0016] Figure 5 illustrates a partial cross-sectional view through a staple refill set of the reusable circular stapling instrument of figure 1 in an unmounted configuration;
[0017] Figure 6 illustrates a cross-sectional view through a staple refill set of the reusable circular stapling instrument of figure 1 in an assembled configuration with an anvil set in an open position and an annular blade in one pre-shooting position;
[0018] Figure 7 illustrates the view of figure 6 with the anvil set moved to a closed position and with the annular blade still in the pre-firing position;
[0019] Figure 8 illustrates an exploded perspective view of the anvil assembly of the reusable circular stapling instrument of figure 1;
[0020] Figure 9 illustrates a flowchart of a modality of a method of aligning a staple refill set of a circular stapling instrument;
[0021] Figure 10 illustrates an exploded perspective view of another embodiment of an anvil set;
[0022] Figure 11 illustrates a perspective view of the reusable circular stapling instrument of figure 1, replacing the anvil assembly with the anvil assembly of figure 10 separated from the rest of the reusable circular stapling instrument;
[0023] Figure 12 illustrates an exploded perspective view of an additional embodiment of an anvil set;
[0024] Figure 13 illustrates a perspective view of the reusable circular stapling instrument of figure 1, replacing the anvil assembly with the anvil assembly of figure 12 separated from the rest of the reusable circular stapling instrument;
[0025] Figure 14 illustrates a flow chart showing a modality of a method of manufacturing an anvil set;
[0026] Figures 15A and 15B illustrate perspective views, during different stages of assembly, of an anvil closing handle and anvil reciprocating adjustment rod of the reusable circular stapling instrument of figure 1;
[0027] Figures 16A and 16B illustrate perspective views, during different stages of assembly, of the anvil close-up handle connected with the anvil reciprocating adjustment rod of figures 15A and 15B together with an instrument cable. reusable circular stapling of figure 1;
[0028] Figures 17A, 17B and 17C illustrate perspective views, during different assembly stages, of the anvil closing handle connected with the anvil reciprocating adjustment rod and the cable of figures 16A and 16B together with a bar unloading staples from the reusable circular stapling instrument of figure 1;
[0029] Figures 18A and 18B illustrate perspective views, during different stages of assembly, of the anvil closing handle connected with the anvil reciprocating adjustment rod, the cable and the staple discharge bar of figures 17A, 17B and 17C together with a cover for the support of the reusable circular stapling instrument of figure 1;
[0030] Figures 19A, 19B and 19C illustrate perspective views, during different stages of assembly of the anvil closing handle connected with the anvil reciprocating adjustment rod, the cable, the clamp discharge bar and the lid the support of figures 18A and 18B together with a rod assembly of the reusable circular stapling instrument of figure 1;
[0031] Figure 20 illustrates a perspective view of a curved reusable circular stapling instrument that has an open set architecture, according to another preferred mode;
[0032] Figure 21 shows an exploded perspective view of the curved reusable circular stapling instrument of figure 20;
[0033] Figure 22 illustrates a cross-sectional view of a curved circular stapling instrument that has a friction reducing element, with the instrument in an open condition;
[0034] Figure 23 illustrates a curved cross-sectional view of a circular stapling instrument that has a friction reducing element, with the instrument in a closed position before the clamp fires;
[0035] Figure 24 illustrates a cross-sectional view of a curved circular stapling instrument that has a friction reduction element, with the instrument in a completely triggered condition by firing staples;
[0036] Figure 25 illustrates a perspective view of a staple discharge bar of a curved circular stapling instrument that has a friction reducing element;
[0037] Figure 26 illustrates an exploded perspective view of a staple discharge bar of a circular stapling instrument that has a friction reducing element;
[0038] Figure 27 illustrates a cross-sectional view of a staple discharge bar of a circular stapling instrument that has a friction reducing element;
[0039] Figure 28 illustrates an enlarged side view of a staple discharge bar of a circular stapling instrument that has an alternative modality of a frictional reduction element adjacent to an anvil reciprocating adjustment rod;
[0040] Figure 29 illustrates a cross-sectional view of an annular blade of the stapling refill assembly of the circular stapling instrument of figure 4;
[0041] Figure 30 illustrates a perspective view of an annular separation washer attached to a protective element;
[0042] Figure 31 illustrates the view of figure 7 with the annular blade moved to the firing position by cutting an annular separation washer while the anvil assembly is in the closed position;
[0043] Figure 32 illustrates a close view, inside the dotted circle of the annular blade of figure 31, which shows the annular blade cutting through the annular separation washer;
[0044] Figure 33 illustrates the view of figure 31 with the anvil assembly being moved back to the open position after the annular blade has been fired;
[0045] Figure 33A illustrates a close-up side view of a modality of an anvil control element connected to a cable of a reusable circular stapling instrument;
[0046] Figure 34 illustrates the view of figure 33 with an anvil from the anvil assembly removed from the circular stapling instrument and the annular separation washer and a protective element attached to the annular blade;
[0047] Figure 35 illustrates the view of figure 34 with a new anvil trying to fix itself to the stapling recharge set, and the protective element and the annular separation washer interfering with the fixation;
[0048] Figure 36 illustrates a close view of the dotted circle of figure 35 that shows the protective element and the annular separation washer, interfering in the fixation of the new anvil with the staple refill set;
[0049] Figure 37 illustrates a flow chart of a modality of a method of locking a blade in a separation washer of a circular stapling instrument;
[0050] Figure 38 illustrates a cross-sectional view through the reusable circular stapling instrument of figure 1 with the anvil set disposed in an open position, outside a firing zone, away from a compartment with a firing trigger in a locked pre-trigger state;
[0051] Figure 38B illustrates a close-up view showing the relationship between a trigger trigger and the clip unloading bar in the assembled condition of figure 17C;
[0052] Figure 39 illustrates a partial perspective view of the cross-sectional view of figure 38;
[0053] Figure 40 illustrates a cross-sectional view through line 40-40 of figure 38;
[0054] Figure 41 illustrates a cross-sectional view through the reusable circular stapling instrument of Figure 1 with the anvil set disposed in a closed position, in the firing zone, adjacent to the compartment with the firing trigger in a state of unlocked pre-shot ready for firing;
[0055] Figure 42 illustrates a cross-sectional view in partial perspective of figure 41;
[0056] Figure 43 illustrates a cross-sectional view through line 43-43 of figure 41;
[0057] Figure 44 illustrates a cross-sectional view through the reusable circular stapling instrument of figure 1 with the anvil set disposed in the closed position, in the firing zone, adjacent to the compartment with the firing trigger being fired;
[0058] Figure 45 illustrates a partial perspective view of the cross-sectional view of Figure 44;
[0059] Figure 46 illustrates a cross-sectional view through line 46-46 of figure 44; and
[0060] Figures 47A and 47B illustrate cross-sectional views of a staple refill set in a state attached to a cable, with an anvil in open and closed conditions respectively. DETAILED DESCRIPTION
[0061] With reference to figure 1, an innovative surgical circular stapling instrument 100 is shown for the removal of tissue from a human patient in accordance with the present description. The surgical circular stapling instrument 100 can be used to remove tissue comprising internal hemorrhoids or other types of human tissue. The circular stapling instrument 100 is adapted from a conventional circular stapling instrument, as shown in US Patent No. 6,102,271, the contents of which are incorporated herein by reference in the present invention in their entirety. The circular stapling instrument 100 has a stapling refill set 102 adapted to place an annular arrangement of staples 104 (see figures 7 and 31) in a mucous layer at the base of internal hemorrhoids and to cut the mucous tissue together with the internal hemorrhoids from the inner wall of the rectum or anus. In general, the circular stapling instrument 100 can be used to anastomize two sections of intestines together with an annular ring of staples 104 (see figures 7 and 31) while cutting a lid from a center of a annular ring of clamp formed for the passage of fecal material.
[0062] Referring to figures 1 and 2, the circular stapling instrument 100 includes an ergonomic stem assembly 106, a stapling cartridge assembly 108 that has a compartment 110, and an anvil assembly 112 separably connected anvil reciprocating adjustment rod 114. The stapling refill assembly 102 of the circular stapling instrument includes stapling cartridge assembly 108 and anvil assembly 112. As shown in figures 1 to 3, the circular stapling instrument 100 additionally includes a cable 116 that forms a cavity 118. An anvil control element 120 is located at the proximal end of the cable 116 and is operatively coupled to the anvil assembly 112 such that the rotation of the anvil control element 120 moves the anvil assembly 112 proximally or distally, depending on the direction of rotation of the anvil control element 120. the anvil control element 120 pod and comprise an anvil closure handle or other type of anvil control element. The circular stapling instrument 100 includes a trigger trigger 122 which is rotatable in direction 124 from the open position shown to a closed position in which staples 104 (see figures 7 and 31) are injected into the tissue (see figure 31 ) and the excess tissue is cut with an annular blade 126 (see figure 31) of the staple refill assembly 102. A safety lock 128 is located on the trigger trigger 122 and is shown in a top and engaged position which prevents the trigger trigger 122 from operating. When safety lock 128 is disengaged and moved in and down in direction 128a, trigger trigger 122 is free to rotate in direction 124 from the open position to the closed position . The stem assembly 106 extends distally from the cable 116 and is separably coupled to the cable 116 at a proximal end with the use of a connecting nut 130 that attaches to a threaded portion 132 (see figure 3) of the cable 116. Opposite fixing elements 134 (see figure 4) of compartment 110 are separably coupled to receiving elements 136 (see figure 3) at a distal end of the stem assembly 106. The fixing elements 134 comprise deflectable press-fit elements and the receiving elements 136 comprise openings. In other embodiments, the fastening elements 134 and the receiving elements 136 can comprise any type of corresponding elements.
[0063] As shown in figure 2, compartment 110 has an outer surface 138 that has an enlarged driver portion 140 and an outer tubular driver portion 142. Passages 144 comprise a surface opening of the compartment extending from the enlarged driver portion 140 to external tubular driver portion 142. An annular clamp retainer 148 (see figures 4, 5, 7 and 31) is attached to a distal end of compartment 110 with fixing elements 150 (see figures 4, 7 and 31) of the clamp retainer 148 separably connected to the receiving elements 152 (see figures 4, 7 and 31) of the compartment 110. The fastening elements 150 comprise press-fit projections and the receiving elements 152 comprise inserts deflectable pressure. In other embodiments, the fasteners 150 and the receiving elements 152 can each comprise any type of connectable elements. The annular clamp retainer 148 includes an annular arrangement of clamp slots 154 (see figures 4, 7 and 31) for securing and emitting the clamps 104 (see figure 31).
