Tissue storage and retrieval system and method

Abstract

To provide systems and methods for the surgical removal of tissue through small incision sites and / or body orifices.SOLUTION: A containment system includes a primary chamber interconnected with a secondary channel extending from the primary chamber. A tissue specimen is floated inside a body cavity and put into the primary chamber through a first opening. The first opening is pulled through a first incision or orifice, and the narrower secondary channel is placed at a second incision or orifice. A second opening disposed at the end of the secondary channel permits, via a scope inserted through the second opening, observation of the tissue specimen in the primary chamber undergoing morcellation via the first opening. Other systems and methods for deployment, containment, debulking and sealing of the second opening to create a closed system enabling safe retrieval of the tissue specimen are provided.SELECTED DRAWING: Figure 1A

Description

[Technical Field]

[0001] This application relates to medical devices, and in particular to systems and methods for surgically removing tissue through small incisions and / or body orifices, such systems including specimen-containing bags.

[0002] Description of Related Applications This application claims priority to and benefits from U.S. Provisional Patent Application No. 62 / 038,740, filed August 18, 2014, entitled "Power morcellation system," which is incorporated herein by reference in its entirety. [Background technology]

[0003] If necessary, a small incision is made in the patient to access the surgically targeted tissue located within the body cavity. The surgically targeted tissue can also be accessed through a body orifice without an initial incision. In some cases, the target tissue is accessed directly through the incision or body orifice. In some cases, an access device system is placed and positioned in, 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 acts as a gate or portal for accessing the target tissue located within or adjacent to the body cavity or body orifice. The target tissue is dissected from adjacent and surrounding tissue using known surgical techniques or procedures. Once freed, the target tissue is ready for removal through the small incision or body orifice. If the target tissue is too large to remove in its entirety, the target tissue is reduced in size and partially removed through the small incision. Ideally, the surgeon will "core" or "skin" the target tissue and keep it as whole as possible. However, more than 50% of the time, the target tissue breaks into many small pieces.

[0004] Reducing the size of target tissue is called morcellation. In morcellation, a scalpel or knife is used to manually or with an electric morcellator to cut the target tissue into small pieces, and the target tissue is cut so that it can be removed through a small incision. The small pieces of target tissue are removed from the patient through the small incision. When reducing the size of the target tissue so that it fits through the small incision, small pieces of tissue may be cut off and left inside the patient. Therefore, morcellation is contraindicated in cases of malignant tumors or endometriosis. When cancer is morcellated, the cancer may spread malignant tissue, up-stage the cancer, and increase the patient's mortality.

[0005] Hysterectomy is one example of a surgical procedure that may involve morcellation. Over 500,000 hysterectomies are performed on women in the United States each year. The usual reasons for a woman to undergo a hysterectomy are the presence of fibroids, cancer, endometriosis, or uterine prolapse. Approximately 200,000 of these hysterectomies are performed laparoscopically. If the uterus is too large (over 300 g) to be removed through the vagina or if the cervix is ​​still in place, the specimen must be reduced in size for removal through an abdominal incision or through the vagina. During myomectomy (fibroid removal), it may be necessary to remove large fibroids using a morcellation technique. During morcellation, the target tissue (usually the uterus and possibly adnexal structures) is brought to the abdominal wall surface, for example, with a tissue grasper, reduced in size with a blade, and removed from the pelvic cavity through the incision. Alternatively, the target tissue is removed through a body orifice, for example, the vagina. Fibroids or uterine leiomyomas account for approximately 30% to 40% of hysterectomies. These benign tumors of the uterus can cause severe and painful bleeding. In the past, these tumors were thought to be missed cancers or leiomyosarcoma, affecting approximately 1 in 10,000 women. More recent data support the extremely high risk of missed malignancy among these tumors, estimated to range from 1:1000 to 1:400. Because of this high risk, many surgeons have begun to modify their techniques and perform a closed morcellation process by encasing the specimen in a pouch to contain stray particles and prevent the spread and seeding of tumor cells, rather than morcellating without a pouch in a process called open morcellation.Many GYN (gynecological) societies, including the American Association of Gynecologists (AAGL), the American Congress of Obstetricians and Gynecologists (ACOG), and the Society of the American Oncology (SGO), have issued statements warning of the potential dangers of open morcellation. Effective April 17, 2014, the FDA issued a statement discouraging the use of open power morcellation for the performance of hysterectomies and myomectomies for women undergoing these procedures for fibroids. The FDA also increased the estimated likelihood of malignancy to 1 in 350. For these reasons, there is a need for systems and methods for safely and effectively reducing tissue specimens. The present invention relates to such safe systems and methods for both manual and power morcellation performed in a closed system. Summary of the Invention

[0006] According to one aspect of the present invention, a tissue containment bag is provided. The tissue containment bag has a first opening and a second opening connected to each other by a side wall made of a flexible material. The side wall defines a first internal compartment and a base configured to receive a tissue specimen into the first internal compartment through the first opening and to support the tissue specimen on the base. The side wall defines an elongated, hollow, sleeve-like neck extension defining a second internal compartment having a proximal end interconnected with the first internal compartment and a distal end interconnected with the second opening. The second opening is in fluid communication with the second internal compartment. The second internal compartment is in fluid communication with the first internal compartment, and the first internal compartment is in fluid communication with the first opening. The proximal end of the neck extension is connected to the side wall of the first internal compartment at a first side. The neck extension extends laterally away from a first longitudinal axis defined by the radial plane of the first opening when the bag is in the unflexed configuration. A second longitudinal axis is defined by the radial plane of the second opening when the bag is in the unflexed configuration. The sidewall has a width perpendicular to the first longitudinal axis and a length along the first longitudinal axis at the first internal compartment, and the neck extension has a width perpendicular to the second longitudinal axis and a length along the second longitudinal axis. The width of the neck extension is less than the width of the first internal compartment. The proximal end of the neck extension defines an inlet passage intersection between the first and second compartments at the first internal compartment.

[0007] According to another aspect of the present invention, a tissue containment bag is provided. The tissue containment bag has a first opening and a second opening connected to each other by a sidewall made of a flexible material. The sidewall defines a first internal compartment and a base configured to receive a tissue specimen into the first internal compartment through the first opening and to support the tissue specimen on the base. The sidewall defines an elongated, hollow, sleeve-like neck extension defining a second internal compartment having a proximal end interconnected with the first internal compartment and a distal end interconnected with the second opening. The second opening is in fluid communication with the second internal compartment. The second internal compartment is in fluid communication with the first internal compartment, and the first internal compartment is in fluid communication with the first opening. The proximal end of the neck extension is connected to the base of the first internal compartment. The neck extension extends in a direction along a first longitudinal axis defined by the radial plane of the first opening when the bag is in the unflexed configuration, and the second longitudinal axis is defined by the radial plane of the second opening when the bag is in the unflexed configuration. The sidewall has a width perpendicular to the first longitudinal axis and a length along the first longitudinal axis at the first internal compartment. The neck extension has a width perpendicular to the second longitudinal axis and a length along the second longitudinal axis. The width of the neck extension is smaller than the width of the first internal compartment. The proximal end of the neck extension defines an inlet passage intersection between the first compartment and the second compartment at the first internal compartment.

[0008] According to another aspect of the present invention, a storage container is provided. The storage container has a first opening at a first end, a second opening at a second end, and a sidewall interconnecting the first and second openings. The sidewall defines an interior extending between the first and second openings. The sidewall has a diameter and cross-section perpendicular to the longitudinal axis and a length. The storage container further has at least one fastener coupled to the sidewall around the interior at a location located between the first and second openings. The fastener is configured to reduce the diameter of the sidewall at the location of the fastener.

[0009] According to another aspect of the present invention, a method for deploying a tissue containment bag in a body cavity is provided. The method includes providing a tissue containment bag having a first opening and a second opening connected to each other by a sidewall made of a flexible material. The sidewall defines a first internal compartment and a base, the base configured to receive a tissue specimen into the first internal compartment through the first opening and to support the tissue specimen on the base. The sidewall defines an elongated, hollow, sleeve-like neck extension defining a second internal compartment having a proximal end interconnected with the first internal compartment and a distal end interconnected with the second opening. The second opening is in fluid communication with the second internal compartment. The second internal compartment is in fluid communication with the first internal compartment, and the first internal compartment is in fluid communication with the first opening. The proximal end of the neck extension is connected to the first internal compartment. The neck extension extends outward from the first internal compartment when in the deployed configuration. The neck extension has a retracted delivery configuration. The method includes inserting the tissue containment bag into a body cavity while in the delivery configuration. The method includes moving the neck extension from the delivery configuration to a deployed configuration within the body cavity.

[0010] According to another aspect of the present invention, a method for removing a tissue specimen from a body cavity is provided. The method includes providing a tissue storage bag having a first opening at a first end, a second opening at a second end, and a sidewall interconnecting the first and second openings. The sidewall defines an interior extending between the first and second openings and has a diameter and cross-section perpendicular to the longitudinal axis. The tissue storage bag has a resilient, compressible ring coaxially connected to the sidewall with the second opening and configured to maintain the second opening in an open position. The method includes inserting the second opening and ring of the tissue storage bag through a body opening or incision into the body cavity. The method includes inserting the tissue specimen through the second opening and into the interior of the tissue storage bag. The method also includes moving the second opening and ring into the interior of the tissue storage bag, past the tissue specimen contained in the storage bag, toward the first opening, to deposit the tissue specimen into the storage bag.

[0011] According to another aspect of the present invention, a method of performing a hysterectomy on a patient is provided. The method includes making an abdominal incision to access a body cavity. The method includes mobilizing a uterus within the body cavity. The method includes providing a tissue containment bag having a first opening and a second opening connected to each other by a sidewall of a soft material. The sidewall defines a first internal compartment and a base, the base configured to support the tissue sample on the base while allowing the tissue sample to pass through the first opening and into the first internal compartment. The sidewall forms an elongated, hollow, sleeve-like neck extension defining a second internal compartment having a proximal end interconnected with the first internal compartment and a distal end interconnected with the second opening. The second opening is in fluid communication with the second internal compartment. The second internal compartment is in fluid communication with the first internal compartment, and the first internal compartment is in fluid communication with the first opening. The proximal end of the neck extension is connected to the first internal compartment. The neck extension extends outward from the first internal compartment when in the deployed configuration. The method includes inserting a tissue containment bag into a body cavity. The method includes inserting a uterus into a first opening of the tissue containment bag. The method includes moving the neck extension to the deployed configuration. The method includes withdrawing a second opening of the tissue containment bag through the patient's vaginal canal to the outside of the patient while the first internal compartment remains positioned within the body cavity. The method includes withdrawing the first opening of the tissue containment bag into an abdominal incision while the first internal compartment remains positioned within the body cavity. The method includes simultaneously reducing the volume of the uterus in the tissue containment bag through either the first opening or the second opening while observing the uterus in the first internal compartment through the other of the first opening or the second opening. The method includes removing the uterus from the patient.

[0012] According to another aspect of the present invention, a method for removing a tissue specimen from a body cavity is provided. The method includes the steps of making an abdominal incision to access the body cavity. The method includes the step of mobilizing a tissue specimen within the body cavity. The method includes the step of providing a tissue collection bag having a first opening and a second opening interconnected by a side wall made of a soft material. The side wall defines an internal compartment. The side wall has a first external pocket on one side of the side wall and a second external pocket on the opposite side. The first pocket and the second pocket are positioned near the second opening. The method includes the step of inserting the tissue collection bag into the body cavity. The method includes the step of inserting the tissue specimen through the first opening of the tissue collection bag into the internal compartment. The method includes the step of folding a distal side wall of the first pocket to place the rolled side wall into the first pocket. The method includes the step of pushing the first pocket into the second pocket.

