Wound retractor

Background of the Invention

Field of the Invention

0001This invention generally relates to an improved wound retractor providing ease of incremental retraction and alignment to fit a wide range of incision sizes, including audible and tactile feedback to the user.

Discussion of the Prior Art

0002Surgery typically involves making an incision large enough to accommodate a surgeon's hand and/or multiple instruments. The incision must be kept clean since it is susceptible to infection if touched by diseased body parts and/or contaminated instruments. As such, wound protectors are available to insure that exposed sides of an incision are covered and protected from contaminants. A common deficiency of wound protectors is their lack of ease of retraction adjustability and stability. <patcit id="pcit0001" dnum="US5524644A"><text>U.S. Patent Nos. 5,524,644</text></patcit> and <patcit id="pcit0002" dnum="US6382211A"><text>6,382,211</text></patcit>, both to Crook, attempt to address this deficiency with a wound protector including an outer ring having an oblate cross-section and opposed flat surfaces that allegedly provide retraction adjustability and stability. The oblate design of the outer ring of Crook, however, provides only limited incremental retraction and can be difficult to twist or turn. In addition, the Crook design does not provide for an audible feedback to the user. Accordingly, there is a need in the art for an improved wound retractor that can be easily retracted to fit a wide range of incision sizes. The improved wound retractor preferably provides audible and/or tactile feedback to the user during retraction. International patent applications, publication numbers <patcit id="pcit0003" dnum="WO03077726A2"><text>WO 03/077726A2</text></patcit>, <patcit id="pcit0004" dnum="WO03061480A1"><text>WO 03/061480 A1</text></patcit> and <patcit id="pcit0005" dnum="WO03028573A2"><text>WO 03/028573 A2</text></patcit> disclose alternative arrangements of wound retractor. These documents fall under Article 54(3) EPC.

Summay of the Invention

0003The present invention provided an adjustable wound retractor adapted to dilate a surgical wound incision to a desired diameter, comprising: a first ring having a diameter greater than the desired diameter of the wound incision and being adapted for disposition interiorly of the wound incision; a second ring having an annular axis and a diameter greater than the desired diameter of the wound incision and being adapted for disposition exteriorly of the wound incision; and a flexible sleeve disposed in a cylindrical form between the first ring and the second ring, wherein the second ring may be rolled over itself and around the annular axis to provide the sleeve with a radial retraction force sufficient to stretch the incision to the desired diameter, characterized in that the second ring comprises at least two circular tubes, wherein rolling the second ring around the annular axis inverts the positions of the at least two circular tubes.

0004The wound retractor can provide a path for a surgeon to insert his hand and/or instruments through the opening formed by the wound retractor. The wound retractor can be incrementally adjustable to fit a wide range of incision sizes. The wound retractor may be installed or placed in a body cavity such that the inner and outer rings expand around inner and outer edges of the incision. Any portion of the flexible sleeve extending outside the incision can be easily rolled onto the outer ring to tightly seal the sides of the wound. The outer ring is preferably shaped to provide audible and/or tactile feedback to the user. In particular, the outer ring may include surfaces that are easy to grip and turn to allow the user to manually turn the outer ring and roll up the flexible sleeve with ease. The outer ring may be solid or include a lumen with a rod placed therein to provide audible signal to the user as the outer ring is turned.

0005These and other features and advantages of the invention will become more apparent with a discussion of preferred embodiments in reference to the associated drawings.

