Sample cartridge comprising a plurality of collection trays for collecting tissue samples from a fluid stream

Abstract

A box for obtaining a plurality of tissue samples from a fluid stream. The box includes a bypass conduit and a plurality of voids. A collection tray is removably disposed in each void. A fitting extends from the box. The box has an outlet opening through which suction is conducted. The box also has a valve. The valve directs a fluid stream from the fitting so that the fluid stream flows through the bypass conduit or through one of the voids in which the collection tray is disposed.

Description

[0001] This application is a divisional application of a Chinese patent application with an application date of January 19, 2017, application number 201780019829.8, and titled “A sample box comprising multiple collection plates for collecting tissue samples from a fluid flow”. Technical Field

[0002] The present invention generally relates to a system and method for collecting waste fluid and retrieving tissue samples produced during surgical procedures. More specifically, the present invention relates to a system and method for retrieving multiple samples without significantly interrupting the flow of waste fluid from the surgical site. Background Art

[0003] A byproduct of performing certain medical and surgical procedures is the generation of liquid waste, semi-solid waste, and solid waste. The waste includes body fluids such as blood and flushing fluids introduced into the body part where the operation is performed. The solid waste and semi-solid waste generated during the operation include tissue fragments and small pieces of surgical material that may be left behind at the part. Ideally, the waste is collected once it is generated so that the waste does not visually obstruct or contaminate the surgical part, nor does it become a biohazard in the operating room or other locations where the operation is being performed.

[0004] A variety of systems are available for surgical personnel to collect waste as it is generated. Typically, such systems include a suction source, a tubing extending from the suction source, and a storage container between the tubing and the suction source. When the system is activated, waste is drawn through the distal end of the tubing. The suction draws waste through the tubing so that it flows into the storage container and is at least temporarily retained in the storage container. One such system is Applicant's U.S. Patent Publication No. US 2007 / 0135779 A1 / PCT Publication No. WO 2007 / 070570 A2, the contents of which are incorporated herein by reference.

[0005] In some surgical procedures such as colonoscopy, it is desirable to collect one or more tissue samples from a patient during the surgical procedure. Tissue samples are usually sent to a pathology laboratory for analysis. Analysis of samples helps to assess the medical status of the patient from which the sample is collected. In order to collect a tissue sample, the pipeline that is connected to a waste container for a medical device for suctioning a patient can be temporarily disconnected. A separate device is placed in series with the pipeline so as to be located upstream of the container. The tissue sample is captured in the device. The device is then removed and the pipeline from the suction applicator is directly reconnected to the waste container. In the collection process of multiple samples, the repeated connection and disconnection of the pipeline increases the additional time to complete the surgical procedure. Once the pipeline is disconnected, a small amount of uncontained liquid waste and semi-solid waste adhered to the pipeline can be released into the surrounding environment, thereby potentially contaminating the floor and other surfaces in the surgical facility.

[0006] A solution to this problem is provided in the applicant's U.S. Patent Publication No. US 2014 / 0323914 Al / PCT Publication No. WO2013 / 090579 Al, the contents of which are incorporated herein by reference, which discloses a variety of different boxes designed to be removably attached to a suction system. Each of these boxes includes a removable tissue trap. The tissue trap is formed with a screen that allows fluid to flow through while retaining material fragments, and the size of the retained material is generally at least 1mm. A plurality of these boxes each include a set of conduits and valves. These conduits and valves are designed to allow the fluid flow extracted into the system to flow along one of two paths. When the fluid flow does not include tissue that needs to be collected, the valve is set so that when the fluid flows into the storage container, the fluid removed bypasses the tissue trap. During surgery, tissue worth studying can be entrained in the suction flow. When the practitioner realizes that the event is about to occur, the box valve is set from the bypass position to the collection position. When the valve is set in this way, the fluid flows along a path extending across the tissue trap. The tissue to be collected is captured by a screen that is integral with the tissue trap. Once the sample is captured, the valve is returned to the bypass position.

[0007] The capture of the above-described cartridges can be used to capture multiple samples. A disadvantage of this approach is that when multiple samples are captured, it is not possible to determine the location within the patient where the sample was obtained for each sample. In surgeries where there is the possibility of needing to capture multiple samples, the inability to so distinguish between individual samples reduces the usefulness of such cartridges. This is because in order to assess the patient's condition, it is important to know not only the pathology of the sample, but also the precise location on or in the patient's body from which the sample was obtained.

[0008] Therefore, in order to use this type of box to collect multiple samples, it is necessary to stop retrieving material from the patient after the samples are collected. During this pause period, at least a new trap needs to be assembled to the box. As a choice, the used box must be replaced with a new box. In either case, the pause of the operation prolongs the total time spent to perform the operation. The need to extend the time spent to perform the operation is contrary to one of the usual goals associated with performing medical or surgical operations. This is the goal of performing the operation as quickly as possible. This efficiency is desired to minimize the time to keep the patient in an anesthetized state and to minimize the time to expose the patient's usually covered internal tissues to the surrounding environment and the infection inducers that are basically inevitably present in the environment.

[0009] Another disadvantage of some boxes is that the trap can be retracted while the valve is set to allow suction on the box. The weight of these samples may be relatively light. When the box is retracted while the valve is in this state, a lightweight sample may be inadvertently drawn into the container. For most intents and purposes, this results in the loss of sample for analysis. Summary of the invention

[0010] The present invention relates to a novel and useful trap for collecting tissue removed from a patient during a medical or surgical procedure. The assembly of the present invention is configured to allow rapid capture of multiple samples, each in its own trap, without requiring significant interruption of suction from the point where the sample is removed.

[0011] The present invention is in the form of a box that is placed between an aspiration line and an aspiration pump through which a sample containing a fluid stream is taken out that draws the fluid stream from a patient. Typically, the box is placed between the aspiration line and a container for holding the fluid drawn away from the patient.