[0064] As shown in figures 4 to 7, a staple driver 156 slidily connects with the annular staple retainer 148 with the keys 158 (see figure 4) of the staple driver 156 providing an arrangement that is a separable connection of the locks 160 (see figure 4) of the annular clamp retainer 148. The clamp actuator 156 is movably mounted inside the housing 110 with alignment slits 162 of an external annular actuator surface 164 of the clamp actuator 156 connected in a manner movable to alignment slots 166 of a surface of the annular inner compartment 168 of compartment 110 that allows longitudinal movement of the clip driver 156 inside compartment 110 while preventing rotation of the clip driver 156 inside compartment 110. A the outer driver surface 164 of the clamp driver 156 has an enlarged driver portion 170 and an external tubular driver portion 171. The slots alignment 162 and alignment grooves 166 are arranged parallel to the longitudinal geometric axis 172 and 174 of staple driver 156 and housing 110. In other embodiments, housing 110 and staple driver 156 can be aligned in relation to each other with the use of any number, type or configuration of alignment elements that allow longitudinal movement.
[0065] The clip driver 156 has a plurality of fingers 176 that are received inside the clip slots 154 within the clip retainer 148. The fingers 176 are for engaging and actuating a plurality of clips 104 (see figure 31) from the staple slots 154 of the staple retainer 148 as the staple trigger 156 is moved from a pre-trigger position (see figure 7) to a trigger position (see figure 31) through the actuation of the trigger trip 122 (see figure 3). As shown in figures 4 and 7, the flexible holding elements 178 of the staple driver 156 are separably connected to the holding projections 180 of the housing 110. This arrangement allows the longitudinal movement of the staple driver 156 only when a predetermined proportion of force is exerted by a staple discharge bar 282 (see figures 44 to 46) on the staple driver 156. When the required force is exerted, the deflectable detent elements 178 on the staple driver 156 tilt inward, thereby , disengage from the detent projections 180 in compartment 110 allowing the clip driver 156 to move longitudinally and distally. In other embodiments, the flexible holding element 178 and the holding projections 180 may comprise other types of corresponding elements.
[0066] The annular blade 126 is mounted inside the distal end of the clip driver 156 and is fixed by a plurality of blade mounting pins 182 (see figures 5 and 31) that project through an equal number of mounting holes 184 within a base 186 of the annular blade 126. The annular blade 126 has a blade opening 188 (see figures 5 and 31) within the base 186. The open distal end 190 (see figures 4, 29 and 31) of the annular blade 126 has a cutting edge 192. The annular blade 126 moves with the staple trigger 156 when the staple trigger 156 is moved distally from the pre-firing position of figure 7 to the firing position of figure 31 using the trigger trigger 122 (see figure 3). When trigger trigger 122 is triggered, trigger trigger 122 rotates in direction 124 from its position in figures 38 to 43 to its position in figures 44 to 46 by forcing a corresponding clamp discharge bar 282 into compartment 110 to stop. move in the direction 392 which is contiguous with and forcing the clamp trigger 156 to also move inside compartment 110 in direction 392. This movement triggers the clamp trigger 156 and its annular blade 126 from its position of pre-trigger of figures 7 and 38 to 43 to their trigger position of figures 31 and 44 to 46. During trigger of the staple trigger 156, the fingers 176 of the staple trigger 156 fire the staples 104 from their pre-position firing at the clip retainer 148 shown in figure 7 to its firing position outside the clip retainer 148 shown in figure 31.
[0067] The anvil reciprocating adjustment rod 114 (see figures 4 and 6) is located inside the stapling cartridge assembly 108 and is positioned to extend through and move inside an annular internal stem 194 (see figures 4 and 6) of the clip driver 156. As shown in figures 3A and 3B, a cross section of the anvil reciprocating adjustment rod 114 varies in shape and size with respect to a portion along the line in cross section 3A-3A which is circular in shape and has a diameter 401 as shown in figure 3A, and another portion along the line in cross section 3B-3B that has parallel side walls separated by a distance 402, less than a diameter 401, as shown in the figure 3B. As shown in figure 4, the inner annular stem 194 extends longitudinally within the staple driver 156 parallel to the longitudinal geometric axis 172 of the staple driver 156. An orifice 196 extends within the inner annular stem 194. An alignment surface force claw 198 extending longitudinally along an inner annular surface 200 of the inner annular stem 194. The force claw alignment surface 198 comprises at least one longitudinal slot. In other embodiments, the force gripper alignment surface 198 may comprise any number or type of alignment surfaces in different configurations. An outer surface 204 of the inner annular stem 194 is spaced from another inner annular surface 206 of the clamp actuator 156 with an annular hole 208 extending between the outer surface 204 of the inner annular stem 194 and the inner annular surface 206.
[0068] With reference to figures 1, 2, 4 to 7 and, in particular, figure 8, the anvil assembly 112 comprises an anvil 210, a clamp forming surface 212, an annular separating washer 214 and a rod of metal 216. Anvil 210 is a one-piece polymeric molded part comprising an anvil stem 218 integrally molded on an anvil base surface 220. Anvil 210 is produced from a polymer comprising glass-filled nylon or with carbon. In other embodiments, anvil 210 can be produced from similar composite materials that have a tensile strength greater than 103.4 MPa (15,000 psi) in order to avoid excessive inclination under fabric forces.
[0069] The anvil base surface 220 is molded to the staple forming surface 212 and the metal rod 216. In other embodiments, the anvil base surface 220 can be attached to the staple forming surface 212 with the use of mechanisms different fixing points. The staple forming surface 212 is produced from a sheet or metal plate that comprises stainless steel, has an annular shape and includes staple forming pockets. In other embodiments, the staple forming surface 212 may be made of aluminum or other materials that can withstand the staple forming forces.
[0070] The annular separation washer 214 is pressed into a cavity 222 of the anvil base surface 220 adjacent to the anvil base surface 220. In other embodiments, the annular separation washer 214 can be fixed within the cavity 222 of the anvil base surface 220 using different fixing mechanisms. The annular separation washer 214 is produced from a plastic comprising ABS (Acrylonitrile-Butadiene-Styrene). In other embodiments, the annular separation washer 214 may be made of nylon, polyethylene or polypropylene.
[0071] Anvil shank 218 is molded around an outer surface 224 of an end 226 of metal shank 216, with metal shank 216 extending into a molded hole 228 of anvil shank 218. The molded orifice 228 of the anvil stem 218 ends within the anvil stem 218 and does not extend through the distal end of the anvil base surface 220. An inner surface 230 of the anvil stem 218 comprises receiving elements 232 that are molded into fasteners 234 of the outer surface 224 of the end 226 of the metal rod 216. The receiving elements 232 comprise molded annular ribs (figure 38) and the fasteners 234 comprise annular grooves (figure 8). In other embodiments, the receiving elements 232 and the fastening elements 234 can comprise grooves and threads, female and male elements or other types of fastening mechanisms. In still other embodiments, the anvil rod 218 can be attached to the metal rod 216 using different clamping mechanisms. A proximal end channel 236 extends through metal rod 216. End 238 of metal rod 216 includes expansion slots 240 (see figure 2). The metal rod 216 is made of stainless steel. In other embodiments, the metal rod 216 can be produced from different materials.
[0072] At the time of manufacture of the anvil assembly 112, the metal rod 216 and the clamp forming surface 212 are prefabricated. The prefabricated metal rod 216 and the prefabricated clamp forming surface 212 are then inserted into an injection mold. The mold is then used to form the anvil 210 inside the molded cavity, causing the anvil 210 to be molded both on the prefabricated metal rod 216 and on the prefabricated staple forming surface 212. During the molding process, the anvil base surface 220 forms and is molded on the prefabricated staple forming surface 212, while the anvil stem 218 forms and is molded around the end 226 of the pre-machined metal rod 216. A annular separating washer 214 is then snap-fitted into cavity 222 of the molded anvil base surface 220. In other embodiments, the manufacturing process may vary.
[0073] The coupling element 244 (see figures 2 and 6) of the anvil reciprocating adjustment rod 114 is separably coupled inside the proximal end channel 236 of the metal rod 216 with the use of a plug-in coupling by pressure. This arrangement operationally couples the metal rod 216 and the anvil fixed 210 to the anvil control element 120 of the anvil reciprocating adjustment rod 114. In other embodiments, the engagement element 244 of the anvil reciprocating adjustment rod 114 can be attached to the metal rod 216 using other clamping mechanisms. Expansion slots 240 allow the end 238 of the metal rod 216 to expand during coupling to the engagement element 244 of the anvil reciprocating adjustment rod 114. After using the circular stapling instrument 100 on a patient, the entire anvil set 112 is thrown away. During a subsequent procedure, a new staple refill set 102 is used, which includes a new anvil set 112.
[0074] As shown in figure 8, the anvil stem 218 includes an alignment surface 246 formed at the time of molding of the anvil 210. The alignment surface 246 comprises at least one groove disposed parallel to a longitudinal geometric axis 248 of the stem. anvil 218. The alignment surface 246 extends from a top portion 250 of the anvil stem 218, along an outer annular surface 252 of the anvil stem 218 to a bottom portion 254 of the anvil stem 218. The stem of the anvil metal 216 of anvil assembly 112 does not contain an alignment surface. In other embodiments, the alignment surface 246 can comprise any number or type of alignment surfaces in different configurations. For example, as shown in figure 12, in an embodiment in which the anvil assembly 112 includes only the anvil stem 218 without the metal rod 216 being attached to the anvil assembly 112, the alignment surface 246 may extend from a top portion 250 of the anvil stem 218, along the outer annular surface 252 of the anvil stem 218 and stop at a middle portion 256 of the anvil stem 218 without extending to the bottom portion 254 of the anvil stem 218.
[0075] The anvil set 112 is movable from an open position (see figure 6) in which the staple forming surface 212 is arranged in the opposite direction to a compartment 110 for receiving the tissue, up to a closed position (see figure 7 ) in which the staple forming surface 212 is disposed adjacent to the compartment 110 of the staple cartridge assembly 108, securing the fabric between the staple retainer 148 and the staple forming surface 212 prior to firing the staple trigger 156 for stapling and cut the trapped fabric. This is due to the fact that the tip 242 (see figures 2 and 6) of the engagement element 244 of the anvil reciprocal adjustment rod 114 extends inside the annular inner rod 194 of the clamp driver 156 and is connected inside of channel 236 of proximal end 238 of metal rod 216 of anvil assembly 112. As a result, due to the movement of the anvil reciprocating adjustment rod 114 connected, the anvil rod 218, which is connected to the metal rod 216, is arranged movably within the annular inner rod 194 of the staple driver 156 allowing the movement of the staple forming surface 212 of the anvil assembly 112 in relation to the staple driver 156 and the housing 110.
