JP2011502660A - Rectal stump closure device for rectal resection - Google Patents

Abstract

  Surgical devices used in rectal surgery include a rectal stump closure device 1 that is inserted through a circular anal dilator 2 that defines a passage opening 10 and a passage opening 10 of the circular anal dilator 2. An anoscope 3 configured to be enabled, comprising an anoscope 3 having a distal end 18 and a rectal stump closure obturator 4 having a first peripheral anchoring surface 30, comprising: The peripheral anchoring surfaces of the rectal stump closure obturator 4 and the rectal stump closure obturator 4 are configured so that the rectum 46 can be anchored to the anchoring surface from the outside of the rectum 46. An obturator connector 5 removably connected to the distal end 18 of the device.

Description

Disclosure details

〔Explanation〕
The present invention relates to a surgical apparatus and method for resecting the lower rectum, particularly in the treatment of patients with small or medium sized rectal carcinoid tumors.

  A known surgical technique for performing lower rectal resection is the so-called low anterior resection (LAR), which can be performed by open surgery or laparoscopically using the Knight-Griffen technique, also known as the double staple technique. . Under general anesthesia, the rectum is mobilized from the sacrum, including division of the lateral ligament, under direct laparoscopic observation or by open surgery. The intestine is divided between the sigmoid colon and the rectum using, for example, a linear stapler. The lower rectum (including the tumor) is then transected using a linear or contour stapler.

  Thus, a stapled proximal colon stump and a stapled rectal stump are formed, which need to be combined to re-establish colon-rectal continuity.

  For this purpose, a circular stapler anvil is introduced into the proximal colon stump through a small skin incision, for example in the left lower abdomen, and a shaft cartridge device of the circular stapler is inserted through the rectum through the anus. The shaft and anvil of the circular stapler are then reapplied under laparoscopic observation, closed and fired. During this end-to-end anastomosis, a circular staple line is released over the previous line of used staples to make a transverse rectal incision (staple crossing), which can cause leakage at the anastomosis site.

  Furthermore, with known devices and procedures in both laparoscopic and open surgery, it is difficult for the surgeon to determine the exact positioning of the stapler relative to the tumor to be excised. In particular, if the tumor location makes it impossible to flip the rectum through the anal canal and the transverse incision at the rectal stump is formed by incision or laparoscopic stapling, the resection directly visualizes the tumor Without being done blindly.

  Accordingly, there is a need to have a free-use surgical device and method that overcomes the shortcomings of prior art instruments and methods for low anterior rectal resection and end-to-end anastomosis of colon and rectal stumps.

  Accordingly, an object of the present invention is a surgical device for rectal stump closure in a rectal resection intervention that combines endoscopic-laparoscopic or endoscopic-incision features that overcome the drawbacks listed with respect to the prior art. It is to provide a surgical device.

  Within the scope of the foregoing objective, a particular object of the present invention is to propose a rectal stump closure device and method that prevents or reduces staple line crossings during end-to-end anastomosis of the colon and rectal stumps.

  A further specific object of the present invention is to propose a rectal stump closure device and method that allows direct visual control of the tumor or lesion to be excised.

These objects are achieved by a surgical device for closure of the rectal stump, the surgical device comprising:
A circular anal dilator defining a passage opening;
An anoscope configured to be insertable through a passage opening of a circular anal dilator having a distal end;
A rectal stump closure obturator having a first peripheral tie up surface, wherein the first peripheral anchoring surface is located outside the rectal lumen from the rectal lumen to the first peripheral anchoring surface. A rectal stump obturator configured to be moored with
An obturator connector that removably connects the rectal stump closure obturator to the distal end of the anoscope.

  The stump closure device allows the surgeon to close the rectal stump by tethering the rectum to the rectal stump closure obturator, and tightening and resecting the rectum during an anoscope to which the rectal stump closure obturator is connected. The stump obturator and rectum are stabilized, and finally the anoscope can be removed, leaving the rectal stump obturator in place.

  This allows the surgeon to create a purse-like rectal stump to avoid or at least reduce staple crossing during end-to-end anastomosis.

  According to one aspect of the invention, the surgical device includes a distal obturator, the distal obturator being arranged distally from the rectal stump closure obturator, and a second peripheral anchoring surface, The rectum has a second peripheral anchoring surface configured to be anchored from the outside of the rectum to a second peripheral anchoring surface. The first and second anchoring surfaces define two adjacent anchoring planes. A latch member connects the rectal stump closure obturator and the distal obturator between two adjacent anchoring planes, the latch member cutting the cutting device during rectal resection between the two anchoring planes. It may be configured to form a block, such as a knife or RF snare.

  The latch member may be removably connected to one or both of the rectal stump closure plug and / or the distal plug plug, or may be configured to be disconnected by a cutting device so that a transverse incision is made from the rectal stump. Can be removed.

  According to a further aspect of the invention, the rectal stump obturator and the distal obturator are approximately coaxial with the longitudinal axis of the anoscope and have a diameter smaller than the diameter of the anoscope, the distal plate comprising: Arranged distally from the distal obturator, the distal plate has a diameter greater than the diameter of the rectal stump obturator and the distal obturator. Both the distal end of the anoscope and the distal plate define a window opening that extends radially beyond the rectal stump obturator and the distal obturator so that it is far away. Transanal visual access to the distal tumor or other lesion from the distal plate is provided. This allows the surgeon to accurately place the anoscope and two adjacent anchoring planes against the tumor before tightening the rectum against the obturator anchoring surface. Thus, the positioning of the transverse incision plane (between two adjacent anchoring planes) with respect to the tumor is much more accurate than with known devices.

  According to a further aspect of the present invention, the anchoring surface of the rectal stump closure and distal obturator forms a peripheral channel that allows the snare to be positioned and clamped around the rectum by open surgery or laparoscopy And facilitate tightening.

  According to a further aspect of the invention, the surgical device includes a toothed zip tie for tightening the rectum against the rectal stump obturator and the distal obturator, respectively.

  According to a further aspect of the invention, the surgical device includes a laparoscopic or open surgical cutting means, such as a radio frequency snare, distal from the first anchoring surface and between the first and second anchoring surfaces. Make a transverse incision.

