Tissue removal containment systems

Abstract

To provide improved methods and systems of collecting and containing a specimen.SOLUTION: A tissue removal containment system is provided that includes a tissue removal and / or containment bag 10 arranged to be inserted through an opening into a confined space. The bag 10 has a support or ring 12 having a compressed, partially compressed and / or uncompressed state or position. The bag 10 can also include an enclosure 16 or a film 14 defining the enclosure 16 connected to the support, with the enclosure 16 having a confined state and a deployed or unconfined state.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] (Related Applications) This application claims the benefit of U.S. Provisional Patent Application No. 62 / 734,093, filed September 20, 2018, the entire disclosure of which is incorporated herein by reference.

[0002] (Technical field) TECHNICAL FIELD This application relates generally to tissue removal systems and methods, and more particularly to tissue containment systems and methods prior to and / or during a morcellation procedure. [Background technology]

[0003] Specimens removed during certain surgical procedures require specimen storage and collection. In one such exemplary surgical procedure, single-site gynecological procedures, such as laparoscopic hysterectomy, have limited visualization of the surgical space and surrounding environment, especially in the case of a large uterus, because the volume of the specimen can occupy a large portion of the surgical space. Therefore, complete visualization of the specimen from the access site is not achieved in such cases, and the laparoscope must be continuously manipulated proximal to the access site to enable visualization. Furthermore, due to the limited surgical space, repositioning or generally moving the specimen within this narrow surgical space is difficult. Additionally, in laparoscopic hysterectomy, the uterus is cut, mobilized, and collected. The uterus is removed through a trocar or an incision ranging in size from 2.5 cm to 4 cm, thereby increasing the difficulty of specimen collection and collection. Summary of the Invention [Problem to be solved by the invention]

[0004] Methods and systems for collecting and containing such specimens in this and other procedures have drawbacks, and improvements to such methods and systems are desirable. [Means for solving the problem]

[0005] According to various embodiments, a containment system is provided. The containment system includes a containment bag configured to be inserted through a body orifice and, in various embodiments, configured to contain a variety of specimen sizes larger than the size of a trocar incision. The containment bag is configured to reduce the potential spreading or displacement of unwanted tissue during morcellation or other similar surgical procedures.

[0006] According to various embodiments, the tissue containment bag includes a support or ring having an inner periphery that defines an open end, the ring being deformable from an initial, uncompressed state in which the open end defined by the ring is unobstructed to a compressed state in which the open end defined by the ring is partially obstructed. The bag further includes a film coupled to the ring to form an enclosure having an interior and a closed end, the interior of the enclosure being accessible through the open end defined by the ring. The film and the interior of the enclosure are expandable from a confined state in which the film, including its distal-most end, is confined adjacent the ring to a deployed state in which the distal-most end of the film extends away from the ring. In various embodiments, the bag includes a strap coupled to the ring, the strap in a fastened state securing the ring in a compressed state and the film in a confined state. In various embodiments, the strap has an unfastened state in which the strap simultaneously releases the ring from the compressed state and the film from the confined state. In various embodiments, the strap has a fastener attachment that releasably couples to itself. In various embodiments, the bag includes a tab coupled to the ring opposite the strap. In various embodiments, the bag has a first tab coupled to a location on the ring relative to the location of the strap, and a second tab coupled to a location on the ring between the first tab and the strap.

[0007] According to various other embodiments, a tissue containment system is provided, comprising a tissue containment bag and a surgical instrument configured to facilitate insertion of the tissue containment bag into a body cavity of a patient, the surgical instrument converting a ring of the tissue containment bag from a compressed state to an uncompressed state and a film of the tissue containment bag from a confined state to a deployed state, or converting the ring of the tissue containment bag from an uncompressed state to a partially compressed state.

[0008] According to various embodiments, a method of preparing a tissue containment bag includes providing a tissue containment bag including a ring and a film coupled to the ring, the film defining an enclosure; placing the ring in a compressed state; placing the film in a confining state; and / or securing the ring in the compressed state and the film in the confining state.

[0009] According to various embodiments, a method of deploying a tissue containment bag is provided, the method including the steps of providing a tissue containment bag including a ring or support, a film coupled to the ring, and a strap coupled to the ring and the film, wherein the film defines an enclosure, placing the ring in a compressed state and the film in a confining state, wrapping the strap coupled to the ring around portions of the ring and portions of the film, fastening the strap to itself, inserting the tissue containment bag into a confined space with the ring in a compressed state and the film in a confining state, wherein the entire film is overlapped and positioned adjacent to and secured within the outer periphery of the ring, the ring defining a narrowed opening and having an hourglass shape, and / or releasing the strap from itself to release the film from the confining state and the ring from the compressed state.

[0010] According to various embodiments, a method of removing a specimen is provided, the method including the steps of providing a tissue containment bag including a ring or support and a film coupled to the ring, the film defining an enclosure, placing the ring in a compressed state and the film in a confining state, securing the ring in the compressed state and the film in the confining state, inserting the tissue containment bag into a patient's body cavity with the ring in the compressed state and the film in the confining state, releasing the film from the confining state to a deployed state and the ring from the compressed state to an uncompressed state, placing a specimen through an opening defined by the ring in the uncompressed state and into the enclosure defined by the film in the deployed state, partially closing the opening defined by the ring to secure the ring in a partially compressed state while the film remains in the patient's body cavity, removing the ring in the partially compressed state from the patient's body cavity while the film remains in the patient's body cavity, releasing the ring from the partially compressed state to move it to an uncompressed state, and / or removing the specimen from the enclosure and out through the opening in the ring. In various embodiments, the method can include closing a portion of the enclosure between a ring or support and the film, and / or closing a portion of the enclosure between the ring or support and the film by pulling a cinch from the film, the cinch being coupled to the film and positioned below the ring.

