# Patent

## Title
Circular surgical retractor

## Abstract

A wound retractor for retracting a surgical incision includes an inner ring, an outer ring and a distensible sleeve coupled to the inner and outer rings. The outer ring includes at least a pair of circular tubes coupled to each other. At least one of the circular tubes includes a lumen and a split that forms open ends. A noncompliant tubular hoop having a split therein is positioned in the lumen. The tubular hoop is oriented with its open ends positioned away from the split of the circular tubes. A core is positioned in the lumen of the tubular hoop. The core has a first end and a second end and is oriented with the ends positioned away from the split in the tubular hoop. The circular tubes may be parallel or may form a helical pattern similar to a Mobius strip.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation of U.S. application Ser. No. 12/768,328, filed Apr. 27, 2010, now U.S. Pat. No. 7,892,172, which is a continuation of U.S. application Ser. No. 11/548,767, filed Oct. 12, 2006, now U.S. Pat. No. 7,704,207, which claims the benefit of: U.S. Application No. 60/828,089, filed Oct. 4, 2006; U.S. Application No. 60/803,965, filed Jun. 5, 2006; U.S. Application No. 60/803,346, filed May 26, 2006; U.S. Application No. 60/745,730, filed Apr. 26, 2006; and U.S. Application No. 60/726,826, filed Oct. 14, 2005, the entire disclosures of which are incorporated by reference.