  These and other objects and advantages of the invention will become apparent from the accompanying drawings and description thereof. The accompanying drawings and description thereof illustrate embodiments of the invention, and together with the general description of the invention described above and the detailed description of the embodiments described below, serve to explain the principles of the invention.

  Referring to the drawings wherein like reference numerals indicate like components throughout the several views, FIG. 1 shows a surgical device 1 for closing a rectal stump in a rectal resection intervention.

  The apparatus 1 includes a circular anal dilator 2, an anoscope 3, a rectal stump closure obturator 4, an obturator connector 5, a distal plate 6 with a distal obturator 7, a latch member 8, including.

  Throughout the description of the surgical device, the expressions “distal” and “proximal” relate to the surgeon's point of view. For the gastrointestinal tract, the expression “distal” indicates “towards the mouth” and the expression “proximal” indicates “towards the anus”.

  The circular anal dilator 2 (CAD) includes a circular cylindrical ring wall 9, which is configured to be inserted transanally into the rectum and has a passage opening 10. Is defined inside. The passage opening 10 provides a transanal access opening for visualization and surgery and protects the inner sphincter and anal wall from damage. A connecting portion 11 is arranged at the proximal end of the ring wall 9 and is configured to hold the ring wall 9 inside the rectum. The connecting portion 11 includes two opposing flat wings 12, 13 that project laterally outward from the ring wall 9 to accommodate the anatomy of the patient's anus and perianal region. Inclined proximally. Each wing 12, 13 has a narrow bottleneck portion 14 and a ring-shaped end configured to be sewn to the skin around the patient's anus to secure the position of the device 1 within the anus. 15 are formed.

  The anoscope 3 includes a side wall 16 having a straight cylindrical shape defining a working channel 17 and a distal end 18. The side wall 16 is insertable, is translatable and rotatable longitudinally (in the distal-proximal direction DP) inside the ring wall 9 of the circular anal dilator 2, and proximal Includes an edge 19 or flange. The proximal edge 19 or flange can extend radially beyond the inner surface of the ring wall 9 to define the end of stroke surface, so that the anoscope 3 is ringed inside the rectum. It is prevented from being inserted too far through the wall 9. The flat handle portion 20 projects laterally-proximal from the proximal edge 19 and is configured to allow manual rotation and translation of the anoscope 3 inside the ring wall 9 of the anal dilator. And adjust the position of the distal end 18 to which the rectal stump obturator and the distal plate are connected to the tumor or lesion to be removed.

  The distal end 18 of the anoscope 3 includes a distal end wall 21 configured to provide an adjacent surface to the rectal stump obturator 4 and the rectal stump closure obturator 4 away from the analscope 3. One or more seats configured to receive one or more obturator connectors 5 that hold securely against the distal end wall 21. According to certain embodiments, the distal end wall 21 includes a substantially flat ring wall arranged approximately perpendicular to the longitudinal axis of the anoscope 3. The ring wall 21 engages the rectal stump closure obturator 4 through the ring wall 21 to lock the rectal stump closure obturator 4 against the distal end 18 of the anoscope. A through hole 22 sized so as to be matched is formed.

  According to an alternative embodiment, the distal end wall 21 defines a seat that directly engages the rectal stump closure obturator 4, for example by snap engagement, screwing or press fit.

  According to a further embodiment, the rectal stump closure obturator 4 is formed integrally with the anoscope 3 and the point at which a breakage is to occur to separate the rectal stump closure obturator 4 from the anoscope 3 or It is connected to the distal end wall 21 or the side wall 16 by a connector such as a breaking tie having a wire, a breaking rib or a breaking wall.

  The distal end 18 of the anoscope 3 further includes one or more window openings 23, which extend radially beyond the rectal stump closure obturator 4 and the distal obturator 5, Allows direct transanal visualization of the tumor 48 or other lesion and its margin. This allows the surgeon to accurately place the surgical device against the tumor and thus better control the ablation site and rectal stump formation.

  According to one embodiment, the distal end 18 of the anoscope 3 includes an approximately truncated cone shaped window ring 24, which is the distal edge (conical frustum) of the cylindrical side wall 16. At least one, preferably three or four inclined bars 25 connecting the distal end wall 21 (forming the smaller base of the truncated cone). A window opening 23 defined between the bar 25, the distal end wall 21 and the side wall 16 extends radially outside the distal end wall 21 and extends from the obturator 4 and 7 to the region distal to it. Provide direct visual access or even instrument access.

  On the concave surface 26 on the inside of the side wall 16, a graded series of marks 27 is printed, embossed or otherwise applied, indicating for example a centimeter scale, so that the insertion depth of the anoscope is A direct visual indication of the distance and distance of the distal end 18 from the anal rim. Each mark 27 may include a central numeral indicating the distance from a fixed reference point in the proximal end region of the sidewall 16 and one or two reference lines extending to either side of the numeral, Thus, it is easy to associate a specific distance to an instrument that is not located too close to the number without being compromised by the difficult visual prospective provided by the relatively long tubular working channel 17 Can do.

  As already mentioned, the anoscope 3 is slidably and rotatably received by the ring wall 9 of the circular anal dilator 2 to provide access to a depth of about 5-15 cm from the anal edge. It has a length that protrudes distally from.

  The ring wall 9 of the anal dilator 2 defines a group of parallel latch ribs 67 extending circumferentially on its inner surface, and the side wall 16 of the anoscope 3 is a group of circumferentially extending outer surfaces. A parallel corresponding latch rib 68 is defined, and the corresponding latch rib 68 is configured such that the corresponding latch rib 68 can be engaged with and disengaged from the latch rib 67 by rotational movement of the anoscope 2 relative to the anal dilator 2. Has been. In the disengaged configuration, the anoscope 3 can translate in the distal-proximal direction within the anal dilator 2, and in the engaged configuration, the anoscope 3 moves to the anal dilator 2. It is locked against.

  For this purpose, the latch rib 67 and the corresponding latch rib 68 extend only along a limited portion of the periphery of the opposing surfaces of the anal dilator and the anoscope, and in an unlocked configuration, the latch rib 67 is It can be positioned in a zone without a corresponding latch rib.

