Surgical procedure

[0001] This application claims the benefit of U.S. Provisional Application No. 61/150,385 filed Feb. 6, 2009. The content of this provisional application is incorporated herein by reference.

[0002] The invention relates to a method of performing a surgical procedure on a body organ such as the bladder, the uterus, the colon or the stomach.

[0003] To date surgical procedures on such organs involves major trauma to the patient with relatively long recovery times.

[0004] According to the invention there is provided a method of carrying out a procedure in a hollow body organ comprising the step of:—

• • [0005] inflating the hollow organ; and
  • [0006] carrying out a procedure in the inflated hollow organ.

[0007] In one embodiment the hollow organ is inflated using a fluid such as air or water.

[0008] The hollow organ may be the bladder, the uterus, the stomach or the intestine.

[0009] In one embodiment the method comprises the step of making an incision to form a wound opening and presenting the inflated hollow organ to the wound opening.

[0010] In one case the method comprises the steps of engaging the inflated organ and pulling the inflated organ towards the wound opening. The inflated organ may be engaged by one or more sutures.

[0011] In one embodiment the method comprises the step of making an incision in the inflated organ to provide access to the interior of the organ.

[0012] The method may comprise:—

• • [0013] providing an instrument access device comprising at least one instrument seal, a distal anchoring member, and a retractor member extending proximally from the distal anchoring member within the organ interior;
  • [0014] retracting laterally the sides of the opening in the organ using the retracting member; and
  • [0015] inserting one or more surgical instruments through the instrument seal into the organ.

[0016] In one case the device is inserted at least partially through the wound opening using an introducer device. The method may comprise the step of inserting at least part of the access device into the introducer device.

[0017] In one case the method comprises the step of inserting the introducer device at least partially through the opening. The method may comprise the step of ejecting at least part of the instrument access device from the introducer device within the organ interior. The method may also comprise the step of removing the introducer device from the opening.

[0024] Referring to the drawings there is illustrated various steps in performing a surgical procedure according to the invention. The procedure can be carried out on any suitable hollow organ, such as a gall bladder located beneath an abdominal wall 1.

[0025] In a first step of the procedure the hollow organ 2 is inflated by air or water through an inflation line 3 so that the organ 2 swells up as illustrated in FIG. 2. A scalpel 5 is then used to create an incision 6 in the abdominal wall 1 [FIG. 2]. Sutures 8 are then inserted through the opening 6 [FIG. 3] and these are used to pull up the inflated organ 2 to the opening 6 [FIG. 4]. The inflated organ 2 is now presented to the opening 6 and a laparascopic procedure is carried out on the organ 2.

[0026] A number of medical devices may be employed to perform the procedure for example a scalpel 5, an introducer device 202, an instrument access device 203, an insufflator 204, a camera device 205, and various surgical instruments 206. For example medical devices described in US2009-0036745A may be employed. The entire contents of US2009-0036745A are incorporated herein by reference.

[0027] In use, the introducer device 202 and the instrument access device 203 are supplied in a pack 207. The pack 207 is opened (FIG. 9), and the introducer device 202 and the instrument access device 203 are removed from the pack 207 (FIG. 10).

[0028] FIG. 9 illustrates the peel off lid 208, the multiport access device 203, the injector introducer 202, and the plastic blister pack tray 207 which is a sterile pack. In FIG. 9 the user peels open the tray lid 208. FIG. 10 illustrates the injector introducer 202, the thumbswitch 209, the blunt dissecting tip 210, the distal ring 211, the sleeve 212, the removal ribbon 213, the removal ring 214, the insufflation line 215, the 5 mm ports 216, the 12 mm port 217, and the outer proximal ring 218. In FIG. 10 the user removes the introducer 202, and the multiport access device 203.

[0029] The distal ring 211 of the instrument access device 203 is inserted into the introducer device 202 (FIG. 11). A scalpel may be used to create an opening in the hollow inflated organ 2.

[0030] In FIG. 11 the user inserts the distal ring 211 into the end of the injector introducer 202.

[0031] The introducer device 202 is inserted through the opening in the organ 2 until the distal ring 211 of the instrument access device 203 is within the interior (FIGS. 12 and 13).

[0032] In FIG. 12 the tip of the injector introducer 202 is placed in the incision in the organ. Downward pressure and axial rotation of the injector introducer 202 cause the blunt dissecting tip 210 to burrow through into the organ (FIG. 13).

[0033] The thumbswitch 209 of the introducer device 202 is depressed to eject the distal ring 211 of the instrument access device 203 into the organ interior (FIG. 14), and the introducer device 202 is removed from the organ opening 219 (FIG. 15).

[0034] In FIG. 14 the thumbswitch 209 is pressed downwards to eject the distal ring 211. In FIG. 15 the injector introducer 202 is removed from the incision 219 leaving the distal ring 211 in the inflated organ 2. The sleeve 212 is pulled upwards to engage the distal ring 211 with the underside of the organ wall.

