EP2224859A1 - A rectal stump closure device for rectal resection - Google Patents

A rectal stump closure device for rectal resection

Info

Publication number
EP2224859A1
EP2224859A1 EP08717126A EP08717126A EP2224859A1 EP 2224859 A1 EP2224859 A1 EP 2224859A1 EP 08717126 A EP08717126 A EP 08717126A EP 08717126 A EP08717126 A EP 08717126A EP 2224859 A1 EP2224859 A1 EP 2224859A1
Authority
EP
European Patent Office
Prior art keywords
rectal
plug
anoscope
distal
tie
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP08717126A
Other languages
German (de)
French (fr)
Inventor
Laszlo Csiky
Michele D'arcangelo
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ethicon Endo Surgery Inc
Original Assignee
Ethicon Endo Surgery Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from PCT/EP2007/062351 external-priority patent/WO2009062548A1/en
Application filed by Ethicon Endo Surgery Inc filed Critical Ethicon Endo Surgery Inc
Priority to EP08717126A priority Critical patent/EP2224859A1/en
Publication of EP2224859A1 publication Critical patent/EP2224859A1/en
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/31—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the rectum, e.g. proctoscopes, sigmoidoscopes, colonoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/1114—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis of the digestive tract, e.g. bowels or oesophagus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/115—Staplers for performing anastomosis in a single operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/115—Staplers for performing anastomosis in a single operation
    • A61B17/1155—Circular staplers comprising a plurality of staples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12009—Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
    • A61B17/12013—Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot for use in minimally invasive surgery, e.g. endoscopic surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A61B17/3423—Access ports, e.g. toroid shape introducers for instruments or hands
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1407—Loop

