US20100219091A1

US20100219091A1 - Tissue retrieval bag

Info

Publication number: US20100219091A1
Application number: US12/715,205
Authority: US
Inventors: Craig Turner
Original assignee: PRIMARY PURPOSE LLC
Current assignee: Anchor Products Co
Priority date: 2009-02-27
Filing date: 2010-03-01
Publication date: 2010-09-02
Also published as: WO2010099541A1

Abstract

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. In one embodiment, a bag has an overall tapered shape and includes 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. 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.

Description

CROSS REFERENCE TO RELATED APPLICATIONS

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.

FIELD

The present application concerns surgical devices generally, and more particularly, tissue containment bags for receiving and containing tissue during a surgical procedure.

BACKGROUND

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.

SUMMARY

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 FIG. 1) that can be collapsed and held in a collapsed state by a restraining force (e.g., by a surgeon's hand) for insertion into and/or removal from an incision or a surgical port. Such elastically deformable mouth portions can return to their expanded, or undeformed, state when the restraining force is released to hold a corresponding bag opening in an open configuration so that tissue can be more easily inserted into the bag.
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 FIG. 1) have an asymmetrically elongated neck portion for increasing the ease with which tissue, particularly large volumes of tissue and/or large organs, can be inserted into the disclosed bags.
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.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a top plan view of a first representative embodiment of a tissue containment bag having an optional throat constrictor, or bag closure device.

FIG. 2 shows an isometric view of the tissue containment bag shown in FIG. 1.

FIG. 3 shows a side elevation view of the tissue containment bag shown in FIG. 1.

FIG. 4 shows a front elevation view of the tissue containment bag shown in FIG. 1.

FIG. 5 shows a top plan view of a second representative embodiment of a tissue containment bag.

FIG. 6 shows an isometric view of the tissue containment bag shown in FIG. 5.

FIG. 7 shows a side elevation view of the tissue containment bag shown in FIG. 5.

FIG. 8 shows a front elevation view of the tissue containment bag shown in FIG. 5.

FIG. 9 shows a side elevation view of a third representative embodiment of a tissue containment bag.

FIG. 10 shows top plan view of the tissue containment bag shown in FIG. 9.

FIG. 11 shows a side elevation view of a tissue containment bag of the type shown in FIGS. 1 and 5 at an intermediate stage of collecting a tissue inside a body cavity.

FIGS. 12A and 12B show an exemplary mouth portion of a bag being folded to a collapsed state for insertion through a surgical opening in the body.

FIG. 13 is a side perspective view of a fourth representative embodiment of a tissue containment bag.

FIG. 14 is a cross-sectional, partial view of the bag shown in FIG. 13 taken along line 14-14.

FIG. 15 is a front elevation view of the bag shown in FIG. 13.

FIG. 16 is a rear elevation view of the bag shown in FIG. 13.

FIG. 17 is a top plan view of the bag shown in FIG. 13.

FIGS. 18-20 illustrate steps in a hand-assisted laparoscopy in which the bag of FIG. 13 is used to retrieve and remove a kidney from the body.

FIGS. 21-23 illustrate steps in a pure laparoscopy in which the bag of FIG. 13 is used to retrieve and contain a kidney while a morcellator is used to cut the kidney into smaller pieces for removal from the body.

FIG. 24 is a side perspective view of a fifth representative embodiment of a tissue containment bag.

