Patent Description:
A byproduct of the performance of some medical and surgical procedures is the generation of liquid, semi-solid and solid waste. This waste includes body fluids, such as blood, and irrigating solution that are introduced to the body site at which the procedure is performed. Solid and semisolid waste generated during a procedure includes bits of tissue and small pieces of the surgical material that may be left at the site. Ideally, the waste is collected upon generation so the waste neither visually obstructs nor fouls the surgical site nor becomes a biohazard in the operating room or other location at which the procedure is being performed.

A number of systems are available for use by surgical personnel for collecting this waste as it is generated. Generally, this type of system includes a suction source, tubing that extends from the suction source and a storage container between the tubing and the suction source. When the system is actuated, waste is drawn through the distal end of the tubing. The suction draws the waste through the tubing so that it flows into and is at least temporarily held in the storage container. One such system is Applicant's US Pat. No. <CIT>/<CIT>.

In some surgical procedures, such as a colonoscopy, it is desirable to collect one or more tissue samples from the patient during the surgical procedure. The tissue sample typically is sent to a pathology lab for analysis. The analysis of the sample aids in the evaluation of the medical state of the patient from which the sample was collected. To collect a tissue sample, the tubing connecting the medical instrument used to apply suction to the patient to a waste container may be temporarily disconnected. A separate device is placed in series with the tubing so as to be located upstream from the container. The tissue sample is captured in the device. The device is then removed and the tubing from the suction applicator is reconnected directly to the waste container. Repetitive connecting and disconnecting of the tubing during the collection of multiple samples adds additional time to the completion of the surgical procedure. Upon disconnection of the tubing, small amounts of adhered uncontained liquid and semisolid waste in the tubing can be released into the surrounding environment potentially contaminating the floors and other surfaces in the surgical facility.

A solution to this problem is offered in the Applicant's <CIT>/<CIT> discloses a number of different cassettes designed for removable attachment to a suction system. These cassettes include each include a removable tissue trap. The tissue trap is formed with a screen that allows fluid to flow through while retaining bits of matter, typically matter at least <NUM> in size. A number of these cassettes each include a set of conduits and valve. The conduits and valve are designed to flow the fluid stream drawn into the system along one of two paths. When the fluid stream does not include tissue in need of collection, the valve is set so the withdrawn fluid bypasses the tissue trap as the fluid flows into the storage container. During the procedure, tissue that worthy of study may become entrained in the suction flow. When the practitioner becomes aware that this event is about to occur, the cassette valve is set from the bypass position to the collection position. When the valve is so set the fluid flows along a path that extends across the tissue trap. The tissue to be collected is trapped by the screen integral with the tissue trap. Once the sample is trapped, the valve is returned to the bypass position.

The trap of the above described cassette can be used to capture plural samples. A disadvantage of this practice is that is that when plural samples are trapped, it is not possible to determine, for each sample, the location internal to the patient from which the samples was extracted. The inability to so differentiate between the individual samples reduces the utility of this type of cassette in a procedure in which there is a likelihood that there is a need to capture plural samples. This is because in order to evaluate the condition of the patient it is important to know not just the pathology of the sample, but the precise location on or in the patient's body from which the sample was extracted.

Accordingly, to use this type of cassette to collect plural samples it is necessary to, after a sample is collected, stop the withdrawal of material from the patient. During this suspension period, at a minimum, a new trap needs to be fitted to the cassette. Alternatively, a new cassette must be substituted for the used cassette. In either situation, this suspension of the procedure increases the overall time it takes to perform the procedure. Having to so extend the time it takes to perform the procedure is contrary to one of the generally objectives associated with perform a medical or surgical procedure. This is the objective that the procedure should be performed as quickly as possible. This efficiency desirable to both minimize the amount of time the patient is held under anesthesia and that patient's normally covered internal tissue is exposed to the ambient environment and infecting-inducing agents that are essentially inevitably present in this environment.

Still another disadvantage of some cassettes is that it is possible to withdraw the trap while the valve is set to allow a suction to be drawn on the cassette. These specimens can be relatively light in weight. When the cassette is withdrawn while the valve is in this state a light weight specimen can inadvertently be drawn into the container. For most intents and purposes, this results in the loss of the specimen for analysis.

A cassette for use with a medical waste collection system is known from document <CIT>. The cassette includes a housing shaped to be removably attached to a receptacle integral with the housing. A sleeve is attached to the cassette so as to be located forward of the housing. The sleeve is formed with a void space. A fitting for connection to a suction line is attached to the sleeve. A screen is removably fitted in the sleeve void space. The screen is fitted in the sleeve void space when it is desirable to catch tissue that may be entrained in the fluid stream from the suction line.

A disposable sample trap system having a cylindrical hollow sample trap body formed with a bottom end wall and an upper open end and with multiple dividers extending across the hollow body to divide the hollow body into a plurality of chambers is described in document <CIT>. A cap is rotatably attached to and seals said open end of the trap body. An inlet and outlet conduit is attached to an opening in the cap to allow for passage of fluid and samples through the cap opening into one of the plurality of chambers which is aligned with the opening and subsequently out of the trap. There are narrow slots in the dividers to fluidly connect the inlet conduit to the outlet conduit through the plurality of chambers so that when the outlet conduit is connected to a vacuum source, the vacuum causes fluid and samples to be drawn into the one of the plurality of chambers through the inlet passage while allowing the fluid entering into the one of the plurality of chambers to pass through at least one of the narrow slots to the outlet and trapping the sample in the one of the plurality of chambers, since the sample cannot pass through the slot.

