Surgery: splint – brace – or bandage – Bandage structure
Reexamination Certificate
2000-07-24
2003-06-17
Lucchesi, Nicholas D. (Department: 3764)
Surgery: splint, brace, or bandage
Bandage structure
C602S048000
Reexamination Certificate
active
06580011
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to post-operative wound dressings, and in particular to wound dressings to be applied to a penis.
2. Description of the Prior Art
Circumcision is one of the oldest of all surgical procedures, and is the operation most frequently performed on males in the United States. While circumcision is sometimes performed on adults and young children, the operation is most commonly performed on newborn infants.
As in any surgical procedure, there is a risk of infection associated with circumcision. Cleanliness and proper dressing of the wound site is of utmost importance. Bandages applied to the penile area are difficult to maintain, and the application of post-surgical dressings to infants presents particular problems. Ordinary strip gauze material and 4″×4″ gauze is frequently used to bandage the newly circumcised penis of an infant. The necessity of simultaneously diapering the infant tends to interfere with the placement of the bandage, as the removal of the diaper may rip away the bandage. The delicacy of the operated area, as well as the need for frequent changing of the dressing, preclude the use of strenuous means to secure the bandage, such as excessive taping and pressing to mold gauze material to the newly circumcised penis. The application of ordinary bandaging materials to the penis of an infant can therefore be awkward, and such a bandage can easily fall off, leaving the infant susceptible to infection.
In the prior art, Scherz, U.S. Pat. No. 5,183,460, relates to a bandage designed to maintain a post-operative penile dressing in place. The bandage disclosed by Scherz is used in conjunction with protective gauze or other surgical dressing. The bandage is substantially L-shaped, the shorter leg portion being divided into three strips. In use, the three segments of the shorter leg portion are adhered to the skin adjacent to the base of the penis, and the longer leg portion is wrapped circumferentially around the penis so as to hold the gauze in place.
Several examples of tubular or sleeve-like bandages exist in the prior art. Scholl, U.S. Pat. No. 2,646,796, discloses a tubular bandage in which the interior surface is coated with a self-bonding adhesive material. The bandage is secured in place by pressing the outer edges of the bandage together so as to seal them, thereby obviating the need for a fastening device. Delao, U.S. Pat. No. 5,592,953, discloses a tubular sleeve secured by drawstrings on either end, the primarily function of which is to protect the bandaged area from water contamination while bathing.
Sleeve-like devices which are secured by Velcro® straps are disclosed in Lemon, U.S. Pat. No. 3,710,790, and Smith, III, U.S. Pat. No. 5,085,210. Both devices are intended for use as a brace for muscle or joint injuries.
None of the patents cited above relates to a penile dressing which is suitable for use on the penis of an infant or adult. There remains a need for a post-operative penile dressing configured for placement on the circumcised penis of an infant or adult which can be readily applied and removed without requiring adhesive to contact the skin, and which can also be secured without the use of excessively forceful means.
It is a common practice today to treat circumcision of an infant as a minor operation with very little post-operative care. After the operation, a small amount of petroleum jelly is applied, a piece of gauze is placed on the wound without being secured, and the infant is diapered. The diaper and gauze must be changed approximately every three hours.
Surprisingly, topical antibiotics and anesthetics are not used to dress the wound. Historically, it was believed that the circumcised infant did not experience a great deal of pain. Recent research and the increasing number of adult circumcisions, however, indicate that there is significant pain associated with circumcisions. It would therefore be desirable to apply topical anesthetics to the wound site. To prevent infection, it would also be desirable to apply topical antibiotics to the wound site. In order to avoid excessive handling of the operated area, it would be highly advantageous to provide a post-operative penile dressing which includes topical antibiotics and anesthetics within the dressing.
SUMMARY OF THE INVENTION
It is an object of the invention to provide a surgical dressing for a circumcised penis which is configured to be placed over the penis as a sheath-like cover.
It is another object of the invention to provide a surgical dressing for a circumcised penis that includes an attachment means which maintains the dressing firmly in place without excessive force.
It is yet another object of the invention to provide a surgical dressing for a circumcised penis that includes an attachment means which allows the dressing to be readily and painlessly applied and removed.
It is still another object of the invention to provide a surgical dressing for a circumcised penis which preserves hygienic conditions by providing a means to attach and remove the dressing with a minimal amount of direct skin contact with the wound site and the dressing itself.
It is still another object of the invention to provide a surgical dressing for a circumcised penis which includes topical antibiotics and topical anesthetics within the dressing.
In accordance with the above objects, in one aspect, the invention features a post-operative surgical dressing for bandaging a penis. The dressing includes a flexible sleeve portion having an inner wall defining a lumen sized and shaped to contain the penis, and an outer wall forming the outside surface of the sleeve portion. The sleeve portion can be deformable into a tube-like shape having a first aperture through which the penis can be inserted into the lumen and a second aperture. A urine drainage component, which can be composed of a material through which urine can flow, can be affixed to the sleeve portion over the second aperture. A means for securing the dressing on the penis is also included.
In preferred variations, the dressing further includes a lining attached to the inner wall of the sleeve portion. The lining can be made of a material that prevents adherence of the penis to the dressing (e.g., petrolatum or petrolatum impregnated gauze such as Xeroform), and can also include a topical antiseptic agent and/or a topical anesthetic agent such as lidocaine.
The means for securing the dressing on the penis can include two securement straps, each of which is composed of an elongated strip of material having a free distal end and a proximal end affixed to the sleeve portion. In some variations of this embodiment, the securement straps are elastic. In other variations, a fastener part (e.g., a hook component of a hook and loop type fastener or an adhesive strip covered by a removable protective layer) is attached to the distal end of each securement strap.
The dressing of the invention can have the sleeve portion slit along its length. The closure flap can have a first portion movably affixed to the sleeve portion and a second portion having thereon an adhesive strip. The second portion of the closure flap can be adapted to be affixed to the outside surface of the sleeve portion, thereby securing the dressing on the penis.
The urine drainage component is composed of a material through which urine can flow. For example, this material can be a porous material such as polypropylene mesh, although the invention is not limited in that regard. The material preferably has an aperture with a surface area of about 0.5-3.5 cm
2
, although the size of the aperture can vary depending upon the overall size of the dressing (e.g., 1 cm
2
aperture for infant-sized dressings and 2 cm
2
for adult-sized dressings).
In another aspect, the invention features a circumcision wound dressing kit. This kit includes a sterilized dressing (such as the one described above) hermetically sealed within a sterilized envelope. The envelope can be, e.g., a sterilized foil packet or a sterilized paper
Akerman & Senterfitt
Lucchesi Nicholas D.
Thanh Quang D
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