O-ring for incrementally adjustable incision liner and retractor

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation-in-part of application Ser. No. 10/196,647, filed Jul. 16, 2002, which is itself a continuation of application Ser. No. 09/970,416, filed Oct. 3, 2001, and now issued as U.S. Pat. No. 6,450,983.

FIELD OF THE INVENTION

[0002] The present invention relates generally to surgical wound protectors, and more particularly to an adjustable surgical wound protector for use in protecting incised cavity walls of various thicknesses from harmful contaminants during surgery.

BACKGROUND OF THE INVENTION

[0003] The sides of a wound during surgery are inherently susceptible to bacterial infection if touched by contaminated substances such as diseased body parts and fluids as they pass through the wound. Therefore extreme care must be exercised to insure that the exposed sides of an incision are completely covered by a material impervious to solids and fluids containing bacteria and other contaminants before surgery proceeds.

[0004] Various techniques have been used to insulate any incised tissue from exposure. One form of protection for relatively large incisions typically employs soft cotton sponges held against the sides of the wound by metal retractors to minimize contamination as well as to give the surgeon better access into the operating site. Another form of wound protector, particularly suitable for surgery, is disclosed in U.S. Pat. No. 3,347,227 to Harrower. Harrower discloses a surgical incision protector consisting of a pair of flexible rings joined by a thin, tubular-shaped sheet of flexible material. Harrower's rings have sufficient preforming to give a generally oval shape, be resilient and flexible, and so as to be easily flexed for insertion through a wound opening. The thin sheet is preferably made of plastic and must be impermeable to fluids and bacteria, physiologically inert, unaffected by autoclaving or sterilization, free of electrostatic hazard, resistant to melting, non-flammable, and somewhat elastic. Each of Harrower's flexible rings has a substantially circular cross-section. Harrower's incision protector is assembled by securing each end of the tubular sheet of flexible material to a ring, so that each ring is positioned at an end of the thin sheet of tubular material. In use, one ring is squeezed into an oblong shape, inserted through the peritoneum, and allowed to expand to the preformed shape over the inside edge of the wound. The other ring overlaps the outside edge causing the sleeve to stretch into contiguous contact with the entire surface of the sides and inner and outer edges of the wound. To obtain a form-fitting contiguous contact with the sides of the wound, the circumference of both rings in their preformed shape are slightly larger than that of the incision, and the extended length of the sleeve between the rings is slightly greater than that of the wall thickness. To accommodate variations in wound size, Harrower's wound protectors are manufactured in numerous combinations and permutations of both circumference and length.

[0005] U.S. Pat. No. 3,347,226 to Harrower describes an adjustable wound protector which reduces, to a degree, the number of sizes required. It requires a number of predetermined lengths similar to U.S. Pat. No. 3,347,227, except the circumference of the wound protector is adjustable, before being installed in the wound, by the rings having telescoping ends, and the side of the sleeve having overlapping lengthwise edges. Any overlapping excess may be cut off. The rings have a maximum adjustable circumference slightly larger than that of the largest incision anticipated so that they are sure to overlap the inner and outer edges of the wound. However, a sleeve length must be selected which will closely conform to the wall thickness at the wound.

[0006] U.S. Pat. No. 5,524,644, issued to Crook discloses an incrementally adjustable apparatus for protecting an incised wound from exposure to bacterial and other harmful contaminants. Crook provides a pair of resilient O-rings that are connected to opposite ends of an impermeable pliable sleeve. One of the O-rings is formed to engage the inner edge of the wound with a portion of the sleeve which is capable of being rolled onto the other ring to draw the remaining sleeve portion contiguous with the sides of the wound. Significantly, Crook relies upon flat surfaces on the rolled ring, that form an oblate cross-section, to provide a gripping surface to turn the ring about its annular axis.

SUMMARY OF THE INVENTION

[0007] The present invention provides an O-ring for use in an adjustable surgical wound protector of the type having an impermeable tubular sleeve extending between O-rings. The O-ring comprises a non-circular radial cross-section with opposed surfaces so as to enable a snap-action rolling of the O-ring in predetermined increments. In this way, a portion of the tubular sleeve may be rolled upon itself about the O-ring to shorten the sleeve in predetermined increments and to resist subsequent lengthening. The non-circular radial cross-section may have more than one centroid disposed between opposed surfaces. In one embodiment, a stacked arrangement of two, three, or more individual O-rings are provided where a centroid is disposed between adjacent stacked O-rings.

[0008] In an alternative embodiment, an O-ring is provided for use in an adjustable surgical wound protector of the type having an impermeable tubular sleeve extending between O-rings. The O-ring comprises an astroidal cross-section having a centroid and a torsional preloading so as to enable a snap-action rolling of the O-ring in predetermined increments for rolling a portion of the tubular sleeve on itself about the O-ring to shorten the sleeve in predetermined increments and to resist subsequent lengthening.

[0009] An adjustable surgical wound protector is also provided that comprises an elongate open-ended tube formed of a pliable material that is impervious to solid and fluid contaminants for inserting lengthwise into a surgical incision. Two O-rings are provided, one each secured around the open ends of the tube, and having a resilient configuration for overlapping the inner edge of the wound and for squeezing into an oblong shape that is insertable with a lengthwise portion of the sleeve adjacent to one of the O-rings in the surgical incision. At least one O-ring comprises a non-circular radial cross-section with opposed surfaces so as to enable a snap-action rolling of the O-ring in predetermined increments for rolling a portion of the tubular sleeve on itself about the O-ring to shorten the tube in predetermined increments and to resist subsequent lengthening. In one embodiment, a stacked arrangement of two, three, or more individual O-rings are provided as the at least one O-ring, where a centroid is disposed between adjacent stacked O-rings.