Description of the Drawings

0006<ul id="ul0001" list-style="none" compact="compact"><li><figref idref="f0001">FIG. 1</figref> illustrates a cutaway side view and an isometric view of an incrementally adjustable wound retractor in accordance with the invention;</li><li><figref idref="f0002">FIGS. 2a-2d</figref> illustrate the retraction of the outer ring of the wound retractor of <figref idref="f0001">FIG. 1</figref> to fit a desired incision;</li><li><figref idref="f0003">FIG. 3</figref> is a longitudinal cross-section view of the wound retractor of <figref idref="f0001">FIG. 1</figref> taken along line A-A;</li><li><figref idref="f0004">FIG. 4</figref> illustrates the wound retractor of <figref idref="f0001">FIG. 1</figref> installed in an incision;</li><li><figref idref="f0005">FIG. 5</figref> illustrates a longitudinal cross-section view of an outer ring including a wire in accordance with a third embodiment of the invention;</li><li><figref idref="f0005">FIGS. 6 and 7</figref> illustrate the rolling of the outer ring to fit a desired incision size in accordance with the third embodiment of the invention;</li><li><figref idref="f0006">FIG. 8</figref> is a three-dimensional cross-section view of the wound retractor of <figref idref="f0005">FIG. 5</figref>;</li><li><figref idref="f0007 f0008">FIGS. 9a-9e</figref> illustrate cross-section views of additional embodiments of the outer ring of the invention;</li><li><figref idref="f0009">FIG. 10</figref> illustrates an axial cross-section view of a surgical access device with a slightly modified gel cap and/or abdominal base in accordance with another embodiment of the invention;</li><li><figref idref="f0010">FIG. 11</figref> is an axial cross-section view of a surgical access device in accordance with another embodiment of the invention;</li><li><figref idref="f0011 f0012 f0013">FIGS. 12-14</figref> illustrate additional exemplary embodiments of the invention having modifications that could be made to the gel cap and/or the abdominal base so that the surgical access device can be used with the wound retractor;</li><li><figref idref="f0014">FIG. 15</figref> illustrates a perspective view of a base of a surgical access device in accordance with another embodiment of the invention;</li><li><figref idref="f0014">FIG. 16</figref> is an axial cross-section view of the embodiment illustrated in <figref idref="f0014">FIG. 15</figref>;</li><li><figref idref="f0015">FIGS. 17 and 18</figref> illustrate a base of a surgical access device in accordance with another embodiment of the invention having at least one toggle or latch adapted to fit a corresponding cap ring; and</li><li><figref idref="f0016">FIGS. 19 and 20</figref> illustrate a base of a surgical access device in accordance with another embodiment of the invention having a raised wall on an inner diameter and adapted to fit a corresponding cap ring.</li></ul>

Description of Preferred Embodiments and Best Mode of the Invention

0007<figref idref="f0001">FIG. 1</figref> illustrates a wound retractor 100 in accordance with a first embodiment of the invention. The wound retractor 100 comprises a double-tube outer ring 102, an inner ring 104, and a distensible sleeve 106 connecting the outer ring 102 and the inner ring 104. The sleeve 106 may be attached to the outer ring 102 and the inner ring 104 by heat seal or adhesive. The outer ring 102 and the inner ring 104 are preferably made of a material of sufficient hardness to retain their shape after twisting and rolling of the rings. That is, the material must be compliant enough to allow the outer ring 102 to be turned around its annular axis as further described below and illustrated in <figref idref="f0002">FIGS. 2a-2d</figref>. The shape of the outer ring 102 affects both its ability to grip and to provide stability during and after adjustment. The sleeve 106 is preferably made of a material that is flexible and impermeable to fluids and bacteria. The double-tube outer ring 102 preferably comprises a first circular tube 108 and a second circular tube 110 joined together by a small web 112. Each of the circular tubes 108 and 110 may be solid or include a lumen.

0008<figref idref="f0002">FIGS. 2a-2d</figref> illustrate the retraction and adjustment of the outer ring 102 to fit an incision. In accordance with the invention, the wound retractor 100 is axially adjustable in increments. In particular, the upper end of the sleeve 106 can be wrapped around the outer ring 102 so as to tightly seal the sides or edges of the incision. The unique shape of the outer ring 102 provides for an easy snap action when rolled about itself. The outer ring 102 also provides for incremental shortening of the sleeve 106 and for stability after installation. <figref idref="f0003">FIG. 3</figref> illustrates a longitudinal cross-section view of the wound retractor 100 taken along line A-A.