[0013] According to another aspect of the present invention, a method for extracting a tissue specimen from a body cavity is provided. The method includes providing a tissue storage bag having a first opening at a first end, a second opening at a second end, and a sidewall interconnecting the first and second openings. The sidewall has a diameter and cross-section perpendicular to the longitudinal axis and defines an interior and a length extending between the first and second openings. The storage bag has a plurality of fasteners connected to the sidewall around the interior and spaced apart along the length of the storage bag between the first and second openings. Each fastener is configured to individually reduce the diameter of the sidewall at the location of the fastener upon actuation. The method includes inserting at least the second opening of the storage bag into the body cavity. The method includes passing a tissue specimen having the first diameter through the second opening into the interior of the storage bag. The method includes reducing the diameter of the tissue specimen to a second diameter by actuating one or more fasteners at the location of the tissue specimen to reduce the diameter of the container, and removing the tissue specimen having the reduced second diameter. [Brief explanation of the drawings]

[0014] [Figure 1A] FIG. 1 is a top perspective view of a storage bag of the present invention. [Figure 1B] FIG. 1 is a top perspective view of a storage bag of the present invention. [Figure 2] FIG. 1 is a top perspective view of a storage bag of the present invention. [Figure 3A] FIG. 1 is a top perspective view of a storage bag of the present invention. [Figure 3B] FIG. 1 is a top perspective view of a storage bag of the present invention. [Figure 3C] FIG. 1 is a top perspective view of a storage bag of the present invention. [Figure 4] FIG. 2 is a side view of the storage bag of the present invention. [Figure 5A] FIG. 1 is a top perspective view of a storage bag of the present invention. [Figure 5B] FIG. 1 is a top perspective view of a storage bag of the present invention. [Figure 6] 1 is a schematic diagram of a containment bag of the present invention positioned within a patient's body. [Figure 7A] FIG. 1 is a top perspective view of a storage bag of the present invention. [Figure 7B] FIG. 1 is a top perspective view of a storage bag of the present invention. [Figure 7C] FIG. 1 is a top perspective view of a storage bag of the present invention. [Figure 7D] FIG. 1 is a top perspective view of a storage bag of the present invention. [Figure 7E] FIG. 1 is a top perspective view of a storage bag of the present invention. [Figure 7F] FIG. 1 is a top perspective view of a storage bag of the present invention. [Figure 7G] FIG. 1 is a top perspective view of a storage bag of the present invention. [Figure 7H] FIG. 1 is a top perspective view of a storage bag of the present invention. [Figure 7I] 7I is a cross-sectional view of the containment bag of the present invention taken along line 7I in FIG. 7H. [Figure 7J] FIG. 1 is a top perspective view of a storage bag of the present invention. [Figure 7K]FIG. 1 is a top perspective view of a storage bag of the present invention. [Figure 7L] FIG. 2 is a cross-sectional view of the storage bag of the present invention. [Figure 7M] FIG. 2 is a cross-sectional view of the storage bag of the present invention. [Figure 7N] FIG. 2 is a cross-sectional view of the storage bag of the present invention. [Figure 7O] FIG. 2 is a cross-sectional view of the storage bag of the present invention. [Figure 7P] FIG. 2 is a cross-sectional view of the storage bag of the present invention. [Figure 7Q] 1 is a schematic diagram of two retractors, a scope, a trocar, a tissue specimen, and a containment bag of the present invention positioned within a patient's body. [Figure 7R] FIG. 1 is a top perspective view of a storage bag of the present invention. [Figure 8A] FIG. 2 is a cross-sectional view of the storage bag of the present invention. [Figure 8B] FIG. 2 is a cross-sectional view of the storage bag of the present invention. [Figure 8C] FIG. 2 is a cross-sectional view of the storage bag of the present invention, showing a state in which a portion of the storage bag is rolled up. [Figure 8D] 1 is a cross-sectional view of a containment bag of the present invention, showing a state in which a portion of the containment bag is rolled up and inserted into a first pocket. FIG. [Figure 8E] FIG. 2 is a cross-sectional view of the containment bag of the present invention, showing a state in which a portion of the containment bag is rolled up and inserted into the first pocket and the second pocket. [Figure 9] 1 is a cross-sectional view of a containment bag with a tie end of the present invention. [Figure 10] 1 is a cross-sectional view of a containment bag with a sealed edge of the present invention. [Figure 11] 1 is a cross-sectional view of a containment bag of the present invention having an interlocking releasable seal at one end. [Figure 12] 1 is a cross-sectional view of a containment bag of the present invention configured to be heat sealed, as well as a cross-sectional view of an instrument used to heat seal the containment bag. [Figure 13] FIG. 1 is a top perspective view of a storage bag of the present invention. [Figure 14A]1 is a schematic diagram of a grasper drawing a specimen into a containment bag of the present invention. [Figure 14B] 1 is a schematic diagram of a specimen positioned within a containment bag of the present invention and a grasper grasping the second opening of the containment bag. [Figure 14C] 1 is a schematic illustration of a specimen positioned within a containment bag of the present invention and a grasper pulling a second opening of the containment bag over the specimen to invert the second opening proximally to place the specimen within the containment bag. [Figure 15] FIG. 1 is a top perspective view of a containment bag of the present invention with two rings on one end. [Figure 16] FIG. 1 is a top perspective view of a containment bag of the present invention with seven openings. [Figure 17] FIG. 1 is a top perspective view of a containment bag of the present invention with four openings. [Figure 18A] FIG. 1 is a top perspective view of a containment bag of the present invention with a scope window. [Figure 18B] FIG. 1 is a cross-sectional view of a scope positioned at a scope window of a containment bag of the present invention. [Figure 19A] FIG. 1 is a top perspective view of a containment bag of the present invention with a sealing port. [Figure 19B] 1 is a cross-sectional view of a scope inserted past a sealing port of the containment bag of the present invention. [Figure 20] 1 is a schematic illustration of a trocar inserted into an opening in a containment bag at a tissue wall in accordance with the present invention. [Figure 21] 1 is a schematic illustration of the proximal end and opening of a containment bag being retracted through a lumen of a trocar at a tissue wall in accordance with the present invention. [Figure 22] FIG. 1 is a top perspective view of a seal at the opening of the containment bag of the present invention. [Figure 23] FIG. 1 is a top perspective view of a trocar at the opening of a containment bag of the present invention. [Figure 24A] FIG. 1 is a top perspective view of a containment bag with channels of the present invention. [Figure 24B] FIG. 1 is a top perspective view of a containment bag with channels of the present invention. [Figure 24C]1 is a cross-sectional view of a containment bag with a channel of the present invention. [Figure 25] 1 is a schematic diagram of a containment bag and an insufflation or insufflation system for a body cavity of the present invention. [Figure 26] 1 is a schematic diagram of a double-walled containment bag and insufflation system of the present invention. [Figure 27] FIG. 1 is a top perspective view of a perforated storage bag of the present invention. [Figure 28] 1 is a top perspective view of a storage bag with a clip holder according to the present invention; FIG. [Figure 29] 1 is a perspective view of a storage bag with an adhesive retainer according to the present invention, seen from above. [Figure 30] FIG. 1 is a top perspective view of a containment bag with the neck extension of the present invention inverted; [Figure 31] FIG. 1 is a top perspective view of a containment bag with an exterior pocket for a neck extension of the present invention. [Figure 32A] 1 is a schematic representation of a specimen in a containment bag with a drawstring of the present invention. [Figure 32B] 1 is a schematic representation of a containment bag of the present invention and a specimen within the containment bag with the drawstring activated to reduce the diameter of the specimen. [Figure 32C] 1 is a schematic representation of a containment bag of the present invention and a specimen within the containment bag with the drawstring activated to reduce the diameter of the specimen. [Figure 33A] 1 is a schematic illustration of a knot pusher and drawstring in an open configuration around the periphery of a containment bag of the present invention. [Figure 33B] 1 is a schematic illustration of a knot pusher and drawstring in a contracted or activated configuration around the periphery of a containment bag of the present invention. [Figure 34A] FIG. 1 is a schematic representation of a specimen in a containment bag of the present invention, showing a drawstring and coring device inserted into the containment bag positioned across the body wall. [Figure 34B] FIG. 1 is a schematic representation of a specimen in a containment bag of the present invention, showing the drawstring in a retracted or activated configuration. [Figure 34C]FIG. 1 is a schematic representation of a specimen in a containment bag of the present invention, showing the drawstring in a retracted or activated configuration. [Figure 35A] FIG. 1 is a schematic representation of a specimen in a containment bag of the present invention, showing the drawstring and coring instrument initially inserted into the containment bag. [Figure 35B] FIG. 1 is a schematic representation of a specimen within a containment bag of the present invention, showing the drawstring in a retracted or activated configuration and the coring instrument being inserted into the containment bag for a second time. [Figure 35C] FIG. 1 is a schematic representation of a specimen in a containment bag of the present invention, showing the drawstring in a retracted or activated configuration. [Figure 36A] FIG. 1 is a schematic representation of a specimen in a containment bag of the present invention, showing the drawstring and coring instrument initially inserted into the containment bag. [Figure 36B] FIG. 1 is a schematic representation of a specimen within a containment bag of the present invention, showing the drawstring in a retracted or activated configuration and the coring instrument being inserted into the containment bag for a second time. [Figure 36C] FIG. 1 is a schematic representation of a specimen in a containment bag of the present invention, showing the drawstring in a retracted or activated configuration. DETAILED DESCRIPTION OF THE INVENTION

[0015] 1A and 1B, a containment bag 10 of the present invention is shown. The containment bag 10 has a first opening 12 and a second opening 14, also referred to as a mouth, interconnected by a sidewall 16. A first ring 18 is provided at the first opening 12, and a second ring 20 is provided at the second opening 14. The rings 18 and 20 are connected to the sidewall 16 by heat-healing the sidewall 16 itself and / or by enclosing the rings 18 and 20 within a pocket formed therein using an adhesive. The sidewall 16 is made of any suitable flexible material, including polymers, fabrics, fabric-reinforced polymers, mesh, nylon, fibers, and the like. The first opening 12 is larger or has a larger diameter than the second opening 14, and the sidewall 16 is in the form of a frusto-cone. Thus, the first ring 18 is larger or has a larger diameter than the second ring 20. The sidewall 16 is formed by heat-sealing the sidewall material, thereby forming one or more longitudinal seams or joints along the length of the bag 10. As shown in FIG. 1B, the bag 10 can optionally include at least one fastener or zipper 22 connected to the sidewall 16 at a location between the two rings 18, 20. In one form, the fastener 22 comprises a hoop, girdle or cinch, tape, or other means known in the art that can be pulled to at least partially tighten the sidewall 16 and reduce the diameter of the sidewall 16 at the location of the fastener 22. Other types of fasteners 22 are within the scope of the present invention. Multiple fasteners 22 can also be employed, spaced apart along the longitudinal axis of the bag 10, as will be described in more detail below. The single fastener 22 functions to reduce the diameter of the bag 10 approximately midway between the two openings 12, 14, thereby forming a base 24, also referred to as a bottom, floor, or semi-floor, for the bag 10 that can support a surgical tissue specimen. Generally, the fastener 22 also functions to close the side walls 10 to create two compartments or chambers within the bag 10: a first proximal compartment 26 and a second distal compartment 28, separated from one another by a abdominal band.Fastener 22 is advantageously releasable so that the lumen of bag 10 is continuous from first opening 12 to second opening 14. A first tether and tag can be attached to first ring 18 and a second tether and tag can be attached to second ring 20 to facilitate placement of bag 10 and to facilitate removal of bag 10. As shown in Figures 1A and 1B, first opening 12 and second opening 14 are coaxial or disposed substantially along the longitudinal axis of bag 10 when bag 10 is in its normal, unflexed orientation, thereby forming a sleeve-like tubular structure.

[0016] In use, the containment bag 10 of the present invention is used for a surgical procedure involving ablation and subsequent morcellation of the uterus or other surgical target. In use, an incision is first made in the abdominal region of the patient, typically at the umbilicus. A retractor is inserted into the incision.