Definitions

  • the present invention relates to surgical devices and methods for the resection of the lower rectum, particularly in the treatment of patients with small or medium size rectal carcinoid tumors.
  • a known surgical technique to perform the resection of the lower rectum is the so called low anterior resection (LAR) which can be performed either by open surgery or laparoscopically using the Knight-Griffen technique, also known as double staple technique.
  • LAR low anterior resection
  • the rectum is mobilized from the sacrum including division of the lateral ligaments under direct view of the laparoscope or by open surgery.
  • the bowel is divided, e.g. between the sigmoid colon and the rectum using a linear stapler.
  • the lower rectum (containing the tumor) is then transected using a linear or contour stapler .
  • a stapled proximal colon stump and a stapled rectal stump are formed, which need to be joined in order to reestablish colon - rectum continuity.
  • an anvil of a circular stapler is introduced into the proximal colon stump through a small skin incision, e.g. on the left lower abdomen, and the shaft and cartridge device of the circular stapler is inserted through the rectal stump via the anus. The shaft and the anvil of the circular stapler are then re- approximated under laparoscopic view, closed and fired.
  • the aim of the present invention is therefore to provide a surgical device for rectal stump closure in a combined endoluminal-laparoscopic or endoluminal-open rectal resection intervention having features which overcome the drawbacks cited with reference to the prior art.
  • a particular aim of the present invention is to propose a rectal stump closure device and method which allows direct eye control of the tumor or lesion to be excised.
  • a further particular aim of the present invention is to propose a rectal stump closure device and method which allows better visual control of the rectal resection position.
  • a yet further particular aim of the present invention is to propose a rectal stump closure device and method which obviates or reduces the crossing of staple-lines during the end-to-end anastomosis of colon and rectal stumps.
  • a surgical device for use in rectal resection surgery including a transanal visualization and positioning device, comprising : - a circular anal dilator defining a passage opening,
  • anoscope configured to be insertable through said passage opening of said circular anal dilator, said anoscope having a distal end portion
  • a plug device connected to said anoscope distal end portion and defining a rectal resection zone, said anoscope distal end portion defining a first window opening which extends radially beyond said plug device to provide transanal visual access distally from said plug device, - a distal plate rigidly linked to said anoscope distal end portion, said distal plate having a widening portion arranged distally from said rectal resection zone of said plug device and comprising second window openings which extend radially outside said plug device to provide direct visual access to the region distally from the widening portion.
  • the plug device and distal plate may include a position reference device for indicating a rectal resection position with respect to a tumor or other lesion which is directly transanally visually accessible through said first and second window openings.
  • the position reference device may comprise circumferential reference surfaces configured to indicate a rectal resection plane which can be felt from outside the rectum by urging the rectum radially against the plug device.
  • the position reference device may comprise a reference light source configured to indicate a rectal resection plane by emitting light across the rectal wall which can be seen from outside the rectum.
  • the tie up surfaces are provided which form circumferential channels to facilitate positioning and tightening snares which can be positioned and tightened about the rectum by open surgery or by laparoscopy.
  • the surgical device comprises laparoscopic or open surgery cutting means, e.g. a radio frequency snare, to transect the rectum distally from the first tie up surface and between the first and second tie up surfaces, respectively.
  • the present invention also concerns a surgical method for performing a rectal resection, comprising the steps of creating a rectal stump, creating a proximal colon stump, performing an end-to-end anastomosis to join said rectal stump and proximal colon stump with lumen continuity, wherein the step of creating a rectal stump comprises the steps of:
  • anoscope having a distal end portion, a plug device connected to said anoscope distal end portion and defining a rectal resection zone, wherein said anoscope distal end portion defines a first window opening which extends radially beyond said plug device to provide transanal visual access distally from said plug device, a distal plate rigidly linked to said anoscope distal end portion, said distal plate having a widening portion arranged distally from said rectal resection zone of said plug device and comprising second window openings which extend radially outside said plug device to provide direct visual access to the region distally from the widening portion, during insertion of said anoscope, transanally visualizing said widening portion and lesion of the rectum through said first window opening of said anoscope distal end portion and through said second window openings of said distal plate,
  • FIG. 1 is an exploded side view of a surgical device for rectal stump closure according to an embodiment of the invention
  • - Figure 2 is a cross sectional view of the device in figure 1 in a longitudinal cross sectional plane, the device being in an assembled configuration
  • FIG. 3 to 14 illustrate the use of the device in figure 1 together with a tie up device and a resection device in different phases of a method for rectal resection, rectal stump closure and colon - rectal stump end-to-end anastomosis according to an embodiment of the invention
  • FIG. 15 to 17 illustrate the use of the device in figure 1 together with an alternative tie up device and resection device in phases of a method for rectal resection and rectal stump closure according to a further embodiment of the invention
  • FIG. 18 is a partial side view of a surgical device according to a further embodiment of the invention.
  • Figure 19 is an exploded perspective view of the device in figure 18;
  • FIG. 20 is a perspective view of a tie up tape applier according to an embodiment of the invention
  • FIG. 21 illustrates a detail of the applier in figure 20.
  • figure 1 depicts a surgical device 1 for rectal stump closure in a rectal resection intervention.
  • the device 1 comprises a circular anal dilator 2, an anoscope 3, a rectal stump closure plug 4, a plug connector 5, a distal plate 6 with a distal plug 7 and a latching member 8.
  • distal indicates “toward the mouth”
  • proximal indicates “toward the anus”.
  • the circular anal dilator 2 comprises a circular cylindrical ring wall 9 adapted to be transanally inserted into the rectum and defining internally a passage opening 10 which provides a transanal access opening for visualization and surgery and protects the internal sphincter muscle and the anal wall from damaging.
  • a connecting portion 11 is arranged at a proximal end of the ring wall 9 and adapted to hold the ring wall 9 inside the rectum.
  • the connecting portion 11 comprises two flat opposite wings 12, 13 protruding laterally outward from the ring wall 9 and inclined proximally to adapt to the anatomy of the anus and perianal region of the patient. Each wing 12, 13 forms a narrowed bottleneck section 14 and a ring shaped end portion 15 adapted to be sutured to the perianal skin of the patient in order to fixate the position of the device 1 inside the anus.
  • the anoscope 3 comprises a side wall 16 having the shape of a longitudinally straight cylinder defining a working channel 17 as well as a distal end portion 18.
  • the side wall 16 is insertable, longitudinally (in a distal- proximal direction D-P) translatable and rotatable inside the ring wall 9 of the circular anal dilator 2 and comprises a proximal edge 19 or flange which might extend radially beyond the internal surface of the ring wall 9 to define an end of stroke surface which prevent the anoscope 3 from being inserted too far through the ring wall 9 inside the rectum.
  • a flat handle portion 20 protrudes laterally-proximally from the proximal edge 19 and is configured to enable manual rotation and translation of the anoscope 3 inside the ring wall 9 of the anal dilator in order to adjust the position of the distal end portion 18 to which the rectal stump closure plug and distal plate are connected, with respect to the tumor or lesion intended to be removed.
  • the distal end portion 18 of the anoscope 3 comprises a distal end wall 21 adapted to provide an abutment surface for the rectal stump closure plug 4 and one or more seats adapted to receive one or more plug connectors 5 which hold the rectal stump closure plug 4 firmly against the distal end wall 21 of the anoscope 3.
  • the distal end wall 21 comprises a substantially flat ring wall arranged approximately perpendicularly to a longitudinal axis of the anoscope 3.
  • the ring wall 21 forms a through hole 22 dimensioned in a manner that the plug connector 5 can be passed through the ring wall 21 and engage the rectal stump closure plug 4, in order to lock the latter against the anoscope distal end portion 18.
  • the distal end wall 21 defines a seat for directly engaging the rectal stump closure plug 4, e.g. by snap-engagement by screwing or by press-fit.
  • the rectal stump closure plug 4 is integrally formed with the anoscope 3 and connected to the distal end wall 21 or to the side wall 16 by a connector, such as a breaking tie, a breaking rib or a breaking wall having points or lines at which a break is intended to occur in order to separate the rectal stump closure plug 4 from the anoscope 3.
  • a connector such as a breaking tie, a breaking rib or a breaking wall having points or lines at which a break is intended to occur in order to separate the rectal stump closure plug 4 from the anoscope 3.
  • the distal end portion 18 of the anoscope 3 further comprises one or more window openings 23 which extend radially beyond the rectal stump closure plug 4 and the distal plug 5 in order to enable direct transanal visualization of the tumor 48 or of other lesion and its margins. This enables the surgeon to precisely place the surgical devices with respect to the tumor and, hence, to better control the location of resection and rectal stump formation.
