Specimen collection manifold for a medical waste collection system

Abstract

A specimen collection tray and manifold for collecting a tissue sample. The specimen collection tray is removably insertable into a sleeve of the manifold. The tray defines a sample collection cavity. A base of the tray further defines a pocket within the sample collection cavity, and at least a portion of pores or apertures are disposed within the pocket. Lateral sidewalls defining the pocket are positioned inwardly from the opposing sides of the tray. The tray further includes feet extending downwardly from the base. A distal portion of the feet may be thinner and / or wider than middle and distal portions of the feet so as to deflect inwardly upon engagement with a distal opening of the sleeve. A chamfer of the distal portion may facilitate the inward deflection. Proximal ends of the feet the terminate on opposing sides of the apertures of the pocket.

Description

SPECIMEN COLLECTION MANIFOLD FOR A MEDICAL WASTE COLLECTION SYSTEMCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and all the benefits of United States Provisional Patent Application No. 63 / 719,034, filed November 11, 2024, the entire contents of which are being hereby incorporated by reference.BACKGROUND

[0002] Certain surgical procedures include the removal of a tissue specimen for evaluation. For example, a polypectomy involves removal of a polyp from within the patient, such as the colon or the endometrial tissue that lines the uterus. Often, the polyp is aspirated with a suction tube, collected, then transferred to a formalin jar. The collection and retrieval of the polyp is an area of particular interest and development. For example, commonly owned International Patent Publication No. WO 2013 / 090579, published June 20, 2013, hereby incorporated by reference, discloses an embodiment of a cassette for use with the medical waste collection system in which a tray is removably positionable within an accessory sleeve of the cassette for collecting the tissue sample.

[0003] Because the tray may be removed from the accessory sleeve while the vacuum is being drawn therethrough, there have been instances in which the tissue sample is compromised by being ejected from the catch tray. The manifold disclosed in commonly owned International Patent Publication No. WO 2019 / 222655, published November 22, 2019, hereby incorporated by reference, provides for, among other advantageous features, a bleed configuration in which a suction path is generated below the catch tray prior to and / or during removal of the catch tray from the sleeve. Even further improvements are disclosed in commonly owned International Patent Publication No. WO 2021 / 101731, published May 27, 2027, hereby incorporated by reference, wherein ribs define pockets within the catch tray to provide low pressure regions of air as the tray is removed from within the sleeve.

[0004] There remains a need in the art for continued improvements to preserve the integrity of the collected tissue sample, and facilitate ease of retrieval and transfer. Additional advantages of the present disclosure will be readily appreciated from the description below and accompanying drawings.SUMMARY

[0005] The present disclosure is directed to a specimen collection tray and a manifold for collecting a tissue sample with a medical waste collection system. In certain implementations, a base of the tray defines a pocket within a sample collection cavity, and at least a portion of pores or apertures are disposed within the pocket. Lateral sidewalls defining the pocket may be positioned inwardly from the opposing sides of the specimen collection tray. A proximal side of the tray further defines the pocket at an angled interface. The tray further includes feet extending downwardly from the base. A distal portion of the feet may be thinner and / or wider than middle and distal portions of the feet so as to deflect inwardly upon engagement with a distal opening of the sleeve. A chamfer of the distal portion may facilitate the inward deflection. Proximal ends of the feet the terminate on opposing sides of the apertures of the pocket.

[0006] In certain implementations, a sleeve of the manifold may include plateaus defining a trough therebetween, and a rib extending upwardly from the lower barrier of the trough to support the base of a specimen collection tray. The rib may be oriented longitudinally between the plateaus. The rib may extend above a channel that opens into the sleeve. An inlet fitting may open into the sleeve at a position distal to the channel. A distal side of the tray may be ramped upwardly towards a distal handle. The inlet fitting may be positioned above the ramped distal side with the tray removably disposed within the sleeve. The base may define a proximal pocket with apertures disposed within the proximal pocket. A proximal side of the tray may be oriented relative to the base at approximately 90 degrees.

[0007] According to a first aspect of the present disclosure, a manifold for collecting a tissue sample is provided. A specimen collection tray includes a distal handle, a base defining apertures, and opposing sides extending upwardly from the base to define a sample collection cavity. The base of the specimen collection tray defines a pocket. At least a portion of the apertures are disposed within the pocket. The manifold includes a housing having a sleeve defining a distal opening configured to removably receive insertion of the specimen collection tray in a proximal direction. The sleeve comprises an inlet fitting configured to be removably coupled with a suction tube.

[0008] In certain implementations, the specimen collection tray includes lateral sidewalls extending downwardly from the base, and a distal wall extending downwardly from thebase. The pocket is a proximal pocket defined by the lateral sidewalls, the distal wall, and a proximal side of the specimen collection tray. The proximal side may be angled relative to a bottom of the proximal pocket. The lateral sidewalls may be positioned inwardly from the opposing sides of the specimen collection tray. The specimen collection tray may include feet extending downwardly from the base. The feet may be spaced inwardly from the opposing sides. Each of the feet may include a proximal portion, a middle portion, and a distal portion. The distal portion may be thinner and / or wider than the middle and distal portions such that the distal portions deflect inwardly upon engagement with the distal opening of the sleeve. A proximal end of the distal portions of the feet may include a chamfer configured to engage the distal opening and cause the inward deflection. Each of the feet may include a proximal end extending inwardly from the proximal portion. The proximal ends terminate on opposing sides of the apertures of the pocket. A thickness of each the proximal ends narrow so as to provide, together with an arcuate contour to the pocket, a generally flat profile to an underside of the specimen collection tray associated with the pocket.