[0076] The alignment surface 246 (see figure 8) of the anvil stem 218 is configured to correspond with the force jaw alignment surface 198 (see figure 4) of the clip driver 156 to rotationally align the forming surface of staple 212 with staple retainer 148 when the anvil base surface 220 is in the closed position (see figure 7) adjacent to staple cartridge assembly 108. Initially, as shown in figure 6, as the adjustment rod reciprocating anvil 114 moves, the metal rod 216 and the anvil rod 218 thus move the anvil base surface 220 from the open position shown in figure 6 towards the closed position shown in figure 7, with the alignment surface 246 (see figure 8) of the anvil stem 218 does not correspond with the force jaw alignment surface 198 (see figure 4) of the annular inner stem 194 of the clamp driver 156 due to the fact that and that the force jaw alignment surface 198 will only be disposed adjacent to metal rod 216 which does not have an alignment surface. During this period, the clamp forming surface 212 will not be rotationally aligned with the clamp retainer 148. However, as shown in Figure 7, when the alignment surface 246 of the anvil stem 218 reaches the inner annular stem 194 of the driver of staples 156, the alignment surface 246 will correspond with the force claw alignment surface 198 of the annular inner stem 194, rotationally aligning the staple forming surface 212 with the staple retainer 148 as the base surface anvil 220 move to the closed position adjacent to the staple cartridge assembly 108. Referring to Figure 33A, the marks 120A adjacent to the anvil control element 120 visually indicate the gap distance between the staple forming surface 212 of the anvil 112 (see figure 7) and the staple guide 148 (see figure 7), providing feedback to the user about the thickness of the compressed tissue. When the device is almost completely closed, the proximal end of the anvil reciprocating adjustment rod 114 fires through the hole 120F in the anvil control element 120.
[0077] When the anvil assembly 112 is in the closed position of figure 7 and the circular stapling instrument is fired 100, moving the staple driver 156 from its pre-firing position within compartment 110 shown in figure 7 to its position shown in figure 31, the fingers 176 of the staple trigger 156 trigger the staples 104 from the staple slots 154 of the staple retainer 148 against the staple forming surface 212 of the anvil assembly 112. The staple forming surface 212 forms the ejected staples 104 in a closed staple format, thereby stapling portions of fabric together. At the same time, the staple driver 156 drives the annular blade 126 on the compressed tissue captured between the staple forming surface 212 on the anvil 210 and the surface of the staple guide 148, thereby cutting the fabric against the separating washer 214 of the anvil set 112.
[0078] Figure 9 illustrates a flowchart 258 showing a modality of a method of aligning a staple refill set of a circular stapling instrument. In step 260, a stapling refill kit for a circular stapling instrument is provided. The circular stapling instrument provided includes a compartment, a staple retainer attached to the compartment, a staple actuator, an annular blade and an anvil. In step 262, the clamp actuator is movably mounted inside the compartment in an aligned configuration and the clamp actuator fasteners are connected to the receiving elements of the compartment, preventing the clamp actuator from moving back to a certain point within the compartment until a predetermined proportion of force is applied to the staple driver by a staple discharge bar. In step 264, an anvil base surface of the anvil is moved from an open position away from the compartment, where a staple forming surface of the anvil is not rotationally aligned with the staple retainer attached to the compartment, toward a closed position adjacent to the compartment. In step 266, an anvil alignment surface is engaged with a staple actuator force grab alignment surface to rotationally align the anvil's staple-forming surface with the staple retainer when the base surface of the anvil anvil is in the closed position adjacent to the compartment. The alignment surface of the anvil comprises at least one groove and the force grab alignment surface of the staple actuator comprises at least one slot. In other embodiments, the number, type and configuration of the anvil alignment surface and the actuator force jaw alignment surface may vary.
[0079] One or more modalities of the present description can reduce one or more problems associated with alignment in previous surgical circular stapling instruments. For example, the use of one or more of the description modes can provide an appropriate alignment directly between the anvil and the staple driver, rather than requiring a first alignment between the anvil and the housing, and a second alignment between the staple driver and the compartment as it is done in current devices. This method of directly aligning the actuator and the anvil reduces the potential for alignment variation and results in the improved clamp shape.
[0080] Figure 10 illustrates an exploded view of another embodiment of an anvil assembly 112A comprising an anvil 210A, a clamp forming surface 212A, an annular separating washer 214A and a metal rod 216A. Anvil 210A is a one-piece molded polymer part comprising an anvil stem 218A molded on an anvil base surface 220A. The anvil 210A is produced from a polymer comprising nylon loaded with glass or carbon. In other embodiments, burret 210A can be produced from similar composite materials that have a tensile strength greater than 103.4 MPa (15,000 psi) in order to avoid excessive tilting under fabric forces.
[0081] The metal rod 216A extends through a molded hole 228A that extends through the anvil stem 218A and the anvil base surface 220A. An end 226A of the metal rod 216A extends out of the molded orifice 228A and is contiguous against a top portion 268 of the anvil base surface 220A. The end 226A of the metal rod 216A has a larger diameter 270 than the diameter 272 of the molded orifice 228A. The other end 238A of the metal shank 216A extends out of the molded hole 228A of the anvil shank 218A. The metal rod 216A comprises fixing elements (hidden from view) that attach to receiving elements (hidden from view) of the anvil stem 218A. The fastening elements comprise threads and the receiving elements comprise grooves. In other embodiments, the fastening elements and receiving elements can comprise male and female elements or other types of fastening mechanisms. In still other embodiments, the metal rod 216A can be attached to the anvil rod 218A using different clamping mechanisms. A channel 236A extends into the proximal end 238A of metal rod 216A. The end 238A of the metal rod 216A also includes expansion slots 240A. The 216A metal rod is produced from a metal that comprises heat-treated stainless steel. In other embodiments, the metal rod 216A can be produced from other steels.
[0082] The anvil base surface 220A is molded to the staple forming surface 212A. In other embodiments, the anvil base surface 220A can be attached to the clamp forming surface 212A using different fixing mechanisms. The staple forming surface 212A is produced from a sheet of metal that comprises austenitic stainless steel, has an annular shape and includes staple forming pockets. In other embodiments, the clamp forming surface 212A can be produced from other metals, stainless steel, aluminum, sheet or plate.
[0083] The annular separation washer 214A is pressed into a cavity 222A of the anvil base surface 220A adjacent to the anvil base surface 220A. In other embodiments, the annular separating washer 214A can be fixed within the cavity 222A of the anvil base surface 220A using different fixing mechanisms. The annular separation washer 214A is produced from a plastic comprising ABS (Acrylonitrile-Butadiene-Styrene). In other embodiments, the annular separation washer 214A can be made of nylon, polyethylene or polypropylene.
[0084] At the time of manufacture of the anvil assembly 112A, the clamp forming surface 212A is prefabricated. The prefabricated staple forming surface 212A is then inserted into an injection mold. The mold is then used to form the anvil 210A within the molded cavity, causing the anvil 210A to be molded to the staple forming surface 212A. During the molding process, the anvil base surface 220A is formed and is molded to the staple forming surface 212A. The annular separation washer 214A is then pressed into the cavity 222A of the molded anvil base surface 220A. After molding the anvil base surface 220A, the end 238A of a prefabricated metal rod 216A is extended into the molded hole 228A in the anvil base surface 220A and out of the molded hole 228A in the anvil stem 218A, such as that the end 226A of the metal rod 216A is contiguous against the top portion 268 of the anvil base surface 220A. This step can be performed by the user before use. The metal rod 216A is separably connected to the anvil rod 218A due to the fact that the fastening elements (hidden from view) of the metal rod 216A correspond with the receiving elements (hidden from view) of the anvil rod 218A to the as the end 238A of the prefabricated metal rod 216A is extended in and out of the molded orifice 228A in the anvil 210A. In other fashion, the manufacturing process may vary.
[0085] As shown in figure 11, the engagement element 244 of the anvil reciprocating adjustment rod 114 is separably coupled within the proximal end channel 236A of the metal rod 216A using a snap fit coupling which operationally couples the metal rod 216A and the anvil fixed 210A to the anvil control element 120 via the anvil reciprocating adjustment rod 114. In other embodiments, the engaging element 244 of the anvil reciprocating adjustment rod 114 can be fixed to the metal rod 216A using other clamping mechanisms. Expansion slots 240A allow end 238A of metal rod 216A to expand during coupling with engagement element 244 of the anvil reciprocating adjustment rod 114. After using the circular stapling instrument 100 on a patient, the rod of metal 216A can be removed from anvil 210A by uncoupling the fastening elements (hidden from view) of metal rod 216A from the receiving elements (hidden from view) of anvil stem 218A, with anvil 210A being discarded, the metal rod 216A can be sterilized and the metal rod 216A can be attached to a new anvil using the same process described above to allow the metal rod 216A to be reused in another patient in combination with the new anvil and a new stapling cartridge assembly.
[0086] As shown in figures 10-11, the anvil stem 210A includes an alignment surface 246A formed at the time of molding the anvil 210A due to the mold. The alignment surface 246A comprises at least one groove disposed parallel to a longitudinal geometric axis 248A of the anvil stem 218A. The alignment surface 246A extends from a top portion 250A of anvil stem 218A, along an outer annular surface 252A of anvil stem 218A to a bottom portion 254A of anvil stem 218A. The metal rod 216A of the anvil assembly 112A does not contain an alignment surface. In other embodiments, the alignment surface 246A can comprise any number or type of alignment surfaces in different configurations.
[0087] Figure 12 illustrates an exploded view of another embodiment of an anvil assembly 112B comprising an anvil 210B, a clamp forming surface 212B and an annular separating washer 214B. Anvil 210B is a one-piece molded polymer part comprising an anvil stem 218B molded on an anvil base surface 220B. The anvil 210B is produced from a polymer comprising nylon loaded with glass and carbon. In other embodiments, the anvil 210B can be produced from similar composite materials that have a tensile strength greater than 103.4 MPa (15,000 psi) in order to avoid excessive tilting under fabric forces. A proximal end channel 236B extends within the anvil stem 218B. An anvil stem 218B includes expansion slots 240B.