This invention is related to a new and useful trap for collecting tissue that is withdrawn from a patient during a medical or surgical procedure. The assembly of this invention is constructed to allow the rapid capture of plural samples, each in its own trap, without requiring an appreciable interruption of the suction draw from the site at which the samples are withdrawn.

This invention is in the form of a cassette that is placed between the suction line through which the sample containing fluid stream is withdrawn and the suction pump that draws the fluid stream from the patient. Typically, the cassette is placed between suction line and the container used to hold the fluid drawn away from the patient.

The cassette has, at the distal end, a fitting to which the suction line is attached. The cassette has, at a proximal end, an opening through which the suction is drawn by the pump. Internal to the cassette are plural voids. These voids are open to the outside. The cassette is formed to define plural flow paths. One flow path extends from each void to the opening in the proximal end of the cassette. There is also an additional flow path, a bypass.

This additional flow path does not extend from the voids. Instead, this flow path leads directly to the proximal end opening in the cassette.

The cassette of this invention includes a valve. The valve directs the fluid flow from the fitting so the fluid flows into either a select one of the plurality of the voids or the flow path that bypasses the voids.

Also part of this invention are plural catch trays. The catch trays are shaped to removably be received in the voids internal to the cassette. A catch tray is designed to allow fluid flow through the tray while retaining an object beyond a certain size, the size of a sample, in the tray. Each catch tray can be independently inserted into and removed from the associated void without requiring the insertion or removal of another one of the catch trays.

In some versions of the invention, the fitting is part of the valve. In some versions of the invention, the valve is rotatably attached to the rest of the cassette. The rotational orientation of the valve relative to the rest of the cassette shifts relative to the setting of the valve.

In some versions of the invention the cassette and attached components are part of an assembly known as a manifold. This manifold serves as the removable interface that connects a suction line to a waste collection unit. In these versions of the invention, the manifold may also include a filter. This filter is located between the catch trays and the proximal end opening of the cassette. This filter prevents material not captured in one of the sample trays from flowing into the container used to hold the withdrawn fluid.

This invention is also related to a new and useful cassette that prevents the withdrawal of the trap when the valve is in the collection position, the position in which the valve directs fluid flow through the tray. In these versions of the invention a lock out is connected to the valve. When the valve is in the trap position the lock out abuts the tray so as to prevent removal of the tray. When the valve is set to direct the fluid stream away from a particular catch tray, the movement of the valve results in a like movement of the lock out. In some versions of the invention the lock out is integrally formed with the valve. Alternatively, valve and lock out are separate components. A linkage connects the lock out to the valve so that when the valve moves away from a specimen collection position, the lock out moves away from the associated catch tray.

The invention is pointed out with particularity in the claims. The above and further features and benefits of this invention are understood by reference to the following Detailed Description taken in conjunction with the accompanying drawings in which:.

<FIG> illustrates a waste collection unit <NUM> to which a sample cassette <NUM> of this invention is coupled. In some versions of the invention, cassette <NUM> is referred to as a manifold. Accordingly, in this document manifold <NUM> is understood to be the cassette <NUM>. In the illustrated version of the invention, waste collection unit <NUM> is mobile. The waste collection unit <NUM> includes a base <NUM>. The cover and door assemblies that normally conceal the components are mobile unit <NUM> are not present in <FIG> so that the normally concealed components can be seen. Wheels <NUM> attached to the bottom of the base <NUM> provide waste collection unit <NUM> with mobility. Two canisters <NUM> and <NUM> are mounted to the base <NUM>. A first one of the canisters, canister <NUM>, has a relatively large interior volume, between approximately <NUM> and <NUM> liters. The second canister, canister <NUM>, has a smaller volume, between approximately <NUM> and <NUM> liters. Each canister <NUM> and <NUM> has a cap <NUM> and <NUM>, respectively.

Attached to each canister cap <NUM> and <NUM> is a manifold receiver <NUM>. A manifold <NUM> of this invention, seen in <FIG> and <FIG>, is removably seated in each manifold receiver <NUM>. Each manifold <NUM> includes a fitting <NUM>. Fitting <NUM> receives a separate suction line <NUM>, (one shown in <FIG>). The distal end of each suction line <NUM> is attached to a suction applicator <NUM>. ("Distal," it is understood means towards the surgical site at which the suction is applied. "Proximal" means away from the surgical site. ) While in <FIG>, suction applicator <NUM> is shown as handpiece specifically and solely designed to apply suction, it should be understood that this is exemplary, not limiting. Sometimes the suction applicator <NUM> is built into another surgical tool, such as an endoscope or ablation tool, applied to surgical site to accomplish a task other than applying suction. Sometimes the suction applicator <NUM> is the open distal end of the suction line <NUM>.

Internal to each manifold receiver <NUM> is a fitting <NUM>. A conduit <NUM> extends from the fitting <NUM>. Conduit <NUM> functions as a fluid communications path from the manifold <NUM> into the canister <NUM> or <NUM> with which the receiver <NUM> is associated.

Also part of mobile unit <NUM> is a suction pump <NUM>. Conduits <NUM> and <NUM>, (shown as dashed lines in <FIG>) connect each canister <NUM> and <NUM> to the inlet port of the suction pump <NUM>. When suction pump <NUM> is actuated, the resultant suction draws matter into the suction applicator <NUM> and through the associated suction line <NUM>, manifold <NUM> and manifold receiver <NUM>. The waste stream flows from the manifold receiver <NUM>, through conduit <NUM> into the associated canister <NUM> or <NUM>. Liquid and small solid bits of matter entrained in this flow stream precipitate out of the stream into the canister <NUM> or <NUM>. This waste is stored in the canister <NUM> or <NUM> until the canister is emptied. Gas and small bits of matter entrained in this flow stream flow from the canister towards the suction pump <NUM>. Filters, not illustrated and not part of this invention, trap the viral and bacterial-sized matter and some of the components of the gas in this fluid stream prior to the stream being drawing into and exhausted out of the suction pump <NUM>.

