Surgery: splint – brace – or bandage – Bandage structure
Reexamination Certificate
2002-07-16
2003-09-02
Lucchesi, Nicholas D. (Department: 3764)
Surgery: splint, brace, or bandage
Bandage structure
C602S060000, C600S206000, C600S208000
Reexamination Certificate
active
06613952
ABSTRACT:
FIELD OF THE INVENTION
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
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.
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.
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.
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
In one preferred embodiment, an O-ring is provided for use in an adjustable surgical wound protector comprising a solid cross-section including a cross-sectional center that is spaced from a central longitudinal axis and a resilient configuration for squeezing into an oblong shape that is insertable into a surgical incision. At least one recess is defined in the O-ring that is selectively sized and shaped to enable a snap-action rolling of the O-ring about the cross-sectional center in predetermined increments. The recess may comprise various cross-sectional shapes, such as, at least one circumferential groove, a plurality of circumferentially positioned recesses, or be shaped such that the O-ring comprises a cruciform cross-section.
In one preferred embodiment of the invention, an O-ring is provided for use in an adjustable surgical wound protector that comprises a circular torus having a solid cross-section including a cross-sectional center that is radially equidistant from a central longitudinal axis. This O-ring also comprises a resilient configuration that is suitable for squeezing into an oblong shape that is insertable into a surgical incision. Advantageously, two recesses are formed in the O-ring that are selectively sized and shaped to enable a snap-action rolling of the O-ring about the cross-sectional center in predetermined increments. The circular cross-section of the O-rings preferably comprises four quadrants, with the material defining two diagonally opposed quadrants being removed, leaving two diagonally opposed recesses. The solid portion of each O-ring defines a first solid quadrant and a diagonally opposed second solid quadrant, with the first solid quadrant including a curved outer surface, a curved annular surface, and a sinusoidal surface, and the second solid quadrant also including a curved outer surface, a curved annular surface, and a sinusoidal surface. The first and second curved annular surfaces are preferably disposed at substantially the same radial distance from the central longitudinal axis, and are vertically oriented so as to be substantially parallel with the central longitudinal axis. The sinusoidal surfaces extend transversely relative to the central longitudinal axis.
An improved 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 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. Advantageously, at least one of the O-rings comprises at least one recess for enabling selected snap-action rolling of the at least one O-ring for rolling the remaining lengthwise portion of the sleeve on itself about the O-ring to shorten the sleeve in predetermined increments and to resist subsequent lengthening, whereby the sleeve length can be adjusted before or after placement in the wound.
REFERENCES:
patent: 2305289 (1942-12-01), Coburg
patent: 3347226 (1967-10-01), Harrower
patent: 3347227 (1967-10-01), Harrower
patent: 4975247 (1990-12-01), Badolato et al.
patent: 5514133 (1996-05-01), Golub et al.
patent: 5524644 (1996-06-01), Crook
patent: 5640977 (1997-06-01), Leahy et al.
patent: 5649550 (1997-07-01), Crook
patent: 5769794 (1998-06-01), Conlan et al.
patent: 5810721 (1998-09-01), Mueller et al.
patent: 5813409 (1998-09-01), Leahy et al.
patent: 5906577 (1999-05-01), Beane et al.
patent: 5957913 (1999-09-01), de la Torre et al.
patent: 6024736 (2000-02-01), de la Torre et al.
patent: 6033426 (2000-03-01), Kaji
patent: 6042573 (2000
Hamilton Lalita M.
Lucchesi Nicholas D.
Morris LLP Duane
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