BACKGROUND
This invention relates generally to surgical wound retractors and more specifically to circular wound retractors that provide circumferential retraction of an incision or wound and also provide isolation of the surgical incision or wound from the lumen of the retractor.
Retraction and isolation of a surgical incision can be an important element associated with a surgical procedure. Adequate access may be provided by a circumferential retraction device so that a surgeon may operate in a clear and open, generally unrestricted field. In addition, a circumferential retractor having a fluid impermeable sleeve extending through the incision or wound may prevent excessive bleeding or contamination of adjacent tissue. In some surgeries, it is important to avoid contaminating the incision or wound site.
Common procedures for placing current circumferential wound retraction devices involve placement of an internal retention ring that is coupled to a thin-walled sleeve or tube that is further coupled to an external retention member. The external retention member is wound or turned upon itself to wind the sleeve upon the external retention member. The physics associated with winding a sleeve upon a circular winding collar or external retention member dictate that ample energy must be applied to the external winding motion to provide adequate circumferential retraction of a linear incision. The initial windings of the process are not overwhelming, however, as the process continues the retraction becomes more difficult and the mechanical advantages first appreciated begin to dissipate. The final windings are more difficult since a balance between the force required to wind the sleeve upon the external retention member must be balanced with the force acting to unwind the sleeve from the external retention member.
There remains a need to provide a substantially rigid, noncompliant circumferential retractor that easily shortens the length of an associated tubular sleeve coupled to an internal retention member so that the shortening of the sleeve results in dramatic retraction of an incision or wound. Additionally, the retention members must remain substantially circular so that the incision is retracted symmetrically.
SUMMARY
The invention is directed to an adjustable wound retractor adapted to retract a surgical incision in a body wall to a desired diameter. The wound retractor includes a first, inner ring, a second, outer ring and a distensible sleeve coupled to the first, inner ring and to the second, outer ring. The first, inner ring is adapted to be inserted into the incision and to be juxtaposed with an inner surface of the body wall. The second, outer ring is adapted for juxtaposition with an outer surface of the body wall. The outer ring includes a first substantially circular tube having a first lumen. The first circular tube is made of a flexible material. The outer ring also includes a second substantially circular tube that is spaced axially from the first circular tube and is coupled to the first circular tube of the outer ring. The second circular tube has a second lumen. The second circular tube is made of a flexible material. The outer ring also includes a first rigid, noncompliant tubular hoop having a split therein. The split forms open ends of the first tubular hoop. The first tubular hoop is positioned in the first lumen of the first circular tube of the outer ring. The outer ring also includes a second rigid, noncompliant tubular hoop having a split therein with the split forming open ends of the second tubular hoop. The second tubular hoop is positioned in the second lumen of the second circular tube of the outer ring. The outer ring also includes a first core positioned in the lumen of the first tubular hoop and a second core positioned in the lumen of the second tubular hoop. Each of the first and second cores has a first end and a second end. The first core is oriented with the first and second ends of the first core positioned away from the split in the first tubular hoop. The second core is oriented with the first and second ends of the second core positioned away from the split in the second tubular hoop. The sleeve includes a first, distal end and a second, proximal end. The first, distal end of the sleeve is coupled to the inner ring of the wound retractor and the second proximal end of the sleeve is coupled to the outer ring of the wound retractor. The outer ring of the wound retractor is substantially rigid and noncompliant.
In one aspect, at least one of the first and second cores includes a substantially rigid, noncompliant wire, while in another aspect at least one of the first and second cores includes a cable. In another aspect, the first circular tube is coupled to the second circular tube through a substantially thin mid-section. In another aspect, the sleeve is made from a thin film. In another aspect, the first and second substantially circular tubes of the outer ring are made of an elastomeric material. In one aspect, the first and second substantially circular tubes are made of a plastic material, while in another aspect the first and second substantially circular tubes are made of a rubber material. In another aspect, the first and second ends of the first core are positioned substantially opposite the first and second ends of the first tubular hoop, and the first and second ends of the second core are positioned substantially opposite the first and second ends of the second tubular hoop. In another aspect, each of the combinations of the first tubular hoop with the first core and the second tubular hoop with the second core functions as an axle about which the outer ring may turn for half a rotation. In one aspect, the first circular tube of the outer ring of the wound retractor is adapted to be rolled outside the second circular tube of the outer ring with the circumference of the first split tubular hoop in the first circular tube expanding to clear the second split tubular hoop in the second circular tube of the outer ring. The second circular tube of the outer ring of the wound retractor is adapted to be rolled outside the first circular tube of the outer ring with the circumference of the second split tubular hoop in the second circular tube expanding to clear the first split tubular hoop in the first circular tube of the outer ring. In one aspect, at least one of the first and second tubular hoops is made of a metallic material, and at least one of the first and second cores is made of a metallic material. In another aspect, at least one of the first and second tubular hoops is made of a composite material, and at least one of the first and second cores is made of a metallic material. In another aspect, at least one of the first and second tubular hoops is made of a metallic material, and at least one of the first and second cores is made of a composite material. In another aspect, at least one of the first and second tubular hoops is made of a composite material, and at least one of the first and second cores is made of a composite material. In one aspect, the first and second substantially circular tubes are parallel to each other, while in another aspect the first and second substantially circular tubes form a helical pattern.
These and other features and advantages of the invention will become more apparent with a discussion of embodiments in reference to the associated drawings.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 depicts a technique for placing a surgical wound retractor within an incision;
FIG. 2 depicts the surgical wound retractor within an incision;
FIG. 3 is a perspective view of an assembled surgical wound retractor;
FIG. 4 is a perspective view of an assembled surgical wound retractor of FIG. 3;
FIG. 5 is a perspective view of an assembled surgical wound retractor having a rigid central support in an outer ring of the wound retractor;
FIG. 6 is a plan view depicting a first step of a technique employed to wind a sleeve of a wound retractor upon the rigid outer ring of the wound retractor;
FIG. 7 is a plan view depicting a second step of the technique employed to wind the sleeve of the wound retractor upon the rigid outer ring of the wound retractor;
FIG. 8 is a plan view depicting a third step of the technique employed to wind the sleeve of the wound retractor upon the rigid outer ring of the wound retractor;
FIG. 9 is a side view depicting the first step of the technique employed to wind the sleeve of the wound retractor upon the rigid outer ring of the wound retractor;
FIG. 10 is a side view depicting the second step of the technique employed to wind the sleeve of the wound retractor upon the rigid outer ring of the wound retractor;
FIG. 11 is a side view depicting the third step of the technique employed to wind the sleeve of the wound retractor upon the rigid outer ring of the wound retractor;
FIG. 12 is a side view of the assembled wound retractor prior to winding the sleeve upon the rigid outer ring;
FIGS. 13A-13C are side views depicting the sequence of winding the sleeve upon the rigid outer ring of the wound retractor;
FIGS. 14A-14C are side views depicting the proportions of changes of the length of the sleeve as the winding of the sleeve progresses;
FIG. 15 is a plan view of the rigid outer ring of the wound retractor in a normal at-rest state;
FIG. 16 is a plan view of the rigid outer ring of the wound retractor in an expanded state;
FIG. 17 is a plan view of the rigid outer ring of the wound retractor in a first winding state;
FIG. 18 is a plan view of the rigid outer ring of the wound retractor in a second winding state;
FIG. 19 is a plan view of the rigid outer ring in a normal at-rest state;
FIG. 20 is a plan view of the rigid outer ring in an expanded state;
FIG. 21 is a plan view depicting the positioning of a first rigid tube within the outer ring;
FIG. 22 is a plan view depicting the positioning of a second rigid tube within the outer ring;
FIG. 23 is a cross sectional view of the rigid outer ring;
FIG. 24 is a detail cross sectional view of the rigid outer ring;
FIG. 25 is a cross sectional view of a rigid outer ring having two portions;
FIG. 26 is a cross sectional view of a rigid outer ring having two portions;
FIG. 27 is a cross sectional view of a rigid outer ring having two portions;
FIG. 28 is a cross sectional view of a rigid outer ring having two portions;
FIG. 29 is a cross sectional view of the rigid outer ring having three portions with a single lumen that is positioned in the center portion;
FIG. 30 is a cross sectional view of the rigid outer ring having three portions with a lumen in each of the three portions;
FIG. 31 is a cross sectional view of the rigid outer ring having three portions with a lumen in each of the three portions;
FIG. 32 is a cross sectional view of the rigid outer ring having three portions with two lumens with the lumens being positioned in the outer portions;
FIG. 33 is a perspective view of an assembled wound retractor having a twisted, rigid outer ring;
FIG. 34 is a perspective view of the outer ring of the wound retractor of FIG. 33;
FIG. 35 is a side view of the wound retractor of FIG. 33;
FIG. 36 is a top perspective view of a gel cap having a lever for coupling the gel cap to the outer ring of a wound retractor;
FIG. 37 is a bottom perspective view of a cap ring of the gel cap of FIG. 36;
FIG. 38 is a bottom perspective view of the gel cap of FIG. 36;
FIG. 39 is a partial section view of the gel cap of FIG. 36 coupled to the outer ring of the wound retractor;
FIG. 40 is a top perspective view of the lever portion of the gel cap of FIG. 36;
FIG. 41 is a partial bottom view of the cap ring of FIG. 36 with the lever in a first, open state;
FIG. 42 is a partial section view of the gel cap of FIG. 36 coupled to the outer ring of the wound retractor with the lever in a second, closed state;
FIG. 43 is a top perspective view of the gel cap of FIG. 36 coupled to the wound retractor;
FIG. 44 is a partial bottom view of the cap ring of FIG. 36 with the lever in the second, closed state;
FIG. 45 is a partial section view of the gel cap of FIG. 36 coupled to the outer ring of the wound retractor with the lever in a second, closed state and the lever having a catch for engaging the outer ring of the wound retractor to hold the lever in the closed state;
FIG. 46 is a top plan view of a cap ring portion of a gel cap of the invention configured for coupling the gel cap to the outer ring of the wound retractor;
FIG. 47 is a bottom perspective view of the cap ring of FIG. 46 depicting lips for engaging the outer ring of the wound retractor;
FIG. 48 is a top perspective view of the cap ring of FIG. 46;
FIG. 49 is a side cross-sectional view of the cap ring of FIG. 46;
FIG. 50 is a side cross-sectional view of the gel cap incorporating the cap ring of FIG. 46;
FIG. 51 is a bottom perspective view of the gel cap of FIG. 50;
FIG. 52 is a top perspective view of the gel cap of FIG. 50;
FIG. 53 is a top perspective view of the gel cap of FIG. 50 coupled to the outer ring of the wound retractor;
FIG. 54 is a partial section view of the gel cap of FIG. 50 coupled to the outer ring of the wound retractor; and
FIG. 55 is a side view of the gel cap of FIG. 50 coupled to the outer ring of the wound retractor.