  The rectal stump closure obturator 4 includes a ring body with a substantially flat proximal end face 28 configured to be held against the distal end wall 21 of the anoscope 3. A passage zone 29 is formed in the ring body where the trocar 40 of the circular stapling device 41 passes through the rectal stump closure obturator 4 and the stapling assembly 42 of the stapling device 41 during end-to-end anastomosis and It is comprised so that the anvil 43 may be connected. Such a passage zone 29 may be embodied as a channel 29 or alternatively as a part made of an easily pierceable material such as rubber or expanded polymer. Therefore, the ring body of the rectal stump closure obturator 4 is not necessarily from the beginning, but when it is punctured by the trocar 40 of the circular stapling device 41, it becomes an annular shape.

  The ring body of the rectal stump closure obturator 4 includes a first outer peripheral anchoring surface 30 that extends across the periphery of the obturator 4 and is intended to provide an abutment. The lumen of the rectum 46 can be moored from the outside against this abutment to form a closure for the rectal stump 47.

  According to certain embodiments, the first anchoring surface 30 is positioned around the rectum and then has a peripheral groove 31 to facilitate positioning and tightening of the snare 34 that can be tightened by open surgery or laparoscopy. Including. Thanks to the peripheral groove 31, while tightening the snare 34, the snare 34 is biased to accurately position the snare 34 on the first anchoring surface 30, and the annular structure of the rectum 46 is located inside the peripheral groove 31. Is pushed between the snare 34 and the first mooring surface 30.

  The rectal stump closure obturator 4 further includes a coupling seat 32 provided to connect the distal plate 6 to the rectal stump closure obturator 4. According to one embodiment, the coupling seat 32 is formed near the distal end face 33 of the rectal stump closure obturator 4 as a groove or as a separate separate latch member 8 dedicated to or instead of the distal plate 6. Can be embodied as a cavity having an undercut suitable for engaging a corresponding tooth or edge.

  If an obturator connector 5 is provided, the obturator connector 5 connects the rectal stump closure obturator 4 to the distal end 18 of the anoscope 3. As already mentioned, the obturator connector 5 may be embodied as an integral part of the anoscope 3 and the rectal stump closure plug 4, which are manufactured as a single piece and the rectal stump closure plug. It is provided with points or lines that are intended to cause destruction in order to separate the child 4 from the anoscope 3.

  Instead, the obturator connector 5 is formed on either the rectal stump closure obturator 4 and the distal end 18 of the anoscope, and on the rectal stump closure obturator 4 and the distal end 18 of the anoscope. It may be embodied as a connecting portion configured to removably engage each of the other.

  According to the exemplary embodiment shown in FIGS. 1 and 2, the obturator connector 5 engages both the rectal stump closure obturator 4 and the connector receiving seat at the distal end 18 of the anoscope. The two elastic springs 51 and 52 are included. When in their operating position, the elastic springs 51, 52 extend through the hole 22 in the distal end wall 21 and at least partially through the passage channel 29 of the rectal stump closure obturator 4. The proximal ends 49 of the springs 51, 52 are positioned so that they can be accessed by the grasping instrument 50 through the working channel 17 of the anoscope 3. This makes it possible to grip the springs 51, 52 and remove, cut or break the springs 51, 52 to separate the anoscope 3 from the rectal stump closure obturator 4.

  According to one embodiment, the obturator connector includes a bayonet connector 69 rotatably supported by the distal end 18 of the anoscope. The insertion pin connector 69 includes a distal bayonet key 70 configured to removably engage a corresponding insertion pin seat 71 formed on the rectal stump closure obturator 4, and an anus. Projecting proximally into the working channel 17 of the mirror and including an actuating portion 72 that is to be grasped and rotated transanally by a surgical grasping device. The actuating portion 72 has a flat plate-like shape and the insertion pin connector 69 is visually aligned with the slant bar 25 of the anoscope window ring 24 in the obturator-connected configuration. It is configured so as not to prevent access (FIGS. 18 and 19).

  The distal plate 6 includes a distal obturator 7 arranged distally from the rectal stump closure obturator 4 and having a second peripheral anchoring surface 52.

  Similar to the rectal stump closure obturator 4, the second anchoring surface 52 may also extend integrally around the distal obturator 7 and is intended to provide an abutment for which the rectum 46 lumens can be anchored from the outside to form a closure for the rectal portion 54 to be removed.

  According to certain embodiments, the second anchoring surface 52 is positioned around the rectum 46 to facilitate positioning and tightening of the second snare 34 'that can be subsequently tightened by open surgery or laparoscopy. The second peripheral groove 55 is included. Thanks to the second peripheral groove 55, during tightening of the snare 34 ′, the snare 34 ′ is biased to accurately position the snare 34 ′ over the second anchoring surface 52 and the annular structure of the rectum 46 is And is pushed between the snare 34 ′ and the second anchoring surface 52 inside the peripheral groove 55.

  The distal plate 6, more precisely the distal obturator 7, includes a coupling seat 56 provided to connect the distal plate 6 to the rectal stump closure obturator 4.

  According to one embodiment, the connecting seat 56 is formed near the proximal end face 57 of the distal obturator 7 and is a separate latch member 8 dedicated as a groove or for the rectal stump closure obturator 4 or alternatively. Can be embodied as a cavity having an undercut suitable for engaging a corresponding tooth or edge.

  According to an embodiment, the distal plate 6 has an enlarged ring 58 arranged distally from a distal enlarged portion, for example a distal obturator 7 and having a diameter smaller than the inner diameter of the passage opening 10 of the anal dilator 2. And allows insertion of the anoscope 3 with the rectal stump closure obturator 4 and the distal plate 6.

  The expansion ring 58 is connected to the distal obturator 7 by at least one, preferably three or four inclined bars 59. The free space defined between the bar 59 and the expansion ring 58 provides a window opening 60 that extends radially outside the distal obturator 7 and from the distal obturator 7. And also provide direct visual access, or even instrument access, to a region distal to the expansion ring 58.

  According to one aspect of the invention, the surgical device is between the distal enlarged ring 58 and the distal anchoring plane (defined by the anchoring surface 53 of the distal obturator 7) as well as the ablation plane (between the obturators 4, 7). Is designed to provide sufficient clearance between the tumor or lesion boundary and the ablation plane and tissue squeezing zone, and a precise reproduction of the ablation ring 58 in front of the tumor will result in a standardized reproduction of the ablation plane Possible positions are automatically determined.