[0010] In an alternative embodiment, an adjustable surgical wound protector is provided including an elongate open-ended tube formed of a pliable material that is impervious to solid and fluid contaminants, and that can be inserted lengthwise into a surgical incision. Two O-rings are also provided, one each secured around the open ends of the tube. The O-rings have a resilient configuration for overlapping the inner edge of the wound and for squeezing into an oblong shape that is insertable with a lengthwise portion of the sleeve adjacent to one of the O-rings in the surgical incision. At least one O-ring comprises an astroidal cross-section having a centroid and a torsional preloading so as to enable a snap-action rolling of the O-ring in predetermined increments for rolling a portion of the tubular sleeve on itself about the O-ring to shorten the sleeve in predetermined increments and to resist subsequent lengthening.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] These and other features and advantages of the present invention will be more fully disclosed in, or rendered obvious by, the following detailed description of the preferred embodiment of the invention, which is to be considered together with the accompanying drawings wherein like numbers refer to like parts and further wherein:

[0012]FIG. 1 is a perspective, partially broken away view of an incrementally adjustable surgical wound protector formed in accordance with the present invention;

[0013]FIG. 2 is a perspective view of an O-ring formed in accordance with a preferred embodiment of the present invention;

[0014]FIG. 3 is a cross-sectional view of the O-ring shown in FIG. 2, as taken along lines <b>3</b>-<b>3</b> in FIG. 2, and including a portion of the interior side surface of the O-ring;

[0015]FIG. 4 is a side-elevational view of the O-ring shown in FIG. 2;

[0016]FIG. 5 is a broken away, cross-sectional view of the incrementally adjustable surgical wound protector shown in FIG. 1, as taken along lines <b>5</b>-<b>5</b> in FIG. 1, illustrating the interconnection between the O-ring and sleeve;

[0017] FIGS. <b>6</b>-<b>9</b> illustrate in sequence, the operation of the incrementally adjustable surgical wound protector shown in FIG. 1;

[0018]FIG. 10 is a perspective view of one alternative embodiment of O-ring;

[0019]FIG. 11 is a side elevational view of the O-ring shown in FIG. 10;

[0020]FIG. 12 is a cross-sectional view, taken along line <b>12</b>-<b>12</b> in FIG. 11;

[0021]FIG. 12A is a cross-sectional view similar to that shown in FIG. 12, but illustrating an alternative cruciform cross-section having radiused end surfaces;

[0022]FIG. 13 is a perspective view of another embodiment of O-ring;

[0023]FIG. 14 is a side elevational view of the O-ring shown in FIG. 13;

[0024]FIG. 15 is a cross-sectional view, as taken along lines <b>15</b>-<b>15</b> in FIG. 14, showing an alternative cruciform cross-section;

[0025]FIG. 15A is a cross-sectional view similar to that shown in FIG. 15, but illustrating an alternative cruciform cross-section having radiused end surfaces;

[0026]FIG. 16 is a perspective view of yet another alternative embodiment of O-ring;

[0027]FIG. 17 is a side elevational view of the O-ring shown in FIG. 16;

[0028]FIG. 18 is a cross-sectional view, as taken along line <b>18</b>-<b>18</b> in FIG. 17, showing an embodiment of recess used in connection with the present invention;

[0029]FIG. 19 is a perspective view of a further alternative embodiment of O-ring;

[0030]FIG. 20 is a side elevational view of the O-ring shown in FIG. 19;

[0031]FIG. 21 is a cross-sectional view, as taken along the line <b>21</b>-<b>21</b> in FIG. 20;

[0032]FIG. 22 is a perspective view of yet a further alternative embodiment of O-ring;

[0033]FIG. 23 is a front elevational view of the O-ring shown in FIG. 22;

[0034]FIG. 24 is a cross-sectional view, as taken along lines <b>24</b>-<b>24</b> in FIG. 23;

[0035]FIG. 25 is a perspective view of yet a further alternative embodiment of O-ring;

[0036]FIG. 26 is a front elevational view of the O-ring shown in FIG. 25;

[0037]FIG. 27 is a cross-sectional view, as taken along lines <b>27</b>-<b>27</b> in FIG. 26;

[0038]FIG. 28 is a perspective view of yet a further alternative embodiment of O-ring;

[0039]FIG. 29 is a front elevational view of the O-ring shown in FIG. 28;

[0040]FIG. 30 is a cross-sectional view, as taken along lines <b>30</b>-<b>30</b> in FIG. 29;

[0041]FIG. 31 is a perspective view of yet a further alternative embodiment of O-ring;

[0042]FIG. 32 is a front elevational view of the O-ring shown in FIG. 31;

[0043]FIG. 33 is a cross-sectional view, as taken along lines <b>33</b>-<b>33</b> in FIG. 32

[0044]FIG. 34 is a perspective view of yet a further alternative embodiment of O-ring;

[0045]FIG. 35 is a front elevational view of the O-ring shown in FIG. 34;

[0046]FIG. 36 is a cross-sectional view, as taken along lines <b>36</b>-<b>36</b> in FIG. 35;

[0047]FIG. 37 is a perspective view of yet a further alternative embodiment of O-ring;

