Patent Description:
Where needed, a small incision is made in a patient to access surgically targeted tissue located inside a body cavity. Surgically targeted tissue may also be approached through a body orifice without an initial incision. Sometimes the targeted tissue is approached directly through the incision or body orifice. Other times, an access device system is placed and/or positioned into, across, at, and/or within the incision and/or body orifice to retract tissue, enlarge, reshape, and/or isolate the incision or body orifice. The access device system serves as a portal for accessing targeted tissue that is located in or adjacent to the body cavity or body orifice. The targeted tissue is detached from adjacent and surrounding tissue employing known surgical techniques and procedures. Once freed, the targeted tissue is ready for removal through the small incision or body orifice. If the targeted tissue is too large to be removed in whole, then it is reduced in size and removed in parts through the small incision. Ideally, the surgeon will "core" or "peel" the targeted tissue to keep it in one piece as much as possible. However, more likely than not, the targeted tissue will be reduced into multiple pieces.

Reducing the size of the targeted tissue is called morcellation. A morcellation procedure includes cutting the targeted tissue into smaller pieces manually with a scalpel or knife, for example, or employing a power morcellator to cut the targeted tissue so that it is removable through the small incision. Pieces of the targeted tissue are removed from the patient through the small incision. As the targeted tissue is being reduced in size in order to fit through the small incision, small pieces of tissue may be cut off and left behind in the patient. As such, morcellation is contraindicated in cases of malignancy or endometriosis. If cancer is morcellated, it can spread malignant tissue and upstage cancer and increase patient mortality.

A hysterectomy is an example of a surgical procedure that may involve morcellation. More than <NUM>,<NUM> hysterectomies are performed annually on women in the United States. Common reasons that a woman may have a hysterectomy are the presence of fibroids, cancer, endometriosis or prolapse. Of these hysterectomies, about <NUM>,<NUM> are performed laparoscopically. When the uterus is too large (><NUM>) to be removed through the vagina or if the cervix is still in place, the specimen must be reduced in size to be removed through an abdominal incision or through the vagina. During myomectomy (fibroid removal), large fibroids may also need to be extracted using a morcellation procedure. During morcellation, the targeted tissue (usually a uterus and sometimes adnexal structures) is brought to the abdominal wall surface within the pelvic cavity such as with a tissue grasper and is reduced in size using a blade and removed through the incision from the pelvic cavity. In another variation, the targeted tissue is removed through a body orifice such as through the vagina. Fibroids, or uterine leiomyoma, account for about <NUM>-<NUM>% of hysterectomies. These are benign tumors of the uterus that can lead to heavy and painful bleeding. In the past there has been a mild concern that these tumors could be undetected cancer, or Leiomyosarcoma, and it was believed to affect about <NUM> in <NUM>,<NUM> women. More recent data has come out to support a much higher risk of undetected malignancy in these tumors, putting the range at <NUM>:<NUM> to <NUM>:<NUM>. Because of this elevated risk, many surgeons have begun changing their technique to try to enclose the specimen to do a closed morcellation process by morcellating in a bag to contain errant pieces, rather than morcellating without a bag in a process called open morcellation. Many GYN societies, including the American Association of Gynecologic Laparoscopists (AAGL), the American Congress of Obstetricians and Gynecologists (ACOG), and the Society of Gynecologic Oncology (SGO), have released statements warning of the potential danger of open morcellation. On April <NUM>, <NUM>, the FDA issued a statement discouraging the use of open power morcellation for hysterectomies and myomectomies for women undergoing these procedures for fibroids. The FDA also increased their estimated of malignant likelihood to <NUM> in <NUM>. For these reasons, systems and methods are needed to safely and effectively reduce tissue specimens. The present invention sets forth such safe systems and methods for both manual morcellation and power morcellation performed in closed system.

According to one aspect of the invention a tissue containment bag is provided in accordance with Claim <NUM> of this specification.

Turning now to <FIG>, there is shown a containment bag <NUM>. The containment bag <NUM> includes a first opening <NUM>, also called a mouth, and a second opening <NUM> interconnected by a sidewall <NUM>. A first ring <NUM> is provided at the first opening <NUM> and a second ring <NUM> is provided at the second opening <NUM>. The rings <NUM>, <NUM> are connected to the sidewall <NUM> by enclosing the rings <NUM>, <NUM> in a pocket formed by the sidewall <NUM> heat sealed onto itself and/or with adhesive. The sidewall <NUM> is formed of any suitable flexible material including but not limited to polymer, fabric, polymer reinforced with fabric, mesh, nylon, fibers and the like. The first opening <NUM> is larger than the second opening <NUM> and the sidewall <NUM> forms a frusto-conical configuration. Accordingly, the first ring <NUM> is larger than the second ring <NUM>. The sidewall <NUM> is formed by heat-sealing the sidewall material longitudinally forming one or more seams along the length of the bag <NUM>. As shown in <FIG>, the bag <NUM> may optionally include at least one fastener <NUM> connected to sidewall <NUM> at a location between the two rings <NUM>, <NUM>. In one variation, the fastener <NUM> includes a cincture, belt, girdle or cinch comprising a string, tape or other means known in the art that girds the sidewall <NUM> at least in part and can be pulled to reduce the diameter of the sidewall <NUM> in the location of the fastener <NUM>. Other types of fasteners <NUM> may be used. Multiple fasteners <NUM> may be also employed and spaced apart along the longitudinal axis of the bag <NUM> as will be described in greater detail below. The single fastener <NUM> functions to reduce the diameter of the bag <NUM> at a location approximately midway between the two openings <NUM>, <NUM> and as a result creates a base <NUM> also called a bottom or floor or semi-floor for the bag <NUM> upon which a surgical tissue specimen may be supported. In general, the fastener <NUM> also functions to close the sidewall <NUM> and create two compartments or chambers in the bag <NUM> a first proximal compartment <NUM> and a second distal compartment <NUM> separated by the cinch. The fastener <NUM> can advantageously be released such that lumen of the bag <NUM> is uninterrupted from the first opening <NUM> to the second opening <NUM>. A first tether and tag may be attached to the first ring <NUM> and a second tether and tag may be attached to the second ring <NUM> to facilitate placement of the bag <NUM> and to facilitate removal of the bag <NUM>. As shown in <FIG>, the first opening <NUM> and second opening <NUM> are coaxial or substantially located along the longitudinal axis of the bag <NUM> when the bag <NUM> is in a normal undeflected orientation forming a sleeve-like, tubular structure.

In use for a surgical procedure that involves detaching a uterus or other surgical target and its subsequent morcellation, the containment bag <NUM> is employed. In use, an incision is first made in the patient's abdominal region, typically, in the umbilicus. A retractor is inserted into the incision.

The retractor (not shown) typically comprises a first ring and a second ring interconnected by a flexible sidewall. The sidewall defines a lumen interconnected between an opening of the first ring and an opening of the second ring of the retractor. The second ring is resilient and compressible. When compressed the second ring forms an oval elongated shape and is inserted through the incision in the abdominal wall and into an abdominal cavity which may have already been expanded by insufflation gasses to create a surgical working space. When the second ring is no longer compressed into a low-profile condition it freely expands into its original high-profile configuration due to its own resiliency as a result of being made of suitable materials, construction and design. The sidewall of the retractor connects the second ring to the first ring. When the second ring is located inside the patient, the sidewall traverses the incision and the abdominal wall while the first ring resides above the abdominal wall outside the patient. Because the sidewall is relatively loose, the small incision tends to bow the sidewall inwardly toward the retractor lumen. The first ring is configured to be rolled down to retract and enlarge the opening in the abdominal wall. The first ring is flipped about itself to roll the sidewall material onto the first ring of the retractor reducing the length of the retractor. As the length of the retractor is decreased the second ring is drawn closer to the first ring. Continued rolling of the first ring reduces the length of the sidewall increases tension on the sidewall moving it outwardly toward its cylindrical shape and thereby, retracting tissue in contact with the outer surface of the sidewall and, thereby, enlarging the opening in the abdominal wall. The first ring has an elongated, oblong, oval cross-sectional shape which facilitates rolling of the sidewall and prevents unrolling of the sidewall compared to a ring having a circular cross-section. The sidewall is made of polyurethane laminate or similar material including woven or reinforced polymeric material to resist cuts and breaks through the sidewall. Various examples of access systems to be included or integrated into the morcellation system in which the entire access systems, portions of the access systems or combinations of access systems and/or components thereof arranged to provide a channel and/or a protective region are described in <CIT>; <CIT>; <CIT>, <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>.

After the retractor is inserted into the incision and the opening at the incision is enlarged, an access port cap/platform is attached to the first ring of the retractor covering and sealing the opening created by the retractor. The access port cap may include one or more access ports including an insufflation port and/or be made of penetrable material such as gel that seals around an inserted instrument. Insufflation gas is delivered across the incision sealed with the access port cap to insufflate the patient's abdominal cavity and create an expanded surgical working space. The body cavity is insufflated by delivering gas across the access port cap into the abdominal cavity. Instruments such as graspers, scissors, scopes, and electrocautery/electrosurgical instruments are inserted through the access port to detach the uterus. The instruments are removed and the access port cap/platform is removed.

In use, the bag <NUM> is inserted through the incision in the umbilicus. The access port cap/platform is re-attached to the first ring of the retractor and the body cavity is re-insufflated to allow for visualization of the procedure via a scope inserted through the access port cap/platform or secondary incision. The detached tissue specimen such as the uterus is inserted into the first opening <NUM> of the bag <NUM> with graspers while inside the abdominal cavity. The first opening <NUM> is larger than the second opening <NUM> of the bag <NUM> making it easy to introduce the tissue specimen. Also, the rings <NUM>, <NUM> are flexible and can be compressed into a low-profile configuration suitable for insertion through a small port and/or incision. The tether attached to the first ring <NUM> is pulled to bring the larger first ring <NUM> through the umbilicus incision. The access port cap/platform is removed and the first ring <NUM> of the bag <NUM> and a portion of the sidewall <NUM> near the first ring <NUM> is pulled out of the first incision. A portion of the sidewall <NUM> overlays the first ring of the retractor and the access port cap/platform is re-attached to the retractor capturing the bag between the access port cap/platform and the retractor ring. The tether attached to the second ring <NUM> of the bag <NUM> grasped from the vaginal canal which is now opened because the uterus has been detached. The second ring <NUM> of the bag <NUM> is pulled through the vaginal opening and a second access port cap/platform is attached to the second ring <NUM>. The second ring <NUM> may be compressed into a low-profile orientation to facilitate removal of the second ring <NUM>. The access port cap/platform is smaller to fit the smaller second ring <NUM>. A scope is inserted through the second access port cap/platform into the bag <NUM>. The second opening <NUM> is smaller in order to be sized and configured for placement along the vaginal canal and/or for the insertion of a narrow long instrument such as a scope for observation or a power or manual morcellating instrument for morcellation of the uterus inside the bag. Alternatively, a trocar may be inserted through the second access port cap/platform and a scope inserted through the trocar. In yet another variation, an access port cap/platform is not employed and a balloon trocar is inserted into the second opening <NUM> through which a scope is inserted. In another variation, a scope is inserted into the bag <NUM> without an access port cap/platform or retractor. In another variation, a retractor may be placed inside the second opening <NUM> of the bag <NUM> and the vaginal canal retracted together with the bag <NUM> with the retractor. Or, alternatively, the second opening <NUM> of the bag <NUM> is pulled through the lumen of a retractor already in position within the vaginal canal.

