The present application concerns surgical devices generally, and more particularly, tissue containment bags for receiving and containing tissue during a surgical procedure.
Conventional surgical procedures for resecting abnormal and/or diseased tissue (including organs) are well known. As used herein, “tissue” means a tissue, plural tissues, an organ, plural organs, and/or portions of tissue(s) or organ(s). In conventional procedures, one or more incisions are made to create a port (or ports) through which a surgeon can reach a hand and/or an instrument to access a tissue to be excised. Alternative techniques are also well known, such as, for example, laparoscopic surgery. Laparoscopic surgery generally relates to abdominal and thoracic surgical procedures using instruments (including a camera for viewing the procedure) being inserted through one or more relatively small (e.g., a couple of centimeters) incisions relative to conventional surgical procedures relying on one or more incisions sized to receive a surgeon's hand.
Medical commentators have reported metastases at surgical port sites. Diseased tissue contacting healthy tissue during resection is believed, at least in some instances, to contribute to such port-site metastases. Bags for containing tissue (e.g., diseased tissue) during resection procedures have been used to reduce the likelihood of such contact and have led to reduced instances of port-site metastases. For example, tissue to be resected can be placed in one or more containment bags before dissection. After dissection, the bag containing the tissue can be removed from the surgical port (whether conventional or laparoscopic), completing resection of the tissue and reducing or eliminating contact with healthy tissue. Surgical port(s) can then be closed using known techniques.
Conventional bags for containing tissue during resection generally form a pliable enclosure having an opening portion through which tissue can be inserted. Such bags are often thin-walled, film-like structures formed, at least in part, from a plastic or other polymer acceptable for contacting interior anatomical structures and tissue. However, placing tissue within known bags can be difficult. The opening portion, being formed of a thin-walled and pliable film, is difficult to open when the bag is in a body cavity.
U.S. Pat. No. 5,769,794 discloses a cylindrically shaped tissue retrieval bag having a wide mouth and folds for insertion through an incision to a body cavity to form a flat tray and receive tissue after dissection. The disclosed bag has an annular ring forming a circular rim at the mouth of the bag that automatically opens wide and lies flat on a base portion to form a flat tray on which tissue can be placed. Cylindrical bags, such as disclosed in the '794 patent, suffer from the problem that when a relatively large organ, such as a kidney, is placed in the bag, the organ tends to bunch in the bottom of the bag as the surgeon tries to pull the bag outwardly through the incision, which impedes the extraction and significantly prolongs the procedure. Such bags also require a relatively larger surgical incision.
Other known bags have an overall conical shape comprising a wide mouth and a sharply tapered body portion extending from the mouth. The taper of such bags purportedly facilitates extraction through an incision. Unfortunately, the tapered sides of such bags may prevent an irregularly shaped or elongated organ from settling at the bottom of the bag and therefore the organ can fall out of the bag and into the body cavity, risking undesirable contact between diseased and healthy tissue.
Accordingly, there exists a need for improved tissue retrieval bags and methods for their use.
The present disclosure describes bags for retrieving and/or containing tissue and portions thereof that improve insertion and/or containment of tissue (e.g., organs or portions of organs) in such bags. The disclosed bags generally comprise a wall structure, e.g., a thin-film type wall structure, partially enclosing an internal volume and defining an opening for receiving a tissue.
As will be more fully described, some openings are configured with an elastically deformable mouth portion (e.g., the mouth portion 20 in
Also, tissue bags as disclosed herein can comprise a mouth portion having a first characteristic dimension and a body portion having a second characteristic dimension being greater than the first characteristic dimension. Such configurations can improve retention of tissue within tissue containment bags, thereby reducing the likelihood of undesirable contact between diseased and healthy tissue. Some disclosed bags (e.g., the bag 10 in
In other embodiments, disclosed bags have an overall tapered shape and include a relatively wide mouth and a tapered body for containing tissue. The front of the body has a curved longitudinal wall section in an opposing relationship with a rear wall section of the body that extends perpendicular to the mouth along substantially the entire length of the bag. The curved wall section is sized and shaped to allow a relatively large organ, such as a kidney, to easily settle into and occupy a lower end portion of the bag to prevent or at least minimize the risk of the organ falling out of the bag and into the body cavity. The bag is also shaped to support the organ in the lower end portion of the bag in an orientation that generally aligns the length of the organ in the removal direction to facilitate extraction of the organ from the body.