[0011] According to various embodiments, a tissue containment bag is provided, the bag comprising a support or ring coupled to an enclosure, or a film defining the enclosure, and at least one of a strap, a tab, a string, and / or a cinch, or any combination thereof.

[0012] Many of the attendant features of the present invention can be readily appreciated as the same becomes better understood by reference to the foregoing and following description when considered in conjunction with the accompanying drawings.

[0013] The present invention can be further understood in conjunction with the accompanying drawings, in which like reference numerals refer to like parts throughout the drawings. [Brief explanation of the drawings]

[0014] [Figure 1] 1 is a top perspective view of a containment bag according to various embodiments of the present invention. FIG. [Figure 2] 1 is a top view of a containment bag according to various embodiments of the present invention. [Figure 3] 1 is a side view of a containment bag according to various embodiments of the present invention. [Figure 4] 1 is a side perspective view of a containment bag according to various embodiments of the present invention. FIG. [Figure 5] 1 is a top perspective view of a containment bag according to various embodiments of the present invention. FIG. [Figure 6] 1 is a bottom perspective view of a containment bag according to various embodiments of the present invention. FIG. [Figure 7] 1A-1C are top views of a containment bag in an inserted or compressed / confined state, according to various embodiments of the present invention. [Figure 8] 1A-1C are side views of various embodiments of containment bags in various states, positions, or configurations according to various embodiments of the present invention. [Figure 9] 1A-1C are side views of various embodiments of containment bags in various states, positions, or configurations according to various embodiments of the present invention. [Figure 10] 1A-1C are side views of various embodiments of containment bags in various states, positions, or configurations according to various embodiments of the present invention. [Figure 11] 1A-1C are side views of various embodiments of containment bags in various states, positions, or configurations according to various embodiments of the present invention. [Figure 12] 1A-1C are side views of various embodiments of containment bags in compressed / confined positions or states in association with surgical instruments or tools inserted into a confined space through a sheath or body wall, according to various embodiments of the present invention. [Figure 13]1A-1C are perspective side views of one of the straps and / or grips and supports or rings of a containment bag according to various embodiments of the present invention. [Figure 14] 1A-1C are perspective side views of one of the straps and / or grips and supports or rings of a containment bag according to various embodiments of the present invention. [Figure 15] 1A-1C are top views of straps and fastener attachments according to various embodiments of the present invention. [Figure 16] 1A-1C are side views of cinches and films according to various embodiments of the present invention. [Figure 17] 1A-1C are side views of cinches and films according to various embodiments of the present invention. [Figure 18] 1A-1C are side views of cinches and films according to various embodiments of the present invention. [Figure 19] 12A-12C are top perspective views of a strap threaded through a loop of a grip or tab of a containment bag according to various embodiments of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0015] For example, specimens removed during gynecological procedures require specimen storage and collection. According to various embodiments, the specimen is collected in a storage bag prior to size reduction. In one such exemplary surgical procedure, e.g., a laparoscopic hysterectomy, the specimen, e.g., the uterus, is cut, mobilized, and collected in a storage bag. The specimen is exposed to the surface of the body wall through a laparoscopic access port, a trocar, or through an incision or orifice in the body wall. The size or length of the incision can range from 2.5 cm to 4 cm.

[0016] Placing a containment bag and containing a specimen within the surgical space can be challenging, particularly for large specimens, e.g., uteri larger than 20 weeks and / or 1,000 grams, and in some surgical procedures, such as laparoscopic hysterectomies. The limited space within the abdomen minimizes the space available for placing a containment bag. Single-site gynecological procedures, such as laparoscopic hysterectomies, also result in limited visualization of the surgical space and surroundings, as the volume of the specimen can occupy a large portion of the surgical space, especially for large uteri. Therefore, complete visualization of the specimen from the access site is often not achieved in such cases, and the laparoscope must be continuously manipulated proximal to the access site to enable visualization. Furthermore, visualization of the surgical space can be hindered by the addition of a containment bag, which can occupy significant surgical space. Furthermore, due to the limited surgical space, repositioning or generally moving the bag relative to the specimen within the restricted surgical space is difficult. Therefore, the size of the specimen and the size of the containment bag in its deployed state can limit visibility and the surgeon's working area.

[0017] Additionally, the accommodation of larger specimens may require more manipulation of the bag to place the specimen in the bag. Furthermore, manipulation of the bag may be limited by the bag itself, particularly its configuration, size, and / or shape. The film of the bag in one example provides a smooth and durable surface while minimizing rough or abrasive surfaces to avoid potential tissue trauma or issues. However, such a surface also minimizes the ability to grasp and manipulate the containment bag. Furthermore, the ring of the containment bag in various embodiments surrounds the outer periphery of the specimen prior to collection. Thus, the containment of the specimen encompasses a large portion of the specimen volume occupying the containment bag. The film wrapping or otherwise covering the ring of the containment bag also makes manipulation of the bag opening, for example, to the incision or bodily orifice, more difficult. Without friction on the film, slippage or unexpected movement of the bag may occur. Thus, specimen placement, accommodation, and retrieval may depend on the bag and the ease and ability to manipulate the containment bag.