[0035] The sleeve 212 of the instrument access device 203 is pulled proximally and the outer proximal ring 218 is pushed distally to retract laterally the sides of the organ opening 219 (FIG. 16). The excess sleeve material is cut-away, and the removal ribbon 213 is pulled proximally to remove any excess ribbon from the organ interior (FIG. 17).

[0036] In FIG. 16, the user keeps upward tension on the sleeve 212, and the outer proximal ring 218 is pushed down until sufficient retraction is achieved. In FIG. 17 the removal ribbon 213 is gently pulled to remove slackness from inside the organ. The excess sleeve 212 is cut and removed.

[0037] An insufflator 204 may be connected to the insufflation line 215 to further insufflate the organ (FIG. 18), and one or more instruments 206 may be inserted through the ports 216, 217 (FIG. 19).

[0038] FIG. 18 illustrates the insufflation supply 204, the insufflation line 215, the gel ports 216, 217. In FIG. 18 the insufflation line 215 is attached to the insufflation supply 204. In FIG. 19 up to three instruments 206 may be used simultaneously through the multiport device 203. Each leg 216, 217 have an individual valve on top. The legs 216, 217 are rubbery and so can accommodate the instruments 206 moving off axis. Moving one instrument 206 does not cause leaks in either of the other two instruments 206.

[0039] Instruments 206 may be inserted through the ports 216, 217 of the instrument access device 203 to access the organ interior, and/or the camera 205 may be inserted through one of the ports 216, 217 to access the organ interior (FIG. 20). In this case the camera 205 has a light source 222 inclined at an angle to the longitudinal axis of the camera 205, and the instruments 206 are straight.

[0040] In FIG. 20 there are two 5 mm ports 216 and one 12 mm port 217. FIG. 38 illustrates the 5 mm camera 205, the 5 mm instruments 206, the insufflation supply 204, the organ wall 221, and the 12 mm port 217.

[0041] The device comprises a distal anchoring ring 211, a retractor member 212, a proximal ring assembly 218, a connector sleeve, and instrument seals 216, 217. One such retractor is described in our US 2005-0090717 A, the entire contents of which are incorporated herein by reference.

[0042] The distal anchoring ring 211 is located within a wound interior, in use. In this case the distal, anchoring ring 211 is provided in the form of an O-ring.

[0043] The proximal ring assembly 218 is located externally of a wound opening, in use. The proximal ring assembly 218 may comprise an inner ring part and an outer ring part. In one case the inner ring part is provided in the form of an O-ring.

[0044] The retractor member 212 may be employed to retract laterally the sides of a wound opening. The retractor member 212 may extend between the distal anchoring ring 211 and the proximal ring assembly 218 in two layers. A first end of the retractor member is fixed to the inner ring part. The retractor member 212 extends distally from the inner ring part to the distal anchoring ring 211, is looped around the distal anchoring ring 211, extends proximally from the distal anchoring ring 211 to the proximal ring assembly, and extends proximally between the inner ring part and the outer ring part. The retractor member 212 is slidably movable relative to the distal anchoring ring 211, and a second end of the retractor member is slidably movable between the inner ring part and the outer ring part. In this case the retractor member is provided in the form of a sleeve.

[0045] In one case a retractor comprises a distal anchoring ring in the form of an O-ring 211. A retractor member comprises a sleeve 212 which in this case extends in two layers between the distal anchoring ring 211 and a proximal ring assembly 218.

[0046] The device comprises instrument seals 216, 217. Connector sleeves 219 extend from the seals 216, 217 to the proximal assembly.

[0047] Each instrument seal 216, 217 may be employed to effect a seal around a separate instrument extended through the device. Each instrument seal 216, 217 is formed separately from the other instrument seals, and is spaced apart from the other instrument seals. A first instrument seal may have a diameter equal to the diameter of a second instrument seal. The third instrument seal may have a larger diameter than the second instrument seal.

[0048] Each connector sleeve 219 connects the proximal ring assembly to one of the instrument seals 216, 217. Each connector sleeve 219 is inclined relative to the proximal ring assembly.

[0049] Each instrument seal 216, 217 comprises a sealing part which may be of a gelatinous elastomeric material, and a mounting part of a rigid material. The sealing part effects a seal around an instrument extended through the device. The mounting part facilitates releasable mounting of the instrument seal 216, 217 to the connector sleeve 219 in a gas-tight manner. The mounting part may comprise an outwardly protruding barb for an interference fit between the mounting part and the connector sleeve. The sealing part may be overmoulded over part of the mounting part to connect the sealing part to the mounting part.

[0050] The device comprises a connector base to releasably mount the connector sleeves 219 to the proximal assembly in a gas-tight manner. The base may comprise outwardly protruding ridges for an interference fit between the base and the inner ring part. A rigid reinforcement ring may be embedded within the base to reinforce the base.

[0051] The invention facilitates extraction of organs or parts thereof without contamination of the body wall.

[0052] Various features of the invention are described and illustrated. It will be appreciated that at least some of the features described in relation to one embodiment may be used not only in the embodiment specifically described but also in other appropriate embodiments.

[0053] The invention is not limited to the embodiments hereinbefore described, with reference to the accompanying drawings, which may be varied in construction and detail.