Tissue Removal Containment System

Abstract

To provide systems and methods for the containment of tissue prior to and / or during morcellation procedures.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 has a support or ring 12 having a compressed, partially compressed and / or uncompressed state or position. The bag can also include an enclosure 16 or a film 14 defining the enclosure connected to the support, with the enclosure 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 Sep. 20, 2018, the entire disclosure of which is incorporated herein by reference.

[0002] (Technical field) FIELD OF THE DISCLOSURE 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 gynecologic procedures such as laparoscopic hysterectomy have limited visualization of the surgical space and surroundings, especially for large uteruses, as the volume of the specimen may occupy a large portion of the surgical space. For this reason, 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. Also, due to the limited surgical space, repositioning or generally moving the specimen within this narrow surgical space is difficult. In addition, in laparoscopic hysterectomy, the uterus is cut, mobilized, and collected. The uterus is removed through a trocar or incision ranging in size from 2.5 cm-4 cm, which increases 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 suffer from shortcomings and improvements in such methods and systems are desirable. [Means for solving the problem]

[0005] According to various embodiments, a containment system is provided that 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 configured to reduce potential spreading or displacement of unwanted tissue during morcellation or other similar surgical procedures.

[0006] According to various embodiments, the tissue containment bag comprises a support or ring having an inner periphery that defines an open end, the ring being deformable from an initial uncompressed state, bounded by the ring and with the open end unobstructed, to a compressed state, in which the open end bounded by the ring is partially obstructed. The bag further comprises 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 bounded by the ring. 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. In various embodiments, the bag comprises a strap coupled to the ring, the strap in a fastened state securing the ring in a compressed state and the film in a simultaneously confined state. In various embodiments, the strap has an unfastened state, in which the strap releases the ring from the compressed state and the film from the confined state simultaneously. In various embodiments, the strap has a fastener attachment that releasably couples itself to the bag. In various embodiments, the bag has 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 that includes 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 transforming 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 transforming 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 confined state, and / or securing the ring in the compressed state and the film in the confined state.

[0009] According to various embodiments, a method of deploying a tissue containment bag is provided that includes 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 to the film, the film defining an enclosure, placing the ring in a compressed state 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 overlapping and positioned adjacent to and secured within an 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 confined state and the ring from the compressed state.

[0010] According to various embodiments, a method of removing a specimen is provided that includes 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 a compressed state and the film in the confining state, inserting the tissue containment bag into a patient's body cavity with the ring in a compressed state and the film in a confining state, releasing the film from the confining 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 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 deployed state, removing the ring in the partially compressed state outside 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, 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, where the cinch is coupled to the film and positioned below the ring.

[0011] According to various embodiments, a tissue containment bag is provided, the bag comprising at least one of a support or ring coupled to an enclosure, or a film defining an enclosure, and a strap, tab, tie, and / or 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 above and following descriptions 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 numbers refer to like parts throughout the drawings. [Brief description of the drawings]

[0014] [Figure 1] 1 is a top perspective view of a containment bag according to various embodiments of the present invention. [Diagram 2] 1 is a top view of a containment bag according to various embodiments of the present invention. [Diagram 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. [Diagram 5] 1 is a top perspective view of a containment bag according to various embodiments of the present invention. [Figure 6] 1 is a bottom perspective view of a containment bag according to various embodiments of the present invention. [Figure 7] 1A-1D 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 a containment bag 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 a containment bag 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 a containment bag 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 a containment bag 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 a containment bag in a compressed / confined position or state in association with a surgical instrument or tool to be inserted into a confined space through a sheath or body wall, according to various embodiments of the present invention. [Figure 13]1 is a perspective side view of one of the straps and / or grips and supports or rings of a containment bag according to various embodiments of the present invention. FIG. [Figure 14] 1 is a perspective side view of one of the straps and / or grips and supports or rings of a containment bag according to various embodiments of the present invention. FIG. [Figure 15] 1A-1D are top views of straps and fastener attachments according to various embodiments of the present invention. [Figure 16] 1A-1D are side views of cinches and films according to various embodiments of the present invention. [Figure 17] 1A-1D are side views of cinches and films according to various embodiments of the present invention. [Figure 18] 1A-1D are side views of cinches and films according to various embodiments of the present invention. [Figure 19] 1 is a top perspective view 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 PREFERRED EMBODIMENTS

[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., uterus, is cut, mobilized, and collected in a storage bag. The specimen is exposed to the surface of the body wall via a laparoscopic access port, trocar, or through an incision in the body wall or orifice in the patient. The size or length of the incision can range from 2.5 cm to 4 cm.

