Fluid handling – With leakage or drip collecting
Reexamination Certificate
2002-01-16
2003-10-28
Walton, George L. (Department: 3753)
Fluid handling
With leakage or drip collecting
C128S849000, C128S855000, C137S001000, C137S362000, C137S56100R, C137S602000, C220S571000, C141S086000, C141S088000, C604S356000
Reexamination Certificate
active
06637453
ABSTRACT:
REFERENCE TO GOVERNMENT-SPONSORED RESEARCH
None
TECHNICAL FIELD
The present invention relates to methods and apparatus for control of fluids in work areas. More specifically, the invention relates to methods and disposable apparatus for collecting fluids emanating from a work area. In particular, the present invention provides apparatus and methods for collecting and quantifying the amount of infused and bodily fluids released during surgical procedures, for example during hysteroscopy and urological procedures.
BACKGROUND
A problem affecting the health and safety of a variety of workers is that of providing a safe, non-slippery, dry area upon which the workers can stand. Hospital operating room personnel are routinely required to stand and work in conditions in which the floor is inundated with several liters of distension media, blood, bodily fluids, and other liquids during a single procedure. The abundance of fluids released during surgery is due in part to refinements to diagnostic and surgical equipment, especially the improvements to endoscopic equipment and and the widespread implementation of improved surgical techniques, especially the laparoscopic surgical techniques made possible by improved laparoscopy and other endoscopy tools during recent years.
Fluids dispersed onto operating room tables and floors are a considerable inconvenience to workers, increase the likelihood of contamination, and elevate the potential for spread of infectious disease. Others have attempted to reduce the dangers of slippery floors and the like. For example, U.S. Pat. No. 4,635,913, issued Jan. 13, 1987; U.S. Pat. No. 4,718,653, issued Jan. 12, 1988; and U.S. Pat. No. 4,811,937, issued Mar. 14, 1989, Rothman disclosed a series of Portable Surgical Drainage Platforms. The inventions he developed could assist surgeons and other surgical staff by supporting the personnel on grating and removing liquid that falls through the grating. The platforms are, however, rather heavy and are also difficult to sterilize, especially in the limited amount of time that may be available between surgeries.
LaRooka received U.S. Pat. No. 4,243,214 on Jan. 6, 1981, for her Irrigation-Debridement-Repair Caddy. That disclosure is directed to an apparatus that can be placed under an extremity of a person during a surgical procedure. The Irrigation-Debridement-Repair Caddy is designed to collect some of the irrigation distension fluid and excised tissue that would otherwise drip onto the floor and collect the fluid in a closeable bottle for eventual disposal.
Other devices such as the AquaVac mat marketed by Arthroplastics of P.O. Box 332 Chagrin Falls, Ohio 44022 appear to be directed primarily toward removing water from floors rather than quantifying the amount of fluid received from a patient in order to determine whether the patient's condition is satisfactory.
Endoscopic diagnostic and surgical procedures often use some type of distension fluid (usually a clear liquid) infused into the region where the procedure is being conducted to allow the surgeon to see the affected tissue much more clearly than would otherwise be possible. In addition, the distension fluid can separate and stabilize the tissue to improve surgical precision and reduce the time required to carry out procedures. Any of several liquid distension media may be used during diagnostic and surgical endoscopic procedures. Ringer's solution and 0.9% saline solution may be used during diagnostic examination or laser surgery but are unsuitable when electrosurgery or electrocautery procedures might be undertaken. Non-electrolytic distension media such as 1.5% glycine, mannitol, or sorbitol solutions, among others, can be used for electrosurgery or laser surgery. Since all of the liquid distension media formulations are selectable and equivalent for the purposes of this disclosure, they may be referred to indistinguishably as distending medium, distending media, distension medium, distension media, whether singular or plural.
Hysteroscopic, urologic, and some other surgical patients are usually infused with a distension medium. If non-electrolytic distension medium enters the circulatory system, it can cause blood dilution and lowered ionic strength. Swelling can result as tissue takes up water to restore the correct blood osmolarity. A patient can suffer serious, or even fatal, complications if too much distension media is absorbed. The variety of symptoms associated with the absorption of large volumes of distension media is called “post-TURP syndrome” by urologists. Symptoms include bradycardia and hypertension followed by hypotension, nausea, vomiting, headache, visual disturbances, agitation, confusion, and lethargy; the symptoms result from hypervolemia, dilutional hyponatremia and decreased osmolarity. Without treatment, possible results include seizures, coma, cardiovascular collapse, and death.
The amount of distension media that a patient can absorb without intolerably dangerous adverse effects is related in non-intuitive ways to various individual physical, chemical, and other factors. The preoperative nurse will estimate the volume of distension media that each patient is reasonably expected to absorb without complications by factoring the patient's age, weight, fitness, hormonal balance, the formulation of the distension media, the procedure being performed, and a host of other variables before the patient arrives in the operating room. Unfortunately, the full utility of that estimate can be realized only if the amount of fluid actually retained by the patient can be timely determined with sufficient accuracy while the procedure is being performed. Some reports suggest that most patients can absorb approximately one liter without life-threatening effects. However, fluid overload with very serious complications caused by absorption of 0.8 liters of distension medium has been reported.
The quantity of distending medium absorbed by a patient naturally increases with the length of time required to perform the procedure. Hospitals, surgeons, and patients normally seek to conclude the surgery as quickly as possible for good reasons. Other things being equal, the less time required to perform a surgery, the better the expected outcome and the quicker the patient is expected to recover.
Instilled fluids are taken up by the patient more rapidly during some procedures, compared to others. Sometimes distension fluids are absorbed so rapidly that the surgeon may not have enough time to address and correct all of the problems and complexities discovered during the surgery. In such instances, it might be necessary to terminate a procedure when only a few additional minutes of the surgeon's time would be sufficient to complete the process as desired. That is a very undesirable situation because patients in those cases must be allowed to recover in the hospital for several days and then, often in a weakened condition, again be prepared, anesthetized, and the surgery resumed. Because those additional risks are widely recognized, as is the risk of continuing a surgery when a patient may, or may not, be in danger from excessive absorption of distension media fluids, the surgeon, lacking accurate information, is forced to make a decision that can easily be criticized in hindsight. It is necessary to expand some tissues, for example the uterus, in order to adequately view the structures for diagnosis and surgery.
Based on these factors, it is easy to understand that surgeons, hospitals, and their patients would be greatly assisted by more accurate knowledge of the amount of distending medium retained by surgical patients. Although instilled distending medium may accumulate in the abdomen or the patients extremities, the greatest concern is for accumulation and absorption of distension medium during surgeries in which severed veins are exposed to pressurized distending medium. Hysteroscopic and, to a lesser extent, urologic procedures performed using monopolar electrosurgery inherently give rise to conditions that can quickly lead to dang
Promethean Medical Technologies, Inc.
Schwegman Lundberg Woessner & Kluth P.A.
Walton George L.
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