As seen best in <FIG>, the proximal portion of manifold <NUM> is an open ended shell <NUM>. A cap <NUM> covers the open distal end of the shell <NUM>. Collectively, the shell <NUM> and cap <NUM> forming the body or housing of the manifold <NUM>. Shell <NUM> and cap <NUM> are further collectively dimensioned to define a void space internal to the manifold body, (void space not identified).

The shell <NUM> is generally tube like in shape. The shell <NUM> is the portion of the manifold dimensioned to seat in an open ended bore in the manifold receiver <NUM>. Shell <NUM> is further formed to have, at the proximal end, a circularly shaped base plate <NUM>. Base plate <NUM> is formed to have an opening <NUM>. Opening <NUM> provides a fluid communications path from the void space internal to the manifold. The opening <NUM> is dimensioned to receive the fitting <NUM> internal to the manifold receiver <NUM>. A drip stop <NUM>, seen only in <FIG> and <FIG>, is disposed over opening <NUM>. When the manifold <NUM> is disconnected from the receiver <NUM>, the drip stop <NUM> prevents fluid flow out of the opening <NUM>.

Cap <NUM>, seen best in <FIG>, <FIG>, is formed to have a tube like base <NUM>. Base <NUM> has an open proximal end. The cap <NUM> is formed so the open end of base <NUM> seats over the open distal end of the shell <NUM>. Not identified and not part of the present invention are the fingers that extend forward from the shell <NUM> and the complementary features internal to the cap base <NUM> that facilitate the snap securement of the cap <NUM> over the shell <NUM>. A face plate <NUM> that extends over the distal end of the base <NUM> formed the front face of the cap <NUM>.

A head <NUM>, also part of the body of manifold <NUM>, is integrally formed with and extends distally forward from the cap face plate <NUM>. The head <NUM> is formed to have planar top and bottom faces <NUM> and <NUM>, respectively. In <FIG> and <FIG> only the edge of the bottom face <NUM> is identified. The head <NUM> also has an arcuately shaped front face front face <NUM>. Front face <NUM> is the most distally located surface of the head <NUM>. Head <NUM> is further formed so that immediately proximal to the front face <NUM> a step <NUM> is formed in the top of face <NUM>. Step <NUM> is arcuate in shape. The surface of step <NUM> is understood to be recessed relative to the surface of the adjacent portion of the top face <NUM>.

The head <NUM> is formed to so that a bore <NUM> extends inwardly from the surface of step <NUM>. Bore <NUM> is centered on an axis the extension of which intersects the longitudinal proximal-to-distal axis through the manifold <NUM>. Bore <NUM> does not extend completely through the head to the bottom faced <NUM>. Instead, bore <NUM> opens into a longitudinally extending bore <NUM> that extends proximally longitudinally through the head <NUM>. Bore <NUM> opens up into the portion of the void internal the body of the manifold defined by the cap base <NUM>.

Manifold head <NUM> is further formed that plural voids <NUM> extend inwardly from the front face <NUM>. In the illustrated version of the invention there are two voids <NUM>. Voids <NUM> are symmetrically located on opposed sides of the proximal-to-distal longitudinal axis of the manifold <NUM>. Voids <NUM> are thus located on opposed sides of the open end of bore <NUM>. The head <NUM> is formed so that the internal walls of the head that define the sides of each opening taper inwardly towards each other, walls not identified. Each of these internal walls is located on a separate radial line. The radial lines along which these walls are located project outwardly from a common point located on the longitudinal center plane of the manifold. Head <NUM> is further shaped so that the portion of the head that defines the base of each void <NUM> includes a center surface <NUM> (surfaces <NUM> identified only in <FIG>) that is recessed relative to two opposed planar perimeter surfaces <NUM> (one surface <NUM> identified in each of <FIG> and <FIG>). The proximal end of each opening <NUM> is defined by a wall <NUM> internal to the head <NUM>, one wall <NUM> identified in <FIG>. Walls <NUM> are understood to be located inwardly relative to the front face <NUM>. Head <NUM> also has two additional internal bores, bores <NUM>, one bore <NUM> identified in <FIG> and <FIG>. Each bore <NUM> extends proximally inwardly from an associated one of the inner walls <NUM>. Each bore <NUM> extends to and terminates at the bore <NUM>.

The head <NUM> is further formed so there are two openings <NUM> in step <NUM> as seen in <FIG>. Each opening <NUM> opens into a separate one of the voids <NUM>. The openings <NUM> are located on the opposed sides of the opening into bore <NUM>. Head <NUM> also has three indentations <NUM> that extend proximally inward from the distal arcuate edge of step <NUM>, (one indentation identified in <FIG>). A first one of the indentations <NUM> is centered on a line that radiates from a line that extends from the axial center of bore <NUM>. The remaining two of the indentations <NUM> are each centered on separate lines that radiate from the centers of the individual openings <NUM>.