[0012] The box has a fitting at the distal end to which the suction line is attached. The box has an opening at the proximal end through which suction is performed by the pump. Located inside the box are a plurality of voids. These voids lead to the outside. The box is formed to define a plurality of flow paths. One flow path extends from each void to the opening in the proximal end of the box. There is also an additional flow path, a bypass flow path. The additional flow path does not extend from the voids. Instead, the flow path leads directly to the proximal opening in the box.

[0013] The cassette of the present invention includes a valve that directs fluid flow from the fitting so that the fluid flows into a selected one of a plurality of voids or into a flow path that bypasses a void.

[0014] Also part of the present invention are a plurality of collection trays. The collection trays are shaped to be removably received in a void located within the interior of the cartridge. The collection trays are designed to allow fluid to flow through the trays while retaining objects in the trays that exceed a certain size (the size of the sample). Each collection tray can be individually inserted into an associated void to be removed from the associated void without inserting or removing another of the collection trays.

[0015] In some variations of the invention, the fitting is part of the valve. In some variations of the invention, the valve is rotatably attached to the remainder of the cassette. The rotational orientation of the valve relative to the remainder of the cassette is displaced relative to the setting of the valve.

[0016] In some variations of the present invention, the box and attached components are part of an assembly known as a manifold. The manifold is used as a removable interface for connecting the suction line to a waste collection unit. In these variations of the present invention, the manifold may also include a filter. The filter is located between the collection tray and the proximal opening of the box. The filter prevents material not captured in one of the sample trays from flowing into a container for preserving the fluid removed.

[0017] The present invention also relates to a novel and useful box that prevents the removal of the trap when the valve is in a collection position in which the valve directs fluid flow through the dish. In these variations of the present invention, a locking member is connected to the valve. When the valve is in the trapping position, the locking member abuts the dish to prevent the dish from being removed. When the valve is set to direct fluid flow away from a specific collection dish, movement of the valve causes a similar movement of the locking member. In some variations of the present invention, the locking member is integrally formed with the valve. Alternatively, the valve and the locking member are separate components. A connecting rod connects the locking member to the valve so that when the valve moves away from the sample collection position, the locking member moves away from the associated collection dish. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The present invention is particularly pointed out in the claims. The above and other features and advantages of the present invention will be understood by referring to the following detailed description taken in conjunction with the accompanying drawings, in which:

[0019] Figure 1 A surgical waste collection unit is depicted on which is mounted a cassette (manifold) in one form of the present invention;

[0020] Figure 2 The manifold of the present invention is shown in cross-section positioned in a receiver of a waste collection unit;

[0021] Figure 3 is a perspective view of the manifold;

[0022] Figure 4 is a side plan view of the manifold;

[0023] Figure 5 is an exploded view of the manifold;

[0024] Figure 6 is a cross-sectional view of the manifold;

[0025] Fig. 7A and Figure 7B is a perspective view of the head of the manifold, Fig. 7A The valve is attached to the manifold, Figure 7B In, the valve is removed;

[0026] Figure 8 is a perspective view of the bottom of the valve;

[0027] Fig. 9 is a perspective view of the top of the valve;

[0028] Fig.10 is a cross-sectional view of the valve;

[0029] Fig.11 is a perspective view of the top of the collection tray;

[0030] Fig.12 is a perspective view of the bottom of the collection tray;

[0031] Fig.13 is a cross-sectional view of the collection tray;

[0032] Fig.14 is a perspective view of an alternative valve of the present invention; and

[0033] Fig.15 yes Fig.14 A cross-sectional view of the positioning of the valve, when the valve is in the sample collection position, the valve is positioned to the collection tray so as to direct fluid flow into the collection tray. DETAILED DESCRIPTION

[0034] Figure 1 The waste collection unit 20 of the present invention is shown coupled to a sample cartridge 60. In some variations of the present invention, the cartridge 60 is referred to as a manifold. Thus, in this document, the manifold 60 should be understood to be the cartridge 60. In the illustrated variation of the present invention, the waste collection unit 20 is movable. The waste collection unit 20 includes a base 24. A cover and door assembly that typically shields the components of the mobile unit 20 is provided in a Figure 1The base 24 is not present, so that the parts that are usually covered by the cup can be seen. Wheels 26 attached to the bottom of the base 24 provide mobility for the waste collection unit 20. Two canisters 28 and 30 are mounted to the base 24. The first canister (canister 28) has a relatively large internal volume between about 10 liters and about 40 liters. The second canister (canister 30) has a small volume between about 1 liter and about 10 liters. Each canister 28 and 30 has a lid 36 and 38, respectively.

[0035] Attached to each tank cover 36 and 38 is a manifold receiver 40. Figure 2 and Figure 3 The manifold 60 of the present invention as seen in FIG. 1 is removably disposed in each manifold receiver 40. Each manifold 60 includes a fitting 138. The fitting 138 receives a separate suction line 50 (at Figure 1 1 is shown in FIG. 1 ). The distal end of each suction line 50 is attached to a suction applicator 48. (“Distal” should be understood to mean toward the surgical site where suction is applied. “Proximal” means away from the surgical site.) Although in Figure 1 In the embodiment of the present invention, the suction applicator 48 is shown as a handpiece that is specifically and only designed to apply suction, but it should be understood that this is exemplary and not limiting. Sometimes the suction applicator 48 is embedded in another surgical tool (such as an endoscope or ablation tool) that is applied to the surgical site to complete tasks other than applying suction. Sometimes the suction applicator 48 is the open distal end of the suction line 50.

[0036] Inside each manifold receiver 40 is a fitting 41. Extending from the fitting 41 is a conduit 42. The conduit 42 serves as a fluid communication path from the manifold 60 to the tank 36 or 38 with which the receiver 40 is associated.