DETAILED DESCRIPTION

The present disclosure concerns embodiments of bags for retrieving and containing tissue for removal from the body. By way of example, FIG. 1 shows a bag 10, according to a first representative embodiment, having a mouth portion 20 defining an opening for receiving tissue and a body 30 defining an interior in communication with the opening. The opening in this example is smaller (e.g., d_1,mouth, d_2,mouth) than an interior cross-sectional dimension of the body portion 32 (e.g., D₁, D₂, H). It should be noted that in this embodiment, the body 30 comprises a thin film (e.g., a thin plastic), so the outer dimension D₁is approximately the same as the corresponding interior dimension (not shown).
As can be seen in, for example, FIG. 3, the body 30 can have a constricted, or narrowed, neck portion 34 extending from the mouth portion 20 to a relatively larger tissue-containment portion 32. The neck portion 34 has a characteristic cross-sectional dimension d_neckbeing less than d_1,mouth, d_2,mouth, D₁, D₂and H. Such a relatively narrow neck can help retain tissue within the bag. The flared mouth portion 20 and tapering neck portion 34 can facilitate insertion of tissue by gently guiding the tissue being inserted along a front wall section 36 of the neck, through the constricted neck and into the relatively larger tissue-containment portion 32.
As seen in the side elevation view of FIG. 3, the neck portion 34 can be asymmetrically located relative to the tissue-containment portion 32. Such an asymmetric positioning can provide further improved containment for diseased tissue since a diseased portion of the tissue (not shown) can be placed into the bag 10 so as to be distally located from the mouth 20 and its corresponding opening.
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, FIG. 2. The illustrated mouth portion 20 is tilted relative to the body 30 such that a leading edge 22 extends upwardly of a trailing edge 24, as shown in FIG. 3.
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 L₂from the body 30 and the trailing edge 24 extends a distance L₁from the body 30, with L₂being greater than L₁. As described below with respect to FIG. 11, the leading edge 22 of the curved mouth portion 20 can provide improved support and underlying engagement with tissue, particularly large volumes of tissue and/or large organs, as the mouth portion 20 receives a tissue as by sliding under the tissue.
As seen in FIGS. 1, 2, 3 and 4, the tissue containment bag 10 can have a throat constrictor, or closure device, for closing (or substantially closing) the throat to further reduce the chance of a contained tissue spilling from the bag. As shown in these drawings, the constrictor can comprise a drawstring 28 for cinching the throat 34 closed after tissue has been deposited within the tissue-containment portion 32. As shown, the drawstring 28 can be threaded through eyelets, or apertures, in the throat 34 of the bag. The apertures can be reinforced with grommets or the like to prevent tearing.
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.
FIGS. 5-8 show a tissue containment bag 40, according to a second representative embodiment. The bag 40 has the same construction as the bag 10, except the bag 40 does not include a throat constrictor 28.
FIGS. 9-10 show a tissue containment bag 50, according to a third representative embodiment. The bag 50 has a mouth portion 52 that is different than the configuration of the mouth portion in the first and second representative embodiments. The mouth portion 52 has a first, rear portion 54 having a generally upwardly facing concave curvature facing away from the body 60, a second, forward portion 56 having a generally upwardly facing convex curvature, and at least one inflection-point where the general curvature of the mouth transitions from the first portion 54 to the second portion 56, e.g., from being upwardly concave to upwardly convex, as shown in FIG. 9. Such a mouth portion, when viewed from a side, can take on a gentle S-type curvature. The mouth portion 52, with its narrowed forward portion 56 (FIG. 10) and forward jutting leading edge 58 forms a scoop-like leading edge that can be used for scooping tissue into the bag, such as when the tissue is surrounded by adjacent tissues to be left intact.
As shown in FIG. 10, the rear portion 54 can have a relatively large diameter that smoothly tapers on both edges to the forward portion 56, which is relatively more narrow than the rear portion 54. The rear portion 54 is sized to receive a large volume of tissue after it is scooped up by the leading edge 58. As with the bags described above, a constricted neck portion 62 can be located between the mouth portion and the body, and the trailing edge 64 of the mouth portion can be set closer to the body 60 than the leading edge 58.
Viewed in plan from above, as in FIG. 1, FIG. 5 and FIG. 10, mouth portions of the disclosed bags can generally take any shape. For example, some mouth portions define a circular opening, others define an oval shaped opening (e.g., FIGS. 1 and 5), some define an elliptical opening, and some define a generally oval shaped opening with one end being “pinched,” as shown in FIG. 10, to form a sort of scoop near a leading edge of the mouth portion, such as can be used to selectively engage a tissue.
With reference to FIG. 11, an in situ insertion of a tissue 72 (e.g., a kidney) within a bag 40 is shown. A surgical incision 74 has been made in the patient's outer tissues 76 and the bag 40 has been placed within a body cavity 70. In the illustrated example, a first portion (e.g., leading edge 22) of the mouth portion 20 has been placed in a generally tangential orientation relative to a leading edge 73 of the tissue. The leading edge 22 of the mouth has been slid under the leading edge of the tissue 72. As the mouth passes under the tissue 72, the elongated neck portion 34 can support the tissue and/or guide it through the neck portion into the containment portion 32. Once the tissue 72 has been placed within the bag 40, the constricted neck portion 34 reduces the likelihood the tissue will spill and come into contact with healthy tissue during or after removal from the patient via the incision 74.
