Abstract:
A fluid management assembly for use in an endoscopic procedure is provided. The assembly comprises a first line for fluid to flow therethrough from an endoscope to a Y-connector and a second line for fluid to flow therethrough from a drape to the Y-connector. The Y-connector is also in fluid communication with a third line which connects the Y-connector to a suction source which supplies a suction force and receives the fluid. According to the present invention the Y-connector is located in close proximate relation with respect to the suction source and the first and second lines are preferably co-joined along a portion of their lengths. The first and second lines define scope and drape legs, respectively, which are elongated in comparison to more conventional designs. These features of the present invention serve to optimize distention and eliminate pressure fluctuations in the operative organ during the surgical procedure.

Description:
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&#39;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&#39;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 surgical procedure and result in an increase in bleeding which in turn results in a reduction in visibility of the anatomy. 
     Another associated disadvantage of the conventional system is that often suction is applied directly to the outflow port of the hysteroscope and during this type of application high levels of suction may be applied to the uterus and hence reduce the distention thereof. This results in the same above-mentioned difficulties being experienced and generally complicates the surgical procedure. In addition, the Y-connector  18 , as previously described, serves to receive both the fluids from the first and second fluid carrying members  12 ,  22  under suction so that all of the patient&#39;s fluids may be pooled into one collection canister (the collection receptacle). Using a Y-connector arrangement can result in a decrease in performance since the system flow needs to be mechanically balanced to allow adequate simultaneous entrainment from both the first and second legs  20 ,  30  of the Y-connector  18 . If the first and second legs  20 ,  30  are not balanced, flow may be biased to one of the first and second legs  20 ,  30  because the fluid seals the leg with less resistance causing a sumping action to occur. The occurrence of a sumping action results in cycling of intrauterine pressures, uterine bleeding and increases surgical procedure time. For example, when there is a fluid build-up in the hysteroscopy pouch drape, the drape acts as a reservoir creating a column of fluid in the second fluid carrying member  22 . Because of the column of fluid, the pressure in the second fluid carrying member  22  is increased and this may create a fluid seal which limits the fluid flow through the first fluid carrying member  12  (endoscope line). This causes a recycling of the intrauterine pressure which is undesirable. 
     Therefore, there is need for an improved management assembly for use in an endoscopic, e.g., hysteroscopic, surgical procedure which permits the operative organ to be optimally distended during the entire surgical procedure. The management assembly of the present invention satisfies these and other needs. 
     SUMMARY OF THE INVENTION 
     The present invention concerns improvements in fluid management assemblies for use in endoscopic procedures. According to the present invention, it has been discovered that locating the Y-connector so as to elongate the scope and drape legs results in improved distention and eliminates the deficiencies associated with the conventional designs. Specifically, the Y-connector is positioned so that the Y-connector is in proximate relationship with the suction canister which provides suction forces and collects the fluid. Because the Y-connector is proximately located relative to the suction source, the Y-connector is exposed to a greater suction force. Furthermore, the elongation of the scope and drape legs of the present assembly results in minimal mixing of the fluids and minimizes the dependency between the lines. By delivering the fluids further downstream before they are combined at the Y-connector and by subjecting the Y-connector to a greater suction force, pooling of fluid within the Y-connector is avoided. As will be described in greater detail hereinafter, the position of the Y-connector eliminates pooling since the fluid is entrained upwardly into the Y-connector in comparison with the conventional design in which the fluid is entrained downwardly. The present assembly also eliminates or substantially reduces the likelihood that a liquid seal will occur in the Y-connector resulting in flow restriction within the endoscopic line because the present design permits the pressure within the endoscopic and drape lines to be substantially balanced. 
     The arrangement of the Y-connector relative to the scope and drape legs also eliminates the need for a flow restrictor in the drape line yet provides adequate suction on the endoscope when the drape is empty. Accordingly, any pressure fluctuations in the uterus are eliminated and flow is enhanced when fluid is aspirated simultaneously from the drape and the scope. 
    
    
     Other features and advantages of the present invention will be apparent from the following detailed description when read in conjunction with the accompanying drawings. 