  According to certain aspects of the present invention, the distal obturator 7 is configured as a substantially impermeable block, and leakage and tumor dissemination are prevented during both resection and removal of the rectal portion 54.

  The overall frustoconical shape of the distal plate 6 and the frustoconical shape of the distal end 18 of the anoscope 3 define an overall peripheral groove, which provides guidance, Facilitates precise positioning of the mooring snares 34, 34 ', band or tape 35 described in detail.

  As already mentioned, the distal plate 6 may be connected to the rectal stump closure obturator 4 in different ways. According to certain embodiments, a latch member 8 may be provided, which includes a proximal flange 36 configured to engage the coupling seat 32 of the rectal stump closure obturator 4, and a distal plate. A distal flange 37 configured to engage a corresponding coupling seat 56 formed in the six distal obturators 4. Removable or reversible between the obturators 4, 7 in order to separate the healthy rectal stump 47 and the unhealthy luminal part containing the tumor 48 around each obturator 4, 7 before separating them It is desirable to configure the latch member 8 to provide a secure connection.

  This can be done, for example, by making the latch member 8 from a material (rubber, polymer) that can be cut off by snap fit or press fit or by the same cutting device used for rectal resection, by connecting flanges 36, 37 of the latch member 8. And by configuring them so that the respective connecting seats 32, 56 of the obturators 4, 7 can be removably engaged. For this purpose, the latch member 8 can be configured to form a cutting block for a cutting device, for example a laparoscopic high-frequency snare 62.

  Furthermore, opposing peripheral guide surfaces 39 may be formed in the latch member 8 itself, or alone or together with the latch member 8 in the obturators 4, 7 that define the peripheral cutting groove 61. The peripheral cutting groove 61 allows the cutting device to position the cutting device itself at a predetermined cutting plane between the first and second anchoring planes determined by the corresponding first anchoring surface 30 and second anchoring surface 53. Is to encourage.

  According to one embodiment, the rectal stump closure obturator 4 and the distal obturator 7 are approximately coaxial with the longitudinal axis L of the anoscope 3, and the anoscope side wall 16 and the distal plate expansion ring 58 It has a diameter that is smaller than the diameter, allowing the tumor to be visualized directly transanally through the obturators 4,7.

  Looking again at the tightening snares 34, 34 ′, according to one embodiment, a toothed zip tie can be used to anchor the rectum 46 to the rectal stump closure obturator 4 and the distal obturator 7, respectively ( 4 and 6). Toothed zip ties provide a ratchet-like one way and non return tightening.

  Mooring snares 34, 34 'can be applied laparoscopically or by an incision procedure.

  Alternatively (FIGS. 15-17), the clamping snare can be anchored around the rectum 46 and locked in a tissue compression configuration by a locking member, such as a staple or clip 63 or a ratchet-like toothed locking portion. .

  According to one embodiment, the inner surface of the fastening snare or fastening band, which is to be opposed to the first anchoring surface 30 and the second anchoring surface 53, is shaped in the manner of the anchoring surfaces 30, 53, in particular the peripheral grooves 31, 55. The shape is approximately complementary to the shape.

  Both anchoring planes during transverse incision of the rectum with the same cutting instrument having a width that extends over both the rectal stump closure obturator 4 and the distal obturator 7 and used to transversely incise the rectal lumen It is also contemplated to provide an anchoring tape 35 that can be cut between.

  According to one embodiment, the anchoring snare and cutting instrument is secured to the loop tape 35 having a width that covers both the rectal stump closure plug 4 and the distal plug 7, and the loop tape 35. It is integrated into a single open surgical or laparoscopic device that includes a cutting snare extending parallel to the extension of the tape 35 along the centerline, such as a high frequency snare 64 or a mechanical or mechanical vibration cutting snare. Thus, the clamped tape 35 ensures the correct position of the integrated cutting snare (eg, RF snare 64) during cutting.

  20 and 21 illustrate an exemplary, non-limiting embodiment of an open surgical and / or laparoscopic anchoring tape applier 73. The applier 73 includes a proximal handle 74, a distal tape anchor assembly 75, and an elongated straight or curved shaft 79 that extends from the handle 74 to the tape anchor assembly 75. The tape securing assembly 75 includes a tape holder seat 76 that supports the tape 35 during positioning and clamping, a tape pulling mechanism operable by a lever 77 or other manually moving member, a staple fastener, and a clip applier. Or a tape locking device that can be embodied as a ratchet-like toothed locking seat provided directly at one end of the tape.

  The tape applier 73 also includes a cutting mechanism that includes a mechanical cutting blade that is housed in the tape securing assembly 75 and that is manually operable through a cutting actuating member, such as a knob 78, connected to the cutting mechanism. Alternatively, a heatable, eg, resistive cutting edge coupled with an energizing circuit may be provided, which can be activated by moving an electrical switch on the handle 74.

  If an RF or mechanical cutting snare is integrated into the mooring tape 35, the tape applier 73 may also include a cutting snare tensioning mechanism and an energizing circuit for the cutting snare.

  According to a further embodiment, a peripheral cutting blade may be provided between the first and second anchoring surfaces, the blade being used to clamp the rectum tube while tightening the rectum against the first and second anchoring surfaces. The cavity can be configured to be pressed against the blade and disconnected from the inside.

  Alternatively, a cutting blade may be rotatably mounted between the first and second anchoring surfaces, and the blade is moved through the luminal wall tissue by the rotational motion produced by the manually operable rotating rod. sell. The rotating rod is in torsional engagement with the cutting blade and extends into the working channel 17 of the anoscope.

  As those skilled in the art will appreciate, the anchoring tape applicator described above provides easy access to the lower anterior rectal region by laparoscopic or open surgery and attaches the anchoring tape with controllable traction, It is possible to perform excision at a more preferable working position as compared with.

