Patent Description:
Abdominal surgical procedures often entail entry into a patient's abdominal cavity and subsequent manipulation of internal structures therein, such as the small intestine, colon, mesentery, and other fatty structures. For example, large portions of a patient's small intestine are often displaced to provide clear access to the patient's spleen in some surgical procedures thereon. Gauze pads and/or sponges are often used to dam-up the displaced structures. Pads and/or sponges often slip and/or are difficult to place, however, especially through smaller incision sites. The pads and/or sponges are also typically carefully accounted for during surgery, thereby preventing one from being left behind within the patient.

Recent abdominal surgical procedures prefer smaller incisions, for example, laparoscopic surgeries. Laparoscopic surgical procedures often involve multiple small incisions of from between about five millimeters to about twelve millimeters. Some more complex procedures include a larger single incision. For instance, a five centimeter incision at the umbilicus that is circumferentially retracted by a circular wound retractor accommodates several laparoscopic instruments at the same time, or even a surgeon's hand extending into the abdominal cavity. Maintaining a clear operative area within the abdominal cavity while limiting the access area is desirable.

Additionally, surgical procedures of the lower abdomen and pelvis are also performed using single-incision techniques, in which a clear, unrestricted working space is also desirable.

Examples of known retractor for use in surgical procedures are disclosed in <CIT>, <CIT>, <CIT> and <CIT>.

According to the present invention there is provided a surgical access device as recited in claim <NUM>.

Similar reference characters refer to similar features throughout.

<FIG> is a front view of a patient <NUM> for surgery of the abdomen <NUM> with an incision site <NUM> at the umbilicus. <FIG> is a partial cross section illustrating abdominal content <NUM> confined by a body wall <NUM>, various adhesions, and connections. The content <NUM> is generally moist, slippery, and difficult to manage, and is especially true for the small intestine <NUM>. As shown schematically in <FIG> and in a partial side cross section in <FIG>, a circular retractor <NUM> is placed through an incision in the body wall <NUM> and into an abdominal cavity <NUM>, thereby providing a surgeon with clear access to the abdominal content <NUM>.

<FIG> is a perspective view of an embodiment of a surgical access device <NUM> comprising a wound retractor <NUM> and an adjustable internal retractor <NUM>. The wound retractor <NUM> is disposed at a proximal end <NUM> of the device <NUM>, and the internal retractor <NUM> is disposed at a distal end <NUM>. A longitudinal axis <NUM> extends from the proximal end <NUM> to the distal end <NUM>. An access channel <NUM> extends through the device <NUM>.

In the illustrated embodiment, the wound retractor <NUM> comprises a proximal or outer ring <NUM>; a deformable distal or inner ring <NUM>; and a flexible, tubular sheath <NUM> disposed between the outer ring <NUM> and the inner ring <NUM>.

The inner ring <NUM> is deformable or flexible, which permits a user to insert the inner ring <NUM> through an incision or opening in a body wall with a smaller diameter than a relaxed diameter of the inner ring <NUM>, and into a body cavity. The inner ring <NUM> is also sufficiently rigid to resist deformation when disposed against an inner surface of the body wall and under tension by the tubular sheath <NUM> extending through the incision or opening.

The wound retractor <NUM> is adjustable or non-adjustable. In the illustrated embodiment, the wound retractor <NUM> is an adjustable wound retractor. In the illustrated embodiment, the outer ring <NUM> is rotatable around an annular axis thereof, which winds and/or unwinds the tubular sheath <NUM> therearound, thereby adjusting an effective length of the tubular sheath <NUM> and a distance between the outer ring <NUM> and the inner ring <NUM>. This adjustability permits a user to retract an opening or wound in a body cavity. The illustrated outer ring <NUM> comprises a first tube 252a and a second tube 252b. In other embodiments, the outer ring <NUM> has another shape, for example, comprising an oval, elliptical, and/or elongated cross section, with a major or longer axis either parallel with or perpendicular to the longitudinal <NUM>. In some embodiments, the outer ring <NUM> further comprises one or more circumferential lumens. In some embodiments, a wire or hoop is disposed in one or more of the lumens. In some embodiments, the wire(s) or hoop(s) is non-compliant. In some embodiments, the wire(s) or hoop(s) is a split hoop.

The outer ring <NUM>, inner ring <NUM>, and tubular sheath <NUM> independently comprise any suitable biocompatible material, for example, one or more polymer resins. In embodiments in which the outer ring <NUM> comprises a wire or hoop, the wire or hoop comprise at least one of metal, stainless steel, spring steel, nitinol, polymer, ceramic, fibers, composites thereof, and the like.

