Manifolds and trays for collecting tissue samples
The tray with a seal member and basket features addresses inefficiencies in tissue sample collection by ensuring safe and continuous operation of the medical waste collection assembly, facilitating efficient sample retrieval.
Patent Information
- Application Number
- JP2022529409
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2020-04-10
- Filing Date
- 2020-11-06
- Publication Date
- 2025-09-09
- Estimated Expiration
- 2040-11-06
AI Technical Summary
Existing surgical procedures face challenges such as increased time, inconvenience, and potential exposure to hazardous medical waste during tissue sample collection, with an inability to efficiently collect multiple samples using medical waste collection assemblies.
A tray configured to collect tissue samples under vacuum, featuring a seal member and a basket with defined pore or hole features, ribs, and adjustable members to facilitate sealing and suction path management, allowing for efficient sample collection and retrieval without disrupting the operation of the medical waste collection assembly.
The tray enables efficient collection and retrieval of tissue samples with reduced exposure to hazardous waste, minimizing the risk of sample loss and maintaining operational continuity of the medical waste collection assembly.
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Abstract
Description
[Technical Field]
[0001] [Priority claims and related applications] This application claims priority to and the full benefit of U.S. Provisional Application No. 62 / 937,931, filed November 20, 2019, and U.S. Provisional Application No. 63 / 008,026, filed April 10, 2020, the entire contents of each of which are incorporated herein by reference. This application is related to International Application PCT / US2019 / 032911, filed May 17, 2019, the entire contents of which are incorporated herein by reference.
[0002] The present disclosure is directed generally to devices, systems, and methods for surgical procedures, and more particularly, but not exclusively, to surgical procedures involving the collection of tissue samples under suction using a medical waste collection assembly. [Background technology]
[0003] Certain surgical procedures involve removing tissue samples for evaluation. For example, a polypectomy procedure involves removing polyps from a surgical site within a patient, such as the colon or endometrial tissue lining the uterus. Often, polyps are aspirated with suction applied at the surgical site using a medical waste collection assembly. Retrieving polyps once collected within the suction path is an area of particular interest and development. Summary of the Invention [Problem to be solved by the invention]
[0004] Many known systems and methods are associated with several drawbacks, including increased time and inconvenience during a surgical procedure, potential exposure to hazardous medical waste, and an inability to collect multiple tissue samples, among others. Accordingly, there is a need in the art for improved manifolds and methods for collecting tissue samples using manifolds and medical waste collection assemblies. [Means for solving the problem]
[0005] A first aspect of the present disclosure is directed to a tray configured to collect tissue samples under vacuum by being removably positioned within a sleeve having an opening. The tray includes a seal member configured to be disposed in sealing engagement with the opening when the tray is removably positioned within the sleeve. A basket extends from the seal member and includes a base portion and opposing sides coupled to the base portion to collectively define a tissue collection cavity. The base portion, together with the tissue collection cavity, defines (i.e., defines or defines) a plurality of pore features for collecting tissue samples. The base portion includes a plurality of ribs disposed within the tissue collection cavity.
[0006] A second aspect of the present disclosure is directed to a tray configured to collect tissue samples under vacuum by being removably positioned within a sleeve having an opening. The tray includes a seal member configured to be disposed in sealing engagement with the opening when the tray is removably positioned within the sleeve. A basket extends from the seal member and includes a base portion and opposing sides coupled to the base portion to collectively define a tissue collection cavity. The base portion, together with the tissue collection cavity, defines a plurality of hole features for collecting tissue samples. The base portion includes ribs extending between the opposing sides and dividing the tissue collection cavity into a plurality of pockets.
[0007] A third aspect of the present disclosure is directed to a tray configured to collect tissue samples under vacuum by being removably positioned within a sleeve having an opening. The tray includes a sealing member configured to be disposed in sealing engagement with the opening when the tray is removably positioned within the sleeve. A basket extends from the sealing member and has a length greater than a width such that the basket is elongated. The basket includes a base portion and opposing sides coupled to the base portion that collectively define a tissue collection cavity. The base portion, together with the tissue collection cavity, defines a plurality of hole features for collecting tissue samples. The base portion includes ribs within the tissue collection cavity. The ribs are elongated and oriented along an axis transverse to the longitudinal axis.
