 introducer
专利摘要:
CIRCULAR STAPLER INTRODUCER WITH HARD COVER SET CONFIGURED FOR EASY REMOVAL. These are introductors to introduce a circular surgical stapler to a patient. Various embodiments comprise a flexible hollow sheath that has a distal end and an open proximal end that is sized to receive a stapling head portion of the circular stapler thereon. A rigid cover assembly can be configured to move selectively between a closed position where a distal face of the stapling head is covered and an open position where the distal face of the stapling head is exposed. A portion of the rigid cover assembly has a shape that substantially corresponds with a perimeter shape of a staple head portion to allow proximal passage of the rigid cover assembly through the staple head when the introducer is removed from the patient. 公开号:BR112012012047B1 申请号:R112012012047-6 申请日:2010-11-17 公开日:2020-11-17 发明作者:Chester O. Baxter, Iii；John V. Hunt；Danius P. Silkaitis；Jeffrey P. Wiley；Paul T. Franer；John B. Schulte；Daniel J. Abbott 申请人:Ethicon Endo-Surgery, Inc； IPC主号:
专利说明:
FIELD OF THE INVENTION [0001] The present invention relates, in general, to surgical staplers and, more particularly, to devices and methods for introducing a circular stapling device into a patient's colon. BACKGROUND OF THE INVENTION [0002] In certain types of surgical procedures, the use of surgical staples has become the preferred method for joining tissues and, for this reason, specially configured surgical staplers have been developed for these applications. For example, intraluminal or circular staples have been developed for use in surgical procedures involving the lower colon and sections of the lower colon are joined after a diseased portion has been excised. Circular staplers useful for carrying out such procedures are presented, for example, in US Patent Nos. 5,104,025, 5,205,459, 5,285,945 and 5,309,927, each of which is incorporated herein by way of reference, in their respective totalities. [0003] In general, a conventional circular stapler typically consists of an elongated rod that has a proximal drive mechanism and a distal stapling mechanism mounted on the elongated rod. The distal stapling mechanism commonly consists of a fixed stapling cartridge that contains a plurality of staples configured in a concentric circular assembly. A scalpel for round cutting is mounted inside the cartridge, concentrically in relation to the clamps, to obtain an axial path inside it. Extending axially from the center of the cartridge is a movable trocar shaft, adapted to have a staple anvil attached to it in a removable manner. The anvil is configured to form the ends of the clamps as they are guided to it. The distance between a distal face of the staple cartridge and the staple anvil is commonly controlled by an adjustment mechanism that is mounted on the proximal end of the staple rod to control the axial movement of the trocar. The tissues that are clamped between the staple cartridge and the staple anvil are simultaneously stapled and cut when the trigger mechanism is activated by the surgeon. [0004] When performing a lower colon procedure using a circular stapler, the intestine is typically stapled using a conventional surgical stapler, with double rows of staples being placed on either side of the diseased intestine portion a be removed. The target portion is simultaneously cut as the contiguous end is stapled. After removing the diseased portion, the surgeon typically inserts the anvil into the proximal end of the lumen, next to the stapling line. This is done by inserting the anvil head in an entrance door cut by the surgeon in the proximal lumen. In certain cases, the anvil can be positioned transanal, by placing the anvil head on the distal end of the stapler, and inserting the instrument through the rectum. The surgeon then ties the proximal end of the intestine to the anvil stem using a suture or other conventional lashing device. Then, the surgeon cuts the excess tissue adjacent to the tie and attaches the anvil to the stapler's trocar shaft. The surgeon then closes the gap between the anvil and the cartridge, thus pinching the proximal and distal ends of the intestine in the gap. Then, the surgeon activates the stapler, causing several rows of staples to be conducted through both ends of the intestine and formed, in order to join the ends and form a tubular path. Simultaneously, as the staples are conducted and formed, the concentric circular blade of the scalpel is guided through the ends of the intestinal tissue, cutting the ends adjacent to the internal row of staples. The surgeon then removes the stapler from the intestine and the procedure is complete. [0005] During such lower colon procedures, it may be difficult to insert the surgical stapler through the anus and beyond the transverse folds in the rectal wall that project into the colon, which are commonly called the "Houston Valves" and subsequently manipulated to the desired area. This problem is exacerbated when the stapler must be inserted without the anvil in position. In particular, the anterior or distal end of most circular staples comprises a relatively abrupt circular shaped member designed to support a circular staple cartridge. Such a blunt / abrupt shape makes it difficult to advance the front end of the stapler beyond the Houston Valves and other fabric. [0006] Thus, there is a need for devices and methods to easily insert a surgical stapler through a patient's anus into the lower colon or other areas within the patient. [0007] The previously mentioned discussion is only intended to illustrate some of the disadvantages present in the field of the invention at the moment, and should not be taken as a denial of the scope of the embodiments. SUMMARY [0008] In connection with a general aspect of the present invention, an introducer is provided for introducing a circular surgical stapler that has a cable portion, an elongated rod that protrudes from the cable assembly, a stapling head that is coupled to the elongated rod, and an anvil removably attached to a patient. In conjunction with various embodiments, the introducer comprises a flexible hollow sheath that has a distal end and an open proximal end. The hollow flexible sheath can be sized to receive the stapling head and at least a portion of the stem elongated therein. A rigid cover assembly can be attached to the distal end of the flexible hollow sheath. A rigid cover assembly can be configured to move selectively between a closed position where a distal face of the stapling head is covered by the rigid cover assembly when the stapling head has been inserted into it to a full insertion position, and an open position in which the cover assembly can be removed proximally from around the stapling head and the elongated stem. The lid assembly may have a portion that is shaped compatible with the shape of a corresponding portion of the staple head to allow the rigid lid assembly to pass beyond the staple head when it is removed from it. [0009] In connection with another general aspect of the present invention, an introducer is provided to introduce a circular surgical stapler that has a handle portion, an elongated stem that protrudes from the handle portion, a stapling head that is attached to the elongated rod, and an anvil removably attached to a patient. In conjunction with various embodiments, the introducer comprises a flexible hollow sheath that has a distal end and an open proximal end. The hollow flexible sheath can be sized to receive the stapling head and at least a portion of the stem elongated therein. A radially openable cylinder element can be attached to a distal end of said flexible hollow sheath which defines an opening for receiving the stapling head thereon. A locking member can be oriented in engagement with a pair of opposite ends of the radially openable cylinder element. The locking member can be selectively movable from a locked position with the locking member engaging the opposite ends of the cylinder element and from an unlocked position, the opposite ends being able to move radially away from each other. A rigid cover element can be foldably attached to the radially openable cylinder element and can be moved between a closed position, the rigid cover element being retained in a closed position that covers a distal end of the opening of the cylinder element , and an open position, the rigid lid element being movable to a position that exposes the one at the distal end of the opening. The rigid cover member may have a bottom side that is shaped that is compatible with a perimeter shape of a corresponding portion of the stapling head to allow the rigid cover element to pass beyond the staple head when it is removed from it . BRIEF DESCRIPTION OF THE FIGURES [00010] The attached drawings, which are incorporated into this specification and form part of it, illustrate modalities of the invention and, together with the general description provided above and the detailed description of the modalities provided below, serve to explain the principles of present invention. [00011] Figure 1 is a perspective view of a surgical circular stapling instrument; [00012] Figure 2 is another perspective view of the surgical circular stapling instrument of Figure 1 before installing an embodiment of the introducer of the present invention in it; [00013] Figure 3 is a side elevation view of an embodiment of the introducer of the present invention; [00014] Figure 4 is a top view of the introducer of Figure 2; [00015] Figure 5 is a top view of the introducer of Figures 3 and 4; [00016] Figure 6 is another view from the top of the introducer of Figures 2 to 5 with the cover panel removed from the cable assembly; [00017] Figure 7 is a partial perspective view of an embodiment