[0009] In certain implementations, a distal side of the specimen collection tray is ramped upwardly towards the distal handle. The inlet fitting may open into the sleeve at a position distal to the pocket of the specimen collection tray. The housing may define a manifold volume, and the sleeve may further defines a channel providing fluid communication between the sleeve and the manifold volume. The pocket may be positioned above a distal portion of the channel, and optionally, positioned proximal to a distal end of the channel.

[0010] According to another aspect of the present disclosure, the sleeve includes an upper barrier comprising the inlet fitting configured to be removably coupled with a suction tube, and the opposing sides include plateaus defining a trough therebetween. The plateaus are configured to support the specimen collection tray for the base to be spaced apart from a lower barrier of the trough. A rib within the sleeve extends upwardly from the lower barrier of the trough and configured to support the base of the specimen collection tray.

[0011] In certain implementations, the rib is oriented longitudinally between the plateaus. The rib may be laterally spaced equidistant between the plateaus. The base of the specimen collection tray may be arcuate between the sides, and a height of the rib is sized for an upper edge of the rib to be abutting or positioned adjacent to the arcuate base. A proximal end of the rib may be coupled to a proximal barrier of the sleeve. A distal end of the rib may be coupledto the lower barrier at a position distal to the distal portion of the channel. The distal end of the rib may be ramped. The housing defines a manifold volume, and the sleeve may define at channel providing fluid communication between the trough and the manifold volume. The rib may extend above a distal portion of the channel that opens into the sleeve. The inlet fitting may define a bore opening into the sleeve at a position distal to a distal end of the channel. The rib may not extend to the distal opening of the sleeve.

[0012] In certain implementations, the distal side of the specimen collection tray is ramped upwardly towards the distal handle so as to promote laminar flow of fluid being drawn through the inlet fitting and into the sample collection cavity. The ramped distal side may be arcuate. The inlet fitting may be positioned above the ramped distal side with the specimen collection tray removably disposed within the sleeve. An angle between an axis defined by the inlet fitting and the ramped distal side may be obtuse. The ramped distal side of the specimen collection tray may define additional apertures or pores. The proximal pocket may be configured to engage the rib with the specimen collection tray removably disposed within the sleeve.BRIEF DESCRIPTION OF THE DRAWINGS

[0013] FIG. 1 depicts a specimen collection manifold configured to be inserted into a medical waste collection system.

[0014] FIG. 2 is an exploded view of the manifold. A first implementation of the specimen collection tray is configured to be removably inserted into a sleeve of a head portion of the manifold.

[0015] FIG. 3 is a sectional view of the head portion of the manifold of FIG. 2 taken along section lines 3-3.

[0016] FIG. 4 is an axial elevation view of the head portion of the manifold.

[0017] FIG. 5 is the sectional view of FIG. 3 with the specimen collection tray positioned within the sleeve.

[0018] FIG. 6 is a partial perspective view of a prior art specimen collection tray positioned with a prior art housing of the manifold. A turbulent flow path is represented.

[0019] FIG. 7 is a partial perspective view of a second implementation of the specimen collection tray removably inserted into the sleeve. An improved flow path through the sleeve is represented.

[0020] FIG. 8 is a perspective view of the second implementation of the specimen collection tray.

[0021] FIG. 9 is a plan view of the second implementation of the specimen collection tray.

[0022] FIG. 10 is an elevation view of the second implementation of the specimen collection tray.

[0023] FIG. 11 is a perspective view of a third implementation of the specimen collection tray.

[0024] FIG. 12 is a plan view of the third implementation of the specimen collection tray.

[0025] FIG. 13 is an elevation view of the third implementation of the specimen collection tray.

[0026] FIG. 14 is a perspective view of a fourth implementation of the specimen collection tray.

[0027] FIG. 15 is an elevation view of the fourth implementation of the specimen collection tray.

[0028] FIG. 16 is a bottom plan view of the fourth implementation of the specimen collection tray.

[0029] FIG. 17 is an exploded perspective view of another implementation of the housing of the manifold with multiple specimen collection trays.DETAILED DESCRIPTION

[0030] FIG. 1 depicts a medical waste collection system 20 for collecting medical waste and tissue samples under the influence of suction. One suitable medical waste collection system is sold under the tradename Neptune by Stryker Corporation (Kalamazoo, Mich.), and disclosed in commonly-owned International Patent Publication No. WO 2007 / 070570, published June 21, 2007, International Patent Publication No. WO 2017 / 112684, published June 29, 2017, and International Patent Publication No. WO 2020 / 210763, published October 15, 2020, the entire contents of each being hereby incorporated by reference. The medical waste collection system 20 may be a cart 22 supporting a waste container 24 in fluid communication with a vacuum source (not shown). A manifold receiver 26 is configured to removably receive a manifold 30, which isthen coupled to one or more suction tubes (not shown). A suction instrument is coupled to one of the suction tubes, and vacuum from the vacuum source aspirates medical waste from a surgical site, through the suction tube and the manifold 30 to be collected in the waste container 24. The implementations of the manifold 30 to be described are configured to collect a tissue sample as the medical waste is being drawn therethrough under the influence of vacuum.

