NZ332938A - Surgical apparatus for laparoscopically assisted vaginal hysterectomy, vagina sealed by inflatable diaphragm - Google Patents

Description

New Zealand No 332938 International No. PCT/NZ97/00066 TO BE ENTERED AFTER ACCEPTANCE AND PUBLICATION Priority dates 24 05 1996,27 05 1996,13 02 19097,13 05 19 97, Complete Specification Filed 23 05 1997 Classification (6) A61B17/42 Publication date 28 October 1999 Journal No 1445 NEW ZEALAND PATENTS ACT 1953 COMPLETE SPECIFICATION Title of Invention Surgical apparatus Name, address and nationality of applicant(s) as in international application form MICHAEL CHARLES EAST, a New Zealand citizen of 26 Cramner Square, Christchurch 8001, New Zealand SURGICAL APPARATUS Technical Field The invention relates to a surgical apparatus for use in laparoscopy assisted 5 vaginal hysterectomies.

Background Art Hysterectomies have traditionally been performed by making a cut through the abdomen wall, freeing up the uterus and removing the uterus through the cut in 10 the wall. In more recent times some hysterectomies have been able to be performed through the vaginal opening which consists in freeing up the uterus by using laparoscopic instruments and then removing the uterus through an opening made at the top of the vagina.

Laparoscopic procedures require the abdomen to be inflated with gas. to form a pneumoperitoneum, which enables the surgeon to see what needs to be done and easily move the instruments around and position them to make the necessary cuts, sutures etc. Thus laparoscoplcally assisted vaginal hysterectomy (LAVH) Is considered an. advanced laparoscopic operative procedure » One difficulty with LAVH procedures is that once the cut is made at the top of the vagina in order to allow the uterus to be removed, the gas in the abdomen escapes, making it difficult and time consuming to finally release the uterus from the abdomen (cut ligaments etc) and remove it through the vaginal opening. Therefore, 25 although LAVH allows patients to avoid undergoing abdomen hysterectomyprocedures, thus affording them a more rapid recovery, the vaginal portion of the operation can still be extremely difficult If there is little descent of the cervix, especially when the uterus Printed from Mimosa WO 97/45053 PCT/N797/00066 is very large In such instances the vaginal portion or the surgery can take almost as long as the laparoscopic portion and can cause great stress to the surgeon and lead to significant blood loss The more dissection performed laparoscoplcally, the easier the vaginal component of the surgery Therefore, the longer the pneumoperitoneum can 5 be maintained the more efficient the procedure becomes Bleeding and/or damage to the ureter is also a significant problem Formation of the "bladder flap' can be difficult and hazardous with perforation of the bladder on occasions occurring However, the bladder has to be dlsected off the lower segment of the uterus before the uterine arteries can be approached In an attempt to make the "bladder flap" dissection easier 10 the initial dissection has been performed vaginally without opening the peritoneal fold of the utero-veslcal space However, If the fold of the peritoneum Is breached, then gas can escape from the abdomen into the vagina thus deflating the abdomen and making it impossible to continue the surgery In order to minimise this problem saline packs have been placed into the vagina in an attempt to slow down gas leak, but rarely does 15 this prove to be satisfactory In addition to this, in order for the hysterectomy procedure to be completed efficiently via the laparoscope, it Is necessary to manipulate certain organs in order to obtain access to make the necessary cuts, sutures etc For example, 11 may be 20 necessary to push the uterus high up Into the abdomen to free the ligaments for access by the surgeon A further difficulty occurs In forming the pneumoperitoneum as standard techniques usually Involve the blind insertion of the gas used via a Verres needle As 25 this is a blind insertion of the gas, the operator cannot have complete confidence in where the gas is being Inserted 2 Printed from Mimosa WO 97/45053 PCT/NZ9 7/00066 Sabella et a] In Obstet Gynccol 1996 87 465 entitled "A Technique for Laparoscopic Completion of Vaginal Hysterectomy" disclosed a uterine manipulator including an Inflatable cuff that seals the vaginal orifice thus maintaining the