  In accordance with a further aspect of the present invention, a circular stapling device 41 is provided, which includes a handle, an insertion shaft, an anvil access mechanism, a staple driving mechanism and a cutting mechanism coupled to the staple fixing assembly. 42, and a stapler main body 65 provided with the main body 65. The circular stapling device 41 further includes an anvil 43 with a proximal stapling surface and a proximally projecting connection shaft 44. A connecting trocar 40 is operably linked to the anvil access mechanism and protrudes distally from the staple securing assembly 42. The connecting trocar 40 and the connecting shaft 44 are configured to removably engage each other and to couple the anvil 43 to the main body 65 of the circular stapling device 41 in a manner that transmits tension. The circular stapling device 41 is particularly suitable for anastomosing the rectal stump 47 with the proximal colon stump 66 end-to-end. For this reason, the outer diameter of the staple fixing assembly 42 is slightly smaller than the inner diameter of the passage opening 10 of the anal dilator 2.

  Further, the staple securing assembly 42 and / or anvil 43 defines a tissue receiving cavity 45 having a diameter and depth greater than the outer diameter and axial length of the rectal stump closure obturator 4. In particular, the tissue receiving cavity 45 receives the rectal stump closure obturator 4 with a tethered snare (the overhanging lace may be cut off prior to performing the anastomosis) and a clamped tissue ring. Has a sufficient diameter and depth.

  According to a further embodiment, the surgical device has a first anchoring surface 30 and / or a second anchoring surface 53 and / or by a sufficiently strong optical signal to pass through the rectal wall and to be visible from outside the rectal lumen. Illumination means configured to mark the ablation plane is included to indicate the exact location of the mooring snare and ablation. Such illuminating means includes optical fiber light transmitting means extending along the anoscope and terminating near the first anchoring surface 30 and the second anchoring surface 53, which may be at least partially transparent. Good.

  3-14 illustrate a method for performing rectal resection, rectal stump closure, and rectal stump end-to-end anastomosis with a surgical device according to the present invention.

  After the circular anal dilator 2 is introduced into the patient's anus and the circular anal dilator 2 is secured on the skin around the anus with stay sutures, the rectal stump closure obturator 4 and the distal plate 6 are attached. The anoscope 3 to be held is introduced into the passage opening 10 of the dilator 2 and locked in place with respect to the dilator 2 (FIG. 3).

  During insertion of the anoscope 3 through the circular anal dilator 2, the anoscope is held in an angled position with respect to the anal dilator and the latch rib 67 of the anal dilator 2 and the corresponding latch rib 68 of the anoscope 3 interfere. Without it, the length of the anoscope 3 (proximal-distal) is allowed to move. Once the anoscope 3 is positioned at the correct insertion depth, the anoscope 3 is rotated relative to the anal dilator 2 and the latch rib 67 engages the corresponding latch rib 68, so that the anal dilator 2 is Thus, the anoscope 3 is locked in the length direction.

  First and second anchoring snares, particularly zip ties 34, 34 ', are looped around the rectum 46 by laparoscopic or open surgery (FIG. 4).

  The positioning of the anoscope and zip tie is aided by direct transanal visualization through the distal end 18 of the anoscope and the window openings 23, 60 of the distal plate 6 (FIG. 5).

  The surgical device is such that the distance between the distal dilating ring 58 and the distal anchoring plane (defined by the anchoring surface 53 of the distal obturator 7) as well as the ablation plane (between the obturators 4, 7) is such that the tumor or lesion is Note that it is designed to determine the exact clearance between the boundary and the ablation plane and tissue squeeze zone. Thus, by positioning the distal plate 6 with the distal expansion ring 58 in front of the tumor, it is possible to obtain a standardized and reproducible clearance between the tumor and the tissue compression zone and the ablation plane.

  Once accurate positioning of the rectal stump closure obturator 4 with respect to the tumor 48 has been achieved, the zip tie 34 can be used to secure the first anchoring surface 30 and second anchoring surface of the rectal stump closure obturator 4 and the distal obturator 7, respectively. The rectal stump is tightened around the obturators 4, 7 which are clamped around 53 and supported and stabilized by the anoscope 3. The obturator is still securely connected to the anoscope 3. At this stage, the peripheral grooves 31 and 55 of the obturators 4, 7 receive the zip ties 34, 34 'and ensure the correct positioning of the zip ties (FIGS. 6, 7). After sealing the rectum 46 against the obturators 4, 7, an excision can be made between the two anchoring planes. For this purpose, an open surgery or laparoscopic cutting device is brought into place and the rectum is transected between the zip ties 34, 34 '. According to certain embodiments, the use of an RF snare (FIG. 8) inserted over the rectal stump 47 and clamped between the distal obturator 7 and the rectal stump closure obturator 4 is contemplated. Thanks to the guide surface 39, a cutting groove 61 is provided between the obturators 4, 7, which allows the RF snare 62 to self-align during the transverse incision.

  According to an embodiment of the present invention, the cutting instrument cuts completely through both the rectum and the latch member 8, thereby removing the rectal stump from the rectal lumen portion 54 to be removed. The rectal stump closure obturator 4 is separated from 6 (FIGS. 8, 9, and 10).

  According to another embodiment, the cutting instrument cuts the rectum, but the latching element 8 does not transect, and the latching element 8 is then disengaged from the distal obturator or rectal stump closure obturator, The obturators can be separated from each other.

  Once the rectal resection is complete (FIG. 10), the unhealthy luminal portion 54 containing the tumor 48 or lesion is removed from the patient.

  A healthy rectal stump 47 can be thoroughly washed and rinsed to remove any remaining tumor cells that may have been accidentally seeded or pushed into healthy tissue.

  A healthy rectal stump 47 that is still joined by a tethered snare (zip tie 34) is now ready for end-to-end anastomosis, and a proximal colon stump 66 is either by purse string closure or straight stapling Has already been prepared.

  In order to provide access space for the circular stapling device 41, the anoscope 3 must be removed from the circular anal dilator 2 and therefore the anoscope 3 must be separated from the rectal stump closure obturator 4. Don't be. This is done by the surgical grasping instrument 50, which is inserted through the working channel 17 of the anoscope 3 to its distal end and then manipulated to the proximal portion of the obturator connector 5. 49, the obturator connector 5 is disengaged from the rectal stump closure obturator 4 (FIGS. 10 and 11).