[0048]FIG. 38 is a front elevational view of the O-ring shown in FIG. 37;

[0049]FIG. 39 is a cross-sectional view, as taken along lines <b>39</b>-<b>39</b> in FIG. 38;

[0050]FIG. 40 is a perspective view of yet a further alternative embodiment of O-ring;

[0051]FIG. 41 is a front elevational view of the O-ring shown in FIG. 40;

[0052]FIG. 42 is a cross-sectional view, as taken along lines <b>42</b>-<b>42</b> in FIG. 41;

[0053]FIG. 43 is a perspective view of yet a further alternative embodiment of O-ring;

[0054]FIG. 44 is a front elevational view of the O-ring shown in FIG. 43;

[0055]FIG. 45 is a cross-sectional view, as taken along lines <b>45</b>-<b>45</b> in FIG. 44;

[0056]FIG. 46 is a perspective view of yet a further alternative embodiment of O-ring;

[0057]FIG. 47 is a front elevational view of the O-ring shown in FIG. 46;

[0058]FIG. 48 is a cross-sectional view, as taken along lines <b>48</b>-<b>48</b> in FIG. 47;

[0059]FIG. 49 is a perspective view of yet a further alternative embodiment of O-ring;

[0060]FIG. 50 is a front elevational view of the O-ring shown in FIG. 49;

[0061]FIG. 51 is a cross-sectional view, as taken along lines <b>51</b>-<b>51</b> in FIG. 50;

[0062]FIG. 52 is a perspective view of yet a further alternative embodiment of O-ring;

[0063]FIG. 53 is a front elevational view of the O-ring shown in FIG. 52;

[0064]FIG. 54 is a cross-sectional view, as taken along lines <b>54</b>-<b>54</b> in FIG. 53;

[0065]FIG. 55 is a perspective view of yet a further alternative embodiment of O-ring;

[0066]FIG. 56 is a front elevational view of the O-ring shown in FIG. 55;

[0067]FIG. 57 is a cross-sectional view, as taken along lines <b>57</b>-<b>57</b> in FIG. 56;

[0068]FIG. 58 is a perspective view of yet a further alternative embodiment of O-ring;

[0069]FIG. 59 is a front elevational view of the O-ring shown in FIG. 58;

[0070]FIG. 60 is a cross-sectional view, as taken along lines <b>60</b>-<b>60</b> in FIG. 59;

[0071]FIG. 61 is a perspective view of yet a further alternative embodiment of O-ring;

[0072]FIG. 62 is a front elevational view of the O-ring shown in FIG. 61;

[0073]FIG. 63 is a cross-sectional view, as taken along lines <b>63</b>-<b>63</b> in FIG. 62;

[0074]FIG. 64 is a perspective view of yet a further alternative embodiment of O-ring;

[0075]FIG. 65 is a front elevational view of the O-ring shown in FIG. 64;

[0076]FIG. 66 is a cross-sectional view, as taken along lines <b>66</b>-<b>66</b> in FIG. 65;

[0077]FIG. 67 is a perspective view of yet a further alternative embodiment of O-ring;

[0078]FIG. 68 is a front elevational view of the O-ring shown in FIG. 67;

[0079]FIG. 69 is a cross-sectional view, as taken along lines <b>69</b>-<b>69</b> in FIG. 68;

[0080]FIG. 70 is a perspective view of an O-ring having a non-circular radial cross-section or stacked group of individual O-rings;

[0081]FIG. 71 is a front elevational view of the O-ring shown in FIG. 70;

[0082]FIG. 72 is a cross-sectional view, as taken along lines <b>72</b>-<b>72</b> in FIG. 71;

[0083]FIG. 73 is a perspective view of an O-ring having a non-circular radial cross-section or stacked group of individual hollow O-rings;

[0084]FIG. 74 is a front elevational view of the O-ring shown in FIG. 73;

[0085]FIG. 75 is a cross-sectional view, as taken along lines <b>75</b>-<b>75</b> in FIG. 74;

[0086]FIG. 76 is a perspective view of an O-ring having a non-circular radial cross-section or stacked group of individual solid O-rings;

[0087]FIG. 77 is a front elevational view of the O-ring shown in FIG. 76;

[0088]FIG. 78 is a cross-sectional view, as taken along lines <b>78</b>-<b>78</b> in FIG. 77;

[0089]FIG. 79 is a perspective view of another O-ring having a non-circular radial cross-section or stacked group of individual hollow O-rings;

[0090]FIG. 80 is a front elevational view of the O-ring shown in FIG. 79;

[0091]FIG. 81 is a cross-sectional view, as taken along lines <b>81</b>-<b>81</b> in FIG. 80;

[0092]FIG. 82 is a perspective view of yet another O-ring having a non-circular radial cross-section or stacked group of individual hollow O-rings;

[0093]FIG. 83 is a front elevational view of the O-ring shown in FIG. 82;

[0094]FIG. 84 is a cross-sectional view, as taken along lines <b>84</b>-<b>84</b> in FIG. 83;

[0095]FIG. 85 is a perspective view of an O-ring having a non-circular radial cross-section or stacked group of individual solid O-rings;

[0096]FIG. 86 is a front elevational view of the O-ring shown in FIG. 85;

[0097]FIG. 87 is a cross-sectional view, as taken along lines <b>87</b>-<b>87</b> in FIG. 86;

[0098]FIG. 88 is a perspective view of an O-ring having a stacked group of individual astroidal O-rings;