[0031] Referring to FIG. 2, the manifold 30 includes a housing 32 adapted to be removably engaged with the manifold receiver 26. The housing 32 may include a trunk 34, and a head portion 36 coupled to the trunk 34. The trunk 34 may define a manifold volume, and an outlet opening 38 disposed at a proximal end of a first leg 40. A seal (not shown) may be coupled to the first leg 40 and sized to cover the outlet opening 38. The trunk 34 may include features configured to engage complementary features of the manifold receiver 26 of the medical waste collection system 20, for example, as disclosed in the aforementioned United States Patent No. 10,471,188 and further disclosed in International Publication No. WO 2022 / 103832, published May 19, 2022, the entire of which are hereby incorporated by reference. The features may include a second leg 42 spaced apart from the first leg 40 by a void, one or more arms 44 at least partially disposed on the first leg 40, one or more lock elements 46, a spine 48, and one or more catches 50 disposed on the second leg 42. A filter element 52 may be disposed within the trunk 34. The filter element 52 may be basket-shaped and includes porous features such as apertures, holes, slots, or the like, configured to capture or collect the semisolid or solid waste material entrained within the liquid waste material being drawn through the manifold 30.

[0032] In certain implementations, the head portion 36 and the trunk 34 are removably coupled to one another. With continued reference to FIG. 2, the head portion 36 includes at least one or more cap couplers 54 configured to be removably coupled with one or more trunk couplers 56 of the trunk 34. The complementary couplers 54, 56 may be formed as keys and keyways including geometries configured to provide for rotational inputs to reversibly decouple and couple the head portion 36 with the trunk 34, for example, as disclosed in the aforementioned International Patent Publication No. WO 2019 / 222655. In doing so, the filter element 52 is accessed as a secondary or backup means of collecting and retrieving the tissue sample. In alternative variant, the head portion 36 and the trunk 34 are rigidly connected through a suitable joining process, for example, spin welding, adhesives, mechanical fastening, and the like.

[0033] The head portion 36 includes a head faceplate 58 sized to a distal opening of the trunk 34. The cap couplers 54 may extend proximally from the head faceplate 58. The head portion 36 of the housing 32 further includes a sleeve 60 coupled to and positioned distal to the head faceplate 58. The sleeve 60 includes an upper barrier 62, opposing sides 64, and a lower barrier 74 oriented in the proximal-to-distal direction such that the sleeve 60 is generally boxshaped. The upper barrier 62 includes at least one inlet fitting 66 configured to be removably coupled with a suction tube. With further reference to FIG. 3, the inlet fitting 66 defines a bore in fluid communication with an interior of the sleeve 60. The illustrated implementation shows the inlet fitting 66 extending upwardly from the upper barrier 62. In manners to be described, the sleeve 60 is configured to removably receive a specimen collection tray 100 for collection of the tissue sample.

[0034] In certain implementations, the head portion 36 includes a second inlet fitting 68 configured to receive a suction tube. The second inlet fitting 68 extends distally from the head faceplate 58 and defines a bore extending through the head faceplate 58 and opening into the trunk 34. In other words, the second inlet fitting 68 may bypass the sleeve 60 for the medical waste to directly enter the manifold volume without encountering the specimen collection tray 100. The arrangement provides for selective or concurrent use of two suction tubes - a first suction tube coupled to the first inlet fitting 66 to be used for collection of the tissue sample, and / or a second suction tube coupled to the second inlet fitting 68 for suctioning of other fluids. Should the second inlet fitting 68 not be needed, the head portion 36 includes a tethered cap 70 configured to be secured to the second inlet fitting 68 to preserve the suction path through the manifold 30.

[0035] The sleeve 60 defines a distal opening 72 configured to removably receive insertion of the specimen collection tray 100 in the proximal direction (directional convention annotated in FIG. 2). With further reference to FIG. 4, the distal opening 72 and the sleeve 60 may be at least collectively defined by the upper barrier 62, the opposing sides 64, and the lower barrier 74. The sleeve 60 may be in fluid communication with the manifold volume of the trunk 34 through a channel 76. More particularly, a distal portion 78 of the channel 76 may be a cavity defined by the lower barrier 74 of the sleeve 60, and a proximal opening 81 of the channel 76 may extend through the head faceplate 58. A backflow prevention valve (not shown) may be coupled to the head portion 36 and include resilient flapper valves each sized to cover the proximal opening 81 the channel 76, and a proximal opening of the second inlet fitting 68.

[0036] Referring to FIG. 4, the opposing sides 64 of the sleeve 60 are formed with geometries or grooves 80 for slidably receiving an upper rail 65 of the specimen collection tray 100. The grooves 80 facilitate properly orienting and locating the specimen collection tray 100 within the sleeve 60. Further, the opposing sides 64 may include plateaus 82 defining a trough 84 therebetween. The plateaus 82 (and the grooves 80) are configured to support the specimen collection tray 100 within the sleeve 60.