0009<figref idref="f0004">FIG. 4</figref> illustrates a process of installing the wound retractor 100 in a wound opening 400. An incision in the shape of a slit is first made in a patient's body, e.g., the abdominal wall. The inner ring 104 and the sleeve 106 are then manually inserted into body cavity 402 through the incision with the outer ring 102 remaining external to the body cavity 402. Once the inner ring 104 is within the body cavity 402, it expands around the inner surface of the incision so as to be generally parallel to the abdominal wall. The sleeve 106 provides a channel from the outside to the inside of the body cavity 402. The outer ring 102 initially rests above the abdominal wall around the wound opening 400. Since the upper end of the sleeve 106 is connected to the outer ring 102, the sleeve 106 can be drawn upwards and radially outward or inward, thereby drawing the inner ring 104 tightly against the inner surface of the abdominal wall. Moreover, the intermediate portion of the sleeve 106 is drawn tightly against the sides and edges of the wound opening 400, thereby retracting the adjacent tissue and producing a tightly sealed opening in the body cavity 402. That is, the sleeve 106 contacts the entire wound surface and protectively covers the same and seals it from contamination and infection. Depending on the size and depth of the incision, the user can roll up the sleeve 106 by gripping the double-tube outer ring 102 and turning it in a direction 200 as illustrated in <figref idref="f0002">FIGS. 2a-2c</figref> until the sleeve 106 abuts the outer edge of the wound opening 400. It should be appreciated that the outer ring 102 can be turned around its annular axis in either an outward or inward direction to roll the sleeve 106.

0010The outer ring 102 has a unique and novel double-tube configuration wherein through simple manipulation of forcing a first tube in a first direction and a second tube in a second direction, the positions of the first and second tubes can be inverted resulting in fast and easy turning of the tubes as illustrated in <figref idref="f0002">FIGS. 2a-2d</figref>. In one embodiment of the invention, the outer ring 102 is rotated by pushing the bottom tube or second circular tube 110 inward while pulling the top tube or first circular tube 108 outward (see <figref idref="f0002">FIG. 2a</figref>). The combination of the above steps results in inversion of the first and second circular tubes as illustrated in <figref idref="f0002">FIG. 2d</figref>. That is, the outer ring 102 can be rotated in 180° turns thereby retracting the sleeve 106. The above process can be repeated until a desired compression or wound opening is achieved.

0011An advantage of the invention is it provides for an easier, faster and higher retraction rate than that known in the prior art, thereby resulting in less traumatic effects to the patient. Another advantage of the invention is it provides tactile gripping and incremental rolling of the sleeve about the outer ring. In the above description, the first and second tubes of the outer ring are in a vertical position but it should be appreciated that the first and second tubes may be in different positions relative to one another such as a horizontal position.

0012In another embodiment of the invention, a small wire 302 such as a stainless steel wire is placed inside a lumen of the double-tube outer ring 102 (see <figref idref="f0003">FIGS. 3</figref> and <figref idref="f0005 f0006">5-8</figref>) so as to provide an audible signal as the outer ring 102 is turned. That is, as the double-tube outer ring 102 is turned, the wire 302 deflects against the tubing wall so as to provide an audible sound feedback to the user. Another feature of the wire 302 is it provides retraction stability to the wound retractor 100.

0013After surgery, the wound retractor 100 may be retrieved by grabbing the inner ring 104 and the sleeve 106 and pulling them through the wound opening 400. The use of the sleeve 106 and the ease of retracting the outer ring 102 provide higher compression between the inner and outer rings. As a result, the wound retractor 100 of the invention provides incremental adjustability to fit a wide range of incision sizes and isolates and protects the wound from bacterial infection as the diseased body parts and contaminated instruments are passed through the wound.

0014It is appreciated that the outer ring can be designed in various shapes and sizes to achieve various retraction rates and/or to conform with different body surfaces as illustrated in <figref idref="f0007 f0008">FIGS. 9a-9e</figref>. For example, the outer ring may comprise multiple tubes of different shapes and sizes. The single or multiple tubes may be solid or include lumens of different shapes and sizes.