[0016] The placement of the containment bag and the containment of the specimen within the surgical space may be difficult, especially for larger specimens, including uteruses larger than 20 weeks and / or 1,000 grams, and in some surgical procedures, such as laparoscopic hysterectomy. The limited space within the abdomen minimizes the space for the containment bag placement. Also, single-site gynecologic procedures, such as laparoscopic hysterectomy, result in limited visualization of the surgical space and surroundings, especially for large uteruses, as the volume of the specimen may occupy a large portion of the surgical space. Thus, 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 allow visualization. Furthermore, visualization of the surgical space may be hindered by the addition of the containment bag, which may occupy a significant amount of surgical space. Also, due to the limited surgical space, repositioning or generally moving the bag relative to the specimen within the restricted surgical space is difficult. Thus, the size of the specimen and the size of the containment bag in the deployed state may limit the visibility and the surgeon's working area.

[0017] Additionally, 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 embodiment is arranged to provide 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 grip 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 includes a large portion of the specimen volume that occupies 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 body orifice, difficult. Without friction on the film, slippage or unexpected movement of the bag may occur. Thus, placement, containment, and retrieval of the specimen may depend on the bag and the ease and ability to manipulate the containment bag.

[0018] According to various embodiments, as shown, for example, in FIGS. 1-7, the containment bag 10 comprises 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 that is greater than the thickness or width of the film. In various embodiments, the ring has an inner and outer diameter, and the enclosure has a defined inner and outer diameter. 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 rings may have a variety of shapes, sizes, and may be configured to capture and contain a particular specimen or a variety of specimen sizes larger than the size of the trocar or incision, and / or to mitigate potential spreading or migration of unwanted tissue. In various embodiments, the enclosure defined by the film and / or rings may be arranged to have a variety of shapes and / or sizes to aid in the 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 in a direction 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 flat hourglass pattern. According to various embodiments, the film 14 is compressible and arranged to be wound or stacked in a direction along or parallel to the longitudinal axis of the containment bag. In various embodiments, when the ring is in a 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 into the inner circumference defined by the ring. The film of the containment bag in various embodiments 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, the surgeon wraps the straps around the stacked films and rings in an elongated shape for insertion or through a patient's incision or opening.

[0021] The containment bag further comprises one or more fasteners or connectors 24 attached to or integral 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 integral 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 in its entirety within the patient's body. In various embodiments, the fasteners are released or released by grasping the straps having the fasteners 24 with a grasper or similar surgical or laparoscopic instrument and pulling in opposite directions. In various embodiments, the fasteners are snap-type attachments 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 manipulation drawstring or loop 32 and a tether tag 34. The manipulation drawstring and tether tag are external to the body while the remainder of the bag is fully inserted into the body cavity. According to various embodiments, the manipulation drawstring and tether tag allow a user external access, i.e., not within the body cavity, to manipulate 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 any combination thereof. In various embodiments, the gripping portion is a polyurethane film or polyester laminate fabric gripping portion. According to various embodiments, the one or more gripping portions provide an anchor or gripping point 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 impede 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 harvested by grasping and removing it from the bag and / or by performing an extracorporeal manual morcellation. In various embodiments, at least two gripping portions or tabs are provided at approximately 90° from each other and / or from the 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 / contained 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 with minimal obstruction to the surgeon's view or visualization.

[0025] In various embodiments, a user or surgeon can stack, roll, fold, or fan-fold the film in the containment bag and secure it using straps and fasteners. The location of the straps and fasteners allows the 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 into a space that does not obstruct other anatomical features requiring access. A confined bag can be deployed or released, for example, by releasing the fastener using a grasper to grasp and pull the excess or portion of the tab or strap 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 containment are subject to manipulation, and one or more tabs or gripping portions 26 attached to the entry or opening of the containment bag facilitate specimen placement and containment in the bag. In various embodiments, the positioning of one or more gripping portions, straps, and / or ties loops facilitates managing the entry or opening of the containment 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 portions and / or straps to manage manipulation of the bag. Additionally, according to various embodiments, through openings or loops formed on or by the gripping portions and / or straps 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 and threaded through openings, gaps, or formed loops in the gripping portion or tab, as shown, for example, in FIG. 19, thus forming a bond, thus facilitating containment and / or removal of the specimen and bag from the patient. In various embodiments, the bond aids in 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 or spilling out of the bag, for example, when removal is performed 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 are sized and / or shaped to be separately grasped and tied together. In various other embodiments, a pin or protrusion on one side of the strap is positioned 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 is made of a laminated fabric. In various embodiments, the strap and / or gripping portion has 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 that is 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 pass. In various embodiments, the loop of the tab is formed by the tab being bonded to itself, and in various embodiments, when the strap passes through the loop, the ring is in a partially compressed state, and the open end bounded by the ring is blocked, no longer unblocked in the initial uncompressed state, but not as blocked as the ring in the compressed state. In various embodiments, the loop of the tab 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 loop of the tab. In various embodiments, the bag includes 2 / 3 tabs located in different 2 / 3 quadrants along the ring or support, and the strap is located in the 3 / 4 quadrant along the ring not occupied by any of the 2 / 3 tabs to facilitate support, deployment, fastening, and / or manipulation of the bag.