[0037] Referring again to FIG. 2, the specimen collection tray 100 includes a distal handle 102, a base 104 defining apertures 106, and sides 108 extending upwardly from the base 104 to define a sample collection cavity 110. A proximal side 112 extends upwardly from the base 104 between the sides 108. Additional apertures 106 may be defined in the proximal side 112. A distal side 114 is angled or ramped upwardly from the base 104 towards the distal handle 102, which will be discussed in more detail. The distal side 114 may define additional apertures 106. The specimen collection tray 100 may be a monolithic structure formed from a suitable manufacturing process, for example, injection molding of a polymeric material.

[0038] The base 104 and the sides 108 extend proximally from the distal handle 102. The distal handle 102 may include an upper control member 116 and a lower control member 118 spaced apart from the upper control member 116. The distal handle 102 includes a sealing member 120 sized and shaped to be arranged be in sealing engagement with the distal opening 72 with the specimen collection tray 100 disposed within the sleeve 60. As best shown in FIG. 5, a proximal portion of the sealing member 120 is sized slightly smaller than the distal opening 72, and a flange portion of the sealing member 120 is sized slightly larger than the distal opening 72. The sealing member 120 includes a resiliently flexible portion, for example, a living hinge 122, configured to resiliently and pivotably move at a lower portion of the sealing member 120 away from the lower barrier 74 defining the distal opening 72 to provide a second suction path. The upper and lower control members 116, 118 may be tabs or flanges extending distally from the sealing member 120 and disposed on opposing sides of the living hinge 122.

[0039] With the specimen collection tray 100 disposed within the sleeve 60, the plateaus 82 support the base 104 of the specimen collection tray 100. In particular, feet 124 of the specimen collection tray 100 are configured to rest upon or otherwise be supported by the plateaus 82 such that the base is spaced apart from the lower barrier 74 defining the trough 84. Should it be desired to temporarily break suction or remove the specimen collection tray 100 from the sleeve60, the user may pinch the upper and lower control members 116, 1 18. Owing to the structure of the distal handle 102 and the presence of the living hinge 122, the lower control member 118 pivots towards the upper control member 116, thereby breaking the sealed engagement between the sealing member 120 and the lower barrier 74. A second suction path is generated below the specimen collection tray 100 (z.e., within the trough 84 between the base 104 and the lower barrier 74), thereby reducing the likelihood that the first suction path passing through the first inlet fitting 66, across and through the sample collection cavity 110, and though the channel 76 will cause disruption to the tissue sample collected therein. The user may then remove the specimen collection tray 100 from the sleeve 60. Since the space beneath the base 104 is larger than a gap between an upper edge of the sample collection cavity 110, nearly an entirety of the second suction path is below the specimen collection tray 100 as is removed from the sleeve 60. Further description regarding the second suction path is disclosed in the aformentioned International Patent Publication No. WO 2019 / 222655. Should the specimen collection tray 100 not be needed, the head portion 36 includes a tethered cover 86 sized and configured to be secured to cover the distal opening 72 of the sleeve 60.

[0040] It has been observed that during removal of the specimen collection tray 100 from the sleeve 60, a user may inadvertently “tip” the specimen collection tray 100 (e.g., upwardly or downwardly), particularly as the specimen collection tray 100 becomes less constrained by the sleeve 60. Therefore, the manifold 30 of the present disclosure addresses such instances by including at least one rib 130 disposed within the sleeve 60. In particular, the manifold 30 includes the rib 130 extending upwardly from the lower barrier 74 of the trough 84. The rib 130 is configured to support the base 104 of the specimen collection tray 100.

[0041] With reference to FIGS. 3-5, the rib 130 is oriented longitudinally between the plateaus 82. The illustrated implementation shows the rib 130 laterally spaced equidistant between the plateaus 82. Other suitable arrangements are contemplated, and more ribs may be provided. The rib 130 may be a continuous fin, as depicted, or may a series of shorter protrusions arranged and configured to provide the functional effects disclosed herein.

[0042] The rib 130 extends distally within the sleeve 60 to a position suitably near the distal opening 72 such that tipping with removal of the specimen collection tray 100 is limited or prevented. In one example, a distal end 132 of the rib 130 is positioned between and distal to a distal portion 78 of the channel 76, and proximal to the distal opening 72. The rib 130 may notextend to the distal opening 72 of the sleeve 60. The distal end 132 of the rib 130 may be ramped, for example, to engage and guide the proximal side 112 of the specimen collection tray 100 into the sleeve 60. A proximal end 134 of the rib 130 may be coupled to a proximal barrier 126 of the sleeve 60, as best shown in FIGS. 3 and 5. Therefore, in certain implementations in which the distal portion 78 of the channel 76 is a cavity within the lower barrier 74, the rib 130 extends above the channel 76.

