Apparatus for peritoneal retraction

The present invention relates to an apparatus for mechanically lifting the abdominal wall away form the underlying abdominal organs during laparoscopic procedures according to the precharacterizing portions of claims 1 and 6. In its more specific aspects, the invention is concerned with such an apparatus wherein the abdominal wall is lifted internally by a mechanical device which is introduced blindly or laparoscopically and, once in place, expanded to engage an extensive area of the abdominal wall. The invention is also concerned with an apparatus for draping the abdominal organs and displacing a particular organ, such as the gallbladder, for treatment.

Laparoscopy dates back to the turn of the 20^th Century. Early laparoscopic techniques were used primarily for diagnostic purposes to view the internal organs, without the necessity of convention surgery. Since the 1930s, laparoscopy has been used for sterilization and, more recently, for the suturing of hernias. US-A-4 919 152 and 4 944 443 are concerned with techniques of the latter type. Another very recent innovation is the use of laparoscopic surgery for removal of the gallbladder.

The concept of using mechanical retraction schemes to lift the abdominal wall away from the underlying abdominal organs during laparoscopic procedures is new to the present invention. Procedures presently use carbon dioxide insufflation to tent up the interior of the abdominal wall. This requires gas seals to be present at all entry ports through the abdominal wall, and because of the doming effect of insufflation, the laparoscopic instruments (graspers, scissors, electrocautery instruments, etc.) need long shafts (on the order of 30.5 to 33 cm (12 to 13 inches)) to reach the treatment site. Such instruments are difficult to control and result in exaggerated movements during instrument application.

In US-A-3 774 596, Cook shows an arrangement of flat, inflatable panels stacked in a collapsed state on a base. The spices of the inflatable panels are joined using longitudinal rods. After insertion into a body cavity through an existing orifice, the inflatable panels are inflated. This causes them to unfurl from the base and form a hollow polygonal structure that permits inspection and treatment of the body cavity. Windows can be formed in the inflatable panels.

Cook's apparatus is unsuitable for lifting the abdominal wall during laparoscopic surgery because its polygonal arrangement of flat inflatable panels is incapable of generating the force required to lift the abdominal wall unless very high inflation pressure are used. This, in turn, requires using a thick material for the flat, inflatable panels, which makes the device too bulky for the device to be usable laparoscopically.

To retract the liver to gain access to treat the gall bladder, published

EP-A-0 246 086 shows a device with four fingers that extend through a single laparoscopic puncture in the abdominal wall. After the fingers have been inserted, a mechanism outside the abdominal wall is operated to spread the fingers apart to expose the gall bladder. This apparatus has the disadvantage that additional incisions are required to insert the endoscope and to insert instruments used for treating the gall bladder. Moreover, the apparatus includes no provision for gripping the gall bladder.

DE-A1-28 47 633 shows a balloon catheter in which a balloon is carried on the distal end of a hollow shaft. An additional lumen in the shaft provides a passage for inflating the balloon once inside a body cavity. Using the balloon catheter for extracting gall stones from the bile duct is described. However, the structure shown is incapable of piercing the gall bladder from outside.

The publication WO-A-92/18056 (cited according to article 54(3) and (4) EPC, and prior art only in the countries AT, BE, CH, LI, DE, DK, ES, FR, GB, IT, NL) discloses an abdominal cavity expander for use in endoscopy, comprising a rod at the distal end of which at least one pivotal unit is fixed in such a way that its position can be varied from flush alignment (initial position) with the rod being perpendicular to it (second position). When it is in the second position it is possible to lift the abdominal wall away from the underlying organs in pulling the rod.

The apparatus of the present invention for lifting the abdominal wall is defined in the characterizing portion of claims 1 and 6.

The variation mechanical retraction schemes of the present invention allow intraperitoneal placement via small limited incisions or puncture sites. The abdomen does not need to be sealed against gas leaks and doming up of the abdominal wall is avoided. The abdominal wall is lifted by means of externally disposed posts or mechanical arms.