In one representative embodiment, a tissue retrieval bag for retrieving tissue from a surgical site comprises a flexible body defining a bag interior sized and shaped to receive tissue. The body has an open end in communication with the bag interior and a closed end. The body also has an overall taper from the open end to the closed end such that the body is wider at the open end than at the closed end. The body also has a longitudinal edge comprising a curved convex first section forming the closed end, a curved concave intermediate second section extending from the first section, and a curved convex third section extending from the second section toward the open end of the body. The bag can also have a resilient, self-expandable shape-memory member coupled to the open end. The shape-memory member is configured to be collapsible to a collapsed state by a restraining force for insertion into the body and self-expandable to an expanded state upon removal of the restraining force. In the expanded state, the expanded shape-memory member retains the open end in an open configuration for inserting tissue into the bag interior.
In another representative embodiment, a tissue retrieval bag for retrieving tissue from a surgical site comprises a flexible body defining a bag interior sized and shaped to receive tissue. The body also has an open end in communication with the bag interior and a closed end. The body can also have an overall taper from the open end to the closed end such that the body is wider at the open end than at the closed end. The body can also have a longitudinal edge comprising a curved convex first section forming the closed end, a curved concave intermediate second section extending from the first section, and a curved convex third section extending from the second section toward the open end of the body. The body can also have a wall section opposite the longitudinal edge that extends perpendicular to the open end and substantially straight along the length of the bag from the open end to the closed end.
In another representative embodiment, a method for removing tissue from the body is provided. The method comprises forming an incision in the body, inserting an access device in the incision to provide a hand port for accessing a body cavity, and inserting a tissue bag through the hand port and into the body cavity. The bag can have a deformable, self-expandable mouth portion defining a bag opening and a flexible body defining an interior of the bag sized to receive tissue. After inserting the bag into the cavity, tissue can be placed in the bag and then the bag and the tissue in the bag can be removed from the body cavity via the hand port.
In another representative embodiment, a method for retrieving tissue from the body comprises forming an incision in the body, inserting a trocar having a port sleeve into the incision to access a body cavity, and providing a tissue bag. The bag can have a deformable, self-expandable mouth portion defining a bag opening and a flexible body defining an interior of the bag sized to receive tissue. The method can further include rolling up the bag into a rolled configuration, advancing the bag through the port sleeve and into the body cavity, placing tissue into the bag while it is in the body cavity, removing the mouth portion of the bag from the body cavity such that a portion of the bag body containing the tissue remains in the body cavity, and inserting a surgical instrument into the bag and breaking up the tissue contained in the bag into smaller pieces for removal. For example, a morcellator can be inserted into the bag for morcellating the tissue.
The foregoing and other features and advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.
The present disclosure concerns embodiments of bags for retrieving and containing tissue for removal from the body. By way of example,
As can be seen in, for example,
As seen in the side elevation view of
The illustrated mouth portion 20 is generally curved upwardly away from the body 30 (e.g., a convex portion of the mouth faces the body, and a corresponding concave portion faces away from the body) when the bag 10 is positioned as shown in, for example,
With such a mouth orientation, the neck portion 34 tends to asymmetrically extend from the body 30 such that the leading edge 22 extends a distance L2 from the body 30 and the trailing edge 24 extends a distance L1 from the body 30, with L2 being greater than L1. As described below with respect to
As seen in
Bags and mouth portions thereof as described herein can be constructed of any material suitable for the uses and characteristics described. For example, thin-plastic and/or rubberized films suitable for surgical applications can form the body and neck-portion wall structures. Suitable materials for the bag body include, but are not limited to, polyurethane, polyethylene, PEBAX® block copolyetheramide, or any of various other suitable materials known in the art. These materials can be transparent, as to enable viewing contained tissue, or translucent or opaque. Mouth portions can be formed of any sufficiently resilient and/or shape-memory material that can be deformed as described. Examples of materials that can used to form the mouth portion of a bag include any of various suitable natural or synthetic elastomers, such as silicone rubber, urethane, butyl rubber, buna-L, polyethylene, of any of various suitable metals or metal alloys, such as Nitinol, stainless steel, or various combinations thereof.
