Surgical containment apparatus

Abstract: A surgical tissue bag (301) for percutaneously debulking large volumes of tissue contained within the bag (301). The tissue bag (301) comprises two layers of material, an inner layer of a puncture-resistant material and an outer layer of moisture-proof material for containing cells and fluid therein. The bag (301) material is foldable and flexible for insertion through an access sheath (302) into the surgical site and for forming a gas-tight seal when extended through the access sheath (302) or puncture site. A drawstring (310) is attached to the open end of the bag (301) to close the bag (301) when the tissue is contained therein and pulled through the puncture site in the outer surface of the skin (304). After the closed open end of the bag (301) is pulled through the puncture site, the closed end is fanned out against the outer layer of the skin, and a morcellator is inserted into the bag for debulking the large volume of tissue. The open end of the bag is continully fanned out to maintain a compact and tight containment of the tissue and fluid remaining in the bag. The morcellation process is continued until the entire volume of tissue is removed at which time the remaining portion of the bag (301) is completely removed from the surgical site area.

Description: This invention relates to surgical containment apparatus. One problem with minimally invasive surgery is the removal of large volumes of tissue through an access sheath which could be 5mm. to 20mm. diameter. Surgical instruments, and an endoscope, are inserted through these sheaths to the surgical site which can be insufflated with a gas to facilitate viewing and manipulation. Valves or other sealing devices may also be utilized. When the volume of the tissue to be removed is small with respect to the access sheath, removal is relatively straightforward. However, when large volumes of tissue must be removed, the use of debulking instruments such as a morcellator can be utilized to reduce the size of the tissue for removal through the access sheath. Manually operated morcellators are impractical. The containment of malignant or pathogenic tissue from surrounding healthy tissue is very important. A malignancy thus would normally indicate a more invasive procedure in which the cavity is opened and the affected tissue is removed. These invasive open cavity procedures increase the recovery period of the patient and subject the patient to additional discomfort and complications. On the other hand, the debulking of large malignant tissue volumes percutaneously through an access sheath presents significant morbidity risks to the patient. Only when other complicating factors are involved is the debulking of large malignant tissue volumes even indicated. D.E.-A-3542667 describes a container as defined in the preamble of claim 1. According to the invention, there is provided a container as defined in claim 1. The container or bag of an embodiment advantageously effects and maintains a gas-tight seal when the bag traverses the percutaneous puncture site. The bag compliantly plugs the puncture site, thus preventing any significant loss of body cavity insufflating gas. In one embodiment, the two layers are in the form of a single sheet of material to form the bag. In another embodiment the container comprises an inner bag formed from a sheet of the puncture-resistant material and an outer bag formed from a sheet of the moisture-proof material. The inner and outer bags each include a sheet of the respective puncture-resistant and moisture-proof material, and each sheet is folded and formed in the manner of the first-mentioned embodiment. As segments of tissue are removed with the morcellator, the bag can be further extracted from the body cavity to advantageously maintain a tight containment of the remaining tissue in the bag. This advantageously stabilizes the organ or tissue by reducing the bag volume as the morcellation proceeds and leads toward controlled removal of the tissue and the bag from the body cavity. Brief description of the drawings FIG.1A depicts an embodiment of the present invention; FIG.1B is a top view along the line 1B-1B; FIG.2 depicts another embodiment; FIGS.3 to 9 depict the method for percutaneously debulking tissue. Depicted in FIG. 1A is a surgical tissue container or bag 100 for containing tissue whilst it is being percutaneously debulked. The layers of the tissue bag should be flexible, foldable and capable of being inserted into a body through an access sheath. The bag effects and maintains a gas-tight seal while traversing the percutaneous puncture site. The flexible material also compliantly plugs the puncture site, and should prevent any significant loss of body cavity insufflating gas. The tissue bag is preferably formed from a single sheet 101 of material having two layers 102 and 103 for containing the tissue or organ therein. The inner layer 102 comprises a puncture-resistant material such as nylon in either a woven, as shown, or solid layer form for resisting penetration or damage by a surgical morcellating instrument, such as described in co-pending application EP-A-463 798 (E.D. Pingleton 1-3) filed on the same day as the present application. Outer layer 103 comprising a moisture-proof material such as a plastisol has been peeled away to view the inner puncture-resistant material layer 102. A moisture-proof material layer contains tissue within the bag and prevents the transmission of fluid or malignant tissue cells to healthy tissue within the surgical site. The two layers have been formed integrally bonded or laminated together to form single sheet 101 having opposite first and second ends 104 and 105 folded back on each other to form folded side 106 of the bag. Depicted in FIG.1B is top view of bag 100 of FIG. 1A along the line 1B-1B to better visualize the