[0088] The base surface of the anvil 220B is molded to the staple forming surface 212B. In other embodiments, the anvil base surface 220B can be attached to the staple forming surface 212B using different fixing mechanisms. The staple forming surface 212B is produced from a metal that comprises austenitic stainless steel, has an annular shape and includes staple forming pockets. In other embodiments, the staple forming surface 212B can be produced from other metals, stainless steel, aluminum, sheet or plate.
[0089] The annular separation washer 214B is pressed into a cavity 222B of the anvil base surface 220B adjacent to the anvil base surface 220B. In other embodiments, the annular separating washer 214B can be fixed within cavity 222B of the anvil base surface 220B using different fixing mechanisms. The 214B annular separation washer is made from a plastic comprising ABS (Acrylonitrile-Butadiene-Styrene). In other embodiments, the annular separating washer 214B can be produced from different materials.
[0090] At the time of manufacture of the 112B anvil assembly, the staple forming surface 212B is prefabricated. The prefabricated staple forming surface 212B is then inserted into an injection mold. The mold is then used to form the anvil 210B within the molded cavity, causing the anvil 210B to be molded to the staple forming surface 212B. During the molding process, the anvil base surface 220B is formed and is molded to the staple forming surface 212B. At the same time, the anvil rod 218B, including the attachment portion of the anvil rod, is integrally molded to the base surface of the anvil 220B. The annular separating washer 214B is then pressed into the cavity 222B of the molded anvil base surface 220B. In other embodiments, the manufacturing process may vary.
[0091] As shown in figure 13, the engagement element 244 of the reciprocating anvil adjustment rod 114 is separably coupled within the proximal end channel 236B of the anvil stem 218B using a snap fit coupling which operationally couples anvil stem 218B from anvil 210B to the anvil control element via the anvil reciprocating adjustment rod 114. In other embodiments, the engaging element 244 of the anvil reciprocating adjustment rod 114 can be attached to the anvil stem anvil 218B using other fixation mechanisms. Expansion slots 240B allow the anvil stem 218B to expand during coupling with the engagement element 244 of the anvil reciprocating adjustment rod 114. After using the circular stapling instrument 100 on a patient, the anvil 210B can be discarded and a new anvil can be used with the circular stapling instrument 100 to perform another procedure on a different patient.
[0092] As shown in figures 12 and 13, the anvil rod 218B includes an alignment surface 246B formed at the time of molding the anvil 210B. The alignment surface 246B comprises at least one groove disposed parallel to a longitudinal geometric axis 248B of the anvil stem 218B. The alignment surface 246B extends from a top portion 250B of anvil stem 218B, along an outer annular surface 252B of anvil stem 218B, and stops at a middle portion 256B of anvil stem 218A without extending to the bottom portion 254B of the anvil stem 218A. In other embodiments, the alignment surface 246B can comprise any number or type of alignment surfaces in different configurations.
[0093] Figure 14 illustrates a flowchart 274 showing a modality of a method of manufacturing an anvil set. In step 276, a prefabricated staple forming surface, which can be produced from metal or other material, is arranged within a mold. In step 278, the anvil assembly is formed by molding an anvil onto the prefabricated staple-forming surface inside the mold, with the anvil being shaped to have an anvil stem extending from a surface of anvil base. The anvil can be shaped to be a part from a polymer such as nylon loaded with glass or carbon. In other embodiments, the anvil can be molded out of other materials. In one embodiment, step 278 may also include molding the anvil stem to have at least one alignment surface that comprises an alignment groove or other type of alignment surface. In another embodiment, step 278 may also include the molding of the anvil assembly, such that the anvil stem is molded on a prefabricated stem, which can be produced from metal or other materials, arranged inside the mold during step 276. In an additional embodiment, in a subsequent step, a prefabricated stem, which can be produced from metal or other materials, can be attached to the anvil stem of the molded anvil assembly after the anvil is molded. In step 280, a separating washer is fixed, using pressure fitting or other fixing mechanisms, to the anvil base surface of the molded anvil assembly. The separation washer can be annular or have another shape, it can be produced from a plastic that comprises ABS (Acrylonitrile-Butadiene-Styrene) or it can be produced from other types of materials. In other embodiments, one or more steps in the method may vary.
[0094] One or more modalities of the description can reduce one or more problems associated with previous anvil sets. For example, the use of one or more embodiments of the description can provide an anvil set that can be manufactured at a third of the cost of current anvil sets.
[0095] As shown in figures 1 to 3, the circular stapling instrument 100 includes cable 116, anvil reciprocating adjustment rod 114, staple discharge bar 282, support cover 284, stem assembly 106 coupled separable with cable 116, stapling cartridge assembly 108 and anvil assembly 112 that is separably coupled with the anvil reciprocating adjustment rod 114. Cable 116 forms a cavity 118 that receives the staple discharge bar 282 and the anvil reciprocating adjustment rod 114. The anvil reciprocating adjustment rod 114 has an engagement element 244 at one end 242 of the anvil reciprocating adjustment rod 114 and a threaded adjustment element 286 that is separably coupled to the anvil control element 120 at a proximal end of the anvil reciprocating adjustment rod 114.
[0096] The clamp discharge bar 282 is used to stabilize and secure the anvil reciprocating adjustment rod 114 inside the cable 116. The clamp discharge bar 282 forms a pair of coupling grooves 288 and 290 and has a engagement rod 292 at a distal end of the clip discharge bar 282. The engagement grooves 288 and 290 are preferably formed on opposite sides of the clip discharge bar 282. The trigger trigger 122 includes an upper end 294 which engages the coupling grooves 288 and 290 and securely holds the clip discharge bar 282 and the anvil reciprocating adjustment rod 114 inside the cavity 118 of the cable 116. Alternatively, the coupling grooves 288 and 290 can be replaced by any separable coupling as described in the present invention. Preferably, when the clip discharge bar 282 and the anvil reciprocating adjustment rod 114 are placed inside the cavity 118, the upper end portions 294 of the trigger trigger 122 each extend into one of the coupling grooves 288 and 290, separably securing the staple unloading bar 282 and the anvil reciprocating adjustment rod 114 in the cavity 118. By separably gripping both the staple unloading bar 282 and the reciprocating anvil adjustment 114 in cavity 118, the engagement grooves 288 and 290 and the upper end 294 of the trigger trigger 122 allow both the clamp discharge bar 282 and the anvil reciprocating adjustment rod 114 to be easily placed and removed cavity 118 allowing them to be easily repaired or replaced. The design of the cavity 118 and the characteristics of the components described above are such that they allow clear visualization by the user as they are placed in the correct location and orientation. This arrangement also prevents the user from incorrectly mounting the device.
[0097] The coupling rod 292 forms an opening 296 through which the tip 242 and the engaging element 244 of the reciprocating anvil adjustment rod 114 are received. Receiving the anvil reciprocating adjustment rod 114 through the opening 296 of the engagement rod 292 helps to center the anvil reciprocating adjustment rod 114 within the cable 116 and align the anvil reciprocating adjustment rod 114 within the cartridge assembly. stapling 108. Stapling cartridge assembly 108 (see figures 1 and 2) is separably coupled to a distal end of stem assembly 106 (see figure 3). The tip 242 of the engagement element 244 of the anvil reciprocating adjustment rod 114 extends into and through the compartment 110 (see figure 2) and couples separably to the channel of the proximal end 236 (see figure 2) of the stem metal 216 of the anvil assembly 112 using a snap fit coupling.
[0098] With reference to figure 3, the support cover 284 slides over the cable 116 and covers the clip discharge bar 282 and a portion of the anvil reciprocating adjustment rod 114 inside the cavity 118. Preferably, the cover of the anvil support 284 forms an opening 298 through which a threaded portion 132 of cable 116 is received. The opening 298 is preferably U-shaped and formed on a lower side 300 of the support cover 284, so that when the support cover 284 is slid over the cable 116, a leveling portion 302 of the support cover 284 is pressed against a portion of the handle 116, indicating that the support cover 284 is properly positioned over the clip discharge bar 282 and a portion of the reciprocating anvil adjustment rod 114 within the cavity 118. Allowing the support cover 284 slide over the handle 116, the support cover 284 protects both the staple discharge bar 282 and the anvil reciprocating rod 114 within the cavity 118 and allows them to be easily repaired or replaced.
[0099] The stem assembly 106 is separably coupled to the cable 116 at a proximal end and separably coupled to the stapling cartridge assembly 108 (see figure 1) at a distal end. For use in the present invention, the term separable refers to a first component or element that is designed to be loosened or disconnected without damage to another component or element. Additionally, for use in the present invention, the term separably coupled or separably attached refers to the coupling or gripping of a first element to a second element in such a way that the two elements are designed to be loosened or disconnected one the other without damage to the elements. This allows, in order to repair the two elements, a user to disconnect or release the two elements from each other without damage. Separable couplings may include a snap-fit coupling, a friction coupling that includes elements that frictionally engage one another, a threaded coupling, a magnetic coupling, or a mechanical coupling such as a hook and loop closure.
[00100] With reference to figure 3, preferably, the stem assembly 106 has the connection nut 130 with internal threads 304 which are separably coupled to the threaded portion 132 in the cable 116. Alternatively, the connection nut 130 can be replaced by any separable coupling as described in the present invention. Once separably coupled to cable 116, stem assembly 106 securely attaches holder cover 284 to cable 116 allowing the circular stapling instrument 100, and its components, such as stem assembly 106, the stem cover support 284, cable 116, staple discharge bar 282 and anvil reciprocating adjustment rod 114 are easily disassembled and repaired.
[00101] Through the separable coupling of the rod assembly 106 to the cable 116, through the separable gripping of both the clamp discharge bar 282 and the anvil reciprocating adjustment rod 114 in the cavity 118, allowing the cover of the support 284 slide over the cable 116, through the separable coupling of the anvil reciprocating adjustment rod 114 to the anvil control element 120, through the separably coupling of the stem assembly 106 to the cable 116 or through the coupling in an separable from the anvil assembly 112 (see figure 1) with the anvil reciprocating adjustment rod 114, the assembly and disassembly of the circular stapling instrument 100 becomes easier and allows the repair and maintenance of the various components with the stapling instrument circular 100.
[00102] With reference to figures 15A and 15B, in the assembly of the circular stapling instrument 100, the anvil control element 120 is separably coupled to the reciprocating adjustment rod of anvil 114. Preferably, the control element anvil 120 is separably coupled to the threaded adjustment element 286 at a proximal end of the anvil reciprocating adjustment rod 114 through the turning of the anvil control element 120 on the threaded adjustment element 286. Typically, the turning of the anvil anvil control element 120 counterclockwise opens the device and the clockwise turn closes the device.