[0043] A height of the rib 130 may be of suitable height to situated adjacent to or abutting the base 104 of the specimen collection tray 100. With reference to FIGS. 4 and 5, the base 104 of the specimen collection tray 100 has an arcuate profile; i.e., concave between the sides 108. Likewise, the plateaus 82 are arcuate and complementarily contoured to the arcuate profile of the base 104. With the feet 124 of the specimen collection tray 100 supported on the plateaus 82, the height of the rib 130 is sized for an upper edge 136 to be adjacent to or abutting the base 104.

[0044] The rib 130 also provides for improved suction path through the sample collection cavity 110. FIG. 6 depicts a prior art manifold and tray (T) in which a partition (P) exposes only a small distal portion of the channel, and at an axial location distal to the inlet fitting (IF) where the suction path enters the manifold. As a result, the suction path is highly turbulent flow (HTF), which itself may compromise the tissue specimen. Further, the suction path may result in the tissue specimen (TS) resting at a more distal position within the tray, which could result in an increased likelihood of ejection with the initial removal of the tray. As appreciated from the sleeve 60 of the present disclosure depicted in FIG. 7, an appreciable length of the channel 76 is exposed to the sleeve 60 (on each side of the rib 130), thereby providing an improved flow path (IFP) through the sample collection cavity 110.

[0045] FIG. 7 further shows the inlet fitting 66 being distal to the channel 76. With further reference to FIGS. 3 and 5. the axial location 67 of the inlet fitting 66 is distal to an axial location 77 of the channel 76. As a result, the improved flow path does not require the flow “double back,” unlike the turbulent flow path about the partition of the prior art manifold of FIG. 6. Moreover, the improved flow path generally moves proximally within the sleeve 60 towards the channel 76, thereby urging the tissue sample (TS) more proximally within the sample collection cavity 110 and decreasing the likelihood of ejection of the tissue sample with the initial removal of the specimen collection tray 100.

[0046] Even further, the more distal location of the inlet fitting 66 improves visualization of the tissue sample within the specimen collection tray 100. The medical waste collection system 20 may include a light 28 positioned adjacent to and above the manifold receiver 26, as shown in FIG. 1. The light 28 is selectively operable through a user input to a user interface. The head portion 36 remains external to the manifold receiver 26 with the trunk 34 disposed therein, and the light 28 is directed downwardly towards the head portion 36. The upper barrier 62 the sleeve 60 may be transparent, and therefore the specimen collection tray 100 is visible therethrough. With improved flow path, the tissue sample is urged towards the light 28, and the inlet fitting 66 may not obstruct the light path between the light 28 and the upper barrier 62.

[0047] As mentioned, the distal side 114 is angled or ramped upwardly from the base 104 towards the distal handle 102. With continued reference to FIG. 7, the axial location 67 of the inlet fitting 66 may be positioned above the ramped distal side 114. Among other advantages, the arrangement may promote laminar flow of the suction path being drawn through the inlet fitting 66 and into the sample collection cavity 110. The ramped distal side 114 may be flat or arcuate. An angle, a, between the base 104 and the ramped distal side 114 (bolded lines) is obtuse, thereby providing a more gradual transition to the direction of flow. Further, the ramped distal side 114 may be positioned distal to the distal portion 78 of the channel 76, and may further be substantially coplanar with a contouring of the distal end 79 of the channel 76, as shown in FIG. 7.

[0048] In certain implementations, the specimen collection tray 100 may include a proximal pocket 140 recess disposed within the sample collection cavity 110. Referring now to FIGS. 8-10, the proximal pocket 140 may be positioned distal to the distal portion 78 of the channel 76. In one example, the proximal pocket 140 is bounded by the base 104 and the proximal side 112. Alternatively, the proximal pocket 140 is bounded by only the base 104 and spaced apart from the proximal side 112. Contours and dimensions of the proximal pocket 140 may vary but selected to provide a likely location at which the tissue sample will remain situated within the sample collection cavity 110. Optionally, additional apertures 106 may be defined with the proximal pocket 140.

[0049] As best shown in the elevation view of FIG. 10, an implementation of the manifold 30 includes the proximal pocket 140 extending downwardly from the base 104 with the feet 124 of the specimen collection tray 100 also extending downwardly from the base 104 by a width to be generally aligned with the proximal pocket 140. The feet 124 may include a distalportion 125 that is wider than a middle portion 127, and the middle portion 127 may be axially spaced from the proximal pocket 140. The distal portion 125 may contact the plateaus 82 in manners to be further described, whereas the middle portion 127 and the axial spacing are configured to permit flow therethrough. Among other advantages, the feet 124 may be designed to impart the desired flow characteristics of the second suction path.

[0050] FIGS. 11-13 show another variant of the specimen collection tray 100 in which the proximal side 112 is oriented more upright relative to the base 104. For example, an angle, p, between the proximal side 112 and the base 104may be approximately 90 degrees. The upright proximal side 112 may be provided on other implementations of the specimen collection tray 100, including those with or without the proximal pocket 140. Further, in certain implementations, the apertures 106 defined by the base 104 may be arranged in groupings 146 spaced spart from one another, as best shown in the plan views of FIGS. 9 and 12. The groupings 146 may be laterally spaced and axial spaced in any suitable arrangement to achieve the desired flow characteristics through the sample collection cavity 110.