various sheet ends, sides, and attachments thereof. The first and second folded-back ends of the sheet are attached together using any one of a number of well-known means of attachment such as an adhesive, a vulcanization or lamination or, as shown, a thread-like material 107 to stitch or attach the folded-back ends together which forms seamed second side 108 of the bag. Sheet 101 also has opposite sides 109 and 110 with each side folded back on itself. The facing portions 114 and 115 of folded-back side 109 are attached together between the folded and second sides of the bag to form seamed closed end 111 of the bag. The second folded-back side 110 of the sheet forms open end 112 of the bag. The tissue bag also includes closure means such as a loop drawstring 113 attached about the open end 112 of the bag and has a portion extending from the open end and having a length extendable through an access sheath during the surgical procedure for drawing the open end of the bag closed and pulling the closed open end of the bag from the cavity and through the puncture site. Folded side 106 of the bag has a spring type property or construction to cause open end 112 of the bag to open for receiving tissue once the bag has been inserted through the access sheath into the body cavity. The colour of the bag is also preferably opaque to prevent glare to the endoscopist. Depicted in FIG.2 is surgical tissue bag 200 which includes an inner bag 201 and an outer bag 202 for percutaneously debulking tissue while containing the tissue and preventing the spread of malignant cells or fluid to healthy tissue. Tissue bag 200 includes two separated layers of material to form the inner and outer bags. The single layer bags are made of material that is both flexible and foldable for percutaneous insertion through an access sheath during a minimally invasive surgical procedure. The inner bag comprises a puncture-resistant material for resisting penetration by a surgical morcellating instrument, whereas the outer bag comprises a moisture-proof material for preventing the transmittal of fluid or tissue cells to healthy tissue within the surgical site. The two flexible material layers of the bag also effect and maintain a gas-tight seal when traversing the puncture site. Inner bag 201 includes a sheet 203 of puncture-resistant material having opposite ends 204 and 205 folded back on each other to form a folded side 206 of the inner bag and are attached together to form a seamed second side 207 of the inner bag. Opposite ends 204 and 205 of the inner bag are attached together using a thread-like material 208 or any other well-known fastening material or process as shown in the partial cut-away view. As previously described, these ends may be glued, laminated, or vulcanized depending on the type of puncture-resistant material utilized. Sheet 203 also includes opposite sides 209 and 210 with each side folded back on itself. The facing portions of folded-back side 209 are attached together to form the seamed closed end 211 of the inner bag. Folded-back side 210 forms the open end 212 of the inner bag. Outer bag 202 includes a sheet 213 of moisture-proof material. Similar to sheet 203, outer sheet 213 has opposite first and second ends 214 and 215 folded back on each other to form folded side 216 of the outer bag. Folded back ends 214 and 215 are attached together to form a seamed second side 217 of the outer bag and are attached together using a suitable fastening material 218, as shown in the partial cut-away view, such as thread, glue, and the like or fastened with the use of ,a suitable bonding process. Opposite sides 219 and 220 of the sheet are each folded back on itself. The facing portions of folded-back side 219 are attached together using suitable fastening means 223 to form the seamed closed end 221 of the outer bag. The second folded-back side 220 of the sheet forms the open end of the outer bag. The open ends of the inner and outer bags are attached together and a drawstring 222 attached in a well-known manner thereabout, which is pullable around the open ends thereof. The drawstring has a length extendable through an access sheath during the surgical procedure for drawing the open ends of the two bags closed. Depicted in FIGS.3 to 9 is the method of percutaneously debulking tissue in tissue bag 301 through an access sheath 302 that is inserted through a puncture site 314 into body cavity 303. As depicted in FIG.3, access sheath 302 is pushed into peritoneal cavity 303 through outer layers of tissue 304 such as skin, muscle, fat, etc. This is a well-known surgical procedure utilizing a trocar sheath. The illustrative surgical procedure utilized will be directed to a nephrectomy in which kidney 305 of the patient is percutaneously cut from connective tissue, and each of artery 306, vein 307, and ureter 308 is severed between surgical clips to prevent leakage of blood and urine into the cavity. After the trocar sheath 302 has been inserted into the peritoneal cavity 303, tissue bag 301 is folded and inserted through passageway 311 of the trocar sheath with a blunt tip push rod 309 into peritoneal cavity 303. As depicted in FIG.4, drawstring 310 extends from the tissue bag in the peritoneal cavity through passageway 311 of the trocar sheath and external to the patient for subsequently closing the open end 312 of the bag. The bag has been folded as previously described such that when introduced into the insufflated peritoneal cavity, the bag will readily open or with minimal assistance with an endoscopic instrument that is inserted through another trocar sheath (not shown). Although tissue bag 301 has been described as including a folded side for opening the open end, the bag may also be formed with an open end such as in a molding or an injection molding process. After insertion through the trocar sheath, the molded