[0018] According to various embodiments, as shown in, for example, FIGS. 1-7 , a containment bag 10 includes a support or ring 12 and one or more films 1 attached to the ring 12 to form a sealed space or enclosure 16. In various embodiments, the support is a dual-lumen ring, and in other embodiments, the support is shaped, sized, and positioned to define or delimit the opening or proximal end of the containment bag. In various embodiments, the film is made of the same material as the ring, and in one embodiment, the film is made of thermoplastic urethane. In various embodiments, the ring has a thickness or width greater than the thickness or width of the film. In various embodiments, the ring has an inner and outer diameter, and the enclosure has defined inner and outer diameters. In various embodiments, the inner and outer diameters of the enclosure are greater than the inner and outer diameters of the ring. Thus, the film is positioned to surround a specimen inserted into the enclosure 16 defined or delimited by the film 14. According to various embodiments, the enclosure defined by the film and / or ring has various shapes, sizes, and is configured to capture and contain a particular specimen or various specimen sizes larger than the trocar or incision size, and / or to mitigate potential spreading or migration of unwanted tissue. In various embodiments, the enclosure defined by the film and / or ring is arranged to have various shapes and / or sizes to aid in deployment, manipulation, and / or removal of the containment bag within and / or from the body cavity.

[0019] The support or ring 12 is compressible or deformable, and in various embodiments, is compressible only transverse to the longitudinal axis of the containment bag. Thus, the ring has an initial, uncompressed state in which it defines a predetermined pattern, e.g., a circular shape, and a compressed state in which it defines a narrowed or closed opening, e.g., an elongated oval or flattened hourglass pattern. According to various embodiments, the film 14 is compressible and arranged to be wound or stacked along or parallel to the longitudinal axis of the containment bag. In various embodiments, when the ring is in the compressed state, the containment bag is wound, folded, stacked, or fan-folded to gather, draw, bunch, or compress the film, e.g., the entire length of the film, up to and / or within the inner circumference defined by the ring. In various embodiments, the film of the containment bag has a wound state in which it is wound up to and / or against the ring, and a deployed or unconstrained state in which the film can rotate or extend away from the ring. Such states, configurations and operations are illustrated in Figures 8-12.

[0020] The containment bag further comprises one or more elongated strips, tabs, or straps 22 disposed on or around the support or ring 12, the film 14, or some combination thereof. In various embodiments, the elongated straps are polyurethane film or polyester laminated fabric straps. According to various embodiments, the films are confined or held in a stacked or confined state by one or more straps. In various embodiments, the straps are wrapped around a portion of the stacked films and rings to hold the rings in a compressed state and the films in a confined state. In use, in one embodiment, a surgeon wraps the straps around the stacked films and rings in an elongated shape for insertion into or through a patient's incision or opening.

[0021] The containment bag further includes one or more fasteners or connectors 24 attached to or integrated with one or more straps 22. In various embodiments, the one or more fasteners are attached to the rings 12, the film 14, or some combination thereof. The fasteners or connectors are attached to or integrated with one of the straps 22 and, in various embodiments, operatively secure the rings in a compressed state and the film in a confined state, thus, in various embodiments, placing and / or maintaining the containment bag in an inserted state. Once the bag is inserted and placed in a patient's body cavity, the fasteners are released and the bag can expand to a deployed state. In various embodiments, the entire bag is configured to be inserted and placed entirely within the patient's body. In various embodiments, the fasteners are released or released by using a grasper or similar surgical or laparoscopic instrument to grasp the straps carrying the fasteners 24 and pull in opposite directions. In various embodiments, the fasteners are snap-type fittings having a snap or coupling portion located on one portion of the strap and a receiving portion located on another portion of the strap distal to the coupling portion. In various embodiments, the fastening arrangement is configured to remain covered by straps or tabs 22 and therefore not be exposed so as to not interfere with insertion and operation of the bag.

[0022] In various embodiments, the containment bag includes or further comprises a control drawstring or loop 32 and a tethering tag 34. The control drawstring and tethering tag are external to the body while the remainder of the bag is fully inserted into the body cavity. According to various embodiments, the control drawstring and tethering tag allow a user external access, i.e., not within the body cavity, to control the bag and to aid in removing the bag and any specimen therewith from the patient.

[0023] According to various embodiments, the containment bag further comprises one or more strips, protrusions, tabs, or gripping portions 26 disposed on or around the support or ring 12, the film 14, or some combination thereof. In various embodiments, the gripping portions are polyurethane film or polyester laminate fabric gripping portions. According to various embodiments, the one or more gripping portions provide anchors or gripping points to aid in removal of the bag from the patient's body. In various embodiments, the one or more gripping portions or tabs 26 are formed as loops and / or have textured surfaces or other surface features that provide a gripping means for a grasper or other similar surgical instrument to aid in removal or manipulation of the containment bag. Additionally, the gripping portions are configured so as not to interfere with the opening and / or storage of the bag and any specimens contained therein. Additionally, in various embodiments, the gripping portions are positioned so as not to impede or interfere with removal, placement, or manipulation of the bag and / or specimens. Once the captured specimen is brought to the surface of the body or external thereto with the proximal portion of the containment bag, in various embodiments, the specimen can be collected by grasping and removing it from the bag and / or by performing extracorporeal manual morsel removal. In various embodiments, at least two gripping portions or tabs are disposed at approximately 90° from each other and / or from one or more tabs to help provide a level and / or stable area for manipulating the bag from various angles or using one or more instruments.

