Fluid management assembly for use in endoscopic procedures

Details Fluid management assembly for use in endoscopic procedures Fluid management assembly for use in endoscopic procedures

2000-09-01

2003-09-30

Lazarus, Ira S. (Department: 3749)

Surgery

Endoscope

Having auxiliary channel

C600S573000, C600S581000, C600S578000, C600S158000, C600S153000, C604S317000, C604S118000, C604S119000, C604S319000, C604S327000

Reexamination Certificate

active

06626827

ABSTRACT:

FIELD OF THE INVENTION
The invention relates to the field of fluid management systems and, more particularly, to an endoscope distention fluid management assembly for use in an endoscopic operative procedure, such as a hysterectomy procedure.
BACKGROUND OF THE INVENTION
The occurrence of surgical procedures which require medical instruments which use fluid irrigation to ensure visualization of the operative area continues to increase over time. One such medical procedure is a hysteroscopic procedure in which a hysteroscope is used to provide fluid irrigation for permitting visualization of the uterine area. Operative hysteroscopy uses pressurized solutions to distend the operative space (the uterus) so that the clinician can clearly identify the anatomy and subsequently remove the diseased tissue during the operative procedure. 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 hysteroscope. Since fluid monitoring is a very important part of managing the patient during the operative procedure, all fluids exiting the uterus must be balanced with the fluids entering the organ 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 health is not jeopardized.
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. As previously mentioned, the endoscope contains an outflow port in which fluid is transferred from the uterus to a remote location where it is collected in a receptacle and then measured to ascertain the total fluid loss of the patient during the procedure. During the procedure, a hysteroscopy pouch drape or the like is typically used and is disposed underneath the patient's buttocks area. This drape is designed to collect any fluid which may be discharged from the uterus during the procedure. The fluid is caught in a pouch portion and is collected therein for delivery to the remote collection receptacle. 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 the hysteroscope (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 the hysteroscopy 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 hysteroscopy 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 preferably further includes a flow restrictor (not shown) which is coupled to the first end
24
of the second fluid carrying member
22
. The hysteroscopy pouch drape does not always contain fluid and when this condition exists, the Y-connector
18
is vented to atmosphere which reduces the suction applied to the endoscope line (the first fluid carrying member
12
). By being inserted into the second fluid carrying member
22
, the flow restrictor
39
is designed to enhance the suction in the endoscope line so that the fluid is properly drawn from the hysteroscope whether or not fluid is present in the drape.
While suitable for its intended purpose, the above-described conventional management assembly
10
has associated disadvantages which result in reduced uterine distention. Because uterine distention is dependent upon on both inflow and outflow performance, optimization of the fluid inflow and outflow will result in uterine distention being likewise optimized. During distention of the uterus, fluid is pumped into the uterine space to develop positive pressure which is required in order to increase the volume of the uterine space. The fluid pumped into the uterine space is delivered by means of the hysteroscope which has an inflow port along with the aforementioned outflow port. Fluid which enters the uterine space through the inflow port is then relieved through the outflow port. When the fluid is relieved through the outflow port, it is permitted to flow under gravity into the hysteroscopy pouch drape for subsequent aspiration into the collection receptacle.
During gravity flow from the outflow port, the fluid flows through a vertical length of the first fluid carrying member
12
which creates a siphon effect. The magnitude of the siphon effect will depend upon the length of the first fluid carrying member
12
which hangs below the uterus of the patient. This siphon effect acts as a negative pressure which serves to reduce the positive pressure acting within the uterine cavity and hence, reduces the amount of uterine distention. This reduction in distention, if significant enough, can slow down the s

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