In some embodiments, the retractor <NUM> is manufactured in a plurality of sizes, for example, diameters of at least one of the outer ring <NUM>, the inner ring <NUM>, and sheath <NUM>, and/or length of the sheath <NUM>. Some embodiments of the access device <NUM> further comprise a cap or lid (not illustrated) couplable to the outer ring <NUM>, which closes and/or seals the access channel <NUM>. Some embodiments of the cap or lid permit instrument and/or hand access through the cap or lid and into the access channel <NUM>. Suitable wound retractors, caps, and lids are also disclosed in <CIT>; <CIT>; and <CIT>, and <CIT>.

The internal retractor <NUM> in the illustrated embodiment is coupled to the inner ring <NUM> of the retractor <NUM> and extends distally of the inner ring <NUM>. In the illustrated embodiment, the internal retractor <NUM> comprises a plurality of a plurality of elongate, shapeable members <NUM>, each extending distally from the inner ring <NUM> of the wound retractor <NUM>. In the illustrated embodiment, each shapeable member <NUM> angles away from the longitudinal axis <NUM>, although in other embodiments, one or more of the shapeable members <NUM> extends in a different direction, for example, substantially parallel with the longitudinal axis <NUM> and/or towards the longitudinal axis <NUM>.

Each shapeable member <NUM> in the illustrated embodiment comprises an elongate segment and/or wing that comprises any suitable material, for example, at least one of a polymer resin or metal. Some embodiments of the shapeable members <NUM> comprise an elastically deformable material, for example, metal, stainless steel, spring steel, polymer, fibers, and combinations thereof. Some embodiments of the shapeable members <NUM> comprise a malleable and/or plastically deformable material, for example, metal, stainless steel, a super elastic material, a shape memory material, clay, clay-like material, and combinations thereof. In some embodiments, one or more of the shapeable members <NUM> is partially or completely coated and/or covered with at least one of fabric, gauze, and foam thereby improving traction and/or fluid absorption. In some embodiments, one or more of the shapeable members <NUM> is partially or completely coated and/or covered with a fluid repellant and/or fluid impermeable material. In some embodiments, one or more of the shapeable members <NUM> comprises a textured and/or non-slip surface. Some embodiments of the shapeable members <NUM> comprise, for example, wire, strips, sheets, and perforated sheets.

In some embodiments one or more of the shapeable members <NUM> is curved along a transverse axis, thereby stiffening the shapeable members <NUM> using the principle that stiffens a Venetian blind slats. In the illustrated embodiment, at least one of an angle with the longitudinal axis <NUM>, and a shape of each individual shapeable member <NUM> is adjustable, thereby retracting structures or organs from, and/or preventing structures or organs from entering a selected surgical field or area, thereby improving access to surgical targets therein. For example, in some embodiments, at least a portion of a shapeable member <NUM> is bendable transverse to a local longitudinal axis <NUM> thereof. In some embodiments, at least a portion of a shapeable member <NUM> is bendable or twistable around the local longitudinal axis <NUM>.

In some embodiments, at least one of the shapeable members <NUM> is integrated with the inner ring <NUM>. In some embodiments, at least one of the shapeable members <NUM> is separately manufactured, then coupled to the inner ring <NUM>. For example, some embodiments of the inner ring <NUM> comprise at least one connecting feature to which the shapeable members <NUM> are coupled. In some embodiments, a proximal end of at least one shapeable member <NUM> comprises a connecting feature that secures the shapeable member <NUM> to the inner ring <NUM> at a desired angle with respect to the longitudinal axis <NUM>. Suitable connecting features include, for example, mechanical fasteners, clips, clamps, friction fittings, hook-and-loop fasteners, snaps, ties, screws, latches, joints, hinges, ball joints, living hinges, and the like. In some embodiments, the shapeable members <NUM> are coupled to the inner ring <NUM> as a unit, for example, joined by a web and/or ring at a proximal end of the internal retractor <NUM>. In some embodiments, shapeable members <NUM> are individually coupled to the inner ring <NUM>. In some embodiments, one or more of the shapeable members <NUM> are removable as desired, for example, by cutting, breaking off, and the like. In some embodiments, the internal retainer <NUM> is removable, for example, after completing a portion of a surgical procedure. Some embodiments of the internal retractor <NUM> are not coupled to a wound retractor and are used independently of the wound retractor.

In the illustrated embodiment, the local axis <NUM> of each shapeable member <NUM> is substantially normal to the inner ring <NUM>. In other embodiments, the local axis <NUM> of at least one shapeable member <NUM> subtends another angle with the inner ring <NUM> in a generally helical configuration. For example, in some embodiments, all of the shapeable members <NUM> together define a helical internal retractor <NUM>.

Some embodiments of the internal retractor <NUM> further comprise a dam or cover (not illustrated) that is securable to one or more of the shapeable members <NUM>, thereby defining an umbrella-like structure, which improves retraction of internal organs. The cover is similar to the dam portions described and illustrated below, and like the dam portions, comprises a single piece or a plurality of pieces, and similar materials. The cover is permanently or temporarily secured, for example, using adhesive, pressure sensitive adhesive, mechanical fasteners, clips, clamps, friction fittings, hook-and-loop fasteners, snaps, ties, screws, latches, and the like. In some embodiments, the cover comprises one or more pockets dimensioned to receive one or more of the shapeable members <NUM> therein. In some embodiments, one or more portions of the cover are removable by a user, for example, by cutting or tearing.