  According to one embodiment, the anoscope 3 is designed to break the rectal stump closure obturator 4 by breaking one or more connection bridges between the anoscope distal end 18 and the rectal stump closure obturator 4. Can be separated from

  Circular stapling device 41 is now introduced through anal dilator 2 until its staple securing assembly 42 reaches rectal stump closure obturator 4. A connecting trocar 40 projecting distally from the staple securing assembly 42 is inserted through the passage zone 29 of the obturator 4 or passes through the passage zone 49. The anvil 43 of the circular stapling device 41 is introduced through a small incision into the proximal colon stump 66 and purse string purging is performed around its connecting shaft 44. The shaft 44 and trocar 40 are then connected under laparoscopic observation and the stapling device 41 is closed and fired. A so-called cut-out tissue donut is encapsulated in a dedicated tissue receiving space 45 together with the rectal stump closure obturator 4 and the anchoring snare 34 (FIGS. 13 and 14).

  The circular stapling device 41 is then pulled proximally from the patient, the tissue donut is checked, and a leak test is performed to ensure that the anastomosis is air-liquid tight.

  The apparatus and method described above have many advantages. These devices and methods allow direct visual control of the tumor to be cut prior to making the rectal stump, and by creating a staple-free rectal stump that can be fully contained in the tissue receiving cavity of the stapler. , Avoid cross-stapling. This eliminates the risk of leakage associated with prior art double staple techniques.

  The present invention is illustrated by the description of several embodiments, and the exemplary embodiments are described in considerable detail, but the claims are limited to such details or limited in any way. Not intended to do.

Embodiment
(1) In a surgical device used in rectal resection surgery, including a rectal stump closure device (1),
A circular anal dilator (2) defining a passage opening (10);
An anoscope (3) configured to be insertable through the passage opening (10) of the circular anal dilator (2) having a distal end (18) When,
A rectal stump closure obturator (4) having a first peripheral anchoring surface (30), wherein the first peripheral anchoring surface (30) is connected to the rectum (46) from outside the rectum (46). A rectal stump closure obturator (4) configured to be anchored to the first peripheral anchoring surface (30);
An obturator connector (5) removably connecting the rectal stump closure obturator (4) to the distal end (18) of the anoscope (3);
Including a surgical device.
(2) In the surgical apparatus according to Embodiment 1,
A distal obturator (7) arranged distally from the rectal stump obturator (4) and having a second peripheral anchoring surface (53), the second peripheral anchoring surface (53) Is configured such that the rectum (46) can be anchored to the second peripheral anchoring surface (53) from outside the rectum (46), and the first and second anchoring surfaces ( 30, 53), the distal obturator (7) defining two adjacent anchoring planes;
A latch member (8) connecting the rectal stump closure obturator (4) and the distal obturator (7) between the two adjacent anchoring planes; A latch member (8) forming a cutting block for the cutting device (62; 64) during resection of the rectum (46);
And a surgical device.
(3) In the surgical apparatus according to Embodiment 2,
The surgical apparatus wherein the latch member (8) is removably connected to one of the rectal stump closure obturator (4) and the distal obturator (7).
(4) In the surgical apparatus according to embodiment 2,
Surgical device wherein the latch member (8) is configured to be disconnected by the cutting device (62; 64) during resection of the rectum (46).
(5) In the surgical apparatus according to any one of Embodiments 1 to 4,
The rectal stump closure obturator (4) is approximately coaxial with the longitudinal axis (L) of the anoscope (3) and smaller than the inner diameter of the working channel (17) of the anoscope (3) Has an outer diameter,
The distal end (18) of the anoscope defines a window opening (23) that extends radially beyond the rectal stump obturator (4), whereby the rectal stump closure obturator A surgical device that provides transanal visual access of a tumor (48) or other lesion distal to (4).
(6) In the surgical apparatus according to any one of Embodiments 1 to 5,
The rectal stump closure obturator (4) and the distal obturator (7) are approximately coaxial with respect to the longitudinal axis (L) of the anoscope (3) and of the anoscope (3) Having an outer diameter smaller than the inner diameter of the working channel (17);
A distal enlarged portion (58) is arranged distally from the distal obturator (7), the distal enlarged portion (58) comprising the rectal stump closure obturator (4) and the distal obturator. Having a diameter larger than the diameter of (7),
The distal end (18) of the anoscope and the distal enlarged portion (58) have a window opening extending radially beyond the rectal stump obturator (4) and the distal obturator (7). Surgical device defining a portion (23, 60), thereby providing transanal visual access of a tumor (48) or other lesion distal from the distal enlarged portion (58).
(7) In the surgical apparatus according to any one of Embodiments 1 to 6,
The anchoring surface (30, 53) of the rectal stump closure obturator (4) and the distal obturator (7) forms a peripheral groove (31, 55) to form a rectal stump closure obturator (4 ) And the anchoring snare (34, 34 '; 35) around the distal obturator (7) and the surgical device.
(8) In the surgical apparatus according to any one of Embodiments 1 to 7,
Toothed zip ties (34, 34 ') for anchoring the rectum (46) to the rectal stump closure obturator (4) and to the distal obturator (7), respectively;
Including a surgical device.
(9) In the surgical apparatus according to any one of Embodiments 1 to 8,
The rectum (46) is inserted between the first and second anchoring surfaces (30, 53) so as to be inserted over a rectal stump (47) and distally from the first anchoring surface (30). ) A high frequency snare (62), configured to transect
Including a surgical device.
(10) In the surgical apparatus according to any one of Embodiments 1 to 9,
The distal end (18) of the anoscope (3) forms a substantially flat ring wall (21) arranged approximately perpendicular to the longitudinal axis (L) of the anoscope 3 The ring wall (21) is inserted into the rectal stump closure obturator (4) through the ring wall (21) so that the obturator connector (5) passes through the distal end (18) of the anoscope. Surgical device defining a through hole (22) dimensioned to be able to engage and lock with respect to.