[0051] Referring now to FIGS. 14-16, another implementation variant of the specimen collection tray 100 is depicted with like numerals indicating like components, and in some respects, has features combined from the previously described implementations with additional features to be described. The specimen collection tray 100 includes the distal handle 102, the base 104, and the sides 108 extending upwardly from the base 104 to define the sample collection cavity 110. The distal handle 102 may include the upper control member 116, the lower control member 118, and the sealing member 120. The distal side 114 is angled or ramped upwardly from the base 104 towards the distal handle 102. The distal side 114 may define additional apertures 106. The specimen collection tray 100 includes the proximal pocket 140 to be described in further detail. A strut 135 may rigidly extend between the sealing member 120 and an underside of the ramped distal side 114.

[0052] The feet 124 of the specimen collection tray 100 may be configured to rest upon or otherwise be supported by the plateaus 82 such that the base is spaced apart from the lower barrier 74 defining the trough 84. The feet 124 extend downwardly from the base 104 and spaced inwardly from the sides 108. As mentioned, the feet 124 may include a distal portion 125, and a middle portion 127 positioned proximal to the distal portion 125. The distal portion 125 may be wider than the middle portion 127. The present implementation of the feet 124 further include aproximal portion 129 positioned proximal to the middle portion 127, and, optionally, a proximal end 131 that extends inwardly (z.e., towards the center of the specimen collection tray 100) relative to the proximal portion 129.

[0053] As best shown in FIG. 16, the middle portion 127 is thinner than the proximal portion 129, and the distal portion 125 is thinner than the middle portion 127. With the specimen collection tray 100 formed from a polymeric material, the distal portion 125 is sufficiently thin so as to be laterally flexible or deflectable. Furthermore, the width of the distal portion 125 (i.e., the distance by which the distal portion 125 extends downwardly from the base 104) is large enough to so as to contact the distal opening 72 of the sleeve 60 as the specimen collection tray 100 is inserted into the sleeve 60. In other words, with the upper rails 65 being slidably inserted into the grooves 80 of the sleeve 60, the proximal and middle portions 125, 127 of the feet 124 - being narrower than the distal portion 125 - do not contact the distal opening 72. The distal portion 125, however, engages a section of the distal opening 72 associated with the plateaus 82. Owing to the lateral flexibility of the distal portions 125 and the shape of the section, the distal portions 125 deflect inwardly and provide a fluid seal against the plateaus 82 within the sleeve 60. Among other advantages, the fluid seal advantageously prevents the suction path from passing underneath the specimen collection tray 100 until the specimen collection tray 100 is sufficiently removed from the sleeve 60. To facilitate the distal portions 125 of the deflecting inwardly upon engaging the distal opening 72, a proximal end of the distal portion 125 may include a chamfer, as best shown in FIG. 15.

[0054] Referring now to FIG. 14, the proximal pocket 140 is defined between lateral sidewalls 141, a distal barrier 145, and the proximal side 112 of the specimen collection tray 100. The lateral sidewalls 141 may be spaced inwardly from the sides 108 of the specimen collection tray 100. Further, the proximal pocket 140 meets the proximal side 112 at an edge or boundary 143 that provides for ease with urging the specimen along the proximal side 112 from within the proximal pocket 140. The edge or boundary 143 is defines an angle but is otherwise a smooth transition, which is in contrast with, for example, the implementation of FIG. 8 in which there is a step-like feature that could frustrate specimen transfer. In other words, an exemplary workflow includes the user removing the specimen collection tray 100 from the sleeve 60. The method optionally includes the user using a device (e.g., a cotton swab) to urge the tissue specimen along the base 104 to within the proximal pocket 140. Thereafter, with the specimen resting within theproximal pocket 140, user may tip the specimen collection tray 100 in one hand while using the device to further urge the tissue specimen from within the proximal pocket 140, along the proximal side 112, and into the formalin jar. Alternatively, the user may dip a portion of the specimen collection tray 100, in particular the proximal pocket 140, into the formalin jar, wherein the fluid in the formalin jar effectuates the transfer of the tissue specimen from the proximal pocket 140 to the jar along the proximal side 112. The user may reinsert the specimen collection tray 100 into the sleeve 60 to obtain additional tissue samples, if desired. A step-like feature at the boundary would otherwise make urging the tissue sample with the device cumbersome.

[0055] The present implementation also includes the proximal ends 131 of the feet 124 extending inwardly from the proximal portion 129. FIG. 15 shows a thickness of the proximal ends 131 tapering, and FIG. 16 shows the proximal ends 131 terminating on opposing sides of the apertures 106 associated with the proximal pocket 140. Owing to the arcuate contours of the base 104 and the proximal pocket 140, the tapering and positioning of the proximal ends 131 provides a generally flat profile to the underside of the proximal pocket 140 (other than a slight gap between the proximal ends 131). The proximal ends 131 are configured to prevent or limit tipping or inadvertent jostling during removal of the specimen collection tray 100 from the sleeve 60. In other words, as the user removes the specimen collection tray 100 from the sleeve 60, the proximal ends 131 “ride along” the plateaus 82 while the upper rails 65 slide within the grooves 80. The constraints from above and below cooperate to prevent the tipping of the specimen collection tray 100 until it is at least nearly fully removed from the sleeve 60.