A morcellator is inserted through the first access port cap/platform and morcellation of the specimen is commenced under observation via the scope inserted through the vaginal canal and through the second opening <NUM> in the bag <NUM> advantageously providing an unobstructed view of the procedure. This procedure constitutes morcellation through the umbilicus or other incision site in the abdominal region. An alternative to morcellating through the umbilicus is morcellating through the vaginal canal which will be described further below.

After the morcellation through the umbilicus or other incision site is completed, the bag <NUM> is removed from the patient by first removing the access port cap/platform at the vaginal canal attached to the smaller second ring <NUM>. If a retractor is employed at the vaginal opening, it is also removed. The second opening <NUM> of the bag is sealed prior to removal of the bag by various methods which will be described in greater detail below. For example, the sidewall <NUM> near the second opening <NUM> may be rolled-up and tucked into one or more pockets or the sidewall <NUM> may be sealed by tying the distal end of the bag <NUM> into a knot. The first access port cap/platform and retractor, if one is employed, are removed at the umbilicus or other abdominal incision. With the second opening <NUM> of the bag sealed, the entire bag <NUM> is removed from through the abdominal incision. At the point of removal, most of the uterus or tissue specimen is already removed or reduced in size by the morcellation process making removal of large specimens easy. Sealing the second opening <NUM> prior to removal of the bag prevents the bag contents from spilling out. Hence, the system remains fully contained.

In another variation of morcellation through the umbilicus or other abdominal location, after the bag <NUM> is inserted into the abdominal cavity and a specimen is inserted into the first opening <NUM>. Before the first ring <NUM> is pulled to the abdominal surface of the patient, the access port cap/platform is removed from the retractor and also, the retractor is removed. Then, the first ring <NUM> is squeezed into a low-profile configuration and a proximal portion of the bag <NUM> is pulled out through the umbilicus with the remainder of the bag with the specimen inside it remaining inside the abdominal cavity. The retractor is re-inserted into the mouth of the bag <NUM> and then the tissue is advantageously retracted together with the sidewall <NUM> of the bag <NUM> as shown in <FIG>. The access port cap/platform is re-attached to the retractor ring as shown in <FIG>. The proximal portion of the bag <NUM> overlays the retractor and first ring <NUM> of the bag <NUM> is resident outside of the patient.

As an alternative to morcellation through the umbilicus, morcellation of the tissue specimen, such as the uterus, through the vaginal canal will now be described. The bag <NUM> is inserted through the incision in the umbilicus or other abdominal location. A retractor may be inserted into the incision and the surrounding tissue retracted. The access port cap/platform is re-attached to the first ring of the retractor and the body cavity is re-insufflated to allow for visualization of the procedure via a scope inserted through the access port cap/platform or secondary incision. The detached tissue specimen such as the uterus is inserted into the first opening <NUM> of the bag <NUM> with graspers. The tether attached to the first ring <NUM> is pulled to bring the larger first ring <NUM> through the vaginal canal instead of through the umbilical incision. The first ring <NUM> of the bag <NUM> and a portion of the sidewall <NUM> near the first ring <NUM> is pulled out of the vaginal canal. A retractor is inserted into the first opening <NUM> of the bag <NUM> and the vaginal canal is retracted together with the bag <NUM> in the location of the retractor by rolling the first ring about itself to wind the sidewall around the first ring of the retractor. An access port cap/platform is attached to the retractor ring. Alternatively, a retractor may be placed before the bag <NUM> is pulled through the vaginal opening in which case the access port cap/platform captures the bag <NUM> against the first ring of the retractor. The tether attached to the smaller second ring <NUM> of the bag <NUM> is grasped from the umbilical incision or other abdominal incision. The second ring <NUM> of the bag <NUM> is pulled through the umbilical incision or other abdominal incision and a second access port cap/platform is attached to the second ring <NUM>. The second access port cap/platform is smaller to fit the smaller second ring <NUM> relative to the first access port cap/platform. A scope is inserted through the second access port cap/platform into the bag <NUM> to observe the morcellation process. Alternatively, a trocar may be inserted through the second access port cap/platform and a scope inserted through the trocar. Alternatively, a balloon trocar may be employed without an access cap/platform or retractor or simply the scope may be inserted into the bag <NUM> at the second opening <NUM> resident at the umbilical or other incision. A morcellator is inserted through the first access port cap/platform through the vaginal canal and morcellation of the specimen is commenced under observation via the scope that is inserted through the umbilical first incision and through the second opening <NUM> in the bag <NUM> advantageously providing an unobstructed view of the procedure. The bag <NUM> is removed from the patient by removing the first access port cap/platform attached to the retractor at the vaginal opening. The retractor at the vaginal opening is also removed. Any retractor or second access port cap/platform at the second opening <NUM> is removed. The second opening <NUM> of the bag <NUM> is sealed by various methods which will be described in greater detail below. For example, the sidewall <NUM> near the second opening <NUM> may be rolled-up and tucked or the sidewall <NUM> may be tied into a knot. With the second opening <NUM> sealed, the entire bag <NUM> is removed through the vaginal canal. At the point of removal, most of the uterus or tissue specimen is already removed or reduced in size by the morcellation process.

Turning now to <FIG>, another containment bag <NUM> variation will now be described using like numbers to designate like parts. The bag <NUM> of <FIG> may also be used in any one or more of the methods described above. The bag <NUM> includes a first opening <NUM>, also called a mouth, and a second opening <NUM> interconnected by a sidewall <NUM>. A first ring <NUM> is provided at the first opening <NUM> and a second ring <NUM> is provided at the second opening <NUM>. The rings <NUM>, <NUM> are connected to the sidewall <NUM> by enclosing the rings <NUM>, <NUM> in a pocket formed by the sidewall <NUM> heat sealed onto itself and/or with adhesive. The sidewall <NUM> is formed of any suitable flexible material including polymer, fabric, polymer reinforced with fabric, mesh, nylon, fibers and the like. The first opening <NUM> is larger than the second opening <NUM> and, accordingly, the first ring <NUM> is larger than the second ring <NUM>. The sidewall <NUM> forms a funnel-like shape configuration dividing the lumen of the bag <NUM> into a first compartment <NUM> and a second compartment <NUM>. The first compartment <NUM> is substantially parabolic, funnel-like in shape having curved sidewalls when the bag <NUM> is in a natural undeflected orientation. The sidewall <NUM> is formed by heat-sealing the sidewall material longitudinally forming one or more seams along the length of the bag <NUM>. At the intersection of the first compartment <NUM> and second compartment <NUM>, there is a reduced diameter location entryway <NUM> that advantageously reduces the amount of specimen passing therethrough and, as a result, creates a base <NUM> also called a bottom or floor or semi-floor for the bag <NUM> upon which a surgical tissue specimen may be supported for morcellation with the small entryway preventing tissue specimen from readily moving into the second compartment <NUM>. The curved sidewall <NUM> helps retain the specimen at the base <NUM> forming a reservoir-like configuration. From the intersection <NUM> to the second opening <NUM>, the cross-sectional opening is substantially constant and/or gradually increases or decreases to create a tubular, sleeve-like section of the bag <NUM> that is sized and configured for placement through the vaginal canal and that is much narrower than the first compartment <NUM> which has a larger cross-sectional opening along the first compartment <NUM>. A first tether and tag may be attached to the first ring <NUM> and a second tether and tag may be attached to the second ring <NUM> to facilitate placement of the bag <NUM> and to facilitate removal of the bag <NUM>.

Turning now to <FIG>, there is shown another containment bag <NUM>. The containment bag <NUM> includes a first opening <NUM>, also called a mouth, and a second opening <NUM> interconnected by a sidewall <NUM>. A first ring <NUM> is provided at the first opening <NUM> and a second ring <NUM> is provided at the second opening <NUM>. The rings <NUM>, <NUM> are connected to the sidewall <NUM> by enclosing the rings <NUM>, <NUM> in a pocket formed by the sidewall <NUM> heat sealed onto itself and/or with adhesive. The sidewall <NUM> is formed of any suitable sheet of flexible material including but not limited to polymer, polymer reinforced with fabric, mesh, nylon, fibers and the like. The first opening <NUM> is larger than the second opening <NUM> and the sidewall <NUM> forms a frusto-conical configuration. Accordingly, the first ring <NUM> is larger than the second ring <NUM>. The sidewall <NUM> is formed by heat-sealing the sidewall material longitudinally forming one or more seams along the length of the bag <NUM>. The bag <NUM> includes one or more inwardly extending lateral seams <NUM> reducing the lumen of the bag <NUM> at a location between the first opening <NUM> and the second opening <NUM>. The seams <NUM> are formed into the sidewall <NUM> by selectively hot-sealing portions of the sidewall <NUM> together to reduce the diameter of the sidewall <NUM> in the location of the seam. Four seams <NUM> spaced around the sidewall <NUM> are shown in <FIG> and two seams <NUM> are shown oppositely disposed in <FIG>. The seams <NUM> function to reduce the diameter of the bag <NUM> at a location anywhere including midway between the two openings <NUM>, <NUM> and as a result creates a base <NUM> also called a bottom or floor or semi-floor for the bag <NUM> upon which a surgical tissue specimen may be supported. In general, the seams <NUM> function to close the sidewall <NUM> and create two compartments in the bag <NUM>, a first proximal compartment <NUM> and a second distal compartment <NUM>, separated by the seams <NUM>. At the intersection of the first compartment <NUM> and second compartment <NUM> there is a reduced entryway <NUM> that advantageously reduces the amount of specimen passing therethrough and, as a result, creates a base <NUM> or semi-base. A first tether and tag may be attached to the first ring <NUM> and a second tether and tag may be attached to the second ring <NUM> to facilitate placement of the bag <NUM> and to facilitate removal of the bag <NUM>.