With reference to FIGS. 12A and 12B, an elastically deformable, self-expandable mouth portion of the type described above is shown without the corresponding neck and body portions for ease of illustration. When inserting a bag (e.g., bag 10) through a surgical incision or port into the body, the mouth portion can be folded or otherwise collapsed to a collapsed state to facilitate insertion into the body. For example, the mouth portion 20 of the bag 10 (FIG. 1) has a generally oval shape in its relaxed, expanded state. As shown in FIGS. 12A and 12B, for insertion into the body, the mouth portion 20 can be first twisted into a figure-8 configuration (FIG. 12A) and then folded or doubled back on itself to form an exemplary collapsed state, or insertion configuration (FIG. 12B). A surgeon can use his or her hand to contain the mouth portion in this configuration as it is inserted through a surgical opening (e.g., the incision 74 shown in FIG. 11). Once released, the elasticity of the mouth portion causes it to unfurl or expand to its expanded state (FIG. 1). The mouth portion has sufficient rigidity to retain an open configuration when placing tissue in the bag.
FIGS. 13-17 show various views of a fourth representative embodiment of a tissue containment bag, indicated at 100. As best shown in FIG. 13, the bag 100 includes a mouth portion 102 and a body portion 104. The body portion 104 tapers from a first width or diameter at the mouth portion 102 to a second, smaller width or diameter at the bottom of the bag (i.e., the end opposite the mouth portion). The mouth portion 102 defines an opening 106 that is in communication with the interior of the bag. The mouth portion 102 has a leading edge 130 and a rear, or trailing, edge 132. As shown in FIG. 17, the mouth portion 102 in this embodiment comprises an oval ring when viewed in a top plan view. In alternative embodiments, the mouth portion 102 can have any of the various shapes described above, such as circular, elliptical, oval, an overall concave shape, such as shown in FIG. 3, and/or an overall tapered or pinched shape, as such as shown in FIG. 10.
As best shown in FIG. 13, the front side of the body 104 in the illustrated configuration has a front wall section that includes a longitudinal edge 108 that forms the closed end of the bag and extends lengthwise of the bag to the mouth portion 102. The longitudinal edge 108 can have a first, curved convex section 110 that forms the bottom, or closed end of the bag, a second, curved concave section 112 that extends from the first section 110 along a mid-section of the body, and a third, curved convex section 114 that extends from the second section 112 to the mouth portion 102. The rear of the body 104 in the illustrated embodiment includes a rear wall section that extends along a substantially straight path along the length of the bag and can intersect section 110 of the longitudinal edge 108 at the lower end of the body and the mouth portion 102 at the upper end of the body. The body 104 can be formed from a sheet of polymeric material that has two opposing longitudinal edge portions 120, 122 (FIG. 15) that are secured to each other (such as by welding or adhesives) to form the longitudinal edge 108 of the formed body 104.
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 FIG. 14). The annular space 124 can be formed by folding an upper portion 126 of the material used to form the body over and around the shape-memory member 118 and securing the upper portion 126 to itself at 128, such as by welding, stitching, or adhesives.
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 FIG. 13, the overall shape of the body 104 of the bag is particularly suited to retrieve and remove organs having an elongated shape (e.g., a kidney) from the body. For purposes of illustration, FIG. 13 shows an average-sized adult kidney 140 contained within the bag 100. Applicant has found that an average sized adult kidney, including attached fatty tissue on the outer surface of the kidney, is about 20 cm in length, about 12 cm in width, and about 8.5 cm in thickness. The opening and upper portion of the body desirably is larger than the average width and thickness of a kidney (or other organ to be retrieved) to facilitate initial insertion of the organ into the bag.
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 FIG. 13, the bag 100 in particular embodiments desirably is sized and shaped such that an average sized kidney will occupy the lower portion and part of the mid-section of the bag, leaving sufficient space between the upper rim of the bag and the top of the organ inside the bag to help ensure that the organ remains in the bag as it is removed from the body. The tapered lower end portion is sized and shaped to maintain the organ (e.g., kidney 140) in a position in the bag such that the organ can be pulled lengthwise along the direction of removal through a surgical incision or hand port when the bag and organ are removed from the body.
In particular embodiments, the bag 100 can have an overall length L (FIG. 13) of about 6 inches to about 20 inches, with about 12 inches being a specific example. The bag 100 can have a maximum diameter D_max(FIG. 17) at the mouth portion 102 of about 4 inches to about 10 inches, with about 6.5 inches being a specific example. The mouth portion 102 of the bag 100 can have a minimum diameter D_min(FIG. 17) of about 3 inches to about 8 inches, with about 4.5 inches being a specific example. The portion of the bag 100 containing kidney 140 can have a maximum width W near the mid-section of concave section 112 of about 4.5 to about 5.5 inches.
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.
FIGS. 18-20 illustrate a hand-assisted laparoscopic procedure for retrieving and removing an organ from the body using the bag 100. In this example, the bag 100 is shown being use to remove a kidney 140 from the body, although the bag 100 (and other bags disclosed herein) and the disclosed procedure can be used to remove any other organs (or portions thereof) from the body. As shown in FIG. 18, the surgeon creates an incision (e.g., about 10-12 cm) through the surface tissue layers large enough to allow the surgeon's hand to be inserted into the operative site 144 below the skin. A surgical access device 142 (which can be a thin, flexible sleeve in certain embodiments) (shown schematically in FIG. 18) typically is placed within the incision to create a surgical port 146 (also referred to as a hand port) for accessing the operative site 144 within the abdominal cavity. As used herein, the term “surgical port” refers to the lumen or opening that extends through any surgical access device that is placed within an incision. A surgical port can be a relatively large hand port that allows insertion of a hand into a body cavity or a smaller laparoscopic port that allows access of small surgical instruments.