of the introducer of the present invention installed in a circular stapling instrument; [00018] Figure 8 is a partial side elevation view of the introducer and circular stapler of Figure 7; [00019] Figure 9 is a view of the partial upper part of the introducer and circular stapler of Figures 7 and 8; [00020] Figure 10 is an elevation view of an embodiment of the cover assembly of the present invention; [00021] Figure 11 is another elevation view of the cover assembly of Figure 10 with the release latch removed from it; [00022] Figure 12 is a perspective view of the cover assembly of Figures 8 to 11 with the release latch removed from it and the cover disengaged from the cylinder assembly; [00023] Figure 13 is a cross-sectional view of a cover assembly embodiment of the present invention with the cover engaged with the cylinder assembly; [00024] Figure 14 is a partial side elevation view of a portion of a circular stapler and a cover of an introducer embodiment of the present invention; [00025] Figure 14A is another partial elevation side view of the circular stapler and cover with the cover sliding off the perimeter of the stapling head portion of the circular stapler; [00026] Figure 15 is a top view of an embodiment of the lid assembly of the present invention with the lid in an open position; [00027] Figure 16 is another view from the top of the cover assembly mode of Figure 15 with a line illustrating a low profile cover mode; [00028] Figure 18 is a top perspective view of a cover assembly embodiment of the present invention; [00029] Figure 19 is a bottom view of the cover assembly of Figure 18; [00030] Figure 20 is a top perspective view of another embodiment of the lid assembly of the present invention; [00031] Figure 21 is a bottom view of the cover assembly of Figure 20; [00032] Figure 22 is a perspective view of a surgical circular stapling instrument before installing another embodiment of the introducer of the present invention therein; [00033] Figure 23 is a perspective view of a surgical circular stapling instrument before installing another embodiment of the introducer of the present invention in it; [00034] Figure 24 is an exploded elevation view illustrating another embodiment of the present invention prior to installation in a stapling head portion of a circular stapler; [00035] Figure 25 is a cross-sectional view of the introducer of Figure 24 installed on the stapling head of a circular stapler; [00036] Figure 26 is a distal end view of an introducer embodiment of the present invention; [00037] Figure 27 is a distal end view of another embodiment of the present invention; [00038] Figure 28 is a distal end view of another embodiment of the present invention; [00039] Figure 29 is a cross-sectional view of another embodiment of the introducer of the present invention installed in a stapling head of a circular stapler; [00040] Figure 30 is a side elevation view of another embodiment of the introducer of the present invention in a closed position; [00041] Figure 31 is another side elevation view of the introducer of Figure 31; [00042] Figure 32 is another side elevation view of the introducer of Figures 30 and 31 in a closed position; [00043] Figure 33 is a view of the distal end of another embodiment of the introducer of the present invention attached to the stapling head of a circular stapler; [00044] Figure 34 is a side elevation view of another embodiment of the introducer of the present invention attached to the stapling head of a circular stapler with the trocar portion of the circular stapler in an extended position; [00045] Figure 35 is a view of the distal end of another embodiment of the introducer of the present invention attached to the stapling head of a circular stapler; [00046] Figure 36 is a side elevation view of another embodiment of the introducer of the present invention attached to the stapling head of a circular stapler with the trocar portion of the circular stapler in an extended position; [00047] Figure 37 is another side elevation view of the introducer and stapling head of Figure 36 with the trocar portion of the circular stapler in a retracted position; [00048] Figure 38 is a side elevation view of another embodiment of the introducer of the present invention attached to the stapling head of a circular stapler; [00049] Figure 39 is a partial perspective view of another embodiment of the introducer of the present invention attached to the stapling head of a circular stapler; [00050] Figure 40 is another partial perspective view of the modality of the introducer of Figure 39 being unrolled from the stapling head of the circular stapler; [00051] Figure 41 is a partial perspective view of another embodiment of the introducer of the present invention attached to the stapling head of a circular stapler; [00052] Figure 42 is a partial perspective view of another embodiment of the introducer of the present invention attached to the stapling head of a circular stapler; [00053] Figure 43 is another partial perspective view of the introducer of Figure 42 being removed proximally from the stapling head of the circular stapler; [00054] Figure 44 is a partial perspective view of another embodiment of the introducer of the present invention attached to the stapling head of a circular stapler; [00055] Figure 45 is another partial perspective view of the modality of the introducer of Figure 44 being that a movement of release was initially applied to it; and [00056] Figure 46 is another partial perspective view of the introducer of Figures 44 and 45 that illustrate additional applications of the release movement therein. DETAILED DESCRIPTION [00057] The Applicant for the present application also holds the US patent applications identified below which were filed on the same date as the present application and which are each incorporated herein by reference in full, respectively: [00058] U.S. Patent Application Serial No., entitled "DEVICES AND METHODS FOR INTRODUCING A SURGICAL CIRCULAR STAPLING INSTRUMENT INTO A PATIENT", attorney's summary number END6320USNP / 090234; [00059] U.S. Patent Application Serial No., entitled "CIRCULAR STAPLER INTRODUCER WITH RADIALLY-OPENABLE DISTAL END PORTION", attorney's summary number END6616USNP / 090246; [00060] U.S. patent application serial number, entitled "CIRCULAR STAPLER INTRODUCER WITH RIGID DISTAL END PORTION", attorney's summary number END6617USNP / 090247; and [00061] U.S. Patent Application Serial No., entitled "CIRCULAR STAPLER INTRODUCER WITH MULTI-LUMEN SHEATH", Attorney Summary No. END6618USNP / 090233. [00062] Certain exemplary modalities will now be described to provide a general understanding of the principles of structure, function, manufacture and use of the devices and methods described here. One or more examples of such modalities are illustrated in the attached drawings. Those of ordinary skill in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are exemplary non-limiting modalities, and that the scope of the various modalities of the present invention is defined only by the embodiments. The aspects illustrated or described in connection with an exemplary modality can be combined with the aspects of other modalities. These modifications and variations are intended to be included in the scope of the present invention. [00063] The terms "proximal" and "distal" are used in the present invention with reference to a clinician manipulating the handle portion of the surgical instrument. The term "proximal" refers to the portion closest to the clinician, and the term "distal" refers to the portion located farthest from the clinician. It will also be understood that, for the sake of convenience and clarity, spatial terms such as "vertical", "horizontal", "up" and "down" can be used in the present invention with respect to the drawings. However, surgical instruments can be used in many orientations and positions, and these terms are not intended to be limiting and absolute. [00064] Figure 1 illustrates a conventional circular stapler 10. The construction and operation of such circular staples are well known in the art. Thus, the specific components and features of such a circular stapler will not be discussed in detail in this document beyond what may be necessary to understand the construction and operation of the various embodiments of the present invention. As the present Detailed Description proceeds, those of ordinary skill in the art will understand that the various embodiments of the present invention can be effectively employed with a variety of different circular stapler configurations without deviating from the character and scope of the present invention. Accordingly, the scope of protection provided to the various embodiments of the present invention should not be otherwise limited for use with the exemplary circular stapler shown in this document. [00065] As can be seen in Figure 1, a conventional circular stapler 10 generally includes a portion of cable 12 that has an elongated stem 14 projecting from it. A stapling head 16 is coupled to the distal end 15 of the elongated stem 14 and is configured to operationally support a staple cartridge 17 and movable knife assembly (not shown) thereon. The circular stapler 10 additionally includes an anvil 20 that has an anvil body 22. Anvil 20 has an anvil stem 24 that is configured to be removably attached to a trocar (not shown) that is movably supported within the elongated rod 14 of the circular stapler 10. Movement of the trocar is achieved by rotating an adjustment knob 18 which is located at the proximal end of the cable portion 12. An indicator panel 19 can be provided on the cable portion 12 to provide the user with an indication of the position of the body portion 22 of the anvil 20 in relation to the staple