<FIG> is a perspective view of an embodiment of a surgical access device <NUM> in accordance with the present invention which has similarities with the embodiment discussed above. The access device <NUM> comprises a proximal end <NUM>, a distal end <NUM>, a longitudinal axis <NUM>, an access channel <NUM>, a wound retractor <NUM> disposed at the proximal end <NUM>, and an adjustable internal retractor <NUM> disposed at the distal end <NUM>. The wound retractor <NUM> is generally similar to the embodiment of the wound retractor <NUM> described above, and comprises an outer ring <NUM>, an inner ring <NUM>, and a flexible sheath <NUM>. The internal retractor <NUM> is integrated with the wound retractor <NUM> or manufactured as a separate component, which is preattached to the wound retractor <NUM> or user attached, or used without coupling to a wound retractor, as discussed above.

The illustrated embodiment of the internal retractor <NUM> comprises a plurality of longitudinally extending inflatable supporting members <NUM> and a plurality of dam portions <NUM> extending between adjacent supporting members <NUM>. In other embodiments, a single dam portion <NUM> extends across a plurality of inflatable supporting members <NUM>. The illustrated embodiment also comprises a peripheral ring <NUM>. In some embodiments, the peripheral ring <NUM> is fluidly connected to at least one supporting member <NUM>, and consequently, is inflatable with the at least one supporting member <NUM>. In other embodiments, the peripheral ring <NUM> is not inflatable. In some embodiments, the peripheral ring <NUM> comprises a plurality of linked members, for example, ball-and-socket segments. In the illustrated embodiment, the internal retractor <NUM> is generally frustoconical in an inflated state, diverging distally from the longitudinal axis <NUM>.

In the illustrated embodiment, the internal retractor <NUM> comprises an open area or window <NUM>, which permits access to tissue and/or organs outside the perimeter of the internal retractor <NUM>. The open area or window <NUM> allows a surgeon to place instruments and/or a hand into areas above, to the side of, and/or below the internal retractor <NUM>, which is useful, for example, when working in the lower abdomen or pelvis. Some embodiments comprise a plurality of open areas or windows <NUM>. In some embodiments, the internal retractor <NUM> is supplied without an open area or window <NUM>, and the user creates one or more as desired, for example, by removing selected dam portions <NUM>. In some embodiments, the spacing of the supporting members <NUM> is not uniform, thereby permitting a user to select a desired size of the open area or window <NUM>.

Embodiments of the internal retractor <NUM> comprise at least one of rubber, polymer resin, fabric, foam, and elastomer. In some embodiments, the supporting members <NUM>, the dam portions <NUM>, and the peripheral ring <NUM> comprise different materials. Some embodiments of the dam portions <NUM> comprise at least one of polymer, membrane, film, rubber, webbing, gauze, film, fabric, woven fabric, non-woven fabric, and knit fabric. In some embodiments, the dam portions <NUM> comprise an elastomeric or stretchable material, for example spandex. Some embodiments of the internal retractor <NUM> further comprise at least one flexible reinforcing member, for example, one or more ribs disposed on, through, or within at least one supporting member <NUM>, dam portion <NUM>, and/or the peripheral ring <NUM>. In some embodiments, at least one supporting reinforcing member <NUM> is elastically deformable. In some embodiments, at least one supporting member <NUM> is plastically deformable. Suitable materials for the supporting member are described above. Suitable materials for the reinforcing members <NUM> include at least one of metal, a super elastic material, a shape memory material, polymer, fibers, and composites thereof. In some embodiments, the reinforcing members comprise at least one of wires, strips, bands, and the like.

In some embodiments, a retraction and/or retention force that the internal retractor <NUM> exerts on internal organs depends on the degree of inflation thereof. Consequently, the retraction and/or retention force is adjustable by the end user. Embodiments of the internal retractor are inflatable with gas, carbon dioxide, nitrogen, air, liquid, water, saline, Ringer's solution, isotonic solutions, and the like. In some embodiments, the inflation fluid is cooled and or heated as desired.

<FIG> is a perspective view of another embodiment of a surgical access device <NUM> that is generally similar to the embodiments discussed above. The access device <NUM> comprises a longitudinal axis <NUM> extending from a proximal end <NUM> to a distal end <NUM>, an access channel <NUM> extending through the device <NUM>, a wound retractor <NUM> at the proximal end <NUM>, and an adjustable internal retractor <NUM> at the distal end <NUM>. The wound retractor <NUM> is generally similar to the embodiments of the wound retractor described above, and comprises an outer ring <NUM>, an inner ring <NUM>, and a flexible sheath <NUM>. Embodiments of the internal retractor <NUM> are integrated, preattached, or user attached to the wound retractor <NUM>, or used without coupling to a wound retractor, as discussed above.