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 FIG. 18. After inserting the bag into the body, the surgeon can release the mouth portion 102 of the bag to allow the mouth portion to spring open. The kidney can then be inserted into the bag 100 in any convenient manner. In one approach, as depicted in FIG. 19, the surgeon can use the mouth portion 102 as a scoop, such as by grasping the mouth portion 102 at the front of the bag, placing the trailing edge of the mouth portion underneath the kidney and scooping it into the bag.
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 (FIG. 13) (e.g., a piece of string or flexible wire) can be secured to the tag 134 or directly to the leading edge 130 of the mouth portion to assist in pulling the leading edge of the bag upwardly through the surgical port. In one specific approach, as depicted in FIG. 20, the entire mouth portion is pulled out of the surgical port before the surgeon begins to pull the remaining portion of the bag, along with the kidney, from the body. During the process of placing the kidney in the bag, a relatively small kidney may be able to slide all the way to the closed end of the bag under gravity. A relatively larger kidney may slide partially into the lower end portion of the bag under gravity. As the curved edge 108 is withdrawn upwardly through the port, the surrounding tissue exerts inward pressure against the bag and the kidney because the size of the surgical incision typically is smaller than the smallest dimension of the kidney. Due to the shape of the curved edge 108, the kidney is forced to move all the way to the closed end of the bag and substantially occupy the lower end portion of the bag. Stated differently, the inward force of the surrounding tissue against the curved edge 108 forces or pushes a relatively larger kidney further into the lower end portion of the bag.
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.
FIGS. 21-23 illustrate a pure laparoscopic procedure for retrieving and removing an organ (a kidney 140 in the illustrated example) from the body using the bag 100. In this procedure, the bag 100 is used to retrieve and contain the kidney as the surgeon cuts the kidney into smaller pieces for removal from the body. A relatively small incision (e.g., about 10-12 mm) is made in the surface tissues and a conventional trocar or equivalent mechanism is inserted through the incision. The trocar has a port sleeve 150 (shown schematically in FIG. 22) that serves as a surgical port for accessing the operative site 144 within the abdominal cavity. As known in the art, the trocar can have a sharpened center portion (not shown) that cuts or spreads fascia and muscle during insertion. This component typically is removed, leaving the port sleeve 150 in place for accessing the body cavity.
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 FIG. 21. As shown in FIG. 22, the rolled up bag 100 is then pushed downwardly through the port sleeve of the trocar into the operative site 144 within the abdominal cavity. The shape-memory member 118, which is relatively stiffer than the bag body, provides enough rigidity to the rolled-up bag for pushing it through the sleeve.
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 FIG. 23, after the kidney or other organ is placed within the bag, the port sleeve can be removed and the mouth portion 102 of the bag can be pulled upwardly through the incision to position the mouth portion outside of the body. Thereafter, a morcellator 152 or another surgical instrument can be inserted into the bag, as depicted in FIG. 23, for cutting or otherwise tearing the kidney into smaller pieces. For example, the distal end portion 154 of the morcellator has a cutting blade (not shown) for cutting the kidney into smaller pieces, which can then be removed from the body through the incision. The pieces of tissue can be aspirated through the lumen of the morcellator or removed from the body using a separate instrument. After the kidney is removed piecemeal from the body via the bag, the bag can then be removed from the body.
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 FIG. 13, the bag 100 can include an optional drawstring 138 that can be tightened or cinched to collapse the mouth portion 102. The drawstring 138 can extend through the annular space 124 (FIG. 14) and can have exposed end portions that extend outwardly from the mouth portion (FIG. 13). In other implementations, the drawstring 138 can be spaced from the mouth portion 102, for example, one to three inches below the mouth portion 102. The drawstring can be threaded through eyelets, such as shown in FIG. 2. Spacing the drawstring from the mouth portion can help close the bag more tightly when cinching the drawstring.
FIG. 24 illustrates a bag 200, according to a fifth representative embodiment. The bag 200 includes a self-expandable mouth portion 202, a tapered body 204 extending from the mouth portion 202, and a longitudinal edge 206 extending from the closed end of the bag to the mouth portion. The construction of the bag 200 can be the same as that of the bag 100, except that the shape of the longitudinal edge is slightly modified. Specifically, in the embodiment of FIG. 24, the longitudinal edge 206 includes a lower convex section 208, a concave section 210 extending from the convex section along a mid-section of the body, an upper convex section 212 extending from the concave section 210, and a straight section 214 extending from the upper convex section 212 to the mouth portion 202. The upper convex section 212 and the straight section 214 define the upper portion of the bag body 204. Although the portion of the bag body extending along the straight section 214 is not tapered, the bag body is considered to have an overall tapered shape that tapers from a maximum width at the mouth portion to a minimum width at the closed end of the bag. The non-tapered portion of the body is provided to increase the overall length of the bag without enlarging the size of the bag opening. The bag 200 can be used in the same manner to retrieve and remove tissue from a patient's body as described above in connection with the bag 100.
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.