(11) In the surgical apparatus according to any one of Embodiments 1 to 10,
Surgical device, wherein the obturator connector (5) includes a seat formed at the distal end (18) that removably connects directly to the rectal stump closure obturator (4).
(12) In the surgical apparatus according to any one of Embodiments 1 to 11,
The rectal stump closure obturator (4) is formed integrally with the anoscope (3) and is broken to separate the rectal stump closure obturator (4) from the anoscope (3). Surgical device connected to the distal end (18) of the anoscope (3) by a breaking member having a point that is intended to occur.
(13) In the surgical apparatus according to any one of Embodiments 1 to 12,
The cutting instrument (62; 64) is at a predetermined cutting plane between the first and second anchoring planes determined by the first and second anchoring surfaces (30, 53). Opposing peripheral guide surfaces (39) defining peripheral cutting grooves (61) configured to facilitate positioning themselves;
Including a surgical device.
(14) In the surgical apparatus according to any one of Embodiments 1 to 13,
Circular stapling device (41),
Including
The circular stapling device (41) includes:
A stapler main body (65) comprising a handle, an insertion shaft, and a staple securing assembly (42) to which an anvil access mechanism, a staple drive mechanism and a cutting mechanism are operatively coupled;
An anvil (43) with a proximal staple forming surface and a proximally projecting connection shaft (44);
A connecting trocar (40) operably linked to the anvil access mechanism and projecting distally from the staple securing assembly (42);
Including
The connecting trocar (40) and connecting shaft (44) are configured to removably connect the anvil (43) to the main body (65) of the circular stapling device (41);
An outer diameter of the staple fixing assembly (42) is smaller than an inner diameter of the passage opening (10) of the anal dilator (2);
The staple anchoring assembly (42) and the anvil (43) included the anchoring snare (34) and an annulus of tissue clamped between the staple anchoring assembly (42) and the anvil (43). A surgical device defining a tissue receiving cavity (45) having a diameter and depth greater than the outer diameter and axial length of the rectal stump closure obturator (4).
(15) In the surgical method of performing rectal resection,
Creating a rectal stump (47);
Creating a proximal colon stump (66);
Performing an end-to-end anastomosis to join the rectal stump (47) and proximal colon stump (66) with a continuous lumen;
Including
Said step of creating a rectal stump (47) comprises:
Inserting the rectal stump obturator (4) into the rectum (46) transanally, the rectal stump closure obturator (4) defining a first peripheral anchoring surface (30); Process,
An anchoring snare (34; 35) is positioned around the rectum (46) and the anchor snare (34) is pressed against the first anchoring surface (30) of the rectal stump closure obturator (4). 35) closing the rectal stump (47) by tightening; and
Transecting the rectum (46) distally from the first anchoring surface (30);
Including a method.

1 is an exploded side view of a surgical apparatus for rectal stump closure according to an embodiment of the present invention. FIG. FIG. 2 is a cross-sectional view of the device of FIG. 1 in a longitudinal cross-sectional plane, the device being in an assembled configuration. FIG. 3 illustrates the use of the apparatus of FIG. 1 with an anchoring device and ablation device in certain aspects of a method of rectal resection, rectal stump closure and colon-rectal stump end-to-end anastomosis, according to embodiments of the present invention. FIG. 3 illustrates the use of the device of FIG. 1 with an anchoring device and ablation device in another aspect of a method of rectal resection, rectal stump closure and colon-rectal stump end-to-end anastomosis, according to an embodiment of the present invention. FIG. 3 illustrates the use of the device of FIG. 1 with an anchoring device and ablation device in another aspect of a method of rectal resection, rectal stump closure and colon-rectal stump end-to-end anastomosis, according to an embodiment of the present invention. FIG. 3 illustrates the use of the device of FIG. 1 with an anchoring device and ablation device in another aspect of a method of rectal resection, rectal stump closure and colon-rectal stump end-to-end anastomosis, according to an embodiment of the present invention. FIG. 3 illustrates the use of the device of FIG. 1 with an anchoring device and ablation device in another aspect of a method of rectal resection, rectal stump closure and colon-rectal stump end-to-end anastomosis, according to an embodiment of the present invention. FIG. 3 illustrates the use of the device of FIG. 1 with an anchoring device and ablation device in another aspect of a method of rectal resection, rectal stump closure and colon-rectal stump end-to-end anastomosis, according to an embodiment of the present invention. FIG. 3 illustrates the use of the device of FIG. 1 with an anchoring device and ablation device in another aspect of a method of rectal resection, rectal stump closure and colon-rectal stump end-to-end anastomosis, according to an embodiment of the present invention. FIG. 3 illustrates the use of the device of FIG. 1 with an anchoring device and ablation device in another aspect of a method of rectal resection, rectal stump closure and colon-rectal stump end-to-end anastomosis, according to an embodiment of the present invention. FIG. 3 illustrates the use of the device of FIG. 1 with an anchoring device and ablation device in another aspect of a method of rectal resection, rectal stump closure and colon-rectal stump end-to-end anastomosis, according to an embodiment of the present invention. FIG. 3 illustrates the use of the device of FIG. 1 with an anchoring device and ablation device in another aspect of a method of rectal resection, rectal stump closure and colon-rectal stump end-to-end anastomosis, according to an embodiment of the present invention. FIG. 3 illustrates the use of the device of FIG. 1 with an anchoring device and ablation device in another aspect of a method of rectal resection, rectal stump closure and colon-rectal stump end-to-end anastomosis, according to an embodiment of the present invention. FIG. 3 illustrates the use of the device of FIG. 1 with an anchoring device and ablation device in another aspect of a method of rectal resection, rectal stump closure and colon-rectal stump end-to-end anastomosis, according to an embodiment of the present invention. FIG. 4 illustrates the use of the apparatus of FIG. 1 with an alternative anchoring device and ablation device in a method aspect of rectal resection and stump closure according to a further embodiment of the present invention. FIG. 4 illustrates the use of the apparatus of FIG. 1 with an alternative anchoring device and ablation device in a method aspect of rectal resection and stump closure according to a further embodiment of the present invention. FIG. 4 illustrates the use of the apparatus of FIG. 1 with an alternative anchoring device and ablation device in a method aspect of rectal resection and stump closure according to a further embodiment of the present invention. FIG. 6 is a partial side view of a surgical device according to a further embodiment of the present invention. FIG. 19 is an exploded perspective view of the apparatus of FIG. 18. 1 is a perspective view of a mooring tape applier according to an embodiment of the present invention. The details of the applier of FIG. 20 are shown.