[0099]FIG. 89 is a front elevational view of the O-ring shown in FIG. 88;

[0100]FIG. 90 is a cross-sectional view, as taken along lines <b>90</b>-<b>90</b> in FIG. 89;

[0101]FIG. 91 is a perspective view of another O-ring having a stacked group of individual astroidal O-rings;

[0102]FIG. 92 is a front elevational view of the O-ring shown in FIG. 91;

[0103]FIG. 93 is a cross-sectional view, as taken along lines <b>93</b>-<b>93</b> in FIG. 92;

[0104]FIG. 94 is a perspective view of yet another O-ring having a stacked group of individual astroidal O-rings;

[0105]FIG. 95 is a front elevational view of the O-ring shown in FIG. 94;

[0106]FIG. 96 is a cross-sectional view, as taken along lines <b>96</b>-<b>96</b> in FIG. 95;

[0107]FIG. 97 is a perspective view of a further alternative O-ring having a stacked group of individual astroidal O-rings;

[0108]FIG. 98 is a front elevational view of the O-ring shown in FIG. 97;

[0109]FIG. 99 is a cross-sectional view, as taken along lines <b>99</b>-<b>99</b> in FIG. 98;

[0110]FIG. 100 is a perspective view of yet a further alternative O-ring having a stacked group of individual astroidal O-rings;

[0111]FIG. 101 is a front elevational view of the O-ring shown in FIG. 100;

[0112]FIG. 102 is a cross-sectional view, as taken along lines <b>102</b>-<b>102</b> in FIG. 101;

[0113]FIG. 103 is a perspective view of another further alternative O-ring having a stacked group of individual astroidal O-rings;

[0114]FIG. 104 is a front elevational view of the O-ring shown in FIG. 103;

[0115]FIG. 105 is a cross-sectional view, as taken along lines <b>105</b>-<b>105</b> in FIG. 104;

[0116]FIG. 106 is a perspective view of a further alternative O-ring having a stacked group of individual astroidal O-rings;

[0117]FIG. 107 is a front elevational view of the O-ring shown in FIG. 106;

[0118]FIG. 108 is a cross-sectional view, as taken along lines <b>108</b>-<b>108</b> in FIG. 107;

[0119]FIG. 109 is a perspective view of another further alternative O-ring having a stacked group of individual astroidal O-rings;

[0120]FIG. 110 is a front elevational view of the O-ring shown in FIG. 109;

[0121]FIG. 111 is a cross-sectional view, as taken along lines <b>111</b>-<b>111</b> in FIG. 110;

[0122] FIGS. <b>112</b>-<b>115</b> are each a broken-away perspective view of alternative embodiments of astroidal cross-section O-rings formed in accordance with the present invention;

[0123]FIG. 116 is a perspective view of an O-ring having an astroidal cross-section and a torsional preloading formed in accordance with another embodiment of the invention;

[0124]FIG. 117 is a front elevational view of the preloaded O-ring shown in FIG. 116;

[0125]FIG. 118 is a cross-sectional view, as taken along lines <b>118</b>-<b>118</b> in FIG. 117; and

[0126]FIG. 119 is a perspective, partially broken away view of an incrementally adjustable surgical wound protector comprising an O-ring having an astroidal cross-section and a torsional preloading formed in accordance with the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0127] This description of preferred embodiments is intended to be read in connection with the accompanying drawings, which are to be considered part of the entire written description of this invention. In the description, relative terms such as “horizontal,” “vertical,” “up,” “down,” “top” and “bottom” as well as derivatives thereof (e.g., “horizontally,” “downwardly,” “upwardly,” etc.) should be construed to refer to the orientation as then described or as shown in the drawing figure under discussion. These relative terms are for convenience of description and normally are not intended to require a particular orientation. Terms including “inwardly” versus “outwardly,” “longitudinal” versus “lateral” and the like are to be interpreted relative to one another or relative to an axis of elongation, or an axis or center of rotation, as appropriate. Terms concerning attachments, coupling and the like, such as “connected” and “interconnected,” refer to a relationship wherein structures are secured or attached to one another either directly or indirectly through intervening structures, as well as both movable or rigid attachments or relationships, unless expressly described otherwise. The term “operatively connected” is such an attachment, coupling or connection that allows the pertinent structures to operate as intended by virtue of that relationship. In the claims, means-plus-function clauses are intended to cover the structures described herein as performing the recited function, including not only structural equivalents but also equivalent structures.

[0128] Referring to FIG. 1, an incrementally adjustable surgical wound protector <b>5</b> comprises a thin flexible sleeve <b>8</b> positioned between a first O-ring <b>10</b> and a second O-ring <b>12</b>. Sleeve <b>8</b> comprises a tube having a uniform circumference along its length, an upper end edge <b>16</b>, and a lower end edge <b>18</b>. Upper end edge <b>16</b> of sleeve <b>8</b> is fastened or bonded to a surface portion of first O-ring <b>10</b> by sealing, e.g., thermally, ultrasonically or, with proper pretreatment, adhesives, but without (i) the portion of sleeve <b>8</b> adjacent to upper end edge <b>16</b> being wrapped around the circumference of first O-ring <b>10</b>, or (ii) overlapped upon itself. Likewise, lower end edge <b>18</b> of sleeve <b>8</b> is fastened or bonded to a surface portion of O-ring <b>12</b> by sealing, e.g., thermally, ultrasonically or, with proper pretreatment, adhesives, but without (i) the portion of sleeve <b>8</b> adjacent to lower end edge <b>18</b> being wrapped around the circumference of O-ring <b>12</b>, or (ii) overlapped upon itself (FIGS. <b>5</b>-<b>9</b>). Sleeve <b>8</b> may also simply be attached to O-rings <b>10</b>,<b>12</b> by adhesive without pretreatment, but with less than satisfactory results.