[0037] Also part of the mobile unit 20 is a suction pump 58. The conduits 54 and 56 (at Figure 1 Each tank 36 and 38 is connected to the inlet port of a suction pump 58 (shown in phantom in the figure). When the suction pump 58 is activated, the suction generated draws material into the suction applicator 48 and through the associated suction line 50, the manifold 60 and the manifold receiver 40. The waste stream flows from the manifold receiver 40 through the conduit 42 to the associated tank 36 or 38. Small solid fragments of liquid and material entrained in the fluid flow settle out of the flow and settle in the tank 36 or 38. The waste is stored in the tank 36 or 38 until the tank is emptied. The gas and small material fragments entrained in the fluid flow flow from the tank toward the suction pump 58. Before the fluid flow is sucked into the suction pump 58 and discharged from the suction pump 58, a filter not shown and not part of the present invention captures virus and bacteria sized materials in the fluid flow and some components of the gas in the fluid flow.

[0038] As in Figure 3-5 As best seen in FIG. 1 , the proximal portion of the manifold 60 is an open-ended housing 64. A cover 72 covers the open distal end of the housing 64. The housing 64 and the cover 72 together form a body or housing for the manifold 60. The housing 64 and the cover 72 are further collectively sized to define a void space (void space not identified) located within the interior of the manifold body.

[0039] The housing 64 is generally tubular in shape. The housing 64 is a portion of the manifold that is sized to fit into an open-ended bore in the manifold receiver 40. The housing 64 is further formed to have a circular base plate 66 at the proximal end. The base plate 66 is formed to have an opening 68. The opening 68 provides a fluid communication path from the void space located inside the manifold. The opening 68 is sized to receive the fitting 41 inside the manifold receiver 40. Figure 5 and Figure 6 A drip stop 70, visible in FIG. 4 , is disposed on the opening 68. The drip stop 70 prevents fluid from flowing out of the opening 68 when the manifold 60 is disconnected from the receiver 40.

[0040] exist Figure 4 , Fig. 7A and Figure 7B The cover 72, best seen in FIG. 1 , is formed to have a tubular base 74. The base 74 has an open proximal end. The cover 72 is formed so that the open end of the base 74 rests on the open distal end of the housing 64. Not identified and not part of the present invention are fingers extending forward from the housing 64 and complementary features located on the interior of the cover base 74 that help snap-fit ​​the cover 72 onto the housing 64. A panel 76 extending beyond the distal end of the base 74 forms the front face of the cover 72.

[0041] A head 78, which is also part of the body of the manifold 60, is integrally formed with the cover panel 76 and extends distally and forwardly from the cover panel 76. The head 78 is formed to have a flat top surface 80 and a flat bottom surface 84, respectively. Figure 4 and Figure 7B , only the edge of the bottom surface 84 is identified. The head 78 also has a curved front face 82. The front face 82 is the farthest located surface of the head 78. The head 78 is further formed so that adjacent to the front face 82, a step 86 is formed in the top surface 80. The step 86 is curved. The surface of the step 86 is understood to be concave relative to the surface of the adjacent portion of the top surface 80.

[0042] The head 78 is formed so that a bore 88 extends inwardly from the surface of the step 86. The center of the bore 88 is located on an axis whose extension intersects the longitudinal proximal-distal axis through the manifold 60. The bore 88 does not extend completely through the head to the bottom surface 84. Instead, the bore 88 opens into a longitudinally extending bore 89 that extends longitudinally proximally through the head 78. The bore 89 opens upwardly into the portion of the void defined by the cap base 74 located inside the body of the manifold.

[0043] The manifold head 78 is further formed such that a plurality of voids 92 extend inwardly from the front face 82. In the illustrated variation of the invention, there are two voids 92. The voids 92 are symmetrically positioned on opposite sides of the proximal-distal longitudinal axis of the manifold 60. The voids 92 are thus positioned on opposite sides of the open end of the bore 88. The head 78 is formed such that the inner walls of the head defining the sides of each opening taper inwardly toward each other, and these walls are not identified. Each of these inner walls is positioned on a separate radial line. The radial lines along which these walls are positioned project outwardly from a common point located on the longitudinal center plane of the manifold. The head 78 is further formed such that the portion of the head defining the base of each void 92 includes a planar perimeter surface 98 (at a position substantially parallel to the longitudinal center plane of the manifold) relative to two opposing planar perimeter surfaces 98. Figure 5 and Figure 7B A surface 98 is identified in each of the Fig. 7A The proximal end of each opening 92 is defined by a wall 102 located within the interior of the head 78. Fig. 7A A wall 102 is identified in FIG. 1 . Wall 102 is understood to be located inwardly relative to front face 82. Head 78 also has two additional internal bores (boreholes 104) at Figure 2 and Fig. 7A A bore 104 is identified in FIG. Each bore 104 extends proximally inwardly from an associated inner wall 102. Each bore 102 extends to bore 89 and terminates at bore 89.

[0044] The head 78 is further formed such that there are two openings 106 in the step portion 86, such as Figure 7B Each opening 106 leads to a separate void 92. The openings 106 are positioned on opposite sides of the opening leading to the bore 88. The head 78 also has three notches 108 ( Figure 7B The center of the first notch 108 is located on a line radiating from a line extending from the axial center of the bore 88. The centers of the remaining two notches 108 are each located on a separate line radiating from the center of each opening 106.

[0045] Manifold head 78 also has a closed-end bore 112 extending inwardly from head top surface 80. Borehole 112 is disposed above borehole 89 and does not intersect borehole 89. Borehole 112 has the shape of a truncated circle in a plane perpendicular to a longitudinal axis passing through the top-to-bottom of borehole 112. The axis about which borehole 112 is centered intersects a center point from which radial lines defining two sides of void 92 emanate. A plurality of flexible fingers 114 ( Figure 6 The illustrated variation of the invention has four fingers 114. The fingers 114 are arcuately spaced from one another and are positioned on a circle centered on the longitudinal axis through the bore. The manifold head 78 is shaped so that the fingers 114 extend above the top surface 82. Each finger 114 has an outwardly directed end 116 that extends upwardly from the surface of the base defining the bore located on the interior of the head. The illustrated variation of the invention has four fingers 114. The fingers 114 are arcuately spaced from one another and are positioned on a circle centered on the longitudinal axis through the bore. The manifold head 78 is shaped so that the fingers 114 extend above the top surface 82. Each finger 114 has an outwardly directed end 116 that extends upwardly from the top surface 82. Figure 2 and Figure 7B Each finger tip 116 extends radially outwardly from and arcuately around an outer surface of the finger 114 with which it is integral.