Manifold head <NUM> also has a closed end bore <NUM> that extends inwardly from the head top face <NUM>. Bore <NUM> is disposed over and does not intersect bore <NUM>. Bore <NUM>, in planes perpendicular to the top to bottom longitudinal axis through the bore <NUM> has a shape of a truncated circle. The axis around which bore <NUM> is centered interests the center point from which the radial lines that define the sides of voids <NUM> emanate. Plural flexible fingers <NUM>, two identified in <FIG>, extend upwardly from the surface internal to head that defines the base of the bore. The illustrated versions of the invention there are four fingers <NUM>. Fingers <NUM> are arcuately spaced apart from each other and are located on a circle that is centered on the longitudinal axis through the bore. The manifold head <NUM> is shaped so the fingers <NUM> project above the top face <NUM>. Each finger <NUM> has an outwardly directed tip <NUM>, one identified in <FIG> and <FIG>. Each finger tip <NUM> extends radially outwardly from and arcuately around the outer surface of the finger <NUM> with which the tip is integral.

The head <NUM> is also formed with a groove <NUM> that extends inwardly from the top face <NUM>. Groove <NUM> is arcuate in shape and centered on the axis around which bore <NUM> is centered. Head <NUM> is shaped so groove <NUM> is spaced radially outwardly and away from bore <NUM>. The groove <NUM> extends further into the head <NUM> than bore <NUM>. More particularly, the head <NUM> is formed so that groove <NUM> intersects bore <NUM> and both bores <NUM>.

Head <NUM> is formed from plastic. At least the portion of the top face <NUM> of the head that forms the structural members that extend over voids <NUM> is transparent.

A web <NUM> extends outwardly from the cap face plate <NUM>. Web <NUM> extends to the bottom face <NUM> of the head <NUM>. Web <NUM> provides structural support for the head <NUM>.

A valve <NUM>, also part of manifold <NUM>, now described by reference to <FIG> is moveably mounted to the head <NUM>. Valve <NUM> includes a plate <NUM> that is disposed above the head top face <NUM>. Plate <NUM> has a proximal section <NUM> that is generally circular in shape. The plate <NUM> has a distal section <NUM> that extends forward from an arcuate portion of the proximal section. The plate <NUM> is shaped so that, as the opposed sides of the plate distal section <NUM> extend forward from the proximal section <NUM>, the sides taper outwardly. The front edge of the plate distal section <NUM> is arcuate in shape, edge not identified. Valve <NUM> is further formed so that an opening <NUM> extends top to bottom through the plate proximal section <NUM>. Opening <NUM> is centered on the center of the plate proximal section <NUM>. Opening <NUM> has a diameter slightly greater than the diameter of the circle defined by fingers <NUM> and less than the diameter of the circle defined by the finger tips <NUM>.

As part of the assembly of manifold <NUM>, valve <NUM> is fitted over the head <NUM>, so fingers <NUM> and tips <NUM> extend through opening <NUM>. The finger tips <NUM> extend outwardly beyond the portion of the plate <NUM> that defines the perimeter of opening <NUM>. Fingers <NUM> thus rotatably hold the valve <NUM> to the rest of the manifold <NUM>.

A dome <NUM> protrudes upwardly from the plate proximal section <NUM>. More particularly, at least the dome <NUM> of valve <NUM> is formed from a transparent material, typically plastic. Dome <NUM> is shaped to magnify the view of objects disposed below the dome. The dome <NUM> is positioned so that, by selectively setting the rotational position of the valve, the dome can be located over the sections of the head <NUM> that defines either one of the voids <NUM>.

Fitting <NUM> protrudes distally forward from the distally directed face of the dome <NUM>. The fitting <NUM> is dimensioned to receive the proximal end of the suction line <NUM> through which a fluid stream is introduced into the manifold <NUM>. A bore <NUM> extends proximally from the distal end of the fitting. Bore <NUM> extends a short distance into dome <NUM>. The bore <NUM> is L-shaped. The short section of bore <NUM> extends perpendicularly downwardly from the longer distal-to-proximal long section of the bore. The short section of bore <NUM> extends through the dome and has an opening in the undersurface of plate distal section <NUM>. This opening from bore <NUM> is positioned so that, depending on the rotational position of the valve <NUM> the opening can be placed in registration with opening into head bore <NUM> or either one of the openings <NUM>. A ring <NUM> extends downwardly from the underside face of the plate distal section <NUM>. Ring <NUM> surrounds the opening that leads out of bore <NUM>. The ring <NUM> is dimensioned to fit in the space between step <NUM> integral with head <NUM> and the undersurface of the plate. Ring <NUM> prevents fluid loss or suction leakage between the head <NUM> and the fitting <NUM>.

Valve <NUM> is further formed to have a stop <NUM> that extends downwardly from the undersurface of the plate proximal section <NUM>. Stop <NUM> is in the form of a curved plate. When the valve <NUM> is mounted to rest of the manifold <NUM>, stop <NUM> seats in groove <NUM> internal to the head <NUM>. Stop <NUM> is formed to define a through hole <NUM>. Hole <NUM> is centered around a top to bottom plane in which the longitudinal distal to proximal longitudinal axis of the fitting extends.

The valve <NUM> is also formed so a rim <NUM> projects around the outer distally directed curved end of the plate distal section <NUM>. Rim <NUM> extends below the undersurface of the plate distal section <NUM>. The rim <NUM> is located in front of the front face <NUM> of the head. A curved tab <NUM> extends proximally rearward from the proximally directed surface of the rim. Tab <NUM> is thus located below the undersurface of the plate distal section. The tab <NUM> is centered on the top-to-bottom plane in which the distal-to-proximal longitudinal axis through the fitting <NUM> extends. Tab <NUM> is dimensioned to seat in each of the indentations <NUM> formed in the manifold head <NUM>. Finger grips <NUM> extend upwardly from the opposed ends of the rim <NUM>.