cartridge 17. Thus, when the anvil stem 24 is attached to the movable trocar, the position of the anvil body 22 in relation to the staple cartridge 17 on the staple head assembly 16 can be adjusted by turning the adjusting knob 18. The staple head 16 additionally supports a staple trigger assembly (not shown), the operation of which is controlled from through a trigger assembly 26 in the cable portion 12. Further details regarding the operation and assembly of the exemplary circular stapler 10, for example, can be gleaned from the reference to US patent application serial number 12 / 408,905, filed on March 23, 2009, entitled "Circular Surgical Stapling Instrument With Anvil Locking System" with John P. Measamer, whose disclosure is hereby incorporated by reference, in its entirety. [00066] Figures 2 to 6 illustrate a circular stapler introducer 100 of the present invention that can be used in conjunction with a circular stapler 10. In various embodiments, the introducer 100 comprises an elongated hollow flexible sheath 110 that can be manufactured from of, for example, a plastic material such as polyurethane, polyester, polyethylene or polypropylene blends that have a thickness of 0.102 to 0.381 mm (0.004 to 0.015 inches) and forms a first lumen 29 sized to be readily inserted in relation to the elongated stem 14 of a circular stapler 10. Sheath 110 has a distal end 114 and an open proximal end 112 as well as an upper portion generally referred to as 111 and a lower portion 113. See Figure 3. A cable assembly 130 can be attached to the open proximal end 112 using, for example, adhesive or ultrasonic welding, radio frequency (RF) welding or hot mounting. A distal end 114 of the sheath 110 can be attached to a rigid cover assembly 130 by means of adhesive welding or by ultrasonic welding, radio frequency (RF) welding or heat mounting. In various embodiments, a "weakened region" in the form of, for example, a perforated junction line 116 may extend along the lower portion 113 of the sheath 110 from the open proximal end 112 to the distal end 114. In addition , a second lumen 120 can be formed on the wall of the sheath 110 and extends from the open proximal end 112 to the distal end 114. In particular, the second lumen 120 can extend helically from the upper portion 111 of the end proximal 112 to the lower portion 113 at the distal end 114. The second lumen 120 can accommodate a release member 122 which extends from the cable assembly 130 to a lock member 140 that is movably supported at an end portion distal second lumen 120. In various embodiments, the release member 122 may comprise, for example, a suture. In other embodiments, the release member 122 may comprise a relatively thin flexible bar or similar member to transmit a release movement to the lock member 140 attached thereto. The second lumen 120 can be formed on the wall of the sheath 110 by, for example, sewing, ultrasonic welding, radio frequency (RF) welding, hot mounting, etc. Release member 122 and lock member 140 can collectively form a release arrangement, generally referred to as 121. See Figure 10. [00067] Figures 10 to 19 illustrate a rigid cover assembly 150 that can be used in conjunction with various embodiments of the present invention. The rigid cover assembly 150 may have a cylinder member 152 that is attached to the distal end 114 of the sheath 110. The cylinder member 152 comprises a partial ring-like member that has two opposite ends 154, 156. A cover member rigid 160 is "hingedly attached" to the cylinder member 152 via a string 162. See Figure 17. In various embodiments, the rigid cover assembly 150 is manufactured as a single injection molded part that has significantly different physical properties . In various embodiments, for example, the rigid cover assembly 150 can be injection molded from polyurethane, polyester, polyethylene or polypropylene blends. [00068] As will be discussed in more detail below, cover member 160 is made rigid by increasing its area in cross section while cord 162 and cylinder member 152 are preferably designed to allow significant deflection in directions specific to the reduce their respective cross sections. The cap member 160 has a relatively blunt distal surface 164 that is substantially smooth to minimize the force required to insert the introducer 100 and the portions of the circular stapler 10 housed therein through the patient's sphincter, as well as to facilitate navigation of the device through the Houston Valves and another anatomy. The lower side 166 of the cover member 160 may have a series of reinforcement ribs 168 formed thereon to increase its cross-sectional area and make the cover member 160 substantially rigid. See Figures 13 and 19. [00069] In various embodiments, the bottom side 166 of the cover member has a shape that is substantially compatible with the shape of a portion of the perimeter of the stapling head 16. More specifically and as can be seen in Figure 13, the bottom side 166, which is formed by reinforcement ribs 168, has an arcuate shape that is compatible with a portion of the circular perimeter shape of the stapling head 16 of the circular stapler 10. As can be seen further in Figure 14, the cover member 160 has sides 170, 172 where each has a cut-out wall portion 174 that corresponds to the arcuate bottom side 166. Such an arcuate bottom side 166 and cut-out wall portions 174 enable the cover assembly 150 to pass proximally out of the stapling head 16 when it is removed proximally in relation to the circular stapler 10 to thereby reduce the radial distension of the intestines when the cap assembly 150 passes over the head clip 16 of circular stapler 10. For example, Figure 16 provides a comparison between a cover assembly 150 without arched underside 166 (represented by dotted line 180) and cover assembly 150 with an arched underside 166. As illustrated , during an exemplary modality, the lid assembly without the arched underside has an upper of 0.56 cm (0.22 ") and would therefore further distend the intestine as it is removed proximally in relation to the head stapling 16. [00070] In various embodiments, the cord 162 can be designed to be longer than the distance required to connect the cap member 160 to the cylinder member 152 in the closed position (Figure 10). That is, the cord 162 may rewind within the lid assembly 150 when the rigid lid portion 160 is retained in the closed position. Such an arrangement allows the cover member 160 to follow a substantially curved path while passing over the corner of the stapling head 16 of the stapler 10 and moving independently from the cylinder member 152 during removal. See Figures 14 and 14A. In one embodiment, cord 162 is diametrically opposite the location with lock member 140 engaging opposite ends 154, 156 of cylinder member 152. See Figures 18 and 19. In an alternative embodiment, cord 162 is located at 90 degrees of lock member 140. See Figures 20 and 21. [00071] Various modalities of the lid assembly 150 employ features that work together to ensure that the lid member 160 does not open during the insertion process while retaining the ability to be easily opened and removed at the appropriate time. For example, as can be seen in Figure 13, various embodiments of the cover assembly 150 may include an inwardly extending retainer flange 190 that is formed in portions of the cylinder member 152. The retainer flange 190 can be positioned to engage retaining shape corresponding retaining ribs 167 formed at the lower edge of the cover member 160. As can be seen in Figure 13, a series of interlinings 194 can be formed with the retaining flange 190 to further stabilize and stiffen the retaining flange 190. Several lid member embodiments can include at least one retaining rib on the lid member 160 to retain the lid member 160 in a closed position with the lid member 160 covering the distal face 25 of the stapling head 16 ( Figure 10). In various embodiments, a series of three ribs 200, 202, 204 can be formed in the two portions of the cap member 160 that are between the cord 162 and the arched indented portions 174. The two outer ribs 200, 202, 204 can be provided of chamfered outlet portions 206. See Figure 12. Such chamfered outlet portions 206 are interfaced with the retaining flange 190 on the cylinder member 152 and can serve to minimize the chances of the cap member 160 connecting to the retaining flange 190 during the unlocking process without significantly impairing the ability to arrange the rib 167 and the retaining flange 190 to transport loads during the insertion process. [00072] As can be seen in Figures 11 and 12, the opposite ends 154, 156 of the cylinder member 152 are spaced from each other to define a lock region 210 to receive the lock member 140 therein. The locking member 140 can be formed from a plastic material and has a portion of the body 141 that has a pair of distally projecting locking tabs 142, 144 formed therein. See Figure 11. Lock tabs 142, 144 are sized to extend into lock cavities 157, 159 formed at opposite ends 154, 156 of bar 152. See Figures 10 and 11. Thus, when lock tabs 142, 144 are received in the lock cavities 157, 159, the cylinder member 152 forms a structure similar to a radially openable ring dimensioned to accommodate the stapling head 16 of the circular stapler 10 therein. In various embodiments, when the cylinder member 152 is locked in the closed position with the cover member 160 covering the distal face 25 of the stapling head 16 of the circular stapler 10, the cover member 160 can sit directly on the distal face 25 of the stapling head 16 of the circular stapler 10 without interfering with any of the staple pockets in the staple cartridge holder 17 therein. Such an arrangement allows the forces experienced by the