[0046] The head 78 is also formed with a groove 118 extending inwardly from the top surface 82. The groove 118 is arcuate and centered on an axis about which the bore 112 is centered. The head 78 is formed so that the groove 118 is spaced radially outward and away from the bore 112. The groove 118 extends farther into the head 78 than the bore 112. More specifically, the head 78 is formed so that the groove 118 intersects the bore 89 and the two bores 104.

[0047] The head 76 is formed of plastic. At least a portion of the top surface 82 of the head forming a structural member extending above the void 92 is transparent.

[0048] The web 120 extends outwardly from the cover panel 76. The web 120 extends to the bottom surface 84 of the head 78. The web 120 provides structural support for the head 78.

[0049] Now refer to Figures 8 to 10A valve 124, also described as part of the manifold 60, is movably mounted to the head 78. The valve 124 includes a plate 126 disposed above the head top surface 80. The plate 126 has a generally circular proximal section 128. The plate 126 has a distal section 132 extending forwardly from an arcuate portion of the proximal section. The plate 124 is shaped such that as the opposite sides of the plate distal section 132 extend forwardly from the proximal section 128, the sides taper outwardly. The front edge of the plate distal section 132 is arcuate, and the edge is not identified. The valve 124 is further formed such that an opening 130 extends from the top to the bottom through the plate proximal section 128. The opening 130 is centered on the center of the plate proximal section 128. The diameter of the opening 130 is slightly larger than the diameter of the circle defined by the finger-shaped member 114 and smaller than the diameter of the circle defined by the finger-shaped member end 116.

[0050] As part of the assembly of the manifold 60, the valve 124 is assembled on the head 78, whereby the finger 114 and the end 116 extend through the opening 130. The finger end 116 extends outwardly beyond the portion of the plate 124 that defines the perimeter of the opening 130. Thus, the finger 114 rotatably retains the valve 124 to the remainder of the manifold 60.

[0051] The dome 136 protrudes upward from the plate proximal section 132. More specifically, at least the dome 136 of the valve 124 is formed of a transparent material, typically plastic. The dome 136 is shaped to magnify the view of objects disposed below the dome. The dome 136 is positioned so that by selectively setting the rotational position of the valve, the dome can be positioned above the section of the head 78 that defines any of the voids 92.

[0052] The fitting 138 protrudes forwardly and distally from the distal leading surface of the dome 136. The fitting 138 is sized to receive the proximal end of the suction line 50 through which the fluid flow is introduced into the manifold 60. A bore 140 extends proximally from the distal end of the fitting. The bore 140 extends a short distance into the dome 136. The bore 140 is L-shaped. The short section of the bore 140 extends vertically downward from the longer distal-proximal long section of the bore. The short section of the bore 140 extends through the dome and has an opening in the lower surface of the plate distal section 132. The opening from the bore 140 is positioned so that, depending on the rotational position of the valve 124, the opening can be placed in registration with either the opening into the head bore 88 or the opening 106. A ring 142 extends downward from the bottom side of the plate distal section 132. A ring 142 surrounds the opening leading from the bore 140. The ring 142 is sized to fit in the space between the step 86 integral with the head 76 and the bottom surface of the plate. The ring 142 prevents fluid loss or suction leakage between the head 78 and the fitting 138.

[0053] The valve 124 is further formed with a stopper 146 extending downwardly from the bottom surface of the plate proximal section 128. The stopper 146 is in the form of a bent plate. When the valve 124 is mounted to the remainder of the manifold 60, the stopper 146 is seated in the groove 118 located inside the head 78. The stopper 146 is formed to define a through hole 148. The through hole 148 is centered in the top-bottom plane in which the longitudinal proximal-distal longitudinal axis of the fitting extends.

[0054] The valve 124 is also formed so that a rim 150 protrudes around the outer distally guided arcuate end of the plate distal section 132. The rim 150 extends below the bottom surface of the plate distal section 132. The rim 150 is positioned in front of the front face 82 of the head. An arcuate protrusion 152 extends proximally and rearwardly from the proximal guiding surface of the rim. The protrusion 152 is thus positioned below the bottom surface of the plate distal section. The center of the protrusion 152 is located in the top-bottom plane, and the longitudinal axis through the distal-proximal side of the fitting 138 extends in this plane. The protrusion 152 is sized to be seated in each of the recesses 108 formed in the manifold head 78. Finger grips 154 extend upwardly from opposite ends of the rim 150.

[0055] The manifold 60 is shown having a second fitting, Figure 6 . The fitting 156 extends distally outwardly from the cover panel 76. The fitting 156 opens into the void space located inside the manifold 60. Figure 5 Two backflow prevention valves 157, as seen in FIG. 1 , are mounted to the inner surface of the panel 76. Each backflow prevention valve 157 allows flow from the borehole 89 and the fitting 156 into the void space while preventing flow from the void space through the borehole 89 and the fitting 156. In the illustrated variation of the invention, the two backflow prevention valves 157 extend from a common hub (not labeled). The hub is mounted to the inner surface of the panel 76 by means not shown and not part of the invention.

[0056] The filter 158 is disposed in the void space located within the interior of the manifold 60. The filter 158 captures solid and semi-solid matter that is larger in size than that which would be contained in the tank 28 or 30 with which the manifold 60 is associated.