[0017] A retractor (not shown) typically has a first ring and a second ring interconnected by a flexible sidewall. The sidewall defines an interconnected lumen between the openings of the first and second rings of the retractor. The second ring is elastic and compressible. When compressed, the second ring assumes an oval, elongated shape and is inserted through an incision in the abdominal wall into the abdominal cavity, which may have already been expanded with insufflation or insufflation gas to create a surgical workspace. When the second ring is no longer compressed to its low-profile state, it freely expands to its original high-profile configuration due to its own elasticity, as a result of being made of appropriate material, construction, and design. The sidewall of the retractor connects the second ring to the first ring. When the second ring is placed inside the patient, the sidewall traverses the incision and abdominal wall, while the first ring lies outside the patient's body above the abdominal wall. Because the sidewall is relatively loose, a small incision tends to cause the sidewall to bow inward toward the retractor lumen. The first ring is configured to be rolled down to retract and widen the abdominal wall opening. The first ring turns over on itself to wrap the sidewall material around the first ring of the retractor, thereby decreasing the length of the retractor. While the length of the retractor is being decreased, the second ring is drawn toward the first ring. As the first ring continues to be rolled, the length of the sidewall decreases, thereby increasing tension on the sidewall, thereby moving the sidewall outward toward its cylindrical shape, retracting tissue and bringing it into contact with the outer surface of the sidewall, thereby widening the abdominal wall opening. The first ring has an elongated, oval-shaped cross-sectional shape that facilitates rolling of the sidewall and inhibits unrolling of the sidewall compared to rings with circular cross-sections. The sidewalls are made of polyurethane laminate or similar material, including woven or reinforced polymeric materials to resist cuts or tears in the sidewalls.Various examples of access systems to be included in or integrated into a morcellation system, where the entire access system, portions of the access system, or a combination of the access system and / or components thereof are arranged to provide channels and / or approximate areas in accordance with various embodiments of the present invention, are described in U.S. patent application Ser. Nos. 13 / 865,854, filed April 18, 2013; 61 / 880,641, filed September 20, 2013; 12 / 578,422, filed October 13, 2009; 61 / 104,963, filed October 13, 2008; 12 / 358,080, filed January 22, 2009; and 11 / 374,188, filed March 13, 2006. No. 11 / 683,821 filed March 8, 2007; No. 12 / 396,624 filed March 3, 2009; No. 14 / 209,161 filed March 13, 2014; No. 12 / 873,115 filed August 31, 2010; No. 12 / 840,989 filed July 21, 2010; Nos. 11 / 548,758, filed October 12, 2000; 10 / 516,198, filed November 30, 2004; and 10 / 666,579, filed September 17, 2003, all of which are incorporated by reference herein as if set forth herein.U.S. Provisional Patent Application Nos. 61 / 970,436, filed March 26, 2014, 61 / 987,413, filed April 23, 2014, 62 / 014,038, filed June 18, 2014, 62 / 024,698, filed July 15, 2014, 62 / 079,171, filed November 13, 2014, 62 / 081,297, filed November 18, 2014, 61 / 982,997, filed April 23, 2014, and 62 / 107,107, filed January 23, 2015, are also incorporated herein by reference in their entireties.

[0018] After inserting a retractor into the incision and widening the opening at the incision, an access port cap / platform is attached to the first ring of the retractor, thereby covering and sealing the opening created by the retractor. The access port cap may have one or more access ports, including an insufflation port, and / or may be made of a penetrable material, such as a gel, that seals around the inserted instrument. Insufflation gas is directed across the incision sealed by the access port cap to insufflate the patient's abdominal cavity and create an expanded surgical working space. The body cavity is insufflated or insufflated by directing gas across the access port cap and into the abdominal cavity. Instruments, such as graspers, scissors, a scope, and electrocautery / electrosurgical instruments, are inserted through the access ports to ablate the uterus. The instruments are removed, and the access port cap / platform is removed.

[0019] To use the pouch 10, insert it through the umbilical incision. The access port cap / platform is reattached to the first ring of the retractor, and the body cavity is re-insufflated to allow visualization of the procedure with a scope inserted through the access port cap / platform or a secondary incision. A grasper is used to insert a dissected tissue specimen, such as a uterus, into the first opening 12 of the pouch 10 while it is positioned within the abdominal cavity. The first opening 12 is larger than the second opening 14 of the pouch 10, thereby facilitating the introduction of the tissue specimen. The rings 18 and 20 are also flexible, allowing them to be compressed into a low-profile configuration suitable for insertion through small ports and / or incisions. The tether attached to the first ring 18 is pulled to thread the larger first ring 18 through the umbilical incision. The access port cap / platform is then removed, and the first ring 18 of the pouch 10 and a portion of the side wall 16 adjacent to the first ring 18 are pulled out of the first incision. A portion of the side wall 16 covers the first ring of the retractor, and the access port cap / platform is reattached to the retractor, thereby capturing the bag between the access port cap / platform and the retractor ring. With the uterus separated, the tether attached to the second ring 20 of the bag 10 is grasped from the now-open vaginal canal. The second ring 20 of the bag 10 is retracted into the vaginal opening, and a second access port cap / platform is attached to the second ring 20. The second ring 20 is compressed into a low-profile orientation to facilitate removal of the second ring 20. The access port cap / platform is small to fit over the smaller second ring 20. A scope is inserted into the bag 10 through the second access port cap / platform. The second opening 14 is small so as to be sized and shaped to allow insertion of a long, thin instrument for placement and / or observation along the vaginal canal, such as a scope or a powered or manual morcellation instrument for morcellating the uterus within the pouch. Alternatively, a trocar may be inserted through the second access port cap / platform and a scope may be inserted through the trocar.In yet another embodiment, an access port cap / platform is not used, and a balloon catheter is inserted into the second opening 14 through which the scope has been inserted. In another embodiment, the scope is inserted into the pouch 10 without an access port cap / platform or retractor. In another embodiment, a retractor may be placed within the second opening 14 of the pouch 10, and the vaginal canal can be retracted along with the pouch 10 by the retractor. Or, alternatively, the second opening 14 of the pouch 10 is pulled through the lumen of a retractor already in place within the vaginal canal.

[0020] A morcellator is inserted through the first access port cap / platform and morcellation of the specimen begins under visualization via a scope inserted through the vaginal canal and through the second opening 14 of the pouch 10, advantageously providing an unobstructed view of the procedure. This procedure results in morcellation through the umbilicus or other incision site within the abdominal field. An alternative to morcellation through the umbilicus is morcellation through the vaginal canal, as described further below.

[0021] After morcellation through the umbilicus or other incision site is complete, the pouch 10 is removed from the patient by first removing the access port cap / platform at the vaginal canal attached to the small second ring 20. If a retractor is used at the vaginal opening, it is also removed. The second opening 14 of the pouch is sealed prior to removal by various methods, described in detail below. For example, by tying a knot at the distal end of the pouch 10, rolling or rolling up the side wall 16 near the second opening 14 and tucking it into one or more pockets or side walls 16. The first access port cap / platform and retractor, if one is used, are removed at the umbilicus or other abdominal incision. With this second opening 14 of the pouch sealed, the entire pouch 10 is removed through the abdominal incision. At the time of removal, the majority of the uterus or tissue specimen has already been removed or reduced in size by the morcellation process, which facilitates removal of larger specimens. By sealing the second opening 14 prior to removal of the bag, the contents of the bag are prevented from spilling out, and the system therefore remains completely enclosed.

[0022] In another form of morcellation performed through the umbilicus or other abdominal location, the bag 10 is inserted into the body cavity and the specimen is inserted into the first opening 12. The access port cap / platform is removed from the retractor before the first ring 18 is drawn against the patient's abdominal surface, and the retractor is then removed. The first ring 18 is then squeezed to a low-profile configuration, and the proximal portion of the bag 10, along with the remainder of the bag, is withdrawn through the umbilicus, with the specimen therein remaining within the abdominal cavity. The retractor is then reinserted into the mouth of the bag 10, and the tissue is then advantageously retracted together with the side wall 16 of the bag 10, as shown in FIG. 6. The access port cap / platform is then reattached to the retractor ring as shown in FIG. 6. The proximal portion of the bag 10 covers the retractor, and the first ring 18 of the bag 10 is positioned outside the patient's body.

[0023] As an alternative to morcellation through the umbilicus, morcellation of a tissue specimen, e.g., a uterus, through the vaginal canal will now be described. The pouch 10 is inserted through an incision in the umbilicus or other abdominal location. A retractor can be inserted into the incision, and the surrounding tissue can be retracted. The access port cap / platform is reattached to the first ring of the retractor, and the body cavity is again insufflated to allow visualization of the procedure with a scope inserted through the access port cap / platform or a secondary incision. The dissected tissue specimen, e.g., a uterus, is inserted into the first opening 12 of the pouch 10 using a grasper. A tether attached to the first ring 18 is pulled to thread the larger first ring 18 through the vaginal canal rather than through the abdominal incision. The first ring 18 of the pouch 10 and a portion of the side wall 16 located near the first ring 18 are pulled out of the vaginal canal. A retractor is inserted into the first opening 12 of the bag 10, and the vaginal canal is retracted along with the bag 10 at the location of the retractor by rolling the first ring onto itself and wrapping the sidewall around the first ring of the retractor. An access port cap / platform is attached to the retractor ring. Alternatively, the retractor may be placed before the bag 10 is pulled through the vaginal opening, in which case the access port cap / platform captures the bag 10 against the first ring of the retractor. A tether attached to the small second ring 20 of the bag 10 is grasped through the umbilical incision or other abdominal incision. The second ring 20 of the bag 10 is pulled through the umbilical incision or other abdominal incision, and a second access port cap / platform is attached to the second ring 20. The second access port cap / platform is small enough to fit the small second ring relative to the first access port cap / platform. A scope is inserted through the second access port cap / platform into the pouch 10 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 port cap / platform or retractor, or a scope may simply be inserted into the pouch 10 at the second opening 14 located at the umbilicus or other incision. A morcellator is inserted through the first access port cap / platform and down the vaginal canal, and morcellation of the specimen begins under observation via a scope inserted through the vaginal canal and through the second opening 14 of the pouch 10, advantageously providing an unobstructed view of the procedure. The pouch 10 is removed from the patient by removing the first access port cap / platform, which is attached to the retractor at the vaginal introitus. The retractor at the vaginal introitus is also removed. Any retractor or second access port cap / platform at the second opening 14 is removed. The second opening 14 of the pouch 10 is sealed by various methods, which are described in detail below. For example, the side wall 16 located near the second opening 14 may be rolled up and tucked, or a knot may be tied in the side wall 16. With the second opening 14 sealed, the entire pouch 10 is removed through the vaginal canal, at which point the majority of the uterus or tissue specimen has already been removed or reduced in size by the morcellation process.

[0024] Referring now to FIG. 2, another embodiment of a containment bag 10 will be described below, using the same reference numerals to indicate like parts of the invention. The bag 10 of FIG. 2 can also be used in any one or more of the methods described above. The bag 10 has a first opening 12 and a second opening 14, also referred to as a mouth, interconnected by a sidewall 16. A first ring 18 is provided at the first opening 12, and a second ring 20 is provided at the second opening 14. The rings 18, 20 are connected to the sidewall 16 by heat-healing the sidewall 16 itself and / or by enclosing the rings 18, 20 in a pocket formed therein using an adhesive. The sidewall 16 is made of any suitable flexible material, including polymers, fabrics, fabric-reinforced polymers, mesh, nylon, fibers, and the like. The first opening 12 is larger or has a larger diameter than the second opening 14, and therefore the first ring 18 is larger or has a larger diameter than the second ring 20. The sidewall 16 is funnel-shaped, thereby dividing the lumen of the bag 10 into a first compartment 26 and a second compartment 28. The first compartment 26 is substantially parabolic funnel-shaped with a curved sidewall when the bag 10 is in its natural, unflexed orientation. The sidewall 16 is formed by longitudinally heat-sealing the sidewall material to form one or more seams along the length of the bag 10. At the intersection of the first compartment 26 and the second compartment 28, a reduced-diameter local access channel 30 is provided, which advantageously reduces the amount of specimen passing therethrough, thereby creating a base 24, also referred to as a floor or semi-floor, for the bag 10 that can support a surgical tissue specimen; the reduced-diameter access channel prevents the tissue specimen from easily migrating into the second compartment 28. The curved sidewalls 16 help retain the specimen at the base 24, thereby forming a reservoir-like configuration.From intersection 30 to second opening 14, the cross section of the opening remains substantially constant and / or gradually increases or decreases, thereby forming a tubular, sleeve-like section of bag 10 that is sized and shaped for placement through the vaginal canal, yet is significantly narrower than first compartment 26, with a larger cross-sectional opening along first compartment 26. A first tether and tag can be attached to first ring 18, and a second tether and tag can be attached to second ring 20, which facilitates placement of bag 10 and facilitates removal of bag 10.