DETAILED DESCRIPTION
Referring to the drawings, FIGS. 1 and 2 depict the placement of a wound retractor 100 into an incision 102 made through a body wall 104 of a patient 106. Generally, a first, inner ring 108 is deformed and placed into the incision 102. The first, inner ring 108 is released when it has passed through the body wall 104 of the patient 106 and has reached a body cavity 110 or a reasonably open space. The inner ring 108 typically returns to a substantially circular condition and is subsequently drawn or pulled outwardly and against the inner surface 112 of the body wall 104. Tension between the inner ring 108 and the external components, such as a second, outer ring 114, of the wound retractor 100 is transmitted by means of a substantially cylindrical distensible sleeve 116 that is coupled between the inner ring 108 and the outer ring 114. Tension is increased between the inner and outer rings 108, 114 by winding the sleeve 116 upon the second, outer ring. As the sleeve 116 is shortened, it supplies a retracting or opening force away from the axis of the assembled wound retractor 100. The second, outer ring 114 is easily turned upon itself or inverted by the use of one or two hands 118 of a single user 120 and does not require the use of tools or assistants.
Referring to FIGS. 3-5, the inner ring 108 of the wound retractor 100 may be circular, oval, elliptical or otherwise shaped to provide easy insertion through the incision 102 (FIG. 1) or opening in the body wall 104 (FIG. 1) and appropriate retraction once in place. The cylindrical sleeve 116 may be made from a thin film and include a first, distal end that is coupled to the inner ring 108. The sleeve 116 has a diameter and a length that forms an open central region 122 that is appropriate for the required retraction and thickness of the body wall 104 (FIG. 1). A second, proximal end of the sleeve 116 is coupled to the second, outer ring 114 that is sized and configured to provide a rigid, noncompliant, substantially circular structure. The rigid, noncompliant outer ring 114 may include an extruded or molded profile that facilitates an inversion step for winding the sleeve 116 upon the outer ring.
The process of winding the sleeve 116 upon the outer ring 114 is illustrated in FIGS. 6-14. A user 120 (FIG. 1) grasps the outer ring 114 and rolls it inwardly toward the center of the wound retractor 100. The user 120 may roll the outer ring 114 sequentially or asymmetrically using one hand 118 at a time, or the user may use both hands symmetrically. The outer ring 114 may be rolled over and over several times, resulting in a shortening of the functional length of the sleeve 116 coupled thereto. The outer ring 114 is substantially rigid and noncompliant and, therefore, requires considerable force to invert or roll. An object of the invention is to minimize the force required to invert the outer ring 114 and increase the tension upon the sleeve 116. A very soft plastic or rubber material may be used to make a first circular tube 130 and a second circular tube 132 of a multiple-tube outer cover portion 124 of the outer ring 114, such as a double-tube outer ring or a triple-tube outer ring. The soft material favors traction between the outer ring 114 and the hands 118 of the user 120. The rolling or inverting may, therefore, be accomplished with the thumbs 126 and fingertips 128 of the user 120. As depicted in FIGS. 9 and 12, the first and second circular tubes 130, 132 may be substantially parallel to each other.
The first circular tube 130 of the outer ring 114 rotates through the open central region 122 of the second circular tube 132 of the outer ring, resulting in a first winding of the sleeve 116. The second circular tube 132 of the outer ring 114 may then be rotated through the open central region 122 of the first circular tube 130 of the outer ring, resulting in a second winding of the sleeve 116. These actions may be repeated until appropriate tension is placed upon the sleeve 116 and sufficient retraction 134 (FIG. 12) is applied to the incision 102 (FIG. 1) in the body wall 104. In one aspect, the hands 118 of the user 120 alternately move the first circular tube 130 of the outer ring 114 through the central region 122 of the second circular tube 132 of the outer ring and so on in a first direction (FIG. 6) 136, 138, 140 that results in a winding of the sleeve 116 outwardly and away from the axis of the wound retractor 100. Alternatively, the hands 118 of the user 120 alternately move the first circular tube 130 of the outer ring 114 through the central region 122 of the second circular tube 132 of the outer ring and so on in a second direction (FIG. 7) that results in a winding of the sleeve 116 inwardly toward the axis of the wound retractor 100. The inner ring 108 of the wound retractor 100 is adapted for juxtaposition with the inner surface 112 of the body wall 104 and the outer ring 114 of the wound retractor is adapted for juxtaposition with the outer surface of the body wall. Both the inner ring 108 and the outer ring 114 are adapted for disposition relative to the incision 102 in the body wall 104. The sleeve 116 is adapted to traverse the incision 102 in the body wall 104.
The construction of the rigid, noncompliant outer ring 114 is further detailed in FIGS. 6, 7 and 15-24 where a generally circular structure is shown having a flexible, elastomeric plastic or rubber extrusion or molded elongate body 124 having a first end 142 and a second end 144. The outer ring 115 of the wound retractor 100 also includes at least one lumen. In one aspect, the outer ring 114 of the wound retractor 100 includes a first lumen 146 and a second lumen 148 extending from the first end 142 to the second end 144 through the elongate body 124. This construction generally favors an extrusion manufacturing method.
A rigid, noncompliant metal or plastic tubular hoop 150 extends from the first end 142 of the elongate body to the second end 144 of the elongate body 124. The rigid, noncompliant tubular hoop 150 may be made from a substantially straight tube and bent or formed into an open circular form having a tube diameter slightly smaller than the lumen diameter of the elongate body 124 when it is coupled end to end. More particularly, a first circular rigid, noncompliant tubular hoop 150 is inserted into the first lumen 146 of the elongate body 124. The first tubular hoop 150 includes a split that forms open ends 158 of the first tubular hoop. A second circular rigid, noncompliant tubular hoop 152 is inserted into the second lumen 148 of the elongate body 124. The second tubular hoop 152 includes a split that forms open ends 160 of the second tubular hoop.