open end will return to its original size. After tissue bag 301 has been inserted into the peritoneal cavity 303, kidney 305 is inserted into the open end 312 of the tissue bag as depicted in FIG.5. After kidney 305 is placed entirely within the tissue bag, drawstring 310 is externally pulled through the trocar sheath to close the open end of tissue bag 301 as depicted in FIG.6. The drawstring is further pulled to bring the closed open end of the bag against the distal end 313 of trocar sheath 302 as depicted in FIG.7. Tension is applied to the drawstring to pull the closed open end 312 of the tissue bag and the trocar sheath through the opening 314 of the outer tissue layers 304. After the closed open end is pulled through puncture site 314 of the outer tissue layers 304, the trocar sheath is removed from the drawstring, and the closed open end is opened and fanned out against the outer layer of the skin as depicted in FIG.8. When positioned through the puncture site, the flexible material bag maintains a gas-tight seal to prevent any significant loss of body cavity insufflating gas. As depicted in FIG.9, an open-ended morcellator 315 as described in the copending application, is then inserted through open end 312 of the bag to debulk kidney 305 which remains in the peritoneal cavity along with the distal end of the tissue bag. The morcellator includes a rotary cutting tube 316 which cuts and suctions segments or pieces of the kidney externally through a vacuum port 317. The debulking process is continued until the entire kidney has been removed from the tissue bag. The puncture-resistant layer of the bag prevents the morcellator from cutting through the bag and into the peritoneal cavity 303, spilling possibly malignant cells and fluid into the cavity. As the kidney is debulked, the open end of the bag is continued to be pulled out of puncture site 314 of the tissue to keep a tight compact volume in which the morcellator may cut and remove the remaining portions of the kidney. It is to be understood that the above-described surgical tissue bag and method for percutaneously debulking a large volume of tissue is merely illustrative, and that other tissue bags may be devised by those skilled in the art. In particular, the surgical tissue bag may be formed from molded or injection-molded material having both moisture-proof and puncture-resistant qualities and/or layers. The bag material would be flexible and foldable enough to insert through the trocar sheath but yet readily open upon insertion into the surgical site cavity during the minimally invasive endoscopic procedure. The flexible material of the bag would also maintain a gas-tight seal when positioned through the puncture site. The surgical bag advantageously contains the cells therein to minimize contamination of the surgical site. The method of percutaneously debulking a large volume of tissue also contemplates pulling the closed open end of the surgical tissue bag entirely through the hollow passageway of the trocar sheath. Other means of drawing the open end of the tissue bag are also contemplated.

Claims: An open-ended container (100) for a minimally invasive surgical procedure, comprising a sheet of puncture resistant material (102) with a drawstring (113) attached about the open end (112) of the container, the latter being flexible and foldable for percutaneous insertion through an access sheath (302) into a patient during surgery, with the drawstring having a length extendable through the sheath to enable the open end to be closed, characterised in that the container comprises a layer or sheet of moisture proof material (103), the puncture resistant sheet and moisture proof layer or sheet having opposite first and second ends (104,105) folded back on each other and forming a folded side (106) of the container, said folded side having a spring type property or construction to cause the container to open, said first and second folded back ends being affixed together and forming a second side (108) of the container, the sheets also having opposite first and second sides, (109) each side being folded back on itself, facing portions (114,115) of said first folded-back side being attached together between said folded (106) and second sides (108) of the container, and forming a closed end (111) of the container, said second folded-back side (110) forming the open end of the container. The container of claim 1, further characterised by an adhesive material affixing said first and second folded-back ends (104,105) of said sheet together and affixing said facing portions of said first folded-back side together, or means for laminating said first and second folded back ends of said sheet together and said facing portions of said first folded-back side together, or thread means for affixing said first and second folded-back ends of said sheet together and for affixing said facing portions of said first folded-back side together. The container of claim 1 or 2, characterised in that said puncture-resistant material (102) comprises nylon, and/or said moisture-proof material comprises a plastisol. The container of claim 1,2 or 3, characterised in that said layers are laminated together, or integrally bonded together. The container of claim 1,2,3 or 4, characterised in that at least one of said layers is opaque. A container according to any one preceding claim, characterised in that the said one sheet forms an inner bag, and in that the said other sheet forms an outer bag with the inner bag positioned therein, each bag being formed in accordance with the preceding claims.

Inventors: CLAYMAN RALPH VICTOR, PINGLETON EDWARD DUANE, CLAYMAN, RALPH VICTOR, PINGLETON, EDWARD DUANE
Applicants: VANCE PRODUCTS INC, VANCE PRODUCTS INCORPORATED D/B/A COOK UROLOGICAL INCORPORATED
Application year: 1991
Main classification: A61B19
IPC codes: A61B17, A61L33