As shown in
Viewed in plan from above, as in
With reference to
With reference to
As best shown in
The mouth portion 102 is configured to be self-expandable so that it can be deformed or collapsed into a collapsed state for insertion through a relatively smaller surgical port and self-expand to its expanded state once inside the body. In the illustrated embodiment, for example, the mouth portion 102 comprises an annular shape-memory member 118 that circumscribes or substantially circumscribes the opening 106 of the bag. The shape-memory member 118 can be secured to the body 104 in a suitable manner, such as by containing the shape-memory member 118 in an annular space 124 of the mouth portion (as best shown in
The material used to form the shape-memory member and its wall thickness is selected to allow the mouth portion to be easily deformed or collapsed for insertion into the body and then self-expand to its expanded state once inside the body and retain the opening 106 of the bag in an open configuration for inserting tissue (e.g., an organ) into the bag. Another desirable characteristic of the member 118 is that it exhibits sufficient rigidity in its expanded state to allow use of the mouth portion 102 for scooping tissue into the bag. In particular embodiments, the shape-memory member 118 comprise a piece of tubing made of a material having shape-memory characteristics. For example, the member 118 can be a piece of tubing made of silicone rubber, urethane, butyl rubber, buna-L, polyethylene, Nitinol, or equivalent materials. In a specific example, the member 118 comprises ¼-inch diameter elastomeric tubing. In alternative embodiments, the member 118 can be made from similar materials but can be a non-tubular, elongated piece of material (i.e., a piece of material that does not have an axial opening) and can be formed with any of various cross-sectional shapes. For example, the member 118 can be a flat strip of material. In another implementation, the member 118 can comprise a stainless steel coil.
The bag 100 can include an optional tag 134 that extends outwardly from the leading edge 130 of the mouth portion adjacent the longitudinal edge 108. The tag 134 can include color indicia to help the surgeon easily identify the leading edge of the mouth portion while the bag is inside the patient's body. In one implementation, for example, the bag body is formed from a substantially transparent material to provide visual access to the interior of the bag using for example, a laparoscopic camera, while the tag 134 includes a material that has a different color from the rest of the bag. The contrasting color helps the surgeon easily identify the leading edge of the mouth portion for scooping an organ into the bag and/or removing the bag from the body, as described in detail below. In lieu of or in addition to the tag 134, other portions of the mouth portion 102 or the body 104 can be color coded to help the surgeon position or manipulate the bag within the body.
Referring again to
The kidney, as with some other internal organs, has a gelatinous-like consistency and is sufficiently deformable such that when placed in the bag, it can slide into and substantially occupy the lower portion of the bag (i.e., the kidney deforms and fills out the space in the lower portion of the bag). As shown in
In particular embodiments, the bag 100 can have an overall length L (
However, these specific dimensions (as well as other dimensions provided in the present specification) are given to illustrate the invention and not to limit it. The dimensions provided herein can be modified as needed in different applications or situations.
The access device 142 can be adapted to provide a sealed surgical port that can be used to pressurize the body cavity with an insufflation gas to increase the working space within the body cavity and maintain the body cavity in a pressurized state as surgical instruments or the surgeon's hand are inserted through the access device. Such surgical access devices are known and are not described in detail in the present disclosure. Reference can be made to U.S. Pat. No. 7,163,510, which is incorporated herein by reference, for a detailed description of a surgical access device.
After the kidney to be removed is freed from the patient's vasculature, the surgeon can collapsed the bag with one hand and insert the entire hand through the surgical port into the body, as depicted in
As noted above, the kidney, as with some other internal organs, has a gelatinous-like consistency and is sufficiently deformable such that when placed in the bag, it can slide into and substantially occupy the lower portion and part of the mid-section of the bag. Unlike conventional tapered tissue retrieval bags, the bag 100 is configured to allow the kidney (or another organ) to easily slide into the lower end portion of the bag regardless of the orientation of the organ when it is initially inserted into the bag. For example, if the kidney is initially positioned transverse relative to the bag length (the length of the kidney is perpendicular to the bag length) after it is placed in the bag, there is sufficient room within the upper portion of the bag to allow the kidney to tilt, slide and/or rotate toward the lower portion of the bag. Consequently, because the kidney settles into a position spaced several inches from the upper edge of the mouth portion, the risk of the kidney falling out of the bag and into the abdominal cavity as the surgeon pulls the mouth portion upwardly through the surgical port is greatly reduced. This is in contrast to known bags having a triangular or conical shape, which have tapered sides that can prevent the kidney from moving into a lower portion of the bag. Consequently, such bags suffer from the disadvantage that the kidney can more easily fall out of the bag and into the abdominal cavity as the surgeon pulls the mouth portion upwardly through the surgical port.