Turning now to <FIG>, there is shown a containment bag <NUM> for the purposes of showing the various dimensions of the bag <NUM>. The dimensions are not limited to the exact configuration for the bag <NUM> but approximately the same dimensions may be used for any one or more the bag variations disclosed herein. The length A of the bag <NUM> is approximately <NUM> (<NUM> inches). The diameter B at the first opening <NUM> is approximately <NUM> (<NUM> inches). The diameter C at the second opening <NUM> is approximately <NUM> (<NUM> inches). The distance D to the seams <NUM> or fastener <NUM> from the second opening <NUM> is approximately <NUM> (<NUM> inches). The diameter G of the entryway <NUM> is approximately <NUM> (<NUM> inches). The rings <NUM>, <NUM> are rigid, resilient and flexible and made of plastic capable of assuming a low-profile, compressed configuration from a relaxed, normal, undeformed high-profile expanded configuration. The low-profile configuration is elongated and oval with the opening reduced in side and configured for easy insertion through a small incision. The high-profile configuration is substantially circular but may be of any shape. The rings <NUM>, <NUM> are capable of supporting the bag sidewall <NUM> opening the bag sidewall <NUM> as the ring <NUM>, <NUM> moves from a low-profile configuration to a high profile configuration. The rings <NUM>, <NUM> are resilient and tend to spring back to their undeformed high-profile configuration. A clinician can easily compress the ring <NUM>, <NUM> to reduce its size for insertion through an incision into a body cavity.

Turning now to <FIG>, there is shown another variation of the containment bag <NUM> wherein like reference numbers are used to describe like parts. The containment bag <NUM> includes a first opening <NUM>, also called a mouth, and a second opening <NUM> interconnected by a sidewall <NUM>. A first ring <NUM> is provided at the first opening <NUM> and a second ring <NUM> is provided at the second opening <NUM>. The rings <NUM>, <NUM> are connected to the sidewall <NUM> by, for example, enclosing the rings <NUM>, <NUM> in a pocket formed by the sidewall <NUM> heat sealed onto itself and/or with adhesive. The sidewall <NUM> is formed of any suitable flexible material including fabric, polymer, polymer reinforced with fabric, mesh, nylon, fibers and the like. The first opening <NUM> is larger than the second opening <NUM>. Accordingly, the first ring <NUM> is larger than the second ring <NUM>. The sidewall <NUM> is formed by heat-sealing the sidewall material longitudinally forming one or more seams along the length of the bag <NUM>. As shown in <FIG>, the bag <NUM> is formed into a first compartment <NUM> and a second compartment <NUM> with an entryway <NUM> at their intersection. The first compartment <NUM> has a proximal section that is substantially cylindrical in shape with a vertical sidewall <NUM> connected to a distal section that is funnel-like in shape having an angled sidewall <NUM> when the bag <NUM> is in a normal undeflected orientation as shown. The distal section that is funnel-like in shape is connected to the second compartment <NUM> via the entryway <NUM>. The entryway <NUM> is sized and configured to permit a scope to pass. A scope would be typically inserted through the second opening <NUM> into the second compartment <NUM> and extended all the way to near the entryway <NUM> for observation of morcellation taking place in the first compartment <NUM>. Therefore, the entryway <NUM> is sized as small as possible to prevent escape of specimen from the first compartment <NUM> and to form a large enough base <NUM> to support a specimen and large enough to receive the scope shaft. The angled sidewall <NUM> of the funnel-like distal section of the first compartment <NUM> forms the base <NUM> also called a bottom or floor or semi-floor for the bag <NUM> upon which a surgical tissue specimen may be supported. The entryway <NUM> is as small as the diameter of a <NUM>-<NUM> scope. In the variation shown in <FIG>, the diameter of the entryway <NUM> is smaller than the diameter of the second opening <NUM>. The larger diameter at the second opening <NUM> compared to the diameter at the entryway <NUM> facilitates the second ring <NUM> being rolled upon itself to reduce the length of the second compartment <NUM>. A third ring (not shown) may be further provided near the second ring <NUM> such that the second ring <NUM> and the third ring serve as a built-in, integral retractor of the like described above. The larger second opening <NUM> relative to the diameter at the entryway <NUM> also facilitates insertion of instruments and retraction of tissue. The sidewall <NUM> of the second compartment <NUM> angles outwardly progressively with distance from the entryway <NUM> to the second opening <NUM>. The bag <NUM> of <FIG> is shown provided with a seal mechanism <NUM> configured to seal the second opening <NUM> so that specimen does not spill from the bag <NUM>. The various possible seal mechanisms <NUM> that can be including in this variation as well as in any variation of the containment bag <NUM> will be described in greater detail below. A first tether/tag <NUM> may be attached to the first ring <NUM> and a second tether/tag <NUM> may be attached to the second ring <NUM> to facilitate placement of the bag <NUM> and to facilitate removal of the bag <NUM>.

Turning now to <FIG>, there is shown a containment bag <NUM>. The containment bag <NUM> includes a first opening <NUM>, also called a mouth, and a second opening <NUM> interconnected by a sidewall <NUM>. A first ring <NUM> is provided at the first opening <NUM> and a second ring <NUM> is provided at the second opening <NUM>. The rings <NUM>, <NUM> are connected to the sidewall <NUM> by, for example, enclosing the rings <NUM>, <NUM> in a pocket formed by the sidewall <NUM> heat sealed onto itself and/or with adhesive. The sidewall <NUM> is formed of any suitable flexible material including but not limited to fabric, polymer, polymer reinforced with fabric, mesh, nylon, fibers and the like. The first opening <NUM> is larger than the second opening <NUM>. The sidewall <NUM> forms a teapot shape wherein the second opening <NUM> forms the opening at the spout or neck of the vessel. The sidewall <NUM> includes a base <NUM> configured for supporting a tissue specimen. Unlike the previous variations described above in which the first opening <NUM> and second opening <NUM> were substantially coaxial or otherwise described as being in alignment with each other along a longitudinal axis of the bag <NUM> when the bag <NUM> is laid flat or suspended in air in an undeflected orientation, in this variation, the first opening <NUM> and the second opening <NUM> are adjacent to each other or have longitudinal axes that are parallel or angled with respect to each other wherein the first ring <NUM> defines a first central longitudinal axis perpendicular to the radial plane of the ring <NUM> and/or opening <NUM> and the second ring <NUM> defines a second central longitudinal axis perpendicular to the radial plane of the ring <NUM> and/or opening <NUM>. The openings <NUM>, <NUM> are eccentric or nonconcentric. The base <NUM> defines a first side <NUM> and a second side <NUM> relative to the base and first opening <NUM>. The second opening <NUM> is formed in the first side <NUM> of the bag <NUM>. The first side <NUM> of the bag <NUM> may form an extension neck <NUM> of various sizes, shapes, lengths, and positional locations with respect to the side <NUM> and base <NUM>. In <FIG>, the second opening <NUM> is slightly lower than the first opening <NUM> as measured from the base <NUM>. In <FIG>, the second opening <NUM> is at approximately the same height from the base <NUM> as the first opening <NUM>. In <FIG>, the second opening <NUM> is higher from the base <NUM> relative to the first opening <NUM> and also includes a narrower and longer neck extension <NUM> leading to the second opening <NUM> compared to a shorter neck extension <NUM> shown in <FIG> and <FIG>. In <FIG>, the neck extension <NUM> is positioned at the bottom of the side <NUM> closer to the base <NUM>. The angle of the neck extension <NUM> with respect to the base <NUM> in <FIG> is less than the angle of the neck extension <NUM> with respect to the base <NUM> in <FIG>, <FIG>. In one such variation of <FIG>, one side of the neck extension <NUM> is contiguous with the base <NUM> forming a larger effective base. The angle of the neck extension <NUM> is substantially equal to the base <NUM> and the neck extension <NUM> is positioned a distance or height from the base <NUM>. In <FIG>, the neck extension <NUM> is located in the middle of the side <NUM>. In such a variation, the base <NUM> forms a larger bowl having wide sides for containing the specimen <NUM> and, advantageously, preventing movement of specimen into the neck extension <NUM>. In <FIG>, the neck extension is located at the top of the side <NUM> near the first opening <NUM> and a greater distance from the base <NUM>. Still referencing <FIG>, the size of the entryway <NUM> or intersection between with the neck extension <NUM> may vary. For example, in <FIG>, the entryway is larger than in <FIG>, similar to the difference in the entryway in <FIG>. In <FIG>, the entryway <NUM> is very small and located between the first opening <NUM> and the base <NUM> or substantially midway along the first side <NUM>. In <FIG>, the entryway <NUM> is near and contiguous with the base <NUM>. In <FIG>, the entryway <NUM> is near the first opening <NUM>.

Turning now to <FIG>, the various tethers/tags and their various configurations will now be described. Each bag <NUM> includes at least one of a first tether <NUM> and an optional tag associated with the first opening <NUM> and a second tether <NUM> with an optional tag associated with the second opening <NUM>. Some figures in this description show no tether, one tether at the first opening, one tether at the second opening, or a tether at both of the first and second openings; however, any number of tethers and combinations may be used, regardless of whether a figure shows such a combination of various tether locations and tether exclusions or inclusions. A tether can include a string such as one made of nylon, a tab, a film, a tape, a lead or the like. A tag is attached to the proximal end of the string. The tag is a piece of plastic that facilitates locating and grasping the tether. The tether may or may not include a tag. Furthermore, the word "tether" may be interchanged with the word "tab" and vice versa. In <FIG>, a first tab <NUM> is shown at the second side <NUM> and a second tab <NUM> at the second opening <NUM>. In one variation, the first tab <NUM> is connected to the first ring <NUM> and the second tab <NUM> is connected to the second ring <NUM>.