Claims (14)

In a surgical device used in rectal resection surgery, including a rectal stump closure device (1),
A circular anal dilator (2) defining a passage opening (10);
An anoscope (3) configured to be insertable through the passage opening (10) of the circular anal dilator (2) having a distal end (18) When,
A rectal stump closure obturator (4) having a first peripheral anchoring surface (30), wherein the first peripheral anchoring surface (30) is connected to the rectum (46) from outside the rectum (46). A rectal stump closure obturator (4) configured to be anchored to the first peripheral anchoring surface (30);
An obturator connector (5) removably connecting the rectal stump closure obturator (4) to the distal end (18) of the anoscope (3);
Including a surgical device. The surgical device of claim 1, wherein
A distal obturator (7) arranged distally from the rectal stump obturator (4) and having a second peripheral anchoring surface (53), the second peripheral anchoring surface (53) Is configured such that the rectum (46) can be anchored to the second peripheral anchoring surface (53) from outside the rectum (46), and the first and second anchoring surfaces ( 30, 53), the distal obturator (7) defining two adjacent anchoring planes;
A latch member (8) for connecting the rectal stump closure obturator (4) and the distal obturator (7) between the two adjacent anchoring planes, wherein the latching member (8) between the two anchoring planes; A latch member (8) forming a cutting block for the cutting device (62; 64) during resection of the rectum (46);
And a surgical device. The surgical device of claim 2, wherein
The surgical device wherein the latch member (8) is removably connected to one of the rectal stump closure obturator (4) and the distal obturator (7). The surgical device of claim 2, wherein
Surgical device wherein the latch member (8) is configured to be disconnected by the cutting device (62; 64) during resection of the rectum (46). The surgical apparatus according to any one of claims 1 to 4,
The rectal stump closure obturator (4) is approximately coaxial with the longitudinal axis (L) of the anoscope (3) and smaller than the inner diameter of the working channel (17) of the anoscope (3) Has an outer diameter,
The distal end (18) of the anoscope defines a window opening (23) extending radially beyond the rectal stump closure obturator (4), whereby the rectal stump closure obturator A surgical device that provides transanal visual access of a tumor (48) or other lesion distal to (4). The surgical device according to any one of claims 1 to 5,
The rectal stump closure obturator (4) and the distal obturator (7) are approximately coaxial with respect to the longitudinal axis (L) of the anoscope (3) and of the anoscope (3) Having an outer diameter smaller than the inner diameter of the working channel (17);
A distal enlarged portion (58) is arranged distally from the distal obturator (7), the distal enlarged portion (58) comprising the rectal stump closure obturator (4) and the distal obturator. Having a diameter larger than the diameter of (7),
The distal end (18) of the anoscope and the distal enlarged portion (58) have a window opening extending radially beyond the rectal stump closure obturator (4) and the distal obturator (7) Surgical device defining a portion (23, 60), thereby providing transanal visual access of a tumor (48) or other lesion distal from the distal enlarged portion (58). The surgical device according to any one of claims 1 to 6,
The anchoring surface (30, 53) of the rectal stump closure obturator (4) and the distal obturator (7) forms a peripheral groove (31, 55) to form a rectal stump closure obturator (4 ) And the anchoring snare (34, 34 '; 35) around the distal obturator (7) and the surgical device. The surgical device according to any one of claims 1 to 7,
Toothed zip ties (34, 34 ') for anchoring the rectum (46) to the rectal stump closure obturator (4) and to the distal obturator (7), respectively;
Including a surgical device. The surgical device according to any one of claims 1 to 8,
The rectum (46) is inserted between the first and second anchoring surfaces (30, 53) so as to be inserted over a rectal stump (47) and distally from the first anchoring surface (30). ) A high frequency snare (62), configured to transect
Including a surgical device. The surgical device according to any one of claims 1 to 9,
The distal end (18) of the anoscope (3) forms a substantially flat ring wall (21) arranged approximately perpendicular to the longitudinal axis (L) of the anoscope 3 The ring wall (21) is inserted into the rectal stump closure obturator (4) through the ring wall (21) so that the obturator connector (5) passes through the distal end (18) of the anoscope. Surgical device defining a through hole (22) dimensioned to be able to engage and lock with respect to. The surgical device according to any one of claims 1 to 10,
Surgical device, wherein the obturator connector (5) includes a seat formed at the distal end (18) that removably connects directly to the rectal stump closure obturator (4). The surgical device according to any one of claims 1 to 11,
The rectal stump closure obturator (4) is formed integrally with the anoscope (3) and is broken to separate the rectal stump closure obturator (4) from the anoscope (3). Surgical device connected to the distal end (18) of the anoscope (3) by a breaking member having a point that is intended to occur. The surgical device according to any one of claims 1 to 12,
The cutting instrument (62; 64) is at a predetermined cutting plane between the first and second anchoring planes determined by the first and second anchoring surfaces (30, 53). Opposing peripheral guide surfaces (39) defining peripheral cutting grooves (61) configured to facilitate positioning themselves;
Including a surgical device. The surgical device according to any one of claims 1 to 13,
Circular stapling device (41),
Including
The circular stapling device (41) includes:
A stapler main body (65) comprising a handle, an insertion shaft, and a staple securing assembly (42) to which an anvil access mechanism, a staple drive mechanism and a cutting mechanism are operatively coupled;
An anvil (43) with a proximal staple forming surface and a proximally projecting connection shaft (44);
A connecting trocar (40) operably linked to the anvil access mechanism and projecting distally from the staple securing assembly (42);
Including
The connecting trocar (40) and connecting shaft (44) are configured to removably connect the anvil (43) to the main body (65) of the circular stapling device (41);
An outer diameter of the staple fixing assembly (42) is smaller than an inner diameter of the passage opening (10) of the anal dilator (2);
The staple anchoring assembly (42) and the anvil (43) included the anchoring snare (34) and an annulus of tissue clamped between the staple anchoring assembly (42) and the anvil (43). A surgical device defining a tissue receiving cavity (45) having a diameter and depth greater than the outer diameter and axial length of the rectal stump closure obturator (4).

Images