[0030] According to various embodiments, the containment bag includes a cinch 41. The cinch, in various embodiments, 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, the 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, and the surgeon can close a portion of the containment bag by simultaneously pulling on both ends of the cinch or cinch gripping area in opposite directions, 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 removal of the bag, since 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 long, and in various embodiments, about 1.75 inches. The one or more straps are about 4.25 inches to about 7.0 inches long, and in various embodiments, about 6.7 inches. The straps and / or gripping portions are about 0.018 inches to about 0.023 inches thick, 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 wide, and in various embodiments, about 0.75 inches. At least one strap is about 0.05 inches to 0.75 inches wide, 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. Further, 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 rings in a trapped / compressed state to trap or release or deploy the bag.

[0032] In various embodiments, the distance from the bottom of the ring or support to the location of 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 location of the cinch 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, as the ring or support may resist the movement of closing the bag.

[0033] According to various embodiments, as shown in FIG. 13, the 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 achieve fixation of the one or more straps and / or gripping portions to the ring. Thus, one end of the straps and / or gripping portions forms a cavity in which a portion of the support is disposed. In various embodiments, the 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 attachment portion 25 having one or more projections or pins extending from a tab that are adapted to be removably coupled to gaps or openings on fastener receiver 27. In various embodiments, attachment portion and / or receiver are integral or bonded to the strap, and in various embodiments, the positions of each portion are reversed. According to various embodiments, the projection and gap coupling is a friction fit. In various embodiments, fastener is a hook / loop type configuration. In various embodiments, attachment portion and / or receiver are welded to the strap, and in various embodiments, attachment portion and / or receiver are one or more boss pins that penetrate the strap and are press fit through holes or gaps 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 strip is made of the same material as the containment bag film. In various embodiments, the film strip is about 7.5 inches long and about 0.75 inches wide, and is sealed at the top and bottom to the containment bag film to encircle 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 the bag film to allow one or more string loops to feed and pass through the film strip. In various embodiments, the string loops are secured, glued, or tied on both ends, with 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 impeding insertion, removal, or manipulation of the bag.

[0036] In various embodiments, as shown in FIG. 18, a sealed string area 45 for encircling 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 addition of 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 feeding and threading the string or string loop through multiple openings or gaps in the bag film or film strip, and in other embodiments, can be covered by an additional film or film strip to cover or keep the cinch unexposed to prevent interference with any surrounding tissue or to prevent impeding 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 the opposite side of the outside of the film, and movement of each end of the double cinch in opposite directions away from the bag pinches the film and closes a 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 that is attached and heat sealed to the film and / or has 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 only deformable in a direction transverse to the longitudinal axis of the bag. In various embodiments, the ring or support has a predetermined resiliency 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 circumference 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 a plurality of films bonded to one another and to the ring to form side walls and a closed end and define an interior of the enclosure. In various embodiments, the film is folded over on itself, 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 and define an interior of the enclosure. In various embodiments, the bag enclosure has an inner diameter defined by an inner circumference of the ring and / or the enclosure has an outer diameter larger than an outer diameter of the ring defined by an outer circumference 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 extends 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 aspects of operation 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, whether simulated or not. Thus, according to various embodiments, the ring or support in a compressed state and the film in a confined state 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 a non-compressed state, and / or the specimen can enter the enclosure defined by the film in the deployed state through an opening defined by the ring in the non-compressed state. In various embodiments, the opening or open end defined by the ring can be partially closed while the film remains in the deployed state, 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 outside the confined space in a partially compressed state, and the ring can be released from the partially compressed state to transition to a non-compressed state. The specimen can be removed out of 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, 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 procedures.