  • the distal end portion 18 of anoscope 3 comprises an approximately truncated cone shaped window ring 24 with at least one, preferably three or four inclined bars 25 connecting a distal edge of the cylindrical side wall 16 (which forms the major base of the truncated cone) to the distal end wall 21
  • a graduated sequence of marks 27 indicating e.g. a centimeter-scale is printed, embossed or otherwise applied to provide an immediate visual indication of the depth of insertion of the anoscope and of the distance of distal end portion 18 from the anal verge.
  • Each mark 27 may comprises a central numeral indicating a distance from a fixed reference point at the proximal end region of the side wall 16 and one or two reference lines extending on either side of the numeral so that a certain distance can easily be associated also to instruments which do not lay very close to the numeral without being impaired by the difficult visual prospective provided by the comparatively long tubular working channel 17.
  • the anoscope 3 is slidably and rotatably received by the ring wall 9 of the circular anal dilator 2 and has a length such that it protrudes distally from the ring wall 9 in order to provide access to a depth of about 5 to 15 cm from the anal verge.
  • the ring wall 9 of the anal dilator 2 defines at its internal surface a group of circumferentially extending parallel latching ribs 67 and the side wall 16 of the anoscope 3 defines at its external surface a group of circumferentially extending parallel counter-latching ribs 68 configured in a manner that the counter-latching ribs 68 can be engaged and disengaged from the latching ribs 67 by a rotational movement of the anoscope 2 with respect to the anal dilator 2, wherein, in the disengaged configuration the anoscope 3 can translate inside the anal dilator 2 in a distal - proximal direction and in the engaged configuration the anoscope 3 is locked with respect to the anal dilator 2.
  • the rectal stump closure plug 4 comprises a ring body with a substantially flat proximal end face 28 adapted to be held against the distal end wall 21 of the anoscope 3.
  • a passage zone 29 is formed in the ring body and configured to enable a trocar 40 of a circular stapling device 41 to pass through the rectal stump closure plug 4 in order to couple a staple fastening assembly 42 and an anvil 43 of the stapling device 41 during the end-to-end anastomosis.
  • Such passage zone 29 can be embodied as a channel 29 or, alternatively, as a portion made of an easily penetrable material, such as rubber or expanded polymer. Accordingly, the ring body of the rectal stump closure plug 4 takes its annular shape not necessarily from the beginning, but when pierced through by the trocar 40 of the circular stapling device 41.
  • the ring body of the rectal stump closure plug 4 comprises a first external circumferential tie up surface 30 which extends all around the plug 4 and is intended to provide an abutment against which the lumen of the rectum 46 can be tied up from outside in order to form a closure of the rectal stump 47.
  • the first tie up surface 30 comprises a circumferential groove 31 to facilitate positioning and tightening of a snare 34 which can be positioned about the rectum and subsequently tightened by open surgery or by laparoscopy.
  • the rectal stump closure plug 4 further comprises a coupling seat 32 which is provided for the connection of the distal plate 6 to the rectal stump closure plug 4.
  • the coupling seat 32 is formed near a distal end face 33 of the rectal stump closure plug 4 and may be embodied as a groove or as a cavity having an undercut suitable for engaging a corresponding tooth or edge of the distal plate 6 or, alternatively, of a dedicated separate latching member 8.
  • the plug connecter 5 couples the rectal stump closure plug 4 to the distal end portion 18 of the anoscope 3.
  • the plug connecter 5 can be embodied as an integral part of the anoscope 3 and of the rectal stump closure plug 4 which are manufactured as a single piece and provided with points or lines at which a break is intended to occur in order to separate the rectal stump closure plug 4 from the anoscope 3.
  • the plug connecter 5 can be embodied as a connection portion formed on either of the rectal stump closure plug 4 and anoscope distal end portion 18 and configured to removably engage the other, respectively.
  • the plug connector 5 comprises two elastic springs 51, 52 which engage both the rectal stump closure plug 4 and connector receiving seats in the distal end portion 18 of the anoscope.
  • the elastic springs 51, 52 When in their operational position, the elastic springs 51, 52 extend through the hole 22 of distal end wall 21 and at least partially through the passage channel 29 of the rectal stump closure plug 4.
  • a proximal end portion 49 of springs 51, 52 is positioned in a manner to be accessible by a 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 them to separate the anoscope 3 from the rectal stump closure plug 4.
  • the plug connector comprises a bayonet connector 69 rotatably supported by the anoscope distal end portion 18.
  • the bayonet connector 69 comprises a distal bayonet key 70 configured to removably engage a corresponding bayonet seat 71 formed in the rectal stump closure plug 4 and an activation portion 72 proximally protruding into the anoscope working channel 17 and destined to be transanally grasped and rotated by a surgical grasping device.
  • the activation portion 72 has a flat plate like shape and the bayonet connector 69 is configured such that, in a plug coupling configuration, the activation portion 72 is aligned with the inclined bars 25 of the anoscope window ring 24 in order not to obstruct visual access (figures 18, 19) .
  • the distal plate 6 comprises a distal plug 7 arranged distally from the rectal stump closure plug 4 and having a second circumferential tie up surface 52.
  • the second tie up surface 52 may extend all around the distal plug 7 and is intended to provide an abutment against which the lumen of the rectum 46 can be tied up from outside in order to form a closure of the portion 54 of rectum intended to be removed.
  • the second tie up surface 52 comprises a second circumferential groove 55 to facilitate positioning and tightening of a second snare 34' which can be positioned about the rectum 46 and subsequently tightened by open surgery or by laparoscopy. Thanks to the second circumferential groove 55, during tightening the snare 34', the latter is biased to position itself exactly above the second tie up surface 52 and a ring of the rectum 46 is pressed between the snare 34' and the second tie up surface 52 inside the circumferential groove 55.
  • the distal plate 6, and more precisely the distal plug 7 thereof, comprises a coupling seat 56 which is provided for the connection of the distal plate 6 to the rectal stump closure plug 4.
  • the coupling seat 56 is formed near a proximal end face 57 of the distal plug 7 and may be embodied as a groove or as a cavity having an undercut suitable for engaging a corresponding tooth or edge of the rectal stump closure plug 4 or, alternatively, of the dedicated separate latching member 8.
  • the distal plate 6 comprises a distal widening portion, for instance a widening ring 58 arranged distally from the distal plug 7 and having a diameter which is smaller than the internal diameter of the passage opening 10 of anal dilator 2, in order to allow insertion of the anoscope 3 equipped with rectal stump closure plug 4 and distal plate 6.
  • the widening ring 58 is connected to the distal plug 7 by at least one, preferably three or four inclined bars 59, wherein the free spaces defined between bars 59 and widening ring 58 provide window openings 60 which extend radially outside the distal plug 7 and provide direct visual access or also instrument access to the region distally from the distal plug 7 and from the widening ring 58.
  • the surgical device is designed so that the distance between the distal widening ring 58 and the distal tie up plane (defined by distal plug 7 tie up surface 53) as well as the resection plane (between plugs 4 and 7) provides a sufficient margin between a tumor or lesion border and the resection plane and tissue squeezing zone, so that a correct positioning of widening ring 58 in front of a tumor automatically determines a standardized and repeatable positioning of the resection plane.
  • the distal plug 7 is configured as a substantially impermeable block, so that leakage and tumor seeding are prevented both during resection and removal of the rectum portion 54.
  • the overall truncated cone shape of distal plate 6 and the overall truncated cone shape of the distal end portion 18 of anoscope 3 define an overall circumferential groove which provides guidance and facilitate the correct positioning of tie up snares 34, 34', bands or tapes 35 which will be described in detail below .
  • a latching member 8 can be provided, which has a proximal flange 36 adapted to engage with the coupling seat 32 of the rectal stump closure plug 4 and a distal flange 37 adapted to engage with the corresponding coupling seat 56 formed in the distal plug 4 of distal plate 6.
  • a proximal flange 36 adapted to engage with the coupling seat 32 of the rectal stump closure plug 4
  • distal flange 37 adapted to engage with the corresponding coupling seat 56 formed in the distal plug 4 of distal plate 6.
  • the coupling flanges 36, 37 of latching member 8 and the respective coupling seats 32 and 56 of plugs 4, 7 can be configured to form a cutting block for the cutting device, e.g. a laparoscopic radiofrequency snare 62.
  • opposite circumferential guide surfaces 39 can be formed in the latching member 8 itself or in plugs 4, 7 which define alone or together with the latching member 8 a circumferential cutting groove 61 which invites the cutting device to position itself in a predetermined cutting plane between first and second tie up planes determined by the corresponding first and second tie up surfaces 30, 53.
  • the rectal stump closure plug 4 and the distal plug 7 are approximately coaxial to a longitudinal axis L of the anoscope 3 and have a diameter which is smaller than the diameters of the anoscope side wall 16 and of the distal plate widening ring 58 in order to enable direct transanal tumor visualization over both plugs 4, 7.