In the illustrated embodiment, the internal retractor <NUM> comprises a plurality of individual segments <NUM> arrayed in a fan-like configuration. In the illustrated embodiment, each segment <NUM> angles away from the longitudinal axis <NUM>. At least some of the segments <NUM> are slidably coupled to a hub <NUM>, thereby defining an iris-like or folding-fan structure, there by allowing a user to adjust an opening or window <NUM> in the internal retractor as desired, thereby adjusting the degree of retention and/or retraction of internal organs. In the illustrated embodiment, the hub <NUM> comprises one or more tracks in which a proximal end of at least some segments <NUM> is slidably coupled. In some embodiments, the internal retainer <NUM> comprises a one-way mechanism that permits opening in one direction, only. In some embodiments, at least a portion of some of the segments <NUM> is malleable or plastically deformable. In the illustrated embodiment, a flexible cover or dam <NUM> similar to the cover or dam described above, is disposed over one or more of the segments <NUM>.

<FIG> illustrates in a perspective view another embodiment of a surgical access device <NUM> that is generally similar to the embodiments described above. The surgical access device <NUM> comprises a longitudinal axis <NUM> extending from a proximal end <NUM> to a distal end <NUM>, an access channel <NUM> extending through the device <NUM>, a wound retractor <NUM> disposed at the proximal end <NUM> and an internal retractor <NUM> disposed at the distal end <NUM>. The wound retractor <NUM> is generally similar to the embodiments of the wound retractor described above, and comprises an outer ring <NUM>, an inner ring <NUM>, and a flexible sheath <NUM>. Embodiments of the internal retractor <NUM> are integrated, preattached, or user attached to the wound retractor <NUM>, or used without coupling to a wound retractor, as discussed above.

The internal retractor <NUM> comprises a distally extending skirt member <NUM> and a support member <NUM> coupled to a distal portion of the skirt member <NUM>. Embodiments of the skirt member <NUM> comprise any material as discussed above for the cover or dam portion. Embodiments of the support member <NUM> comprise one or more of elastic, malleable, and/or plastically deformable portions, for example comprising one or more of the materials described above. In the illustrated embodiment, the support member <NUM> comprises an inwardly extending projection <NUM> defining and extending over an undercut or hollow portion <NUM>, which provides the support member <NUM> with shape-memory characteristics. In other embodiments, the support member <NUM> comprises a plurality of linked members, for example, ball-and-socket segments.

The illustrated embodiment also comprises a window <NUM>. In some embodiments, the window <NUM> is preformed. In others, the window <NUM> is user created. In the illustrated embodiment, the window <NUM> includes a gap in the support member <NUM>. In other embodiments, the window <NUM> extends only through the skirt member <NUM> and does not comprise a gap in the support member <NUM>.

<FIG> is a perspective view of another embodiment of an access device <NUM> that is generally similar to the embodiments described above. The surgical access device <NUM> comprises a longitudinal axis <NUM> extending from a proximal end <NUM> to a distal end <NUM>, an access channel <NUM> extending through the device <NUM>, a wound retractor <NUM> disposed at the proximal end <NUM> and an internal retractor <NUM>. The wound retractor <NUM> is generally similar to the embodiments of the wound retractor described above, and comprises an outer ring <NUM>, an inner ring <NUM>, and a flexible sheath <NUM>. Embodiments of the internal retractor <NUM> are integrated, preattached, or user attached to the wound retractor <NUM>, or used without coupling to a wound retractor, as discussed above.

The internal retractor comprises a tubular skirt <NUM> coupled to the wound retractor <NUM> and a retention ring <NUM> coupled to the free end of the skirt <NUM>. In the illustrated embodiment, a diameter of the retention ring <NUM> is larger than a diameter of the outer ring <NUM> or the inner ring <NUM>. In the illustrated embodiment, the tubular skirt <NUM> is coupled to the distal end of the wound retractor <NUM>, for example, the inner ring <NUM>. In other embodiments, the tubular skirt <NUM> is coupled to the proximal end of the of the wound retractor <NUM>, for example, the outer ring <NUM>. The skirt <NUM> comprises any suitable flexible material, for example, the materials described above for the cover or dam portion. The retention ring <NUM> comprises a malleable, deformable, shapeable, plastically deformable, and/or elastically deformable material, for example any of the materials described above. Some embodiments of the retention ring <NUM> comprise an internal malleable or plastically deformable spine. Some embodiments comprise a plurality of linked members, for example, ball-and-socket segments. Consequently, some embodiments of the retention ring are shapeable in a plane or in all directions.

The illustrated embodiment of the internal retractor <NUM> does not comprise a window. In some embodiments, one or more windows are preformed in the skirt <NUM>. In some embodiments, a user creates windows in the skirt <NUM> as desired.