A first core 154 may be inserted into the lumen of the first circular rigid, noncompliant tubular hoop 150 and a second core 156 may be inserted into the lumen of the second circular rigid, noncompliant tubular hoop 152. Each of the first and second cores 154, 156 may include a first end and a second end to facilitate insertion into the respective lumens of the first and second tubular hoops 150, 152. At least one of the first and second cores 154, 156 may include a substantially rigid, noncompliant wire or a stranded cable. The first core 154 is advanced through the lumen of the first rigid, noncompliant tubular hoop 150 so that the ends of the core are an appropriate distance away from the open ends 158 thereof (FIG. 7), such as substantially opposite the open ends of the first tubular hoop. The second core 156 is similarly advanced through the lumen of the second rigid, noncompliant tubular hoop 152 so that the ends of the core are an appropriate distance away from the open ends 160 thereof (FIG. 6), such as substantially opposite the open ends of the second tubular hoop. The ends of the first and second cores 154, 156 may be positioned about 180° from the open ends of the rigid, noncompliant circularly formed tubular hoops 150, 152.
The cores 154, 156 stabilize the open ends of the rigid, noncompliant tubular hoops 150, 152 within the lumens 146, 148 of the outer ring 114 so that the open ends of the rigid, noncompliant tubular hoops remain substantially constantly aligned as they open and close in response to the rolling action 136, 138, 140 applied to the outer ring. Each of the combinations of the first tubular hoop 150 with the first core 154 and second tubular hoop 152 with the second core 156 functions as an axle about which the outer ring 114 may turn for half a rotation, or 180°. More particularly, the first circular tube 130 of the outer ring 114 of the wound retractor 100 may be rolled outside the second circular tube 132 of the outer ring with the circumference of the first split tubular hoop 150 in the first circular tube expanding to clear the second split tubular hoop 152 in the second circular tube. Likewise, the second circular tube 132 of the outer ring 114 of the wound retractor 100 may be rolled outside the first circular tube 130 of the outer ring with the circumference of the second split tubular hoop 152 in the second circular tube expanding to clear the first split tubular hoop 150 in the first circular tube.
Referring to FIGS. 23-28, an outer ring 114 is shown including an extruded or molded profile 124 having a first circular tube 130 and a second circular tube 132. The outer ring 114 may include a cross section that resembles the numeral eight (8). The first circular tube 130 and the second circular tube 132 are axially spaced from each other and are coupled together through a substantially thin mid-section 162. The outer ring 114 includes the first lumen 146 in the first circular tube 130 and the second lumen 148 in the second circular tube 132. A first rigid, noncompliant tubular hoop 150 having a split that forms open ends 158 may be inserted into the first lumen 146 of the outer ring 114 and a second rigid, noncompliant tubular hoop 152 having a split that forms open ends 160 may be inserted into the second lumen 148 of the outer ring. A rigid, noncompliant core 154, 156, such as a wire hoop or a loop of stranded cable, is inserted into the lumen of each of the rigid, noncompliant tubular hoops 150, 152 and advanced until the ends of the respective core are positioned well within the rigid, noncompliant tubular hoops. The first and second cores 154, 156 serve to maintain alignment of the two opposed ends of the rigid, noncompliant tubular hoops 150, 152. The tubular hoops 150, 152 containing cores 154, 156 are subsequently advanced to positions well within the lumens 146, 148 of the outer ring 114. More particularly, the first tubular hoop 150 is oriented such that the open ends 158 of the first tubular hoop are positioned away from the first and second ends 142, 144 of the first circular tube 130 of the outer ring 114, such as substantially opposite the first and second ends of the first circular tube. Similarly, the second tubular hoop 152 is oriented such that the open ends 160 of the second tubular hoop are positioned away from the first and second ends 188, 192 of the second circular tube 132 of the outer ring 114, such as substantially opposite the first and second ends of the first circular tube.
Referring to FIG. 25, the outer ring 114 may include a highly resilient outer portion 124, a first rigid, noncompliant composite tubular hoop 150, a second rigid, noncompliant composite tubular hoop 152, a first core 154, such as a rigid, noncompliant metallic member and a second core 156, such as a rigid, noncompliant metallic central member. The rigid, noncompliant tubular hoops 150, 152 are sized and configured to maintain a generally circular shape relative to the central axis of the wound retractor 100 (FIG. 1). In addition, the cores 154, 156 within the tubular hoops 150, 152 provide additional rigidity and also maintain alignment of the ends 158, 160 of the tubular hoops. The rigid, noncompliant composite tubular hoops 150, 152 may be made from composites that are well known in the art, such as phenolic, polycarbonate, polyester or other plastics filled with glass fiber, carbon fiber or other well known materials.
Referring to FIG. 26, the outer ring 114 may include a highly resilient outer portion 124, a first rigid, noncompliant metallic tubular hoop 150, a second rigid, noncompliant metallic tubular hoop 152, a first core 154, such as a rigid, noncompliant metallic member, and a second core 156, such as a rigid, noncompliant metallic member. The rigid, noncompliant tubular hoops 150, 152 are sized and configured to maintain a generally circular shape relative to the central axis of the wound retractor 100 (FIG. 1). In addition, the cores 154, 156 within the rigid, noncompliant tubular hoops 150, 152 provide additional rigidity and also maintain alignment of the ends 158, 160 of the central tubular hoops.
Referring to FIG. 27, the outer ring 114 may include a highly resilient outer portion 124, a first rigid, noncompliant metallic tubular hoop 150, a second rigid, noncompliant metallic tubular hoop 152, a first core 154, such as a substantially rigid, noncompliant composite member and a second core 156, such as a substantially rigid, noncompliant composite member. The rigid, noncompliant tubular hoops 150, 152 are sized and configured to maintain a generally circular shape relative to the central axis of the wound retractor 100 (FIG. 1). In addition, the composite cores 154, 156 within the rigid, noncompliant tubular hoops 150, 152 provide additional rigidity and also maintain alignment of the ends 158, 160 of the central tubular hoops. The rigid, noncompliant composite cores 154, 156 may be made from composites that are well known in the art, such as phenolic, polycarbonate, polyester or other plastics filled with glass fiber, carbon fiber or other well known materials.
Referring to FIG. 28, the outer ring 114 may include a highly resilient outer portion 124 and solid hoops 163 within the lumens 146, 148 of the external retention member.