The illustrated manifold <NUM> has a second fitting, fitting <NUM>, identified in <FIG>. Fitting <NUM> extends distally outwardly from the cap face plate <NUM>. Fitting <NUM> opens into the void space internal to the manifold <NUM>. Two backflow prevention valves <NUM>, seen in <FIG>, are mounted to the inner surface of the face plate <NUM>. The individual backflow prevention valves <NUM> allow flow from the bore <NUM> and fitting <NUM> into the void space while blocking flow from the void space out through the bore <NUM> and the fitting <NUM>. In the illustrated version of the invention, both backflow prevention valves <NUM> extend from a common hub (not identified). The hub is mounted to the inner surface of face plate <NUM> by a means not illustrated and not part of the present invention.

A filter <NUM> is disposed in the void space internal to the manifold <NUM>. Filter <NUM> traps solid and semisolid material of a size larger than what should be held the canister <NUM> or <NUM> with which the manifold <NUM> is associated.

A catch tray <NUM>, now described by reference to <FIG>, is removably seated in each one of the voids <NUM> formed in the manifold head <NUM>. The catch trays <NUM> are formed from a single piece of elastomeric material such as plastic, rubber or silicone rubber. Each catch tray <NUM> includes a base plate <NUM>. The base plate <NUM> has a proximal section <NUM> and a distal section <NUM>. When the manifold <NUM> is aligned with the horizontal plane, the plate proximal section <NUM> is likewise in the horizontal plane. The plate distal section <NUM>, extending distally from the distal end of the proximal section <NUM> angles upwardly from the proximal section <NUM>. An end plate <NUM> extends perpendicularly upward from the proximal end of the plate proximal section <NUM>. Opposed side plates <NUM> extend perpendicularly upward from the opposed sides of the tray base plate <NUM>. Each side plate <NUM> extends to the adjacent end of the tray end plate <NUM>. A front panel <NUM> extends perpendicularly upward from the distal end of the plate distal section <NUM>. The front panel <NUM> extends around the whole of the distal perimeter of the plate distal section <NUM>. The front panel <NUM> extends to and projects outwardly beyond the distal ends of each of the side plates <NUM>.

As mentioned above, catch trays <NUM> are dimensioned to seat in the voids <NUM> internal to the manifold <NUM>. Accordingly, each catch tray <NUM> has a shape that can be considered that of a truncated pie slice. The sides of the base plate <NUM>, extending distally to proximally, taper towards each other. The opposed proximal and distal ends of the base plate <NUM> are curved. By extension both the end plate <NUM> and front panel <NUM> are curved in shape. Collectively, the features of the catch tray <NUM> are shaped so that, when the tray is seated in the manifold void <NUM>, the outer perimeter of the proximally directed face of the front panel <NUM> seats against the perimeter portion of manifold face <NUM> that defines the opening into the void <NUM>.

Each catch tray <NUM> is further formed so that the side panels <NUM> and front panel <NUM> extend below the distal section <NUM> of the base plate <NUM>. Two webs <NUM>, extend radially inward from the proximally directed face of the front panel to the undersurface of the distal section <NUM> of the base plate <NUM>. The tray <NUM> is formed so that when the tray is seated in the associate void <NUM>, the webs <NUM> rest on the perimeter surfaces <NUM> on either side of the recessed center surface <NUM> that defines the base of the void. A tab <NUM> extends outwardly from the outer face of the tray front panel <NUM>. In the illustrated version of the invention, tab <NUM> has three panels. The tab <NUM> is dimensioned to facilitate the finger griping of the catch tray <NUM>.

Each catch tray <NUM> is formed so that plural pores <NUM>, one pore identified, extend through the end plate <NUM>. Pores <NUM> are formed in the section of the plate <NUM>, that when the tray is fitted to the manifold that is in registration with the open end of the bore <NUM> formed in the adjacent wall <NUM> internal to the manifold head. Pores <NUM> are dimensioned to allow fluid flow but are smaller is size than the samples the catch tray <NUM> is employed to trap. The tray base plate <NUM> is also formed to have the pores <NUM>. Base plate <NUM> is formed so the pores <NUM> are located in the section of the plate between webs <NUM>.

Manifold <NUM> of this invention is prepared for use by inserting a catch tray <NUM> in each of the voids <NUM>. The manifold <NUM> is inserted in the receiver <NUM> of the waste collection unit <NUM> with which the manifold is used. As a result of this process the fitting <NUM> internal to the receiver <NUM> seats in opening <NUM> in the proximal end of plate <NUM>. The fitting <NUM> extends past the drip stop <NUM>. The drip stop <NUM> forms a barrier between the fitting <NUM> and the portion of plate <NUM> that forms the outer perimeter of opening <NUM>. Fitting <NUM> thus provides a fluid communications path from the void space internal to the manifold <NUM> to the canister <NUM> or <NUM> with which the fitting <NUM> is associated.

Once manifold <NUM> is fitted to the receiver, suction line <NUM> is attached to the manifold and suction pump <NUM> turned on, waste collection unit <NUM> is ready for use.

Typically there is not an immediate need to trap a sample entrained in the fluid flow at the start of a procedure in which system <NUM> is employed. Accordingly, at the start of the procedure, the valve <NUM> is typically set in the bypass position. Valve <NUM> is in placed in the bypass position, by setting plate <NUM> so the opening in the distal end of bore <NUM> is in registration with the opening into bore <NUM>. As a result of this positioning of valve <NUM>, stop <NUM> assumes an orientation in groove <NUM> in which the through hole <NUM> internal to the stop is in registration with bore <NUM>. On both sides of hole <NUM>, sections of stop <NUM> interrupt the bores <NUM> that lead to bore <NUM>. Stop <NUM> thus blocks the suction draw from openings <NUM> that would otherwise occur through bores <NUM>.