In <FIG>, a first tab <NUM> is interconnected with a second tab <NUM> wherein the first tab <NUM> is located at the first opening <NUM> and exits at the first side <NUM> and the second tab <NUM> extends along the neck extension <NUM> and out at the second opening <NUM>. In <FIG>, the first tab <NUM> and the second tab <NUM> are the same tab, the free ends of which extend out from the bag <NUM> and include tags as shown and may or may not be attached fixedly to their respective rings <NUM>, <NUM>. In another variation, the first tab <NUM> and the second tab <NUM> are formed with separate tabs. The one or more tabs are fixed relative to the bag <NUM> and/or respective ring <NUM>, <NUM>. Of course, as mentioned above, the tabs may be tabs, strings, tethers, film, tape, lead and the like. <FIG> shows an enlarged section of the second opening <NUM> of <FIG>, wherein the second tab <NUM> is wrapped around the second ring <NUM> before exiting at the second opening <NUM>. The first tab <NUM> may also be similarly wrapped around the first ring <NUM>. In a variation in which the first tab <NUM> and the second tab <NUM> are separate tabs, the first tab <NUM> may be connected to the first ring <NUM> and not extend along the first side <NUM> of the bag <NUM>. In another variation in which the first tab <NUM> and the second tab <NUM> are separate tabs, the first tab <NUM> is fixed to the first ring <NUM> and or to the sidewall <NUM> and, if fixed to the sidewall <NUM> it may extend along the sidewall <NUM> by any distance. In one variation, the first tab <NUM> extends along the first side <NUM> of the sidewall <NUM> to approximately near the intersection of the sidewall <NUM> and the neck extension <NUM>. This configuration is advantageous because when the first tab <NUM> is pulled, the sidewall <NUM> portion that is above the neck extension <NUM> is pulled upwardly bringing the bag <NUM> closer to the abdominal wall and will scrunch together that portion of the sidewall <NUM> above the neck extension <NUM> making removal of the bag <NUM> from the abdominal cavity easier. Also, the second tab <NUM> may also extend along only a portion the neck extension <NUM>. The neck extension <NUM> is a distinct tubular, sleeve-like arm that branches from the main bag first compartment <NUM> and extends laterally outwardly from the sidewall <NUM> in a straight or angled orientation to interconnect the second opening <NUM> with the first compartment <NUM> via an intersection called an entryway <NUM> that is located between the first opening <NUM> and the second opening <NUM>.

In <FIG>, the bag <NUM> includes a first tab <NUM> at the second side <NUM> exiting at the first opening <NUM> and a second tab <NUM> exiting the second opening <NUM>. The second tab <NUM> extends along the bottom of the neck extension <NUM> and runs contiguously along the base <NUM> as shown and may or may not interconnect with the first tab <NUM>.

In <FIG>, the bag <NUM> includes a first tab <NUM> at the first opening <NUM> and second side <NUM> adjacent and above the neck extension <NUM> and a second tab <NUM> at the second opening <NUM>. The second tab <NUM> extends along the length of the neck extension <NUM> and upwardly along the first side <NUM> to the first opening <NUM> but does not exit at the first opening <NUM>. Also, <FIG> illustrates a relatively large and deep specimen receiving portion in the lateral and vertical direction because the base <NUM> extends contiguously into the neck extension <NUM> at the first side <NUM>. The first side <NUM> is shown in <FIG> to extend from the first opening <NUM> approximately one third of the length of the first side <NUM> wherein the specimen receiving portion rises approximately two thirds upwardly from the base <NUM> along the length of the first side <NUM>. Having a large specimen receiving portion which is the case in variations in which the base <NUM> is contiguous with the neck extension <NUM> prevents twisting of the neck extension <NUM> because the neck extension <NUM> is smaller at the second opening <NUM> compared to the width of the neck extension <NUM> at an entryway <NUM> formed by the intersection of the neck extension <NUM> with the first side <NUM>. Therefore, the neck extension <NUM> flares out or widens in diameter with distance towards the bag <NUM> and decreases in size or narrows in diameter with distance towards the second opening <NUM>. A scope that is inserted in through the second opening <NUM> can land the distal end of the scope near the base <NUM> to observe that careful morcellation is proceeding without compromise to the bag walls. Also, a zero degree scope may be employed easily to observe morcellation taking place inside the bag. Referring back to <FIG>, there is shown a neck extension <NUM> that has approximately the same width or diameter at the second opening <NUM> as at the entryway <NUM> formed by the intersection of the neck extension <NUM> with the first side <NUM>. The wider entryway <NUM> advantageously provides a larger specimen viewing and receiving location and also minimizes twisting of the neck extension <NUM> about itself.

Turning now to <FIG>, the configuration of the tab with respect to the bag <NUM> will be described in greater detail wherein the neck extension <NUM> is shown for illustrative purposes and the same configuration may be applied to anywhere in the bag <NUM> where a tab is located including the sidewall <NUM>, first side <NUM>, and second side <NUM>. The sidewall <NUM> will have a primary seam 46a, 46b formed along the edges of the bag. The primary seam 46a, 46b is formed by adhesive and/or hot sealing two sides of the bag sidewall <NUM> together. The primary seam 46a, 46b helps define the shape of the bag <NUM>. A secondary seam <NUM> is shown adjacent to a primary seam 46a and spaced apart from the primary seam 46a to form a channel <NUM> for the tab <NUM>, <NUM>. Of course, in some areas of the bag <NUM>, there may be no primary seam 46a, 46b, in which case, the secondary seam <NUM> is formed near the edge of the sidewall <NUM>. The tab <NUM>, <NUM> may be fixed within the channel <NUM> or may be free to translate within the channel <NUM>. <FIG> illustrates the axis of the tab <NUM> which defines an axis of rotation about which the neck extension <NUM> would tend to rotate. The presence of a tab <NUM> at the neck extension <NUM> advantageously permits a rotated or twisted neck extension <NUM> to be quickly straightened by simply pulling the tether <NUM> at the proximal end where the tag is located. The tab <NUM> may be at anywhere around the neck extension <NUM>. In one variation, the tab <NUM> is along at least a portion of top of the neck extension <NUM>. This configuration advantageously permits the second tab <NUM> to be lifted by raising the tag at the end of the tab <NUM> and allowing the weight of the remainder of the neck extension <NUM> that is wrapped or tangled about itself along and around the longitudinal axis of the neck extension <NUM> to unfurl and unflip in a relatively downwardly direction to open the lumen of the neck extension <NUM>. The unfurling or untangling of the neck extension <NUM> is preferably performed while the neck extension <NUM> is inside an insufflated patient cavity and before the second ring <NUM> is pulled into a position such as through an incision or body orifice such as the vagina. After the second ring <NUM> is resident outside the patient, untwisting the neck extension <NUM> becomes more difficult due to pressure from the adjacent tissue margin onto the neck extension <NUM>. The tab <NUM> along at least a portion of the neck extension <NUM> greatly assists in quickly orienting and positioning the neck extension relative to the anatomy. Pulling or lifting the tab <NUM> untwists the neck extension <NUM> and prevents it from interfering with the scope when it is inserted and also when the scope is viewing specimen. The tab <NUM>, <NUM> may be contrast colored against the rest of the bag sidewall so that the user can view the tab <NUM>, <NUM> to discern if the position of the neck extension <NUM> is correct. For example, a user will see the colored tab <NUM>, <NUM> and if it is oriented along a bottom end of the neck extension <NUM> or does not form a straight line, for example, the user will know that there is one or more twists in the neck extension <NUM> and that the tab <NUM>, <NUM> needs to be pulled such that the tab <NUM>, <NUM> is a straight line along the top of the neck extension <NUM>. In lieu, of a tab <NUM>, <NUM> serving as an indicator for the proper orientation of the bag <NUM>, the bag <NUM> itself may be printed with indicator markers such as lines and arrows in contrast color to provide information to the user about the position of the bag <NUM> and/or neck extension <NUM>.

In another variation, and with reference to <FIG>, the channel <NUM> along the neck extension <NUM> can be connected to a source of insufflation fluid, which when delivered into the channel <NUM>, unfurls the neck extension <NUM> into the proper orientation and direction. The channel <NUM> may extend only along the neck extension <NUM> or along the sidewall <NUM> of the bag <NUM>. In <FIG>, the channel <NUM> is shown to extend along both the neck extension <NUM> and sidewall <NUM> to the first opening <NUM> from the second opening <NUM>. The proximal end of the channel <NUM> can have a connector <NUM> configured for connection to the source of insufflation fluid and resident outside the patient, for example near the first opening <NUM> as shown in <FIG> or near the second opening <NUM> as shown in <FIG>. In both <FIG>, the channel <NUM> extends from the first opening <NUM> to the second opening <NUM>. The channel <NUM> can be applied for any variation of bag <NUM> described herein and is not limited to the sleeve-like and two-headed bags as shown in <FIG> and 25B. One or more channels <NUM> may be provided that are interconnected or separated. The channels <NUM> are shown to be straight but may also form a pattern suitable for insufflation or include a plurality of spaced apart rings around the neck extension <NUM> or other part of the bag <NUM>. The channel <NUM> is formed by heat sealing a portion of the bag together, as described above, to form a primary seam <NUM> and a secondary seam <NUM> as shown in <FIG>. The channel <NUM> may also be a separate tube attached internally or externally to the bag <NUM>.

In another variation, a connector <NUM> is provided at the proximal end of the bag at or near the first opening <NUM> that is configured to perform one or more of the following functions: insufflating the bag <NUM>, insufflating a second bag <NUM>, insufflating an inner bag, insufflating an outer bag, insufflating the abdominal cavity, and insufflating the channel <NUM>. For example, as shown in <FIG>, a Y-shaped connector <NUM> connected to a source of insufflation fluid can divert insufflation fluid into the interior of the bag <NUM> and into the abdominal cavity <NUM> outside the bag <NUM> via a trocar <NUM> or insufflation needle. An optional access port cap/platform <NUM> may be used to seal the first opening <NUM> and the connector <NUM> may be connected to the cap/platform <NUM> or to the bag <NUM> itself. Insufflation of both the bag <NUM> and abdominal cavity <NUM> creates an equal pressure. The bag <NUM> acts as a membrane and the organs in the abdominal cavity are advantageously moved away from the bag <NUM>, thereby, protecting the organs from inadvertent morcellation. In another example, the connector <NUM> can be a three-way connector to direct insufflation fluid into the abdominal cavity <NUM>, into the bag <NUM> and into the channel <NUM> to unfurl the neck extension <NUM>. Another variation is shown in <FIG> in which the system includes a first bag <NUM> containing the specimen <NUM> and a second bag <NUM> that contains the first bag <NUM>. The first bag <NUM> or inner bag <NUM> is located inside the second bag <NUM> or outer bag <NUM>. A connector <NUM> is configured to deliver insufflation fluid to one or more of the first bag <NUM> and second bag <NUM>. Preferably, both the first bag <NUM> and the second bag <NUM> are insufflated via the connector <NUM>. An access port cap/platform <NUM> is provided to seal insufflation pressure within the first bag <NUM> and the connector <NUM> may be connected directly to the each bag <NUM>, <NUM> or via the cap/platform <NUM> for delivery of insufflation fluid to the first bag <NUM> and directly to the second bag <NUM> for delivery of insufflation fluid to the second bag <NUM>. The connector <NUM> in FIG. <NUM> may be a three-way connector <NUM> and further deliver insufflation fluid into the abdominal cavity <NUM>. The double-bag system of <FIG> advantageously provides added protection in the event the inner bag <NUM> is accidentally punctured with surgical instruments. In such an event, containment of the specimen would not be breached as the outer bag <NUM> would retain the specimen in a closed system.