To remove the bag and the kidney from the body, and according to one embodiment, the surgeon first pulls the leading edge of the mouth portion upwardly through and out of the surgical port. The curved edge 108 of the bag facilitates removal of the bag by providing a smoothly tapered edge against the side of the hand port. If desired, an optional tether 136 (
In any case, due to the overall tapered shape of the bag, the kidney tends to settle in the bag such the length of the kidney is generally aligned with the direction of removal of the kidney through the surgical port 146, which facilitates removal of the kidney through the surgical port. Moreover, as the kidney slides and/or is pushed into the lower end portion of the bag, the kidney is deformed into a more elongated shape having a smaller, compressed cross-sectional profile perpendicular to its length for easier removal.
When using a conventional non-tapered bag, the kidney can randomly settle within the bag in any orientation. As such, the kidney tends to bunch up in a ball at the bottom of the bag as the surgeon begins to pull the bag through the surgical opening. In contrast, as noted above, the bag 100 causes the kidney to settle in an orientation with its length extending in the removal direction, which prevents or at least minimizes such bunching from occurring.
In order to insert the bag 100 into the body for retrieving the kidney, the bag can be rolled up to achieve a small diameter, such as by rolling the body of the bag onto itself in the direction of the bag length, starting at the bottom of the bag and rolling or winding the bag body onto itself toward in a direction toward the mouth portion 102, as depicted in
Once the bag is advanced from the distal end of the port sleeve into the operative site, the mouth portion of the bag springs open to its expanded state. One or more additional surgical ports can be created in order to insert one or more conventional laparoscopic instruments into the operative site. Using the instruments, the surgeon can manipulate the bag to scoop up or otherwise position the kidney or other organ within the bag. Referring to
In particular embodiments, the bag 100 can include an optional closure device that can be used to close the bag once the tissue to be removed is contained within the bag. For example, as shown in
This disclosure makes reference to the accompanying drawings which form a part hereof, wherein like numerals designate like parts throughout. The drawings illustrate specific embodiments, but other embodiments may be formed and structural changes may be made without departing from the intended scope of this disclosure. Directions and references (e.g., up, down, top, bottom, left, right, rearward, forward, etc.) may be used to facilitate discussion of the drawings but are not intended to be limiting. For example, certain terms may be used such as “up,” “down,”, “upper,” “lower,” “horizontal,” “vertical,” “left,” “right,” and the like. These terms are used, where applicable, to provide some clarity of description when dealing with relative relationships, particularly with respect to the illustrated embodiments. Such terms are not, however, intended to imply absolute relationships, positions, and/or orientations. For example, with respect to an object, an “upper” surface can become a “lower” surface simply by turning the object over. Nevertheless, it is still the same surface and the object remains the same. As used herein, “and/or” means “and” as well as “and” and “or.”
Accordingly, this detailed description shall not be construed in a limiting sense, and following a review of this disclosure, those of ordinary skill in the art will appreciate the wide variety of organ containment bag configurations that can be constructed using the various elements described herein. Moreover, those of ordinary skill in the art will appreciate that the exemplary bags disclosed herein can be adapted to various configurations without departing from the concepts providing enhanced insertion and containment of large volumes of tissue and/or organs, among other advantages.
In view of the many possible embodiments to which the principles of the disclosed invention may be applied, it should be recognized that the illustrated embodiments are only preferred examples of the invention and should not be taken as limiting the scope of the invention. Rather, the scope of the invention is defined by the following claims. I therefore claim as my invention all that comes within the scope and spirit of these claims.
The present application claims the benefit of U.S. Provisional Application No. 61/156,410, filed Feb. 27, 2009 and U.S. Provisional Application No. 61/248,836, filed Oct. 5, 2009, both of which applications are incorporated herein by reference.
Number | Date | Country | |
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61156410 | Feb 2009 | US | |
61248836 | Oct 2009 | US |