The internal retractor <NUM> is illustrated in an undeployed state in <FIG> with the retention ring <NUM> is disposed proximally of the outer ring <NUM> of the wound retractor <NUM>, with the skirt <NUM> extending through the access channel <NUM>. <FIG> illustrate a intermediate states in converting the internal retractor <NUM> from the undeployed state or configuration illustrated in <FIG>, to a deployed state or configuration illustrated in <FIG> in which the retention ring <NUM> is distal of the inner ring <NUM>. In the illustrated method, the retention ring <NUM> is passed through the access channel <NUM> through the wound retractor <NUM>. In the conversion process, the large-diameter retention ring <NUM> is squeezed, twisted, and/or otherwise deformed to a size that fits through the access channel <NUM>. In the deployed state or configuration illustrated in <FIG>, the large-diameter retention ring <NUM> is shaped and/or adjusted to retract the internal organs from a desired area in the body cavity. For example, in some embodiments, the retention ring <NUM> is nested beneath internal structures <NUM> (<FIG>), where the weight of the structures <NUM> secures the retention ring <NUM> in place.

<FIG> illustrates in perspective view another embodiment of a surgical access device <NUM> that is generally similar to the embodiments described above. The surgical access device <NUM> comprises a longitudinal axis <NUM> extending from a proximal end <NUM> to a distal end <NUM>, an access channel <NUM> extending through the device <NUM>, a wound retractor <NUM> disposed at the proximal end <NUM> and an internal retractor <NUM>. The wound retractor <NUM> is generally similar to the embodiments of the wound retractor described above, and comprises an outer ring <NUM>, an inner ring <NUM>, and a flexible sheath <NUM>. Embodiments of the internal retractor <NUM> are integrated, preattached, or user attached to the wound retractor <NUM>, or used without coupling to a wound retractor, as discussed above.

In the illustrated embodiment, the internal retractor <NUM> comprises a proximal, short tubular skirt <NUM> coupled to a distal, inflatable torus <NUM>. Some embodiments of the internal retractor <NUM> do not comprise a skirt. In the undeployed state, the torus <NUM> is uninflated, while in the deployed state, the torus <NUM> is selectively inflated. Some embodiments of the skirt <NUM> and/or torus <NUM> comprise stiffening or reinforcing members.

In the illustrated embodiment, the internal retractor <NUM> comprises a generally hollow cylinder or tube with open ends through which the access channel extends. In other embodiments, the internal retractor <NUM> has another shape, for example, an elliptical cylinder, or frustoconical with the larger end distal or with the smaller end distal. Embodiments of the internal retractor <NUM> are manufactured in a range of diameters and/or lengths. The internal retractor <NUM> is elastically deformable or plastically deformable. In some embodiments, one or more portions of the internal retractor <NUM> are elastically deformable and one or more portions are plastically deformable. Plastically deformable portions permit a user to shape the internal retractor <NUM> as desired. The internal retractor <NUM> is sufficiently deformable radially to permit insertion through an incision and/or the wound retractor <NUM>.

In the illustrated embodiment, the internal retractor <NUM> comprises a plurality of stacked, annular segments <NUM>. In the illustrated embodiment, the annular segments <NUM> are toroidal; however, in other embodiments, the annular segments have other shapes and/or a mixture of shapes. In some embodiments, the annular segments are detachable or separable from each other, for example, by cutting or tearing, which permits a user to adjust a length of the internal retractor. Some embodiments of the internal retractor <NUM> are separable longitudinally, for example, using one or more partial or complete longitudinal cuts, which permits a user to generate openings or windows as desired. Some embodiments of the internal retractor <NUM> further comprise a complete or partial cover, as discussed above.

In some embodiments, the internal retractor <NUM> is coupled to the wound retractor <NUM> such that the internal retractor <NUM> is translatable, thereby permitting the user to isolate a surgical field that is not directly below the wound retractor <NUM>. In use, the wound retractor <NUM> is well anchored to a patient, thereby anchoring the internal retractor <NUM>. Suitable coupling devices are known in the art, for example, rods, bars, clamps, clips, swivels, hinges, and the like. In some embodiments, the internal retractor <NUM> is not coupled to the wound retractor <NUM>.

<FIG> is a perspective view of another embodiment of an internal retractor <NUM>, which is similar to the embodiments described above. The internal retractor <NUM> is integrated with, couplable with, used with, or used independently of a wound retractor, as discussed above. The illustrated embodiment of the internal retractor <NUM> comprises a longitudinal axis <NUM>, an access channel <NUM>, and a serpentine frame <NUM> defining a hollow cylinder or tube. In other embodiments, the frame <NUM> defines a different shape, for example, frustoconical or an elliptical cylinder. The serpentine frame <NUM> defines a plurality of circumferential voids or openings <NUM> in the cylindrical surface into which circumferential fingers <NUM> defined by the frame <NUM> interleave when the frame <NUM> is compressed radially, for example, when inserting the internal retractor <NUM>. Those skilled in the art will understand that in other embodiments, the serpentine frame <NUM> has a different shape that defines voids <NUM> and fingers <NUM> with different shapes. The frame <NUM> comprises a plastically deformable material, an elastically deformable material, or a combination thereof. In embodiments comprising a plastically deformable material, the internal retractor <NUM> is reshapeable or adjustable on deployment.