[0057] Now refer to Figure 11-13The described collection tray 160 is removably disposed in each of the voids 92 formed in the manifold head 78. The collection tray 160 is made of a single piece of resilient material, such as plastic, rubber, or silicone rubber. Each collection tray 160 includes a base plate 162. The base plate 162 has a proximal section 164 and a distal section 166. When the manifold 60 is aligned with a horizontal plane, the plate proximal section 164 is also in the horizontal plane. The plate distal section 166 extending distally from the distal end of the proximal section 164 is inclined upward from the proximal section 164. The end plate 168 extends vertically upward from the proximal end of the plate proximal section 164. Opposite side panels 170 extend vertically upward from opposite sides of the tray base plate 162. Each side panel 170 extends to the adjacent end of the tray end plate 168. The front panel 172 extends vertically upward from the distal end of the plate distal section 166. The front panel 172 extends around the entire distal perimeter of the plate distal section 166. The front panel 172 extends to and protrudes outwardly beyond the distal end of each side panel 170.

[0058] As described above, the collection trays 160 are sized to be disposed in the void 92 located within the interior of the manifold 60. Thus, each collection tray 60 has a shape that can be viewed as a truncated sector. The two sides of the base plate 162 extending distally to proximally taper toward each other. The opposing proximal and distal ends of the base plate 162 are arcuate. By extension, the shapes of the end plates 168 and the front panel 172 are both arcuate. Collectively, the features of the collection tray 160 are shaped so that when the tray is disposed in the manifold void 92, the outer perimeter of the proximal guide surface of the front panel 172 rests against a perimeter portion of the manifold face 82 that defines an opening to the void 92.

[0059] Each collection tray 160 is further formed so that the side panels 170 and the front panel 172 extend below the distal section 166 of the base plate 162. Two webs 174 extend radially inward from the proximal leading surface of the front panel to the bottom surface of the distal section 166 of the base plate 162. The tray 160 is formed so that when the tray is placed in the associated void 92, the webs 174 rest on the peripheral surface 98 located on either side of the bottom of the recessed central surface 96 defining the void. A tab 176 extends outwardly from the outer surface of the tray front panel 172. In the illustrated variation of the invention, the tab 176 has three panels. The tab 176 is sized to facilitate finger gripping of the collection tray 160.

[0060] Each collection tray 160 is formed such that a plurality of apertures 169 (one aperture is identified) extend through the end plate 168. The apertures 169 are formed in a section of the plate 168 that align with the open ends of the bores 104 formed in the adjacent wall 102 located on the interior of the manifold head when the tray is assembled to the manifold. The apertures 169 are sized to allow fluid flow, but are smaller than the sample captured using the collection tray 160. The tray base plate 162 is also formed to have the apertures 169. The base plate 162 is formed such that the apertures 169 are located in a section of the plate located between the webs 174.

[0061] The manifold 60 of the present invention is prepared for use by inserting a collection tray 160 in each void 92. The manifold 60 is inserted into the receiver 40 of the waste collection unit 20 used with the manifold. As a result of this process, the fitting 41 located inside the receiver 40 is seated in the opening 68 in the proximal end of the plate 66. The fitting 41 extends over the drip stop 70. The drip stop 70 forms a shield between the fitting 41 and the portion of the plate 66 that forms the outer perimeter of the opening 68. The fitting 41 thus provides a fluid communication path from the void space located inside the manifold 60 to the canister 54 or 56 associated with the fitting 41.

[0062] Once the manifold 60 is assembled to the receiver, the suction line 50 is attached to the manifold, and the suction pump 58 is turned on, the waste collection unit 20 is ready for use.

[0063] Typically, at the beginning of a procedure employing system 20, there is no immediate need to capture a sample entrained in the fluid stream. Therefore, at the beginning of the procedure, valve 124 is typically set in the bypass position. Valve 124 is placed in the bypass position by setting plate 126 so that the opening in the distal end of bore 140 is aligned with the opening leading to bore 88. As a result of this positioning of valve 124, stop 146 assumes an orientation in recess 118 in which a through hole 148 located within the stop is aligned with bore 88. On both sides of hole 148, several sections of stop 146 interrupt bore 104 leading to bore 89. Stop 146 thus prevents suction from opening 92 that would otherwise occur through bore 104.

[0064] Thus, when valve 124 is in the bypass position, fluid flows from suction line 50 through fitting 138, through bores 88 and 89, and into the void space located inside the manifold. If filter 158 is disposed in manifold 60, solids and semisolids that are larger than the size of the pores located inside the filter are captured by filter 158. Fluid flows out of the manifold through receiver fitting 41 disposed in manifold outlet opening 68.

[0065] During surgery, there may be one or more situations where it is determined that it is valuable to retain tissue that will flow through the fluid stream for further study. When it is determined that this situation exists, the valve is rotated from the bypass position to the sample collection position. The valve 124 is placed in the sample collection position by rotating the plate 126 so that the opening in the distal end of the bore 140 is placed in registration with an opening 106 in the manifold head 78. As a result of positioning the valve in this way, the stop 146 is rotated so that the hole 148 moves into registration with the bore 104 associated with the same opening 106. The solid arc section of the stop 146 to the side of the bore interrupts the bore 89 and the remaining bores 104. The stop 146 thus continues to prevent suction through the unselected bore 104 and the bypass bore 89.

[0066] When the valve 124 is in the sample collection position, the fluid flow thus flows from the fitting 138 into the open top of the collection tray 160 in the void space 96 into which the opening 106 leads. The fluid flow flows through the void space, through the aperture 169 in the collection tray, and into the bore 104. Since the void 92 has a recessed base, a portion of the fluid flow passes through the aperture 169 in the tray base plate 162. The remainder of the fluid passes through the aperture 169 in the tray end plate 168. Samples larger in size than the aperture 169 are captured in the collection tray 160. The fluid flows from the bore 104 into the bore 89. The fluid flows from the bore 89 in the same path as when the valve is in the bypass position.

