Surgery – Body protecting or restraining devices for patients or infants – Drapes
Reexamination Certificate
2000-12-15
2004-05-18
Worrell, Danny (Department: 3765)
Surgery
Body protecting or restraining devices for patients or infants
Drapes
C128S887000, C128S888000, C606S148000
Reexamination Certificate
active
06736141
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to surgical devices. In particular, the invention concerns a surgical aid to facilitate closure of a wound following a surgical procedure. The surgical aid is especially useful in abdominal surgery and it will be convenient to hereinafter describe the invention in relation to that example application. It should be understood however that the surgical aid is not limited to abdominal surgery and is capable of wider application and use.
BACKGROUND
Following surgery in the abdominal region, a wound, often of considerable size, needs to be closed by suturing. This is a delicate and time-consuming procedure as the surgeon must carefully suture the various membranes of the abdomen back together whilst being very cautious not to nick or puncture the soft internal organs of the abdomen, known as the viscera.
The procedure is made even more difficult if the patient is overweight because there is a greater need to retain, or hold down, the viscera whilst simultaneously pulling together the edges of the membrane being sutured, such as the peritoneum and posterior rectus sheath. In this situation, the risk of nicks or punctures to internal organs such as the bowel becomes even greater.
To alleviate this problem, surgeons have occasionally used a rectangular piece of rubber, or similar, to retain the viscera and provide a physical barrier against accidental nicks or punctures. The rubber was inserted into the wound over the viscera prior to closure. The wound was then partially closed, by suturing together the edges of the peritoneum, over the rubber, until a hole of sufficient size to remove the rubber remained. The rubber was then removed through that hole and the remainder of the wound closed. This procedure did to some extent address the problem but the stiffness of rubber and the awkward shape made it difficult to remove the piece of rubber from the wound.
One known device, sold under the name Glassman Viscera Retainer, the “Fish” by Adept-Med International Inc. partly addresses this problem. It includes a viscera retaining part, to be inserted into the wound, and a circular ring, to act as a handle to facilitate extraction of the retaining part from the wound. The retaining part includes a roughly diamond shaped, pliable web extending from a solid central rib. Attached to an end of the rib is a string, and at the end of the string is the circular ring. In use, the retaining part is inserted into the wound prior to closure and the wound is then partially closed by suturing over it. The retaining part is then withdrawn by pulling on the string using the ring. It has been found, however, that the solid central rib reduces the ability to remove the retaining part through a small hole. Also, the device is made of a material that cannot be sterilised and re-used. It must be discarded after a single use.
There therefore remains a need for a surgical aid of this type which is easier to use, can be withdrawn through a smaller hole upon partial closure of the wound and which can be re-used in subsequent surgical procedures.
SUMMARY OF THE INVENTION
The present invention provides a surgical aid to facilitate wound closure. The surgical aid includes a body portion and a tail portion. At least the body portion is made predominantly of a planar, flexible and resiliently stretchable material.
The surgical aid is especially useful to facilitate closing of a wound following abdominal surgery. In use, the body portion is inserted into the wound prior to closure, to act as a physical barrier protecting the viscera. The tail portion is not inserted into the wound and remains accessible to facilitate later withdrawal of the body portion from the wound. The peritoneum, posterior rectus sheath or other membrane/layer being closed, is then drawn together and sutured over the body portion of the surgical aid until only a small hole is left, with the tail portion still being accessible outside the wound. The body portion is then withdrawn from the wound by pulling on the tail portion.
The invention is based on a realisation that, in this application, a resiliently stretchable material exhibits special properties which become extremely useful. If tension is applied to a planar piece of such a material, it will have a natural tendency to curl or fold in a direction lateral to the direction of the tension. Thus, in this application, when tension is applied to the body portion of the surgical aid by pulling on the tail portion, the body portion tends to curl, or at least fold. This makes it much easier to pull the body portion of the surgical aid through an opening which is smaller than with prior art devices. In turn, this further reduces the risk of nicks or punctures to the delicate tissue and organs of the viscera whilst the surgeon is closing the remaining section of the wound.
According to the invention, the material must be flexible and, at least to some extent, resiliently stretchable. The degree of stretchability is not critical. It merely needs to be sufficient to encourage a rolling or folding action of the body portion when tension is applied.
In one embodiment, at least the body portion is made solely of a planar, flexible and resiliently stretchable material. Preferably, the body portion is made of surgical grade silicone. More preferably, the body portion includes a silicone rubber compound sold under the name SILASTIC® K760 by Dow Corning. In this application, this material makes it possible to withdraw the surgical aid through an even smaller opening. When in contact with body fluids present during surgery, the surface of the material slides easily with respect to the body tissue of the patient. This further facilitates withdrawal of the surgical aid from the wound.
Surgical grade silicone can also be sterilised in an autoclave, thus making it possible to re-use the surgical aid many times. It does not need to be disposed of after a single use, thereby reducing medical waste.
In a preferred embodiment, at least the body portion is impregnated with barium sulphate to render it radiopaque. In this way, if by any chance, a fragment of the surgical aid remained within the abdomen of the patient after the wound had been closed, it would be detectable in an x-ray.
In a preferred embodiment, the body and tail portions of the surgical aid are integrally formed from a single sheet of material. This reduces manufacturing costs and means that there is no joint in the region between the body and tail portions. This region is merely a narrowed section of the same material which can fold or roll as required to be drawn through a small opening in the wound. The material is preferably of a thickness between 1 and 3 mm, and more preferably between 1.5 and 2.0 mm.
The body portion of the surgical aid is preferably elliptical in shape and, in the preferred embodiment, has a length to width ratio of about 2:1. This ratio has been found to be suitable for a wide range of surgical procedures.
The optimum size of the surgical aid will depend on the size of the wound being closed and the size of the patient. The width of the body portion of the surgical aid is preferably between 100 and 200 mm, and more preferably between 130 and 160 mm. The length of the body portion is preferably between 150 and 400 mm, and more preferably between 200 and 300 mm.
The surgical aid may conveniently be formed in the shape of a fish having a relatively large body portion and a relatively small tail portion. In one form, both the body portion and the tail portion are roughly elliptical in shape, with the region connecting the two portions forming a narrow waist.
The preferred form of the surgical aid, being made from a single sheet of surgical grade silicone, has a further advantage over the prior art device by Adept-Med in that it is far cheaper to manufacture. The prior art surgical device includes multiple parts, such as the solid rib and the pliable membrane, which need to be moulded to form the complete device. Also, a separate string and ring handle need to be attached. I
Baker & Daniels
Worrell Danny
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