In the illustrated embodiment, the internal retractor <NUM> further comprises a cover or dam portion <NUM>, as discussed above. In some embodiments, the cover is cuttable through a void area <NUM>, which permits further adjustment in the deployed state. Other embodiments do not comprise a cover or dam portion.

<FIG> is a perspective view of another embodiment of an internal retractor <NUM>, which is similar to the embodiments described above. The internal retractor <NUM> is integrated with, couplable with, used with, or used independently of a wound retractor, as discussed above. The illustrated embodiment of the internal retractor <NUM> comprises a longitudinal axis <NUM>, an access channel <NUM>, and a serpentine frame <NUM> defining a hollow cylinder or tube. In other embodiments, the frame <NUM> defines a different shape, for example, frustoconical or an elliptical cylinder. The serpentine frame <NUM> defines a plurality of longitudinal voids or openings <NUM> in the cylindrical surface, which permit a user to compress the frame <NUM> radially, for example, when inserting the internal retractor <NUM>. Those skilled in the art will understand that in other embodiments, the frame <NUM> comprises a plurality of longitudinal members instead of a single serpentine or sinuous member. The frame <NUM> comprises a plastically deformable material, an elastically deformable material, or a combination thereof. In embodiments comprising a plastically deformable material, the internal retractor <NUM> is reshapeable or adjustable on deployment.

The illustrated embodiment further comprises a distal support member <NUM> disposed at a distal end of the internal retractor <NUM>. As illustrated in <FIG> in an undeployed state, the internal retractor <NUM> is conical. In deploying the internal retractor <NUM>, the distal support member <NUM> is advanced along the access channel <NUM> until it engages a distal end of the frame <NUM>, for example in a set of hooks <NUM>, as shown in FIG.

Some embodiments of the internal retractor <NUM> comprise a. cover or dam portion (not illustrated). Some embodiments are openable, for example, by cutting the distal support member <NUM>, if present, or portions of the frame <NUM>, which permits additional adjustability.

<FIG> is a perspective view of another embodiment of an internal retractor <NUM>, which is similar to the embodiments described above. The internal retractor <NUM> is integrated with, couplable with, used with, or used independently of a wound retractor, as discussed above. The illustrated embodiment of the internal retractor <NUM> comprises a longitudinal axis <NUM>, an access channel <NUM>, and a lattice frame <NUM> defining a hollow cylinder or tube. In other embodiments, the frame <NUM> defines a different shape, for example, frustoconical or an elliptical cylinder. The lattice frame <NUM> defines a plurality of voids or openings <NUM> in the cylindrical surface, which permit a user to compress the frame <NUM> radially, for example, when inserting the internal retractor <NUM>. In the illustrated embodiment, the frame <NUM> comprises a diamond lattice. In other embodiments, the frame <NUM> comprises a different lattice, for example, a hexagonal lattice. The frame <NUM> comprises a plastically deformable material, an elastically deformable material, or a combination thereof. In embodiments comprising a plastically deformable material, the internal retractor <NUM> is reshapeable or adjustable on deployment.

In the illustrated embodiment, the internal retractor <NUM> further comprises a cover or dam portion <NUM>, as discussed above. Other embodiments do not comprise a cover or dam portion. Some embodiments are openable, for example, by cutting portions of the frame <NUM>, which permits additional adjustability.

<FIG> is a perspective view of another embodiment of an internal retractor <NUM>, which is similar to the embodiments described above. The internal retractor <NUM> is integrated with, couplable with, used with, or used independently of a wound retractor, as discussed above. The illustrated embodiment of the internal retractor <NUM> comprises a longitudinal axis <NUM> extending between a proximal end <NUM> and a distal end <NUM>, a deformable frame <NUM>, and a cover or dam portion <NUM>. The illustrated embodiment also comprises a connection feature <NUM>, which permits coupling the internal retractor <NUM> to a wound retractor, as discussed above. In the illustrated embodiment, the frame <NUM> defines a generally rectangular internal retractor <NUM>. In other embodiments, the frame <NUM> defines a different shape, for example, trapezoidal or rhomboidal. The frame <NUM> is serpentine in the illustrated embodiment. In other embodiments, the frame <NUM> has a different structure, for example, a lattice, a mesh, a solid sheet, a perforated sheet, or a combination of structures. The frame <NUM> comprises a plastically deformable material, an elastically deformable material, or a combination thereof. In embodiments comprising a plastically deformable material, the internal retractor <NUM> is reshapeable or adjustable on deployment.