Consequently when the valve <NUM> is in the bypass position, the fluid flow from the suction line <NUM> is through the fitting <NUM>, through the bore <NUM> and <NUM> and into the void space internal to the manifold. If filter <NUM> is disposed in the manifold <NUM>, solids and semisolids larger than the size of the pores internal to the filter are trapped by filter <NUM>. The fluid flow out of the manifold through the receiver fitting <NUM> seated in the manifold outlet opening <NUM>.

During the course of the procedure, there may be one or more instances in which it is so determined it is worthwhile to retain tissue that will flow through the fluid stream for further study. When it is determined that such a condition exists, the valve is rotated from the bypass position to the sample collection position. The valve <NUM> is placed in the sample collection position by rotating the plate <NUM> so the opening in the distal end of the bore <NUM> is placed in registration with one of the openings <NUM> in the manifold head <NUM>. As a result of the valve being so positioned, the stop <NUM> is rotated so hole <NUM> moves into registration with the bore <NUM> associated with the opening <NUM>. The solid arcuate section of the stop <NUM> to the side of the bore interrupts both bore <NUM> and the remaining bore <NUM>. Stop <NUM> thus continues to block the suction draw through the non-selected bore <NUM> as well as the bypass bore <NUM>.

When valve <NUM> is in the specimen collection positon, the fluid stream thus flows from the fitting <NUM> into the open top of the catch tray <NUM> in the void space <NUM> into which the opening <NUM> opens. The fluid stream flows through the void space, through the pores <NUM> in the catch tray and into the bore <NUM>. Owing to the void <NUM> having a recessed base, a fraction of this fluid flow is through the pores <NUM> in the tray base plate <NUM>. The remaining fraction of this flow is through the pores <NUM> in the tray end plate <NUM>. The sample, which is larger is size than pores <NUM>, is trapped in the catch tray <NUM>. From the bore <NUM> the fluid flows into bore <NUM>. From bore <NUM> the fluid flows in the same path as when the valve is in the bypass position.

During the process, the practitioner may look through dome <NUM> to determine when the sample becomes trapped. Owing to the geometry of the dome <NUM>, the view the practitioner sees in the trap is magnified. This facilitates the prompt visual detection regarding whether or not the sample targeted for retrieval has been trapped.

After the sample is trapped, the procedure may be in a state in which there is not an immediate need to capture an additional sample. If the procedure is in this state, the valve is returned to the bypass position. The fluid stream then simply returns to the state of flowing from the fitting and bores <NUM> and <NUM> into the manifold void space.

Alternatively, almost immediately after one sample is trapped, it may be necessary to trap a second sample. If this condition exists, valve <NUM> is set so the fitting is placed in registration with the second opening <NUM>. This causes the fluid stream to essentially immediately flow through the second catch tray <NUM>. This makes it possible to trap a second sample, even if, owing to the timing of events it is not possible to replace the first catch tray <NUM> removed from the manifold in order to collect and store the first sample.

Once the valve <NUM> is shifted away from the specimen collection position with which a particular catch tray <NUM> is associated, the catch tray can be removed from the void <NUM> in which the tray is seated. A new catch tray can be seated in the void <NUM>. This means valve <NUM> can be returned to the specimen collection position in which a fluid stream that contains a specimen to be collected is flows through the void <NUM> in which an earlier specimen was collected. This newly selected specimen will be trapped in its own tray <NUM>. The trays are often provided with means for the personnel to include data that indicates from where in the patient the specimen was collected.

The cassette <NUM> of this invention thus allows the practitioner to capture plural samples, each in its own catch tray <NUM>, with essentially no interruption of the drawing of the fluid stream in which the samples are entrained. Since each sample is contained in its own catch tray <NUM>, there is minimal effort associated with correlating the sample with the location on or in the patient from which the sample was extracted. This facilitates the proper diagnosis of the state of the patient.

It is a further feature of this invention that the valve <NUM> is bifunctional. The valve <NUM> does more than simply direct the fluid flow through either the bypass conduit, bore <NUM> in the described version of the invention, or into a catch tray <NUM>. Valve <NUM> and more particularly, stop <NUM>, when the valve is in the bypass states, blocks suction draw from the catch trays <NUM>. When the valve is set to facilitate sample capture, the stop <NUM> blocks of suction draw from the bypass conduit and the catch tray not being used for capture. One benefit of this feature of this invention is that it substantially eliminates suction leakage through the flow paths through which the fluid stream is not being routed. A second benefit of this feature is that it reduces the noise that might be otherwise generated if suction is drawn on these non-selected flow paths.

As the valve <NUM> rotates the tab <NUM> integral with the valve seats in and rotates out of the indentations <NUM> in the body of the manifold <NUM>. The varying resistance of the valve <NUM> as the tab so rotates provides tactile feedback regarding the setting of the valve.

It should be appreciated that the above is directed to specific versions of the invention and that other versions of the invention may have features different from what has been described. For example, this invention is not limited to versions of the invention in which the cassette is formed with two voids for receiving separate catch trays. In alternative versions of the invention the cassette may include void spaces for receiving three or more catch trays.

<FIG> illustrates an alternative valve <NUM> that can be employed as part of the cassette of this invention. Valve <NUM> includes essentially all the features of valve <NUM>. Accordingly, the majority of these features are not redescribed. Valve <NUM> also includes a tab <NUM>, seen as a cylindrical member, that extends downwardly from fitting <NUM>. Tab <NUM> is positioned to be located forward of front face <NUM> of head <NUM> of cassette <NUM>.