[0129] Sleeve <b>8</b> is preferably formed from a material that is impervious to solids and/or fluids containing bacteria and other harmful contaminants, e.g., a polymer or elastomeric material of the type known in the art. The materials and dimensions of wound protector <b>5</b> are selected to ensure stability of the wound protector when installed. A preferred polymer material suitable for sleeve <b>8</b> is a heat-sealable <b>2</b>-mil aromatic polyether polyurethane film, such as the PT6100 series manufactured by Deerfield Urethane, Inc., under the tradename DUROFLEX, that may be produced in seamless tubular form or by a flat sheet in a cylindrical form with the meeting margins along the side overlapped and sealed. Other materials that may be used with good effect include, polyolefins and other like plastomers and elastomers that are suitable for use in medical applications. A nominal sleeve length suitable for surgery is typically from about 100 to about 200 mm. Sleeve diameters will vary according to the length of the surgical incision.

[0130] First O-ring <b>10</b> and second O-ring <b>12</b> each are formed so as to engage the inner edge of a surgical incision, with a portion of sleeve <b>8</b> above the incision and capable of being incrementally rolled toward the other O-ring to draw the remaining portion of sleeve <b>8</b> contiguous with the sides of the incision. O-rings <b>10</b> and <b>12</b> are preferably formed from an elastomeric medical grade material of sufficient hardness to retain O-rings <b>10</b> and <b>12</b> expanded in place around the inner and outer edges of the surgical incision. The material must be compliant enough to allow O-ring <b>10</b> or <b>12</b> to be turned by the fingers over 180 degrees about its center. For this purpose, urethane is a preferred elastomeric material. O-rings <b>10</b>,<b>12</b> may be formed from other resilient materials, such as medical grade, polyvinylchloride, silicon, natural rubber, or other elastomeric or rubber-like materials, with good effect.

[0131] Referring to FIGS. <b>1</b>-<b>5</b>, O-rings <b>10</b>,<b>12</b> preferably comprise a torus, i.e., a structure formed by the rotation of a polygon about an axis that lies in the plane of the polygon, but without cutting the polygon. O-rings <b>10</b>,<b>12</b> are formed from a solid or hollow, initially polygonal cross-section torus having a cross-sectional center <b>20</b> that is radially equidistant from a central longitudinal axis <b>24</b> of the O-ring. The polygonal cross-section of each O-ring <b>10</b>,<b>12</b> may be divided into four quadrants (FIGS. <b>3</b>, and <b>5</b>-<b>9</b>). In one embodiment, material defining two diagonally opposed quadrants is removed, leaving two diagonally opposed recesses <b>26</b> and <b>28</b> (best shown in FIG. 3).

[0132] In this embodiment, the solid portion of O-rings <b>10</b>,<b>12</b> that remains defines a first solid quadrant <b>30</b> and a diagonally opposed, second solid quadrant <b>33</b>. First solid quadrant <b>30</b> includes a curved outer surface <b>36</b>, a curved annular surface <b>38</b>, and a sinusoidal surface <b>40</b>. Second solid quadrant <b>33</b> includes a curved outer surface <b>46</b>, a curved annular surface <b>48</b>, and a sinusoidal surface <b>50</b>. Curved annular surfaces <b>38</b>,<b>48</b> are at substantially the same radial distance from central longitudinal axis <b>24</b>, and are vertically oriented so as to be substantially parallel and substantially coaxial with central longitudinal axis <b>24</b>. Sinusoidal surfaces <b>40</b>,<b>50</b> extend transversely relative to the central longitudinal axis <b>24</b> of O-rings <b>10</b>,<b>12</b> (FIGS. 2 and 3).

[0133] Of course, it will be understood that the term “O-ring” is not limited to solid, circular, or single ring structures or classic toroidal shapes, but also includes structures that are not circular, e.g., rectilinear, oval/elliptical, hexagonal, octagonal, non-circular radial, etc., or more than one torus stacked one upon the other, as long as such rings comprise a resilient configuration capable of being squeezed into an oblong shape that is suitable for insertion into a surgical incision.

[0134] By way of example, a urethane O-ring <b>10</b>,<b>12</b> for use with a sleeve having a diameter of about 109 mm, has a diameter of about 7.9 mm, with a radial depth of diagonally opposed recesses <b>26</b> and <b>28</b> of approximately 4.0 mm. Of course, the sizes of the O-rings and sleeves will vary according to incision size and peritoneum wall thickness. The personal preference of the surgeon will also affect the choice of both O-ring and sleeve size for a particular surgical procedure. Each end of sleeve <b>8</b> is sealingly fastened or bonded around an O-ring <b>10</b>,<b>12</b>, e.g., to a curved outer surface <b>46</b>, such that when the sleeve is fully extended, O-rings <b>10</b>,<b>12</b> are positioned in spaced-apart relation to one another (FIGS. 1 and 5).