[0056] Referring to FIG. 17, another implementation of the head portion 150 is shown in which multiple specimen collection trays 152 may be provided. The head portion 150 may include a sleeve 154 defining a cavity 156 that is cylindrical in shape. A bore 158 may extend through the head faceplate 58 to provide fluid communication between the cavity 156 and the manifold volume (not shown). The sleeve 154 may include a spindle 160 disposed centrally within the cavity 156. A plurality of alignment members 162 may be disposed on the spindle 160 and / or an inner surface of the sleeve 154. The alignment members facilitate removable positioning of the multiple specimen collection trays 152 within the cavity 156. All or less than all of the cavity 156 may accommodate one of the specimen collection trays 152.

[0057] A cap 164 may be rotatably coupled to the sleeve 154. The cap 164 may include the inlet fitting 66 configured to receive the suction tube. The cap 164 may be rotated about thespindle 160 to align the inlet fitting 66 with one of the specimen collection trays 152 (or void therebetween). A tab 168 may be coupled to the cap 164 to facilitate removal of the cap 164 and retrieval of the tissue sample collected within one or more of the specimen collection trays 152.

[0058] The foregoing description is not intended to be exhaustive or limit the invention to any particular form. The terminology which has been used is intended to be in the nature of words of description rather than of limitation. Many modifications and variations are possible in light of the above teachings and the invention may be practiced otherwise than as specifically described.

[0059] Further inventive aspects of the present disclosure are included the following exemplary clauses.

[0060] Clause 1 - A manifold for collecting a tissue sample, the manifold comprising: a specimen collection tray comprising a distal handle, a base defining apertures, and sides extending upwardly from the base to define a sample collection cavity; a housing comprising a sleeve defining a distal opening configured to removably receive insertion of the specimen collection tray in a proximal direction, wherein the sleeve comprises: an upper barrier comprising an inlet fitting configured to be removably coupled with a suction tube; opposing sides comprising plateaus defining a trough therebetween, wherein the plateaus are configured to support the specimen collection tray for the base to be spaced apart from a lower barrier of the trough; and a rib extending upwardly from the lower barrier of the trough and configured to support the base of the specimen collection tray.

[0061] Clause 2 - The manifold of clause 1, wherein the rib is oriented longitudinally between the plateaus.

[0062] Clause 3 - The manifold of clause 2, wherein the rib is laterally spaced equidistant between the plateaus.

[0063] Clause 4 - The manifold of any one of clauses 1-3, wherein the base of the specimen collection tray is arcuate between the sides, and wherein a height of the rib is sized for an upper edge of the rib to be abutting or positioned adjacent to the arcuate base.

[0064] Clause 5 - The manifold of any one of clauses 1-4, wherein the housing further defines a manifold volume, wherein the sleeve defines at channel providing fluid communication between the trough and the manifold volume, and wherein the rib extends above a distal portion of the channel that opens into the sleeve.

[0065] Clause 6 - The manifold of clause 5, wherein the inlet fitting defines a bore opening into the sleeve at a position distal to a distal end of the channel.

[0066] Claus 7 - The manifold of clause 6, wherein a proximal end of the rib is coupled to a proximal barrier of the sleeve.

[0067] Clause 8 - The manifold of clause 7, wherein a distal end of the rib is coupled to the lower barrier at a position distal to the distal portion of the channel.

[0068] Clause 9 - The manifold of any one of clauses 1-8, wherein a distal end of the rib is ramped.

[0069] Clause 10 - The manifold of any one of clauses 1-9, wherein the rib does not extend to the distal opening of the sleeve.

[0070] Clause 11 - The manifold of any one of clauses 1-10, wherein a distal side of the specimen collection tray is ramped upwardly towards the distal handle, and wherein the inlet fitting is positioned above the ramped distal side with the specimen collection tray removably disposed within the sleeve.

[0071] Clause 12 - The manifold of clause 11, wherein the ramped distal side of the specimen collection tray defines additional apertures.

[0072] Clause 13 - The manifold of any one of clauses 1-12, wherein the base of the specimen collection tray defines a proximal pocket, and wherein at least a portion of the apertures are disposed within the proximal pocket.

[0073] Clause 14 - The manifold of clause 13, wherein the proximal pocket is configured to engage the rib with the specimen collection tray removably disposed within the sleeve.

[0074] Clause 15 - The manifold of any one of clauses 1-14, wherein a proximal side of the specimen collection tray is oriented relative to the base at approximately 90 degrees.

[0075] Clause 16 - A manifold for collecting a tissue sample, the manifold comprising: a specimen collection tray comprising a distal handle, a base defining apertures, and sides extending upwardly from the base to define a sample collection cavity, wherein a distal side of the specimen collection tray is ramped upwardly towards the distal handle; and a housing comprising a sleeve defining a distal opening configured to removably receive insertion of the specimen collection tray in a proximal direction, wherein the sleeve comprises an upper barrier comprising an inlet fitting configured to be removably coupled with a suction tube, wherein the inlet fitting ispositioned above the ramped distal side with the specimen collection tray removably disposed within the sleeve.