cap member 160 during the insertion process to be transmitted directly to the stapling head 16 of the circular stapler 10 without the need for any balance of force or intermediate components. [00073] Also in various embodiments, the release member 140 can be additionally formed with a release finger 145 which can serve to assist with the radial opening of the cylinder member 152 when the lock member 140 is pulled out proximally of the engagement with the opposite ends 154, 156 of the cylinder member 152. More specifically and with reference to Figure 11, the lock member 140 can be formed with a release finger 145 which is centrally arranged between the lock tabs 142 , 144. The release finger 145 can be formed with portions of meat 147 which are designed to engage meat surfaces 161, 163 formed at opposite ends 154, 156 of cylinder member 152 in such a way that, as per lock member 140 is pulled in the proximal direction "P", the meat portions 147 engage the meat surfaces 161, 163 to urge the opposite ends 154, 156 of the cylinder member 152 radially away from each other (represented by the "R" lines, in Figure 12.). Thus, the lock member 140 is pulled in a direction (proximal direction "P") that is substantially perpendicular to the direction of movement "R" required to disengage the cap member 160 from the cylinder member 152. When the lock member lock 140 is removed and the clinician continues to apply an additional withdrawal movement to the introducer 100, the opposite ends 154, 156 of the cylinder member 152 are allowed to further radially separate and enable the cap member 160 to disengage from the member cylinder 152 and move to an open position. In doing so, the cover member 160 is allowed to rotate to an open lateral position to facilitate the proximal movement of the cover assembly 150 over the stapling head 16 as the introducer 100 is removed proximally from the patient . See Figure 14. [00074] As can be seen in Figures 7 to 9, the cable assembly 130 can be designed to adapt to the geometry of the cable portion 12 of the circular stapler 10 when the stapling head 16 is inserted into the closed cover assembly 150 in a full insertion position. For example, when a lower edge portion of the rigid cover member 160 is in contact with the distal face 25 of the stapling head 16, the stapling head 16 can be considered to be the "fully inserted" position. More broadly, the circular stapler 10 can be considered to be in a position of total insertion when the distal face 25 is in contact with a portion of the rigid cover member 160. [00075] In several embodiments, the cable assembly 130 can be configured in such a way as to avoid improper installation of the introducer 100 in the circular stapler 10. For example, the cable assembly 130 can be "orientation specific", so that include features that are compatible with corresponding surfaces in the cable portion 12 of the circular stapler 10 when the stapling head is inserted in the full insertion position, while at the same time interfering with other surfaces if the introducer 100 is installed incorrectly. In addition, many circular staplers 10 include an indicator panel 19 which is located on the upper side of the cable portion. See Figure 1. This indicator panel 19 can, for example, provide the physician with an indication of the position of the anvil 20 in relation to the stapling head 16. In various embodiments, the cable portion 130 of the introducer 100 can be designed to cover or cover the indicator panel 19 of the circular stapler 10. This arrangement serves to ensure that the user is aware that the introducer 100 is installed in the stapler 10 and thereby prevents the user from attempting to fire the circular stapler 10 without first removing the introducer 100. For example, cable assembly 130 includes a front portion 220 that covers or otherwise covers the indication panel 19 of circular stapler 10. [00076] In various embodiments, the proximal end 124 of the release member 122 or suture is attached to a sliding release element 230. As can be seen in Figure 6, suture 122 can be attached to a front flap portion 232 of the element sliding release 230 which is sized to be received slidingly into a cavity 222 formed in the front portion of the cable assembly 130. The front flap portion 232 is slidably retained within the cavity 222 by a cover 240 that can be attached to the cable assembly 130 by a series of retaining tabs 242 which are oriented to engage by corresponding pressure fitting cavities 224 in the cable assembly 130. See Figures 5 and 6. Numerous embodiments of the present invention may also incorporate a means for multiplying a proximal travel distance of suture 122 with respect to a distance at which the sliding release element 230 is moved in the cable portion 12 of the grain circular router 10. For example, various modalities can employ a pulley-like arrangement 250 to multiply the travel distance of suture 122 relative to the distance at which the sliding release element 230 is moved in the proximal "P" direction. This arrangement may allow for a longer travel to ensure release of the cap member 160 without the need to lengthen the cable portion 130. For example, as shown in Figure 6, the proximal end portion 124 of suture 122 extends through a slot 252 in the cable assembly 130 and turns through a hole 234 in the front sliding tab 232. The end 124 of suture 122 can then be attached to a fixed column 254 in the cable assembly 130 [00077] To facilitate easy removal of the introducer 100, the sliding release element 230 can be provided with a "relatively low profile" to allow the physician to maintain a grip on the handle portion 12 of the stapler 10 without significantly altering its grip or method of what would be done with the circular stapler 10 alone. See Figures 7 to 9. Also, in various embodiments, the sliding release element 230 can be provided with an orifice 236 and / or two side wing portions 238. Thus, this arrangement allows the physician to apply a force to the element release slide 230 in the proximal direction "P" with the use of a single finger in hole 236 or two fingers in the side wing portions 238. [00078] As can be seen in Figure 6, the front portion 220 of the cable assembly 130 can also be provided with stops 229 which are arranged to engage the front flaps 239 formed in the front flap portion 232 of the sliding release element 230 Thus, in use, once the circular stapler 10 is inserted into the introducer 100 in the full insertion position and the stapler 10 and introducer 100 are inserted into a desired position within the patient, the doctor can then pull the element release slider 230 in a proximal direction to apply an amount of tension or release movement to suture 122 in order to attract lock member 140 to an unlocked position. Pulling additionally the sliding release element 230 will cause the front flaps 239 to contact the stops 229. Once the front flaps 239 come into contact with the stops 229, the additional pull of the sliding release element 230 in the proximal direction causes the entire introducer 100 to move in the proximal direction. This arrangement allows the entire introducer 100 to be detached from the stapler 10 and removed from the patient by moving the sliding release element 230 in the proximal direction in the cable portion 12 of the circular stapler 10. Removing the introducer 100 from the stapler 10 can be performed without removing the stapler 10 from the patient. [00079] To use the introducer 100, the physician simply inserts the circular stapler 10 into the sheath 110 in the total insertion position and aligns the introducer 100 with respect to the cable portion 12, so that the anterior portion 220 of the cable portion 130 cover the indication panel 19 of the circular stapler 10. To assist in the insertion process, the stapling head 16 and the shaft portion 14 of the circular stapler 10, as well as the cover assembly 150 and sheath 110 of the introducer 100, can lubricated before the insertion process begins. When the circular stapler 10 is properly inserted into the introducer 100, the edge of the cap 160 which is engaged with the flange 190 of the cylinder assembly 152 and thereby retained in the closed position as shown in Figures 3 to 6, 10 and 13 , will rest on stapling head 16 of stapler 10. The user then inserts stapler 10 and introducer 100 into a desired position in the colon. Once the stapler 10 is in a desired position, the physician can pull the sliding release element 230 in the proximal direction "P", which causes the suture 122 to pull the retaining latch 140 out of the engagement with the ends 154 , 156 of the cylinder assembly 152. As the retainer latch 140 is proximally attracted, the meat surfaces 147 on the release finger 145 cooperate with the meat surfaces 161, 163 formed at opposite ends 154, 156 of the assembly cylinder 152 so that, as the release member 140 is pulled in the proximal direction "P", the ends 154, 156 are propelled radially away. The additional pull of the sliding release element 230 results in the front flaps 232 coming into contact with the stops 229, so that the additional pulling of the sliding element 230 results in the entire introducer 100 being pulled proximally along the circular stapler 10. This pulling the introducer 100 can cause the sheath 110 to separate along the perforation line 116 and the cap 160 to move to an open position (Figures 14 and 15) to thereby allow the introducer 100 to be removed from the patient before the stapler 10 fires. [00080] Figure 22 illustrates another introducer 300 of the present invention. In this embodiment, the introducer 300 comprises a hollow sheath 302 that has a closed end 304 and an open end 306 for insertion on the circular stapler 10. Sheath 302 