Method of controlling post-operative leakage associated with...

Surgery – Miscellaneous – Methods

Reexamination Certificate

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C604S542000, C604S378000, C604S385030, C604S385080

Reexamination Certificate

active

06269820

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to methods of controlling fluid leakage from wounds and, more particularly, to a method of controlling fluid leakage from a tunnel formed in fatty tissue as part of a tumescent liposuction surgical procedure during which large amounts of a tumescent solution are introduced into the fatty tissue.
2. Description of the Background Art
Liposuction is a surgical technique which is widely used to permanently remove excess fat in areas of the body which are resistant to diet and exercise. Early forms of fat removal surgery involved extracting blocks of fat from the body through large incisions, often resulting in long unsightly scars. Liposuction, on the other hand, utilizes an elongate tube with an opening at each end, called a cannula, which is inserted into the body via small incisions and attached to a suction device to remove large amounts of fat with less scarring. While early forms of liposuction were an improvement over large excisions of fat, the instruments were still large, general anesthesia was necessary, bleeding and bruising were commonplace, and recovery tended to be long and difficult.
A more recent approach to liposuction, known as tumescent liposuction or liposculpture, involves infusing large volumes (i.e., many liters) of a very dilute solution of local anesthesia and adrenalin into the areas to be suctioned. This tumescent solution provides the local anesthesia during the procedure allowing the patient to remain awake and comfortable and avoiding the risks of general anesthesia. Large amounts of the dilute adrenalin in the tumescent solution constricts the blood vessels thereby reducing bleeding and bruising to a minimum and allowing the surgeon to spend more time shaping the areas for optimal results. While tumescent liposculpture is an improvement over the older forms of liposuction, leakage of the tumescent solution from the tiny incisions may occur for up to eighteen hours following the procedure. To control fluid leakage, cosmetic surgeons typically place a gauze pad over the portal and secure it with standard surgical tape. As the gauze becomes saturated, however, some of the fluid can seep through the tape thereby adding to the discomfort of the patient by soaking clothing and necessitating frequent substitution of bandages.
SUMMARY OF THE INVENTION
Accordingly, it is an object of the present invention to overcome the above mentioned disadvantages of the prior art by improving methods of controlling fluid leakage from an incision following tumescent liposuction and other types of surgical procedures where large amounts of fluid are introduced into the body.
Another object of the present invention is to improve patient comfort following tumescent liposuction and other types of surgical procedures by increasing the amount of fluid absorbed by a bandage placed over an incision and retaining the absorbed fluid within the bandage.
A first aspect of the present invention is generally characterized in a method of controlling postoperative fluid leakage following a tumescent liposuction surgical procedure during which large volumes of a tumescent solution are infused into fat tissue, including the steps of providing a bandage having an aborbent pad formed of expanded polyvinyl acetate sponge material with a softer outer texture than dry, rigid polyvinyl acetal sponge material, placing the expanded absorbent pad over the opening of a tunnel formed in the fat tissue with a cannula as part of the tumescent liposuction surgical procedure, holding the expanded absorbent pad against the tunnel opening using a flexible backing with adhesive on one side so that tumescent solution leaking from the tunnel is absorbed by the pad, and containing the absorbed tumescent solution within the absorbent pad by interposing a liquid impermeable layer between the absorbent pad and the backing.
Another aspect of the present invention is generally characterized in a method of controlling postoperative fluid leakage following a tumescent liposuction surgical procedure during which large volumes of a tumescent solution are infused into fat tissue, including the steps of placing an expandable absorbent pad in an unexpanded, dry state over the opening of a tunnel formed in the fat tissue with a cannula as part of the tumescent liposuction surgical procedure, holding the expandable absorbent pad against the tunnel opening using a flexible backing with adhesive on one side so that tumescent solution leaking from the tunnel is absorbed by the pad as the pad expands from the dry state to an enlarged wet state, and containing the absorbed tumescent solution within the enlarged absorbent pad by interposing a liquid impermeable layer between the absorbent pad and the backing.
Still another aspect of the present invention is generally characterized in a method of performing tumescent liposuction including the steps of introducing a tumescent solution into fatty tissue in the body, removing fatty tissue by forming one or more tunnels in the fatty tissue via an opening, placing a bandage containing a softened polyvinyl acetal sponge over the opening, and absorbing tumescent solution leaking from the opening in the sponge. The softened polyvinyl acetate sponge material can be placed over the incision in either an unexpanded dry state or an expanded dry state.
Yet another aspect of the present invention is generally characterized in a bandage for controlling post-operative leakage of fluid following tumescent liposuction including a flexible backing with adhesive on one side, and an absorbent pad formed of a softened polyvinyl acetal sponge material with a liquid impermeable surface positioned on the adhesive side of the backing. The softened polyvinyl acetal sponge material has a thickness in a dry state to absorb and retain between 15 and 200 cc of the tumescent fluid so that the bandage can remain in place for about 8 to 12 hours before having to be replaced. The polyvinyl acetal sponge material can be provided in an expanded dry state such that there is little or no enlargement of the sponge material during absorbtion or the sponge material can be provided in an unexpanded dry state so as to expand in size as the fluid is absorbed. The shape and size of the polyvinyl acetal sponge material can be configured to cover one or more incisions. The surface area of the polyvinyl acetal sponge material is preferably less than that of the backing so that an adhesive margin or border remains around the perimeter of the sponge material to permit the bandage to be adhesively secured to the patient at the operative site.
Some of the advantages of the present invention over the prior art are that the bandage does not need to be changed as frequently, that liquid and moisture vapor permeable materials can be used as a backing for the bandage without compromising the fluid controlling properties of the bandage, that the bandage can be provided in various shapes and sizes for use on different parts of the body, and that the amount of fluid absorbed by the bandage can be controlled by altering the density, thickness and/or surface area of the sponge body.
Other objects and advantages of the present invention will become apparent from the following description of the preferred embodiments taken in conjunction with the accompanying drawings, wherein like parts in each of the several figures are identified by the same reference numerals.


REFERENCES:
patent: D. 256162 (1980-07-01), Haerr et al.
patent: 3157178 (1964-11-01), Bentov
patent: 3648692 (1972-03-01), Wheeler
patent: 3797491 (1974-03-01), Zaffaroni
patent: 3814095 (1974-06-01), Lubens
patent: 3900027 (1975-08-01), Keedwell
patent: 3934587 (1976-01-01), Gordon
patent: 3996934 (1976-12-01), Zaffaroni
patent: 4034759 (1977-07-01), Haerr
patent: 4054141 (1977-10-01), Schwaiger et al.
patent: 4060084 (1977-11-01), Chandrasekaran et al.
patent: 4096230 (1978-06-01), Haerr
patent: 4098728 (1978-07-01), Rosenblatt
patent: 4122857 (1978-10-01), Haerr
patent: 4159719 (1979-0

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