Surgery – Means and methods for collecting body fluids or waste material – Aspiration collection container or trap
Reexamination Certificate
1996-04-12
2001-07-17
Weiss, John G. (Department: 3308)
Surgery
Means and methods for collecting body fluids or waste material
Aspiration collection container or trap
C128S126100
Reexamination Certificate
active
06261276
ABSTRACT:
TECHNICAL FIELD
The present invention relates to surgical wound drainage and, in particular, to apparatus for post operatively draining and collecting fluids from a closed surgical wound.
BACKGROUND OF THE INVENTION
It has long been recognized that large surgical wounds are advantageously drained of fluids to facilitate healing and improve the readaptation of tissue layers surrounding the wound. Considerable effort has therefore been invested in designing devices to provide consistent and effective drainage of surgical wounds by partially evacuated collection containers which promote surgical wound drainage.
Such devices may be generally divided into three categories, compressible containers, electric vacuum machines and precharged disposable containers. All three categories of wound drainage devices operate on the principle that a partial vacuum provides suction in the surgical wound to promote the drainage of fluids from the wound. The first category includes simple mechanical devices which are spring biased collapsible containers or containers with elastic memory. Both are generally made of resilient elastomeric material. Such containers are manually compressed to provide suction for removing and collecting fluids from surgical wounds. One example of this type of device is disclosed in U.S. Pat. No. 3,993,080 to Loseff which issued Nov. 23, 1976. Such devices suffer from certain drawbacks. First, such devices have a limited capacity for providing suction, the amount of suction provided being related to the elasticity and the volume of the container. Second, they generally provide no means for monitoring the subatmospheric pressure in the container. It is therefore difficult to judge how much suction is being applied to a wound, and the quality of the vacuum may deteriorate as the container loses its elastic memory over time. Third, such containers collect the fluid drained from the wound and must therefore be discarded after use or emptied, cleaned and sterilized, with all the attendant hazards and time consuming activity involved in handling medical waste.
The second category of wound drainage devices includes the vacuum machines equipped with electrically powered vacuum pumps which are generally controlled by electronic circuits that poll sensors to monitor vacuum levels. Examples of such devices are disclosed in U.S. Pat. No. 4,569,674 to Phillips et al. which issued Feb. 11, 1986, and U.S. Pat. 3,836,287 to Grosholz et al. which issued Sep. 17, 1974. These are complex, expensive machines which may also be used as wound irrigation devices. Some of these machines accumulate fluid in disposable containers (see U.S. Pat. No. 3,836,287) to minimize maintenance. The disadvantages of such machines are that they are generally bulky, most are unusable by ambulatory patients, and they are expensive to manufacture and maintain.
The third category of such devices includes lightweight molded plastic or glass containers which are pre-evacuated to provide either a “high” (about 0.9 bar) or a “low” (about 0.4 bar) vacuum. For example, see U.S. Pat. 4,642,093 to Harle which issued Feb. 10, 1987. These containers are transportable and are usually disposable. Some also include a gauge to indicate whether there is negative pressure in the container. Some of the disadvantages of these devices are that they are useless once the vacuum has been discharged from the container, do not provide adjustable vacuum, and do not provide consistent vacuum over an extended period of time. They also do not permit an optimal regimen for surgical wound drainage whereby the suction force is regulated over time to optimize the readaptation of tissue surrounding the wound. Furthermore, these containers must be carefully handled to ensure that the vacuum is not released before they are used because they provide no mechanism for recharging the vacuum once it is discharged.
Surgical wounds requiring drainage may be located in either “soft tissue”, such as found in the abdominal cavity, or in “hard tissue”, such as striated muscle. It has long been recognized that these two types of tissue require different treatments to ensure that the tissues surrounding the surgical wound are optimally readapted and healing is facilitated. Soft tissues should not be subjected to high vacuums for prolonged periods of time, i.e. suction forces in excess of about 0.5 bar, while hard tissue is preferably subjected to higher vacuum for effective drainage. Hence, precharged wound drainage containers are offered in low pressure and high pressure units, as described above.
It has also been discovered that optimal post-operative results are generally achieved if a regimen is followed in which the suction force for surgical wound drainage is varied over time. The amount of suction for optimal results depends on the type tissue in which the wound is located, as well as the time that has elapsed since the wound was created. It is therefore desirable to provide an apparatus for draining surgical wounds which permits the subatmospheric pressure for promoting drainage to be monitored and adjusted in accordance with an optimal regimen.
It is also known that the suction force provided by most apparatus for draining surgical wounds decreases proportionally with the volume of fluid collected. In other words, as fluid is drained from a wound, the suction forte applied by the container is proportionally reduced. It is therefore desirable to provide a container in which the vacuum can be adjusted to an optimal level until the container has collected its nominal capacity of fluid, or the container is no longer needed.
The spread of blood-borne diseases such as AIDS and Hepatitis-C have also heightened awareness of the value of blood products. It has therefore been recognized that in certain circumstances it may be inappropriate to dispose of wound drainage fluids if they can be used for transfusion back into a post-operative patient. It is therefore desirable to provide a wound drainage collection apparatus which is adapted to collect wound drainage fluids in a container such as a blood bag which permits the fluids to be used for transfusion, if appropriate.
There therefore exists a need for a simple, easy to use, inexpensive wound drainage system that overcomes these known disadvantages of the prior art, and is adapted to permit one to follow an optimal post-operative wound drainage regimen.
SUMMARY OF THE INVENTION
It is an object of the invention to provide a simple surgical wound drainage apparatus for removing and collecting fluids from a closed wound which is inexpensive to manufacture.
It is another object of the invention to provide a simple surgical wound drainage apparatus which provides an inexpensive, safe, disposable collection container for wound drainage wastes.
It is a further object of the invention to provide a simple surgical wound drainage apparatus which provides adjustable and rechargeable vacuum using a hand-operated vacuum pump.
It is yet a further object of the invention to provide a simple surgical wound drainage apparatus which provides a gauge of the subatmospheric pressure in the collection container.
It is another object of the invention to provide an inexpensive surgical wound drainage apparatus which permits the suction force to be regulated over time to facilitate an optimal regimen of surgical wound drainage.
It is yet another object of the invention to provide an inexpensive surgical wound drainage apparatus which permits the collection of wound drainage fluids in a container adapted to permit the fluid to be transfused back into the patient, if appropriate.
In its simplest form, the apparatus in accordance with the invention comprises a plastic container, preferably manufactured from polyethylene, having a sidewall that defines a substantially rigid wound drainage waste collection reservoir located at the bottom of the container and an elastic bellows gauge located above the reservoir. The bellows gauge is preferably incorporated into the neck of the container. Wound drainage waste is collected in the reservoir an
Gilhooly and Crossman
I.S.I. International, Inc.
Ruhl Dennis
Weiss John G.
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