[0024] According to various embodiments, inserting the containment bag into the surgical space in a compressed / confined state, as shown in Figures 7-12, does not impair visualization of the containment bag or other anatomical features. The elongated or narrow shape created by securing the film of the bag with a strap and fastener arrangement facilitates insertion of the bag through a small incision and placement into the surgical space, minimizing obstruction to the surgeon's view or visualization.

[0025] In various embodiments, a user or surgeon can stack, roll, fold, or fan-fold the containment bag film and secure it using straps and fasteners. The location of the straps and fasteners allows a user to confine the film 14, for example, as shown in FIG. 7 . Once confined, the surgeon can introduce and place the containment bag through an incision or access platform in a space that does not obstruct other anatomical features requiring access. A confined bag can be deployed or released, for example, by unfastening the fastener using a grasping tool to grasp the excess or portion of the tab or strap and pull it away from the fastener. Once released, the containment bag returns to its original or initial shape, state, or configuration.

[0026] In various embodiments, specimen placement and storage are subject to manipulation, and one or more tabs or gripping portions 26 attached to the access or opening of the storage bag facilitate specimen placement and storage in the bag. In various embodiments, the positioning of one or more gripping portions, straps, and / or string loops facilitates managing the access or opening of the storage bag and / or encircling the periphery of the specimen, bag, or some combination thereof and / or allowing the surgeon to control manipulation of the bag to facilitate specimen bag placement. In various embodiments, one or more gripping portions and / or straps are made from a laminated fabric, providing additional frictional properties to aid in gripping the gripping portion and / or strap and managing manipulation of the bag. Additionally, according to various embodiments, through openings or loops formed on or by the gripping portion and / or strap allow the surgeon to grasp or insert laparoscopic instruments into the bag to manipulate it.

[0027] In various embodiments, one or more elongated straps are operatively inserted into and threaded through openings, gaps, or formed loops in the gripping portion or tab, as shown in FIG. 19 , thereby forming a bond, thus facilitating the containment and / or removal of the specimen and bag from the patient. In various embodiments, the bond facilitates removal of the bag in a parallel fashion to the abdominal surface with the aid of the string loops on the outside of the abdomen being moved distally or away from the patient or out of the patient's body cavity, thereby reducing or eliminating the possibility of the specimen or portions thereof falling out or spilling out of the bag, for example, when removal occurs at an extreme angle from the surgical or access site.

[0028] According to various embodiments, the fasteners and straps allow for quick engagement and release of the containment bag. In various embodiments, the straps and / or gripping portions are positioned opposite one another and sized and / or shaped to allow for separate grasping and fastening. In various other embodiments, a pin or protrusion on one side of the strap is adapted to be inserted into a keyway, hole, opening, or gap on the opposite side of the strap and is removably secured, thereby providing an engagement and release configuration for containment bag confinement and deployment.

[0029] According to various embodiments, the strap and / or gripping portion are made of a laminated fabric. In various embodiments, the strap and / or gripping portion have specific fabric and / or frictional properties to facilitate and not hinder gripping or manipulation of the tab and / or gripping portion inside and outside the patient. In various embodiments, the inner circumference of the ring has a specific diameter, and the strap has a length greater than the diameter of the inner circumference of the ring. In various embodiments, the strap is longer than the gripping portion or tab. In various embodiments, the tab defines a loop or has a loop attached thereto, the loop defining an opening through which the strap can be threaded. In various embodiments, the tab loop is formed by bonding the tab to itself, and in various embodiments, when the strap is threaded through the loop, the ring is in a partially compressed state, and the open end defined by the ring is blocked, no longer in its initial unblocked state, but not as blocked as the ring in its compressed state. In various embodiments, the tab loop has a diameter equal to or greater than the width of the strap. In various embodiments, the strap has a width greater than the diameter of the tab loop. In various embodiments, the bag includes two / three tabs located in different two / thirds quadrants along the ring or support, and the strap is located in the third / fourth quadrant along the ring not occupied by any of the two / three tabs to facilitate support, deployment, securement, and / or manipulation of the bag.

[0030] According to various embodiments, the containment bag includes a cinch 41. In various embodiments, the cinch is a string, thread, or cord disposed around the film between the open and closed ends of the bag. Once the specimen is within the containment bag, a surgeon can close the top or proximal end of the bag near the bag's entry or opening by pulling or tugging on the cinch. In various embodiments, the cinch is a double cinch, allowing a surgeon to close a portion of the containment bag by simultaneously pulling opposite ends of the cinch or cinch gripping area, for example, using a laparoscopic instrument or grasper. In various embodiments, the cinch can prevent the specimen or portions thereof from falling out of the containment bag and can also aid in bag removal, as portions of the bag, such as the bag's entry or opening, are in a closed or more confined state.