Turning now to <FIG>, there is shown more detail of the tether/tab configuration at either the first opening <NUM> or the second opening <NUM> or both. For illustrative purposes, the second opening <NUM> and a section of the neck extension <NUM> is shown in <FIG>. The tab <NUM> extends inside a channel <NUM> and exits at the second opening <NUM>. Placement of the tab <NUM> inside the channel <NUM> is for exemplary purposes and the tab may be integrally formed with the bag. <NUM>, the detail of the second ring <NUM> is shown for illustrative purposes and the same configuration may be applied to the first ring <NUM> at the first opening <NUM>. In <FIG>, the tether <NUM> is tied or wrapped around the second ring <NUM>. A knot may also be formed. In <FIG>, the tether <NUM> is looped around the second ring <NUM> multiple times forming multiple windings before exiting at the second opening <NUM>. A knot may also be formed in the variation of <FIG> to secure the tether <NUM> to the second ring <NUM>. The tether may be attached anywhere along the ring and/or bag and the same may be applied to the first opening <NUM>. <FIG> illustrates the bag <NUM> of <FIG> in use which will be described in greater detail below. <FIG> illustrates a containment bag <NUM> as described.

Turning now to <FIG>, the seal mechanism <NUM> applicable to the neck extension <NUM> or second compartment <NUM> of a containment bag in accordance with the present invention will be described in greater detail. The seal mechanism <NUM> is configured to seal off the second opening <NUM> of any bag variation shown herein. When the morcellation is completed and the bag <NUM> is ready for removal, it will be removed from either an incision in the abdominal wall such as at the umbilicus or it will be removed through the vaginal opening or other orifice. As such, the bag <NUM> will be pulled out at one end; hence, the opposite end must be sealed off to maintain a closed system and prevent specimen from spilling out. The seal mechanism <NUM> will be described with respect to the second opening <NUM> as that is preferred location for the seal mechanism <NUM>. The seal mechanism <NUM> includes a first pocket <NUM> and a second pocket <NUM>. The first pocket <NUM> is located on one side of the bag <NUM> and the second pocket <NUM> is generally located on the opposite side of the bag <NUM>; however, the invention is not so limited. The first pocket <NUM> is formed by attaching a first patch <NUM> to the outer surface of the sidewall <NUM>. The first patch <NUM> is attached with adhesive or by heat sealing the first patch <NUM> to the sidewall <NUM>. In one variation, the first patch <NUM> is attached along three sides of its perimeter leaving one side of the perimeter detached and serving as part of the mouth to the first pocket <NUM>. The first patch <NUM> is shown with cross hatch marks in <FIG>. The second pocket <NUM> is formed by attaching a second patch <NUM> to the outer surface of the sidewall <NUM> on the opposite side of the first patch <NUM>. The second patch <NUM> is attached with adhesive or by heat sealing the second patch <NUM> to the sidewall <NUM>. In one variation, the second patch <NUM> is attached along three sides of its perimeter leaving one side of the perimeter detached and serving as part of the mouth to the second pocket <NUM>. The second patch <NUM> is shown with dashed hatch marks in <FIG>. The mouth <NUM> of the first pocket <NUM> faces distally away from the second opening <NUM> and the mouth <NUM> of the second pocket <NUM> faces proximally toward the second opening <NUM>. Therefore, the pocket openings <NUM>, <NUM> face each other. Also, the pocket openings <NUM>, <NUM> are aligned longitudinally along the with the second opening <NUM> such that the first pocket <NUM> is distally located from the second opening <NUM> and the second pocket <NUM> is distally located from the first pocket <NUM>.

In use and with reference to <FIG>, the resilient second ring <NUM> is squeezed into a low-profile configuration as shown in <FIG>. The second ring <NUM> is rolled distally such that the sidewall <NUM> of the neck extension <NUM> is rolled onto the second ring <NUM> all the way over the first pocket <NUM> to the distally facing first mouth <NUM> as shown in <FIG>. The rolled up neck extension <NUM> is inserted into the first pocket <NUM> as shown in <FIG>. Then the first pocket <NUM> with contents is folded over towards the back side and the first pocket <NUM> is inserted/tucked into the second pocket <NUM> as shown in <FIG>. The first pocket <NUM> is inserted into the second pocket <NUM> such that the second pocket <NUM> encompasses the first pocket <NUM> and its contents. The tucking of the first pocket <NUM> into the second pocket <NUM> advantageously prevents the rolled bag from snagging onto anything during post morcellation bag retrieval. This configuration of the bag <NUM> and method advantageously seals the contents including fluids inside the bag <NUM> and prevents them from escaping through the second opening <NUM> during bag <NUM> removal. The resilient second ring <NUM> when squeezed is biased to expand to its enlarged high-profile configuration. Advantageously, such resiliency of the second ring <NUM> biases the second ring <NUM> together with the sidewall <NUM> rolled onto it towards the inside walls of the first pocket <NUM>. The resiliency of the second ring <NUM> creates a locking feature and sealing effect as the second ring <NUM> tends outwardly and pushes portions of the sidewall <NUM> against adjacent portions of the rolled-up sidewall <NUM>. Hence, rolling of the bag <NUM> and the resilient second ring <NUM> creates a seal.

Other constructions and methods for sealing the second opening <NUM> will now be described. Turning now to <FIG>, there is shown another method for sealing the second opening <NUM> of the containment bag <NUM> in which a knot <NUM> is tied at the distal end. In another variation, the distal end of the bag <NUM> is provided with double-sided tape <NUM> which seals the second opening <NUM> at a distance proximal to the second ring <NUM> as shown in <FIG>. Turning to <FIG>, an interlocking ridge and groove <NUM> is provided in which the groove is formed on one inner surface of the sidewall <NUM> and the ridge is formed on an opposite inner surface of the sidewall <NUM>. The ridge is configured to interlock with the groove when pressed together by a user's fingers or by employing a zipper. In <FIG>, a seal <NUM> is created by employing a bipolar instrument <NUM> to deliver electrical current or heat to heat seal or melt the opposite sidewalls <NUM> at the neck extension <NUM> together to seal the bag <NUM>. In such a variation, the bag <NUM> is made of suitable material such as thermoplastic and the instrument <NUM> is set so as to not burn or melt the bag <NUM> too much.