[0008] A fourth aspect of the present disclosure is directed to a tray configured to collect tissue samples under vacuum by being removably positioned within a sleeve having an opening. The tray includes a seal member configured to be disposed in sealing engagement with the opening when the tray is removably positioned within the sleeve. A basket extends from the seal member and includes a base portion and opposing sides coupled to the base portion to collectively define a tissue collection cavity. The base portion is defined between an upper surface and an opposing lower surface, and the base portion includes ribs extending upward from the upper surface a distance sufficient to create a pocket, which is a low-pressure area, when the tray is removed from the sleeve.
[0009] A fifth aspect of the present disclosure is directed to a tray configured to collect tissue samples under vacuum by being removably positioned within a sleeve having an opening. The tray includes a seal member configured to be disposed in sealing engagement with the opening when the tray is removably positioned within the sleeve. The basket extends and includes a proximal portion extending from the seal member, opposing sides coupled to the proximal portion, a base portion coupled to the opposing sides, and a distal portion coupled to the base and opposing sides. The proximal portion, opposing sides, base portion, and distal portion collectively define a tissue collection cavity, and the base portion, together with the tissue collection cavity, defines a plurality of hole features for collecting tissue samples. The ribs define at least two pockets disposed within the tissue collection cavity and arranged in series between the proximal and distal portions. The pockets are associated with a low-pressure region when the tray is removed from within the sleeve.
[0010] A sixth aspect of the present disclosure is directed to a tray configured to collect tissue samples under vacuum by being removably positioned within a sleeve having an opening. The tray includes a seal member configured to be disposed in sealing engagement with the opening when the tray is removably positioned within the sleeve. A basket extends from the seal member and includes a base portion and opposing sides coupled to the base portion to collectively define a tissue collection cavity. The base portion includes ribs that divide the tissue collection cavity into a plurality of pockets. The base portion defines a plurality of hole features in each pocket. Each pocket includes a plurality of groups of hole features, where the hole features are equally spaced apart by a first distance. The groups are spaced apart by a second distance greater than the first distance.
[0011] A seventh aspect of the present disclosure is directed to a tray configured to collect tissue samples under vacuum by being removably positioned within a sleeve having an opening. The tray includes a sealing member configured to be disposed in sealing engagement with the opening when the tray is removably positioned within the sleeve. A shelf extends from the sealing member and is sized and shaped complementary to the sleeve to be disposed within the sleeve when the sealing member is in sealing engagement with the opening. The basket includes a proximal portion extending from the shelf, opposing sides coupled to the proximal portion, a base coupled to the opposing sides, and a distal portion coupled to the base and opposing sides. The proximal portion, opposing sides, base, and distal portion collectively define a tissue collection cavity, and the base portion, together with the tissue collection cavity, defines a plurality of hole features for collecting tissue samples. A sealing edge of the proximal portion is flush with an upper surface of the shelf.
[0012] An eighth aspect of the present disclosure is directed to a tray configured to collect tissue samples under vacuum by being removably positioned within a sleeve having an opening. The tray includes a seal member configured to be disposed in sealing engagement with the opening when the tray is removably positioned within the sleeve. A shelf extends from the seal member and is sized and shaped complementary to the sleeve to be disposed within the sleeve when the seal member is in sealing engagement with the opening. The basket includes a proximal portion extending from the shelf, opposing sides coupled to the proximal portion, a base portion coupled to the opposing sides, and a distal portion coupled to the base and opposing sides. The proximal portion, opposing sides, base portion, and distal portion collectively define a tissue collection cavity, and the base portion, together with the tissue collection cavity, defines a plurality of hole features for collecting tissue samples. The proximal portion extends from the shelf portion by at least 5 millimeters so that when the tray is beginning to be removed from the sleeve, air ingress into the sleeve is prevented near the proximal portion while air ingress into the sleeve is permitted near the base portion.
[0013] A ninth aspect of the present disclosure is directed to a tray configured to be removably positioned within a sleeve having an opening. The tray is configured to collect tissue samples drawn through a first suction path. The tray includes a seal member configured to be disposed in sealing engagement with the opening when the tray is removably positioned within the sleeve. The seal member includes a resilient, flexible portion. A first adjustment member extends from the seal member, and a second adjustment member extends from the seal member and is positioned away from the first adjustment member. A basket extends from the seal member in a direction opposite the first and second adjustment members. The basket defines a plurality of hole features for collecting tissue samples from liquid drawn through the first suction path. The first and second adjustment members are positioned opposite the resilient, flexible portion and configured to receive an input to resiliently and pivotably move at least a portion of the seal member away from the opening to provide a second suction path through the opening and the sleeve.