[0031] In various embodiments, the one or more tabs or gripping portions are about 1.5 inches to 2.0 inches in length, and in various embodiments, about 1.75 inches. The one or more straps are about 4.25 inches to about 7.0 inches in length, and in various embodiments, about 6.7 inches. The straps and / or gripping portions are about 0.018 inches to about 0.023 inches in thickness, and in various embodiments, about 0.019 inches. In various embodiments, at least one gripping portion is about 0.05 inches to 1.25 inches in width, and in various embodiments, about 0.75 inches. At least one strap is about 0.05 inches to 0.75 inches in width, and in various embodiments, about 0.625 inches. Thus, the straps and / or gripping portions are configured to facilitate insertion, manipulation, and removal of the containment bag and / or specimen or portions thereof. Additionally, according to various embodiments, the size and / or shape of the straps and / or gripping portions are configured to ensure or facilitate manipulation, engagement, and release of the gripping portions by laparoscopic instruments. Furthermore, according to various embodiments, the length of the straps is configured to ensure or facilitate engagement and / or release of the fasteners and / or tabs to capture or trap the film and ring in a trapped / compressed state to trap, release, or deploy the bag.

[0032] In various embodiments, the distance from the bottom of the ring or support to the cinch and / or its ties is about 1.5 inches to 2.25 inches, and in various embodiments, about 1.5 inches. In various embodiments, the cinch location ensures that most of the specimen volume is captured and is not too large, e.g., less than 1.5 inches, which may make it more difficult for the surgeon to manipulate the cinch because the ring or support can resist the movement to close the bag.

[0033] According to various embodiments, as shown in FIG. 13 , one or more straps and / or gripping portions are attached to the support 12 by one or more heat seals. The distance 21 between the heat seals is greater than the width and / or height of the support 12. In other embodiments, as shown in FIG. 14 , one or more seals or adhesives on the straps and / or gripping portions extending along the top edge or one or more side edges of the support can be applied to secure the one or more straps and / or gripping portions to the ring. Thus, one end of the straps and / or gripping portions forms a lumen in which a portion of the support is disposed. In various embodiments, one or more straps and / or gripping portions are bonded or glued directly to the support. According to various embodiments, the distance between the heat seals and / or attachments of the straps to the support ensures that the straps remain in place on the support and do not interfere with their operation or the bond between the film and the support.

[0034] In FIG. 15, strap 22 and fastener 24 are shown, according to various embodiments. As illustrated, in one embodiment, fastener 24 includes an attachment portion 25 having one or more protrusions or pins extending from a tab that removably couple to slots or openings on fastener receiver 27. In various embodiments, the attachment portion and / or receiver are integral with or adhered to the strap, and in various embodiments, the positions of the portions are reversed. According to various embodiments, the protrusion and gap fit is a friction fit. In various embodiments, the fastener is a hook and loop type configuration. In various embodiments, the attachment portion and / or receiver are welded to the strap, and in various embodiments, the attachment portion and / or receiver are one or more boss pins that penetrate the strap and are press-fit through holes or slots in the respective attachment portion or receiver.

[0035] 16-18, in various embodiments, the containment bag includes a cinch 41. In various embodiments, one or more strips of film 43 are sealed to the containment bag film. In various embodiments, the film strips are made of the same material as the containment bag film. In various embodiments, the film strip is approximately 7.5 inches long and approximately 0.75 inches wide, and is sealed at its top and bottom to the containment bag film to surround and capture portions of the cinch. In various embodiments, openings or perforations are provided or created at one or both ends of the film strip and / or bag film to allow one or more string loops to be fed through and threaded onto the film strip. In various embodiments, the string loops are secured, glued, or tied on both ends, leaving only a single loop exposed on each side. In various embodiments, one or more clips, tabs, or grips are attached to the string to provide a larger area for grasping or accessing the cinch string. In various embodiments, a film strip is provided to cover or keep the cinch unexposed to prevent it from interfering with any surrounding tissue or interfering with the insertion, removal, or manipulation of the bag.

[0036] In various embodiments, as shown in FIG. 18 , a sealing string area 45 for enclosing or capturing the cinch string is provided by folding the bag film over itself to create the string area. After sealing or forming the string area, an excess or additional portion of the film is used to attach a ring at the opposite end of the film, which is similarly sealed. Once the edges of the bag film are sealed, a string or string loop strand can be inserted and tied or attached to form the cinch. According to various embodiments, the cinch 41 can be formed by threading the string or string loop through multiple openings or gaps in the bag film or film strip, and in other embodiments, the cinch can be covered by an additional film or film strip to cover or keep it unexposed to prevent it from interfering with any surrounding tissue or interfering with the insertion, removal, or manipulation of the bag.

[0037] In various embodiments, the cinch is a double cinch, with one end located on the outside of the film and the other end located on an opposite side of the outside of the film, and movement of each end of the double cinch in opposite directions away from the bag cinches the film and closes the path from the closed end of the bag to the open end of the bag. In various embodiments, the cinch is located in a film strip attached and heat sealed to the film and / or in a film strip having an opening through which one or more ends of the cinch extend.