[0067] During this process, the practitioner can look through the dome 136 to determine when the sample has been captured. The practitioner's view into the trap is magnified due to the geometry of the dome 136. This facilitates quick visual detection as to whether the sample targeted for retrieval has been captured.

[0068] After the sample is captured, the procedure may be in a state where it is not necessary to immediately capture an additional sample. If the procedure is in this state, the valve is returned to the bypass position. Fluid flow is then returned to the state where it flows only from the fittings and bores 88 and 89 into the manifold void space.

[0069] Alternatively, it may be desirable to capture a second sample almost immediately after capturing one sample. If this is the case, valve 124 is set so that the fitting is placed in registration with second opening 106. This results in fluid flow through second collection tray 160 substantially immediately. This makes it possible to capture a second sample even if, due to the timing of events, it is not possible to replace the first collection tray 160 that was removed from the manifold in order to collect and store the first sample.

[0070] Once the valve 124 has been deflected from the sample collection position associated with a particular collection tray 160, the tray can be removed from the void 92 in which it was placed. A new capture tray can be placed in the void 92. This means that the valve 124 can be returned to the sample collection position, wherein the fluid stream containing the sample to be collected flows through the void 92 in which the earlier sample was collected. The newly selected sample will be captured in its own tray 160. These trays are typically provided with means for the staff to include data indicating where in the patient the sample was collected.

[0071] The cartridge 60 of the present invention thus allows a medical practitioner to capture multiple samples, each in its own collection tray 160, without substantially interrupting the extraction of the fluid stream entraining the sample. Because each sample is contained in its own collection tray 160, there is minimal effort associated with locating the sample with the location on or in the patient from which it was extracted. This facilitates the correct diagnosis of the patient's condition.

[0072] Another feature of the present invention is that valve 124 is dual-functional. Valve 124 does not simply direct fluid flow through the bypass conduit, the borehole 88 in the described variation of the present invention, or into the collection tray 160. When the valve is in the bypass state, valve 124 and more specifically stopper 146 prevents suction from the collection tray 160. When the valve is set to facilitate sample capture, stopper 146 prevents suction from the bypass conduit and the collection tray that is not used for collection. One advantage of this feature of the present invention is that this substantially eliminates suction leakage through flow paths through which fluid flow is not sent. A second advantage of this feature is that this can reduce noise that may otherwise be generated if suction is performed on these unselected flow paths.

[0073] As the valve 124 is rotated, the protrusions 152 integral with the valve seat into and rotate out of the grooves 108 in the body of the manifold 60. As the protrusions so rotate, the changing resistance of the valve 124 thus provides tactile feedback regarding the setting of the valve.

[0074] It should be appreciated that the above relates to a particular variation of the invention, and that other variations of the invention may have features different from those already described. For example, the invention is not limited to variations of the invention in which the box is formed with two voids for receiving separate collection trays. In alternative variations of the invention, the box may include void spaces for accommodating three or more collection trays.

[0075] Fig.14An alternative valve 188 is shown that can be used as part of the cassette of the present invention. The valve 188 includes substantially all of the features of the valve 124. Therefore, most of these features will not be re-described. The valve 188 also includes a protrusion 190, which is viewed as a cylindrical member, extending downwardly from the fitting 138. The protrusion 190 is positioned forward of the front face 82 of the head 78 of the cassette 60.

[0076] Fig.15 Depicted is the position in which the protrusion 190 is positioned when the valve 188 is in the sample collection position. Fig.15 , only the collecting tray 160 and the valve 188 are shown. The portion of the box head 78 where the collecting tray is placed and the portion of the box head 78 to which the valve is attached are not shown. As seen in the figure, when the valve 188 is in this position, the protrusion 190 is located just in front of the front panel 172 of the collecting tray 160 through which the valve 188 guides the fluid flow. The protrusion 190 is therefore used as a locking member for the box that is integrated with the valve 188. Specifically, when the valve 188 is in the sample collection position, the protrusion 190 prevents the collection tray 160 through which the valve guides the fluid to be retrieved. Due to the position of the valve and the stopper, this substantially eliminates the possibility that the collecting tray 160 can be removed while suction is being performed in the space in which the collecting tray 160 is placed. When the box is in this state, preventing the collection tray from being removed results in also preventing suction performed on the space from causing the sample to be accidentally extracted from the tray.

[0077] When the valve 188 is moved to the bypass position, the stopper 146 is moved to a position where it prevents suction on the tray receiving void 92. The movement of the valve 188 also causes the protrusion 190 to move to a position where it is spaced from the collection tray 160. When the cartridge is in a state where suction is not being applied on the void 92, only the collection tray 160 can therefore be removed. This means that when the tray is retracted, there is substantially no possibility that continued suction through the outlet opening will result in the captured sample being drawn out of the tray.

[0078] It should be appreciated that the stopper 146 performs two functions. The stopper prevents aspiration on unselected openings 88, 106. This prevents loss of aspiration through the flow path, openings 88 and bores 89, or if the valve is in the collection position, this prevents loss of aspiration through the selected opening 106 and associated void space 92. The second function of the stopper 146 is that when the valve 124 or 188 is spaced from the void space 92, the valve prevents aspiration that could result in loss of sample just captured in the collection tray 160.