pneumoperitoneum The technique described by Sabella et al involves proceeding with a vaginal hysterectomy until the opening of the peritoneal reflections and ligature of uterine vessels and uterosacral ligaments It Is at this point, If laparoscopic assistance become"; necessary, that the uterine manipulator with inflatable cuff is Inserted 10 vaginally, allowing completion of the operation laparoscoplcally The uterine manipulator described la the Sabella article suffers from a number of deficiencies Once the cuff is Inflated the uterine manipulator Is fixed in position The manipulator can only be restrlctlvely manoevered about that point and 15 cannot readily extend the uterus further into the pelvis There is no disclosure of any uterine manipulation means able to move Independently in relation to tht apparatus once the cuff is inflated The Sabella device therefore, does not make 11 easy to stretch out the tissue between the cervix and the vagina that it is to be transccteri with, via stapling device or diathermy for example, while maintaining the pneumoperitoneum 20 In addition, the surgeon will be operating In close proximity to the Inflated cuff increasing the Inherent risk of puncture and losing the pneumoperitoneum European Patent Application 0642766 to the United States Surgical Corporation discloses a manipulator apparatus for use In hysterectomy procedures 25 that also includes an inflatable member This apparatus utilises the inflatable member to engage the uterine wall In order to position the uterus for examination purposes The Inflatable member Is not used to seal the vaginal orifice and there is no disclosure 3 Printed from Mimosa —• f** ** RECEIVED 1 2 JUN 1393 of any uterine manipulation means able 10 move independently of the inflatable member There is therefore a need for a device capable of maintaining a 5 pneumoperitoneum throughout LAVH procedures There is also a need for a device which will maintain a pneumoperitoneum together with providing means to manipulate the uterus as may be necessary during the LAVH procedure There is also a need Tor a device which can improve the creation of a pneumoperitoneum during LAVH procedures " The field of surgery is also beginning to utilise mechanical means, such as robotic manipulation, for assisting surgeons in performing surgical procedures This technology involves the surgeon directing the robotic mechanical manipulation means during the performance of a surgical procedure In order for hysterectomies and other 15 uterine procedures to be able to utilise this technology, it will be advantageous if not essential to provide a fixed fulcrum point about which and from which the manipulation device can be moved It is an object of the invention to go some way to meeting the identified needs 20 or to provide the public with a useful choice Summary of the Invention The invention comprises in one form a surgical apparatus including (a) an elongated housing, having a handle end and a manipulation end, (b) a bore extending through the housing, 4 -v. , -) 'I lAWJ '. . ' ' I. " (c) a manipulation means comprising a rod which extends through the bore in the housing with an end poition which extends from the manipulation end of the housing, which rod is reciprocally movable and rotatable within the bore of the housing to enable the end portion of the rod to be further extended from or retracted towards and rotated about the manipulation end of the housing, the end portion of the rod portion having a tip, (d) a diaphragm situated distal the handle end of the housing and adapted to be inflated and deflated substantially circumferentially from the housing, and (e) a channel for passing a gas from the end portion of the rod past the diaphragm, extending along or through the rod and having an exit in or adjacent to the end portion of the rod between the manipulation end of the housing and the tip of the rod In another form the invention comprises a surgical apparatus comprising (a) an elongated housing having a handle end and a manipulation end, - —4- ' I pct/NZ 9 7 / 0 0 0 ?') RECEIVED 1 2 J'j\' pno (b) a bore extending through the housing, (c) manipulation means comprising a rod adapted to reciprocate and rotate within the bore and having 5 a handle on one end of the housing and a portion which extends from and retracts towards the manipulation end of the housing at the other end of the housing, the portion