[0135] The cross-sectional shape of O-rings <b>10</b>,<b>12</b> provides stability in a plane perpendicular to central longitudinal axis <b>24</b>, and provides an over-center “snap-action” or “snap-roll” when O-ring <b>10</b>,<b>12</b> is rolled about itself and sleeve <b>8</b>, thereby providing incremental shortening in predetermined increments and resistance to lengthening after shortening. More particularly, by strategically removing portions of O-rings <b>10</b>,<b>12</b> so as to form recesses <b>26</b>,<b>28</b>, the rate of twist necessary to create the over-center “snap-action” can be gauged and set. Typically, about 33% to about 70% of the mass of the O-ring must be either removed or redistributed in order to obtain a “snap-action” that is suitable for hand twisting. Thus numerous O-rings (FIGS. <b>12</b>-<b>118</b>), having differing amounts, locations, and shapes of material removed from their cross-section may be used in connection with the present invention.

[0136] For example, and referring to FIGS. <b>10</b>-<b>15</b>, rings <b>10</b>,<b>12</b> may comprise a cruciform cross-sectional profile. In this configuration, the cruciform shape of O-rings <b>10</b>,<b>12</b> provide stability in a plane perpendicular to central longitudinal axis <b>24</b> and also provide the over-center, “snap-action” when rolled about themselves and sleeve <b>8</b>. The embodiment disclosed in FIGS. <b>10</b>-<b>12</b> includes a cruciform cross-section having flat surfaces <b>60</b> and <b>62</b>. While FIGS. <b>13</b>-<b>15</b> show a similar O-ring <b>10</b>,<b>12</b> having radiused surfaces <b>65</b> and <b>67</b>. Of course, the end surfaces of the cruciform cross-section O-ring <b>10</b>,<b>12</b> may also have radiused end surfaces, as shown in FIGS. 12A and 15A.

[0137] Referring to FIGS. <b>16</b>-<b>33</b>, O-rings <b>10</b>,<b>12</b> may also include a plurality of recesses defined into a portion of the ring. More particularly, a plurality of recesses <b>70</b> are defined radially inwardly into O-ring <b>10</b>,<b>12</b>, i.e., toward cross-sectional center <b>20</b>, from diametrically opposed positions along the circumference of the O-ring. In this way, recesses <b>70</b> extend into O-ring <b>10</b>,<b>12</b> from each side in an alternating pattern. FIGS. <b>16</b>-<b>18</b> illustrate a rectilinearly shaped plurality of alternating recesses <b>70</b>, while FIGS. <b>19</b>-<b>21</b> illustrate a plurality of round recesses <b>72</b> and FIGS. <b>22</b>-<b>24</b> illustrate a plurality of round, shallow recesses <b>72</b><i>a </i>disposed on both sides of O-ring <b>10</b>,<b>12</b>.

[0138] Referring to FIGS. <b>25</b>-<b>33</b>, a sinusoidally defined recess <b>72</b><i>b </i>may be employed with the present invention. FIGS. <b>25</b>-<b>27</b> illustrate such a sinusoidal recess <b>72</b><i>b </i>disposed on an inner circumferential surface of O-ring <b>10</b>,<b>12</b>, while FIGS. <b>28</b>-<b>30</b> illustrate such a sinusoidal recess <b>72</b><i>b </i>disposed on an outer circumferential surface of O-ring <b>10</b>,<b>12</b>. FIGS. <b>31</b>-<b>33</b> illustrate a pair of sinusoidal recesses <b>72</b><i>b </i>positioned in diametrically opposed relation to one another on O-ring <b>10</b>,<b>12</b>. In each of the foregoing cases, the removal of material from O-ring <b>10</b>, <b>12</b> to define recesses <b>70</b>, <b>72</b>, or <b>72</b><i>b </i>provides stability in a plane perpendicular to central longitudinal axis <b>24</b>, and provides an over-center “snap-action” when the O-ring is rolled about itself and sleeve <b>8</b>.

[0139] Referring to FIGS. <b>34</b>-<b>42</b>, O-rings <b>10</b>,<b>12</b> may also have a continuous recess formed in diametrically opposed portions of O-ring <b>10</b>,<b>12</b>. More particularly, a top recess <b>78</b> and a bottom recess <b>80</b> may be formed in O-ring <b>10</b>,<b>12</b> so as to yield “a bow-tie” cross-sectional profile to O-ring <b>10</b>,<b>12</b> (FIGS. <b>34</b>-<b>36</b>) or may be formed so as to be shallow (FIGS. <b>37</b>-<b>39</b>). The removal of material from O-ring <b>10</b>,<b>12</b> from diametrically opposed portions in a continuous, or annular fashion, provides stability in a plane perpendicular to central longitudinal axis <b>24</b>, and provides an over-center “snap-action” when the O-ring is rolled about itself and sleeve <b>8</b>. A plurality of reinforcing ribs <b>82</b> may be formed within top recess <b>78</b> and/or bottom recess <b>80</b> so as to ease manufacture (FIGS. <b>40</b>-<b>42</b>).

[0140] Referring to FIGS. <b>43</b>-<b>57</b>, O-rings <b>10</b>,<b>12</b> may also be formed so as to have convex top and bottom walls <b>86</b>,<b>88</b>, and substantially flat inner and outer, annular side walls <b>90</b>,<b>92</b> (FIGS. <b>43</b>-<b>45</b>) or convex top and bottom walls <b>86</b>,<b>88</b> and convex inner and outer, annular side walls <b>94</b>,<b>96</b> (FIGS. <b>46</b>-<b>48</b>). The reduction of material from O-ring <b>10</b>,<b>12</b> coupled with the curvature of either the top and bottom walls <b>86</b>,<b>88</b> or the annular inner and outer side walls <b>94</b>,<b>96</b> provides stability in a plane perpendicular to central longitudinal axis <b>24</b>, and provides an over-center “snap-action” when the O-ring is rolled about itself and sleeve <b>8</b>.