Referring to FIG. 29, the outer ring 114 may include a highly resilient extruded or molded outer portion 164 having a first circular tube 168, a second circular tube 170 and a third circular tube 172. The first circular tube 168 is a large diameter cord. The second circular tube 170 is a large diameter cord that is separated from the first circular tube 168 by a third, smaller central circular tube 172 that has a lumen 174 therethrough. Alternatively, the three cords or circular tubes 168, 170, 172 may all be substantially the same size. The first, second and third circular tubes 168, 170, 172 are substantially coaxially aligned and each includes a substantially annular axis of substantially equal diameter. The first and second circular tubes or cords 168, 170 cooperate to provide a detent or snap-over as the first and second cords are sequentially rolled over the third circular tube 172. The lumen 174 of the central, third circular tube portion 172 is supplied with a rigid, noncompliant hoop 176 that is constructed from a length of material that has been formed to substantially the diameter of the wound retractor 100. The rigid, noncompliant hoop 176 functions as an axle.
Referring to FIG. 30, the outer ring 114 may include a moderately resilient extruded or molded outer portion 164 having a first circular tube 168, a second circular tube 170 and a third circular tube 172. The first circular tube 168 is a large diameter cord having a lumen 178 therethrough. The second circular tube 170 is a large diameter cord having a lumen 180 therethrough and is separated from the first circular tube 168 by the third, smaller circular tube 172 that has a lumen 174 therethrough. Alternatively, the three circular tubes cords 168, 170, 172 may all be substantially the same size. The first, second and third circular tubes 168, 170, 172 are substantially coaxially aligned and each includes a substantially annular axis of substantially equal diameter. The first and second circular tubes or cords 168, 170 cooperate to provide a detent or snap-over as the cords are sequentially rolled over the third circular tube 172. The lumen 174 of the third circular tube 172 is supplied with a rigid, noncompliant hoop 176 that is constructed from a length of material, such as a metallic material, that has been formed to substantially the diameter of the circular retractor 100. The rigid, noncompliant hoop 176 functions as an axle.
Referring to FIG. 31, the outer ring 114 may include a highly resilient extruded or molded outer portion 164 having a first circular tube 168, a second circular tube 170 and a third circular tube 172. The first circular tube 168 is a large diameter cord having a lumen 178 therethrough. The second circular tube 170 is a large diameter cord having a lumen 180 therethrough and is separated from the first circular tube 168 by the third, smaller circular tube 172 that has a lumen 174 therethrough. Alternatively, the three circular tubes or cords 168, 170, 172 may all be substantially the same size. The first, second and third circular tubes 168, 170, 172 are substantially coaxially aligned and each includes a substantially annular axis of substantially equal diameter. The first and second circular tubes or cords 168, 170 cooperate to provide a detent or snap-over as the cords are sequentially rolled over the third circular tube 172. The lumen 174 of the third circular tube 172 is configured to remain hollow and unfilled. The lumens 178, 180 of the first and second circular tubes are supplied with rigid metallic first and second tubular hoops 150, 152 therein, respectively, that contain rigid, first and second cores 154, 156, such as noncompliant circular wires. The hollow third circular tube 172 provides additional resilience that allows the first and second circular tubes 168, 170 to pass through each other.
Referring to FIG. 32, the outer ring 114 may include a highly resilient extruded or molded outer portion 164 having a first circular tube 168, a second circular tube 170 and a third circular tube 172. The first circular tube 168 is a large diameter cord having a lumen 178 therethrough. The second circular tube 170 is a large diameter cord having a lumen 180 therethrough and is separated from the first circular tube 168 by a third, smaller circular tube 172 that has no lumen therethrough. Alternatively, the three circular tubes or cords 168, 170, 172 may all be substantially the same size. The first, second and third circular tubes 168, 170, 172 are substantially coaxially aligned and each includes a substantially annular axis of substantially equal diameter. The first and second circular tubes or cords 168, 170 cooperate to provide a detent or snap-over as the cords are sequentially rolled over the third circular tube 172. The cord of the third circular tube 172 is solid. The lumens 178, 180 of the first and second circular tubes 150, 152 are supplied with rigid, metallic first and second tubular hoops 150, 152, respectively, therein that contain cores 154, 156, such as rigid, noncompliant circular wires. The solid third circular tube 172 provides a resilient axle that allows the first circular tube 168 and the second circular tube 170 to pass through each other.
Referring to FIGS. 33-35, the wound retractor 100 may include a first, inner ring 108, a second, outer ring 114, and a sleeve 116 coupling the inner ring to the outer ring. The inner ring 108 may be sized and configured to be deformed and placed through the incision 102 in the body wall 104 and subsequently into the body cavity 110. The sleeve 116 extends through the incision 102 in the body wall 104 and is coupled to the second, outer ring 114 that is sized and configured to be inverted upon itself or rolled to wind the sleeve 116 upon the second, outer ring. The outer ring 114 may include a helical rigid, noncompliant element having a shape similar to a Mobius strip. The helical outer ring 114 may be formed by twisting an extruded or molded element, such as a dual-lumen element 182, so that the first end 184 of the first lumen 186 communicates with the second end 188 of the second lumen 190 and the first end 192 of the second lumen 190 communicates with the second end 194 of the first lumen 186.
The ends 184, 188, 192, 194 of the extruded or molded form 114 are not joined together. A first split tubular hoop 150 is inserted into the first end 184 of the first lumen 186 and advanced until it exits the second end 194 of the first lumen where it is then inserted into the first end 192 of the second lumen 190. A first core 154, such as a rigid, noncompliant wire or a cable may then be inserted into the first tubular hoop 150 and advanced until the ends of the first core are well within the solid portion of the first tubular hoop, such as substantially opposite the ends 184, 186 of the first tubular hoop. The ends of the first core 154 may be separated from the ends of the first rigid, noncompliant tubular hoop 150 by about 180°. The first tubular hoop 150 and first core 154 are then advanced within the first lumen 186 of the extruded or molded element to a point distant from the first and second ends 184, 188 of the twisted circular form 114. A second rigid, noncompliant tubular hoop 152 and a second core 156 are inserted into the first end 192 of the second lumen 190 of the extruded or molded element and advanced as described above. The assembly, which forms an outer ring 114 in the form of a twisted external rigid, noncompliant outer ring, may be inverted or rolled to wind the sleeve 116 upon the outer ring. The helical orientation of the rigid, noncompliant outer ring 114 avoids an extreme detent or snap-over associated with two discrete rigid, noncompliant portions that must pass through each other in a rolling or inverting motion to wind the sleeve 116 upon the rigid, noncompliant outer ring.