[0038] In various embodiments, the support or ring can be oval or non-circular and can define an open end or opening having a similar shape. In various embodiments, the support or ring has a thickness greater than the thickness of the film, and in various embodiments, the ring is deformable only in a direction transverse to the longitudinal axis of the bag. In various embodiments, the ring or support has a predetermined resilience or spring constant to return from a compressed state to an initial, uncompressed state. In various embodiments, the ring in an initial, uncompressed state defines a circular opening, and the ring in a compressed state defines a narrowed opening.

[0039] In various embodiments, the film bonded to the ring covers the entire outer periphery of the ring. In various embodiments, the film is a monolithic film sheet that is impermeable and has no gaps or openings therethrough. In various embodiments, the film has preformed creases to cause the film to fold into an insertion configuration. In various embodiments, the film comprises multiple films bonded to each other and to the ring to form side walls and a closed end and define the interior of the enclosure. In various embodiments, the film is folded over itself, with a pair of first side edges attached to each other and a pair of second side edges attached to each other to form the side walls and the closed end, defining the interior of the enclosure. In various embodiments, the bag enclosure has an inner diameter defined by the inner periphery of the ring and / or an outer diameter defined by the outer periphery of the ring that is larger than the outer diameter of the ring. In various embodiments, the film is in contact with the ring, the ring cannot wrap the film around it, and / or the film can overlap in a direction along the longitudinal axis of the tissue storage bag. In various embodiments, in the confined state, the film overlaps up to and within the periphery of the ring. In various embodiments, in the deployed state, the film expands outwardly, away from the periphery of the ring. In various embodiments, the enclosure has a minimum fill volume in the confined state of the film and a maximum fill volume in the deployed state of the film.

[0040] According to various operational aspects of the various tissue containment bags, the bag can be prepared for deployment, deployed in a confined space, such as a patient's body cavity or a surgical simulator or training machine, and / or utilized to remove a specimen from the confined space, with or without simulation. Thus, according to various embodiments, a compressed ring or support and a confined film can be positioned, secured, and inserted into the confined space. In various embodiments, the film can be released from the confined state to a deployed state, the ring can be released from a compressed state to an uncompressed state, and / or a specimen can enter the enclosure defined by the deployed film through an opening defined by the uncompressed ring. In various embodiments, while the film remains in the deployed state, the opening or open end defined by the ring can be partially closed, and / or the ring can be secured in a partially compressed state. In various embodiments, while the film is within the confined space, the ring can be removed from the confined space in a partially compressed state, and the ring can be released from the partially compressed state to transition to an uncompressed state. The specimen can be removed from the enclosure through the opening in the ring. In various embodiments, the enclosure between the ring or support and the film can be closed by closing and / or pulling the cinch from the film. In various embodiments, a surgical instrument or tool can be utilized to insert, interact with, and / or manipulate the bag and its portions, and such a tool or device can be a grasper or the like and / or can include a tool or instrument set that separately performs some or all of these actions.

[0041] Examples of bags and related accessories and their practical uses are described in U.S. Patent Application Nos. 14 / 885,072, 15 / 068,366, and 15 / 498,157, the entire disclosures of which are incorporated herein by reference. The above description is presented to enable any person skilled in the art to make and use a tissue containment device or system and to practice the methods described herein, and describes the best mode contemplated by the inventors for carrying out these inventions. However, various modifications will still be apparent to those skilled in the art. These modifications are contemplated to be within the scope of this disclosure. Various embodiments or aspects of such embodiments are shown in the various figures and described throughout this specification. However, it should be noted that although separately illustrated or described, each embodiment and its aspects can be combined with one or more of the other embodiments and its aspects, unless expressly stated. Simply for ease of reading this specification, each combination has not been explicitly described.

[0042] While the present invention has been described in terms of specific embodiments, many further modifications and variations will be apparent to those skilled in the art. It is therefore to be understood that the invention can be practiced otherwise than as specifically described, including various changes in size, shape and materials, without departing from the scope and spirit of the invention. The present embodiments, therefore, are to be considered in all respects as illustrative and not restrictive. [Explanation of symbols]

[0043] 10 Storage Bag 12 Ring 14 Film 16 Enclosure 22 Strap 26 Grip part 32 Loops 34 Mooring tug 41 Cinch

Claims

1. 1. A tissue containment bag comprising: a ring having an inner periphery that bounds an open end; the ring is deformable from an initial, uncompressed state in which the open end bounded by the ring is unobstructed to a compressed state in which the open end bounded by the ring is partially obstructed; The tissue storage bag includes: a film bonded to the ring to form an enclosure having an interior and a closed end; the interior of the enclosure is accessible through the open end bounded by the ring, and the film and the interior of the enclosure are expandable from a confined state in which the film, including the distal-most end, is confined adjacent the ring to a deployed state in which the distal-most end of the film extends away from the ring; The tissue storage bag includes: a strap coupled to the ring; a strap having a fastened state, the strap in the fastened state securing the ring in the compressed state and simultaneously the film in the confined state; A tissue containment bag comprising:

2. 2. The tissue containment bag of claim 1, wherein the straps have an unfastened state, in which the straps simultaneously release the ring from compression and the film from confinement.

3. The tissue containment bag of claim 2 , wherein the strap is attached to the ring and the film.

4. The tissue containment bag of claim 3 , wherein the strap is heat sealed to itself, joining the strap to the ring and the film.