[0141] Additionally, O-ring <b>10</b>,<b>12</b> may also be formed so as to have nonparallel top and bottom walls <b>100</b>,<b>102</b>, and convex inner and outer, annular side walls <b>104</b>,<b>106</b> (FIGS. <b>49</b>-<b>51</b>). Alternatively, O-ring <b>10</b>,<b>12</b> may also be formed so as to have nonparallel, convex top and bottom walls <b>108</b>,<b>110</b>, and convex inner and outer, annular side walls <b>112</b>,<b>114</b> (FIGS. <b>52</b>-<b>54</b>). Also, an additional annular flat <b>116</b> may be included at the transition between convex inner and outer, annular side walls <b>112</b>,<b>114</b> and convex top and bottom walls <b>108</b>,<b>110</b> (FIGS. <b>55</b>-<b>57</b>).

[0142] Referring to FIGS. <b>58</b>-<b>66</b>, O-rings <b>10</b>,<b>12</b> may also include a plurality of through-holes <b>120</b> defined radially through O-ring <b>10</b>,<b>12</b>, i.e., through cross-sectional center <b>20</b>, from diametrically opposed positions along the circumference of the O-ring. FIGS. <b>58</b>-<b>63</b> illustrate a plurality of rectilinearly shaped through-holes <b>120</b>, and double through-holes <b>122</b>, respectively, while FIGS. <b>64</b>-<b>66</b> illustrate a plurality of round through-holes <b>124</b>. In each case, the removal of material from O-ring <b>10</b>, <b>12</b> to define through-holes <b>120</b>,<b>122</b>, or <b>124</b> provides stability in a plane perpendicular to central longitudinal axis <b>24</b>, and provides an over-center “snap-action” when the O-ring is rolled about itself and sleeve <b>8</b>.

[0143] Referring to FIGS. <b>67</b>-<b>69</b>, in some instances, O-rings <b>10</b>,<b>12</b> may have additional material added to their circumference so as to form bulbous protrusions <b>128</b> over their outer surface, so as to redistribute the mass of the O-ring <b>10</b>,<b>12</b>. This redistribution of mass and concomitant change in the moment of inertia of O-ring <b>10</b>,<b>12</b> also provides stability in a plane perpendicular to central longitudinal axis <b>24</b>, and provides an over-center “snap-action” when the O-ring is rolled about itself and sleeve <b>8</b>.

[0144] Referring to FIGS. <b>70</b>-<b>78</b>, O-rings <b>10</b>,<b>12</b> may be formed from a plurality of individual O-rings <b>135</b><i>a</i>,<b>135</b><i>b </i>that are stacked one upon another so as to yield a stack of O-rings <b>136</b> that together comprise a non-circular radial cross-section. Individual O-rings <b>135</b><i>a</i>,<b>135</b><i>b </i>may comprise a solid or hollow, elliptical or circular cross-section (FIGS. <b>70</b>-<b>87</b>) or a solid or hollow polygonal or astroidal cross-section (FIGS. <b>88</b>-<b>115</b>). Hollow O-rings <b>135</b><i>a</i>,<b>135</b><i>b </i>may comprise one or more passageways <b>137</b><i>a</i>,<b>137</b><i>b </i>which may or may not be centrally located within each O-ring <b>135</b><i>a</i>,<b>135</b><i>b</i>. Stack of O-rings <b>136</b> provide annular, opposed curved surfaces <b>139</b><i>a</i>,<b>139</b><i>b </i>and unequal concentrations of material distributed about a centroid <b>140</b> that is defined by the point or area of engagement between one another. Sleeve <b>8</b> is fastened or bonded to a portion of either opposed curved surfaces <b>139</b><i>a</i>,<b>139</b><i>b </i>by sealing, e.g., thermally, ultrasonically, or adhesively, In this way, upon rolling or unrolling stacked O-rings <b>135</b><i>a</i>,<b>135</b><i>b </i>on sleeve <b>8</b>, using manual pressure on annular surfaces <b>139</b><i>a</i>,<b>139</b><i>b</i>, stacked O-rings <b>135</b><i>a</i>,<b>135</b><i>b </i>snap incrementally from one stable position to a next stable position.

[0145] Referring to FIGS. <b>79</b>-<b>87</b>, stack of O-rings <b>136</b> may comprise multiple individual O-rings <b>135</b><i>a</i>,<b>135</b><i>b</i>,<b>135</b><i>c </i>thus forming a non-circular radial cross-sectioned portions of stack <b>136</b>. Individual O-rings <b>135</b><i>a</i>,<b>135</b><i>b</i>,<b>135</b><i>c </i>may also comprise a solid or hollow, elliptical or circular cross-section or a solid or hollow polygonal or astroidal cross-section (FIGS. <b>88</b>-<b>115</b>). Hollow O-rings <b>135</b><i>a</i>,<b>135</b><i>b</i>,<b>135</b><i>c </i>may comprise one or more passageways <b>137</b><i>a</i>,<b>137</b><i>b</i>,<b>137</b><i>c </i>which may or may not be centrally located within each O-ring <b>135</b><i>a</i>,<b>135</b><i>b</i>,<b>135</b><i>c</i>. Stack of O-rings <b>136</b> provide annular, opposed curved surfaces <b>139</b><i>a</i>,<b>139</b><i>b</i>,<b>139</b><i>c </i>and unequal concentrations of material distributed about centroids <b>140</b><i>a</i>,<b>140</b><i>b </i>that are defined by the point or area of engagement between one another.