<FIG> depicts where tab <NUM> is located when the valve <NUM> is in the specimen collection position. In <FIG> only the catch tray <NUM> and valve <NUM> are shown. The portions of the cassette head <NUM> in which the catch tray is seated and to which the valve is attached are not illustrated. As seen in this Figure, when valve <NUM> is in this position, tab <NUM> is located immediately in front of the front panel <NUM> of the catch tray <NUM> through which the valve <NUM> directs the fluid stream. Tab <NUM> thus functions as a lock out for the cassette with which the valve <NUM> is integral. Specifically, when the valve <NUM> is in the specimen collection position, the tab <NUM> prevents the withdrawal of the catch tray <NUM> through which the valve is directing the fluid flow. This substantially eliminates the likelihood that a catch tray <NUM> can be removed during times when, owing to the position of the valve and stop, a suction is being drawn on the space in which the catch tray is seated. Preventing removal of the catch tray when the cassette is in this state results in a like prevention that the suction drawn on this space will result in the unintended draw of the specimen out of the tray.

When valve <NUM> is moved to the bypass position, the stop <NUM> moves to a position in which the stop blocks the suction draw on the tray-receiving void <NUM>. The movement of the valve <NUM> also causes tab <NUM> to move to a position in which the tab is spaced from the catch tray <NUM>. Catch tray <NUM> therefore can only be removed when the cassette is a state in which a suction is not being drawing on the void <NUM>. This means that when the tray is withdrawn, there is essentially no likelihood that the suction that is continually drawn through the outlet opening will result in the draw of the trapped specimen out of the tray.

It should be understood that stop <NUM> performs two functions. The stop prevents a draw of suction on the non-selected opening <NUM>, <NUM>. This prevents the loss of suction through the flow path, opening <NUM> and bore <NUM> or, if the valve is in the collection position, the selected opening <NUM> and associated void <NUM>. The second function stop <NUM> is that when the valve <NUM> or <NUM> is spaced from a void space <NUM>, the valve prevents the draw of suction which could result in the loss of the specimen just trapped in the catch tray <NUM>.

It should likewise be understood that while the stop <NUM> and tab <NUM> move with the valve, there is no requirement that in all versions of the invention one or both of these components be formed to be integral with the valve. In some versions of the invention one or both of the stop <NUM> and tab <NUM> may be separate from the valve. A link or a gear may connect the separated stop or tab so that when the valve moves, the disconnected stop or tab engage in the appropriate motion. Specifically, when the valve is in specimen collection positon, the tab or other lock feature is positioned to prevent the catch tray <NUM> from being removed from the void space. Also when the valve is in the specimen collection position, the stop <NUM> is set to allow suction to be drawn on the void <NUM> in which the tray is seated. When the valve is moved away from the void <NUM> holding that particular tray <NUM>, stop <NUM> moves to a position in which the stop blocks the draw of suction on the void space in which the tray is seated. Tab <NUM> or other lock feature moves away from the tray so as to allow removal of the tray. In some versions of the invention the components are designed so that only after the stop <NUM> is set to block suction through a void <NUM> does the tab or other lock feature move into a position in which the lock feature no longer prevents removal of the tray <NUM>.

Likewise this invention is not limited to versions of the invention wherein the valve that sets the state of the cassette between the bypass state and the sample capture state rotates. In alternative versions of the invention, for example the valve may be attached to the cassette to engage in in translation movement. If the catch tray-holding void spaces are arranged linearly in the body of the cassette, the valve may be mounted to the cassette to move linearly. If the catch tray holding void spaces are arranged arcuately around the body of the cassette, the valve may be mounted to the cassette to engage in an arcuate translation motion.

Likewise, it should be understood that there is no requirement that in all versions of the invention, the fitting through which fluid flows to the valve be part of the valve. Thus, it is within the scope of this invention that the fitting be static relative to the rest of the cassette. In these versions of the invention, the valve regulates the flow from the fitting so the fluid stream flows through the bypass conduit or one of the catch tray-holding void spaces.

Also, it may be desirable to, in some versions of the invention, provide the cassette body with plural bypass conduits. This would be useful in versions of the invention where the cassette holds three or more catch trays. In these versions of the invention it may be necessary to provide a bypass conduit between each pair or catch tray-holding void spaces. In these versions of the invention the valve may have two or more position in which the valve can be set to facilitate bypass flow. A benefit of these versions of the invention is that it both lessens the time required to reset the valve from the specimen trap position to the bypass position. A further benefit of this version of the invention is that reduces the likelihood that, when resetting the valve from the specimen trap position to the bypass position, the valve position will result in fluid being momentarily routed through one of the catch trays. Should this event occur, there is possibility that the material not needed as a specimen will be inadvertently captured in the catch tray.

Some versions of the invention may have space for removably receiving only a single catch tray.

It should be appreciated that other versions of the invention may have features different from what has been described. For example, there is no requirement that all cassettes of this invention be provided with the described drip stop <NUM>, bypass fitting <NUM> or filter <NUM>. There is no requirement that in all versions of the invention, the valve and stop be a single piece unit. In some versions of the invention, a link connected between the valve and the stop displaces the stop into the correct position when the valve is set.

Likewise the shapes of the features may vary from what has been described. If the cassette of this invention is not designed to seat in the circular bore of a receiver, there is no need for the cassette to have a circular body. Likewise, there is no requirement that the void spaces for receiving the catch trays be pie-shaped. Thus these void spaces and the catch trays may have shapes different from what has been described. Likewise, some cassettes of this invention may not have a void space for receiving the fluid from a bore similar to bore <NUM>. In these versions of the invention a proximal end of a bore analogues to bore <NUM> may serve as the open end of the cassette that is connected to the suction source. It may not be necessary in all versions of the invention to construct the catch tray so that fluid flow is through plural plates of the tray. In some versions of the invention this flow may be through only one of the plates, typically either the base plate or the end plate.