  • toothed zip ties may be used for tying up the rectum 46 against the rectal stump closure plug 4 and the distal plug 7, respectively (fig. 4, 6) .
  • the toothed zip ties provide a ratchet like one way and non return tightening.
  • the tie up snares 34, 34' can be applied laparoscopically or by open surgery.
  • the tightening snares may be tied up around the rectum 46 and locked in their tissue pressing configuration by a locking member, e.g. a staple or clip 63 or a ratchet like toothed locking portion .
  • an internal surface of the tightening snares or a tightening band destined to face the first and second tie up surfaces 30, 53 are shaped approximately complementary to the shape of the tie up surfaces 30, 53, particularly to the shape of circumferential grooves 31, 55. It is also contemplated to provide a tie up tape 35 which has a width such as to extend over both the rectal stump closure plug 4 and the distal plug 7 and which can be cut through between both tie up planes during rectal transection by means of the same cutting instrument used to transect the rectum lumen.
  • the tie up snare and the cutting instrument are integrated in a single open surgery or laparoscopic device including the looped tape 35 having a width covering both the rectal stump closure plug 4 and the distal plug 7, as well as a cutting snare, e.g. a radiofrequency snare 64 or mechanical or mechanical vibrating cutting snare which is fixed to the looped tape 35 and extends parallel to the extension of tape 35 along a center line of the latter.
  • a cutting snare e.g. a radiofrequency snare 64 or mechanical or mechanical vibrating cutting snare which is fixed to the looped tape 35 and extends parallel to the extension of tape 35 along a center line of the latter.
  • the tightened tape 35 assures a correct position of the integrated cutting snare (e.g. RF snare 64) during cutting.
  • FIGS 20, 21 illustrate an exemplary, non limiting embodiment of an open surgery and or laparoscopic tie up tape applier 73.
  • the applier 73 comprises a proximal handle 74, a distal tape fastening assembly 75 and an elongate straight or curved shaft 79 which extends from handle 74 to the tape fastening assembly 75.
  • the tape fastening assembly 75 comprises a tape holder seat 76 which supports the tape 35 during positioning and tightening, a tape pulling mechanism activatable by a lever 77 or other manual operating member and a tape locking device which can be embodied as a staple fastener, a clip applier, or as a ratchet like toothed locking seat directly provided at one end of the tape.
  • the tape applier 73 also comprises a cutting mechanism involving a mechanical cutting blade housed in the tape fastening assembly 75 and connected to a cutting mechanism which is manually operable through a cutting activation member, e.g. knob 78.
  • a heatable e.g. resistive cutting edge with associated energizing circuit can be provided and activated by operating an electrical switch at the handle 74.
  • the tape applier 73 may also include a cutting snare pulling mechanism and an energizing circuit for the cutting snare.
  • a circumferential cutting blade can be provided between the first and second tie up surfaces and configured so that the rectum lumen is pressed against it and cut through from the inside during cinching of the rectum against the first and second tie up surfaces.
  • a cutting blade may be rotatably mounted between the first and second tie up surfaces and driven through the lumen wall tissue by a rotating movement generated by means of a manually operable rotating rod which torsionally engages the cutting blade and which extends inside the anoscope working channel 17.
  • the above described tie up tape applier makes it possible to comfortably access the low anterior rectal region by laparoscopy or open surgery and to apply the tie up tape with controllable pulling force and perform resection in a more favorable working position compared to prior art techniques .
  • a circular stapling device 41 which includes a stapler main body 65 with a handle, an insertion shaft, a staple fastening assembly 42 to which an anvil approximating mechanism, a staple driving mechanism and a cutting mechanism are associated.
  • the circular stapling device 41 further comprises an anvil 43 with a proximal staple forming surface and a proximally protruding connecting shaft 44.
  • a connecting trocar 40 is operatively linked to the anvil approximating mechanism and protrudes distally from the staple fastening assembly 42.
  • Connecting trocar 40 and connecting shaft 44 are configured to removably engage each other and to couple anvil 43 in a tension force transmitting manner to the main body 65 of circular stapling device 41.
  • the circular stapling device 41 is particularly adapted for an end-to-end anastomosis of the rectal stump 47 with a proximal colon stump 66.
  • the external diameter of the staple fastening assembly 42 is slightly smaller than the internal diameter of the passage opening (10) of anal dilator
  • the staple fastening assembly 42 and or the anvil 43 define a tissue receiving cavity 45 having a diameter and a depth greater than the external diameter and axial length of the rectal stump closure plug 4.
  • the tissue receiving cavity 45 has a diameter and a depth sufficient to receive the rectal stump closure plug 4 together with the tie up snare (whose overhanging laces can be cut away before performing the anastomosis) and the clamped tissue ring.
  • the surgical device comprises illumination means configured to mark the first and/or second tie up surfaces 30, 53 and or the resection plane by a light signal which is sufficiently strong to be go through the rectal wall and to be visible from the outside of the rectum lumen in order to indicate the correct position of the tie up snares and of the resection.
  • illumination means may comprise optical fiber light transmitting means extending along the anoscope and terminating near the first and second tie up surfaces 30, 53 which can be at least partially transparent.
  • Figures 3 - 14 illustrate a method for performing a rectal resection, rectal stump closure and rectal stump end-to-end anastomosis by means of the surgical device according to the invention.
  • the anoscope 3 holding the rectal stump closure plug 4 and the distal plate 6 is introduced in the passage opening 10 of the dilator 2 and locked in position against the latter (fig. 3) .
  • the anoscope is held in an angular position to the anal dilator so that the latching ribs 67 of anal dilator 2 and the counter-latching ribs 68 of the anoscope 3 do not interfere, thereby enabling longitudinal (proximal - distal) movement of the anoscope 3.
  • the anoscope 3 is positioned at the correct insertion depth, it is turned with respect to the anal dilator 2 so that the latching ribs 67 engage the counter-latching ribs 68, thereby locking the anoscope 3 longitudinally with respect to the anal dilator 2.
  • First and second tie up snares are looped around the rectum 46 by laparoscopy or by open surgery (fig. 4) .
  • Positioning of the anoscope and the zip ties is assisted by direct transanal visualization through the window openings 23, 60 of the anoscope distal end portion 18 and of the distal plate 6 (fig. 5) .
  • the surgical device is designed so that the distance between the distal widening ring 58 and the distal tie up plane (defined by distal plug 7 tie up surface 53) as well as the resection plane
  • the circumferential grooves 31 and 55 of plugs 4, 7 receive the zip ties 34, 34' and assure their correct positioning (figs. 6, 7) .
  • resection can be performed between the two tie up planes.
  • an open surgery or laparoscopic cutting device is brought into position and the rectum is transected between both zip ties 34, 34' .
  • an RF snare (fig. 8) is contemplated, which is inserted over the rectal stump 47 and tightened between the distal plug 7 and the rectal stump closure plug 4. Thanks to the guide surfaces 39, a cutting groove 61 is provided between both plugs 4, 7 which enables self alignment of the RF snare 62 during transection.
  • the cutting instrument cuts completely through both the rectum and the latching member 8, thereby separating the rectal stump from the rectal lumen portion 54 to be removed and the rectal stump closure plug 4 from the distal plate 6 (figs. 8, 9, 10) .
  • the cutting instrument cuts through the rectum, but it doesn't transect the latching element 8, which can be subsequently disengaged from the distal plug or from the rectal stump closure plug in order to separate them from one another.
  • the healthy rectal stump 47 can be thoroughly washed and rinsed in order to remove residual tumor cells which might have been accidentally seeded or squeezed into the healthy tissue.
  • the healthy rectal stump 47 still bound by the tie up snare (zip tie 34) is now ready for an end-to-end anastomosis with the proximal colon stump 66 previously prepared by a purse string closure or by linear stapling.
  • anoscope 3 To provide access space for a circular stapling device 41, anoscope 3 must be removed from the circular anal dilator 2 and, hence, it must be detached from the rectal stump closure plug 4. This is done by means of a surgical grasping instrument 50 which is inserted through the working channel 17 of the anoscope 3 up to the distal end portion thereof, and subsequently operated to grasp the proximal portion 49 of plug connector 5 to disengage the latter from rectal stump closure plug 4 (figs. 10, 11) .
  • anoscope 3 can be detached from rectal stump closure plug 4 by breaking one or more connecting bridges between the anoscope distal end portion 18 and the rectal stump closure plug 4.
  • Circular stapling device 41 is now introduced through the anal dilator 2 until its staple fastening assembly 42 reaches the rectal stump closure plug 4.
  • a connecting trocar 40 distally projecting from the staple fastening assembly 42 is inserted or pierced through the passage zone 29 of plug 4.
  • Anvil 43 of circular stapling device 41 is introduced into the proximal colon stump 66 through a small incision and a purse string is performed around its connecting shaft 44. Shaft 44 and trocar 40 are then connected under laparoscopic view, the stapling device 41 is closed and fired.
  • the so called cut-out tissue donut together with the rectal stump closure plug 4 and tie up snare 34 is encapsulated inside a dedicated tissue receiving space 45 (figs. 13, 14) .
  • the circular stapling device 41 is then proximally withdrawn from the patient, tissue donuts are checked and a leak test is performed to assure that the anastomosis is air-liquid tight.