[00103] Then, with reference to figures 16A and 16B, a portion of the anvil control element 120 and a portion of the reciprocating anvil adjustment rod 114 are separably secured within cavity 118 of cable 116. Preferably, the cavity 118 forms an indentation 306 that corresponds to a portion of the anvil control element 120, in order to securely attach the anvil control element 120 and the reciprocating anvil rod 114 within the cavity 118. Alternatively, the relationship indentation and protuberance can be reversed. Once the anvil reciprocating adjustment rod 114 is placed in cavity 118 at location 118A, the flat and parallel walls 114B and 114C (see figure 15B) that join in cavity 118 are connected in a way that prevents rotational movement of the anvil reciprocating adjustment rod 114 in relation to the handle while allowing longitudinal movement.
[00104] With reference to figures 17A, 17B and 17C, the tip 242 and the engagement element 244 of the anvil reciprocating adjustment rod 114 are received through the opening 296 of the engagement rod 292 of the clip discharge bar 282 and, then, the engagement grooves 288 and 290 of the clamp discharge bar 282 are placed on and then around the upper end 294 of the trigger trigger 122, separably securing the clamp discharge bar 282, the reciprocating adjustment of anvil 114 and the anvil control element 120 within the cavity 118.
[00105] With reference to figures 18A and 18B, the support cover 284 is then slid over the cable 116 and covers the clip discharge bar 282 and a portion of the anvil reciprocating adjustment rod 114 within the cavity 118. Preferably, the threaded portion 132 of the cable 116 is received through opening 298 in the support cover 284, and the support cover 284 is slid until the leveling portion 302 of the support cover 284 is pressed against a portion 132a of the cable 116, indicating that the support cover 284 is properly positioned.
[00106] With reference to figures 19A, 19B and 19C, the anvil reciprocating adjustment rod 114 is placed through and inside the stem assembly 106 and the stem assembly 106 is separably coupled to the handle 116. Preferably, the stem assembly 106 has the connecting nut 130 with internal threads 304 which are separably coupled to the threaded portion 132 on the cable 116. The stem assembly 106 separably holds the support cover 284 on the cable 116.
[00107] Then, with reference to figure 2, the stapling cartridge assembly 108 is separably coupled to the stem assembly 106, and the tip 242 of the anvil reciprocating adjustment rod 114 extends through a central axis formed in the stapling cartridge assembly 108. Finally, the anvil assembly 112 is separably coupled to the anvil reciprocating adjustment rod 114 through the engagement element 244 of the anvil reciprocating adjustment rod 114 and the proximal end channel 236 of the rod metal 216 of the anvil assembly 112.
[00108] With reference to figures 20 and 21, in one embodiment, a curved circular stapling instrument 100A is provided including a stapling cartridge assembly 108A that has a 110A compartment, an anvil assembly 112C attached to a curved adjustment rod anvil reciprocating mechanism 114A of an anvil opening mechanism, as discussed above, to prevent accidental removal of the anvil assembly 112C, a curved staple discharge bar 282A that is separably coupled to the flexible anvil adjustment rod 114A , a support cover 284A separably coupled to a cable 116A, a control element 120A separably coupled to the curved anvil reciprocating adjustment rod 114A via a threaded adjustment element 286A, and an ergonomic curved stem assembly 106A which has a connecting nut 130A separably coupled to the cable 116A through the threaded portion 132A. The curved circular stapling instrument 100A includes curved components, such as the 114A reciprocating flexible adjustment rod, the curved staple unloading bar 282A and the curved rod assembly 106A, to assist insertion into a body cavity. mammal.
[00109] Through the presence of components that are separably coupled to each other, the circular stapling instrument 100 or the curved circular stapling instrument 100A provides reusable stapling instrument that has an open architecture using a support cover 284 and 284A which has a U-shaped opening 298 and 298A that allows additional components, such as the anvil reciprocating adjustment rod 114 and 114A and stem assembly 106 and 106A, to be mounted in a mainly transverse direction. A cross-sectional assembly allows easy visualization for assembly and shortens the assembly time, improves the ease of assembly and disassembly. As a result, the amount of time required to assemble the circular stapling instrument 100 or the curved circular stapling instrument 100A that has the open assembly architecture is often less than one minute. Additionally, the open architecture allows the presence of characteristics that communicate where the components need to be placed. In addition, by supplying components that are separably coupled to each other, the circular stapling instrument 100 or 100A is easily assembled or disassembled, allowing cleaning and sterilization of the circular stapling instrument 100 or 100A after use.
[00110] With reference to figures 22 to 28, in one embodiment, a circular stapling instrument 100D is provided including a stapling cartridge assembly 108D that has a 110D compartment, an anvil assembly 112D attached to a reciprocating adjustment rod of anvil opening 114D of an anvil opening mechanism, as discussed above, to prevent accidental removal of the 112D anvil assembly, a 282D clip discharge bar that is separably coupled to the 114D anvil reciprocating adjustment rod, a support cover 284D attached to a 116D cable, a control element 120D attached to the anvil reciprocating adjustment rod 114D, and a rod assembly 106D that has a connecting nut 130D attached to the 116D cable through a threaded portion 132D. Preferably, the 100D circular stapling instrument is a curved circular stapling instrument, as seen with the 100D instrument, and includes curved components, such as a curved 114D anvil reciprocating adjustment rod, a 282D curved staple discharge bar. and an ergonomic curved rod assembly 106D, to assist insertion into a mammalian body cavity. However, the 100D circular stapling instrument does not have to be a curved circular stapling instrument, as seen with the 100D circular stapling instrument, and can be any type of circular stapling instrument, such as a relatively straight circular stapling instrument, as seen with the circular stapling instrument 100, and having relatively straight components, such as a relatively straight anvil reciprocating rod 114D, a relatively straight staple discharge bar 282D, and a relatively straight rod assembly 106D.
[00111] The anvil reciprocating adjustment rod 114D includes a first engagement element 244D on a tip 242D of the reciprocating anvil adjustment rod 114D and a threaded adjustment element 286D on a 402D base of the anvil reciprocating adjustment rod 114D. Preferably, the anvil reciprocating adjustment rod 114D includes a base 402D at one end, a latch element 244D at an opposite end and a flexible tension band 400D, which can be flexible and curved, connecting the base 402D to the 244D hitch. Referring to figures 22 and 23, the clip unloading bar 282D is movably connected at a first end 430D to a trigger trigger 122D and movably connected at a second end 432D to a stapling cartridge assembly 108D through of a second latch element 416D. Referring to Figure 28, the clip discharge bar 282D forms a first engagement surface 406D which faces a respective second engagement surface 408D formed on the anvil reciprocating adjustment rod 114D. Preferably, the tension band 400D forms the second engagement surface 408D which faces the first engagement surface 406D on the clip discharge bar 282D.
[00112] The circular stapling instrument 100D additionally includes a friction reduction element 420D located between the first and second engaging surfaces 406D and 408D in order to reduce the friction between the 114D anvil reciprocating adjustment rod and the discharge bar of 282D clamps. Movement between the anvil reciprocating adjustment rod 114D and the clamp discharge bar 282D occurs when the trigger trigger 122D is engaged by the cable 116D and fired, causing the clamp discharge bar 282D to move in and out. engage the 108D stapling and cartridge assembly and fire clips from the 108D stapling cartridge assembly. Movement between the anvil reciprocating adjustment rod 114D and the clip discharge bar 282D also occurs when the control element 120D is activated causing the reciprocating anvil adjustment rod 114D, and the anvil assembly 112D connected to the tip 242D of the anvil reciprocating adjustment rod 114D, move in or away from the stapling cartridge assembly 108D in order to adjust a distance between the stapling cartridge assembly 108D and the anvil assembly 112D. Movement between the anvil reciprocating adjustment rod 114D and the clamp discharge bar 282D causes the reciprocating anvil adjustment rod 114D to slide the clamp discharge bar 282D, and results in friction between the reciprocating bi-gorna adjustment 114D and the staple unloading bar 282D. The term sliding engaging for use in the present invention, refers to the movement of one surface on a second surface while maintaining smooth continuous contact between the two surfaces. The friction between the anvil reciprocating adjustment rod 114D and the staple discharge bar 282D on the curved circular stapling instrument 100D could typically be 20 to 40% higher over a relatively straight circular stapling instrument 100. In one embodiment, the configuration of the circular stapling instrument 100D causes the tension band 400D to exert a contact force on the staple discharge bar 282D, increasing the friction between the staple discharge bar 282D and the reciprocating adjustment rod of 114D anvil. By placing the frictional reduction element 420D between the first and second engaging surfaces 406D and 408D, the friction between the anvil reciprocating adjustment rod 114D and the clamp discharge bar 282D can be reduced. There are also other areas where the frictional forces between the clamp discharge bar 282D and the other portions of the 116D cable occur during firing of the instrument. These frictional forces are reduced by providing a predetermined angle over the grooved surfaces 288D and 290D of the clamp discharge bar 282D. As shown in figure 38B, the angular surface 288F can be oriented from 5 degrees to 15 degrees from the vertical position. This results in a 10 to 20% reduction in force to push the 282D clamp discharge bar.
[00113] The 420D friction reduction element can be in any mechanical device or chemical compound that can be used to reduce the friction between two elements, such as between the 114D anvil reciprocating adjustment rod and the 282D clamp discharge bar. In particular, the frictional reduction element 420D provides a reduced friction coefficient μreduced between two elements, which is less than a normal μnormal coefficient of friction present between the two elements, when the two elements are without the frictional reduction element. Preferably, the frictional reduction element 420D provides a reduced μreduced friction coefficient that is at least 20% less than, and more preferably, at least 40% less than the μnormal normal friction coefficient present between the two elements.
[00114] Chemical compounds for the 420D friction reduction element may include: solid coatings that include graphite or polymer coatings such as Teflon. Chemical compounds for the friction reducing element 420D can be applied as coatings that bond to one or the other or both the first and second engaging surfaces 406D and 408D. Chemical compounds for friction reduction element 420D can also be applied as coatings to freely move the intermediary components captured between the two engagement surfaces 406D and 408D. The mechanical devices used for the 420D friction reduction element include any mechanical devices that can reduce friction between a pair of surfaces, such as a ball bearing or roller bearing. The friction reduction element 420D can be connected to one or the other or both the anvil reciprocating adjustment rod 114D and the clamp discharge bar 282D. The 402D friction reduction element is designed so that it does not wear or degrade during cleaning and maintenance of the cable for reuse.