0015The wound retractor in accordance with the present invention may be employed to provide access into and out of a patient's body is achieved by a hand assisted laparoscopic (HAL) procedure using a surgical access device such as the Gelport^™ device as described in applicant's international application <patcit id="pcit0006" dnum="US0129682W"><text>PCT/US01/29682, filed on September 21, 2001</text></patcit>, entitled "Surgical Access Apparatus and Method". The purpose of this embodiment is to combine the features and advantages of both the wound retractor of the present invention and the surgical access device as described in the PCT application. As explained in the PCT application, the current surgical access device uses a polyisoprene sheath that is wrapped distally around an O-ring, and once placed into a wound incision, the sheath is then stretched over extended tabs onto an abdominal base. The sheath of the surgical access device requires stretching and often times requires multiple attempts to secure it to the abdominal base. A novelty of this embodiment is to modify the cap and/or the abdominal base of the surgical access device so that it will accept the wound retractor of the present invention to replace the polyisoprene sheath and to maintain an airtight seal. The use of the wound retractor would simplify the HAL procedure and would not require stretching.

0016Referring to <figref idref="f0009">FIG. 10</figref>, there is shown a surgical access device 1000 with slight or moderate modifications to a gel cap 1010 and to an abdominal base 1020. The gel cap 1010 further includes a gel pad 1030 and a circumferential cap ring 1040, which can be inserted and molded to the pad 1030. The resulting gel cap 1010 forms a seal with the base 1020, thereby defining a working channel through the pad 1030, the cap ring 1040, the base 1020, and the sleeve 106 of the wound retractor. In this manner, the working channel includes a single valve formed by the gel pad 1030 which provides both a zero seal and an instrument seal for a wide range of instrument diameters. Referring to <figref idref="f0010">FIG. 11</figref>, the cross-section view of gel cap 1010a illustrates an annular void 1042a that is formed on the inner circumference of cap ring 1040a. This void is of particular advantage in forming a sealing relationship with base 1020a. <figref idref="f0011 f0012 f0013">FIGS. 12-14</figref> illustrate additional exemplary embodiments of the invention having modifications that could be made to the gel cap and/or the abdominal base so that the surgical access device can be used with the wound retractor.

0017<figref idref="f0014">FIG. 15</figref> illustrates a perspective view of a base 1020e in accordance with another embodiment of the invention. <figref idref="f0014">FIG. 16</figref> is an axial cross-section view of the embodiment illustrated in <figref idref="f0014">FIG. 15</figref>. From these views, it will be noted that the base 1020e can be provided with a smooth generally cylindrical inner surface 1022e which extends proximally to a rounded end surface 1024e and outwardly from the end surface 1024e along an annular lip 1026e, which is sized and configured to fit into an annular void formed on the inner circumference of a corresponding cap ring. Proximally of the inner surface 1022e, the base 1020e can also include a rounded end surface 1028e along its inner diameter for securing the outer ring of the wound retractor once the sleeve has been shortened.

0018In another embodiment of the invention, <figref idref="f0015">FIGS. 17 and 18</figref> illustrate a base 1020f having a smooth generally cylindrical inner surface 1022f, a rounded end surface 1024f, an annular lip 1026f, and an end surface 1028f having at least one toggle or latch 1029f sized and configured to fit a corresponding cap ring. In this embodiment, the toggle or latch 1029f operates to change the inner diameter of the cap ring to create a seal or release the cap ring from the base. In yet another embodiment of the invention, <figref idref="f0016">FIGS. 19 and 20</figref> illustrate a base 1020g having a smooth generally cylindrical inner surface 1022g, a rounded end surface 1024g, an annular lip 1026g, and an end surface 1028g having a raised wall sized and configured to fit a corresponding cap ring.

0019An 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 from patient to patient in the thickness of the abdominal wall. In addition, the device effectively seals around the interior and exterior of the incision, and allows a sealing cap to be attached to seal the abdominal cavity and to enable a laparoscopic procedure to be performed.

0020Many alterations and modifications may be made by those having ordinary skill in the art without departing from the scope of the invention as claimed. For these reasons, the above description should not be construed as limiting the invention, but should be interpreted as merely exemplary of preferred embodiments.