[0025] Referring now to Figures 3A-3C, another containment bag 10 of the present invention is shown. The containment bag 10 has a first opening 12 and a second opening 14, also referred to as a mouth, interconnected by a sidewall 16. A first ring 18 is provided at the first opening 12, and a second ring 20 is provided at the second opening 14. The rings 18, 20 are connected to the sidewall 16 by heat-healing the sidewall 16 itself and / or by enclosing the rings 18, 20 within a pocket formed therein using an adhesive. The sidewall 16 is made of any suitable flexible material, including polymers, fabrics, fabric-reinforced polymers, mesh, nylon, fibers, and the like. The first opening 12 is larger than the second opening 14, and the sidewall 16 is frusto-conical in shape. Thus, the first ring 18 is larger or has a larger diameter than the second ring 20. The sidewall 16 is formed by heat-sealing the sidewall material, thereby forming one or more longitudinal seams or joints along the length of the bag 10. The bag 10 has one or more inwardly extending lateral seams 32 that reduce the diameter of the lumen of the bag 10 at locations between the first opening 12 and the second opening 14. The seams 32 are formed in the sidewall 16 by selectively hot-sealing portions of the sidewall 16 together to reduce the diameter of the sidewall 16 at the seam locations. Four seams 32 spaced around the sidewall 16 are shown in FIG. 3B, and two seams 32 are shown positioned opposite each other in FIG. 3C. The seams 32 reduce the diameter of the bag 10 anywhere, including midway between the two openings 12, 14, thereby functioning to form a base 24, also referred to as a bottom, floor, or semi-floor, for the bag 10 that can support a surgical tissue specimen. Generally, the seam 32 functions to close the side wall 16 and to form two compartments within the bag 10: a first proximal compartment 26 and a second distal compartment 28 separated from one another by the seam 32.At the intersection of the first compartment 26 and the second compartment 28, there is a reduced diameter lead-in passage 30 which advantageously reduces the amount of specimen passing therethrough, thereby creating a base 24 or semi-base. A first tether and tag may be attached to the first ring 18, and a second tether and tag may be attached to the second ring 20, which facilitates placement of the bag 10 and facilitates removal of the bag 10.

[0026] Referring now to FIG. 4, a containment bag 10 is shown to illustrate various dimensions of the bag 10 of the present invention. These dimensions are not limited to the exact configuration of the bag 10, and similar dimensions may be used for any one or more variations of the bag disclosed herein. The length A of the bag 10 is approximately 20.0 inches (50.8 cm). The diameter B at the first opening 12 is approximately 9.0 inches (22.86 cm). The diameter C at the second opening 14 is approximately 5.0 inches (12.7 cm). The distance D from the second opening 14 to the seam 32 or fastener 22 is approximately 8.0 inches (20.32 cm). The diameter G of the lead-in passage 30 is approximately 1.5 inches (3.81 cm). The rings 18 and 20 are made of a rigid, resilient, and flexible plastic that can assume a relaxed, normally undeformed, high-profile expanded configuration to a low-profile compressed configuration. The low-profile configuration is elongated and oval with reduced opening sides, allowing for easy insertion through a small incision. The high-profile configuration is substantially circular, but may be any shape. The rings 18, 20 support and open the pouch side walls 16 as the rings 18, 20 move from the low-profile configuration to the high-profile configuration. The rings 18, 20 are resilient, meaning they tend to spring back to their undeformed, high-profile configuration. A physician can easily compress the rings 18, 20 to reduce their size for insertion through an incision and into a body cavity.

[0027] 5A and 5B, another variation of the containment bag 10 is shown, with like reference numerals used to denote like parts. The containment bag 10 has a first opening 12 and a second opening 14, also referred to as a mouth, interconnected by a sidewall 16. A first ring 18 is provided at the first opening 12, and a second ring 20 is provided at the second opening 14. The rings 18 and 20 are connected to the sidewall 16, for example, by enclosing the rings 18 and 20 in a pocket formed by the sidewall 16 itself, heat-healing it and / or using an adhesive. The sidewall 16 is made of any suitable flexible material, including polymers, fabrics, fabric-reinforced polymers, mesh, nylon, fibers, and the like. The first opening 12 is larger or has a larger diameter than the second opening 14, and the sidewall 16 is frusto-conical in shape. Thus, the first ring 18 is larger or has a larger diameter than the second ring 20. The sidewall 16 is formed by heat-sealing the sidewall material, thereby forming one or more longitudinal seams or joints along the length of the bag 10. As shown in FIGS. 5A and 5B, the bag 10 is formed into a first compartment 26 and a second compartment 28, with an access passage 30 formed at the intersection of the compartments. The first compartment 26 has a proximal section that is substantially cylindrical in shape, with a vertical sidewall 16 connected to a distal section that is funnel-shaped in shape, with a sloped sidewall 16 when the bag 10 is in its normal, unflexed orientation as shown. The funnel-shaped distal section is connected to the second compartment 28 via the access passage 30. The access passage 30 is sized and shaped to allow passage of a scope therethrough. A scope is typically inserted through the second opening 14 into the second compartment 28, and the scope extends all the way to near the introduction tract 30 for observation of the morcellation taking place in the first compartment 26.Thus, the access channel 30 is sized as small as possible to prevent the specimen from escaping the first compartment 26, support the specimen, and provide a base 24 large enough to accommodate the scope shaft. The sloped sidewall 16 of the funnel-shaped distal section of the first compartment 26 forms the base 24, also called the bottom, floor, or semi-floor, for the pouch 10, which can support the surgical tissue specimen. The access channel 30 has a diameter approximately as small as the diameter of a 5-10 mm scope. In the variation shown in FIG. 5B, the diameter of the access channel 30 is smaller than the diameter of the second opening 14. The larger diameter at the second opening 14 compared to the diameter at the access channel 30 facilitates lifting the second ring 20 by rolling it up or unrolling it onto itself, thereby reducing the length of the second compartment 28. A third ring (not shown) may also be provided near the second ring 20, with the second ring 20 and the third ring acting as a self-contained, integrated retractor similar to that described above. The larger diameter of the second opening 14 relative to the diameter at the access channel 30 also facilitates instrument insertion and tissue retraction. The sidewalls 16 of the second compartment 28 gradually slope outward with the distance from the access channel 30 to the second opening 14. The bag 10 in FIGS. 5A and 5B is shown with a sealing mechanism 34 configured to seal the second opening 14 and prevent specimen from leaking from the bag 10. Various possible sealing mechanisms 34 that may be included in this configuration, as well as in any variation of the containment bag 10, are described in detail below. A first tether / tag 36 may be attached to the first ring 18, and a second tether / tag 38 may be attached to the second ring 20, facilitating placement and removal of the bag 10.

[0028] 7A-7R, a containment bag 10 of the present invention is shown. The containment bag 10 has a first opening 12 and a second opening 14, also referred to as a mouth, interconnected by a sidewall 16. A first ring 18 is provided at the first opening 12, and a second ring 20 is provided at the second opening 14. The rings 18 and 20 are connected to the sidewall 16, for example, by heat sealing the rings 18 and 20 to themselves and / or by adhesive, thereby placing them within a pocket formed by the sidewall 16. The sidewall 16 is made of any suitable flexible material, including polymers, fabrics, fabric-reinforced polymers, mesh, nylon, fibers, and the like. The first opening 12 is larger or has a larger diameter than the second opening 14. The sidewall 16 is in the shape of a teapot, with the second opening 14 forming an opening at the spout or neck of the container. The sidewall 16 has a base 24 configured to support a tissue sample. Unlike the above-described configurations in which the first opening 12 and the second opening 14 are substantially coaxial or parallel to one another along the longitudinal axis of the bag 10 when the bag 10 is laid flat or suspended in air in an unflexed orientation, in this variation the first opening 12 and the second opening 14 have longitudinal axes that are adjacent to one another, parallel to one another, or angled relative to one another, where the first ring 18 defines a first central longitudinal axis that is perpendicular to the radial plane of the ring 18 and / or opening 12, and the second ring 20 defines a second central longitudinal axis that is perpendicular to the radial plane of the ring 18 and / or opening 14. The openings 12, 14 are eccentric or non-concentric with one another. The base 24 has a first side 40 and a second side 42 relative to the base and the first opening 12. The second opening 14 is formed in the first side 40 of the bag 10. The first side 40 of the bag 10 can form an extension neck 44 of various sizes, shapes, lengths and location relative to the side 40 and the base 24. In FIG. 7A, the second opening 14 is slightly lower than the first opening 12 as measured from the base 24.In FIG. 7B, the second opening 14 is approximately flush with the first opening 12 when viewed from the base 24. In FIG. 7C, the second opening 14 is elevated relative to the first opening 12 when viewed from the base 24, and this second opening also has a long, narrow neck extension 44 leading to the second opening 14, compared to the short neck extension 44 shown in FIGS. 7A, 7B, and 7D. In FIG. 7E, the neck extension 44 is positioned at the bottom of the side 40, near the base 24. The angle of the neck extension 44 relative to the base 24 in FIG. 7E is smaller than the angle of the neck extension 44 relative to the base 24 in FIG. 7A, 7B, 7C, or 7D. In one such variation of FIG. 7E, one side of the neck extension 44 is contiguous with the base 24, thereby forming a larger effective diameter base. The angle of the neck extension 44 is substantially equal to that of the base 24, and the neck extension 44 is positioned a distance or height from the base 24. In FIG. 7F, the neck extension 44 is located midway between the sides 40. In such a configuration, the base 24 forms a large bowl with wide sides to accommodate the specimen 16 and advantageously prevent movement of the specimen into the neck extension 44. In FIG. 7G, the neck extension is located at the top of the sides 40 near the first opening 12 and a long distance from the base 24. Still referring to FIGS. 7A-7R, the dimensions of the inlet passage 30 or its intersection with the neck extension 44 can vary. For example, in FIG. 7A, the inlet passage is larger in diameter than in FIG. 7B, similar to the differences between the inlet passages in FIGS. 7C and 7D. In Figure 7F, the introduction passage 30 is very small and is located between the first opening 12 and the base 24 or substantially midway along the first side 40. In Figure 7E, the introduction passage 30 is located near and contiguous with the base 24. In Figure 7G, the introduction passage 30 is located near the first opening 12.

[0029] Various tethers / tags and their various configurations are now described with reference to Figures 7H-7P. Each bag 10 has at least one of a first tether 36 with an optional tag associated with the first opening 12 and a second tether 38 with an optional tag associated with the second opening 14. While some figures in this description show no tethers, one tether at the first opening, one tether at the second opening, or tethers at both the first and second openings, the present invention is not limited thereto, and any number and combination of tethers is within the scope of the present invention, regardless of whether the figure shows such combinations of various tether locations, and whether the figure shows them without or with tethers. Tethers include strings, such as nylon strings, tabs, films, tapes, leads, and the like. A tag is attached to the proximal end of the string. The tag is a plastic piece that facilitates locating and grasping the tether. A tether may or may not include a tab. Additionally, the term "tether" is used interchangeably with the term "tab," and vice versa. In FIG. 7B, a first tab 36 is shown at the second side 42 and a second tab 38 is shown at the second opening 14. In one form, the first tab 36 is connected to the first ring 18 and the second tab 38 is connected to the second ring 20.

[0030] In FIG. 7H , the first tab 36 is interconnected with the second tab 38, with the first tab located at the first opening 12 and exiting at the first side 40, and the second tab 38 extending along the neck extension 44 and exiting at the second opening 14. In FIG. 7H , the first tab 36 and the second tab 38 are identical tabs, with the free ends of such tabs extending from the bag 10 and carrying tags as shown, which may or may not be fixedly attached to their respective rings 18, 20. In another configuration, the first tab 36 and the second tab 38 comprise separate tags. One or more tabs are fixed relative to the bag 10 and / or the respective rings 18, 20. Of course, as discussed above, the tabs may be tags, strings, tethers, films, tapes, leads, etc. 7I shows an enlarged cross-section of the second opening 14 of FIG. 7H, with the second tab 38 wrapped around the second ring 20 before exiting at the second opening 14. The first tab 36 may similarly be wrapped around the first ring 18. In variations in which the first tab 36 and the second tab 38 are separate tabs, the first tab 36 may be connected to the first ring 18, and such first tab may not extend along the first side 40 of the bag 10. In other variations in which the first tab 36 and the second tab 38 are separate tabs, the first tab 36 may be secured to the first ring 18 and / or the side wall 16, and such first tab, if secured to the side wall 16, may extend any distance along the side wall 16. In one configuration, first tab 36 extends along first side 40 of side wall 16 to approximately the intersection of side wall 16 and neck extension 44. This configuration is advantageous because pulling first tab 36 pulls the portion of side wall 16 above neck extension 44 upward, thereby bringing bag 10 closer to the abdominal wall and squeezing together that portion of side wall 16 above neck extension 44, thereby facilitating removal of bag 10 from the abdominal cavity. Additionally, second tab 38 extends along only a portion of neck extension 44.The neck extension 44 is a separate tubular, sleeve-like arm that branches off from the main first compartment 26 of the bag and extends laterally outward from the side wall 16 in a straight or angled orientation to interconnect the second opening 14 to the first compartment 26 through an intersection referred to as an inlet passage 30 located between the first opening 12 and the second opening 14.