having a tip, (d) a diaphragm situated distal the handle end of the housing and adapted to be inflated and deflated substantially circumferentially from the housing via a passage associated with the bore, and (e) a gas channel passing through the rod and having an exit from the portion of the rod between the manipulation end of the housing and the tip of the rod In a further form the invention comprises a method of laparoscoplcally assisted vaginal hysterectomy utilising a surgical apparatus which includes a diaphragm adapted to be inflated and deflated substantially circumferentially from a housing, a rod which extends through the housing and from a manipulation end of the 25 housing and which can rotate and reciprocate in relation to the housing, and a gas channel which extends through the rod, the method comprising the steps of 6 ^—7 o 7 / 0 0 0 6 5 1 - • r r . • ' (a) inserting the apparatus with a diaphragm in a deflated condition into the vagina, (b) inflating the diaphragm to Tlx the apparatus in position and to seal the vagina, (c) passing a gas through the gas channel and into the peritoneal and abdominal cavity to create a pneumoperitoneum, (d) utilising the rod to manipulate the uterus from within the uterus prior to the vaginal cut, and (e) utilising the rod to manipulate the uterus from 15 outside the uterus after the vaginal cut 7 RECEIVED t 2 JUN 1 Drawings A preferred form of the invention will now be described with the aid of the accompanying drawings, wherein Figure 1 is a diagrammatic longitudinal sectional view of the apparatus showing the diaphragm in a deflated condition, and Figure 2 is a similar view of the apparatus of Figure 1, but illustrating the diaphragm m an inflated condition Figure 3 is an enlarged view of part of Figure 1 Figure 4 is a diagrammatic longitudinal sectional view of a preferred form of the apparatus having a gas channel and showing the diaphragm m an inflated condition Figure 5 is a schematic representation of a preferred form of the apparatus when used in conjunction with a mechanical manipulation means Detailed Description of the Invention As illustrated m the drawings, the apparatus, which may be formed entirely or partly from a plastics material or materials, comprises a housing 1 which can be an elongated tube having a bore 2 The apparatus may also be formed of other suitable materials, such as stainless steel, as will be known in the art A rod 3 which is longer than the housing is engaged within the bore in a manner that it can have both reciprocatory and rotatory movement in the bore One end of the rod, herein the handle end, is provided with a handle 4 which can conveniently be in the form of an 8 vrrvz 9 7 / 0 0 0 - . > - enlargement The housing is provided with a thumbscrew S which may have a suitably threaded shank 9 which can be threaded into a radial hole formed in the housing, with the thumbscrew being so formed that it can be rotated to bear against the rod to lock it in a desired position The distal end of the rod is formed into a tip 10 which may be curved as illustrated in the drawing Alternative configurations can be applied to the tip as required Preferably the rod is also provided with an annular stop 1 1 which will limit the retraction of the rod 3 into the bore 2 of the housing As can be seen from the drawings, the curved tip can be removably attached to the rod 2 such as by forming a spigot and socket joint 12 so the curved tip can engage the end of the rod 3 « The apparatus also includes an inflatable diaphragm 14 and means to inflate and deflate the diaphragm In a highly preferred form, the diaphragm is of a balloon like construction and is sealed at 15 to the housing 1 The diaphragm can be constructed from any suitable material as will be known in the art Plastics ma^nals such as latex or the like are preferred Preferably O rings 16 are utilised for the sealing of the diaphragm to the housing, but other satisfactory methods of sealing the diaphragm to the housing can also be utilised In the construction illustrated, the diaphragm is located on the housing by a diaphragm boss 17 one end of which is fixed at 18 to the housing and the other end fixed to a housing extension 19 In the form of the diaphragm boss 17 illustrated, part of the boss is waisted as at 20 so a gap 21 (see Figure 3) is formed between the periphery of the boss 20 and the inside of the diaphragm 14 The means