[0041] Examples of bags and related accessories and their practical uses are described in U.S. Patent Application Nos. 14 / 885,072, 15 / 068366, 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 to perform the methods described herein, and describes the best mode contemplated by the inventors to carry 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 the present 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. Each combination has not been explicitly described merely for ease of reading this specification.

[0042] While the present invention has been described in a specific embodiment, many further modifications and variations will become apparent to those skilled in the art. It is therefore to be understood that the present 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 are therefore 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 Loop 34 Mooring Tug 41 Cinch

Claims

1. 1. A tissue containment bag comprising: a ring having an inner periphery defining an open end; the ring is 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 tissue storage bag is a film connected to the ring and forming an enclosure having an interior and a closed end; the interior of the enclosure is accessible through an open end defined by the ring, and the film is in a confined state with the film, including a distal end of the film, confined adjacent the ring; The tissue storage bag is a strap connected to the ring; the strap includes a fastener attachment, the fastener attachment configured to releasably connect the strap to itself and releasably attach the strap from a fastened state to an unfastened state, the strap in the fastened state securing the ring in compression and simultaneously securing the film in a confined state, and the strap in the unfastened state releasing the ring from compression and simultaneously releasing the film from the confined state. Tissue storage bag.

2. The tissue containment bag of claim 1 , wherein the strap is attached to the ring and the film.

3. The tissue containment bag of claim 1 , wherein the fastener attachment includes a coupling portion and a receiving portion disposed on the strap.

4. 4. The tissue containment bag of claim 3, wherein the convenience portion is disposed adjacent a first end of the strap and the receiving portion is disposed adjacent a second end of the strap.

5. The tissue containment bag of claim 4 , 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.

6. The tissue containment bag of claim 4 , 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.

7. A tissue containment bag a ring having an inner periphery defining an open end; the ring is 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 tissue storage bag includes: a film connected to the ring and forming an enclosure having an interior and a closed end; the interior of the enclosure is accessible through an open end defined by the ring, and the film is in a confined state with the film, including a distal end of the film, confined adjacent the ring; The tissue storage bag includes: a tab coupled to the ring and having a loop defining an opening; a strap connected to the ring and configured to be threaded through the opening in the loop of the tab; with the strap threaded through the loop, the ring is in a partially compressed state with the open end defined by the ring closed and in a state that is less obstructed than the ring in its compressed state, rather than being unobstructed as in its initial uncompressed state; Tissue storage bag.

8. The tissue containment bag of claim 7 , wherein the tab is coupled to a ring at an opposing location on the strap.

9. The tissue containment bag of claim 8 , further comprising another tab coupled to the ring at a location on the ring between the strap and the tab opposite the strap.

10. The tissue containment bag of claim 8 , wherein the loop of the tab is formed by the tab being bonded to itself.

11. 8. The tissue containment bag of claim 7, wherein the strap includes a fastener attachment configured to place the strap in a fastened or unfastened state, the fastened strap securing the ring in compression and simultaneously securing the film in a confined state, and the unfastened strap releasing the ring from compression and simultaneously releasing the film from the confined state.

12. The tissue containment bag of claim 1 or 7, further comprising a string attached to the ring.

13. The tissue containment bag of claim 12 , wherein the strap has a length that is less than a length of the tether.

14. 14. The tissue containment bag of claim 13, further comprising a tag, the end of the string not attached to the ring being attached to the tag.

15. The tissue containment bag of claim 14 , wherein the film comprises a plurality of films connected to one another and to the ring forming side walls and a closed end and defining an interior of the enclosure.

16. The tissue containment bag of claim 12 , wherein the film extends outwardly away from a periphery of the ring in a deployed state.

17. 20. The tissue containment bag of claim 1, 7 or 16, wherein the film has preformed creases to induce folding of the film into an insertion configuration.

18. 10. The tissue containment bag of claim 1 or 7, further comprising a cinch attached to the film and positioned between the ring and the closed end, the cinch being a double cinch with one end positioned on the outside of the film and the other end positioned on the opposite side of the outside of the film, such that movement of ends of the double cinch in opposite directions away from the bag tightens the film, closing a path from the closed end of the film to the open end of the ring.

19. 10. The tissue containment bag of claim 1 or 7, further comprising a cinch attached to the film and disposed between the ring and the closed end, the cinch being disposed within a film strip attached to the film.

20. 20. The tissue containment bag of claim 19, wherein the film strip has an opening through which one or more ends of the cinch extend.

21. 10. The tissue containment bag of claim 1 or 7, further comprising a cinch attached to the film and positioned between the ring and the closed end, the cinch being positioned within the folded portion of the film.

Images