Referring to FIGS. 36-45, a gel cap 202 includes a cap ring 204 that couples to the outer ring 114 of the wound retractor 100 and a gel pad 206 coupled to the cap ring. The gel pad 206 is made of a gel material and includes an access portion 208 or passage through the gel for providing a passage from external the body to the body cavity 110. In one aspect, the access portion 208 may include a plurality of intersecting dead-end slits 260, 262. The access portion 208 forms an instrument seal in the presence of an instrument, such as the arm of a surgeon, inserted therethrough and a zero seal in the absence of an instrument inserted therethrough.
To combine the gel pad 206 with the cap ring 204, the cap ring may be placed into a mold that includes the shape of the desired gel pad and the uncured gel is added to the mold. Referring to FIG. 37, in one aspect, the cap ring 204 includes a substantially cylindrical ring 210 having a first, proximal portion 212, a second, distal portion 214 and a longitudinal axis 216 extending through the proximal and distal portions. In one aspect, the cap ring 204 may be made of a polymer, such as polycarbonate and may be fabricated by methods including injection molding. The gel pad 206 is positioned at the proximal portion 212 of the cap ring 204. The proximal portion 212 of the cap ring 204 may include a plurality of apertures 218 distributed about the circumference of the cap ring. The apertures 218 may extend through the wall of the proximal portion 212 of the cap ring 204. Sufficient gel may be added to the mold to cover and fill the apertures 218 (see FIG. 38). When adding uncured gel into the mold, the gel flows through the apertures 218 and remains in the apertures. Also, for reasons that will be described below, sufficient gel may be added to the mold to extend into the distal portion 214 of the cap ring 204. When the gel pad 206 is cured, the gel in the apertures 218 connects the gel at the outer portion 220 of the cap ring 204 to the gel at the inner portion 222 of the cap ring, thus forming a mechanical lock between the gel and the cap ring.
The distal portion 214 of the cap ring 204 is substantially cylindrical and is configured to receive the outer ring 114 of the wound retractor 100. In one aspect, the distal portion 214 of the cap ring 204 includes a lip 224 at the distal end 226 thereof (see FIG. 37). The lip 224 curves radially inwardly from the wall 228 of the distal portion 214 of the cap ring 204 and extends around a portion of the circumference of the cap ring. In one aspect, the lip 224 extends around about 30° of the circumference of the cap ring 204; however, the lip may extend longer or shorter distances around the circumference of the cap ring. The lip 224 is configured to receive the outer ring 114 such that the outer ring is positioned between the lip 224 and the gel pad 206 (see FIG. 39). More particularly, when the outer ring 114 of the wound retractor 100 is received by the distal portion 214 of the cap ring 204, the outer ring of the wound retractor embeds into the gel pad 206 at the distal portion of the cap ring and displaces the gel, thereby forming a seal between the gel pad and the outer ring and sleeve 116 of the wound retractor.
In one aspect, the distal portion 214 of the cap ring 204 also includes a swinging lever 230 (FIG. 36) that swings on a plane that is substantially perpendicular to the axis 216 of the cap ring. In one aspect, the lever 230 is positioned substantially opposite the lip 224 on the distal portion 214 of the cap ring 204. The outer surface 232 of the cap ring 204 may include a lug 234 to which the lever 230 is coupled. In one aspect, the lug 234 includes an aperture 236 extending substantially parallel to the longitudinal axis 216 of the cap ring 204 and is adapted to receive a hinge pin 238 portion of the lever 230. When coupled to the cap ring 204, the lever 230 includes a proximal end 240 and a distal end 242. The lever 230 includes a first, distal substantially flat lip 244 positioned at the distal end 242 of the lever and lying in a plane that is positioned substantially perpendicular to the axis 246 of the pin 238 on the lever. It should be noted that the axis 246 of the pin 238 on the lever 230 is substantially parallel to the longitudinal axis 216 of the cap ring 204. The lever 230 may also include a second, proximal substantially flat lip 248 positioned at the proximal end 240 of the lever and also lying in a plane that is substantially perpendicular to an axis 246 of the pin 238 on the lever such that the proximal lip of the lever is substantially parallel to the distal lip 244 of the lever. Both of the distal and proximal lips 244, 248 of the lever 230 extend from the same side of the lever.
In a first, open state (FIG. 41), the lever 230 is swung outwardly, away from the body of the cap ring 204 to provide clearance for inserting the outer ring 114 of the wound retractor 100 into the gel cap. In a second, closed state (FIG. 42), the lever 230 is swung toward the cap ring 204 such that the distal and proximal lips 244, 248 of the lever protrude radially inwardly from the body of the lever and radially inwardly through the wall 228 of the cap ring. In one aspect, the wall 228 of the distal portion 214 of the cap ring 204 includes a first aperture 250 or groove for receiving the distal lip 244 of the lever 230. Similarly, the wall 228 of the distal portion 214 of the cap ring 204 also includes a second aperture 252, such as a slot, for receiving and supporting the proximal lip 248 of the lever 230. In one aspect, the distal lip 244 on the lever 230 extends around about 60° of the circumference of the cap ring and the proximal lip 248 on the lever extends around about 45° of the circumference of the cap ring; however, the distal and proximal lips may extend longer or shorter distances around the circumference of the cap ring.
In use, the wound retractor 100 is first used to retract the incision in the body wall 104 of a patient 106, as described above. With the lever 230 in the first state, the gel cap 202 is brought to the outer ring 114 of the wound retractor 100 at an angle with the lip portion 224 of the cap ring 204 toward the patient 106. The lip portion 224 of the cap ring is slid under the outer ring 114, between the outer ring and the patient 106, and then the remainder of the gel cap 202 is swung onto the outer ring. The lever 230 is then swung closed into the second state (FIG. 43). In the second state, the distal lip 244 of the lever 230 abuts the distal surface of the outer ring 114 of the wound retractor 100 and secures the gel cap 202 to the wound retractor. More particularly, with the gel cap 202 mounted onto the outer ring 114 of the wound retractor 100 and the lever 230 positioned in the second state, the lip portion 224 of the cap ring 204 and the distal lip 244 of the lever receive the outer ring of the wound retractor. The outer ring 114 of the wound retractor 100 is positioned between the lip portion 224 of the cap ring 204 and the distal lip 244 of the lever 230 at the distal end of the outer ring of the wound retractor and the gel pad 206 at the proximal end of the outer ring of the wound retractor.