[00115] With reference to figures 25 to 27, in one embodiment, the frictional reduction element 420D includes a roller 404D which is connected to the clip discharge bar 282D using a pin 412D and which is arranged inside a 410D cavity formed in the staple discharge bar 282D. Preferably, the pin 412D is disposed within an orifice 414D formed through the clip discharge bar 282D. Preferably, more than one 404D roller is connected to the staple unloading bar 282D, like three 404D rollers. In one embodiment, hole 414D forms a circular opening through which pin 412D is arranged, as shown in figure 26, allowing little movement of pin 412D. In one embodiment, the orifice 414D forms an opening with a generally oval shape through which the pin 412D is arranged and can move laterally inside, as shown in figure 28, allowing greater lateral movement of the pin 412D or towards or away from either end 430D, 432D of the clip unloading bar 282D than the top / bottom movement of pin 412D which is not towards or away from either end 430D, 432D of the bar unloading clamps 282D, allowing an additional degree of freedom compared to the previous modality.
[00116] Figure 29 illustrates a perspective view of the annular blade 126 of the stapling cartridge assembly 108 of the circular stapling instrument 100 of figure 4. As shown in figure 29, the annular blade 126 comprises an annular cutting edge 192 and a separating washer fixing element 308. The annular blade 126, including the annular cutting edge 192 and the separating washer fixing element 308, is made of a metal such as stainless steel. In other embodiments, the annular blade 126 can be made of any material hard enough to cut. The separating washer fixing element 308 comprises a plurality of spaced separating washer retaining burrs extending from locations 310 of the annular blade 126 that are adjacent to the cutting edge 192. The separating washer fixing element 308 if extends inward at a non-parallel angle 312 to the cutting edge 192. The non-parallel angle 312 can vary from 56 to 60 degrees. In other embodiments, the non-parallel angle 312 can be in the range of 30 to 60 degrees. In still other embodiments, the separating washer fixing element 308 can vary in material, quantity, shape, size, location, direction or configuration with respect to annular blade 126. For example, in other embodiments, the washer fixing element separating element 308 may comprise a snap-fit, printing, or other type of fixing element.
[00117] Figure 6 illustrates the anvil base surface 220 of the anvil assembly 112 of the staple refill assembly 102 of the circular stapling instrument 100 being in an open position with respect to and separate from compartment 110, the actuator of staples 156 and the fixed annular blade 126 are in a retracted pre-firing position inside compartment 110. Annular separating washer 214 is pressure-adjusted inside cavity 222 of anvil base surface 220 of anvil 210. One protective element 314 is attached, using a hook 316, to a top portion 318 of annular separating washer 214 disposed within cavity 222 of anvil base surface 220.
[00118] Figure 30 shows a close view of the annular separation washer 214 attached to the protective element 314. The protective element 314 comprises an annular protective cover made of a red colored polycarbonate. In other embodiments, the protective element 314 can vary in material, shape, size, location, color, or configuration, and can be attached to the annular separating washer 214 using different fixing mechanisms. In still other embodiments, the protective element 314 may not be used and the annular separating washer 214 may be adjusted by pressure within the cavity 222 of the anvil base surface 220 without the protective element 314.
[00119] Figure 7 shows the anvil base surface 220 of the anvil assembly 112 that has been moved to a closed position relative to and adjacent to compartment 110 with the clip driver 156 and the annular blade fixed 126 still in the position of pre-trigger retracted inside compartment 110 spaced from annular separation washer 214. In this pre-trigger position, the flexible holding elements 178 of the clip driver 156 are separably connected to the holding projections 180 of compartment 110 with the connection preventing the clamp driver 156 from moving until a predetermined amount of force is applied. In other embodiments, the flexible holding elements 178 and the holding projections 180 may comprise varying types of corresponding elements.
[00120] Figure 31 illustrates the staple driver 156 and the fixed annular blade 126 that was triggered by the movement of the staple driver 156 in relation to compartment 110 from the pre-trigger position to the triggered position for which the the cutting edge 192 of the annular blade 126 moves and cuts the annular separating washer 214 while the anvil base surface 220 of the anvil assembly 112 is in the closed position. During firing, the flexible holding elements 178 of the staple driver 156 are released from the holding protrusions 180 of compartment 110, allowing the staple driver 156 to move past a certain point 320 in relation to compartment 110.
[00121] Figure 32 illustrates a close view of the cutting edge 192 of the annular blade 126 of figure 31 cutting the annular separation washer 214. The cutting edge 192 cuts a blanket 320, arranged between spaced walls 322 and 324, of the washer annular separating element 214. As a result, the separating washer fixing element 308 securely attaches to one of the spaced walls 322 of the annular separating washer 214 by locking the annular blade 126 to the annular separating washer 214 with the protecting element 314 (see figure 31) still attached to the top portion 318 (see figure 31) of the annular separation washer 214 disposed within the cavity 222 of the anvil base surface 220.
[00122] Figure 33 illustrates the anvil base surface 220 of the anvil assembly 112 that has been moved back to the open position away from compartment 110 after the clip driver 156 and the fixed annular blade 126 are fired by cutting the lock washer. annular separation 214. The annular separation washer 214 remains locked in place on the annular blade 126, due to the fixing element of the annular separation washer 308, with the protective element 314 still attached to the top portion 318 of the annular separation washer 214 acting as a protective barrier over the cutting edge 192 of the annular blade 126. The protective element 314 prevents the cutting edge 192 of the annular blade 126 from making an involuntary cut after the annular blade 126 has been fired. At least one of the annular separation washer 214 or the protective element 314 comprises a visual indicator 326 which indicates, as a preventive measure, that the clip driver 156 and the fixed annular blade 126 have been triggered. Visual indicator 326 comprises a first color that is different from a second color of compartment 110 of circular stapling apparatus 100. In other embodiments, visual indicator 326 may comprise any type of visual indicator that visually indicates when staple driver 156 and the annular blade fixed 126 were fired. In another embodiment, only the inner portion of the cut annular separation washer 214 and the visual indicator 326 remain attached to the annular blade 126. The outer portion of the cut annular separation washer 214 remains attached to the anvil base surface 220 after opening the instrument.
[00123] Figure 34 shows the anvil 210 of the anvil assembly 112 of figure 33 being removed from the circular stapling instrument 100, after the staple driver 156 and the fixed annular blade 126 are fired by cutting the annular separation washer 214, with the annular separating washer 214 and the protective element 314 remaining behind attached to the annular blade 126 due to the washer fixing element 308. The protective element 314 continues to prevent the cutting edge 192 of the annular blade 126 from making an involuntary cut after the actuator of clamps 156 and the fixed annular blade 126 to be fired. In addition, visual indicator 326 continues to indicate that staple driver 156 and fixed annular blade 126 have been triggered.
[00124] Figure 35 illustrates a new anvil 210C trying to attach to the circular stapling instrument 100 of figure 34. As shown in figure 36, the protective element 314, attached to the annular separation washer 214 which is attached to the fired annular blade 126 , prevents the new anvil 210C from being attached to the circular stapling instrument 100. As shown in figure 35, this is because the diameter 328 of the protective element 314 is greater than an inner diameter 330 of the new annular separating washer 332. Even if the protective element 314 was not attached to the annular separation washer 214, the annular separation washer 214 would still interfere with the attachment of the new anvil 210C to the circular stapling instrument 100 because the annular separation washer 214 has the same diameter or a larger diameter 334 than the inner diameter 330 of the new annular separating washer 332.
[00125] To use the circular stapling instrument 100 of figure 34 again, the staple refill assembly 102 shown in figures 1 to 2 can be removed from the circular stapling instrument 100, thereby removing the fired annular blade 126 and the fixed separation washer 214. After sterilizing the unremoved portion (such as cable 116 and other components not removed from figure 1) of the circular stapling instrument 100, another unused staple refill set, which comprises another unused annular blade used and another unused separating washer, can be attached to the sterile unremoved portion of the circular stapling instrument 100 prior to the use of the circular stapling instrument 100 again. Fig. 37 illustrates a flow chart of an embodiment of a method 340 of locking a blade to a separation washer of a circular stapling instrument. In step 342, a circular stapling instrument is provided. The supplied circular stapling instrument comprises a housing, a staple driver, an anvil assembly, and a blade. The clamp driver is movably arranged inside the compartment. The anvil assembly comprises a separating washer fixed to an anvil base surface. The blade is attached to the staple driver.
[00126] In step 344, the anvil assembly is moved from an open position away from the compartment to a closed position adjacent to the compartment. In step 346, the clamp actuator is moved from a pre-firing position, in which the blade has not cut the separation washer and in which a blade separation washer fastening element has not been attached to the separation washer, for a firing position in which the blade cuts the separation washer and the blade separation washer fixing element is fixedly attached to the separation washer. The separation washer fastening member may comprise at least one separation washer retaining burr that extends from the blade to a degree not parallel to a cutting edge of the blade. The non-parallel angle can be in a range of 56 to 60 degrees. In other modalities, the non-parallel angle can be in a range of 30 to 60 degrees. In still other embodiments, the separating washer fixing element may vary. In one embodiment, step 346 may comprise the blade cutting a blanket of the separation washer, and at least one separation washer retaining burr securely attached to one of the spaced walls of the separation washer.
[00127] In optional step 348, one or more of the following may occur: the separation washer may interfere with one or more components of the circular stapling instrument to prevent the blade from being retracted in the compartment to be used again; the separation washer, or a protective element attached to the separation washer, can act as a protective barrier on the blade; or a visual indicator of the separation washer, or another element attached to the separation washer, can visually indicate that the clamp driver has been triggered.