to inflate and deflate the diaphragm 14 may comprise an inlet 30 into which a one way valve (not shown in the drawings) may be engaged, with the inlet 30 communicating with a duct 31 which extends through the housing and forms part • —'' C 7 / ^ s/ | / RECEIVED 1 2 JUN 1933 of the bore of the housing An orifice or orifices 32 are formed in the boss 17 in a manner that the duct 31 will communicate with the gap 21 between the waisted portion of the boss 17 and the underside of the diaphragm Preferably the rod 3 and the bore 2 are sealed to each other to prevent escape 5 of fluid from the duct 31 In a preferred form, this seal is arranged by O rings 33 which are engaged on the rod and which bear against the wall of the bore 2 so that longitudinal or rotatory movement of the rod will not allow fluid to escape The diaphragm may be inflated, for instance by passing an inflation media, such as a sterile saline solution, air or the like under pressure through the one way valve which can be 10 manipulated wnen required to deflate the diaphragm Although the particular meth»d of inflating the diaphragm by means of the one way valve and the duct 31 are described, it is to be understood this is one form only of a suitable method of inflating and deflating the diaphragm and other arrangements which will provide the desired effect can also be employed With reference to Figure 4, a preferred form of the surgical apparatus comprises a housing 1 having a bore 2 containing a rod 3 The rod 3 contains a gas channel 36 which extends substantially through the center of the rod 3 The apparatus further comprises a nipple 34 for gas entry, and a valve means 35 which controls the 20 flow of gas into the gas channel 36 As shown in Figure 4, both the nipple 34 and the valve means 35 are present at the end of the rod 3 which is distal the diaphragm 14 end of the apparatus The gas channel 36 exits the rod 3 via an opening 37 which is situated adjacent the spigot and socket joint 12 at the end of the rod 3 The opening 37 should be situated on the rod 3 such that, in use, the opening 37 allows gas into 25 the peritoneum, while the vaginal opening has been sealed by the inflated diaphragm 14 J tt/vz 97/ 00 0 66 The preferred form of the apparatus as shown in Figure 4 has the gas channel 36 in the rod 3 Alternative positioning of the channel, as will be known in the art, may be used as well For example, the channel could pass through or along the housing with an exit between the diaphragm 14 and the end of the housing from which 5 the rod 3 extends The essential feature is that the gas exits the apparatus beyond the diaphragm 14 when the diaphragm 14 is inflated This will seal the peritoneal cavity and the pneumoperitoneum can be created by entry of a suitable gas through the apparatus and into the peritoneal cavity toward the top of the vagina The gas emerges just prior to the cervix, distending the upper vagina with gas which in turn allows gas 10 to pass into the peritoneal and abdominal cavity thus insufflating the abdomen and pelvis from below after the vaginal seal has been created by inflation of the diaphragm 14 This allows easier insertion of the trochars when the laparoscopic portion of the surgery is commenced and distances the bowel from the trochar tips at insertion It also allows the operator to have complete confidence in where the gas is being inserted 15 rather than the blind insertion through a Verres needle which is the most commonly used method The means by which gas enters the gas channel, shown as nipple 34 in Fig 4, can be any suitable means as will be known in the art In addition, the gas used to 20 create the pneumoperitoneum can be any suitable gas as will be known in the art Carbon dioxide or similar gaseous substances can be used as are standard xn such techniques The surgical apparatus of the present invention is intended to enhance the 25 laparoscopically assisted vaginal hysterectomy (LAVH) procedure by creating and/or maintaining the pneumoperitoneum for the maximum possible time 11 «*T ctr'1 I '< O I < ' * \ "J UlSSO The LAVH process is well known and has been described, inter alia in Reich et al, J Gynaccol Surg 1989, 5, p 213-216 In laparoscopic procedures, the surgery is peifotnied in the intenoi of the abdomen thiough a small incision In order to allow access to the internal organs, a pneumoperitoneum is created as a result of which the 5 abdomen