In the illustrated embodiment, the internal retractor <NUM> further comprises a cover or dam portion <NUM>, as discussed above. Other embodiments do not comprise a cover or dam portion. Some embodiments are reshapeable, for example, by cutting portions of the frame <NUM> and/or cover <NUM>, which permits additional adjustability.

<FIG> illustrates a side view another embodiment of a surgical access device <NUM> that is generally similar to the embodiments described above. The surgical access device <NUM> comprises a longitudinal axis <NUM> extending from a proximal end <NUM> to a distal end <NUM>, an access channel <NUM> extending through the device <NUM>, a wound retractor <NUM> disposed at the proximal end <NUM> and an internal retractor <NUM>. The wound retractor <NUM> is generally similar to the embodiments of the wound retractor described above, and comprises an outer ring <NUM>, an inner ring <NUM>, and a flexible sheath <NUM>. Embodiments of the internal retractor <NUM> are integrated, preattached, or user attached to the wound retractor <NUM>, or used without coupling to a wound retractor, as discussed above.

As best seen in the detailed view in FIG. 12B ,the internal retractor comprises a body <NUM> comprising a groove <NUM> extending at least partially along a proximal edge thereof, which is dimensioned to receive the inner ring <NUM> of the wound retractor <NUM> therein. The body <NUM> comprises a plastically deformable material, an elastically deformable material, or a combination thereof. In embodiments comprising a plastically deformable material, the body <NUM> is reshapeable or adjustable on deployment. In some embodiments, the body <NUM> is tubular and dimensioned to the diameter of the inner ring <NUM>. In other embodiments, the body <NUM> is supplied as an elongate strip. In either case, some embodiments of the body <NUM> may be trimmed as desired.

In the illustrated embodiment, a connection feature <NUM> extends at least partially along the distal edge of the body <NUM>. As best seen in the perspective view in <FIG>, the connection feature <NUM> of the body <NUM> couples to an extender <NUM>, which comprises a complementary connector <NUM>a extending at least partially along a proximal edge of the extender <NUM>. In the illustrated embodiment, the connection feature <NUM> and the complementary connector <NUM>a are self-complementary, that is, have the same shape. As with the body <NUM>, the extender <NUM> comprises an elastically deformable material, plastically deformable material, or a combination thereof. In the illustrated embodiment, the extender <NUM> further comprises a second complementary connector 1392b disposed along at least a portion of a distal edge of the extender <NUM>, which permits a user to add as many extenders <NUM> as desired. Consequently, in the illustrated embodiment, the internal retractor <NUM> comprises the body <NUM> and any number of extenders <NUM> desired.

In other embodiments, the connection feature <NUM> has the same cross-sectional shape as the inner ring <NUM> of the wound retractor <NUM>. Consequently, the body <NUM> is also an extender in these embodiments.

<FIG> is a perspective view of another embodiment of an internal retractor <NUM>, which is similar to the embodiments described above. The illustrated embodiment of the internal retractor <NUM> comprises a longitudinal axis <NUM> extending between a proximal end <NUM> and a distal end <NUM>, an access channel <NUM>, and a plurality of shapeable members <NUM>. The shapeable members are similar to the shapeable members <NUM> described above, except that the shapeable members <NUM> of the illustrated embodiment are coupled to an outer ring <NUM> of a wound retractor rather than an inner ring.

In the illustrated embodiment, the proximal end of each shapeable member <NUM> comprises a connection feature <NUM> that couples the shapeable member <NUM> to the outer ring <NUM>. The illustrated configuration permits a user to determine the number and spacing of shapeable members <NUM> used in any particular situation. In one embodiment, the user inserts a distal end of the shapeable member <NUM> through the access channel <NUM>, then couples the shapeable member <NUM> to the outer ring <NUM>.

In other embodiments, one or more shapeable members <NUM> are deployed as a unit, for example, comprising a common connection feature <NUM>. In some embodiments comprising a common connection feature <NUM>, the shapeable members <NUM> are substantially longitudinal or convergent when inserted through the access channel <NUM>, then reshaped after coupling to the outer ring <NUM>.

<FIG> is a perspective view of another embodiment of an internal retractor <NUM>, which is similar to the embodiments described above. The illustrated embodiment of the internal retractor <NUM> comprises a longitudinal axis <NUM> extending between a proximal end <NUM> and a distal end <NUM>, an access channel <NUM>, and a plurality of shapeable members <NUM>. The shapeable members are similar to the shapeable members <NUM> and described above, except that the shapeable members <NUM> of the illustrated embodiment are coupled to an outer ring <NUM> of a wound retractor rather than an inner ring.