[00128] In optional step 350, the following steps can be followed: a staple refill assembly can be removed from the circular stapling instrument thereby removing the used blade and separation washer; a portion not removed from the circular stapling instrument can be sterilized; and an unused staple refill assembly may be attached to the circular stapling instrument, which comprises an unused blade and an unused separation washer, prior to the use of the circular stapling instrument again. In other embodiments, one or more steps of method 340 can be varied.
[00129] One or more modalities of the invention can result in any of the following: preventing a used blade from a triggered circular stapling instrument from being used inadvertently again in another procedure, thus improving cleanliness and safety; prevent a used blade from a fired circular stapling instrument from making an involuntary cut; avoid accidental firing of a circular stapling instrument; or other type of benefit.
[00130] Figures 38 to 46 illustrate several views of the circular stapling instrument 100 of the embodiment of figures 1 and 2 showing a locking mechanism 352, in various states, which can be used with any modalities of the invention to prevent accidental firing trigger trigger 122 and corresponding clamp trigger 156. Figures 38 to 40 illustrate various views of anvil assembly 112 arranged in an open position, outside a clamp discharge zone, away from compartment 110 with trigger trigger 122 and the staple driver 156 indirectly affected in a locked state in the pre-trigger position. When the anvil assembly 112 is disposed in the open position, outside the firing zone, away from compartment 110, using the fixed anvil reciprocating adjustment rod 114 and anvil control element 120, the base surface of anvil 220 is arranged at a distance of 354 in a range of 0.25 to 7.62 cm (0.100 to 3.0 inches) away from the end of the staple guide 148. In this pre-trigger position, a threaded end 286 of the anvil reciprocating adjustment rod 114 is disposed in and within an inner portion 358 of the threaded coupling rod 360 of the anvil control element 120, and is disposed separate from the end 362 of the threaded coupling rod 360 of the anvil control element anvil 120.
[00131] A projection 364 of the trigger trigger 122 is bordering against a first portion 366 of the anvil reciprocating adjustment rod 114 which acts as the locking mechanism 352 and blocks and prevents the trigger trigger 122 from rotating in the direction 124. One second portion 370 of the anvil adjustment reciprocating adjustment rod 114 is disposed separate from the projection 364. The projection 364 comprises opposite walls 372 and 374 which are arranged at a distance 376 of 0.48 cm (0.190 inches) from each other. The width 378 of the first portion 366 of the anvil reciprocating adjustment rod 114 is 0.74 cm (0.290 inches). The width 380 (see figure 43) of the second portion 370 of the anvil reciprocating adjustment rod 114 is 0.43 cm (0.170 inches). The trigger trigger 122 is prevented from rotating in the direction 124 due to the width 378 of the first portion 366 which is greater than the distance 376 between the opposite walls 372 and 374 of the projection 364.
[00132] The upper end 294 of the trigger trigger 122 corresponds to the engagement grooves 288 and 290 (see figure 3) of the clip discharge bar 282. The upper end 294 of the trigger trigger 122 comprises opposite surfaces 294A and 294B that are arranged at a distance of 382 from 1.46 cm (0.574 inches) apart. The distance 382 between the opposing surfaces 294A and 294B is greater than the width 378 of the first portion 366 allowing the opposite surfaces 294A and 294B to pass through the first portion 366 to the engagement grooves 288 and 290. The end 384 of the discharge bar clamps 282 are disposed separately from an end 386 of the clamp trigger 156. As a result of the first portion 366 of the anvil reciprocating adjustment rod 114 which prevents the trigger trigger 122 from rotating in direction 124, the end 384 of the discharge bar of clamps 282, which corresponds to trigger trigger 122, remain in a position disposed separately from end 386 of clamp trigger 156 keeping clamp trigger 156 in the pre-triggered locked state.
[00133] Figures 41 to 43 illustrate various views of the anvil assembly 112 disposed in a closed position, in the firing zone, adjacent to compartment 110 with the trigger trigger 122 and the staple trigger 156 indirectly affected in a state unlocked ready to fire, but it still remains in the same pre-firing positions as shown in figures 38 to 40. When the anvil set 112 is disposed in the closed position in the firing zone adjacent to compartment 110, using the fixed rod of reciprocal adjustment of anvil 114 and anvil control element 120, the anvil base surface 220 is arranged at a distance 388 in the range of 0.15 to 0.25 cm (0.06 to 0.100 inches) in the opposite direction to the end of the staple guide148. The anvil control element 120 has been rotated causing the threaded end 286 of the reciprocating anvil adjustment rod 114 to move in the direction 390 in the opposite direction to the inner portion 358 of the corresponding threaded shaft 360 of the anvil control element 120 in the direction and to the end 362 of the corresponding threaded shaft 360 of the anvil control element 120. As a result of this movement, the first portion 366 of the reciprocating anvil adjustment rod 114 was moved in the direction 390 to be disposed separately from the opposite walls 372 and 374 of the projection 364 so that the first portion 366 does not interfere with the projection 364. The second portion 370 of the reciprocating anvil adjustment rod 114 has also been moved in the direction 390 from a position separate from the projection 364 to a position disposed on the projection 364.
[00134] Due to the width 380 of the second portion 370 which is less than the distance 376 between the opposite walls 372 and 374 of the projection 364, the trigger trigger 122 can, at this moment, be released freely without being adjacent to the second adjacent portion 370 The opposite surfaces 294A and 294B of the upper end 294 of the trigger trigger 122 still correspond to the engagement grooves 288 and 290 (see figure 3) of the clip discharge bar 282. Because the trigger trigger 122 has not been turned in the direction 124 and, although it is unlocked, is still in the pre-trigger position, the trigger trigger 122 has not moved the corresponding clamp discharge bar 282 and the end 384 of the clamp discharge bar 282 is still disposed separately from the end 386 of the staple trigger 156 leaving the staple trigger 156 in its non-triggered position, but ready to be triggered.
[00135] Figures 44 to 46 illustrate several views of the anvil assembly 112 disposed in the closed position, in the firing range, adjacent to compartment 110 with the firing trigger 122 turned in direction 124 firing the firing trigger 122 and indirectly affecting the clamp trigger 156. trigger trigger 122 was allowed to fire due to the fact that the first portion 366 of the anvil reciprocating adjustment rod 114 was previously moved in direction 390 to be disposed separate from the projection 364 so that the first portion 366 does not interfere with projection 364, and the width 380 of the second portion 370 of the anvil reciprocating adjustment rod 114 is less than the distance 376 between the opposite walls 372 and 374 of the projection 364 that allowed the trigger trigger 122 to be fired without interference from the second portion 370.
[00136] During the firing of the trigger trigger 122, since the trigger trigger 122 was rotated in the direction 124, the opposing surfaces 294A and 294B of the upper end 294 of the trigger trigger 122 moved in the direction 392 which is contiguous to the corresponding coupling grooves 288 and 290 (see figure 3) of the clamp discharge bar 282 forcing the clamp discharge bar 282 so that it also moves in the direction 392. This movement forced the end 384 of the clamp discharge bar 282 against the 386 end of the staple trigger 156 forcing the staple trigger 156 to also fire and move in direction 392. During this triggering of the staple trigger 156, the movement of the staple trigger 156 ejects the staples 104 (see figures 7 and 31) out of the ring clamp retainer 148 (see figures 4 to 5, 7 and 31) and cuts fabric with the ring blade 126 (see figure 31) attached to the clamp driver 156 as discussed earlier.
[00137] In such a way, the locking mechanism 352 automatically prevents the wrong triggering of the trigger trigger 122 and the corresponding clamp trigger 156 and clamps 104 (see figures 7 and 31) without a user of the circular stapling instrument 100 has to manually deploy a locking mechanism. In addition, the locking mechanism 352 automatically locks the trigger trigger 122 and the corresponding clamp trigger 156 and clamps 104 (see figures 7 and 31) in the pre-trigger position whenever the anvil assembly 112 is in the open position, and automatically unlatches the trigger trigger 122 and the corresponding clamp trigger 156 and clamps 104 (see figures 7 and 31) whenever the anvil set 112 is in the closed position. The locking mechanism 352 works in this way regardless of the number of times the anvil assembly 112 has been opened and closed, and regardless of whether the trigger trigger 122 and corresponding clamp trigger 156 and clamps 104 (see figures 7 and 31) have been fired.
[00138] Figure 47A shows another modality of the circular stapling instrument of figure 1 that has another locking mechanism 352A that prevents movement of the staple driver 156 when the staple refill assembly 108 (see figure 2) is mounted to cable 116 (see figure 2) and anvil 210 is in the open position. In this condition with the anvil 210 in the open position, the portion 114E of the reciprocating anvil adjustment rod 114 adjacent to the flexible holding elements 178 has a size, width or diameter 401 (see figure 3B) which is less than, but close enough the width or diameter 196A of the orifice 196 of the annular inner rod 194 of the clamp actuator 156 preventing the flexible holding elements 178 from having a sufficient distance 400 between the anvil shank 114E portion 114 and the inner orifice surface 196B , to deflect and disengage from the detent protrusions 180, thus preventing, in turn, movement and firing of the clip driver 156. As shown in figure 47B, when the anvil 210 is close to the closed position, the most narrow 114F of the anvil reciprocating adjustment rod 114 adjacent to the flexible detent elements 178 has a size, width or diameter 402 (see figure 3A) that is less than the width or diameter 196A of the orifice 196 of the annular inner rod 194 of the staple driver 156 a in order to allow the flexible holding elements 178 to have a sufficient distance 400 between the anvil shank 114F portion 114 and the inner orifice surface 196B to deflect - remove and disengage from the detent projections 180, thus allowing, in turn, the movement and firing of the clip driver 156.
[00139] The summary is provided in order to allow the reader to quickly determine the nature of the technical presentation. It is presented with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Furthermore, in the detailed description previously mentioned, it can be noted that several characteristics are grouped in various modalities for the purpose of rationalizing the invention. This method of the invention should not be interpreted as reflecting an intention that the claimed modalities require more characteristics than expressly referred to in each claim. On the contrary, as the following claims reflect, the inventive material rests on fewer characteristics than all the characteristics of a single presented modality. In this way, the following claims are hereby incorporated into the detailed description, each claim being independent in its own right as a separately claimed inventive material. Although various embodiments of the invention have been described, it will become apparent to those skilled in the art that other embodiments and implementations are possible within the scope of the invention. Accordingly, the invention should not be restricted, except in the light of the appended claims and their equivalents.