5. The tissue containment bag of claim 1 , wherein the inner periphery of the ring has a diameter, and the strap has a length greater than the diameter of the inner periphery of the ring.

6. The tissue containment bag of claim 2 , wherein the strap includes a fastener attachment that releasably attaches the strap from the fastened state to the unfastened state.

7. The tissue containment bag of claim 6 , wherein the fastener attachment releasably couples the strap to itself.

8. The tissue containment bag of claim 6 , wherein the strap has an outer surface and an inner surface, and the fastener attachment includes a coupling portion and a receiving portion disposed on the inner surface of the strap.

9. The tissue containment bag of claim 8 , wherein the coupling portion is located near a first end of the strap and the receiving portion is located near a second end of the strap.

10. The tissue containment bag of claim 8 , wherein the first end of the strap is coupled to the ring and the second end of the strap is not coupled to the ring.

11. The tissue containment bag of claim 8 , wherein the second end of the strap is coupled to the ring and the first end of the strap is not coupled to the ring.

12. The tissue containment bag of claim 1 or 11, further comprising a tab coupled to the ring opposite the strap.

13. 12. The tissue containment bag of claim 1 or 11, further comprising a first tab coupled to a position on the ring relative to the position of the strap, and a second tab coupled to a position on the ring between the first tab and the strap.

14. The tissue containment bag of claim 12 , wherein the strap is longer than the tab.

15. 15. The tissue containment bag of claim 12 or 14, wherein the tab has a loop that defines an opening through which the strap can pass.

16. 16. The tissue containment bag of claim 15, wherein the strap is threaded through the loop in an unfastened state, and in the unfastened state, the open end defined by the ring is obstructed and is no longer unobstructed as in the initial uncompressed state, but is less obstructed than the ring in the compressed state.

17. The tissue containment bag of claim 16 , wherein the loop of the tab is formed by the tab being bonded to itself.

18. 18. The tissue containment bag of claim 15, 16, or 17, wherein the loop of the tab has a diameter equal to or greater than the width of the strap.

19. 18. The tissue containment bag of claim 15, 16, or 17, wherein the strap has a width greater than a diameter of the loop of the tab.

20. 18. The tissue containment bag of claim 15, 16, or 17, wherein the tab extends away from the ring and the strap extends away from the ring and the tab.

21. 12. The tissue containment bag of claim 1 or 11, further comprising three tabs located in three different quadrants along the ring and a strap located in a fourth quadrant along the ring not occupied by any of the three tabs.

22. The tissue containment bag of claim 12 , wherein the tab is made from a laminate fabric.

23. The tissue containment bag of claim 1 or 12, further comprising a string attached to the ring.

24. 24. The tissue containment bag of claim 23, wherein the strap has a length that is less than a length of the tether.

25. 24. The tissue containment bag of claim 23, further comprising a tag, wherein the end of the string not attached to the ring is attached to the tag.

26. 26. The tissue containment bag of claim 25, wherein the tag and the portions of the string attached to the tag are positioned outside a body cavity of a patient, and the ring and film are positioned within the body cavity of the patient.

27. 30. The tissue containment bag of claim 1 or 26, wherein the ring has a thickness greater than a thickness of the film.

28. 30. The tissue containment bag of claim 1 or 27, wherein the ring is deformable only in a direction transverse to the longitudinal axis of the tissue containment bag.

29. 30. The tissue containment bag of claim 1 or 28, wherein the open end of the ring in the initial, uncompressed state defines a circular opening.

30. 30. The tissue containment bag of claim 1 or 29, wherein the open end of the ring in the compressed state defines a narrowed opening.

31. 31. The tissue containment bag of claim 1 or 30, wherein the film bonded to the ring covers the entire circumference of the ring.

32. 32. The tissue containment bag of claim 1 or 31, wherein the film is made of a thermoplastic urethane.

33. 32. The tissue containment bag of claim 1 or 31, wherein the film comprises a plurality of films bonded together and to the ring to form side walls and a closed end and define an interior of the enclosure.

34. 32. The tissue containment bag of claim 1 or 31, wherein the film is folded over on itself and a pair of first side edges are attached to one another and a pair of second side edges are attached to one another to form side walls and a closed end, defining the interior of the enclosure.

35. 32. The tissue containment bag of claim 1 or 31, wherein the enclosure has an inner diameter defined by the inner periphery of the ring.

36. 36. The tissue containment bag of claim 1 or 35, wherein the enclosure has an outer diameter greater than an outer diameter of the ring defined by an outer surface of the ring.

37. 37. The tissue containment bag of claim 1 or 36, wherein the film is in contact with the ring, and the ring does not allow the film to be wound around it.

38. 40. The tissue containment bag of claim 1 or 37, wherein the film is overlappable in a direction along the longitudinal axis of the tissue containment bag.

39. 40. The tissue containment bag of claim 1 or 38, wherein in the confined state, the film overlaps to and within the outer periphery of the ring.

40. 40. The tissue containment bag of claim 1 or 39, wherein in a deployed state, the film extends outwardly and away from the outer periphery of the ring.

41. 41. The tissue containment bag of claim 1 or 40, wherein the film has preformed creases to induce folding of the film into an insertion configuration.

42. 42. The tissue containment bag of claim 1 or 41, wherein the ring has a predetermined resilience to return from the compressed state to an initial uncompressed state.