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a side elevational view of a conventional fluid management assembly for use during an hysteroscopic surgical procedure; 
     FIG. 2 is a side elevational view of a fluid management assembly according to an exemplary embodiment of the present invention; and 
     FIG. 3 is a side elevational view of the fluid management assembly of FIG. 2 shown in use with conventional surgical equipment during an operative procedure. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     Referring to FIGS. 2 and 3, a fluid management assembly is presented and is generally indicated at  40 . FIG. 3 illustrates the fluid management assembly  40  in use according to the present invention with conventional accessory equipment during a typical endoscopic procedure, as will be described in greater detail hereinafter. The fluid management assembly  40  may be referred to as having a dual lumen design and comprises a first fluid carrying member  42  and a second fluid carrying member  50 . The first fluid carrying member  42  has a first end  44  and an opposing second end  46 . The first end  44  preferably connects to a first connector  48  which is designed to fluidly mate with outflow tubing  91  which includes a connector  93  at one end for mating with an endoscope  90  (e.g., hysteroscope). One type of suitable connector  48  is a large bore Quosina connector which is presented to the sterile field in a capped state. More specifically, the first connector  48  provides fluid communication between an outflow port (not shown) of the hysteroscope  90  and the first fluid carrying member  42  through the outflow tubing  91 . 
     The second fluid carrying member  50  includes a first end  52  and an opposing second end  54  with the second ends  46 ,  54  of the first and second fluid carrying members  42 ,  50 , respectively, being positioned proximate one another. The first end  52  is coupled to a pouch drape  100  (e.g., hysteroscope pouch drape) by means of a second connector  53  so that fluid communication is provided between the hysteroscope pouch drape  100  and the second fluid carrying member  50  for drainage of fluid build-up within the drape  100  during the surgical procedure. One suitable type of second connector  53  is a suction connector for fluidly connecting the drape  100  to the assembly  40 . 
     In the illustrated embodiment, each of the first and second fluid carrying members  42 ,  50  comprises a predetermined length of tubing material. The first and second fluid carrying members  42 ,  50  are preferably co-joined (affixed) along at least a portion of each of their lengths. For the purpose of illustration and according to one exemplary embodiment, the first and second fluid carrying members  42 ,  50  are co-joined for a length of approximately 10 feet and separate at a first location  56  to form a drape leg  58  and a suction outflow leg  60 . It will be appreciated that the drape leg  58  comprises a length of the second fluid carrying member  50  extending from the first location  56  to the first end  52 . The suction outflow leg  60  comprises a length of the first fluid carrying member  42  extending from the first location  56  to the first end  44 . In the exemplary embodiment, the drape leg  58  has a length of approximately 10 inches and the suction outflow leg  60  has a length of about 20 inches. The suction outflow leg  60  is thus attached to the outflow tubing  91  at the connector  48 . The outflow tubing  91  extends from the connector  48  to the endoscope  90  (e.g., hysteroscope) and serves to transfer fluid from the outflow port of the endoscope  90  to the suction outflow leg  60 . 
     In a similar manner, the co-joined first and second fluid carrying members  42 ,  50  separate at a second location  65  which is distal to the first location  56 . The separation at the second location  65  causes the first and second fluid carrying members  42 ,  50  to be spaced from one another for a predetermined length so that each of the members  42 ,  50  may be grasped and manipulated as will be described in greater detail hereinafter. 
     Preferably, the outflow tubing  91  is provided with an atmospheric vent  61  which is disposed proximate to the connector end  93  and thus proximate to the hysteroscope  90 . In the exemplary embodiment, the atmospheric vent  61  is formed approximately 6 inches from the outflow connection of the hysteroscope  90  (at the connector end  93 ). The atmospheric vent  61  permits atmospheric pressure to enter the outflow port of the hysteroscope  90  and this results in a pressure increase at the outflow port. Other features of the atmospheric vent  61  will be described hereinafter when the operation of assembly  40  is described in greater detail. 
     The fluid management assembly  40  further includes a Y-connector which is generally indicated at  62 . The Y-connector  62  is formed of first and second spaced legs  64 ,  66 , respectively, which converge to a main leg  68  which extends in a direction away from the first and second spaced legs  64 ,  66 . The first leg  64  mates with and is secured to the second end  46  of the first fluid carrying member  42  and the second leg  66  mates with and is secured to the second end  54  of the second fluid carrying member  50 . Thus, the first leg  64  serves to receive the fluid flowing through the first fluid carrying member  42  from the hysteroscope  90  and the second leg  66  serves to receive the fluid flowing through the second fluid carrying member  50 . 