can be manufactured from a flexible material such as those materials commonly used to manufacture condoms. In one embodiment, sheath 302 is manufactured from a single piece of material that has an elongated joint line 310 that extends the length of sheath 302. In particular, the sheath material is folded so that the end 312 of the material overlap the end 314 of the material represented by the distance "O" in Figure 22. The ends 312, 314 are then sewn together by a suture 316 forming the junction line 310. Thus, the sheath 302 is inserted over the head of stapling 16 from stapler 10 before insertion into the patient. After the stapler 10 and sheath 302 have been inserted into position, sheath 302 can be removed by pulling on suture 316 to thereby release the seam 310 allowing sheath 302 to be removed. In other embodiments, sheath 302 is manufactured from two pieces of flexible material that are sewn together with two sutures 316 in the manner described above. To remove sheath 302, the doctor simply pulls one or both sutures 316. [00081] Figure 23 illustrates another introducer 300 of the present invention. In this embodiment, the introducer 320 comprises a hollow sheath 322 having a closed end 324 and an open end 326 for insertion on the circular stapler 10. Sheath 322 can be manufactured from a flexible material such as those commonly used to manufacture condoms. In one embodiment, sheath 320 has a closed end 342 and an open end 326 and is provided with at least one weakening area 328 which may comprise a perforated line or junction line that extends along the length of sheath 322. Thus, sheath 322 is inserted over the stapling head 16 of the stapler 10 before insertion into the patient. After the stapler 10 is inserted into position, the sheath 322 can be removed by pulling the weakening area 328 to allow the sheath 322 to be separated from the stapler 12. [00082] Figures 24 to 28 illustrate another introducer 330 of the present invention. In that embodiment, the introducer 330 comprises a sheath 332 that has a closed distal end 334 and an open proximal end 336 that is sized to extend over at least a distal portion of the stapling head 16 of the circular stapler 10. Sheath 332 can be made from, for example, silicone, latex or other material with a relatively low durometer (ie, a 90A durometer). In various embodiments, a protruding bumper area extending circumferentially 338 may be formed around the circumference of the closed distal end 334 as shown in Figures 24 and 25. In some embodiments, a central portion 335 extends inwardly from of the bumper area extending circumferentially 338 to confine an open central area 27 on the stapling head 16. See Figure 25. [00083] As can be seen in Figure 25, the bumper area 338 extends distally beyond (or, in other words, is "highlighted above") a DD plane defined by a distal face 25 of the stapling head 16 In some embodiments, the bumper area 338 is formed from solid material. See Figure 26. In other embodiments, a hollow area extending circumferentially 340 is formed therein. In other embodiments, the hollow area 340 comprises a plurality of pockets 341. See Figure 28. The area 340 and pockets 341 can be loaded with air or liquid such as a saline solution, for example. In use, sheath 332 is rolled over stapling head 16 of stapler 10. Sheath 332 can be left in place while closing and firing stapler 10, in which case area 340 or pockets 341 could be broken with only material remaining under the crown of the clamp inside the rectal lumen. [00084] Figure 29 illustrates another introducer 350 of the present invention. In that embodiment, the introducer 350 comprises a sheath 352 that has a distal end 354 and an open proximal end 356 that is sized to extend over the stapling head 16 of the circular stapler 10. Sheath 352 can be manufactured from, for example, example, silicone, latex or other material with a relatively low durometer (ie, a 90A durometer). In various embodiments, a protruding bumper area extending circumferentially 357 can be formed around the circumference of sheath 352 so that it covers the distal face 25 of the stapling head 16 and a portion 359 extends into the open area central 27 and below the DD plane defined by the distal face 25. See Figure 29. In some embodiments, the bumper area 357 is formed from solid material. In other embodiments, a hollow area extending circumferentially 358 is formed therein. The hollow area 358 can be charged with air or liquid as a saline solution. In other embodiments, the hollow area extending circumferentially 358 is segmented (for example, it comprises a series of distinct pockets extending around the circumference of sheath 352). Different pockets can be loaded with air or a liquid such as saline, for example. In use, sheath 352 is rolled over the distal end portion of the stapling head 16. Sheath 352 can be left in place while stapler 10 is closed and fired, in which case, the hollow area 358 or pockets could be broken remaining only the sheath material under the clamp crown inside the rectal lumen. [00085] Figures 30 to 32 illustrate another 360 introducer of the present invention. In this embodiment, the introducer 350 comprises a cover 362 that is sized to be installed at least in a distal portion of the stapling head 16. In one embodiment, the cover 362 comprises a "C" shaped body portion 363 that can be manufactured from, for example, mixtures of polyurethane, polyesters, polyethylene, polycarbonate or polypropylene and be sized to fit by pressing on the stapling head 16 and the elongated rod portion 14 of the circular stapler 10. See Figure 31. In several modalities, the distal end 364 of the body portion 363 has at least three normally closed fingers 366 which, when moved distally on the stapling head 16, close to form, for example, a "tulip-like" shape for insertion into the anus . See Figure 30. The body portion 363 may have a retracting member 370 formed therein to facilitate the application of a retracted motion to this. When the stapler 10 reaches its targeted insertion point, the cover 362 can be pushed towards the cable portion 12 of the stapler 10, thus, pushing the fingers 366 to the vertical sides of the stapling head 16, exposing the distal face 25 of the staple cartridge 17. See Figure 32. [00086] Figures 33 and 34 illustrate another introducer 380 of the present invention. In this embodiment, the introducer 380 comprises a cover 382 which includes four fingers 384 extending from a centrally arranged connector 386 which has a trocar access hole 388 therethrough. The proximal end 390 of each of the fingers 384 has a retaining flange 392 formed therein that extends to the central opening 27 and engages the portion of the central wall 21 of the stapling head 16. To install the cover 382, the cover 382 is positioned over the stapling head 16 as shown in Figures 33 and 34 and the trocar 23 of the circular stapler 10 is advanced, so that the distal end portion 35 of the trocar 23 protrudes through the hole 388 in the central connector 386. Once in position, the trocar 23 is retracted proximally to the central opening 27, thereby, to force the fingers 384 into a generally bulbous "mushroom-like" cross-sectional shape. Once stapler 10 is positioned in the rectum, trocar 23 can then be installed and pushed through the rectal wall allowing access to accessory fingers 384 that can be removed from trocar 23. [00087] Figures 35 to 37 illustrate another introducer 400 of the present invention. In this embodiment, the introducer 400 comprises a cover 402 which includes four fingers 404 which are attached together by a sheath 410. See Figure 35. The sheath can be produced from, for example, silicone material. The apex area 412 of the sheath 410 may have a trocar access hole 414 therethrough. The proximal end 406 of each of the fingers 404 has a retaining flange 408 formed therein that extends to the central opening 21 in the stapling head 16. To install the cover 400, the cover 402 is positioned over the staple head 16 , as shown in Figures 35 and 36, and trocar 23 of circular stapler 10 is advanced distally, so that the distal end portion 35 of trocar 23 protrudes through hole 414 in sheath 410. Once in position, the trocar 23 is retracted to thereby force the 404 fingers generally in a mushroom section shape. See Figure 37. Once stapler 10 is positioned in the rectum, trocar 23 can then be installed and pushed through the rectal wall allowing access to accessory fingers 404 that can be removed from trocar 23. [00088] Figure 38 illustrates another introducer 420 that can be manufactured from, for example, blends of polyurethane, polyesters, polyethylene, polycarbonate or polyprolylene that have at least four fingers 422 that are interconnected to a connector or apex area 424 The proximal ends 426 of the fingers 422 fit under pressure on the stapling head 16. In this embodiment, the introducer 420 is designed to go to the colon and then be removed. This is different from the introducer 400 described above in which the trocar is in the extended position to remain in place until the device is in position and then the trocar is placed proximally. [00089] Figures 39 and 40 illustrate another introducer 500 that can be used in conjunction with a circular stapler 10. As can be seen in these Figures, introducer 500 can comprise a perforated molded arrangement and can be manufactured from, for example, example, mixtures of polyurethane, polyesters, polyethylene or polypropylene or, alternatively, it could comprise a rolled strip that is sewn together or held in place without covering. The strip 504 can have a width of, for example, 0.635 cm (0.250 inches) and a thickness of, for example, 0.051 cm (0.020 inches). The strip 504 can form a base portion 506 sized to