43. 43. The tissue containment bag of claim 1, 21, or 42, further comprising a cinch attached to the film and positioned between the ring and the closed end.

44. 44. The tissue containment bag of claim 43, wherein the cinch is positioned adjacent to and below the ring.

45. 45. The tissue containment bag of claim 43 or 44, wherein the cinch is a double cinch, one end positioned outside the film and the other end positioned on the opposite side of the film, and movement of the ends of the double cinch in opposite directions away from the bag tightens the film and closes a path from the closed end of the bag to the open end of the ring.

46. 46. The tissue containment bag of claim 43 or 45, wherein the cinch is disposed within a film strip that is attached and heat sealed to the film.

47. 47. The tissue containment bag of claim 46, wherein the film strip has an opening through which one or more ends of the cinch extend.

48. 46. The tissue containment bag of claim 43 or 45, wherein the cinch is disposed within the folded portion of the film.

49. a tissue storage bag; a surgical instrument configured to facilitate insertion of the tissue containment bag into a body cavity of a patient; Equipped with A tissue containment system, wherein the surgical instrument transforms the ring of the tissue containment bag from a compressed state to a non-compressed state and the film of the tissue containment bag from a confined state to a deployed state, or transforms the ring of the tissue containment bag from a non-compressed state to a partially compressed state.

50. a tissue storage bag; means for inserting the tissue bag into a body cavity of a patient with the tissue bag support in a compressed state and the tissue bag film in a confined state; 1. A tissue containment system comprising:

51. a tissue storage bag; means for converting the support of the tissue bag from a compressed state to a non-compressed state and the film of the tissue bag from a confined state to a deployed state; 1. A tissue containment system comprising:

52. a tissue storage bag; means for converting the tissue bag support from an uncompressed state to a partially compressed state with the tissue bag film in a deployed state; 1. A tissue containment system comprising:

53. 1. A method of preparing a tissue containment bag, comprising: providing a tissue containment bag including a ring and a film coupled to the ring, the film defining an enclosure; placing the ring in compression; placing the film in a confined state; fixing the ring in compression and the film in a confined state; A method comprising:

54. 54. The method of claim 53, wherein securing the ring in compression and the film in a confined state further comprises wrapping a strap coupled to the ring around portions of the ring and portions of the film.

55. 55. The method of claim 54, further comprising fastening the strap to itself.

56. 1. A method of deploying a tissue containment bag, comprising: providing a tissue containment bag comprising a ring, a film coupled to the ring, and a strap coupled to the ring and the film, the film defining an enclosure; The method comprises: placing the ring in compression and the film in a confined state; wrapping the strap coupled to the ring around portions of the ring and portions of the film; fastening the strap to itself; inserting the tissue containment bag into a confined space with the ring in a compressed state and the film in a confined state; the entire film is overlapped and positioned adjacent to and secured within the outer periphery of the ring, the ring defining a narrowed opening and having an hourglass shape; The method comprises: releasing the strap from itself to release the film from confinement and the ring from compression; method.

57. 1. A method of removing a specimen, comprising: providing a tissue containment bag including a ring and a film coupled to the ring, the film defining an enclosure; The method comprises: placing the ring in compression and the film in a confined state; fixing the ring in compression and the film in a confined state; inserting the tissue containment bag into a body cavity of a patient with the ring in a compressed state and the film in a confined state; Releasing the film from a confined state to a deployed state and the ring from a compressed state to an uncompressed state; placing a specimen through an opening defined by the ring in an uncompressed state into an enclosure defined by the film in a deployed state; partially closing the opening defined by the ring to secure the ring in a partially compressed state while the film remains in a deployed state; removing the partially compressed ring from the patient's body cavity while the film remains within the patient's body cavity; Releasing the ring from the partially compressed state to move it to an uncompressed state; removing the specimen from the enclosure through the opening in the ring; A method comprising:

58. 58. The method of claim 57, wherein securing the ring in compression and the film in a confined state includes wrapping a strap coupled to the ring around portions of the ring and portions of the film, and fastening the strap to itself.

59. 60. The method of claim 58, wherein the step of releasing the film from a confined state to a deployed state and the ring from a compressed state to an uncompressed state further comprises the step of releasing the strap from itself.

60. 60. The method of claim 59, wherein partially closing the opening defined by the ring to secure the ring in a partially compressed state while the film remains in a deployed state further comprises threading the strap through a loop defined by a tab coupled to the ring, and drawing the strap through the loop to narrow the opening defined by the ring.

61. 61. The method of claim 60, wherein removing the partially compressed ring from the patient's body cavity while the film remains within the patient's body cavity further comprises grasping the ends of the strap and string threaded through the loop and connected to the ring, and pulling the ends of the strap and string out of the patient's body cavity.

62. 62. The method of claim 61, wherein releasing the ring from the partially compressed state to move it to an uncompressed state further comprises releasing the string and the strap to allow the strap to slip out of the loop as the ring springs back to the uncompressed state.

63. 63. The method of claims 57 and 62, further comprising closing a portion of the enclosure between the ring and the film.

64. 64. The method of claim 63, wherein closing a portion of the enclosure between the ring and the film further comprises pulling a cinch means from the film, the cinch being coupled to the film and positioned below the ring.

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