In use, after the uterus has been detached as described above, the insertion and removal of a containment bag <NUM> of the like described with respect to <FIG> will now be described. Aspects of this method may also apply to any bag variation described herein. The containment bags <NUM> of <FIG> will be referred to as dual-head bags <NUM> for ease of reference and to differentiate from the tube-like bags of <FIG>. Firstly, any trocar is removed from the umbilical incision. Any one of the dual-head bags <NUM> of <FIG> is inserted through the umbilical incision and the trocar is re-inserted. The trocar may be inserted directly into the umbilical incision or through an access port cap/platform connected to a retractor placed in the incision. Referring back to <FIG>, the abdominal cavity is re-insufflated via the access port cap/platform <NUM> or through the trocar in order to provide a better view for positioning the bag <NUM>. A scope is inserted through the umbilical incision <NUM> and the detached uterus <NUM> is inserted into the bag <NUM> with graspers. A second incision <NUM> is made through the abdominal body wall <NUM> in a location medial-to-lateral of the umbilicus. A surgical grasper is inserted through the second incision <NUM> and the tether at the second opening <NUM> is grasped and pulled through the second incision <NUM> pulling the neck extension <NUM> towards the abdominal body wall <NUM>. The smaller second ring <NUM> is pulled through the second incision <NUM>. In one variation, if the neck extension <NUM> is sufficiently long, the second ring <NUM> can be pulled through the vaginal canal and opening. The tether attached to the larger first ring <NUM> is pulled toward the umbilical incision. As the first opening <NUM> of the bag <NUM> is drawn towards the abdominal body wall <NUM>, the trocar and/or the access port cap/platform <NUM> are removed and the first ring <NUM> and a proximal portion of the bag <NUM> is pulled through the umbilical incision. If a retractor <NUM> is in position at the umbilical incision, the retractor <NUM> may be removed before the first ring <NUM> is pulled through. If the retractor <NUM> is removed, the first ring <NUM> is brought to the surface of the abdominal body wall <NUM> and the retractor <NUM> is inserted into the first opening <NUM> of the bag <NUM>. The adjacent tissue and the bag <NUM> in the location of the umbilical incision <NUM> is retracted with the retractor <NUM> as shown in <FIG>. The access port cap/platform <NUM> is then connected to the retractor <NUM> by snapping the access port cap/platform <NUM> under or over the first ring of the retractor <NUM>. The bag <NUM> is held firmly in place between the retractor <NUM> and tissue wall <NUM> at the umbilical incision. If the retractor <NUM> is not removed, the bag <NUM> is pulled through the lumen of the retractor <NUM> and laid over the first ring of the retractor outside the abdominal wall. The access port cap/platform <NUM> is re-attached by snapping the access port cap/platform <NUM> either under/over the first ring <NUM> of the bag <NUM> or the first ring of the retractor <NUM>. If the access port cap/platform <NUM> is snapped under/over the first ring of the retractor <NUM>, the bag sidewall <NUM> will be captured between the retractor <NUM> and the access port cap/platform <NUM> holding it in position. If the retractor <NUM> is not be used at all, in which case, the bag <NUM> is inserted into the umbilical incision <NUM> or if a retractor <NUM> is used initially to insert the dual-head bag <NUM>, it may not be re-inserted into the bag <NUM> at the first opening <NUM> as described above. In such a situation, the first ring <NUM> of the bag <NUM> is pulled through the umbilical incision <NUM> and overlaid onto the abdominal body wall <NUM>. The access port cap/platform <NUM> is attached directly to the first ring <NUM> of the dual-head bag <NUM>. A morcellator is inserted into the dual-head bag <NUM> through the first opening <NUM> and a scope <NUM> is inserted through the second opening <NUM> and into the neck extension <NUM> towards the entryway <NUM> to the first compartment <NUM>. The scope <NUM> may be inserted directly into the dual-head bag <NUM> or through a trocar <NUM> placed inside the second opening <NUM> as shown in <FIG>. <FIG> also illustrates in greater detail a trocar <NUM> inserted into the second opening <NUM> of the bag <NUM>. The bag <NUM> is pulled through an incision that is small enough to fit a trocar <NUM> such that the bag sidewall <NUM> is sealed against the tissue margin <NUM> by the trocar <NUM> so that insufflation gas does not escape from the abdominal cavity <NUM> as shown in <FIG>. <FIG> illustrates a trocar <NUM> configured to be removably and sealingly attached at the second opening <NUM>. In <FIG>, an attachment feature at the end of the neck extension <NUM> sealingly snaps and locks onto the trocar <NUM> to maintain a pressure and prevent insufflation fluid from escaping from inside the bag <NUM> or inside the abdominal cavity <NUM>. Alternatively, as shown in <FIG>, at least a proximal portion of the neck extension <NUM> along with the second ring <NUM>, if one is employed, is pulled through the cannula lumen of the trocar <NUM>. In this manner, a seal against the tissue margin <NUM> is provided by the trocar <NUM> being inserted into an incision that is equally sized or smaller than the outer diameter of the trocar <NUM> to prevent the escape of insufflation gases inside the abdominal cavity <NUM>. In one variation, the trocar <NUM> is provided with a balloon <NUM> which retracts the tissue along with the sidewall <NUM> of the bag <NUM> located in the second incision <NUM>. Alternatively, an access port cap/platform may be attached to the second ring <NUM> and the scope <NUM> inserted through the access port cap/platform with or without a trocar <NUM>. In another variation, at least one seal <NUM> is provided at the second opening <NUM> as shown in <FIG>. The seal <NUM> may be removably fitted with the second opening such as in a snap-fit or twist-and-lock configuration. More than one seal can also be provided in a seal assembly fitted and connected the second opening <NUM>. The seal assembly may include a zero seal that prevents escape of gas and fluid across the seal when no instrument is inserted through the zero seal. The zero seal may be a double duckbill type valve or other valve. The seal assembly may further include an instrument seal that seals against an inserted instrument to prevent escape of fluid and gas across the seal. Also, a seal shield may be provided to protect the seal from being damaged due to impingement with an instrument. The morcellation of the uterus <NUM> is commenced while under unobstructed observation via the scope <NUM>. After morcellation is completed, the morcellator, the scope <NUM> and trocar <NUM> (if used) are removed from the second opening <NUM>. The neck extension <NUM> is sealed by closing the second opening <NUM> according to any one of the methods described above to prevent any particles of specimen or fluid remaining inside the bag from escaping the bag <NUM> during the removal of the bag <NUM> from the patient. The second ring <NUM> of the bag <NUM> is inserted into the abdominal cavity <NUM> through the second incision <NUM>. In one variation, the neck extension <NUM> is rolled up and tucked into the first and second pockets <NUM>, <NUM> or, alternatively, the neck extension <NUM> is tied into a knot <NUM>. Any access port cap/platform <NUM> and/or retractor <NUM> at the umbilical incision <NUM> are removed and the dual-head bag <NUM> is removed out of the body cavity <NUM> through the umbilical incision <NUM>. This same procedure may be employed for the tube-like bags <NUM> throughout the specification such as those shown in <FIG>. The containment bag <NUM> and methods effectively create a contained morcellation system wherein morcellation, either manual or power, is carried out inside a closed system provided by the containment bag <NUM> and its placement within the anatomy. The openings to the bag <NUM> are sealed and the procedure carefully performed to prevent inadvertent scattering of tissue throughout the abdominal cavity. The containment bag <NUM> advantageously also provides a portal into the bag via the neck extension or second opening through which a scope can be inserted to further monitor the morcellation procedure making sure that the bag integrity is not broken during the process. This provides to the surgeon an extra safety precaution with direct observation of the surgical morcellation field while maintaining a closed system. The angle of observation via the neck extension or second opening provides the viewer a clear and lateral view of both the bag and the specimen and their position with respect to morcellation instruments throughout the morcellation. Also, the systems and variations disclosed provide an easy way to deploy the bag internally into position.

After a uterus is detached laparoscopically, a bag <NUM> is inserted into the abdominal cavity <NUM> either vaginally or abdominally. At the point of bag insertion, pneumoperitoneum may be lost. After the bag is inserted, pneumoperitoneum is reestablished. The detached uterus is placed inside the bag <NUM> and the bag <NUM> is laparoscopically manipulated to pull the bag openings through the desired locations which may include any one or more of the following locations: umbilicus incision, abdominal incision, lateral incision and vaginal opening. The tether/tab is pulled and a trocar is placed into the second opening <NUM> or the second opening <NUM> is capped with an access platform or port or the second opening <NUM> is pulled through the lumen of the trocar <NUM>. All the bag openings are then closed and sealed and insufflation is introduced into the bag and/or abdominal cavity. The specimen inside the bag is then morcellated. Morcellation may be carried out using power or manual morcellation methods and instruments. The second opening <NUM> and other bag port openings are sealed off except for one opening, such as the first opening <NUM>, that will be pulled to remove the bag such as through the incision at the umbilicus. The bag port openings are sealed to prevent any specimen from escaping containment inside the bag <NUM> as the bag is being removed. The bag is removed by being pulled through the abdominal incision such as an incision at the umbilicus. Additional variations will now be described for which the methods and features described above can be applied in whole or in part to the variations that follow and vice versa.

Turning now to <FIG>, there is shown a containment bag <NUM> wherein like parts are referenced with like numerals. The containment bag <NUM> includes a first opening <NUM>, also called a mouth, and a second opening <NUM> interconnected by a sidewall <NUM>. A first ring <NUM> is provided at the first opening <NUM> and a second ring <NUM> is provided at the second opening <NUM>. The first ring <NUM> and the second ring <NUM> have substantially the same diameters. The rings <NUM>, <NUM> are resilient and capable of deflection into a low-profile configuration for insertion through ports/incisions having diameters that smaller than the rings <NUM>, <NUM>. The sidewall <NUM> of the bag <NUM> has a substantially cylindrical tube-like shape having a constant diameter that is substantially the same diameter as the rings <NUM>, <NUM>. The sidewall <NUM> defines a central lumen that can also be called a first compartment <NUM> between the first opening <NUM> and the second opening <NUM>. The bag <NUM> of <FIG> is bi-directional compared to the bag <NUM>, for example, of <FIG> wherein the smaller second opening <NUM> seats more readily within and at the vaginal opening or other orifice than a bag with a larger second opening <NUM>. However, if any one of the openings <NUM>, <NUM> is too small it will be difficult to insert the specimen into the bag <NUM>.

Turning now to <FIG>, a method of using a containment bag <NUM> will be described. In one variation, a tube-like sleeve bag <NUM> such as shown in <FIG> and <FIG> is provided. A tissue specimen <NUM>, such as a uterus, is detached and the bag <NUM> is inserted through an abdominal incision or orifice into a body cavity. The bag <NUM> is placed such that the first ring <NUM> is resident outside the patient at the location of the abdomen or orifice. A surgical instrument <NUM>, such as surgical graspers, is inserted into the first opening <NUM> of the bag <NUM> and into the lumen of the bag <NUM>. The specimen <NUM> is grabbed and pulled through the second opening <NUM> of the bag <NUM> into the lumen of the bag <NUM> as shown in <FIG>. The proximal end of the instrument <NUM> is manipulated outside the patient to open and close the jaws of the grasper at the distal end of the instrument. The specimen <NUM> is released inside the lumen compartment <NUM> as shown in <FIG>. The instrument <NUM> is then moved distally past the specimen <NUM> to grab the second ring <NUM> of the bag <NUM>. The second ring <NUM> is grasped by the graspers <NUM> and pulled proximally into the lumen compartment <NUM> as shown in <FIG>. The second ring <NUM> is pulled along inside the lumen of the bag <NUM> proximally past the specimen <NUM> as shown in <FIG> and to the surface outside the patient creating a fold in the sidewall <NUM> inwardly into the lumen of the bag <NUM>. After being pulled outside the patient, the second ring <NUM> can then be placed to the side of the first ring <NUM>. The one or more fold divides the bag <NUM> and creates within the bag <NUM> a first pouch <NUM> that contains the specimen <NUM> and a second pouch <NUM> adjacent to the first pouch <NUM>. The bag <NUM> is invaginated, inverted, turned or, otherwise, folded back into itself up the lumen toward the first ring <NUM> to form the pockets <NUM>, <NUM>. This action also advantageously pulls the specimen <NUM> closer to the first ring <NUM> where the specimen <NUM> can be more readily visualized and morcellated. To assist the morcellation, a scope (not shown) may be inserted into the second pouch <NUM> to observe the specimen <NUM> located in the first pouch <NUM> across the sidewall <NUM>. Alternatively, a scope is inserted into the second opening <NUM> of the bag <NUM> and into the abdominal cavity and the specimen <NUM> is observed outside the first pouch <NUM>. In another variation of the method, after the uterus is detached, the bag <NUM> may be inserted through the vaginal opening and the bag <NUM> positioned such that the first ring <NUM> is located outside the patient at the vagina. This method and bag <NUM> can be employed with any specimen, orifice or incision and is not limited to the uterus, vaginal opening and abdominal incision. Of course, the bag can be placed into any incision or orifice and pulled from any incision or orifice including the same incision or secondary incision.