     The Y-connector  62  acts to mix and direct the fluids from the independent fluid conduits (members  42 ,  50 ) to a suction conduit, generally indicated at  70 . The main leg  68  of the Y-connector  62  is coupled to the suction conduit  70  so that fluid communication is established therebetween. More specifically, the suction conduit  70  is connected at a first end  72  to the Y-connector  62  and connects at a second end  74  to a suction source  110  by means of an adapter  80  which is designed to provide a secure attachment between the suction source  110  and the assembly  40  and provide fluid communication therebetween. It will be appreciated that the suction source  110  provides a suction force throughout the system and also serves as a collection receptacle for receiving fluids from both the outflow port of the hysteroscope  90  and the hysteroscopy pouch drape  100 . In one exemplary embodiment, the suction source  110  comprises a suction cannister and the suction conduit  70  comprises a predetermined length of tubing. A suitable suction cannister  110  is commercially available from a number of manufacturers, including Bemis, Baxter, and Abbott Laboratories. According to one exemplary embodiment of the present invention, the suction conduit  70  has a length of approximately 6 inches. 
     The fluid management assembly  40  typically will also include the pinch clamp  36  which is disposed about the first fluid carrying member  42  for selectively restricting the flow of fluid within the first fluid carrying member  42 . Any number of suitable pinch clamps  36  may be used with assembly  40 . The illustrated pinch clamp  36  has a ratchet mechanism that selectively pinches the first fluid carrying member  42 . The first fluid carrying member  42  is disposed between the pair of protuberances  38  and as the ratchet mechanism is actuated, the distance between the protuberances  38  either decreases resulting in the first fluid carrying member  42  being increasingly pinched causing an increased restriction in the fluid flow through member  42  or the distance decreases resulting in an increase in fluid flow through the first fluid carrying member  42 . In the illustrated embodiment, two pinch clamps  36  are shown, one being disposed about the suction outflow leg  60  and the other disposed about the outflow tubing  91 . It will be understood that the precise location of the pinch clamps  36  is not critical and depending upon a number of factors, the pinch clamps  36  may be positioned at a variety of locations along the first fluid carrying member  42 . 
     According to the present invention, it has been discovered that the repositioning of the Y-connector  62  yields several key benefits which result in improved distention of the uterus during the surgical procedure. More specifically, the distance between the Y-connector  62  and the suction source  110  is significantly reduced as it has been discovered that improved performance is realized by relocating the Y-connector  62  to a more proximate position relative to the suction source  110 . The assembly  40  according to the present invention provides constant flow to the hysteroscope  90  and to the hysteroscopy pouch drape  100  by elongating the legs of the Y-tubing set in order to minimize mixing and dependency. In other words, the length of each of the drape leg  58  and the suction outflow leg  60  is increased and represent independent fluid conduits which extend separately from the sterile field before combining at the Y-connector  62 . By repositioning the Y-connector  62  closer to the suction source  110 , the Y-connector  62  and the fluid traveling therethrough are exposed to greater suction forces because the Y-connector  62  is located in a more downstream location relative to the suction source  110  and thus the suction forces acting on the Y-connector  62  are greater and the influence of any variances in fluid between the endoscope line and the drape line are minimized. In the illustrated embodiment, the distance between the Y-connector  62  and the suction source  110  is less than about one foot and preferably is approximately 6 inches. Conventionally, the Y-connector is connected to a conduit (main fluid carrying member  34 ) having a length of about 108 inches and the fluid was to travel this distance before being deposited into the collecting receptacle (suction canister  110 ). It will be understood that the aforementioned lengths are merely illustrative and of an exemplary nature and do not limit the scope of the present invention. 
     Referring now to FIGS. 1-3. Advantageously, the repositioning of the Y-connector  62  in the present assembly  40  eliminates the disadvantages which were associated with fluid pooling within the Y-connector  18  of the conventional assembly  10 . In the conventional assembly  10 , the Y-connector  18  drapes downwardly from the hysteroscopy pouch drape and the hysteroscope and ultimately becomes saturated with fluid as the fluid collects or pools in the Y-connector  18  as the fluid flows downwardly into the Y-connector  18 . In such an assembly  10  which is open to atmosphere, the fluid wants to seek its own level and hence the fluid collected in the hysteroscope pouch drape wants to flow upwardly into the leg of tubing which leads to the hysteroscope. This reflux action prevents fluid from exiting the outflow port of the hysteroscope and hence inhibits fluid turnover in the uterus. 