权利要求:
Claims (8)
[0001]
1. Stapling cartridge assembly (108) for use in a circular stapling instrument (100) having an anvil assembly comprising an annular safety washer attached to a base surface of the anvil, the annular safety washer comprising a pair of spaced walls and a web extending between them, the stapling cartridge comprising: a compartment (110); a clamp driver (156) receivable within the compartment and configured to move within the compartment from a pre-actuated position to an actuated position; and an annular blade (126) attachable to the staple driver, wherein the annular blade comprises an annular cutting edge (192) for cutting the weft of the annular burst washer when the staple driver is moved from the pre-triggered position to the triggered position; characterized by the fact that the annular blade comprises a fixing element for the safety washer (308) comprising at least one retaining bar of the safety washer that extends from the annular blade at an angle not parallel to the cutting edge to fix the fixture securely. one of the spaced walls of the annular safety washer when the clamp actuator is moved from the pre-triggered position to the triggered position, thereby locking the annular blade in the annular safety washer.
[0002]
2. Stapling cartridge assembly, according to claim 1, characterized by the fact that the non-parallel angle varies from 30 to 60 degrees.
[0003]
Stapling cartridge assembly according to claim 1 or 2, characterized in that at least one separating washer retaining bar extends from the annular blade at a location adjacent to the annular cutting edge.
[0004]
4. Circular stapling instrument comprising: the stapling cartridge assembly as defined in any one of claims 1 to 3, characterized by the fact that the staple driver is disposed within the compartment and movable within the compartment, from a pre- fired to a fired position, and the blade is attached to the clamp driver; and the anvil assembly, comprising the annular rupture washer attached to a base surface of the anvil, wherein the anvil assembly is movable from an open position away from the compartment to a closed position adjacent to the compartment; and where when the staple driver is in the pre-firing position, the ring of the annular rupture washer is not cut by the annular blade and the fixing member of the rupture washer is not fixed to one of the spaced walls of the rupture washer annular, and when the staple driver is in the actuated position and the anvil assembly is in the closed position, the annular blade cuts the weft of the annular safety washer and the fixing member of the safety washer is firmly fixed to the spaced walls separated from the cutting annular safety washer, thereby locking the annular blade to the annular safety washer.
[0005]
5. Circular stapling instrument (100) comprising: a compartment (110); a clamp driver (156) disposed within the compartment and movable within the compartment from a pre-triggered position to a triggered position; an anvil assembly (112) comprising an annular rupture washer (214) attached to a base surface of the anvil, wherein the anvil assembly is movable from an open position away from the casing to a closed position adjacent to the casing, the washer annular rupture comprising a pair of spaced walls (322,324) and a web (320) extending between them; and an annular blade (126) attached to the clamp actuator, characterized in that the annular blade comprises a separating washer fixing member (308) comprising at least one separable washer retaining bar extending from the annular blade at an angle not parallel to a cutting edge (192) of the annular blade, where when the staple driver is in the pre-trigger position, the annular safety washer web is not cut by the annular blade and the clamping member the safety washer is not attached to one of the spaced walls of the annular safety washer, and when the staple driver is in the triggered position and the anvil assembly is in the closed position, the annular blade cuts the weft of the annular safety washer and the fixing member of the safety washer is firmly fixed to one of the spaced walls of the cut annular safety washer, thus blocking the annular blade to the annular safety washer.
[0006]
6. Circular stapling instrument according to claim 4 or 5, characterized by the fact that the annular rupture washer comprises, or is attached to, another member, which comprises a visual indicator that visually indicates that the staple driver has been triggered .
[0007]
7. Circular stapling instrument according to claim 6, characterized in that the visual indicator comprises a first color that is different from a second color of the circular stapling instrument case.
[0008]
8. Circular stapling instrument according to any one of claims 4 to 7, characterized by the fact that the annular safety washer is attached to a protection member that acts as a protective barrier on the blade when the fixation member of the annular safety washer is fixedly attached to the safety washer.

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同族专利:

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公开号 | 公开日

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US20120292371A1|2012-11-22|

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JP2012239907A|2012-12-10|

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CN102783981A|2012-11-21|

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PL2524655T3|2017-01-31|

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AU2012202753A1|2012-12-06|

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CA2777150A1|2012-11-19|

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JP6067243B2|2017-01-25|

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EP2524655B1|2016-06-29|

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BR102012001794A2|2013-06-18|

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AU2012202753B2|2013-09-26|

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CN102783981B|2016-03-30|

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RU2012112049A|2013-10-10|

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EP2524655A1|2012-11-21|

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US8573464B2|2013-11-05|

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CA2777150C|2019-03-05|

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法律状态:
2013-06-18| B03A| Publication of a patent application or of a certificate of addition of invention [chapter 3.1 patent gazette]|

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2018-12-18| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2019-09-17| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2020-12-01| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2021-02-02| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 26/01/2012, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US13/111,702|US8573464B2|2011-05-19|2011-05-19|Circular stapling instrument having a breakaway washer attachment member|

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US13/111,702|2011-05-19|

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