In practice of the method, a small opening is formed in the abdominal wall and the lifting device is inserted into the abdomen through the opening in a contracted state. Once within the abdomen, the device is extended to engage an extensive area of the abdominal wall and the wall is lifted with the device.

The apparatus according to the invention for lifting the abdominal wall comprises an abdominal wall engaging means. The abdominal wall engaging means is insertable through a small laparoscopic opening in the abdominal wall, and is expansible from the exterior of the abdominal wall laterally beyond the limited area of the laparoscopic incision to interiorly engage an extensive area of the abdominal wall. The apparatus additionally comprises lifting means for imparting lifting force to lift the abdominal wall through the abdominal wall engaging means.

A principal object of the present invention is to provide a peritoneal retraction system to lift the abdominal wall without insufflation.

Another and related object of the invention is to provide such a system which avoids the requirement of gas seals to be present at all entry ports through the abdominal wall.

Still another object of the invention is to provide such a system which avoids doming of the abdominal wall and the requirement that the laparoscopic instruments be very long in order to accommodate such doming.

Yet another object related to the latter object is to enable laparoscopic surgery to be carried out with instruments having relatively short shafts and to thus ease and increase the control imparted to the instruments by the surgeon.

A further object of the invention is to provide a peritoneal retraction system which drapes the abdominal organs and may serve to displace a particular organ for treatment.

Another object of the invention is to provide a peritoneal retraction system which is gentle and may be controlled to effect the lifting of discreet areas of the abdominal wall.

Yet another and more specific object of the invention is to provide a laparoscopic instrument internally engagable with an organ to be treated to distend and manipulate the organ or withdraw the organ form the body.

Still another object related to the latter object is to provide such an instrument which may be used to withdraw the contents of the organ prior to its removal.

Yet another object of the invention is to provide a system of lifting the abdominal wall for peritoneal retraction which avoids unduly tensioning body tissue.

Another general object of the invention is to provide such a system which avoids gas leaks and the need for trocar valves.

These and other objects will become more apparent when viewed in light of the following detailed description and accompanying drawings. <ul id="ul0001" list-style="none" compact="compact"><li>Fig. 1 is a transverse cross-sectional elevational view of a body, showing a first embodiment of the invention in the process of lifting the abdominal wall;</li><li>Fig. 2 is a transverse cross-sectional elevational view of a body, showing a second embodiment of the invention in the process of being placed for lifting of the abdominal wall;</li><li>Fig. 3 is a transverse cross-sectional view similar to fig. 2, showing a second embodiment in the process of lifting the abdominal wall;</li><li>Fig. 4 is a transverse cross-sectional elevational view of a body, showing a third embodiment of the invention in the process of being placed for lifting of the abdominal wall;</li><li>Fig. 5 is a transverse cross-sectional view similar to fig. 4, showing the third embodiment in the process of lifting the abdominal wall;</li><li>Fig. 6 is a transverse cross-sectional view of a body, showing a fourth embodiment of the invention in the process of being placed for lifting of the abdominal wall;</li><li>Fig. 7 is a transverse cross-sectional view similar to fig. 6, showing the fourth embodiment in the process of lifting the abdominal wall;</li><li>Fig. 8 is a perspective view of the lifting device of a fifth embodiment of the invention, with solid lines showing the device in contracted condition and phantom lines showing the device in the expanded condition;</li><li>Fig. 9 is a perspective view of a body in the process of having the fifth embodiment lifting device inserted into place in the contracted condition , with the abdominal wall broken away for purposes of illustration;</li><li>Fig. 10 is a perspective view similar to Fig. 9, showing the lifting device of the fifth embodiment in the process of being expanded;</li><li>Fig. 11 is a transverse cross-sectional elevational view of a body, showing the fifth embodiment of the invention in the process of lifting the abdominal wall;</li><li>Fig. 12 is a perspective view of the lifting device of a sixth embodiment of the invention, with the device shown in contracted condition and the balloons therein deflated;</li><li>Fig. 13 is a perspective view of the lifting device of the sixth embodiment, with the device shown in expanded condition and the balloons inflated;</li><li>Figs. 14 to 19 are perspective views sequentially illustrating the steps of inserting the fifth embodiment lifting device into place within the abdominal cavity and expanded the device for engagement with the abdominal wall, with part of the abdominal wall broken away for purposes of illustration;</li><li>Fig. 20 is a transverse cross-sectional elevational view of a body, showing a modified version of the fifth embodiment lifting device in the process of lifting the abdominal wall, wherein the device is shown illuminating the area beneath the wall;</li><li>Fig. 21 is a perspective view of another modified version of the fifth embodiment lifting device wherein the distal ends of the expansible elements are provided with balloons to shield them against snagging on body tissue;</li><li>Fig. 22 is a transverse cross-sectional elevational view of a body showing yet another modified version of the fifth embodiment device wherein the expansible legs of the device carry a lifting balloon.</li></ul>