extend around the circumference of the stapling head 16. The base portion 506 can be sized relative to the stapling head 16 so that, when held together in close spiral relationship , the spiral strip 504 forms a relatively tight fit (interference) with the stapling head 16 to retain the introducer in it. The spiral-wound strip 504 forms a plurality of successive passages 508 that taper to a blunt distal end 510. As can be seen in Figure 36, one embodiment resembles a "honeycomb shape" with blunt end that substantially abuts or covers the distal face of the stapling head 16. Spiral passages 508 can be maintained in substantial contiguity relationship (i.e., spiral-wound closed end relationship) by a retaining member 510. In various embodiments, the retaining member 510 can comprise a thin layer (for example, 25.4 to 101.6 microns (1 to 4 Mils)) of shrink wrap that extends across the introducer 500. The introducer 500 also includes a release member 520 that is attached to the material of strip 504, so that by applying a release movement thereon, the spiral-wound strip member 504 is unwound from an engagement with the distal portion of the stapling head 16. In one embodiment, for example, the release member comprises a release suture 520 which is attached to the distal end 512 of strip 504. Release suture 520 may pass through an orifice 522 in a portion of strip 504 forming the portion of base 506 and extends proximally out of the cable portion of the stapler 10 to allow the release suture 520 to be held by the physician. [00090] The introducer 500 can be installed by the supplier of stapler 10 by wrapping the introducer 500 in the stapling head 16 in a shrinkable manner. In use, the doctor inserts the stapler and the introducer set 530 into the patient's anus and in addition to the Houston to the desired area. Once the doctor determines that the stapler 10 is in the desired position, the doctor can then pull the release suture 520 in the proximal direction "P", which causes a shrink wrap 510 to break, thereby allowing allow the introducer 500 to unwind as shown in Figure 40. Continuous pulling of the release suture 520 will allow the introducer 500 to be removed from the patient. [00091] Figures 41 to 43 illustrate another introducer 600 that can be used in conjunction with a circular stapler 10. As can be seen in these Figures, introducer 600 may have a base portion 602 sized to be retained in the stapling head 16 Introducer 600 is formed with a plurality of tapered "petal" portions 504 that taper to a substantially rounded point 606. In some embodiments, for example, there are four diametrically opposed petal portions 604 that, when closed (Figure 41) , converge to form a relatively blunt pointed end 610. The petal portions 604 have an open area 612 between them. In various embodiments, petal portions 604 are retained in the closed position by a releasable retaining member 620. In some embodiments, for example, the retaining member comprises a shrink wrap material 620 that is applied around introducer 600. In some embodiments, a plurality of retaining shoulders 630 can be formed around the inner perimeter of the base 602 to engage the distal face 25 of the stapling head 16 when the shrink wrap 620 is applied. Release sutures 640 can be sewn through those portions 622 of heat shrink wrap 620 that cover open area 612. Release sutures 640 end in or are each attached to a release suture 650 that passes through an orifice 652 in the base portion 602 and extends proximally out of the cable portion of the stapler 10 to allow the release suture 650 to be held by the physician. [00092] The introducer 600 can be installed by the supplier of the stapler 10 by wrapping the introducer 600 in the stapling head 16 in a shrinkable manner. In use, the doctor inserts the stapler and the introducer set 660 into the patient's anus and in addition to the Houston to the desired area. Once the doctor determines that the stapling head of the stapler 10 is in the desired position, the doctor can then pull the release suture 650 in the proximal direction "P", which can cause the shrink wrap 620 to be broken thereby allowing the introducer 600 to be pulled distally over the stapling head 16, as shown in Figure 43. [00093] Figures 44 to 46 illustrate another introducer 700 that can be used in conjunction with a circular stapler 10. As can be seen in these Figures, introducer 700 can be manufactured from, for example, mixtures of polyurethane, polyesters, polyethylene or polypropylene and has a base portion 702 sized to be retained in the stapling head 16. The introducer 700 is formed with a plurality of tapered "segment" portions 704 that taper into a substantially rounded point 706. In some embodiments, for example, there are four diametrically opposed petal portions 604 which, when closed (Figure 44), converge to form a relatively blunt pointed end 710. In the embodiment described in Figures 44 to 46, the introducer 700 includes four segment portions 704. The segment portions 704 are interconnected at their base portions, except for two adjacent segment portions 704 where the bases of the two segment portions 704 are not o are fixed together. More particularly, segment portion 704A has a base edge 705A and segment portion 704B has a base edge 705B. The edges 705A and 705B are not attached to each other. Thus, the segment portion 704A and the segment portion 704B comprise free ends of the base portion 702. The free ends 704A and 704B are retained in contiguity by a retaining member in the form of a radial release flap 720 which it is fixed at 704A and 704B. In various embodiments, the release tab 720 is attached or molded to the segment portion 704A and may not necessarily be removed therefrom. The release tab 720 is removably attached to the segment portion 704B. The release tab 720 can be attached to the segment portion 704 by a removable retainer 722 such as, for example, a removable adhesive or piece of tear-away material. When the release tab 720 is attached as shown in Figure 41, the segment portions 704 form an annular base portion 702 that can be snap-retained over or otherwise engaged with the clip head 16 of the circular stapler 10. The release suture 730 is attached to the release tab 720 and extends proximally out of the cable portion 12 of the stapler 10 to allow the release suture 730 to be held by the physician. [00094] The introducer 700 can be fitted by pressing on or pressed on the stapling head 16 by the physician. In use, the doctor inserts the 740 stapler and introducer set into the patient's anus and beyond the Houston valves to the desired area. Once the doctor determines that the stapling head 16 of the stapler 10 is in the desired position, the doctor can then pull the release suture 730 in the proximal "P" direction, which causes the release flap 720 to release the segment portion 704B to allow the introducer 700 to release the stapling head 16. Continuous pulling on the release suture 730 will allow the introducer 700 to be removed from the patient. [00095] Thus, the various modalities of the circular stapler introducer of the present invention can facilitate transanal and transabdominal navigation and insertion to access the distal stump staple line in lower anterior recessions. The various introductors can be supplied as part of a kit that also includes a circular stapler 10. Various types of introducer will have no impact on the current functions of the circular stapler. [00096] The various embodiments of the present invention represent a vast improvement over previous circular stapling arrangements that failed to provide any means for locking the anvil in a firing arrangement. Although various modalities of the invention have been described, it will be evident, however, that various modifications, alterations and adaptations to these modalities can occur to those skilled in the art, from obtaining part or all of the advantages of the present invention. For example, according to several modalities, a single component can be replaced by multiple components, and multiple components can be replaced by a single component, to perform one or more specific functions. This request is therefore intended to cover all these modifications, changes and adaptations, without departing from the scope and spirit of the presented invention, as defined by the attached embodiments. [00097] Any patent, publication or other description material, in whole or in part, which is said to be incorporated into the present invention for reference purposes, is incorporated into the present invention only to the extent that the incorporated materials do not come into effect. conflict with existing definitions, statements or other description material presented in this description. Accordingly, and to the extent necessary, the description as explicitly stated herein replaces any conflicting material incorporated herein by way of reference. Any material, or portion thereof, that is deemed to be incorporated by reference into the present invention, but which conflicts with definitions, statements, or other description materials existing herein will be incorporated here only to the extent that no conflict will appear between the embedded material and the existing description material. [00098] The invention to be protected should not be interpreted as limited to the specific modalities presented. The modalities should therefore be considered illustrative rather than restrictive. Variations and changes can be made by others, without departing from the spirit of the present invention. Consequently, there is an express intention that all such equivalents, variations and alterations that fit the spirit and scope of the present invention, as defined in the embodiments, are covered by it.