The lever 230 includes locking means 254 (FIG. 40) to prevent unintended opening of the lever from the second state to the first state. In one aspect, to positively lock the lever 230 into the second state, one of the distal and proximal lips 244, 248 of the lever includes a latch 256 that engages the groove/aperture 250, 252 in the cap ring through which the lip protrudes (see FIG. 44). In another aspect, the distal lip 244 of the lever 230 includes a catch 258 (FIG. 45) protruding proximally to engage the outer ring 114 of the wound retractor 100 at a position on the inner circumference of the outer ring.
With the gel cap 202 mounted onto the outer ring 114 of the wound retractor 100 and the lever 230 positioned in the second state, the proximal lip 248 on the lever positioned in the aperture 252 in the cap ring 204 provides support for the lever to counteract cantilever forces induced by the displaced gel of the gel pad 206. Support of the proximal lip 248 also helps the distal lip 244 maintain the position of the outer ring 114 of the wound retractor 100 against the gel pad 206.
In another aspect, the gel cap 202 may include more than one lever 230 with the levers substantially equally spaced between each other and the lip 224 on the cap ring 204. In a further aspect, the lip 224 on the cap ring 204 may be omitted and at least two levers 230 used to secure the gel cap 202 to the wound retractor 100.
Referring to FIGS. 46-55, a gel cap 300 includes a cap ring 302 that couples to the outer ring 114 of the wound retractor 100 and a gel pad 304 coupled to the cap ring. The gel pad 304 is made of a gel material and includes an access portion 306 or passage through the gel for providing a passage from external the body to the body cavity 110. In one aspect, the access portion 306 may include a plurality of intersecting dead-end slits 328, 330. The access portion 306 forms an instrument seal in the presence of an instrument, such as the arm of a surgeon, inserted therethrough and a zero seal in the absence of an instrument inserted therethrough.
To combine the gel pad 304 with the cap ring 302, the cap ring may be placed into a mold that includes the shape of the desired gel pad and the uncured gel is added to the mold. In one aspect, the cap ring 302 includes a substantially cylindrical ring 308 having a first, proximal portion 310, a second, distal portion 312 and a longitudinal axis 314 extending through the proximal and distal portions. In one aspect, the cap ring 302 may be made of a polymer, such as polycarbonate and may be fabricated by methods including injection molding. The gel pad 304 is positioned at the proximal portion 310 of the cap ring 302. The proximal portion 310 of the cap ring 302 may include a plurality of apertures 316 distributed about the circumference of the cap ring. The apertures 316 may extend through the wall of the proximal portion 310 of the cap ring 302. Sufficient gel may be added to the mold to cover and fill the apertures 316. When adding uncured gel into the mold, the gel flows through the apertures 316 and remains in the apertures. Also, for reasons that will be described below, sufficient gel may be added to the mold to extend into the distal portion 312 of the cap ring 302. When the gel pad 304 is cured, the gel in the apertures 316 connects the gel at the outer portion 318 of the cap ring 302 to the gel at the inner portion 320 of the cap ring, thus forming a mechanical lock between the gel and the cap ring.
The distal portion 312 of the cap ring 302 is substantially cylindrical and is configured to receive the outer ring 114 of the wound retractor 100. In one aspect, the distal portion 312 of the cap ring 302 includes a plurality of lips 322 at the distal end 324 thereof. The lips 322 curve radially inwardly from the wall 326 of the distal portion 312 of the cap ring 302 and extend around a portion of the circumference of the cap ring. In one aspect, there are three lips 322 that are substantially equally spaced about the circumference of the distal portion 312 of the cap ring 302. Each of the three lips 322 may extend about 60° around of the circumference of the cap ring 302, however, the lips may extend longer or shorter distances around the circumference of the cap ring. Also, there may be more than three lips 322 with each lip extending a shorter distance around the circumference of the cap ring 302 and the more than three lips being substantially equally spaced about the circumference of the distal portion of the cap ring. In another aspect, there may be two lips 322 that are substantially diametrically opposed about the circumference of the distal portion of the cap ring with each of the lips extending a sufficient distance around the circumference of the cap ring 302 to facilitate adequate coupling of the gel cap 300 to the outer ring 114 of the wound retractor 100. The lips 322 are configured to receive the outer ring 114 of the wound retractor 100 such that the outer ring is positioned between the lips 322 and the gel pad 304. More particularly, when the outer ring 114 of the wound retractor 100 is received by the distal portion 312 of the cap ring 302, the outer ring of the wound retractor embeds into the gel pad 304 at the distal portion 312 of the cap ring 302 and displaces the gel, thereby forming a seal between the gel pad and the outer ring and sleeve 116 of the wound retractor.
In use, the wound retractor 100 is first used to retract the incision 102 in the body wall 104 of a patient 106, as described above. The gel cap 300 is brought to the outer ring 114 of the wound retractor 100 at an angle, with one of the lip portions 322 of the cap ring 302 toward the patient 106. The lip portion 322 of the cap ring that is toward the patient 106 is slid under the outer ring 114, between the outer ring and the patient, and then the remainder of the gel cap 300 is swung onto the outer ring with the remaining lip portions snapping into place under the distal-most circular tube. In an alternative aspect, the gel cap 300 may be brought to the outer ring 114 substantially parallel to the outer ring and the lip portions 322 snapped into place under the outer ring at the same time.
An advantage associated with the modified surgical access device is it enables a surgeon to quickly retract and protectively line an abdominal wall incision while being able to easily accommodate variations in abdominal wall thickness between patients. In addition, the device effectively seals around the interior and exterior of the incision, and allows a sealing cap to be coupled to the device to seal the abdominal cavity and to enable a laparoscopic procedure to be performed.
Many alterations and modifications may be made by those having ordinary skill in the art without departing from the spirit and scope of the invention. For these reasons, the above description should not be construed as limiting the invention, but should be interpreted as merely exemplary of the embodiments.