Claims

1. A tissue retrieval bag for retrieving tissue from a surgical site, the bag comprising:

a flexible body defining a bag interior sized and shaped to receive tissue, the body having an open end in communication with the bag interior and a closed end, the body having 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 having 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; and

a resilient, self-expandable shape-memory member coupled to the open end and 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, the expanded shape-memory member retaining the open end in an open configuration for inserting tissue into the bag interior.

2. The tissue retrieval bag of claim 1, wherein the body comprises a sheet of flexible material having two longitudinal edge portions that are welded together to define the longitudinal edge of the body.

3. The tissue retrieval bag of claim 1, wherein the open end of the body is oval when the shape-memory member is in its expanded state.

4. The tissue retrieval bag of claim 1, wherein the shape-memory member comprises elastomeric tubing.

5. The tissue retrieval bag of claim 1, further comprising an extension portion extending radially outwardly from the open end of the body adjacent the longitudinal edge.

6. The tissue retrieval bag of claim 5, wherein the extension portion has color indicia.

7. The tissue retrieval bag of claim 1, wherein the body comprises a wall section opposite the longitudinal edge, the wall section extending substantially straight along the length of the bag from the open end to the closed end.

8. The tissue retrieval bag of claim 1, wherein the longitudinal edge comprises a straight section extending from the third section to the open end of the body.

9. The tissue retrieval bag of claim 1, wherein the shape-memory member is disposed within an annular space circumscribing the bag opening, the annular space being formed from an upper portion of the body that extends around the shape-memory member.

10. A tissue retrieval bag for retrieving tissue from a surgical site, the bag comprising:

a flexible body defining a bag interior sized and shaped to receive tissue, the body having an open end in communication with the bag interior and a closed end, the body having 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 having 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 also having a wall section opposite the longitudinal edge, the wall section extending perpendicular to the open end and substantially straight along the length of the bag from the open end to the closed end.

11. The tissue retrieval bag of claim 10, further comprising a deformable and resilient mouth portion that is collapsible to a collapsed state for insertion into the body and expandable to an open configuration for inserting tissue into the bag.

12. The tissue retrieval bag of claim 11, wherein the mouth portion comprises a shape-memory member substantially surrounding the bag opening.

13. The tissue retrieval bag of claim 10, further comprising a closure device configured to close the bag.

14. The tissue retrieval bag of claim 13, wherein the closure device comprises a drawstring.

15. A method for removing tissue from the body, comprising:

forming an incision in the body;

inserting an access device in the incision to provide a hand port for accessing a body cavity;

inserting a tissue bag through the hand port and into the body cavity, the bag having a deformable, self-expandable mouth portion defining a bag opening and a flexible body defining an interior of the bag sized to receive tissue;

placing tissue in the tissue bag; and

removing the bag and the tissue in the bag from the body cavity via the hand port.

16. The method of claim 15, wherein placing the tissue in the bag comprises holding the mouth portion in a hand and scooping the tissue into the bag using the mouth portion.

17. The method of claim 15, wherein the organ comprises a kidney and the bag is configured such that the kidney, when placed in the bag, is oriented with its length aligned with the removal direction of the bag through the hand port.

18. A method for retrieving tissue from the body, comprising:

forming an incision in the body;

inserting a trocar having a port sleeve into the incision to access a body cavity;

providing a tissue bag, the bag having a deformable, self-expandable mouth portion defining a bag opening and a flexible body defining an interior of the bag sized to receive tissue;

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 morcellator into the bag and morcellating the tissue contained in the bag.