[0031] In Figure 7J, bag 10 has a first tab 36 located at second side 42 and exiting at first opening 12 and a second tab 38 exiting at second opening 14. Second tab 38 extends along the bottom of neck extension 44 and continues along base 24 as shown, and may or may not be interconnected with first tab 36.

[0032] In FIG. 7K, the bag 10 has a first tab 36 at the first opening 12 and a second tab 38 at the second opening 14 on the second side 42 adjacent to and above the neck extension 44. The second tab 38 extends along the length of the neck extension 44 and upward along the first side 40 to the first opening 12, but does not exit at the first opening 12. FIG. 7K also shows a relatively large and deep specimen receiving portion in both the lateral and vertical directions because the base 24 extends continuously into the neck extension 44 to the first side 40. The first side 40 is shown in FIG. 7K extending from the first opening 12 approximately one-third of the way up the length of the first side 40, with the specimen receiving portion extending approximately two-thirds of the way up from the base 24 along the length of the first side 40. In configurations in which the base 24 is continuous with the neck extension 44, providing such a large specimen-receiving portion prevents twisting of the neck extension 44 because the neck extension 44 has a smaller diameter at the second opening 14 compared to its width at the access passage 30 formed by the intersection of the neck extension 44 and the first side 40. Thus, the neck extension 44 flares outward, or increases in diameter, with increasing distance toward the bag 10, and decreases in size, or decreases in diameter, with increasing distance toward the second opening 14. A scope inserted through the second opening 14 can rest its distal end near the base 24, thereby permitting observation of careful morcellation as it proceeds without damaging the bag wall. Also, a zero-degree scope can be readily employed to observe morcellation occurring within the bag. 7F, neck extension 44 is shown having a width or diameter at second opening 14 that is approximately the same as the width or diameter at introduction passage 30 formed by the intersection of neck extension 44 and first side portion 40. A wider introduction passage 30 advantageously provides a wide specimen viewing and receiving area while also minimizing twisting of neck extension 44 on itself.

[0033] 7L and 7M, the tab configuration for bag 10 will be described in detail; however, neck extension 44 is shown for illustrative purposes; the same configuration can be utilized anywhere within bag 10 where a tab is located, including sidewall 16, first side 40, and second side 42. Sidewall 16 has primary seams 46a, 46b formed along the edge of the bag. Primary seams 46a, 46b are formed by adhesive and / or hot sealing two sides of bag sidewall 16 together. Primary seams 46a, 46b help define the shape of bag 10. A secondary seam 48 is shown adjacent to and spaced apart from primary seam 46a, thereby forming a channel 50 for tabs 36, 38. Of course, some areas of the bag 10 may not have primary seams 46a, 46b, in which case the secondary seam 48 would be formed near the edge of the sidewall 16. The tabs 36, 38 may be fixed within the channel 50 or may be free to translate within the channel 50. FIG. 7M shows the axis of the tab 38 defining the axis of rotation about which the neck extension 44 tends to rotate. The presence of the tab 38 at the neck extension 44 advantageously allows the neck extension 44 to quickly straighten if it becomes twisted or twisted by simply pulling on the tether 38 at the proximal end where the tag is located. The tab 38 can be located anywhere around the neck extension 44. In one form, the tab 38 is located along at least a portion of the top of the neck extension 44. In this configuration, the second tab 38 can be advantageously lifted by lifting the tag at the end of the tab 38, causing the remainder of the neck extension 44, which is wrapped around and entangled with itself along the longitudinal axis of the neck extension 44, to spread in a relatively downward direction and not rotate, opening the lumen of the neck extension 44. The spreading or untangling of the neck extension 44 is preferably performed while the neck extension 44 is positioned within the patient's cavity under insufflation and before the second ring 20 is pulled into position, for example, through an incision or body cavity, such as the vagina.After the second ring 20 is outside the patient's body, unwinding the neck extension 44 can be difficult due to pressure on the neck extension 44 from adjacent tissue edges. The tab 38 along at least a portion of the neck extension 44 greatly aids in quickly orienting and positioning the neck extension relative to the anatomy. Pulling or lifting the tab 38 unwinds the neck extension 44 and prevents it from interfering with the scope during insertion and also when the scope is viewing a specimen. The tabs 36, 38 can be colored a contrasting color to the rest of the bag sidewalls so that the user can observe the tabs 36, 38 to identify whether the neck extension 44 is correctly positioned. For example, a user can look at the colored tabs 36, 38 and know that if, for example, the tabs are oriented along the bottom edge of the neck extension 44 or if they are in a straight line, the user will know that there is one or two twists in the neck extension 44 and that they need to pull the tabs 36, 38 so that they are in a straight line along the top of the neck extension 44. Instead of the tabs 36, 38 serving as an indicator of whether the bag 10 is properly oriented, the bag 10 itself may be printed with contrasting colored indicator markers, such as lines and arrows, that provide the user with information regarding the position of the bag 10 and / or neck extension 44.

[0034] 24A , a channel 50 along the neck extension 44 can be connected to an insufflation fluid source, which, when pumped into the channel 50, expands the neck extension 44 into the proper orientation and direction. The channel 50 can extend only along the neck extension 44 or only along the sidewall 16 of the bag 10. In FIG. 24A , the channel 50 is shown extending from the second opening 14 to the first opening 12 along both the neck extension 44 and the sidewall 16. The proximal end of the channel 50 can have a connector 124 configured for connection to an insufflation fluid source and located outside the patient's body, for example, near the first opening 12 as shown in FIG. 24B or near the second opening 14 as shown in FIG. 24A . In both FIGS. 24A and 24B , the channel 50 extends from the first opening 12 to the second opening 14. The channel 50 can be utilized in any of the configurations of the bag 10 described herein and is not limited to the sleeve-like, two-headed bag shown in FIGS. 24A and 24B. One or more interconnected or separated channels 50 can be provided. While the channels 50 are shown as straight, they may form a pattern suitable for insufflation or may include multiple spaced rings around the neck extension 44 or other portion of the bag 10. The channel 50 is formed by heat-sealing portions of the bag together as described above to form the primary seam 46 and secondary seam 48 as shown in FIG. 24C. The channel 50 may also be a separate tube attached internally or externally to the bag 10.

[0035] In another form, a connector 124 is provided at or near the first opening 12 at the proximal end of the bag and configured to perform one or more of the following functions: insufflate and inflate the bag 10, insufflate and inflate the second bag 10, insufflate and inflate the inner bag, insufflate and inflate the outer bag, insufflate and inflate the abdominal cavity, and insufflate and inflate the channel 50. For example, as shown in FIG. 25 , a Y-shaped connector 124 connected to an insufflation fluid source can shunt insufflation fluid to the interior of the bag 10 and through a trocar 90 or insufflation needle into the abdominal cavity 74 located outside the bag 10. An optional access port cap / platform 76 can be used to seal the first opening 12, and the connector 124 can be connected to the cap / platform 76 or to the bag 10 itself. Insufflation of both the bag 10 and the abdominal cavity 74 creates equal pressure. The bag 10 acts as a membrane, advantageously keeping organs within the abdominal cavity away from the bag 10, thereby protecting them from inadvertent morcellation. In another example, the connector 124 may be a three-way connector for directing insufflation fluid into the abdominal cavity 74, the bag 10, and the channel 50 to widen the neck extension 44. Another configuration is shown in FIG. 26 , in which the system includes a first bag 10 containing a specimen 78 and a second bag 11 containing the first bag 10. The first bag 10, or inner bag 10, is disposed within the second bag 11, or outer bag 11. The connector 124 is configured to deliver insufflation fluid to one or more of the first bag 10 and the second bag 11. Preferably, insufflation of both the first bag 10 and the second bag 11 is accomplished via the connector 124. An access port cap / platform 76 is used to contain the insufflation pressure within the first bag 10, and a connector 124 may be connected directly to each bag 10, 11, or may be connected via the cap / platform 76 for delivery of insufflation fluid to the first bag 10 and directly to the second bag 11 for delivery of insufflation fluid to the second bag 11. The connector 124 in FIG. 26 may be a three-way connector 124, allowing insufflation fluid to be further delivered into the abdominal cavity 74.The double-bagged system of Figure 26 advantageously provides additional protection in the event that inner bag 10 is accidentally punctured by a surgical instrument. In such an event, specimen containment will not be compromised as outer bag 11 keeps the specimen within a closed system.

[0036] 7N-7P, details of an example tether / tab configuration at either or both of the first opening 12 and the second opening 14 are shown. For illustrative purposes, FIG. 7N shows a cross section of the second opening 14 and neck extension 44. The tab 38 extends within the channel 50 and exits at the second opening 14. Placing the tab 38 within the channel 50 is for illustrative purposes only; the tab may be integrally formed with the bag. In FIG. 7O, the tab of the second ring 20 is shown for illustrative purposes; the same configuration can be utilized for the first ring 18 at the first opening 12. In FIG. 7O, the tether 38 is tied or wrapped around the second ring 20. A knot may also be formed. In FIG. 7P, the tether 38 is looped multiple times around the second ring 20, thereby forming multiple turns before exiting at the second opening 14. A knot may also be formed in the configuration of Figure 7P to secure tether 38 to second ring 20. The tether may be attached anywhere along the ring and / or bag, and the same applies to first opening 12. Figure 7Q shows bag 10 of Figures 7A-7R in use, as described in more detail below. Figure 7R shows containment bag 10 as described herein in accordance with the present invention.

[0037] Referring now to FIG. 8A , the sealing mechanism 34, which may be utilized with the neck extension 44 or the second compartment 28, will be described in detail. The sealing mechanism 34 is configured to seal the second opening 14 of any of the illustrated pouch configurations. Once morcellation is complete and the pouch 10 is ready for removal, it may be removed through an incision in the abdominal wall, e.g., at the umbilicus, or through the vaginal or other bodily opening. Therefore, one end of the pouch 10 must be removed, and the opposite end must then be sealed to maintain a closed system and prevent specimen leakage. The sealing mechanism 34 will be described, for example, with respect to the second opening 14, which is the preferred location for the sealing mechanism 34. The sealing mechanism 34 includes a first pocket 52 and a second pocket 54. While the first pocket 52 is located on one side of the pouch 10 and the second pocket 54 is generally located on the opposite side of the pouch 10, the invention is not limited to such a configuration. The first pocket 52 is formed by attaching a first patch 56 to the exterior surface of the side wall 16. The first patch 56 is attached to the side wall 16 by adhesive or by heat sealing the first patch 56. In one form, the first patch 56 is attached along three sides of its perimeter, with one side of the perimeter remaining detached and serving as part of the opening for the first pocket 52. The first patch 56 is shown with a cross-hatched mark in FIG. 8A . The second pocket 54 is formed by attaching a second patch 58 to the exterior surface of the side wall 16 opposite the first patch 56. The second patch 58 is attached to the side wall 16 by adhesive or by heat sealing the second patch. In one form, the second patch 58 is attached along three sides of its perimeter, with one side of the perimeter remaining detached and serving as part of the opening for the first pocket 54. The second patch 58 is shown in Figure 8A with a dashed cross-hatched marking. The mouth 60 of the first pocket 52 faces distally away from the second opening 14, and the mouth 62 of the second pocket 54 faces proximally toward the second opening 14.Thus, the pocket openings 60, 62 are opposite each other and are longitudinally aligned with the second opening 14, such that the first pocket 52 is distal to the second opening 14 and the second pocket 54 is distal to the first pocket 52.