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Abstract

A surgical device for use in rectal resection surgery, includes a rectal stump closure device (1) with 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), the anoscope (3) having a distal end portion (18), a plug device (4, 7) connected to the anoscope (3) and defining a rectal resection zone, the anoscope distal end portion (18) defining a first window opening (23) to provide transanal visual access distally from said plug device (4, 7), a distal plate (6) rigidly linked to said anoscope (3) distal end portion (18), said distal plate (6) having a widening portion (58) arranged distally from therectal resection zone of the plug device (4, 7) and comprising second window openings (60) to provide direct visual access to the region distally from the widening portion (58).

Description

DESCRIPTION
" A RECTAL STUMP CLOSURE DEVICE FOR RECTAL RESECTION "
The present invention relates to surgical devices and methods for the resection of the lower rectum, particularly in the treatment of patients with small or medium size rectal carcinoid tumors.
A known surgical technique to perform the resection of the lower rectum is the so called low anterior resection (LAR) which can be performed either by open surgery or laparoscopically using the Knight-Griffen technique, also known as double staple technique. Under general anesthesia the rectum is mobilized from the sacrum including division of the lateral ligaments under direct view of the laparoscope or by open surgery. The bowel is divided, e.g. between the sigmoid colon and the rectum using a linear stapler. The lower rectum (containing the tumor) is then transected using a linear or contour stapler . In this way, a stapled proximal colon stump and a stapled rectal stump are formed, which need to be joined in order to reestablish colon - rectum continuity. To this end, an anvil of a circular stapler is introduced into the proximal colon stump through a small skin incision, e.g. on the left lower abdomen, and the shaft and cartridge device of the circular stapler is inserted through the rectal stump via the anus. The shaft and the anvil of the circular stapler are then re- approximated under laparoscopic view, closed and fired. During this end-to-end anastomosis, a circular staple line is fired over the previous lines of staples used to perform the rectal transection (staple crossing) which can lead to leakage at the anastomotic site. Moreover, with known devices and procedures in both laparoscopic and open surgery, it is difficult for the surgeon to judge the correct positioning of the stapler with respect to the tumor to be excised. Particularly in cases in which the position of the tumor makes it impossible to evert the rectum through the anal canal and the transverse transection of the rectal stump is formed by open or laparoscopic stapling, the excision is performed blind without direct tumor visualization. Consequently, with reference to low anterior rectal resection and end-to-end anastomosis of the colon and rectal stumps, there is a need to have at one's disposal a surgical device and method which overcome the deficiencies of prior art instruments and methods. The aim of the present invention is therefore to provide a surgical device for rectal stump closure in a combined endoluminal-laparoscopic or endoluminal-open rectal resection intervention having features which overcome the drawbacks cited with reference to the prior art. Within the scope of the above aim, a particular aim of the present invention is to propose a rectal stump closure device and method which allows direct eye control of the tumor or lesion to be excised. A further particular aim of the present invention is to propose a rectal stump closure device and method which allows better visual control of the rectal resection position.
A yet further particular aim of the present invention is to propose a rectal stump closure device and method which obviates or reduces the crossing of staple-lines during the end-to-end anastomosis of colon and rectal stumps.
At least some of these aims are achieved by a surgical device for use in rectal resection surgery, including a transanal visualization and positioning device, comprising : - a circular anal dilator defining a passage opening,
- an anoscope configured to be insertable through said passage opening of said circular anal dilator, said anoscope having a distal end portion,
- a plug device connected to said anoscope distal end portion and defining a rectal resection zone, said anoscope distal end portion defining a first window opening which extends radially beyond said plug device to provide transanal visual access distally from said plug device, - a distal plate rigidly linked to said anoscope distal end portion, said distal plate having a widening portion arranged distally from said rectal resection zone of said plug device and comprising second window openings which extend radially outside said plug device to provide direct visual access to the region distally from the widening portion.
This enables the surgeon to directly visualize the lesion and to exactly place the anoscope with respect to the tumor before proceeding with the rectal transection. According to a further aspect of the invention, the plug device and distal plate may include a position reference device for indicating a rectal resection position with respect to a tumor or other lesion which is directly transanally visually accessible through said first and second window openings. Particularly, the position reference device may comprise circumferential reference surfaces configured to indicate a rectal resection plane which can be felt from outside the rectum by urging the rectum radially against the plug device. This proves very beneficial in both endoluminal - laparoscopic and endoluminal - open surgery approaches, in which the resection is performed by open surgery or laparoscopy but the position reference is provided from inside the rectum by the above said position reference device and under direct transanal visualization. In this way, the positioning of the transection plane with respect to the tumor is much more accurate than with known devices. According to a further aspect of the invention the position reference device may comprise a reference light source configured to indicate a rectal resection plane by emitting light across the rectal wall which can be seen from outside the rectum.
In accordance with a yet further aspect of the invention, the tie up surfaces are provided which form circumferential channels to facilitate positioning and tightening snares which can be positioned and tightened about the rectum by open surgery or by laparoscopy. In accordance with yet a further aspect of the invention, the surgical device comprises laparoscopic or open surgery cutting means, e.g. a radio frequency snare, to transect the rectum distally from the first tie up surface and between the first and second tie up surfaces, respectively. The present invention also concerns a surgical method for performing a rectal resection, comprising the steps of creating a rectal stump, creating a proximal colon stump, performing an end-to-end anastomosis to join said rectal stump and proximal colon stump with lumen continuity, wherein the step of creating a rectal stump comprises the steps of:
- transanally inserting an anoscope having a distal end portion, a plug device connected to said anoscope distal end portion and defining a rectal resection zone, wherein said anoscope distal end portion defines a first window opening which extends radially beyond said plug device to provide transanal visual access distally from said plug device, a distal plate rigidly linked to said anoscope distal end portion, said distal plate having a widening portion arranged distally from said rectal resection zone of said plug device and comprising second window openings which extend radially outside said plug device to provide direct visual access to the region distally from the widening portion, during insertion of said anoscope, transanally visualizing said widening portion and lesion of the rectum through said first window opening of said anoscope distal end portion and through said second window openings of said distal plate,
- positioning said widening portion with respect to said lesion in the rectum under said direct transanal visualization to determine the position of said rectal resection zone.
- transecting the rectum in said rectal resection zone. These and other objects and advantages of the present invention shall be made apparent from the accompanying drawings and the description thereof, which illustrate embodiments of the invention and, together with the general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the present invention .
- Figure 1 is an exploded side view of a surgical device for rectal stump closure according to an embodiment of the invention; - Figure 2 is a cross sectional view of the device in figure 1 in a longitudinal cross sectional plane, the device being in an assembled configuration;
- Figures 3 to 14 illustrate the use of the device in figure 1 together with a tie up device and a resection device in different phases of a method for rectal resection, rectal stump closure and colon - rectal stump end-to-end anastomosis according to an embodiment of the invention;
- Figures 15 to 17 illustrate the use of the device in figure 1 together with an alternative tie up device and resection device in phases of a method for rectal resection and rectal stump closure according to a further embodiment of the invention;
- Figure 18 is a partial side view of a surgical device according to a further embodiment of the invention;
Figure 19 is an exploded perspective view of the device in figure 18;
- Figure 20 is a perspective view of a tie up tape applier according to an embodiment of the invention; - Figure 21 illustrates a detail of the applier in figure 20.
Referring to the drawings where like numerals denote like components throughout the several views, figure 1 depicts a surgical device 1 for rectal stump closure in a rectal resection intervention.
The device 1 comprises a circular anal dilator 2, an anoscope 3, a rectal stump closure plug 4, a plug connector 5, a distal plate 6 with a distal plug 7 and a latching member 8. Throughout the description of the surgical device, the expressions "distal" and "proximal" are referred to the surgeons point of view. With reference to the gastric intestinal tract, the expression "distal" indicates "toward the mouth" and the expression "proximal" indicates "toward the anus". The circular anal dilator 2 (CAD) comprises a circular cylindrical ring wall 9 adapted to be transanally inserted into the rectum and defining internally a passage opening 10 which provides a transanal access opening for visualization and surgery and protects the internal sphincter muscle and the anal wall from damaging. A connecting portion 11 is arranged at a proximal end of the ring wall 9 and adapted to hold the ring wall 9 inside the rectum. The connecting portion 11 comprises two flat opposite wings 12, 13 protruding laterally outward from the ring wall 9 and inclined proximally to adapt to the anatomy of the anus and perianal region of the patient. Each wing 12, 13 forms a narrowed bottleneck section 14 and a ring shaped end portion 15 adapted to be sutured to the perianal skin of the patient in order to fixate the position of the device 1 inside the anus.
The anoscope 3 comprises a side wall 16 having the shape of a longitudinally straight cylinder defining a working channel 17 as well as a distal end portion 18. The side wall 16 is insertable, longitudinally (in a distal- proximal direction D-P) translatable and rotatable inside the ring wall 9 of the circular anal dilator 2 and comprises a proximal edge 19 or flange which might extend radially beyond the internal surface of the ring wall 9 to define an end of stroke surface which prevent the anoscope 3 from being inserted too far through the ring wall 9 inside the rectum. A flat handle portion 20 protrudes laterally-proximally from the proximal edge 19 and is configured to enable manual rotation and translation of the anoscope 3 inside the ring wall 9 of the anal dilator in order to adjust the position of the distal end portion 18 to which the rectal stump closure plug and distal plate are connected, with respect to the tumor or lesion intended to be removed.
The distal end portion 18 of the anoscope 3 comprises a distal end wall 21 adapted to provide an abutment surface for the rectal stump closure plug 4 and one or more seats adapted to receive one or more plug connectors 5 which hold the rectal stump closure plug 4 firmly against the distal end wall 21 of the anoscope 3. In accordance with an embodiment, the distal end wall 21 comprises a substantially flat ring wall arranged approximately perpendicularly to a longitudinal axis of the anoscope 3. The ring wall 21 forms a through hole 22 dimensioned in a manner that the plug connector 5 can be passed through the ring wall 21 and engage the rectal stump closure plug 4, in order to lock the latter against the anoscope distal end portion 18. In accordance with an alternative embodiment, the distal end wall 21 defines a seat for directly engaging the rectal stump closure plug 4, e.g. by snap-engagement by screwing or by press-fit.