## Claims

1. A wound retractor adapted to retract a surgical incision in a body wall, comprising:
a first, inner ring adapted to be inserted into the incision and to be juxtaposed with an inner surface of the body wall;
a second, outer ring adapted for juxtaposition with an outer surface of the body wall, the outer ring comprising three substantially circular tubes, substantially coaxially aligned and coupled together such that the third tube is disposed between the first and second tubes, the first tube having a first lumen and the second tube having a second lumen;
a first rigid, noncompliant tubular hoop having a split therein, the first tubular hoop being positioned in the first lumen of the first circular tube of the outer ring, a second rigid, noncompliant tubular hoop having a split therein, the second tubular hoop being positioned in the second lumen of the second circular tube of the outer ring;
a first core positioned in the lumen of the first tubular hoop;
a second core positioned in the lumen of the second tubular hoop; and
a distensible sleeve, the sleeve including a first, distal end and a second, proximal end, the first, distal end of the sleeve being coupled to the inner ring of the wound retractor and the second proximal end of the sleeve being coupled to the outer ring of the wound retractor.

2. The wound retractor of claim 1, wherein at least one of the first and second cores comprises a substantially rigid, noncompliant wire.

3. The wound retractor of claim 1, wherein the third circular tube includes a third lumen.

4. The wound retractor of claim 3, wherein the hollow third circular tube provides additional resilience that facilitates the passage of the first and second circular tubes through each other.

5. The wound retractor of claim 1, wherein the diameter of the third circular tube is less than the diameter of either the first circular tube or the second circular tube.

6. The wound protector of claim 1, wherein the first and second circular tubes are adapted to provide a detent or snap-over as the first and second circular tubes are sequentially rolled over the third circular tube.

7. The wound retractor of claim 1, wherein the third circular tube is solid.

8. The wound retractor of claim 7, wherein the solid third circular tube functions as a resilient axle about which each of the first and second circular tube may rotate.

9. The wound retractor of claim 1, wherein at least one of the first and second tubular hoops comprises a metallic material and at least one of the first and second cores comprises a metallic material.

10. The wound retractor of claim 1, wherein at least one of the first and second tubular hoops comprises a metallic material and at least one of the first and second cores comprises a composite material.

11. The wound retractor of claim 1, wherein at least one of the first and second tubular hoops comprises a composite material and at least one of the first and second cores comprises a metallic material.

12. The wound retractor of claim 1, wherein at least one of the first and second tubular hoops comprises a composite material and at least one of the first and second cores comprises a composite material.

13. A wound retractor adapted to retract a surgical incision in a body wall, comprising:
a first, inner ring adapted to be inserted into the incision and to be juxtaposed with an inner surface of the body wall;
a second, outer ring adapted for juxtaposition with an outer surface of the body wall, the outer ring comprising three substantially circular tubes, substantially coaxially aligned and coupled together such that the third tube is disposed between the first and second tubes, the third tube having a lumen;
a rigid, noncompliant tubular hoop having a split therein, the tubular hoop being positioned in the lumen of the third circular tube of the outer ring; and
a distensible sleeve, the sleeve including a first, distal end and a second, proximal end, the first, distal end of the sleeve being coupled to the inner ring of the wound retractor and the second proximal end of the sleeve being coupled to the outer ring of the wound retractor.

14. The wound retractor of claim 13, wherein the at least one of the first and second circular tubes includes a lumen.

15. The wound retractor of claim 13, wherein the first and second circular tubes are solid.

16. The wound retractor of claim 13, further comprising a core disposed within the rigid tubular hoop of the third circular tube.

17. The wound protector of claim 13, wherein the first and second circular tubes are adapted to provide a detent or snap-over as the first and second circular tubes are sequentially rolled over the third circular tube.

18. The wound retractor of claim 13, wherein the rigid, noncompliant hoop of the third circular tube functions as an axle about which each of the first and second circular tube may rotate.

19. The wound retractor of claim 13, wherein the diameter of the third circular tube is less than the diameter of either the first circular tube or the second circular tube.

20. The wound retractor of claim 13, wherein the three circular tubes are of substantially equal diameter.