[0038] 8B-8E, in use, the elastic second ring 20 is squeezed into a low-profile configuration as shown in FIG. 8B. The second ring 20 is rolled distally, wrapping the side wall 16 of the neck extension 44 around the second ring 20 all the way to the distally facing first opening 60 on the first pocket 52, as shown in FIG. 8C. The rolled-up neck extension 44 is inserted into the first pocket 52, as shown in FIG. 8D. The first pocket 52, along with its contents, is then folded back, and the first pocket 52 is inserted / nested into the second pocket 54, as shown in FIG. 8E. The first pocket 52 is inserted into the second pocket 54 so that the second pocket 54 surrounds the first pocket 52 and its contents. Neutralizing the first pocket 52 in the second pocket 54 advantageously prevents the rolled-up bag from snagging during retrieval of the bag after slicing. This configuration and method of bag 10 advantageously seals the contents, including fluid, within bag 10 and prevents such contents from escaping through second opening 14 during removal of bag 10. When resilient second ring 20 is squeezed, it is biased to expand to its enlarged, high-profile configuration. Advantageously, this resilience of second ring 20 biases second ring 20, along with side wall 16 wrapped around it, toward the inner wall of first pocket 52. The resilience of second ring 20 tends to force second ring 20 outward and press side wall 16 against the adjacent portion of side wall 16 in its partially rolled-up state, creating a locking feature and sealing effect. Therefore, by rolling bag 10 and resilient second ring 20, a seal is created.

[0039] Other structures and methods for sealing the second opening 14 will now be described. Referring now to FIG. 9, another method for sealing the second opening 14 of a containment bag 10 is shown, with a knot 64 tied at the distal end. In another configuration, the distal end of the bag 10 includes double-sided tape 66, which seals the second opening 14 a distance proximal to the second ring 20, as shown in FIG. 10. Referring to FIG. 11, an interlocking ridge and groove 68 is provided, with the groove formed on one interior surface of the side wall 16 and the ridge formed on the opposite interior surface of the side wall 16. The ridge is configured to interlock with the groove when pressed together by a user's fingers or by employing a zipper. In FIG. 12, the bag 10 is sealed by using a bipolar instrument 72 to deliver electrical current or heat to heat-seal or melt the opposing side walls 15 together at the neck extension 44, thereby sealing the bag 10. In such a configuration, the bag 10 is made of a suitable material, such as a thermoplastic, and the instrument 72 is configured so as not to excessively burn or melt the bag 10.

[0040] In use, after the uterus has been ablated as described above, the insertion and removal of a containment bag 10 similar to that described with reference to FIGS. 7-12 will now be described. Aspects of this method apply to any of the forms of bag described herein. The containment bag 10 of FIGS. 7A-7R is referred to as a dual-headed bag 10 for ease of description and to distinguish it from the tubular bag of FIGS. 1-6. First, the trocar, if present, is removed from the umbilical incision. Any one of the dual-headed bags 10 of FIGS. 7A-7R is inserted through the umbilical incision, and the trocar is reinserted. The trocar may be inserted directly into the umbilical incision or through an access port cap / platform connected to a retractor placed within the incision. Referring back to FIG. 7Q, the abdominal cavity is re-insufflated through the access port cap / platform 76 or through the trocar to obtain a good view for positioning the bag 10. A scope is inserted through the umbilical incision 80, and the separated uterus 78 is inserted into the pouch 10 with the grasper. A second incision 82 is made in the abdominal wall 84 at a location medial-lateral to the umbilicus. A surgical grasper is inserted through the second incision 82 to grasp the tether at the second opening 14 and retract it into the second incision 82, thereby drawing the neck extension 44 to the abdominal wall 84. The smaller second ring 20 is retracted into the second incision 82. In one form, if the neck extension 44 is long enough, the second ring 20 can be retracted into the vaginal canal and opening. The tether attached to the larger or larger diameter first ring 18 is retracted toward the umbilical incision. As the first opening 12 of the bag 10 is drawn toward the abdominal wall 84, the trocar and / or access port cap / platform 76 is removed and the first ring 18 and the proximal portion of the bag 10 are retracted into the umbilical incision. When the retractor 86 is in place at the abdominal incision, the retractor 86 can be removed, followed by retraction of the first ring 18. When the retractor 86 is removed, the first ring 18 is brought to the surface of the abdominal wall 84 and the retractor 86 is inserted into the first opening 12 of the bag 10.The adjacent tissue and pouch 10 at the location of the abdominal incision 80 are retracted with the retractor 86, as shown in FIG. 7Q. The access port cap / platform 76 is then coupled to the retractor 86 by snapping the access port cap / platform 76 under or over the first ring of the retractor 86. The pouch 10 is held securely in place between the retractor 86 and the tissue wall 84 at the umbilical incision. If the retractor 86 cannot be removed, the pouch 10 is retracted into the lumen of the retractor 86 and placed over the first ring of the retractor outside the abdominal wall. The access port cap / platform 76 is then reattached by snapping the access port cap / platform 76 either over the first ring 18 of the pouch 10 or under / over the first ring of the retractor 86. When the access port cap / platform 76 is snapped under / over the first ring of the retractor 86, it captures the bag side wall 16 between the retractor 86 and the access port cap / platform 76, holding it in place. If no retractor 86 is used, in which case the bag 10 is inserted into the umbilical incision 80, or if the retractor 86 is initially used to insert the double-ended bag 10, it is preferable to prevent the retractor from being reinserted into the bag 10 at the first opening 12 as described above. In such a situation, the first ring 18 of the bag 10 is retracted into the umbilical incision 80 and rests on the abdominal wall 84. The access port cap / platform 76 is attached directly to the first ring 18 of the double-ended bag 10. A morcellator is inserted into the double-ended bag 10 through the first opening 12, and a scope 88 is inserted through the second opening 14 and into the neck extension 44 toward the access channel 30 of the first compartment 26. The scope 88 may be inserted directly into the double-ended pouch 10, or may be inserted through a trocar 90 positioned within the second opening 14, as shown in Figure 7Q. Figure 20 also details the trocar 90 inserted into the second opening 14 of the pouch 10.The bag 10 is retracted through an incision small enough to fit the trocar 90, which seals the bag's sidewall 16 against the tissue edge 45, thereby preventing insufflation gas from escaping from the abdominal cavity 74, as shown in FIG. 20. FIG. 23 shows a trocar 90 configured to be removably and sealably attached at the second opening 14. In FIG. 23, an attachment feature at the end of the neck extension 44 sealingly snaps onto and locks onto the trocar 90, thereby maintaining pressure and preventing insufflation fluid from escaping into the bag 10 or the abdominal cavity 74. Alternatively, as shown in FIG. 21, at least the proximal portion of the neck extension 44, along with the second ring 20 (if employed), is retracted into the cannula lumen of the trocar 90. In this manner, a seal against the tissue edge 45 is provided by the trocar 90 inserted into an incision sized equal to or smaller than the outer diameter of the trocar 90, thereby preventing the escape of insufflation gas within the abdominal cavity 74. In one configuration, the trocar 90 includes a balloon 92 that retracts the tissue along with the side wall 16 of the pouch 10 disposed within the second incision 82. Alternatively, an access port cap / platform may be attached to the second ring 20, and the scope 88 is inserted through the access port cap / platform with or without the trocar 90. In another configuration, at least one seal 120 is provided at the second opening 14, as shown in FIG. 22. The seal 120 may be removably fitted to the second opening, for example, in a snap-fit ​​or twist-and-lock configuration. Two or more seals may also be provided in a seal assembly that fits and is coupled to the second opening 14. The seal assembly may include a zero seal that prevents escape of gases and fluids across the seal when no instrument is inserted therethrough. The zero seal may be a double duckbill or other valve. The seal assembly may further include an instrument seal that seals against the inserted instrument to prevent escape of fluids and gases across the seal.A seal shield may also be provided to protect the seal from damage due to impact with instruments. Morcellation of the uterus 78 is initiated while under unobstructed observation by the scope 88. After morcellation is completed, the morcellator, scope 88, and trocar 90 (if used) are removed from the second opening 14. To seal the neck extension 44, the second opening 14 is closed according to any one of the methods described above to prevent particles of specimen or fluid remaining in the bag from escaping the bag 10 during removal of the bag 10 from the patient. The second ring 20 is inserted through the second incision 82 and into the abdominal cavity 74. In one form, the neck extension 44 is rolled up or folded into the first and second pockets 52, 54, or alternatively, the neck extension 44 is tied into a knot 64. The access port cap / platform 76 and / or retractor 86 at the umbilical incision 80 are removed, and the double-ended bag 10 is withdrawn through the umbilical incision 80 and out of the body cavity 74. This same procedure can be employed with the tubular bag 10 throughout the configurations shown in, for example, FIGS. 1-6. The containment bag 10 and method effectively create a contained morcellation system, where morcellation, whether manual or powered, is performed within the closed system provided by the containment bag 10 and its placement within the anatomy. The opening of the bag 10 is sealed, and the procedure is performed carefully to prevent inadvertent scattering of tissue throughout the abdominal cavity. The containment bag 10 advantageously provides a gate or portal into the bag via a neck extension or second opening through which a scope can be inserted to further monitor the morcellation procedure to ensure the integrity of the bag is not compromised during the process. This provides the surgeon with an extra safety precaution, including direct visualization of the surgical morcellation field while maintaining a closed system. The viewing angle through the neck extension or second opening provides the viewer with a clear, external view of both the pouch and specimen and their position relative to the morcellation instrument throughout the morcellation. The system and various configurations of the present invention also provide an easy way to deploy the pouch internally in place.

[0041] After laparoscopically dissecting the uterus, the pouch 10 is inserted into the abdominal cavity 74 either vaginally or abdominally. Pneumoperitoneum may be lost during pouch insertion. After the pouch is inserted, pneumoperitoneum is re-established. The dissected uterus is placed into the pouch 10, which is then laparoscopically manipulated to retract the pouch opening into the desired location, which may include any one or more of the following locations: the umbilical incision, the abdominal incision, the external incision, and the vaginal opening. The tether / tab is pulled, and a trocar is placed into the second opening 14, or the second opening 14 is capped with an access platform or port, or the second opening 14 is retracted into the lumen of the trocar 90. All pouch openings are then closed and sealed, and insufflation is administered into the pouch and / or abdominal cavity. The specimen within the pouch is then morselized. Morselization may be performed using powered or manual morselization methods and instruments. The second opening 14 and other bag port openings are sealed except for one opening, e.g., first opening 12, which is pulled to remove the bag through an incision, e.g., at the umbilicus. The bag port openings are sealed to prevent any specimen from escaping containment within bag 10 as the bag is being removed. The bag is removed by pulling the bag into an abdominal incision, e.g., at the umbilicus. Additional aspects of the present invention will now be described in which the above-described methods and features can be utilized in whole or in part in the following aspects, or vice versa.

[0042] Referring now to FIG. 13, a containment bag 10 of the present invention is shown, with like parts designated by like numerals. The containment bag 10 has a first opening 12 and a second opening 14, also referred to as a mouth, interconnected by a sidewall 16. A first ring 18 is provided at the first opening 12, and a second ring 20 is provided at the second opening 14. The first ring 18 and the second ring 20 have substantially the same diameter. The rings 18 and 20 are elastic, allowing them to flex into a low-profile configuration that is insertable through a port / incision having a smaller diameter than the rings 18 and 20. The sidewall 16 of the bag 10 has a substantially cylindrical, tubular shape with a constant diameter that is substantially the same as the diameter of the rings 18 and 20. The sidewall 16 has a central lumen, sometimes referred to as a first compartment 26, between the first opening 12 and the second opening 14. 1A, the bag 10 of FIG. 13 is bidirectional, such that the smaller diameter second opening 14 fits more easily into the vaginal or other body opening at that location than would a bag with a larger diameter second opening 14. However, if either opening 12, 14 is too small, it may be difficult to insert the specimen into the bag 10.