is inflated in order to enable the surgeon to perform the operation However, with laparoscoplcally assisted vaginal hysterectomies (LAVH) is it is desirable to seal the vagina in order to prevent escape of the gas during the procedure To utilise the apparatus as herein described, surgery begins in the standard 10 manner for routine vaginal hysterectomies Usmg a scalpel, the cervix is circumscnbed, the bladder dissected free of the lower uterine segment and the uteio-vesical fold of the pentoneum open thus entering the pelvic cavity The Pouch of Douglas is entered through the posterior fornix The utero-sacral ligaments are then clamped and divided and ligated This completes the initial vaginal part of the 15 dissection The surgical apparatus of the present application m now passed into the vagina with the diaphragm 14 deflated The curved tip 10 is passed through the cervix with the direction of the curve aimed at the uterine fundus If the uterus is m a 20 retroverted position, turning the handle 4 will help convert the position to anteversion The diaphiagm 14 is then inflated with between 100 and 150 mis of normal saline solution via the one way valve This fixes the vaginal seal in position within the vagina and also seals the upper vagina in an airtight fashion The handle 4 is pushed forward which m turn pushes forward the curved tip 10 which will further distance the ureters 25 from the lateral border of the cervix The thumb screw 8 is used to fix the position of the rod 3 within the housing 1 J OFNl not1 12 i f 9 AUG 1999 .RECEIVED "rT/vz; 9 7 / 0 0 0 o o £ L L : v fc. LI : ' .

Generally, in order to produce the pneumoperitoneum via means other than as shown in Figure 4, the laparoscope is passed Into the abdomen after direct trocar entry through a vertical midline incision at the inferior umbilical verge When entry into the peritoneal cavity has been confirmed by direct vision, carbon dioxide gas is 5 pumped in through a standard insufflator Alternative methods of creating a pneumoperitoneum as will be known to a person skilled in the art may also be used If the surgical apparatus comprises a gas channel 36, as is shown in the apparatus of Fig 4, the pneumoperitoneum will be formed by opening the valve means 10 35 to allow a suitable gas, such as C02, to pass through the gas channel 36 and e^eit the apparatus via the opening 37 The gas will pass from the upper vagina into the abdomen and pelvis forming the pneumoperitoneum Once the pneumoperitoneum is satisfactory the valve means 35 can be closed or a continuous top up insufflation can be achieved by maintaining the valve means 35 in a suitably open position The gas 15 can be supplied to the apparatus via the nipple 34 and can be supplied by standard, known insufflators Following the creation of the pneumoperitoneum it is with relative ease that staples can be applied down the length of the broad ligament The uterine artery can 20 be transected, the upper vagina entered, thus freeing the uterus from all attachments to the body The uterus will now be completely devascularised and, no matter how large, it can be cut into as many pieces as is required to enable it to be extracted through the vagina without difficulty and additional blood loss As will be known in the art, robotic manipulators have been used relatively recently to assist surgical procedures Robotic manipulators can be surgeon-controlled with the advantage that there is a substantial lessening of human fatigue in the 13 RECEIVED 1 2 .'M'l p:; performance of the surgery One difficulty in such robotic assisted surgery when applied to uterine surgical procedures, Is that It Is preferable for a fulcrum point to be « provided within the vagina, arouud which the robotic manipulator can exercise degiees of movement As will be apparent to a person skilled in the art, the diaphragm, when 5 inflated, can be used to provide a suitable fulcrum point for such robotic assisted manipulation With reference to Figures 4 and 5, the inflated diaphragm 14, can be used to provide a fixed, cushioned, fulcrum point within the vagina to allow the rod 3 and the 10 tip 10 to move about the fulcrum point so formed Movement in the upward, downward and right/left arcs will be readily achievable The rod 3 can also move in a reciprocal manner within the bore 2 and a gas can still pass into the peritoneal cavity via the gas channel 36 (if the channel 36 is present