Fluid management assembly having a vented outlet line for...

Surgery – Endoscope – Having auxiliary channel

Reexamination Certificate

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Details

C604S324000, C604S317000, C604S284000, C604S533000

Reexamination Certificate

active

06699184

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates generally to fluid management systems and, more particularly, to an endoscopic distention fluid management assembly, having a vented outlet line, for use in an endoscopic procedure.
BACKGROUND OF THE INVENTION
Systems for distending and irrigating a surgical site during a surgical procedure, e.g., during a procedure to remove diseased tissue in the uterus, knee, shoulder, bladder and the like are well known in the art. A typical irrigation system includes a source of biocompatible fluid, e.g., a feed bag, tubing which delivers the fluid to the surgical site, and a pump which pumps fluid from the fluid source into the surgical site. The purpose of the irrigation system, at least in part, is to distend the operative space within the uterus, knee, shoulder, bladder, and the like, so that the clinician can clearly identify the anatomy and subsequently remove diseased tissue. A means for aspirating the fluid is typically also provided to remove fluid from the operative space, to flush out loose debris in order to maintain visibility of the surgical site for example, when the fluid becomes somewhat opaque and hard to see through. This type of system forms a part of an overall fluid management system or assembly which controls the flow of fluid.
Different surgical procedures require different irrigation parameters, e.g., fluid pressure and flow rate. Therefore, there are known irrigation systems in which the pressure and/or flow-rate of the irrigation fluid are controlled or varied to accommodate different surgical procedures. For example, U.S. Pat. No. 5,460,490 to Carr et al. describes an irrigation system which can be operated in a plurality of modes for different endoscopic surgical procedures, such as laparoscopic, arthroscopic or hysteroscopic procedures, the disclosure of which is hereby expressly incorporated by reference.
Typical aspiration systems include a suction canister which is attached to an outlet tube. The suction canister is operative to create a negative pressure in the outlet tube to remove fluid from the surgical site. In addition, such systems can be typically operated in a gravity flow mode, in which the fluid is aspirated under gravity and is simply collected and stored by the suction canister.
Such an arrangement can result in some negative performance characteristics. For example, in a gravity flow mode the fluid flows through a vertical length of tubing, which creates a siphon effect and therefore a negative pressure within the tube, which acts to reduce the positive pressure in the operative space, thereby reducing the amount of distention. Moreover, when suction is applied through the outlet tube, high levels of suction may be applied to the operative space, thereby also resulting in an unwanted reduction in the degree of distention within the operative space. This is an undesirable condition and can lead to operative complications.
Over the duration of the surgical procedure, an individual, such as a nurse, measures the amount of fluid being delivered to the patient and the amount of fluid which is recovered from the patient during the procedure. If the amount of fluid being recovered from the patient is less than the amount of fluid being delivered to the patient, a fluid deficit results. A fluid deficit may result due to any number of reasons including but not limited to the occurrence of fluid loss which results from leakage through a cervical seal as well as fluid loss through an outflow port of the endoscope. Since fluid monitoring is a very important part of managing the patient during the operative procedure, all fluids exiting the operative space (i.e., an organ or joint capsule) must be balanced with the fluids entering the operative space so as to maintain an account of the occurrence of any fluid deficit during the procedure. In addition, it is important to monitor whether a fluid imbalance occurs as a result of the patient absorbing an excessive quantity of fluid. If a patient absorbs an excessive quantity of fluid, complications can result including those of a serious nature. Therefore, it is important to continuously monitor the fluids in the operative space during the operative procedure to ensure that the uterus is properly distended to permit sufficient visualization thereof and to ensure that the patient's safety is maintained.
Typically, the clinician will use a fluid collection system as the surgical procedure is being performed so that fluid may be recovered and collected from the operative site. The endoscope contains an outflow port in which fluid is transferred from the operative site to a remote location where it is collected in a receptacle, such as the suction canister, and then measured to ascertain the total fluid loss of the patient during the procedure. During the procedure, a pouch drape or the like is typically used and is disposed underneath the patient. This drape is designed to collect any fluid which may be discharged from the patient during the procedure. The fluid is caught in the pouch portion and is collected therein for delivery to the remote collection receptacle (the suction canister). The drape and more specifically the pouch portion thereof is also likewise connected to the collection receptacle by means of a fluid carrying device such as attachable tubing which permits the fluid to be effectively transferred to the collection receptacle.
Now referring to
FIG. 1
which illustrates a conventional fluid management assembly, generally designated at
10
. The collection system
10
comprises a first fluid carrying member
12
which is connected at a first end
14
to a first connector
16
which is designed to engagingly mate with the outflow port of an endoscope (not shown). A second end
17
of the first fluid carrying member
12
is connected to a Y-connector
18
and more specifically is connected to a first leg
20
thereof. The management assembly
10
further includes a second fluid carrying member
22
which is coupled to a pouch drape (not shown) at a first end
24
thereof. The first end
24
preferably has a second connector
26
coupled thereto which is designed to permit attachment of the second fluid carrying member
22
to the pouch drape. A second end
28
of the second fluid carrying member
22
is connected to a second leg
30
of the Y-connector
18
with the first and second legs
20
,
30
being in parallel orientation relative to one another.
The Y-connector
18
also includes a main leg
32
which extends in an opposite direction relative to the first and second legs
20
,
30
. The main leg
32
receives and is coupled to a main fluid carrying member
34
which receives fluid from both the first and second fluid carrying members
12
,
22
and directs the fluid to a suction source (not shown). It will be appreciated that the suction source serves to supply a sufficient suction force so that the fluid is drawn through all the members
12
,
22
,
34
and is delivered to the collection receptacle (the suction source). Preferably, the first, second, and third fluid carrying members
12
,
22
,
34
, respectively, comprise tubing which is suitable for use in the intended medical procedures described herein. At the end of the procedure, the total volume of the fluid collected in the collection receptacle is reconciled with the total input volume and a fluid deficit, if any, is calculated for the patient.
The management assembly
10
also preferably includes a pinch clamp
36
which is disposed about the first fluid carrying member
12
and is designed to selectively restrict the flow rate of fluid through the first carrying member
12
. The illustrated pinch clamp
36
includes a ratchet mechanism which is designed to pinch the first fluid carrying member
12
between a pair of protuberances, generally indicated at
38
. As the pinch clamp
36
is manipulated so that the first fluid carrying member
12
is further constricted between the protuberances
38
, the flow rate of the fluid decreases.
The management assembly
10
also prefer

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