[0043] A method of using the containment bag 10 of the present invention will now be described with reference to Figures 14A-14C. In one embodiment, a tubular sleeve bag 10, such as that shown in Figures 1-6 and 13, is prepared. A tissue specimen 78, such as a uterus, is removed and the bag 10 is inserted into a body cavity through an abdominal incision or a body orifice. The bag 10 is positioned so that the first ring 18 is located outside the patient's body at the location of the abdominal or body orifice. A surgical instrument 94, such as a surgical grasper, is inserted into the first opening 12 of the bag 10 and into the lumen of the bag 10. The specimen 78 is grasped and drawn through the second opening 14 of the bag 10 and into the lumen of the bag 10, as shown in Figure 14A. The proximal end of the instrument 94 is manipulated outside the patient's body to open and close the jaws of the grasper at the distal end of the instrument. The specimen 78 is released within the lumen compartment 26, as shown in Figure 14B. Next, the instrument 94 is moved distally past the specimen 78 to grasp the second ring 20 of the bag 10. The second ring 20 is grasped by the grasper 14 and pulled proximally into the lumen compartment 26, as shown in FIG. 14B. The second ring 20 is pulled within and along the lumen of the bag 10, proximally past the specimen 78 and to a surface located outside the patient's body, as shown in FIG. 14C, thereby forming an inwardly facing fold in the side wall 16 within the bag lumen. After being pulled outside the patient's body, the second ring 20 is then placed to the side of the first ring 18. The one or more folds divide the bag 10 to form a first pouch 96 containing the specimen 78 within the bag 10 and a second pouch 98 located adjacent to the first pouch 96. The bag 10 is folded inward, inverted, inside-out, etc., and folded back onto itself over and along the lumen toward the first ring 18 to form pockets 96, 98. This action also advantageously draws the specimen 78 closer to the first ring 18, where it can be easily visualized and morcellated. To aid in morcellation, a scope (not shown) is inserted into the second pouch 98 to view the specimen 78 contained within the first pouch 96 across the side wall 16. Alternatively, a scope is inserted into the second opening 14 of the bag 10 and into the abdominal cavity, and the specimen 78 is viewed outside the first pouch 96.In another form of this method, after the uterus has been ablated, the bag 10 can be inserted through the vaginal opening and positioned so that the first ring 18 is located outside the patient's body at the vagina. The method and bag 10 can be used with any specimen, body opening, or incision, and are not limited to the uterus, vaginal opening, and abdominal incisions. Of course, the bag can be placed in any incision or body opening and withdrawn through any incision or body opening, including the same incision or a secondary incision.

[0044] Referring now to FIG. 15, a containment bag 10 of the present invention is shown, in which like parts are designated by like numerals. The containment bag 10 has a first opening 12 and a second opening 14, also referred to as a mouth, interconnected by a sidewall 16. A first ring 18 is provided at the first opening 12, and a second ring 20 is provided at the second opening 14. One or more of the first and second ends of the bag 10 include a third ring 100 disposed near the first ring 18 or the second ring 20, respectively. For example, in FIG. 15, the third ring 100 is disposed near the second end of the bag 10 near the second ring 20. The second ring 20 is disposed at the distal second end of the bag 10, and the third ring 100 is spaced proximally from the distal second end a distance set for retraction purposes. The third ring 100, together with the second ring 20, forms a retractor built into the bag 10. When positioned within the anatomical structure described above, the second ring 20 is located outside the patient's body, e.g., outside the vaginal opening, while the third ring 100 is located inside the patient's body. The second ring 20 is elastic and can be turned or inverted on itself to wrap the intermediate sidewall located between the second ring 20 and the third ring 100 around the second ring 20, thereby retracting tissue edges at the body opening or incision and facilitating removal of the specimen contained within the bag 10. While the bag 10 in FIG. 15 is shown having a frusto-conical shape, the use of the third ring 10 is not limited to bags 10 having this shape, and the third ring can be used with any of the various configurations of bags 10 described herein, including double-headed configurations. Of course, in another configuration, a third ring 100 may be positioned near the first ring 18, with the third ring configured to serve the same built-in retraction function. In another configuration, a fourth ring (not shown) is provided adjacent the first ring 18 and the third ring 100 is positioned near the second ring 20 so that tissue retraction can occur at both ends of the pouch 10.

[0045] Referring now to FIG. 16, another embodiment of the containment bag 10 of the present invention is shown, with like reference numerals used to refer to like parts. The bag 10 of FIG. 16 is similar to the teapot-shaped containment bag embodiment of FIGS. 7A-7R, including a neck extension 44. The bag 10 has a first opening 12 and a second opening 14 interconnected by a sidewall 16. A first ring 18 is provided at the first opening 12, and a second ring 20 is provided at the second opening 14. The bag 10 further has a third opening 102 and a fourth ring 104 provided at the third opening 102. The sidewall 16 has a base 24 configured to support a tissue sample. The first opening 12, the second opening 14, and the third opening 102 have longitudinal axes that are adjacent to or angled relative to one another, where the first ring 18 defines a first central longitudinal axis perpendicular to the radial plane of the ring 18 and / or the openings, the second ring 20 defines a second central longitudinal axis perpendicular to the radial plane of the ring 18 and / or the openings 14, and the third ring 100 defines a third central longitudinal axis perpendicular to the radial plane of the ring 104 and / or the openings 102. The openings 12, 14 are eccentric to one another. The base 24 has a first side 40 and a second side 42 relative to the base 24 and the first opening 12. The second opening 14 is formed in the first side 40 of the bag 10, and the third opening 102 is formed in the second side of the bag 10. The first side 40 of the bag 10 can have various sizes, shapes, lengths, and location relative to the side 40 and the base 24 to form an extended neck 44 interconnecting the first opening 12 and the second opening 14, and the second side 42 of the bag 10 can have various sizes, shapes, lengths, and location relative to the side 42 and the base 24 to form a neck extension 106 interconnecting the first opening 12 and the second opening 14. In use, the bag 10 of Figure 16 is positioned relative to the anatomy so that the first opening 12 is located at the abdomen and is inserted, for example, through an umbilical incision, with the first ring 18 located outside the patient's body.The second opening 14 serves as an external port positioned at an external abdominal incision or external orifice, such as the vagina, with the second opening 14 and second ring 20 located outside the patient's body. The third opening 102 also serves as an external port positioned at an external abdominal incision.

[0046] FIG. 17 illustrates yet another configuration of the bag 10, further including a fourth opening 108 and a fourth ring 110 disposed at the fourth opening 108. The fourth opening 108 defines a fourth central longitudinal axis that is perpendicular to the radial plane of the ring 110 and / or opening 108. The fourth longitudinal axis may or may not be parallel to the first longitudinal axis associated with the first opening. The fourth opening 108 is substantially coaxial with the first opening 12, thereby making the bag 10 of FIG. 17 a hybrid bag that combines the teapot-shaped bag of FIGS. 7A-7R and the sleeve-shaped bag of FIGS. 1-6, 13, and 15. The fourth opening 108 is formed in the base 24 of the bag 10, which can have various sizes, shapes, lengths, and location relative to the sides 40 and base 24 to form an extension neck 112 interconnecting the first opening 12 and the fourth opening 108. In use, the bag 10 of FIG. 17 is positioned relative to the anatomy so that the first opening 12 is located at the abdomen and inserted, for example, through an incision in the umbilicus, with the first ring 18 located outside the patient's body. The second opening 14 serves as an external port located at an external abdominal incision, with the second opening 14 and second ring 20 located outside the patient's body. The third opening 102 also serves as an external port located at an external abdominal opening, for example, the vagina.

[0047] 18A and 18B, a containment bag 10 is shown having at least one first opening 12 and a sidewall 16 defining at least one first internal compartment 26 accessible through the first opening 12. A resilient first ring 18 is provided at the first opening 12. The bag 10 has at least one window 114 of clear, transparent glass or plastic that allows visualization of the contents of the compartment 26 from outside the bag 10 via a scope 88. The window 114 may include a lens that enhances visualization when the scope 88 is positioned immediately adjacent to the lens, as shown in FIG. 18B. The window 114 and / or lens may be flush with the exterior sidewall 16 of the bag 10 or may be recessed at the end of an inwardly extending port 116, as shown in FIG. 18B. Port 116 is cylindrical and is sized slightly larger than the distal end of scope 88. Inwardly extending port 116 provides closer visualization of the bag contents and provides a resting ledge for scope 88.

[0048] 19A and 19B, a containment bag 10 is shown having a sidewall 16 defining at least one first opening 12 and at least one first internal compartment 26 accessible through the at least first opening 12. A resilient first ring 18 is provided at the first opening 12. The bag 10 has at least one port 118 in the sidewall 16 providing access to the internal compartment 26. The port 118 includes at least one seal 120. Two or more seals may also be provided in a seal assembly that fits into and is coupled to the second opening 14. The seal assembly may include a zero seal that prevents the escape of gases and fluids across the seal when no instrument is inserted therethrough. The zero seal may be a double duckbill or other valve. The seal assembly may further include an instrument seal that seals against an inserted instrument to prevent the escape of fluids and gases across the seal. A seal shield may also be provided to protect the seal from damage due to impact with instruments. A plastic circumferential stiffener 122 may be provided surrounding the seal 120 and port 118, and may be disk- or funnel-shaped. The stiffener 122 is made of a harder plastic relative to the side wall 16 of the bag 10. The stiffener 122 provides a smooth, funnel-shaped lead-in for guiding instruments through the seal 120 and port 118. The stiffener 122 also provides a platform for connecting the seal 120 or seal assembly to the bag 10. As shown in FIG. 19B, an instrument, such as a scope 88, is inserted through the port 118 to perform a surgical procedure within the bag 10 or to view a specimen being morcellated within the bag. The seal 120 of the bag 10 maintains a pressure differential across the side wall of the bag 10, for example, when the abdomen and / or bag 10 is insufflated.

[0049] 27-29, the containment bag 10 of the present invention is shown with various means for retaining the neck extension 44 in a retracted configuration to facilitate insertion of the bag 10 into the abdominal cavity. In FIG. 27, a perforation 126 is provided in the side wall 16 at a location between the neck extension 44 and the first side of the bag 10. The perforation 126 extends downward to maintain the first opening 12 of the bag 10 interconnected with the second opening 14. The perforation 126 is configured to prevent the integrity of the bag from being compromised by providing reinforcement to prevent further perforation. The bag 10 is then advanced into the abdominal cavity, and the perforation 126 is then cut along the perforation 126 within the abdominal cavity with a surgical instrument or by pulling the tab / tether 38 at the second opening or a tab / tether positioned along the perforation 126. Following cutting along the perforation, the neck extension 44 is positioned within the anatomical structure. In another configuration shown in FIG. 28, a clip 128 is used to hold the neck extension 44 near the first side 40 of the bag 10, thereby facilitating insertion into the abdominal cavity. Once in place within the patient, the clip 128 is removed, and the neck extension 44 is positioned within the anatomy. In another configuration shown in FIG. 29, an adhesive 130, such as an adhesive strip, is used to hold the neck extension 44 near the first side 40 of the bag 10 during deployment. The neck extension 44 is pulled to release the adhesive from the neck extension 44, thereby allowing the neck extension 44 to be positioned within the anatomy.

[0050] Referring now to FIG. 30 , the bag 10 of the present invention is shown with the neck extension 44 inverted within the interior of the bag 10 or first compartment 26 to facilitate delivery of the bag 10 into the abdominal cavity. The bag 10 has an undeployed configuration in which the neck extension 44 is inverted on itself and disposed within the interior of the bag so that it does not protrude from the first side 40. The tab 38 can be pulled outward to place the bag 10 in the deployed configuration. In another configuration, shown in FIG. 31 , a pocket 132 is provided on the exterior surface of the bag side wall 16 adjacent the intersection with the neck extension 44. The neck extension is accordion-folded and inserted into the pocket opening 134, and is then placed within the pocket 132 in the undeployed configuration. While in the undeployed configuration, the bag 10 is easily delivered through an incision or body orifice without the neck extension 44 becoming trapped or getting in the way. Tab 38 is pulled out while inside the patient to extend neck extension 44 into a deployed configuration for placement within the anatomy.

