Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1997-11-13
2001-02-06
Kennedy, Sharon (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S027000, C604S102020
Reexamination Certificate
active
06183437
ABSTRACT:
BACKGROUND
Urological irrigation is a very common medical procedure and is initiated whenever irrigation is indicated following bladder surgery or bladder trauma, as well as for gross hematuria of indeterminate etiology for both female and male patients. In addition, it is routinely used following TURPS (Transuretheral Resection, Prostate), one of the most common of male surgeries, with over 220,000 such operations performed annually in the United States alone.
Historically, irrigation for all of these procedures is by CBI (Constant Bladder Irrigation) using an indwelling irrigating catheter commonly referred to as a Foley “3-way catheter”. The “Foley” designation refers to a catheter that employs a balloon inflated by the introduction of sterile water through a valve, known as a Luer lock, into the balloon after the catheter is inserted into the patient's bladder. The purpose of the Foley inflatable balloon is to retain the catheter within the bladder to prevent inadvertent removal of the catheter.
The “3-way” designation refers to the three lumens employed in the catheter's construction. Those three lumens function as follows: (1) balloon inflating/deflating lumen; (2) bladder irrigation lumen; and (3) bladder drain lumen. Generally, the flow rate of the irrigating fluid is manually adjusted by the nursing personnel and the irrigant is constantly dripped into the bladder until completion of the treatment.
Unfortunately, from the patient's perspective, there are distinct and potentially serious problems with this seemingly simple procedure. As an example, the typical TURP patient is fitted with a “3-way” indwelling catheter and is given CBI (Constant Bladder Irrigation) generally for a 24 hour period, during which time he would consume approximately 20 3-liter bags of saline irrigant while recuperating in his room. An empty, normal bladder has a volume of about 500 cc. Typically, irrigant is fed into the bladder as an approximate flow rate of 2500 cc/hour. If the bladder drain lumen becomes clogged, given the bladder volume and the flow rate, the bladder would become fully distended in approximately 10 to 12 minutes. Catheter drain lumens routinely become clogged or blocked which is a rather common problem with this type of surgery as a result of blood clots and/or surgical debris. Thus, there is a real risk of injury to the patient should his catheter's drain lumen become clogged.
If the drain lumen is not cleared within that 10-12 minute window, the patient's bladder could be over-distended or perforated. Full bladder distention is not only extremely uncomfortable for the patient, but is also a potentially dangerous condition that can readily lead to bladder perforation or rupture, if not immediately rectified. This problem imposes a risk of serious liability on the hospital. Thus, hospitals frequently assign a full time nurse to monitor closely those patients who demonstrate a propensity for this condition.
Bladder distention is particularly serious for patients recovering from bladder surgery, such as bladder cancer, wherein the bladder wall tissue is locally thin and weak in the resected areas. Under such conditions, every effort must be made to prevent bladder distention. Once again, hospitals commonly assign a full time nurse to such patients to avoid bladder distention. Unfortunately, assigning full-time nurses to such patients drastically increases hospital labor costs. In today's “managed care” environment, hospitals are typically reimbursed a fixed amount for each patient recovering from a specific surgical procedure, regardless of their length of hospital confinement or the extent of nursing care required. Therefore, hospitals must save labor costs whenever possible.
Accordingly, there is a need in the art for a system that constantly monitors the status of a catheter and a catheter drain lumen, and automatically interrupts the flow of irrigant should the drain lumen become kinked or obstructed, or should the supply lumen become kinked. To save on labor costs, such a system should also automatically resume the flow of irrigant should the drain lumen become unkinked or cleared on its own.
Another important consideration for hospitals is the quantity of irrigant consumed during post-operative treatment with traditional CBI methods. As noted above, a typical CBI patient will consume about 60 liters of saline irrigant per 24 hour recovery period. Clearly, the cost of such quantities of irrigant can be considerable. Accordingly, a need exists for a device and method that minimizes the amount of irrigant used during post-operative treatment of patients requiring urological irrigation.
SUMMARY
The above needs in the art motivated the instant invention. Accordingly, a first objective of this invention is to provide a device for constantly monitoring the status of the drain lumen of a catheter, and for automatically interrupting the flow of irrigant should the drain lumen become obstructed.
A second objective is to provide a device for automatically resuming the flow of irrigant should the drain lumen obstruction clear itself with or without human intervention.
A third objective is to provide a device that flushes the patient with irrigant, while minimizing the amount of saline irrigant used.
A fourth objective is to provide a device including an electronic control unit and a tubing assembly, with the electronic control unit communicating with the tubing assembly to monitor the status of the drain lumen and to interrupt the flow of irrigant should the drain lumen become obstructed.
A fifth objective is to provide an electronic control unit including a pinch valve whose operation is governed by a control signal, and wherein the control signal is manipulated by the tubing assembly.
A sixth objective is to provide a tubing assembly including a vent line being in communication with an irrigant supply line, and a fluid sensor being in communication with the vent line so that the fluid sensor detects irrigant in the vent line.
A seventh objective is to provide a tubing assembly including a fluid sensor for manipulating a control signal generated by the electronic control unit.
An eighth objective is to provide an electronic control unit that allows the user to select from a plurality of flushing modes.
A ninth objective is to provide a low-cost electronic control unit that is manually-operated, yet automatically detects urinary catheter obstructions and interrupts the flow of irrigant once an obstruction is detected.
A tenth objective is to provide an electronic control unit with the ability to adjust the volume of irrigant supplied to the urinary catheter.
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Caprio Frank M.
Kennedy Sharon
Lam Ann Y.
Lanier Ford Shaver & Payne
Walsh Gerald M.
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