In accordance with a yet further embodiment, the rectal stump closure plug 4 is integrally formed with the anoscope 3 and connected to the distal end wall 21 or to the side wall 16 by a connector, such as a breaking tie, a breaking rib or a breaking wall having points or lines at which a break is intended to occur in order to separate the rectal stump closure plug 4 from the anoscope 3.
The distal end portion 18 of the anoscope 3 further comprises one or more window openings 23 which extend radially beyond the rectal stump closure plug 4 and the distal plug 5 in order to enable direct transanal visualization of the tumor 48 or of other lesion and its margins. This enables the surgeon to precisely place the surgical devices with respect to the tumor and, hence, to better control the location of resection and rectal stump formation.
In accordance with an embodiment, the distal end portion 18 of anoscope 3 comprises an approximately truncated cone shaped window ring 24 with at least one, preferably three or four inclined bars 25 connecting a distal edge of the cylindrical side wall 16 (which forms the major base of the truncated cone) to the distal end wall 21
(which forms the minor base of the truncated cone) , wherein the window openings 23 defined between bars 25, distal end wall 21 and side wall 16 extend radially outside the distal end wall 21 and provide direct visual access or also instrument access to the region distally from the plugs 4 and 7.
At the internal concave surface 26 of the side wall 16, a graduated sequence of marks 27 indicating e.g. a centimeter-scale is printed, embossed or otherwise applied to provide an immediate visual indication of the depth of insertion of the anoscope and of the distance of distal end portion 18 from the anal verge. Each mark 27 may comprises a central numeral indicating a distance from a fixed reference point at the proximal end region of the side wall 16 and one or two reference lines extending on either side of the numeral so that a certain distance can easily be associated also to instruments which do not lay very close to the numeral without being impaired by the difficult visual prospective provided by the comparatively long tubular working channel 17.
As already mentioned, the anoscope 3 is slidably and rotatably received by the ring wall 9 of the circular anal dilator 2 and has a length such that it protrudes distally from the ring wall 9 in order to provide access to a depth of about 5 to 15 cm from the anal verge. The ring wall 9 of the anal dilator 2 defines at its internal surface a group of circumferentially extending parallel latching ribs 67 and the side wall 16 of the anoscope 3 defines at its external surface a group of circumferentially extending parallel counter-latching ribs 68 configured in a manner that the counter-latching ribs 68 can be engaged and disengaged from the latching ribs 67 by a rotational movement of the anoscope 2 with respect to the anal dilator 2, wherein, in the disengaged configuration the anoscope 3 can translate inside the anal dilator 2 in a distal - proximal direction and in the engaged configuration the anoscope 3 is locked with respect to the anal dilator 2.
To this end the latching ribs 67 and the counter- latching ribs 68 extend only along a limited portion of the circumferences of the facing surfaces of the anal dilator and the anoscope, so that in the unlocked configuration the latching ribs 67 can be positioned in a counter-latching rib free zone of the anoscope 3. The rectal stump closure plug 4 comprises a ring body with a substantially flat proximal end face 28 adapted to be held against the distal end wall 21 of the anoscope 3. A passage zone 29 is formed in the ring body and configured to enable a trocar 40 of a circular stapling device 41 to pass through the rectal stump closure plug 4 in order to couple a staple fastening assembly 42 and an anvil 43 of the stapling device 41 during the end-to-end anastomosis. Such passage zone 29 can be embodied as a channel 29 or, alternatively, as a portion made of an easily penetrable material, such as rubber or expanded polymer. Accordingly, the ring body of the rectal stump closure plug 4 takes its annular shape not necessarily from the beginning, but when pierced through by the trocar 40 of the circular stapling device 41.
The ring body of the rectal stump closure plug 4 comprises a first external circumferential tie up surface 30 which extends all around the plug 4 and is intended to provide an abutment against which the lumen of the rectum 46 can be tied up from outside in order to form a closure of the rectal stump 47. In accordance with an embodiment, the first tie up surface 30 comprises a circumferential groove 31 to facilitate positioning and tightening of a snare 34 which can be positioned about the rectum and subsequently tightened by open surgery or by laparoscopy. Thanks to the circumferential groove 31, during tightening the snare 34, the latter is biased to position itself exactly above the first tie up surface 30 and a ring of the rectum 46 is pressed between the snare 34 and the first tie up surface 30 inside the circumferential groove 31. The rectal stump closure plug 4 further comprises a coupling seat 32 which is provided for the connection of the distal plate 6 to the rectal stump closure plug 4. In accordance with an embodiment, the coupling seat 32 is formed near a distal end face 33 of the rectal stump closure plug 4 and may be embodied as a groove or as a cavity having an undercut suitable for engaging a corresponding tooth or edge of the distal plate 6 or, alternatively, of a dedicated separate latching member 8. The plug connecter 5, if provided, couples the rectal stump closure plug 4 to the distal end portion 18 of the anoscope 3. As already described above, the plug connecter 5 can be embodied as an integral part of the anoscope 3 and of the rectal stump closure plug 4 which are manufactured as a single piece and provided with points or lines at which a break is intended to occur in order to separate the rectal stump closure plug 4 from the anoscope 3. Alternatively, the plug connecter 5 can be embodied as a connection portion formed on either of the rectal stump closure plug 4 and anoscope distal end portion 18 and configured to removably engage the other, respectively. In accordance with the exemplary embodiment illustrated in figures 1 and 2, the plug connector 5 comprises two elastic springs 51, 52 which engage both the rectal stump closure plug 4 and connector receiving seats in the distal end portion 18 of the anoscope. When in their operational position, the elastic springs 51, 52 extend through the hole 22 of distal end wall 21 and at least partially through the passage channel 29 of the rectal stump closure plug 4. A proximal end portion 49 of springs 51, 52 is positioned in a manner to be accessible by a 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 them to separate the anoscope 3 from the rectal stump closure plug 4.
In accordance with an embodiment, the plug connector comprises a bayonet connector 69 rotatably supported by the anoscope distal end portion 18. The bayonet connector 69 comprises a distal bayonet key 70 configured to removably engage a corresponding bayonet seat 71 formed in the rectal stump closure plug 4 and an activation portion 72 proximally protruding into the anoscope working channel 17 and destined to be transanally grasped and rotated by a surgical grasping device. The activation portion 72 has a flat plate like shape and the bayonet connector 69 is configured such that, in a plug coupling configuration, the activation portion 72 is aligned with the inclined bars 25 of the anoscope window ring 24 in order not to obstruct visual access (figures 18, 19) .
The distal plate 6 comprises a distal plug 7 arranged distally from the rectal stump closure plug 4 and having a second circumferential tie up surface 52.
Analogously to the rectal stump closure plug 4, also the second tie up surface 52 may extend all around the distal plug 7 and is intended to provide an abutment against which the lumen of the rectum 46 can be tied up from outside in order to form a closure of the portion 54 of rectum intended to be removed.
In accordance with an embodiment, the second tie up surface 52 comprises a second circumferential groove 55 to facilitate positioning and tightening of a second snare 34' which can be positioned about the rectum 46 and subsequently tightened by open surgery or by laparoscopy. Thanks to the second circumferential groove 55, during tightening the snare 34', the latter is biased to position itself exactly above the second tie up surface 52 and a ring of the rectum 46 is pressed between the snare 34' and the second tie up surface 52 inside the circumferential groove 55.
The distal plate 6, and more precisely the distal plug 7 thereof, comprises a coupling seat 56 which is provided for the connection of the distal plate 6 to the rectal stump closure plug 4.
In accordance with an embodiment, the coupling seat 56 is formed near a proximal end face 57 of the distal plug 7 and may be embodied as a groove or as a cavity having an undercut suitable for engaging a corresponding tooth or edge of the rectal stump closure plug 4 or, alternatively, of the dedicated separate latching member 8. In accordance with an embodiment, the distal plate 6 comprises a distal widening portion, for instance a widening ring 58 arranged distally from the distal plug 7 and having a diameter which is smaller than the internal diameter of the passage opening 10 of anal dilator 2, in order to allow insertion of the anoscope 3 equipped with rectal stump closure plug 4 and distal plate 6.
The widening ring 58 is connected to the distal plug 7 by at least one, preferably three or four inclined bars 59, wherein the free spaces defined between bars 59 and widening ring 58 provide window openings 60 which extend radially outside the distal plug 7 and provide direct visual access or also instrument access to the region distally from the distal plug 7 and from the widening ring 58. In accordance with an aspect of the invention, the surgical device is designed so that the distance between the distal widening ring 58 and the distal tie up plane (defined by distal plug 7 tie up surface 53) as well as the resection plane (between plugs 4 and 7) provides a sufficient margin between a tumor or lesion border and the resection plane and tissue squeezing zone, so that a correct positioning of widening ring 58 in front of a tumor automatically determines a standardized and repeatable positioning of the resection plane. In accordance with an aspect of the invention the distal plug 7 is configured as a substantially impermeable block, so that leakage and tumor seeding are prevented both during resection and removal of the rectum portion 54. The overall truncated cone shape of distal plate 6 and the overall truncated cone shape of the distal end portion 18 of anoscope 3 define an overall circumferential groove which provides guidance and facilitate the correct positioning of tie up snares 34, 34', bands or tapes 35 which will be described in detail below .
As already mentioned before, the distal plate 6 can be connected to the rectal stump closure plug 4 in different ways. In accordance with an embodiment, a latching member 8 can be provided, which has a proximal flange 36 adapted to engage with the coupling seat 32 of the rectal stump closure plug 4 and a distal flange 37 adapted to engage with the corresponding coupling seat 56 formed in the distal plug 4 of distal plate 6. In order to separate the healthy rectal stump 47 and the unhealthy lumen portion containing the tumor 48 after tightening them around the respective plugs 4, 7, it is desirable to configure the latching member 8 such that it provides a removable or reversible connection between the plugs 4, 7.
This can be obtained by configuring the coupling flanges 36, 37 of latching member 8 and the respective coupling seats 32 and 56 of plugs 4, 7 so that they can removably engage, e.g. by snap-fit or press fit, or by manufacturing the latching member 8 in a material (rubber, polymer) which can be cut through by the same cutting device which is employed for rectal resection. To this end, the latching member 8 can be configured to form a cutting block for the cutting device, e.g. a laparoscopic radiofrequency snare 62. Moreover, opposite circumferential guide surfaces 39 can be formed in the latching member 8 itself or in plugs 4, 7 which define alone or together with the latching member 8 a circumferential cutting groove 61 which invites the cutting device to position itself in a predetermined cutting plane between first and second tie up planes determined by the corresponding first and second tie up surfaces 30, 53. In accordance with an embodiment, the rectal stump closure plug 4 and the distal plug 7 are approximately coaxial to a longitudinal axis L of the anoscope 3 and have a diameter which is smaller than the diameters of the anoscope side wall 16 and of the distal plate widening ring 58 in order to enable direct transanal tumor visualization over both plugs 4, 7.