In the illustrated embodiment, an arcuate base <NUM> releasably mates with the outer ring <NUM>. In other embodiments, the connection feature has a different arc length, for example, a full circle. The base <NUM> comprises a connector <NUM> that couples to the shapeable members <NUM>. In the illustrated embodiment, the connector <NUM> comprises a T-track into which is received a complementary portion disposed at a proximal end of each shapeable member <NUM>. Those skilled in the art will understand that other embodiments use connectors with other configurations, for example, rails, tracks, holes, posts, and the like. In the illustrated embodiment, the connector <NUM> is disposed along an inner surface of the base. In other embodiments, the connector is disposed on another surface, for example, a proximal face, an outer face, or a face at another angle to the longitudinal axis <NUM>. The shapeable members <NUM> are slidable along the T-track. The T-track comprises a gap <NUM> dimensioned to permit a user to insert or remove shapeable member therethrough. The illustrated configuration permits a user to determine the number and spacing of shapeable members <NUM> used in any particular situation. In one embodiment, the user couples the base <NUM> to the outer ring <NUM>, inserts a distal end of the shapeable member <NUM> through the access channel <NUM>, aligns the shapeable member with the gap <NUM>, then couples the shapeable member <NUM> to the connector <NUM>.

An embodiment of a method for using a surgical access device in abdominal surgery is schematically illustrated in <FIG> and described with reference to the embodiment of the access device <NUM> illustrated in <FIG>, although one skilled in the art will understand that the method is also applicable to all of the embodiments of the access device described herein. <FIG> is a side, partial cross section of a patient in which a wound retractor <NUM> has been placed through a body wall <NUM> and into a body cavity <NUM>, which is an abdominal cavity in this case. The inner ring <NUM> and internal retractor <NUM> are first inserted through an incision in the body wall <NUM> into the body cavity <NUM>. The outer ring <NUM> is then inverted through or rotated around itself, thereby winding the tubular sheath <NUM> around the outer ring <NUM>, thereby retracting the incision. In some embodiments, the outer ring <NUM> of the proximal portion is easily invertible in a snap-over motion, which provides a neutral position that resists rotation under tension generated in the retraction process. The tension secures the retractor <NUM> to the body wall <NUM>.

In the illustrated embodiment, the abdominal cavity <NUM> is inflated with gas, thereby facilitating access to internal structures <NUM>. In some embodiments, a cap or cover (not illustrated) is secured to the proximal portion of the retractor <NUM>, thereby creating a substantially gas-tight closure to the body cavity <NUM>, after which, the body cavity <NUM> is inflated or insufflated, for example, with CO<NUM> gas.

The internal retractor <NUM> is then deployed as desired within the body cavity <NUM>, thereby retracting or retaining internal structures during the surgical procedure. <FIG> illustrates the surgical site <NUM> before deploying the internal retractor <NUM>. For example, in the illustrated procedure, the position of abdominal content <NUM> is adjusted for an operation below the small intestine <NUM>. <FIG> illustrates a front partial cross section and <FIG> illustrates a side partial cross section of a retention pattern in which the internal retractor <NUM> holds the small intestine <NUM> away from the operative site <NUM>.

In the illustrated embodiment, deploying the internal retractor <NUM> comprises positioning the peripheral ring <NUM> of the internal retractor <NUM>, and inflating the inflatable supporting member <NUM> to a desire state of retention or retraction of the internal structures <NUM>. The inflated internal retractor <NUM> dams or walls-off loose structures from the operative site <NUM>. In inserting the access device <NUM>, as well as in deploying the internal retractor <NUM>, the internal retractor <NUM> is manipulated manually and/or with an instrument. For example, in some embodiments, the access device <NUM> is dimensioned and configured for access to the body cavity <NUM> by a surgeon's hand <NUM> through the orifice access channel <NUM> of the access device <NUM>. Other embodiments use a smaller access device <NUM> that is sized and configured to accept surgical instruments, such as laparoscopic tools, therethrough, but not a hand. In some cases, using a single, smaller device <NUM> limits the number of incisions needed in a laparoscopic procedure. Those skilled in the art will understand that the particular deployment procedure for the extendable member differs for each embodiment described above.

Claim 1:
A surgical access device (<NUM>) comprising:
a wound retractor (<NUM>) comprising an outer ring (<NUM>), an inner ring (<NUM>), and a tubular sheath (<NUM>) extending between the outer ring (<NUM>) and the inner ring (<NUM>); and
an internal retractor (<NUM>) characterized by a plurality of inflatable members (<NUM>) each having a proximal and distal end, wherein the proximal end of each of the plurality of inflatable members (<NUM>) is connected to the inner ring (<NUM>) and extends distally into a body cavity, wherein one or more open windows (<NUM>) are provided between inflatable members of the plurality of inflatable members (<NUM>) that allow user access outside a perimeter of the internal retractor (<NUM>), and wherein one or more dam portions (<NUM>) extend across two or more of the plurality of inflatable members (<NUM>).