[0076] Clause 17 - The manifold of clause 16, wherein the ramped distal side is arcuate so as to promote laminar flow of fluid being drawn through the inlet fitting and into the sample collection cavity.

[0077] Clause 18 - The manifold of clause 16 or 17, wherein an angle between an axis defined by the inlet fitting and the ramped distal side is obtuse.

[0078] Clause 19 - The manifold of any one of clauses 16-18, wherein the ramped distal side of the specimen collection tray defines additional apertures.

[0079] Clause 20 - The manifold of any one of clauses 16-19, wherein the housing defines a manifold volume and the sleeve further defines at channel providing fluid communication between the sleeve and the manifold volume, and wherein the ramped distal side of the specimen collection tray is positioned distal to a distal end of the channel.

[0080] Clause 21 - The manifold of clause 19, wherein the ramped distal side is substantially coplanar with the distal end of the channel.

[0081] Clause 22 - The manifold of any one of clauses 20 or 21, wherein the sleeve further comprises opposing sides comprising plateaus defining a trough therebetween, and wherein the channel opens into the trough.

[0082] Clause 23 - The manifold of clause 22, further comprising a rib disposed within the trough and configured to support the specimen collection tray.

[0083] Clause 24 - A manifold for collecting a tissue sample, the manifold comprising: a specimen collection tray comprising a distal handle, a base defining apertures, and sides extending upwardly from the base to define a sample collection cavity; and a housing defining a manifold volume, and comprising a sleeve defining a distal opening configured to removably receive insertion of the specimen collection tray in a proximal direction, wherein the sleeve comprises an upper barrier comprising an inlet fitting configured to be removably coupled with a suction tube, wherein the sleeve further defines at channel providing fluid communication between the sleeve and the manifold volume, and wherein the inlet fitting opens into the sleeve at a position distal to a distal portion of the channel.

[0084] Clause 25 - The manifold of clause 24, wherein the sleeve further comprises opposing sides comprising plateaus defining a trough therebetween, and wherein the distal portion of the channel opens into the trough.

[0085] Clause 26 - The manifold of clause 25, further comprising a rib disposed within the trough and configured to support the specimen collection tray.

[0086] Clause 27 - The specimen collection tray according to any one of claims 1-15.

Claims

CLAIMS1. A manifold for collecting a tissue sample, the manifold comprising: a specimen collection tray comprising a distal handle, a base defining apertures, and opposing sides extending upwardly from the base to define a sample collection cavity, wherein the base of the specimen collection tray defines a pocket, and wherein at least a portion of the apertures are disposed within the pocket; and a housing comprising a sleeve defining a distal opening configured to removably receive insertion of the specimen collection tray in a proximal direction, wherein the sleeve comprises an inlet fitting configured to be removably coupled with a suction tube.

2. The manifold of claim 1, wherein the specimen collection tray further comprises lateral sidewalls extending downwardly from the base, and a distal wall extending downwardly from the base, wherein the pocket is a proximal pocket defined by the lateral sidewalls, the distal wall, and a proximal side of the specimen collection tray.

3. The manifold of claim 2, wherein the proximal side is angled relative to a bottom of the proximal pocket.

4. The manifold of claim 2 or 3. wherein the lateral sidewalls are positioned inwardly from the opposing sides of the specimen collection tray.

5. The manifold of any one of claims 1-4, wherein the specimen collection tray further comprises feet extending downwardly from the base, wherein the feet are spaced inwardly from the opposing sides.

6. The manifold of claim 5, wherein each of the feet comprises a proximal portion, a middle portion, and a distal portion, wherein the distal portion is thinner than the middle and distal portions.

7. The manifold of claim 6, wherein the distal portion is wider than the middle and distal portions and configured to deflect inwardly upon engagement with the distal opening of the sleeve.

8. The manifold of claim 7, wherein a proximal end of the distal portions of the feet comprise a chamfer configured to engage the distal opening and cause the inward deflection.

9. The manifold of any one of claims 6-8, wherein each of the feet comprises a proximal end extending inwardly from the proximal portion, and wherein the proximal ends terminate on opposing sides of the apertures of the pocket.

10. The manifold of claim 9, wherein a thickness of each the proximal ends narrow so as to provide, together with an arcuate contour to the pocket, a generally flat profile to an underside of the specimen collection tray associated with the pocket.

11. The manifold of any one of claims 1-10, wherein a distal side of the specimen collection tray is ramped upwardly towards the distal handle.

12. The manifold of any one of claims 1-11, wherein the inlet fitting opens into the sleeve at a position distal to the pocket of the specimen collection tray.

13. The manifold of any one of claims 1-12, wherein the housing defines a manifold volume and the sleeve further defines a channel providing fluid communication between the sleeve and the manifold volume, and wherein the pocket is positioned above a distal portion of the channel.

14. The manifold of claim 13, wherein the pocket is positioned proximal to a distal end of the channel.

15. The manifold of any one of claims 1-13, wherein the apertures of the base are arranged in groupings spaced apart from one another, wherein a proximal one of the groupings of the aperture is disposed within the proximal pocket.

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