Turning again to the tightening snares 34, 34', in accordance with an embodiment, toothed zip ties may be used for tying up the rectum 46 against the rectal stump closure plug 4 and the distal plug 7, respectively (fig. 4, 6) . The toothed zip ties provide a ratchet like one way and non return tightening.
The tie up snares 34, 34' can be applied laparoscopically or by open surgery. Alternatively (figs. 15 - 17), the tightening snares may be tied up around the rectum 46 and locked in their tissue pressing configuration by a locking member, e.g. a staple or clip 63 or a ratchet like toothed locking portion .
In accordance with an embodiment, an internal surface of the tightening snares or a tightening band destined to face the first and second tie up surfaces 30, 53 are shaped approximately complementary to the shape of the tie up surfaces 30, 53, particularly to the shape of circumferential grooves 31, 55. It is also contemplated to provide a tie up tape 35 which has a width such as to extend over both the rectal stump closure plug 4 and the distal plug 7 and which can be cut through between both tie up planes during rectal transection by means of the same cutting instrument used to transect the rectum lumen.
In accordance with an embodiment, the tie up snare and the cutting instrument are integrated in a single open surgery or laparoscopic device including the looped tape 35 having a width covering both the rectal stump closure plug 4 and the distal plug 7, as well as a cutting snare, e.g. a radiofrequency snare 64 or mechanical or mechanical vibrating cutting snare which is fixed to the looped tape 35 and extends parallel to the extension of tape 35 along a center line of the latter. In this way the tightened tape 35 assures a correct position of the integrated cutting snare (e.g. RF snare 64) during cutting.
Figures 20, 21 illustrate an exemplary, non limiting embodiment of an open surgery and or laparoscopic tie up tape applier 73. The applier 73 comprises a proximal handle 74, a distal tape fastening assembly 75 and an elongate straight or curved shaft 79 which extends from handle 74 to the tape fastening assembly 75. The tape fastening assembly 75 comprises a tape holder seat 76 which supports the tape 35 during positioning and tightening, a tape pulling mechanism activatable by a lever 77 or other manual operating member and a tape locking device which can be embodied as a staple fastener, a clip applier, or as a ratchet like toothed locking seat directly provided at one end of the tape.
The tape applier 73 also comprises a cutting mechanism involving a mechanical cutting blade housed in the tape fastening assembly 75 and connected to a cutting mechanism which is manually operable through a cutting activation member, e.g. knob 78. Alternatively, a heatable e.g. resistive cutting edge with associated energizing circuit can be provided and activated by operating an electrical switch at the handle 74. In case a RF or mechanical cutting snare is integrated in the tie up tape 35, the tape applier 73 may also include a cutting snare pulling mechanism and an energizing circuit for the cutting snare.
In accordance with a further embodiment, a circumferential cutting blade can be provided between the first and second tie up surfaces and configured so that the rectum lumen is pressed against it and cut through from the inside during cinching of the rectum against the first and second tie up surfaces. Alternatively, a cutting blade may be rotatably mounted between the first and second tie up surfaces and driven through the lumen wall tissue by a rotating movement generated by means of a manually operable rotating rod which torsionally engages the cutting blade and which extends inside the anoscope working channel 17. As will be appreciated by those skilled in the art, the above described tie up tape applier makes it possible to comfortably access the low anterior rectal region by laparoscopy or open surgery and to apply the tie up tape with controllable pulling force and perform resection in a more favorable working position compared to prior art techniques .
In accordance with a further aspect of the present invention, a circular stapling device 41 is provided which includes a stapler main body 65 with a handle, an insertion shaft, a staple fastening assembly 42 to which an anvil approximating mechanism, a staple driving mechanism and a cutting mechanism are associated. The circular stapling device 41 further comprises an anvil 43 with a proximal staple forming surface and a proximally protruding connecting shaft 44. A connecting trocar 40 is operatively linked to the anvil approximating mechanism and protrudes distally from the staple fastening assembly 42. Connecting trocar 40 and connecting shaft 44 are configured to removably engage each other and to couple anvil 43 in a tension force transmitting manner to the main body 65 of circular stapling device 41. The circular stapling device 41 is particularly adapted for an end-to-end anastomosis of the rectal stump 47 with a proximal colon stump 66. To this end the external diameter of the staple fastening assembly 42 is slightly smaller than the internal diameter of the passage opening (10) of anal dilator
(2) .
Moreover the staple fastening assembly 42 and or the anvil 43 define a tissue receiving cavity 45 having a diameter and a depth greater than the external diameter and axial length of the rectal stump closure plug 4. Particularly, the tissue receiving cavity 45 has a diameter and a depth sufficient to receive the rectal stump closure plug 4 together with the tie up snare (whose overhanging laces can be cut away before performing the anastomosis) and the clamped tissue ring. In accordance with a yet further embodiment, the surgical device comprises illumination means configured to mark the first and/or second tie up surfaces 30, 53 and or the resection plane by a light signal which is sufficiently strong to be go through the rectal wall and to be visible from the outside of the rectum lumen in order to indicate the correct position of the tie up snares and of the resection. Such illumination means may comprise optical fiber light transmitting means extending along the anoscope and terminating near the first and second tie up surfaces 30, 53 which can be at least partially transparent. Figures 3 - 14 illustrate a method for performing a rectal resection, rectal stump closure and rectal stump end-to-end anastomosis by means of the surgical device according to the invention. After introducing the circular anal dilator 2 in the anus of a patient and fixating it with stay sutures on the perianal skin, the anoscope 3 holding the rectal stump closure plug 4 and the distal plate 6 is introduced in the passage opening 10 of the dilator 2 and locked in position against the latter (fig. 3) . During insertion of the anoscope 3 through the circular anal dilator 2, the anoscope is held in an angular position to the anal dilator so that the latching ribs 67 of anal dilator 2 and the counter-latching ribs 68 of the anoscope 3 do not interfere, thereby enabling longitudinal (proximal - distal) movement of the anoscope 3. Once the anoscope 3 is positioned at the correct insertion depth, it is turned with respect to the anal dilator 2 so that the latching ribs 67 engage the counter-latching ribs 68, thereby locking the anoscope 3 longitudinally with respect to the anal dilator 2.
First and second tie up snares, particularly zip ties 34, 34' are looped around the rectum 46 by laparoscopy or by open surgery (fig. 4) . Positioning of the anoscope and the zip ties is assisted by direct transanal visualization through the window openings 23, 60 of the anoscope distal end portion 18 and of the distal plate 6 (fig. 5) . It is to be noted that the surgical device is designed so that the distance between the distal widening ring 58 and the distal tie up plane (defined by distal plug 7 tie up surface 53) as well as the resection plane
(between plugs 4 and 7) determine a correct margin between a tumor or lesion border and the resection plane and tissue squeezing zone. It is therefore possible, by positioning the distal plate 6 with the distal widening ring 58 in front of the tumor, to obtain a standardized and repeatable margin between the tumor and the tissue squeezing zone and resection plane. Once the correct positioning of the rectal stump closure plug 4 with respect to the tumor 48 is achieved, the zip ties 34 are tightened about the first and second tie up surfaces 30, 53 of the rectal stump closure plug 4 and the distal plug 7, respectively, thereby cinching the rectal stump around the plugs 4, 7 which are supported and stabilized by anoscope 3 to which they are still firmly connected. In this stage, the circumferential grooves 31 and 55 of plugs 4, 7 receive the zip ties 34, 34' and assure their correct positioning (figs. 6, 7) . After having the rectum 46 sealed against the plugs 4, 7, resection can be performed between the two tie up planes. To this end, an open surgery or laparoscopic cutting device is brought into position and the rectum is transected between both zip ties 34, 34' . In accordance with an embodiment, the use of an RF snare (fig. 8) is contemplated, which is inserted over the rectal stump 47 and tightened between the distal plug 7 and the rectal stump closure plug 4. Thanks to the guide surfaces 39, a cutting groove 61 is provided between both plugs 4, 7 which enables self alignment of the RF snare 62 during transection.
In accordance with an embodiment of the invention, the cutting instrument cuts completely through both the rectum and the latching member 8, thereby separating the rectal stump from the rectal lumen portion 54 to be removed and the rectal stump closure plug 4 from the distal plate 6 (figs. 8, 9, 10) .
In accordance with another embodiment, the cutting instrument cuts through the rectum, but it doesn't transect the latching element 8, which can be subsequently disengaged from the distal plug or from the rectal stump closure plug in order to separate them from one another. Once the rectal resection is complete (fig. 10), the unhealthy lumen portion 54 containing the tumor 48 or lesion is removed from the patient.
The healthy rectal stump 47 can be thoroughly washed and rinsed in order to remove residual tumor cells which might have been accidentally seeded or squeezed into the healthy tissue.
The healthy rectal stump 47 still bound by the tie up snare (zip tie 34) is now ready for an end-to-end anastomosis with the proximal colon stump 66 previously prepared by a purse string closure or by linear stapling. To provide access space for a circular stapling device 41, anoscope 3 must be removed from the circular anal dilator 2 and, hence, it must be detached from the rectal stump closure plug 4. This is done by means of a surgical grasping instrument 50 which is inserted through the working channel 17 of the anoscope 3 up to the distal end portion thereof, and subsequently operated to grasp the proximal portion 49 of plug connector 5 to disengage the latter from rectal stump closure plug 4 (figs. 10, 11) .
In accordance with an embodiment, anoscope 3 can be detached from rectal stump closure plug 4 by breaking one or more connecting bridges between the anoscope distal end portion 18 and the rectal stump closure plug 4.
Circular stapling device 41 is now introduced through the anal dilator 2 until its staple fastening assembly 42 reaches the rectal stump closure plug 4. A connecting trocar 40 distally projecting from the staple fastening assembly 42 is inserted or pierced through the passage zone 29 of plug 4. Anvil 43 of circular stapling device 41 is introduced into the proximal colon stump 66 through a small incision and a purse string is performed around its connecting shaft 44. Shaft 44 and trocar 40 are then connected under laparoscopic view, the stapling device 41 is closed and fired. The so called cut-out tissue donut together with the rectal stump closure plug 4 and tie up snare 34 is encapsulated inside a dedicated tissue receiving space 45 (figs. 13, 14) . The circular stapling device 41 is then proximally withdrawn from the patient, tissue donuts are checked and a leak test is performed to assure that the anastomosis is air-liquid tight. The above described device and method have many advantages. They enable direct eye control of the tumor to be excised prior to the rectal stump creation and obviate cross-stapling by creating a staple free rectal stump which can be completely housed in the tissue receiving cavity of the stapler. This eliminates the risk of leakage associated with the prior art double staple techniques.
While the present invention has been illustrated by description of several embodiments and while the illustrative embodiments have been described in considerable detail, it is not the intention to restrict or in any way limit the scope of the appended claims to such detail.