[0051] 32 and 33, the containment bag 10 has a first opening 12 at its proximal end and a second opening 14 at its distal end interconnected by a sidewall 16. The sidewall 16 is gas-tight and non-porous, elongated, thin-walled structure formed, for example, from a flexible polymer, to define an internal lumen. As described above with respect to the tubular, sleeve-like containment bag 10, a resilient, semi-rigid or rigid ring 18 can be provided at the first opening 12, and a resilient, semi-rigid ring 20 can be provided at the second opening 14. The first opening 12 is sized and shaped to permit insertion of a surgical instrument into and through the elongated, tubular body lumen. The second opening 14 is sized and shaped to permit passage of an inserted surgical instrument through and distally beyond the second opening 14. The second opening 14 further includes a circumferential channel 50 containing a drawstring 141. The circumferential drawstring 141 is sized and shaped to close the second opening 14 when activated. The activation procedure involves placing a "knot pusher" tool 150 proximally over a portion of the drawstring 141 and advancing the tool 150 distally to push the slip knot 152 along the drawstring 141 until the second opening 14 is closed. A plurality of drawstring channels 50 are preferably spaced apart and disposed along the entire length of the elongated tubular sidewall 16. It is within the scope of the present invention to provide any number of channels 50 to provide a substantially fixed location for at least a circumferential portion of the drawstring. Other means known to those skilled in the art for circumferentially positioning the drawstring around the sidewall 16, such as a belt-like loop located on the exterior or interior of the sidewall 16, are within the scope of the present invention. Separate drawstrings 141, 142, 143, 144, 145 are provided within each of the circumferential channels 50, with a portion of each drawstring extending along the longitudinal length of the bag 10 toward the proximal end. The longitudinal portions of the drawstrings may be located within the lumen of the bag 10, on the exterior of the bag 10, or within dedicated channels, loops, or tubes provided alongside the length of the bag 10.Each of the drawstrings also preferably has a slip knot 152 along its longitudinal location. The present invention is not limited to slip knots 152. Compression grommets may be used to slide along the drawstring to tighten the circumferential drawstring portion. Alternatively, soft plastic racks and toothed wedges may be used. Each of the drawstrings 141, 142, 143, 144, and 145 may be actuated sequentially, starting with the most distal drawstring 141 and working through the most proximal drawstring 145. Alternatively, the drawstrings may be actuated simultaneously, incrementally, or in any order as needed to reduce the diameter of the elongate tubular body 16 and reduce the specimen 78 in a manner similar to the closure of the second opening 14 by the knot pusher 150 described above. Figures 33A and 33B illustrate an exemplary actuation of a single drawstring 143. Only a portion of the tubular bag side wall 16 is shown in Figures 33A and 33B for illustrative purposes, and the same may be used for any of the drawstrings within the bag 10. Figure 33A shows the knot pusher 150 adjacent to the slip knot 152, with the drawstring 143 extending circumferentially within the channel 50 and longitudinally along the length of the bag 10. The bag 10 has a first diameter at the location of the drawstring 143 within the channel 50. Figure 33B shows the knot pusher 150 advanced distally to tighten the bag 10 and reduce its diameter to a second diameter smaller than the first diameter at the location of the drawstring 143 within the channel 50. In one form of the bag, the second opening 14 is omitted from the bag 10, the specimen is placed into the first opening 12, and the first opening 12 and first ring 18 can be pulled back upward through the incision or body opening and tightening can begin.

[0052] In use, the second opening 14 of the pouch 10 is inserted into a surgical incision or natural orifice and positioned within the body cavity 74. An immobilized anatomical structure 78, such as a tumor, tissue specimen, uterus, or other tissue structure or surgical specimen, can be drawn into the second opening 14 using an elongated surgical grasper, forceps, or the like. Once the specimen 78 is positioned within the elongated tubular body 16, the second opening 14 is closed by acting on the drawstring 141 associated with the second opening 14. In some cases, the specimen or isolated mass 78 may be too bulky or oddly shaped to be easily removed through the surgical incision or natural orifice. In this case, the surgeon may attempt to reduce or reshape the mass 78 so that it can be removed. There are several ways to accomplish this. The first method may involve using surgical scissors or a knife to slice the mass 78 into manageable portions while it is located within the containment bag or sleeve 10. The second method is to compress the mass using a drawstring. The third method is to use 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 damaging the containment bag or sleeve 10. The second opening 14 may be retracted into a separate incision or body opening to create a closed system before morcellation begins.

[0053] Referring now to Figures 34-36, methods using a containment bag with multiple drawstrings, abdominal bands, or belts will be described. These methods minimize the risk of contacting the side wall 16 of the bag 10 with a mechanical cutting element. First, the patient's mass 78 is drawn into the containment container 10 either through the second opening 14 (if provided) or through the first opening 12. Second, the distal second opening 14 (if provided) of the bag 10 is closed in the manner described above using a knot pusher 150 to push a knot 152 around the circumferential portion of the drawstring 141. Third, as shown in Figure 34A, a cutting or "coring" instrument 156 is inserted into the first opening 12 and used to cut or "coring" the mass 78 one or more times while avoiding the risk of contact between the edges 158, 160 of the mass 78 and the side wall 16 of the bag 10. Fourth, the cutting or "coring" instrument 156 may be removed from the container bag 10 as shown in FIG. 34B, leaving behind an elongated, empty core 162, represented by the dotted line in FIG. 34B. Fifth, the drawstrings 141, 142, 143, 144, and 145 are acted upon individually or collectively to tighten the mass 78 within the container bag 10 into an elongated shape having a reduced cross-sectional area as a result of closure of the empty core by tightening the drawstrings, as shown in FIG. 34C. The reduced mass 78 is then pulled through the incision or body opening associated with the first opening 12, either by removing the entire bag 10 or by removing the reduced mass 78 from within the bag 10. The multiple tightening drawstrings 141, 142, 143, 144, 145 advantageously prevent the mass 78 from shifting distally during removal of the bag 10 through an incision or body orifice and creating a bolus at the distal or closed second opening 14 of the bag 10. The specimen 78 is therefore held relatively immobile by the drawstrings.

[0054] Referring now to Figures 35A and 36A, a relatively large mass 78 is cored by a coring instrument 156, leaving behind an empty core 162. In Figure 36A, the second opening 14 remains open compared to Figure 35A, and is shown positioned within the advantageous surgical environment of a bag 10, e.g., placed within another bag. The drawstrings are acted upon to reduce the diameter of the specimen 78, effectively cinch the empty core 162 closed, as shown in Figures 35B and 36B. If the contained mass 78 remains excessively large or improperly shaped after the initial actuation of the drawstrings 141, 142, 143, 144, and 145, the cutting or "coring" morcellation instrument 156 is reinserted to further reduce the mass 78, as shown in Figures 35B and 36B, thereby creating a second empty core 162. Drawstrings 141, 142, 143, 144, 145 are then acted upon a second time to tighten again, thereby tightening and closing empty second core 162, as shown in Figures 35C and 36C, thereby further reducing the profile of contained mass 78 for removal. The specimen 78 is removed from the incision or body orifice along with bag 10 while still within bag 10, or the specimen is removed from the interior of bag 10 through first opening 12 and through the incision or body orifice. In these cases, the compressible nature of containment bag 10 eliminates the need to completely morsel the contained mass or specimen 78 for removal or retrieval, and effectively uses mass edges 158, 160 as buffer zones to protect sidewall 16 from accidental contact with the coring instrument. The edges 158, 160 or portions of the mass 78 in contact with the sidewall 16 of the containment vessel 10 may be left in contact, thereby avoiding the potential for cutting, tearing or catching on the vessel sidewall 16.

[0055] Various examples of bags and devices for inserting, deploying, and / or retrieving the bags to be included in or integrated into a morcellation system, where the entire system, portions of the system, or combinations of the system and / or components thereof are configured to provide a containment means for an object to be morcellated in accordance with various embodiments of the present invention, are described in U.S. patent application Ser. Nos. 08 / 540,795, filed Oct. 11, 1995; 11 / 549,701, filed Oct. 16, 2006; 11 / 549,971, filed Oct. 16, 2006; 12 / 902,055, filed Oct. 11, 2010; and 13 / 252,110, filed Oct. 3, 2011, the entire disclosures of which are incorporated by reference as if set forth herein. Additional bag configurations are described in detail in U.S. Provisional Patent Applications Nos. 61 / 970,436, 62 / 014,038, and 62 / 024,698, filed March 26, 2014, June 18, 2014, and July 15, 2014, respectively, all of which are incorporated herein by reference in their entireties. U.S. Provisional Patent Applications Nos. 61 / 970,436, 62 / 014,038, and 62 / 024,698, filed March 26, 2014, June 18, 2014, and July 15, 2014, respectively, are also incorporated herein by reference in their entireties and in their entireties.

[0056] As will be understood, various modifications can be made to the embodiments disclosed herein. Accordingly, the above description should not be construed as limiting the invention, but merely as exemplifications of preferred embodiments. Those skilled in the art will envision other modifications that fall within the scope and spirit of the invention.

Claims

1. A tissue containment bag comprising: a first opening and a second opening interconnected by a sidewall of a flexible material; the sidewall defines a first internal compartment configured to receive a tissue specimen through the first opening into the first internal compartment; the sidewall forms an elongated hollow sleeve-like neck extension defining a second internal compartment having a proximal end interconnected with the first internal compartment and a distal end interconnected with the second opening, the second opening being in fluid communication with the second internal compartment, the second internal compartment in fluid communication with the first internal compartment, and the first internal compartment in fluid communication with the first opening; further comprising a channel disposed in the sidewall along the neck extension, the channel configured to receive an insufflation fluid under pressure to unfold, untwist, or prevent the neck extension from rotating into a deployed configuration; The tissue containment bag, wherein the channel is comprised of a pair of spaced-apart adjacent seams, the pair of spaced-apart adjacent seams including a primary seam along an upper edge of the neck extension and a secondary seam spaced-apart adjacent from the primary seam to form the channel.

2. A tissue storage bag, a first opening and a second opening interconnected by a sidewall of a flexible material; the sidewall defines a first internal compartment configured to receive a tissue specimen through the first opening into the first internal compartment; the sidewall forms an elongated hollow sleeve-like neck extension defining a second internal compartment having a proximal end interconnected with the first internal compartment and a distal end interconnected with the second opening, the second opening being in fluid communication with the second internal compartment, the second internal compartment in fluid communication with the first internal compartment, and the first internal compartment in fluid communication with the first opening; further comprising a channel disposed in the sidewall along the neck extension, the channel configured to receive an insufflation fluid under pressure to unfold, untwist, or prevent the neck extension from rotating into a deployed configuration; The tissue containment bag, wherein the channel comprises a plurality of spaced apart rings formed around the neck extension.

3. A tissue containment bag as described in claim 1 or claim 2, wherein the neck extension extends laterally outward from the first internal compartment when in the deployed configuration.

4. 4. The tissue containment bag of claim 1, wherein the channel is connected to the side wall extending from the second opening along the upper end of the neck extension to the proximal end of the neck extension and upward along the length of the side wall to the first opening.

5. A tissue containment bag as described in any one of claims 1 to 4, wherein the insufflation fluid is transported through a connector located at the proximal end of the channel, the connector being configured to connect to an insufflation source.

6. The tissue containment bag of claim 1 , wherein the channel is formed by gluing and / or heat sealing both sides of the side wall along the neck extension.

7. The tissue containment bag of claim 1 , wherein the first internal compartment comprises a base configured to support the tissue specimen.

8. The tissue containment bag of claim 7 , wherein the first interior compartment defines a first side and a second side relative to the first opening and the base.

9. The tissue containment bag of claim 8 , wherein the proximal end of the neck extension intersects the base and the first side of the first internal compartment.

10. The tissue containment bag of claim 9 , wherein the intersection of the neck extension is contiguous with or at the base.

11. The tissue containment bag of claim 9 , wherein the intersection of the neck extensions is located along the first side near the base.

12. The tissue containment bag of claim 9 , wherein the intersection of the neck extensions is located along the first side adjacent the first opening.

13. The tissue containment bag of claim 9 , wherein the intersection of the neck extensions is located anywhere along the first side between the base and the first opening.

14. 14. The tissue containment bag of claim 1, wherein the distal end of the neck extension defines a diameter equal to the diameter of the second opening, and the diameter of the neck extension gradually increases toward the proximal end of the neck extension.

15. 14. The tissue containment bag of claim 1, wherein the distal end of the neck extension defines a diameter equal to the diameter of the second opening, and the diameter of the neck extension is constant from the proximal end to the distal end.

16. A tissue containment bag as described in claim 14 or claim 15, wherein the diameter of the second opening is smaller than the diameter of the first opening.

17. A tissue containment bag as described in any one of claims 1 to 16, wherein the side wall of the first internal compartment has a width perpendicular to the first longitudinal axis and a length along the first longitudinal axis.

18. A tissue containment bag as described in claim 17, wherein the neck extension has a width perpendicular to the second longitudinal axis and a length along the second longitudinal axis.

19. A tissue containment bag as described in claim 18, wherein the widest width of the neck extension is less than the width of the side wall in the first internal compartment.

20. A tissue containment bag described in any one of claims 1 to 19, wherein the first opening and the second opening are not concentric with each other.

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