[0146] Referring to FIGS. <b>88</b>-<b>118</b>, O-rings <b>10</b>,<b>12</b> may also be formed with an astroidal or “star-shaped” cross-section, e.g. a cross-sectional shape comprising a hypercycloid having three or more cusps. An astroidal O-ring <b>10</b>,<b>12</b> may have any number of cusps <b>148</b> projecting radially outwardly relative to centroid <b>150</b>. Although an astroidal O-ring may have either a solid or hollow cross-section, a solid cross-section is often preferred. Cusps <b>148</b> may be somewhat rounded or pointed at their apex, and may or may not be symmetrically arranged about a centroid <b>152</b> of the O-ring. O-rings <b>10</b>,<b>12</b> may comprise individual astroidal rings, or may be formed from a plurality of individual astroidal O-rings <b>155</b><i>a</i>,<b>155</b><i>b</i>,<b>155</b><i>c </i>that are stacked one upon another so as to yield a stack of O-rings <b>156</b> that together comprise a non-circular radial cross-section (FIGS. <b>88</b>-<b>111</b>).

[0147] In another embodiment, an astroidal O-ring <b>10</b>,<b>12</b> may comprise a torsional preloading that enhances its ability to snap incrementally from one stable position to a next stable position. In this embodiment, a continuous length of astroidal cross-section, relatively resilient material is extruded in a conventional manner. A discrete length of the extruded material is cut and then twisted such that cusps <b>148</b> are rotated relative to centroid <b>150</b> by as much as 45° to 90° so as to store torsional energy within the extruded material. Once in this position, the free ends of the discrete length of extruded material are arranged so as to be adjacent to one another, and then bonded to one another either thermally of ultrasonically so as to form a ring. In this way, the torsional preload is maintained within the thus formed O-ring <b>10</b>,<b>12</b>.

[0148] Astroidal O-rings <b>10</b>,<b>12</b> may be formed into an incrementally adjustable surgical wound protector <b>5</b> by fastening or otherwise bonding lower end edge <b>18</b> of sleeve <b>8</b> to a surface portion of O-ring <b>12</b> either between cusps <b>148</b>, or directly to cusps <b>148</b>, by sealing, e.g., thermally, ultrasonically or adhesives, but without the portion of sleeve <b>8</b> adjacent to lower end edge <b>18</b> being wrapped around the circumference of O-ring <b>12</b>, or overlapped upon itself (FIG. 119). The torsional preloading enhances the snap-action rolling of astroidal O-ring <b>12</b> by providing a predisposition within the ring to roll in a preferred manner.

[0149] Referring again to FIGS. <b>6</b>-<b>9</b>, when adjustable surgical wound protector <b>5</b> is to be used in an abdominal surgical procedure, the abdomen <b>55</b> is routinely prepared with antiseptics; the site for the incision is traced on abdomen <b>55</b> and covered with a surgical drape; and a muscle-split is made at the site through the peritoneum. One O-ring (identified by reference numeral <b>12</b> in FIGS. <b>6</b>-<b>9</b>) is squeezed lengthwise and inserted into the surgical incision and through the peritoneum, where it is released and returns to its original circular shape. In this position, O-ring <b>12</b> is placed within the body cavity and O-ring <b>10</b> is positioned outside of the body cavity, with sleeve <b>8</b> extending through the body cavity. It will be understood that O-rings <b>10</b>,<b>12</b> are completely interchangeable. Outer O-ring <b>10</b> is then gripped by the thumb and fingers and turned outwardly, in opposite directions, so as to roll sleeve <b>8</b> incrementally, i.e., so as to create repeated over-center “snap-rolls” of the O-ring. As a consequence, sleeve <b>8</b> is reeled onto outer O-ring <b>10</b> until outer O-ring <b>10</b> abuts the outer surface of abdomen <b>55</b>. The portion of sleeve <b>8</b> that is in the incision, and between O-rings <b>10</b>,<b>12</b> is drawn into contiguous contact with the sides of the incision so as to provide a self-retaining protective barrier during surgery which is impervious to contaminating solids and fluids.

[0150] Advantages of the Invention

[0151] Numerous advantages are obtained by employing the present invention.

[0152] The present invention provides a relatively low cost surgical wound protector of simplified and selectively adjustable design which can be easily installed in a wound and adjusted in place to form fit a wide range of cavity wall thicknesses for protection against harmful contaminants.

[0153] Another advantage of the invention is the provision of an adjustable wound protector in which relatively few sizes are needed to form fit a wide range of incision sizes and cavity wall thicknesses.

[0154] Still another advantage of the invention is the provision of a surgical wound protector which can be adjusted after being inserted in a wound to obtain contiguous contact with the sides of the cavity wall.

[0155] A still further advantage of the invention is the provision of a single, easily manufactured O-ring design that provides for a “snap-action” when rolled in itself so as to reel a sleeve onto the O-ring after being inserted in an incision for securing the sleeve in contiguous contact with the sides of the incision.

[0156] It is to be understood that the present invention is by no means limited only to the particular constructions herein disclosed and shown in the drawings, but also comprises any modifications or equivalents within the scope of the claims.