Turning now to <FIG> there is shown a containment bag <NUM> wherein like parts are referenced with like numerals. The containment bag <NUM> includes a first opening <NUM>, also called a mouth, and a second opening <NUM> interconnected by a sidewall <NUM>. A first ring <NUM> is provided at the first opening <NUM> and a second ring <NUM> is provided at the second opening <NUM>. Either one or more of the first end and the second end of the bag <NUM> includes a third ring <NUM> located near the first ring <NUM> or the second ring <NUM>, respectively. For example, in <FIG>, a third ring <NUM> is located near the second end of the bag <NUM> near the second ring <NUM>. The second ring <NUM> is located at the distal second end of the bag <NUM> and the third ring <NUM> is spaced proximally from the distal second end by a distance configured for retraction purposes. Together with the second ring <NUM>, the third ring <NUM> forms a retractor built-in with the bag <NUM>. When positioned within the anatomy as described above, the second ring <NUM> will reside outside the patient such as outside the vaginal opening while the third ring <NUM> will reside inside the patient. The second ring <NUM> is resilient and capable of being flipped about itself to wrap the intermediate sidewall located between the second ring <NUM> and the third ring <NUM> around the second ring <NUM>, thereby, retracting a tissue margin at the orifice, or incision to facilitate removal of a specimen placed inside the bag <NUM>. The bag <NUM> of <FIG> is shown to have a frusto-conical shape; however, the employment of a third ring <NUM> is not limited to a bag <NUM> having this shape and can be used in any of the bag <NUM> variations described herein including the two-headed variations. Of course, in an alternate variation, the third ring <NUM> may be position near the first ring <NUM> and configured to serve the same built in retraction function. In another variation, a fourth ring (not shown) is provided adjacent to the first ring <NUM> and a third ring <NUM> is located near the second ring <NUM> such that retraction of tissue can take place at both ends of the bag <NUM>.

Turning now to <FIG>, there is shown another containment bag <NUM> variation wherein like reference numbers are used to describe like parts. The bag <NUM> of <FIG> is similar to the teapot-like containment bag configurations of <FIG> having a neck extension <NUM>. The bag <NUM> includes a first opening <NUM> and a second opening <NUM> interconnected by a sidewall <NUM>. A first ring <NUM> is provided at the first opening <NUM> and a second ring <NUM> is provided at the second opening <NUM>. The bag <NUM> further includes a third opening <NUM> and a third ring <NUM> at the third opening <NUM>. The sidewall <NUM> includes a base <NUM> configured for supporting a tissue specimen. The first opening <NUM>, second opening <NUM> and third opening <NUM> are adjacent to each other or have longitudinal axes that are angled with respect to each other wherein the first ring <NUM> defines a first central longitudinal axis perpendicular to the radial plane of the ring <NUM> and/or opening <NUM>, the second ring <NUM> defines a second central longitudinal axis perpendicular to the radial plane of the ring <NUM> and/or opening <NUM> and the third ring <NUM> defines a third central longitudinal axis perpendicular to the radial plane of the ring <NUM> and/or opening <NUM>. The openings <NUM>, <NUM>, <NUM> are eccentric. The base <NUM> defines a first side <NUM> and a second side <NUM> relative to the base <NUM> and first opening <NUM>. The second opening <NUM> is formed in the first side <NUM> of the bag <NUM> and the third opening <NUM> is formed in the second side of the bag <NUM>. The first side <NUM> of the bag <NUM> may form an extension neck <NUM> of various sizes, shapes, lengths, and positional locations with respect to the side <NUM> and base <NUM> interconnecting the first opening <NUM> with the second opening <NUM> and the second side <NUM> of the bag <NUM> may form a neck extension <NUM> of various sizes, shapes, lengths and positional locations with respect to the side <NUM> and base <NUM> interconnecting the first opening <NUM> with the third opening <NUM> and, of course, to the interior of the bag <NUM>. In use, the bag <NUM> of <FIG> is positioned with respect to the anatomy such that the first opening <NUM> is at the abdomen such as inserted through an umbilical incision and resident with the first ring <NUM> outside the patient. The second opening <NUM> serves as a lateral port positioned at a lateral incision in the abdomen or at a lateral orifice such as the vagina with the second opening <NUM> and second ring <NUM> residing outside the patient. The third opening <NUM> also serves as a lateral port positioned at a lateral incision in the abdomen.

<FIG> illustrates yet another variation of the bag <NUM> further having a fourth opening <NUM> and a fourth ring <NUM> located at the fourth opening <NUM>. The fourth opening <NUM> defines a fourth central longitudinal axis perpendicular to the radial plane of the ring <NUM> and/or opening <NUM>. The fourth longitudinal axis may or may not be parallel to the first longitudinal axis associated with the first opening. The fourth opening <NUM> is substantially coaxial with the first opening <NUM> making the bag <NUM> of <FIG> a hybrid bag that combines the teapot-like bags of <FIG> and the sleeve-like bags of <FIG>, <FIG>. The fourth opening <NUM> is formed in the base <NUM> of the bag <NUM> and the base <NUM> may form an extension neck <NUM> of various sizes, shapes, lengths, and positional locations with respect to the base <NUM> and base <NUM> interconnecting the first opening <NUM> with the fourth opening <NUM>. In use, the bag <NUM> of <FIG> is positioned with respect to the anatomy such that the first opening <NUM> is at the abdomen such as inserted through an umbilical incision and resident with the first ring <NUM> outside the patient. The second opening <NUM> serves as a lateral port positioned at a lateral incision in the abdomen with the second opening <NUM> and second ring <NUM> residing outside the patient. The third opening <NUM> also serves as a lateral port positioned at a lateral incision in the abdomen and the fourth opening <NUM> is position at a lateral orifice such as the vagina.

Turning now to <FIG>, there is shown a containment bag <NUM> having at least a first opening <NUM> and sidewall <NUM> defining at least an interior first compartment <NUM> accessible via at least the first opening <NUM>. A resilient first ring <NUM> is provided at the first opening <NUM>. The bag <NUM> includes at least one window <NUM> of clear, transparent glass or plastic through which visualization of the contents of the compartment <NUM> is possible from outside the bag <NUM> via a scope <NUM>. The window <NUM> may include a lens that provides an improved visualization when a scope <NUM> is placed next to the lens as shown in <FIG>. The window <NUM> and/or lens may be flush with the exterior sidewall <NUM> of the bag <NUM> or recessed at the end of an inwardly extending port <NUM> as shown in <FIG>. The port <NUM> is cylindrical and sized slightly larger than the distal end of the scope <NUM>. The inwardly extending port <NUM> provides a closer visualization of the bag contents and also provides a resting ledge for the scope <NUM>.

Turning now to <FIG>, there is shown a containment bag <NUM> having at least a first opening <NUM> and sidewall <NUM> defining at least an interior first compartment <NUM> accessible via at least the first opening <NUM>. A resilient first ring <NUM> is provided at the first opening <NUM>. The bag <NUM> includes at least one port <NUM> in the sidewall <NUM> providing access to the interior compartment <NUM>. The port <NUM> is fitted with at least one seal <NUM>. More than one seal can also be provided in a seal assembly fitted and connected to the port <NUM>. The seal assembly may include a zero seal that prevents escape of gas and fluid across the seal when no instrument is inserted through the zero seal. The zero seal may be a double duckbill type valve or other valve. The seal assembly may further include an instrument seal that seals against an inserted instrument to prevent escape of fluid and gas across the seal. Also, a seal shield may be provided to protect the seal from impingement with an instrument. Surrounding the seal <NUM> and port <NUM> may be a circumferential reinforcement <NUM> of plastic having a disk-like or funnel-like shape. The reinforcement <NUM> is made of stiffer plastic relative to the sidewall <NUM> of the bag <NUM>. The reinforcement <NUM> provides a smooth funnel shaped entry to guide an instrument in through the seal <NUM> and port <NUM>. Also, the reinforcement <NUM> provides a platform for connecting the seal <NUM> or seal assembly to the bag <NUM>. As shown in <FIG>, an instrument, such as a scope <NUM>, is inserted in through the port <NUM> to perform surgical procedures inside the bag <NUM> or to observe a specimen undergoing morcellation inside the bag. The seal <NUM> on the bag <NUM> will maintain any pressure differential across the bag <NUM> sidewall if, for example, the abdomen and/or bag <NUM> are insufflated.

Turning now to <FIG>, there is shown a containment bag <NUM> with different means for retaining the neck extension <NUM> in a retracted configuration to facilitate insertion of the bag <NUM> into the abdominal cavity. In <FIG>, a perforation <NUM> is provided in the sidewall <NUM> at a location between the neck extension <NUM> and a first side of the bag <NUM>. The perforation <NUM> extends downwardly such that the first opening <NUM> of the bag <NUM> remains interconnected to the second opening <NUM>. The perforation <NUM> is configured such that integrity of the bag is not compromised by providing a reinforcement that prevents further perforation. The bag <NUM> is delivered into the abdominal cavity and then the perforation <NUM> is perforated inside the abdominal cavity with a surgical instrument or by pulling a tab/tether <NUM> at the second opening or a tab/tether located along the perforation <NUM>. Following the perforation, the neck extension <NUM> is positioned in the anatomy. In another variation shown in <FIG>, a clip <NUM> is used to hold the neck extension <NUM> close to the first side <NUM> of the bag <NUM> to facilitate insertion into the abdominal cavity. Once inside the patient, the clip <NUM> is removed and the neck extension <NUM> is placed in the anatomy. In another variation shown in <FIG>, adhesive <NUM> such as an adhesive strip is used to hold the neck extension <NUM> close to the first side <NUM> of the bag <NUM> during deployment. The neck extension <NUM> may be pulled to release the adhesive from the neck extension <NUM> so that it may be placed in the anatomy.

Turning now to <FIG>, there is shown a bag <NUM> in which the neck extension <NUM> is inverted into the interior or first compartment <NUM> of the bag <NUM> to facilitate delivery of the bag <NUM> into the abdominal cavity. The bag <NUM> includes an undeployed configuration in which the neck extension <NUM> is inverted into itself and placed into the interior of the bag such that the neck extension <NUM> does not protrude from the first side <NUM>. The tab <NUM> may be pulled outwardly to place the bag <NUM> in a deployed configuration. In another variation shown in <FIG>, a pocket <NUM> is provided on the outer surface of the bag sidewall <NUM> adjacent to the intersection with the neck extension <NUM>. The neck extension may be folded in an accordion-like fashion and inserted into the pocket opening <NUM> and placed inside the pocket <NUM> in an undeployed configuration. While in the undeployed configuration, the bag <NUM> is easily delivered through an incision or orifice without the neck extension <NUM> becoming caught up or in the way. The tab <NUM> is pulled out when inside the patient to extract the neck extension <NUM> into a deployed configuration for placement in the anatomy.