in the apparatus) as has been described previously In Figure 5, the rod 3 and gas channel 36 are shown as one 15 combined feature for ease of reference The control of the entry of gas to the apparatus can be external of the apparatus as indicated, but not shown, in Figure 5 The robotic manipulation can be achieved by any suitable means as will be known in the art A robotic arm 40, as shown in Figure 5, can be attached by any suitable means, such as the socket 41 in Figure 5, to the handle 4 of the apparatus to provide the connection 20 between the apparatus of the present invention and the robotic manipulation means The surgical apparatus of the present invention therefore has the capacity to enhance the ability of a surgeon-controlled mechanical arm to manipulate the uterus into all the positions that a human assistant would otherwise do with the advantage of 25 less human fatigue and less damage to the upper vagina 14 n r» — * * I | PC / 0 0 0 6 6 w i \ U C L i \ C, j ' The foregoing describes various preferred forms of the apparatus Alterations and modifications can be made to the apparatus withm the general concept as disclosed as will be obvious to a person skilled in the art. All such alterations and modifications are intended to be included within the scope of the invention as defined 5 by the appended claims 1

Claims (1)

1. CLAIMS l~r r~f • i " ' P 1 A surgical apparatus comprising 5 (a) an elongated housing, having a handle end and a manipulation end, (b) a bore extending through the housing, (c) a manipulation means comprising a rod which 10 extends through the bore in the housing with an end portion which extends from the manipulation end of the housing, which rod is reciprocally movable and rotatable withm the bore of the housing to enable the end portion of the rod to be 15 further extended from or retracted towards and rotated about the manipulation end of the housing, and a tip part extending beyond the end portion of the rod, 20 (d) a diaphragm situated distal the handle end of the housing and adapted to be inflated and deflated substantially circumferentially from the housing, and 25 (e) a channel for passing a gas from the end portion of the rod past the diaphragm, extending along or through the rod and having an exit in or adjac^^-^. 16 Cm^^QFFicTl J 9 AUG 1999 Received • % y. Hf'-T- L o ^ .j O I2lrirfl to the end portion of the rod between the manipulation end of the housing and the tip pari extending beyond the rod 5 2 An apparatus according to claim 1 compnsmg a passage extending from the handle end of the apparatus to the diaphragm for inflating the diaphragm 3 An apparatus according to claim 2 wherein said passage includes means to prevent uncontrolled deflation of the diaphragm ^ 10 4 An apparatus according to claim 1 wherein the tip part extending beyond the rod is curved 5 An apparatus according to claim 1 composing an annular stop of enlarged 15 diameter between the rod and the tip part 6 A surgical apparatus compnsmg (a) an elongated housing having a handle end and a 20 manipulation end, (b) a bore extending through the housing, 25 (c) manipulation means comprising a rod adapted to reciprocate and rotate within the bore and havmg a handle on one end of the housing and a portion which extends from and retracts towards 17 *:<"/ > ' n _nj , .1 o manipulation end of the housing at the other end of the housing, and a tip part extending beyond the end portion of the rod, (d) a diaphragm situated distal the handle end of the housing and adapted to be inflated and deflated substantially circumferentially from the housing via a passage associated with the bore, and (e) a gas channel passing through the rod and having an exit from the portion of the rod between the manipulation end of the housing and the tip part extending beyond the rod 7 A surgical apparatus according to any one of the preceding claims wherein the manipulation means further compnses a releaseably attachable tip 8 A surgical apparatus according to claim 6 wherein the tip part extending beyond the rod is curved 9 A surgical apparatus according to claim 6 comprising an annular stop of enlarged diameter between the rod and the tip part 10 A surgical apparatus substantially reference to any one of the attached Figures i r \ 18 as herein described with particular RUSSELL McVEAGH WEST WALKER attorneys for the applicant pNTELl ECTUXPROPERT70FF(CE1 I OFNZ '9 AUG 1999 I