It similarly is understood the catch trays may not always be tray like in shape. In some versions of the invention, these trays may be elongated structures, that is, structural that have a top-to-bottom height greater than the side-to-side width and/or front-to-back depth.

In some versions of the invention one or both of the cassette and catch trays are provided with latch features. These latch features inhibit the unintended removal of the catch trays from the cassette.

The components from which the cassette of this invention are formed may likewise be different from what is described. For example, there is no requirement that, in all versions of the invention, valve <NUM> be formed from a single piece of material. In some versions of the invention, while most of the valve <NUM> is formed from a hard plastic, one or both of the ring <NUM> and stop <NUM> may be formed from a compressible material, such as rubber. In some versions of the invention, these compressible components are molded into the rigid plastic that forms the rest of the valve <NUM>. Forming the ring <NUM> and/or stop out of a compressible material facilitates the fluid blocking features of these components.

In versions of the invention in which ring <NUM> is formed out of the compressible material, it may further be useful to design the components that hold the valve <NUM> to the head <NUM> so that these components urge the valve against the head. This may be accomplished by the appropriate sizing of the length of the fingers <NUM> that rotatably hold the valve <NUM> to the head. A benefit of this construction of the invention is that when the valve <NUM> is seated on the head <NUM>, ring <NUM> is compressed between the face <NUM> of the head <NUM> and the valve plate <NUM>. This facilities the formation of the seal by the ring <NUM> between the face <NUM> and the valve plate <NUM>.

In versions of the invention in which stop <NUM> is formed from compressible material, it may be advantages to form the stop to have a proximal-to-distal thickness thereacross that is marginally greater (<NUM> to <NUM>) than the width of the groove <NUM> in which the stop is seated. A benefit of this construction of the invention is that when the stop <NUM> is seated in groove <NUM>, the stop is compressed. This increases the fluid blocking ability of the stop <NUM>. In some embodiments of this version of the invention, only sections of the stop are formed from compressible material. For example, there may be a frame of flexible material around the portion of the stop <NUM> that defines the opening <NUM>. This provides the desired seal while minimizing the frictional resistance the compressible material places on the manual displacement of the valve <NUM> or <NUM>.

Other assemblies than the disclosed tab <NUM> may be provided to lock out the removal of a catch tray <NUM> when the valve <NUM> is seat to direct the fluid stream through the catch tray. For example, in some versions of the invention, the components may be arranged so that, when the catch tray is seated in the complementary void internal to the body of the cassette, the front panel is recessed inwardly relative to the face of the panel through which the tray is inserted and withdrawn. In these versions of the invention, the lock out component may be a member that extends through a slot in the cassette body in front of the catch tray.

In some versions of the invention the cassette and catch tray are provided with complementary features to ensure that, when the tray <NUM> is seated in the associated void <NUM>, the tray is in the correct orientation in the void.

Further, it may be desirable to provide the tray with a surface on which it is possible to write information. This would make it possible to write data related to the specimen that is captured in the tray.

Claim 1:
A cassette (<NUM>) for collecting tissue samples from a fluid stream, the cassette comprising:
a body (<NUM>, <NUM>, <NUM>) comprising:
a fitting (<NUM>) for receiving a suction line (<NUM>) through which fluids are drawn away from a patient;
an outlet opening (<NUM>) through which a suction is configured to be drawn;
a tray-receiving void (<NUM>) between the fitting (<NUM>) and the outlet opening (<NUM>), the tray-receiving void (<NUM>) being in a fluid path with the outlet opening (<NUM>); and
a bypass conduit (<NUM>, <NUM>) between the fitting (<NUM>) and the outlet opening (<NUM>), the bypass conduit (<NUM>, <NUM>) forming a bypass fluid path around the tray-receiving void (<NUM>);
a catch tray (<NUM>) removably mounted in the tray-receiving void (<NUM>), the catch tray (<NUM>) adapted to allow fluid flow therethrough into the outlet opening (<NUM>) while retaining material above a certain size that is entrained in the fluid flow through the catch tray (<NUM>);
a valve (<NUM>) moveably mounted to the body (<NUM>, <NUM>, <NUM>) to receive the fluid drawn into the fitting (<NUM>), the valve (<NUM>) adapted to direct the fluid flow from the fitting (<NUM>) into either the bypass conduit (<NUM>, <NUM>) or the tray-receiving void (<NUM>); and
a stop (<NUM>) positionable to (i) allow a suction to be drawn on the tray-receiving void (<NUM>) through the outlet opening (<NUM>) with the valve (<NUM>) positioned to direct the fluid flow into the tray-receiving void (<NUM>), and (ii) block suction draw on the tray-receiving void (<NUM>) from the outlet opening (<NUM>) with the valve (<NUM>) positioned to direct the fluid flow into the bypass conduit (<NUM>, <NUM>),
characterized in that:
a lock feature (<NUM>) is connected to and configured to be moved with the valve (<NUM>) to be positioned to (i) block removal of the catch tray (<NUM>) from the tray-receiving void (<NUM>) with the valve (<NUM>) positioned to direct the fluid flow into the tray-receiving void (<NUM>), and (ii) be spaced from the tray-receiving void (<NUM>) so as to allow removal of the catch tray (<NUM>) from the tray-receiving void (<NUM>) with the valve (<NUM>) positioned to direct the fluid flow into the bypass conduit (<NUM>, <NUM>).