Referring now to Fig. 1, a body is designated therein in its entirety by the letter "B" and is shown having an abdominal cavity "C" with an upper wall "W". The solid lines illustrate the wall in the retracted elevated condition. The phantom lines depict the position the wall would assume when relaxed.

The lifting device of the first embodiment (Fig. 2) comprises a stiff transverse bar 10 passed through a puncture site below the costal margin on one side of the body and out another puncture site below the costal margin on the other side. The puncture sites are placed as far laterally as possible; close to the anterior axiallary line on both sides. The bar is then lifted and placed on slotted posts 12 secured to both sides of the operating table 14. The placement of the bar below the costal margin places the maximum lift at the site of the gall bladder, for cholecystectomy procedures. The bar may be placed through puncture sites located more inferiorly for other procedures. A second transverse bar may also be used to define an entire plane of lift, as four puncture sites are then made in the abdominal wall.

Alternatively, instead of using a rigid bar, a cable may be passed through the abdominal wall and variable tension applied to the cable to yield different degrees of retraction.

In the second embodiment (Fig. 2) a stiff bar 16 is passed into the abdominal cavity through one side. A small puncture is then made at the mid-line of the abdominal wall and the cable loop 18 is then passed into the abdominal cavity. The bar 16 is passed through the loop and the loop is then pulled up (Fig. 3) to achieve retraction. Directional control of the bar is maintained by the portion of the bar that remains outside the abdomen.

The lifting device of the third embodiment (Figs. 4 and 5) comprises a rigid rod 22 having a lateral offset 24 of a generally rectangular shape. The rod 22 is threaded through entry and exit puncture sites in the abdominal wall and then rotated and clamped down to provide retraction, as shown in Fig. 5. Slotted posts 12 support the proximal and distal ends of the rod. A crank 26 is engaged with one of the ends of the rod to rotate it to the retraction position.

The fourth embodiment (Figs. 6 and 7) is essentially a variation of the third embodiment. In the fourth embodiment, the rod 28 is fabricated of a shape-memory metal, such as NITINOL which is straight when cool and assumes a shape with a laterally offset central portion 30 when heated. An electrode (not illustrated) embedded into the rod is used to heat the rod at the transition site, causing the rod to convert to a rectangular shape for retraction, as seen in Fig. 7.

The rod 28 is passed through the abdomen at puncture sites located at the costal margins, similarly to the Fig. 1 embodiment. Once in place, the proximal and distal ends of the rod are engaged on slotted posts 12. A heater 32 (see Fig. 7) is then activated to increase the rod temperature at the transition site, resulting in retraction of the abdominal wall.

The fifth embodiment shown in Figs. 8 to 11 comprises a pair of angle-shaped rigid members 34 and 36 having intermediate sections 38 and 40 extending in generally parallel relationship to one another and rotatably received within a sleeve 42. The proximal ends of the members 34 and 36 are formed with operating levers 44 and 46, respectively. The distal ends of the members 34 and 36 are provided with elongate arms 48 and 50.