Turning now to <FIG>, a containment bag <NUM> includes a first opening <NUM> at a proximal end and a second opening <NUM> at a distal end interconnected by a sidewall <NUM> that is gas-tight and non-porous such as made from a flexible polymer into continuous tubular, thin-walled, elongate structure defining an interior lumen. A resilient, semi-rigid or rigid ring <NUM> may be provided at the first opening <NUM> and a resilient, semi-rigid ring <NUM> may be provided at the second opening <NUM> as described above with respect to the tubular, sleeve-like containment bags <NUM>. The first opening <NUM> is sized and configured to allow insertion of surgical instruments into and through the elongate tubular body lumen. The second opening <NUM> is sized and configured to allow an inserted surgical instrument to pass through and distally beyond the second opening <NUM>. The second opening <NUM> is additionally provided with a circumferential channel <NUM> having a drawstring <NUM> within. The circumferential drawstring <NUM> is sized and configured to close the second opening <NUM> when activated. The activation procedure comprises the placement of a "knot-pushing" device <NUM> proximally upon a portion of the drawstring <NUM> and advancing the device <NUM> distally to push a slip-knot <NUM> along the drawstring <NUM> until the second opening <NUM> is closed. A plurality of drawstring channels <NUM> are arranged about the entire length of the elongate tubular sidewall <NUM> and spaced at preferred intervals. Any number of channels <NUM> may be provide a substantially fixed location for at least the circumferential portion of the drawstring. Other means known to one having ordinary skill in the art for arranging the drawstring circumferential around the sidewall <NUM> such as belt-like loops exterior or interior to the sidewall <NUM> are possible. A separate drawstring <NUM>, <NUM>, <NUM>, <NUM>, <NUM> is provided in each of the circumferential channels <NUM> and a portion of each drawstring extends along the longitudinal length of the bag <NUM> toward the proximal end. The longitudinal portion of the drawstrings may reside inside the lumen of the bag <NUM>, outside the bag <NUM>, or in a specialized channel, plurality of loops or a tube alongside the length of the bag <NUM>. Each of the drawstrings also includes a slip-knot <NUM> preferably along a longitudinal location of the drawstring. A slip-knot <NUM> is not essential. A compression grommet may be used to slide along the drawstring to cinch the circumferential drawstring portion. Also, a flexible plastic rack and toothed wedge may be employed. Each of the drawstrings <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may be acted upon sequentially starting from the distal-most drawstring <NUM> to the proximal-most drawstring <NUM>. Or, alternatively the drawstrings may be acted upon simultaneously or little-by-little as needed or in any order to reduce the diameter of the elongate tubular body <NUM> to effect reduction of the specimen <NUM> in the same manner as the closure of the second opening <NUM> with the knot pusher <NUM> described above. <FIG> are exemplary illustrations of the activation of one drawstring <NUM>. Only a portion of the tubular bag sidewall <NUM> is shown in <FIG> for illustrative purposes and the same illustrations are applicable to any of the drawstrings in the bag <NUM>. <FIG> shows the knot pusher <NUM> in a position adjacent to the slip knot <NUM> with the drawstring <NUM> extending circumferentially within a channel <NUM> and longitudinally along the length of the bag <NUM>. The bag <NUM> has a first diameter at the drawstring <NUM> location inside the channel <NUM>. <FIG> illustrates the knot pusher <NUM> advanced distally to cinch and reduce the diameter of the bag <NUM> to a second diameter smaller than the first diameter at the location of the drawstring <NUM> inside the channel <NUM>. In one variation of the bag, the second opening <NUM> is absent from the bag <NUM> and specimen is placed into the first opening <NUM> and the first opening <NUM> and first ring <NUM> are pulled back up through the incision or orifice and the cinching can commence.

In use, the second opening <NUM> of the bag <NUM> is inserted into a surgical incision or natural orifice and placed within a body cavity <NUM>. An anatomical structure <NUM> such as a tumor, tissue specimen, uterus or other tissue structure that has been mobilized or a surgical specimen may be drawn into the second opening <NUM> using an elongate surgical grasper, forceps or the like. Once the specimen <NUM> is within the elongate tubular body <NUM>, the second opening <NUM> is closed by acting upon the drawstring <NUM> associated with the second opening <NUM>. The specimen or isolated mass <NUM> may, in some cases, be too large, bulky or oddly shaped to be easily removed through the surgical incision or natural orifice. In this instance, a surgeon may attempt to reduce or re-shape the mass <NUM> so that it may be removed. There are several ways to do this. A first method may comprise the use of surgical scissors or knives to slice the mass <NUM> into manageable portions while within the containment bag or sleeve <NUM>. A second method <NUM> is to use the drawstrings to compress the mass. A third method includes the use of a mechanical chopping or slicing device often referred to as a morcellator. Generally speaking, great care must be taken when performing these steps to avoid compromising the containment vessel or sleeve <NUM>. The second opening <NUM> may be pulled through another incision or orifice to create a closed system prior to commencing morcellation.

With reference now to <FIG>, methods of using the containment bag having multiple drawstrings, cinches, or belts will be described. These methods minimize the potential for contacting the sidewall <NUM> of the bag <NUM> with a mechanical cutting element. Firstly, the subject mass <NUM> is drawn into the containment vessel <NUM> either through the second opening <NUM>, if one is provided, or otherwise, through the first opening <NUM>. Secondly, the distal second opening <NUM> of the bag <NUM>, if one is provided, is closed in the manner described above using a knot pusher <NUM> to push a knot <NUM> and cinch the diameter with the circumferential portion of the drawstring <NUM>. Thirdly, as shown in <FIG>, a cutting or "coring" instrument <NUM> is inserted into the first opening <NUM> and used to cut or "core" through the mass <NUM> one or more times while avoiding the margins <NUM>, <NUM> of the mass <NUM> that may be in contact with the sidewall <NUM> of the bag <NUM>. Fourthly, the cutting or "coring" device <NUM> may be removed from the vessel bag <NUM> as shown in <FIG> leaving an elongate empty core <NUM> reflected by the dotted lines in <FIG>. Fifthly, the plurality of drawstrings <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may be acted upon individually or collectively to squeeze the mass <NUM> within the vessel bag <NUM> into an elongate shape having a reduced cross-sectional area as a result of the closing of the empty core with the cinching of drawstrings as shown in <FIG>. The reduced mass <NUM> is then withdrawal through the incision or orifice associated with the first opening <NUM> either by removing the entire bag <NUM> or removing the reduced mass <NUM> from inside the bag <NUM>. The plurality of tightened drawstrings <NUM>, <NUM>, <NUM>, <NUM>, <NUM> advantageously prevents the mass <NUM> from shifting distally during removal of the bag <NUM> through an incision or orifice and creating a bolus at the distal or closed second opening <NUM> of the bag <NUM>. Hence, the specimen <NUM> is retained with the drawstrings in a relatively fixed manner.

Turning now to <FIG> and <FIG>, a relatively large mass <NUM> is cored with the coring instrument <NUM> leaving behind an empty core <NUM>. In <FIG>, the second opening <NUM> is shown as a variation in which the second opening <NUM> remains open compared to <FIG> such as in a benign surgical environment of if the bag <NUM> contained inside another bag. The drawstrings are acted to reduce the diameter of the specimen <NUM> by effectively squeezing closed the empty core <NUM> as shown in <FIG> and <FIG>. In the instance where a contained mass <NUM> remains excessively large or inappropriately shaped after the drawstrings <NUM>, <NUM>, <NUM>, <NUM>, <NUM> have been first acted upon, the cutting or "coring" morcellator device <NUM> may be reinserted to further reduce the mass <NUM> as shown in <FIG> and <FIG> to make a second empty core <NUM>. The drawstrings <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may then be further acted upon a second time and tightened again to further reduce the profile of the contained mass <NUM> for removal by squeezing closed the empty second core <NUM> as shown in <FIG> and <FIG>. The specimen <NUM> is removed through the incision or orifice with the bag <NUM> while inside the bag <NUM> or the specimen is removed from the inside of the bag <NUM> through the first opening <NUM> and through the incision or orifice. In these instances, the constrictive nature of the containment bag <NUM> obviates the need to completely morcellate the contained mass or specimen <NUM> for removal or retrieval and effectively uses the margins <NUM>, <NUM> of the mass as a buffer zone protecting the sidewall <NUM> from inadvertent contact with the coring instrument. The margins <NUM>, <NUM> or portions of the mass <NUM> that are in contact with the sidewall <NUM> of the containment vessel <NUM> may be left, thereby, avoiding the potential for cutting, tearing or snagging the vessel sidewall <NUM>.

Various examples of bags and devices for inserting, deploying and/or retrieving bags to be included or integrated into the morcellation system in which the entire systems, portions of the systems or combinations of the systems and/or components thereof arranged to provide a containment of object to be morcellated in are described in <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>. Additional bag variations are described in greater detail in <CIT>, <CIT>, <CIT>, June <NUM>, <NUM> and July <NUM>, <NUM>.

Claim 1:
A tissue containment bag, comprising a first opening (<NUM>) and a second opening (<NUM>) interconnected by a sidewall (<NUM>) of flexible material,
the sidewall (<NUM>) defining a first interior compartment (<NUM>) configured for receiving a tissue specimen through the first opening (<NUM>) into the first interior compartment (<NUM>);
the sidewall (<NUM>) forming an elongated hollow, sleeve-like neck extension (<NUM>) defining a second interior compartment (<NUM>) having a proximal end interconnected with the first interior compartment (<NUM>) and a distal end interconnected with the second opening (<NUM>);
the second opening (<NUM>) being in fluidic communication with the second interior compartment (<NUM>);
the second interior compartment (<NUM>) being in fluidic communication with the first interior compartment (<NUM>) and the first interior compartment (<NUM>) being in fluidic communication with the first opening (<NUM>);
the sidewall (<NUM>) at the first interior compartment (<NUM>) having a width perpendicular to a first longitudinal axis defined by a radial plane of the first opening (<NUM>) when the bag (<NUM>) is in undeflected configuration and a length along the first longitudinal axis;
the neck extension (<NUM>) having a width perpendicular to a second longitudinal axis defined by a radial plane of the second opening (<NUM>) when in undeflected configuration and a length along the second longitudinal axis; and
the width of the neck extension being smaller than the width of the first interior compartment, the tissue containment bag being characterized in that the neck extension (<NUM>) includes a sealing mechanism (<NUM>) for sealing off the second opening (<NUM>) when the tissue containment bag is ready for removal from an incision or a body orifice; the sealing mechanism (<NUM>) comprising a first pocket (<NUM>) having a first pocket mouth (<NUM>) and a second pocket (<NUM>) having a second pocket mouth (<NUM>), wherein the first and second pockets (<NUM>, <NUM>) are connected to an outer surface of the neck extension such that the first pocket mouth (<NUM>) faces the second pocket mouth (<NUM>).