     By positioning the Y-connector  62  in a more downstream location closer to the suction source  110  itself, the pooling of fluid within the Y-connector body is eliminated since the fluid is entrained upwardly into the Y-connector  62 . More specifically, the suction source  110  is positioned at least above the level of the first and second fluid carrying members  42 ,  50 , respectively, and also preferably above the level of the pouch drape  100 . This results in the fluid being entrained upwardly into the Y-connector  62  during operation. This is in contrast to the previous assembly  10  in which the fluid is entrained downwardly into the Y-connector and thus tends to pool therein resulting in a liquid seal being formed. As previously described, the presence of a liquid seal results in sumping action. The Y-connector leg, having the lesser resistance, is effectively sealed which results in cycling of intrauterine pressures, uterine bleeding and an overall increase in the surgical procedure time. By virtue of repositioning of the Y-connector  62  in the present assembly  40 , the first and second legs  64 ,  66  of the Y-connector  62  are exposed to lower negative pressures and, in combination with the fact that the Y-connector  62  is exposed to greater suction forces due to its repositioning, the overall performance of the assembly  40  is significantly increased in comparison to the prior mechanical restrictor assembly  10 . 
     The assembly  40  has an anti-siphon conduit arrangement provided for use on the outflow port of the hysteroscope  90 . This arrangement relieves negative pressures associated with the vertical positioning of the outflow conduit member (first fluid carrying member  42 ) relative to the uterus. The present assembly  40  also reduces negative pressure applied to uterus when suction is attached directly to the outflow port of the hysteroscope  90 . Furthermore, the atmospheric vent  61  provided in the outflow tubing  91  (scope line) provides suction relief during the surgical procedure. 
     By increasing the length of the drape leg  58  and the suction outflow leg  60  and maintaining the same or similar inner diameters thereof, the flow/pressure within each leg  58 ,  60  is essentially the same; however, the first and second fluid carrying members  42 ,  50  engage the Y-connector  62  further downstream where the suction forces are greater. The inverted positioning of the Y-connector  62  in this downstream location results in the resistance from the fluid in either leg  58 ,  60  being minimized. Because of the substantial length of the drape and suction outflow legs  58 ,  60  prior to their connection to the Y-connector  62 , it is not necessary to restrict flow in the second fluid carrying member  50  (drape line) to provide adequate suction on the hysteroscope  90  when the drape  100  is empty. In one exemplary embodiment, the inner diameter of the suction outflow leg  60  is about 0.190 inches and the inner diameter of the drape leg  58  is 0.125 inches. 
     Thus, the present invention eliminates the need for using a flow restrictor with the endoscopic line and this generally reduces the cost of the surgical procedure and the complexity thereof. Furthermore, the accumulated fluid collected within the drape  100  is unlikely to create a fluid seal which would restrict flow from the hysteroscope  90  when the present assembly  40  is used. Accordingly, pressure fluctuations in the uterus are eliminated and flow is enhanced when fluid is aspirated simultaneously from the drape  100  and the hysteroscope  90 . Using the dual lumen suction design of the present assembly  40  of the present invention, the pressure inside of the uterus is not changed based upon the method of fluid outflow. In other words, the pressure does not change whether the fluid flows by gravity or by means of suction assist. Furthermore, the pressure inside of the uterus is not affected by the presence of fluid in the drape  100  during suction assisted outflow of the fluid. 
     Another consideration in optimizing the level of distention is the rate of which the fluid is being pulled from the uterus. The fluid flow rate is important for visualization purposes (i.e. to minimize white and red outs). This fluid flow rate is a function of airflow rate at the first end of the endoscopic line that is connected to the outflow port of the endoscope. The dual lumen design of the present invention yields equal airflow rates at the points of connection between the endoscopic line and the outflow port of the endoscope  90  and the drape line and the drape  100  and the present design further eliminates the fluctuation of airflow through the endoscopic line when fluid is present in the drape  100 . The airflow rate through the endoscopic line is not reduced when fluid is present in the drape. This results in improved pressure balance and thus distention and visualization are likewise improved. 
     Another advantage of the present invention is that the use of co-joined tubing in the assembly  40  gives the surgeon flexibility in selecting the length for the drape and suction outflow legs  58 ,  60 . This permits the surgeon to custom tailor the length of either of legs  58 ,  60 . For example, if the surgeon prefers to increase the length of the suction outflow leg  60 , the surgeon may simply pull the legs  58 ,  60  apart from one another to further separate the two from one another and thereby increase the length of the leg portions  58 ,  60 . This permits the surgeon greater latitude in using the assembly  40  with a number of types of medical equipment and the precise location of the equipment is not critical since the length of the leg portions  58 ,  60  may be customized to permit the assembly  40  to be effectively hooked-up to all of the requisite equipment. 
     While the invention has been particularly shown and described with reference to the preferred embodiments thereof, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the invention.