In use of the fifth embodiment, and incision 52 is cut into the abdominal wall and the arms 48 and 50 are extended through the incision while in the contracted condition shown in Figs. 8 and 9. The levers 44 and 46 are then moved toward one another and held together to fan the arms outwardly beneath the abdominal wall, as shown in Fig. 10. The abdominal wall may then be lifted as shown in Fig. 11 to retract the abdomen.

The sixth embodiment shown in Figs. 12 and 13 differs from the fifth embodiment only in that the arms, designated 48 and 50 carry elongate balloons 54 and 56, respectively, and that the angle-shaped members are tubular to provide for the conduit of inflation gas to these balloons. The elements of the Figs. 12 and 13 embodiments corresponding to those of the embodiments shown in Figs. 8 to 10 are designed by like numerals, followed by the subscript "a" as follows: intermediate sections 38_a and 40_a; sleeve 42_a; and arms 44_a and 46_a. Flexible conduits 56_a and 58_a are secured to the levers 44_a and 46_a to provide for the conduit of gas thereto to inflate the balloons 54_a and 56_a.

The sixth embodiment is introduced into the abdominal cavity and used for retraction in generally the same manner depicted in Fig. 9 to 11, with the exception that after the arms 48_a and 50_a are fanned out, the balloons 54 and 56 would be inflated, as shown in Fig. 13. This expands and cushions the area of contact between the arms and abdominal wall.

Figs 14 to 19 illustrate the preferred sequence for forming the incision 52 and introducing the fifth or sixth embodiment into the abdominal cavity. In Fig. 14, a Veress needle with a thin plastic sheath 60 forms a puncture in the abdominal wall and enters the abdominal cavity. The Veress needle is then withdrawn, leaving the sheath 60 in place as shown in Fig. 15 and the guidewire 62 is threaded through the sheath and into the abdominal cavity. A small incision 52 (.5 cm) is then made along the sheath adjacent the guidewire and the sheath is removed, leaving the guidewire in place as shown in Fig. 16. A dilator 64 having a plastic guide sheath 66 thereover is then advanced over the guidewire and into the abdomen as shown in Fig. 17 and then the dilator and guidewire are removed, leaving the sheath in place as shown in Fig. 18. The dilator may have a fiberoptic scope to ensure that no bowel loops are impacted by the sheath during its placement. The lifting device or retractor is then introduced into the abdominal cavity through the guide sheath, as shown in Fig. 18, with the sheath protecting abdominal organs from trauma during insertion. Thereafter, the arms 48 and 50 are fanned out to provide expanded engagement with the inside of the abdominal wall, as shown in Fig. 19. There it will also be seen that a mechanical arm 67 is being engaged with the levers 44 and 46 to impart lifting force thereto and, in turn, retract the abdominal wall. The arm 67 has a distal section 69_a and a proximal section connected by a lockable swivel 71. The proximal section is supported on a motorized worm gear actuator 73 mounted on the side of the operating table, designated 75.

The modified version of the fifth embodiment shown in Fig. 20 corresponds in structure and mode of operation to that of Figs. 8 to 11, except that lifting arms 48_b and 50_b incorporate fiberoptic means to illuminate the abdominal cavity. Fig. 20 diagrammatically shows light bulbs 68 at the proximal ends of the levers 44_b and 46_b to provide a light source for the fiber optic illuminators.

The modified fifth embodiment version of Fig. 21 differs from that of Figs. 8 to 11 only in that the angle-shaped members 34_c and 36_c are tubular and provided with inflatable balloons 70 and 72 at the distal ends of the arms 48_c and 50_c. These balloons serve to shield the internal body organs from the ends of the arms. In use, the balloons would be in a contracted deflated condition during introduction of the Fig. 21 lifting device into the abdominal cavity. Once in place within the cavity, the balloons would be inflated through the tubular angle members and the arms 34c and 36c would be spread to fan out beneath the abdominal wall.

Conclusion

From the foregoing description, it is believed apparent that the present invention provides an apparatus for retracting the abdominal wall without insufflation. It also provides improved operating techniques. It should be understood, however, that the apparatus of the invention is not intended to be limited to the specifics of the illustrated embodiments, but rather is defined by the accompanying claims.