权利要求:
Claims (14) [0001] 1. Introducer (100) comprising: a circular surgical stapler (10) that has a handle portion (12), an elongated stem (14) protruding from the handle portion (12), and a stapling head ( 16) coupled to the elongated rod (14), the introducer (100) being used to introduce the circular surgical stapler (10) to a patient and comprising: a flexible hollow sheath (110) that has a distal end (114) and a proximal end open (112), the hollow flexible sheath (110) dimensioned to receive the stapling head (16) and at least a portion of the elongated stem (14) therein; and characterized by the fact that a rigid cover assembly (150) is attached to said distal end (114) of the flexible hollow sheath (110), the rigid cover assembly (150) is configured to move selectively between a position closed in which a distal face (25) of the stapling head (16) is covered by the rigid cover assembly (150) when the stapling head (16) has been inserted into it to a full insertion position, and an open position in which the cover assembly (150) can be removed proximally around the stapling head (16) and the elongated stem (14), the cover assembly (150) has an arcuate underside (166) formed to match a shape of a perimeter of a corresponding portion of the stapling head (16) to allow the rigid cover assembly (150) to pass proximally through the stapling head (16) when being removed from it. [0002] 2. Introducer (100) according to claim 1, characterized in that it additionally comprises a release arrangement (140) which interfaces with the rigid cover assembly (150) to releasably retain the cover assembly rigid (150) in said closed position. [0003] Introducer (100) according to claim 1, characterized in that said rigid cover assembly (150) comprises: a cylinder element (152) coupled to the distal end (114) of the flexible hollow rod (110) ) and defining an opening sized to receive the stapling head (16) through it; and a rigid lid element (160) hingedly attached to the cylinder element (152) and being movable between the closed position and said open position. [0004] 4. Introducer (100) according to claim 4, characterized in that the rigid cover element (160) has a smooth distal surface (164). [0005] 5. Introducer (100), according to claim 1, characterized in that the stapling head (16) has a circular perimeter shape and in which the arched bottom side (166) of the rigid cover element (160) has a shape that corresponds to a portion of the circular perimeter shape of the stapling head (16). [0006] 6. Introducer (100), according to claim 3, characterized by the fact that it additionally comprises a release arrangement (140) which interfaces with the cylinder element (152) so that, in the application of a release movement at the same time, the rigid cover member (160) is movable in the open position. [0007] 7. Introducer (100) according to claim 6, characterized in that the release arrangement (140) comprises a release latch in movable engagement with locking portions (161, 163) in the cylinder element (152) . [0008] 8. Introducer (100) according to claim 7, characterized in that the cap element (160) is articulated to the cylinder element (152) by a cord (162) attached to the cylinder element ( 152) in a position that is diametrically opposed from the closing portions (161, 163) on the cylinder element (152). [0009] 9. Introducer (100) according to claim 7, characterized by the fact that the cover element (160) is hingedly attached to the cylinder element (152) by a cord (162) attached to the cylinder element ( 152) in a position that is located at a right angle from the closing portions (161, 163) on the cylinder element (152). [0010] 10. Introducer (100) according to claim 1, characterized in that it further comprises: a radially openable cylinder element (152) attached to a distal end (114) of the flexible hollow sheath (110) and defining an opening to receive the stapling head (16) on it; and a locking element (140) in engagement with a pair of opposite ends (154, 156) of the radially openable cylinder element (152), the locking element (140) being selectively movable from a locked position which engages with the opposite ends (154, 156) of the cylinder element (152) and an unlocked position in which the opposite ends (154, 156) can radially move away from each other; wherein the rigid cover assembly (150) comprises a rigid cover element (160) hingedly attached to the radially openable cylinder element (152). [0011] 11. Introducer (100), according to claim 10, characterized by the fact that the stapling head (16) has a circular perimeter shape and in which the lower arched side (166) of the cover element (160) has a shape that corresponds to a portion of the perimeter shape circulates from the stapling head (16). [0012] 12. Introducer (100) according to claim 10, characterized in that the cover element (160) is articulated to the cylinder element (152) by a cord (162) attached to the cylinder element ( 152) in a position that is diametrically opposed to said closing element (140). [0013] 13. Introducer (100) according to claim 10, characterized in that the cap element (160) is hingedly attached to the cylinder element (152) by a cable (162) attached to the cylinder element ( 152) in a position that is located at a right angle from the closing element (140). [0014] 14. The introducer (100) according to claim 11, characterized in that the cover element (160) has an abrupt distal end surface (164) which is smooth.