Claims

1. A surgical device for use in rectal resection surgery, including a transanal visualization and positioning device (1), comprising: - a circular anal dilator (2) defining a passage opening (10),
- an anoscope (3) configured to be insertable through said passage opening (10) of said circular anal dilator (2), said anoscope (3) having a distal end portion (18), - a plug device (4, 7) connected to said anoscope (3) distal end portion (18) and defining a rectal resection zone,
- said anoscope distal end portion (18) defining a first window opening (23) which extends radially beyond said plug device (4, 7) to provide transanal visual access distally from said plug device (4, 7),
- a distal plate (6) rigidly linked to said anoscope (3) distal end portion (18), said distal plate (6) having a widening portion (58) arranged distally from said rectal resection zone of said plug device (4, 7) and comprising second window openings (60) which extend radially outside said plug device (4, 7) to provide direct visual access to the region distally from the widening portion (58) .
2. A surgical device according to claim 1, wherein said plug device (4, 7) and distal plate (6) include a position reference device (58, 30, 53) for indicating a rectal resection position with respect to a tumor (48) or other lesion which is directly transanally visually accessible through said first and second window openings (23, 60) .
3. A surgical device according to claim 2, wherein said position reference device comprises circumferential reference surfaces (58, 30, 53) configured to indicate a rectal resection plane which can be felt from outside the rectum by urging the rectum radially against the plug device (4, 7) .
4. A surgical device according to claim 2, wherein said position reference device comprises a reference light source configured to indicate a rectal resection plane by emitting light across the rectal wall which can be seen from outside the rectum.
5. A surgical device according to claim 2, wherein said plug device (4, 7) includes a cutting block for a cutting device (62; 64) during resection of the rectum (46) .
6. A surgical device according to claim 2, wherein said plug device (4, 7) comprises: a rectal stump closure plug (4) having a first circumferential tie up surface (30) configured such that the rectum (46) can be tied up against it from the outside of the rectum (46),
- a plug connector (5) removably connecting said rectal stump closure plug (4) to said anoscope (3) distal end portion (18) ,
- a distal plug (7) arranged distally from the rectal stump closure plug (4) and having a second circumferential tie up surface (53) configured such that the rectum (46) can be tied up against it from the outside of the rectum (46), so that said first and second tie up surfaces (30, 53) define two adjacent tie up planes, said first circumferential tie up surface (30) and second circumferential tie up surface (53) providing said resection position reference surfaces.
7. A surgical device according to claim 6, comprising a latching member (8) connecting said rectal stump closure plug (4) and said distal plug (7) between said two adjacent tie up planes, said latching member (8) forming the said cutting block for a cutting device (62; 64) during resection of the rectum (46) between said two tie up planes.
8. A surgical device according to any one of the preceding claims, wherein said rectal stump closure plug (4) is approximately coaxial to a longitudinal axis (L) of said anoscope (3) and has an external diameter smaller than an internal diameter of a working channel (17) of said anoscope (3), said anoscope distal end portion (18) defining a window opening (23) which extends radially beyond said rectal stump closure plug (4), thereby providing transanal visual access of a tumor (48) or other lesion distally from said rectal stump closure plug (4) .
9. A surgical device according to any one of the preceding claims, wherein said rectal stump closure plug (4) and said distal plug (7) are approximately coaxial to a longitudinal axis (L) of said anoscope (3) and have an external diameter smaller than an internal diameter of a working channel (17) of said anoscope (3), wherein said distal widening portion (58) is arranged distally from the distal plug (7) and has a diameter greater than the diameter of the rectal stump closure plug (4) and the distal plug (7), wherein said anoscope distal end portion (18) and said distal widening portion (58) define said window openings
(23, 60) which extend radially beyond said rectal stump closure plug (4) and said distal plug (7), thereby providing transanal visual access of a tumor (48) or other lesion distally from said distal widening portion (58) .
10. A surgical device according to any one of the preceding claims, wherein said tie up surfaces (30, 53) of said rectal stump closure plug (4) and of said distal plug (7) form circumferential grooves (31, 55) to facilitate positioning and tightening of tie up snares (34, 34'; 35) around rectal stump closure plug (4) and distal plug (7) .
11. A surgical device according to any one of the preceding claims, comprising a radio frequency snare (62) adapted to be inserted over the rectal stump (47) and to transect the rectum (46) distally from the first tie up surface (30) and between the first and second tie up surfaces (30, 53), respectively.
12. A surgical device according to any one of the preceding claims, comprising opposite circumferential guide surfaces (39) defining a circumferential cutting groove (61) adapted to invite the cutting instrument
(62; 64) to position itself in a predetermined cutting plane between first and second tie up planes determined by said first and second tie up surfaces (30, 53) .
13. A surgical method for performing a rectal resection, comprising the steps of:
- creating a rectal stump (47),
- creating a proximal colon stump (66), - performing an end-to-end anastomosis to join said rectal stump (47) and proximal colon stump (66) with lumen continuity, wherein the step of creating a rectal stump (47) comprises the steps of: - transanally inserting an anoscope (3) having a distal end portion (18), a plug device (4, 7) connected to said anoscope (3) distal end portion (18) and defining a rectal resection zone, wherein said anoscope distal end portion (18) defines a first window opening (23) which extends radially beyond said plug device (4, 7) to provide transanal visual access distally from said plug device (4, 7), a distal plate (6) rigidly linked to said anoscope (3) distal end portion (18), said distal plate
(6) having a widening portion (58) arranged distally from said rectal resection zone of said plug device (4, 7) and comprising second window openings (60) which extend radially outside said plug device (4, 7) to provide direct visual access to the region distally from the widening portion (58), - during insertion of said anoscope (3) , transanally visualizing said widening portion (58) and lesion of the rectum through said first window opening (23) of said anoscope distal end portion and through said second window openings (60) of said distal plate (6), - positioning said widening portion (58) with respect to said lesion in the rectum (46) under said direct transanal visualization to determine the position of said rectal resection zone.
- transecting the rectum (46) in said rectal resection zone.
14. A surgical method according to claim 13, comprising the steps of:
- creating a rectal stump (47),
- creating a proximal colon stump (66), - performing an end-to-end anastomosis to join said rectal stump (47) and proximal colon stump (66) with lumen continuity, wherein the step of creating a rectal stump (47) comprises the steps of: - transanal insertion of a rectal stump closure plug (4) into the rectum (46), said rectal stump closure plug (4) defining a first circumferential tie up surface (30),
- positioning a tie up snare (34; 35) around the rectum (46) and closing said rectal stump (47) by tightening said tie up snare (34; 35) to press said rectum against said first tie up surface (30) of said rectal stump closure plug (4) ,
- transecting the rectum (46) distally from said first tie up surface (30) .
EP08717126A 2007-11-14 2008-02-26 A rectal stump closure device for rectal resection Withdrawn EP2224859A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP08717126A EP2224859A1 (en) 2007-11-14 2008-02-26 A rectal stump closure device for rectal resection

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
PCT/EP2007/062351 WO2009062548A1 (en) 2007-11-14 2007-11-14 A rectal stump closure device for rectal resection
PCT/EP2008/052292 WO2009062758A1 (en) 2007-11-14 2008-02-26 A rectal stump closure device for rectal resection
EP08717126A EP2224859A1 (en) 2007-11-14 2008-02-26 A rectal stump closure device for rectal resection

Publications (1)

Publication Number Publication Date
EP2224859A1 true EP2224859A1 (en) 2010-09-08

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Application Number Title Priority Date Filing Date
EP08717126A Withdrawn EP2224859A1 (en) 2007-11-14 2008-02-26 A rectal stump closure device for rectal resection

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EP (1) EP2224859A1 (en)

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2009062758A1 *

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