[0079] It should also be understood that when the stopper 146 and the protrusion 160 move with the valve, in all variations of the present invention, it is not required that one or both of these components should be formed as one piece with the valve. In some variations of the present invention, one or both of the stopper 146 and the protrusion 160 can be separated from the valve. A connecting rod or a gear can connect the separated stopper or protrusion so that when the valve moves, the disconnected stopper or protrusion engages in a suitable movement. Specifically, when the valve is in the sample collection position, the protrusion or other locking feature is positioned to prevent the collection tray 160 from being removed from the void space. Similarly, when the valve is in the sample collection position, the stopper 146 is set to allow suction on the void 92 in which the tray is disposed. When the valve moves away from the void 92 holding the particular tray 160, the stopper 142 moves to a position where the stopper prevents suction on the void space in which the tray is disposed. The protrusion 190 or other locking feature moves away from the tray, thereby allowing the tray to be removed. In certain variations of the invention, the components are designed so that only after the stop 190 is set to prevent suction through the gap 92, the protrusion or other locking feature moves into a position where the locking feature no longer prevents removal of the disc 160.

[0080] Likewise, the present invention is not limited to variations of the present invention in which the valve rotation is set between the bypass state and the sample capture state of the box. In alternative variations of the present invention, for example, the valve may be attached to the box to engage in a translational motion. If the collection tray that maintains the void space is arranged linearly in the body of the box, the valve may be mounted to the box to move linearly. If the collection tray that maintains the void space is arranged arcuately around the body of the box, the valve may be mounted to the box to engage in an arcuate translational motion.

[0081] Likewise, it should be understood that in all variations of the invention, it is not required that the fitting through which the fluid flows to the valve is part of the valve. Thus, it is within the scope of the invention for the fitting to be stationary relative to the rest of the box. In these variations of the invention, the valve regulates the fluid from the fitting so that the fluid flow flows through one of the bypass conduit or the collection tray that maintains the void space.

[0082] Likewise, in some variations of the present invention, it may be desirable to provide a plurality of bypass conduits for the box body. This may be useful in variations in which the box of the present invention accommodates three or more collection trays. In these variations of the present invention, it may be desirable to provide a bypass conduit between each pair of collection trays that maintain a void space. In these variations of the present invention, the valve may have two or more positions, wherein the valve may be set to facilitate bypass flow. The advantage of these variations of the present invention is that this shortens the time required for the valve to be reset to the bypass position from the sample capture position. Other advantages of this variation of the present invention are that, when the valve is reset to the bypass position from the sample capture position, the possibility that the valve position will cause a fluid to be immediately sent through one of the collection trays is reduced. If this event occurs, it is possible that a material that is not required as a sample may be inadvertently captured in the collection tray.

[0083] Certain variations of the present invention may have space for removably receiving only a single collection tray.

[0084] It should be appreciated that other variations of the present invention may have features different from those already described. For example, it is not required that all boxes of the present invention are provided with the described drip preventer 70, bypass fitting 156 or filter 158. In all variations of the present invention, it is not required that the valve and the stopper are single-piece units. In some variations of the present invention, when the valve is set, the connecting rod connected between the valve and the stopper displaces the stopper into the correct position.

[0085] Likewise, the shapes of these features may be different from the shapes already described. If the box of the present invention is not designed to be placed in a circular bore of a receiver, the box does not need to have a circular body. Likewise, the void space for receiving the collection tray is not required to be pie-shaped. Therefore, these void spaces and the collection tray may have shapes different from the shapes already described. Likewise, some boxes of the present invention may not have a void space for receiving fluid from a bore similar to bore 89. In these variations of the present invention, the proximal end of a bore similar to bore 89 may be used as the open end of the box connected to a suction source. In all variations of the present invention, it may not be necessary to construct the collection tray so that the fluid flows through multiple plates of the tray. In some variations of the present invention, the fluid may pass through only one plate, typically a substrate or an end plate.

[0086] It is also understood that the shape of the collection tray may not always be a tray. In certain variations of the invention, the trays may be elongated structures, ie, structures having a top-to-bottom height greater than the side-to-side width and / or front-to-back depth.

[0087] In certain variations of the invention, one or both of the box and the collection tray are provided with latching features. These latching features inhibit accidental removal of the collection tray from the box.

[0088] The parts that form box of the present invention can be different from described parts equally.For example, in all modifications of the present invention, valve 124 is not required to be formed by single piece material.In some modifications of the present invention, although most of valves 142 are formed by hard plastics, one or two of ring 142 and stopper 146 can be formed by compressible material, for example rubber.In some modifications of the present invention, these compressible parts are molded into the rigid plastics that form the remainder of valve 124.Forming ring 142 and / or stopper by compression material helps the fluid blocking feature of these parts.

[0089] In variations of the invention where the ring 142 is formed of a compressible material, it may be further useful to design the components that hold the valve 142 to the head 78 so that they push the valve against the head. This can be accomplished by appropriately sizing the length of the fingers 114 that rotatably hold the valve 142 to the head. An advantage of this configuration of the invention is that when the valve 124 is seated on the head 78, the ring 142 is compressed between the surface 80 of the head 78 and the valve plate 126. This helps to form a seal between the surface 80 and the valve plate 126 by the ring 142.

[0090] In a variation of the present invention in which the stop 146 is formed of a compressible material, it may be advantageous to form the stop to have a proximal-distal thickness across it that is slightly greater (0.1 to 1.0 mm) than the width of the groove 118 in which the stop is disposed. An advantage of this structure of the present invention is that the stop is compressed when the stop 146 is disposed in the groove 118. This enhances the fluid blocking capability of the stop 146. In some embodiments of this variation of the present invention, only sections of the stop are formed of a compressible material. For example, a frame of flexible material may be present around the portion of the stop 146 that defines the opening 148. This provides the desired seal while minimizing the frictional resistance exerted by the compressible material to the manual displacement of the valve 124 or 188.

[0091] When the valve 188 is arranged to direct fluid flow through the collection tray, other components other than the disclosed protrusion 190 may be provided for removal of the locking tray 160. For example, in certain variations of the invention, these components may be arranged so that when the collection tray is positioned in a complementary void located within the body of the box, the front panel is recessed inwardly relative to the surface through which the tray is inserted and removed. In these variations of the invention, the locking component may be a member that extends through a cutout in the box body in front of the collection tray.