类似技术:
公开号 | 公开日 | 专利标题 BR112012012047B1|2020-11-17|introducer BR112013002332B1|2021-01-19|surgical instrument BR112012011963B1|2021-04-27|INTRODUCER TO INTRODUCE A CIRCULAR SURGICAL STAPLER BR112013002304B1|2021-01-19|surgical instrument BR112013002301B1|2020-08-04|DEVICE TO PROTECT TISSUES AND STRUCTURES ADJACENT TO A TUBULAR ORGAN DURING THE PERFORMANCE OF A SURGICAL PROCEDURE IN A PORTION OF THE TUBULAR ORGAN BR112013002338B1|2021-02-17|surgical instrument
同族专利:
公开号 | 公开日 WO2011063051A2|2011-05-26| CN102711653A|2012-10-03| CN102843977A|2012-12-26| RU2559422C2|2015-08-10| ES2626283T3|2017-07-24| US20110114699A1|2011-05-19| JP2013511343A|2013-04-04| EP2512350A1|2012-10-24| BR112012012001A2|2017-09-26| JP5726889B2|2015-06-03| IN2012DN04838A|2015-09-25| PL2512350T3|2017-09-29| AU2010322039B2|2014-09-18| AU2010321963B2|2013-11-14| RU2012125277A|2013-12-27| AU2010322039A1|2012-06-07| JP2013511347A|2013-04-04| EP2501322B1|2020-04-15| AU2010322034B2|2013-10-17| JP5694355B2|2015-04-01| AU2010321963A1|2012-06-07| EP2509512A2|2012-10-17| BR112012012044A2|2016-05-17| PL2509514T3|2015-10-30| US20110118761A1|2011-05-19| US20110114697A1|2011-05-19| EP2501322A2|2012-09-26| CA2781058C|2018-03-06| CN102711653B|2015-01-21| AU2010322033A1|2012-06-07| US8353438B2|2013-01-15| JP2013511344A|2013-04-04| RU2560905C2|2015-08-20| EP2509514A1|2012-10-17| EP2509513A1|2012-10-17| JP2013511345A|2013-04-04| CA2781068A1|2011-05-26| BR112012012047A2|2016-05-17| BR112012012001B1|2020-02-04| CN102724923B|2015-03-25| CN102724923A|2012-10-10| AU2010322033A8|2013-04-18| RU2012125276A|2013-12-27| RU2012125268A|2013-12-27| WO2011063056A3|2011-07-21| CA2781275A1|2011-05-26| WO2011063051A3|2014-06-19| JP2013511346A|2013-04-04| EP2509512B1|2017-05-24| JP5726888B2|2015-06-03| US20110114698A1|2011-05-19| CA2781111A1|2011-05-26| BR112012012047B8|2021-06-22| AU2010322044B2|2014-01-16| BR112012011969B1|2020-02-11| EP2509514B1|2015-04-15| WO2011063046A1|2011-05-26| CN102843977B|2015-05-20| WO2011063040A8|2012-06-21| AU2010322044A1|2012-06-07| JP5694356B2|2015-04-01| JP5726890B2|2015-06-03| CN102883665A|2013-01-16| WO2011063041A8|2012-08-16| WO2011063041A1|2011-05-26| BR112012011969A2|2016-05-10| CA2781068C|2018-05-15| RU2559014C2|2015-08-10| EP2512350B8|2017-06-28| US8899466B2|2014-12-02| WO2011063056A2|2011-05-26| US8622275B2|2014-01-07| IN2012DN04842A|2015-09-25| EP2512350B1|2017-04-19| IN2012DN04889A|2015-09-25| WO2011063040A1|2011-05-26| CA2781055A1|2011-05-26| CA2781058A1|2011-05-26| AU2010322034A1|2012-06-07| RU2557693C2|2015-07-27| AU2010322033B2|2013-10-03| US20110114700A1|2011-05-19| CA2781055C|2018-02-27| CA2781111C|2018-02-13| RU2012125259A|2013-12-27| CN102883665B|2015-11-25| CN102770083A|2012-11-07| US8353439B2|2013-01-15| CN102770083B|2015-11-25| CA2781275C|2018-02-06| RU2012125269A|2013-12-27|
引用文献:
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Llc|Surgical stapler| USD896962S1|2018-05-16|2020-09-22|Ethicon Llc|Surgical stapler| US11197676B2|2018-06-28|2021-12-14|Covidien Lp|Tie-down method for anvil assembly delivery system| US11241234B2|2018-08-14|2022-02-08|Covidien Lp|Anvil assembly with self-retaining backup member| USD914878S1|2018-08-20|2021-03-30|Ethicon Llc|Surgical instrument anvil| US11083458B2|2018-08-20|2021-08-10|Cilag Gmbh International|Powered surgical instruments with clutching arrangements to convert linear drive motions to rotary drive motions| US11253256B2|2018-08-20|2022-02-22|Cilag Gmbh International|Articulatable motor powered surgical instruments with dedicated articulation motor arrangements| US11045192B2|2018-08-20|2021-06-29|Cilag Gmbh International|Fabricating techniques for surgical stapler anvils| US10912559B2|2018-08-20|2021-02-09|Ethicon Llc|Reinforced deformable anvil tip for surgical stapler anvil| US10842492B2|2018-08-20|2020-11-24|Ethicon Llc|Powered articulatable surgical instruments with clutching and locking arrangements for linking an articulation drive system to a firing drive system| US10779821B2|2018-08-20|2020-09-22|Ethicon Llc|Surgical stapler anvils with tissue stop features configured to avoid tissue pinch| US10856870B2|2018-08-20|2020-12-08|Ethicon Llc|Switching arrangements for motor powered articulatable surgical instruments| US11207065B2|2018-08-20|2021-12-28|Cilag Gmbh International|Method for fabricating surgical stapler anvils| US11039834B2|2018-08-20|2021-06-22|Cilag Gmbh International|Surgical stapler anvils with staple directing protrusions and tissue stability features| US10973544B2|2018-10-02|2021-04-13|Covidien Lp|Retaining mechanism for trocar assembly| US11141163B2|2018-10-04|2021-10-12|Covidien Lp|Circular stapling device with anvil rotation locking structure| US11065005B2|2018-11-07|2021-07-20|Covidien Lp|Reload assembly for a circular stapling device| US11147561B2|2018-11-28|2021-10-19|Covidien Lp|Reload assembly for a circular stapling device| US11166728B2|2019-02-08|2021-11-09|Covidien Lp|Reload assembly for a circular stapling device| US11147551B2|2019-03-25|2021-10-19|Cilag Gmbh International|Firing drive arrangements for surgical systems| US11147553B2|2019-03-25|2021-10-19|Cilag Gmbh International|Firing drive arrangements for surgical systems| US11172929B2|2019-03-25|2021-11-16|Cilag Gmbh International|Articulation drive arrangements for surgical systems| US11246599B2|2019-04-25|2022-02-15|Covidien Lp|End effector for circular stapling instrument| US11253254B2|2019-04-30|2022-02-22|Cilag Gmbh International|Shaft rotation actuator on a surgical instrument| US11246678B2|2019-06-28|2022-02-15|Cilag Gmbh International|Surgical stapling system having a frangible RFID tag| US11224497B2|2019-06-28|2022-01-18|Cilag Gmbh International|Surgical systems with multiple RFID tags| US11051807B2|2019-06-28|2021-07-06|Cilag Gmbh International|Packaging assembly including a particulate trap| US11259803B2|2019-06-28|2022-03-01|Cilag Gmbh International|Surgical stapling system having an information encryption protocol| US11241235B2|2019-06-28|2022-02-08|Cilag Gmbh International|Method of using multiple RFID chips with a surgical assembly| US11219455B2|2019-06-28|2022-01-11|Cilag Gmbh International|Surgical instrument including a lockout key| US11123101B2|2019-07-05|2021-09-21|Covidien Lp|Retaining mechanisms for trocar assemblies| US11192227B2|2019-07-16|2021-12-07|Covidien Lp|Reload assembly for circular stapling devices| US11253255B2|2019-07-26|2022-02-22|Covidien Lp|Knife lockout wedge| US11234698B2|2019-12-19|2022-02-01|Cilag Gmbh International|Stapling system comprising a clamp lockout and a firing lockout|
法律状态:
2018-03-27| B15K| Others concerning applications: alteration of classification|Ipc: A61B 1/00 (2006.01), A61B 17/115 (2006.01), A61B 4 | 2018-05-15| B15K| Others concerning applications: alteration of classification|Ipc: A61B 17/068 (2006.01), A61B 17/115 (2006.01), A61B | 2019-01-08| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]| 2019-07-23| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]| 2020-02-11| B07A| Technical examination (opinion): publication of technical examination (opinion) [chapter 7.1 patent gazette]| 2020-06-30| B09A| Decision: intention to grant [chapter 9.1 patent gazette]| 2020-11-17| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 17/11/2020, OBSERVADAS AS CONDICOES LEGAIS. | 2021-06-22| B16C| Correction of notification of the grant|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 17/11/2010, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO |
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申请号 | 申请日 | 专利标题 US12/621,683|US8353439B2|2009-11-19|2009-11-19|Circular stapler introducer with radially-openable distal end portion| US12/621,688|US8622275B2|2009-11-19|2009-11-19|Circular stapler introducer with rigid distal end portion| US12/621,672|US8899466B2|2009-11-19|2009-11-19|Devices and methods for introducing a surgical circular stapling instrument into a patient| US12/621,679|US8353438B2|2009-11-19|2009-11-19|Circular stapler introducer with rigid cap assembly configured for easy removal| US12/621,667|US20110114697A1|2009-11-19|2009-11-19|Circular stapler introducer with multi-lumen sheath| US12/621,679|2009-11-19| PCT/US2010/057104|WO2011063041A1|2009-11-19|2010-11-17|Circular stapler introducer with rigid cap assembly configured for easy removal| 相关专利
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