[0092] In certain variations of the invention, the cassette and collection tray are provided with complementary features to ensure that when tray 160 is positioned in an associated void 92, the tray is in the correct orientation in the void.

[0093] Furthermore, it may be desirable to provide the disc with a surface on which information can be written. This would make it possible to write data relating to the sample trapped in the disc.

[0094] Therefore, it is an object of the appended claims to cover all such modifications and variations as come within the true spirit and scope of the invention.

Claims

1. A manifold for capturing a tissue sample extracted under suction, the manifold comprising: a housing defining an outlet opening; a head coupled to the housing and defining a void; a valve movably mounted to the head and including a fitting configured to receive a suction line; a collection tray configured to be removably positioned within the void, the collection tray comprising: a front panel shaped so that when the collection tray is positioned in the void, the front panel rests against a surface defining an opening of the void; a base plate including a proximal section and a distal section, the proximal section being arranged in a plane, the distal section extending distally from a distal end of the proximal section and sloping upward from the proximal section, and the front panel extending upward from the distal end of the distal section; an end plate extending upwardly from a proximal end of the proximal section; Opposing side panels extending upwardly from opposite sides of the base panel; and an aperture defined in the substrate and sized to allow fluid flow and capture the tissue sample within the collection tray, wherein the manifold is configured to receive input from a user to be actuated between a first sample collection configuration and a second configuration by rotating the valve relative to the head, wherein the first sample collection configuration establishes a first suction path from the suction line through the fitting, the first suction path being further directed through the aperture of the collection tray to capture the tissue sample, and wherein the second configuration establishes a second suction path from the suction line through the fitting, the second suction path not being further directed through the aperture of the collection tray.

2. The manifold according to claim 1, wherein: The manifold also includes a protrusion extending outwardly from an outer surface of the front panel, the protrusion including at least two panels.

3. The manifold of claim 1, wherein: The manifold also includes a web extending from a lower surface of the distal section of the base plate.

4. The manifold of claim 3, wherein: The aperture defined by the base plate is positioned between the webs.

5. The manifold according to any one of claims 1 to 3, wherein: The end plate extends vertically upward from the proximal end of the proximal section.

6. The manifold according to any one of claims 1 to 3, wherein: The manifold also includes additional apertures defined within the end plates.

7. The manifold according to any one of claims 1 to 3, wherein: The collecting tray is formed from a single piece of resilient material.

8. A manifold for capturing a tissue sample aspirated under suction, the manifold comprising: a housing defining an outlet opening; a head coupled to the housing and including a central surface recessed relative to opposing perimeter surfaces to collectively define at least a portion of a void having an opening; and a valve movably mounted to the head and including a fitting configured to receive a suction line; a collection tray configured to be removably positioned within the void, the collection tray comprising: Front panel; a base plate coupled to the front panel and including a proximal section and a distal section, the proximal section being arranged in a plane, the distal section extending distally from a distal end of the proximal section and tilted upward from the proximal section, and the front panel extending upward from the distal end of the distal section; an end plate coupled to the base plate; opposing side panels coupled to the base panel; an aperture defined in the substrate and sized to allow fluid flow and capture the tissue sample within the collection tray; and a web extending from a lower surface of the base, the web being configured to rest on the opposing perimeter surface when the collection tray is positioned in the void, wherein the manifold is configured to receive input from a user to be actuated between a first sample collection configuration and a second configuration by rotating the valve relative to the head, wherein a first suction path is established from the suction line through the fitting, the first suction path being further directed through the aperture of the collection tray to capture the tissue sample, and wherein a second suction path is established from the suction line through the fitting, the second suction path not being further directed through the aperture of the collection tray.

9. The manifold of claim 8, wherein: The front panel of the collection tray is shaped such that when the collection tray is positioned in the void, the front panel rests against a surface defining the opening of the void.

10. A manifold according to any one of claims 8 and 9, wherein A proximal end of the void is defined by a wall located within the head.

11. The manifold according to any one of claims 8 and 9, wherein: The head also includes at least a portion of a top surface extending above the void, the portion of the top surface being transparent.

12. The manifold according to any one of claims 8 and 9, wherein The head includes a magnifying portion positioned to magnify a view of the tissue sample within the collection tray disposed within the void.

13. The manifold of claim 12, wherein: The enlarging portion is a dome portion formed of a transparent material.

14. A manifold for capturing a tissue sample drawn through an aspiration line under suction, the manifold comprising: a housing defining an outlet opening; a head coupled to the housing and defining a void; a valve movably mounted to the head and including a fitting configured to receive the suction line; and a collection tray configured to be removably positioned within the void, the collection tray comprising: Front panel; a base plate coupled to the front panel and including a proximal section and a distal section, the proximal section being arranged in a plane, the distal section extending distally from a distal end of the proximal section and sloping upward from the proximal section, and the front panel extending upward from the distal end of the distal section; an end plate coupled to the base plate; opposing side panels coupled to the base panel; and an aperture defined in the substrate and sized to allow fluid flow and capture the tissue sample within the collection tray, wherein the manifold is configured to receive input from a user to be actuated between a sample collection configuration and a second configuration by rotating the valve relative to the head, wherein a first suction path is established from the suction line through the accessory, the first suction path being further directed through the pores of the collection tray to capture the tissue, and wherein a second suction path is established from the suction line through the accessory, the second suction path not being further directed through the pores of the collection tray.

15. The manifold of claim 14, wherein: In the second configuration, the first suction path is interrupted.

16. A manifold according to any one of claims 14 and 15, wherein The head includes a central surface recessed relative to an opposing peripheral surface to define the void, and the collection tray further includes a web extending from a lower surface of the base, the web being configured to rest on the opposing peripheral surface when the collection tray is positioned in the void.

17. A manifold according to any one of claims 14 and 15, wherein: The head also includes a top surface extending above the void, a portion of the top surface being transparent and configured to allow viewing of objects within the collection tray in the sample collection configuration.

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