[0014] A tenth aspect of the present disclosure is directed to a tray configured to be removably positioned within a sleeve having an opening. The tray is configured to collect tissue samples drawn through a first suction path. The tray includes a seal member configured to be disposed in sealing engagement with the opening when the tray is removably positioned within the sleeve. The seal member includes an upper region and a lower region. A first adjustment member extends from the upper region, and a second adjustment member extends from the lower region and is positioned away from the first adjustment member. A basket extends from the upper region in a direction opposite to the first adjustment member. The basket defines a plurality of hole features for collecting tissue samples, and no portion of the basket extends from the lower region of the seal member. The first and second adjustment members are configured to receive an input for pivoting the lower region of the seal member relative to the upper region to move the lower region away from the opening to provide a second suction path through the opening and sleeve without disturbing the collected tissue sample.
[0015] An eleventh aspect of the present disclosure is directed to a tray configured to be removably positioned within a sleeve having an opening. The tray is configured to collect tissue samples drawn through a first suction path. The tray includes a seal member configured to be disposed in sealing engagement with the opening when the tray is removably positioned within the sleeve. The seal member includes upper and lower regions separated by a living hinge including a reduced-material portion of the seal member. An adjustment member extends from the upper region. A basket extends from the seal member in a direction opposite the adjustment member. The basket includes a plurality of hole features for collecting tissue samples. The adjustment member is configured to receive an input to pivot the lower region of the seal member relative to the upper region about the living hinge to move the lower region away from the opening to provide a second suction path through the opening and the sleeve.
[0016] A twelfth aspect of the present disclosure is directed to a tray configured to be removably positioned within a sleeve having an opening. The tray is configured to collect tissue samples drawn therein under the action of suction (vacuum). The tray includes a seal member configured to be disposed in sealing engagement with the opening when the tray is removably positioned within the sleeve. An adjustment member extends from the seal member. A basket is coupled to the seal member and includes a base portion, opposing sides coupled to the base portion, and a plurality of hole features defined within the base portion for collecting tissue samples, collectively defining a tissue collection cavity. The basket has a first cross-sectional profile defined by a boundary between the base portion, the opposing sides, and an upper aspect of the opposing sides. The basket further includes a neck region extending from the seal member in a direction opposite the adjustment member. The neck region has a second cross-sectional profile defined between a lower transition surface of the neck region and an upper aspect of the opposing side. The second cross-sectional profile is smaller than the first cross-sectional profile such that a void space is defined between the tissue-collecting cavity and the seal member.
[0017] A thirteenth aspect of the present disclosure is directed to a tray configured to be removably positioned within a sleeve having an opening. The tray is configured to collect tissue samples drawn through a first suction path. The tray includes a seal member configured to be disposed in sealing engagement with the opening when the tray is removably positioned within the sleeve. The seal member includes a resilient, flexible portion. An adjustment member extends from the seal member and is configured to receive an input to resiliently and pivotably move at least a portion of the seal member away from the opening to provide a second suction path through the opening and the sleeve. A basket is coupled to the seal member and includes a base portion, opposing sides coupled to the base portion, a plurality of hole features in the base portion for collecting tissue samples, and legs including a plurality of opposed rails extending along the base portion in a direction away from the tissue collection cavity. The legs are configured to pass through (form) the second suction path.
[0018] In some embodiments, the tray can include at least two pockets, e.g., four pockets. One of the pockets can be defined between a rib and the proximal portion and / or between a rib and the distal portion. The basket can have a length greater than a width such that the basket is elongated and has a longitudinal axis, and the ribs can be elongated and oriented along an axis transverse to the longitudinal axis. The ribs can be crescent-shaped. A plurality of hole features can be disposed between the ribs. There can be three ribs, which can be equally spaced apart from one another. More specifically, three ribs can define four pockets in the base portion, and a plurality of hole features are within each of the four pockets. The three ribs can be parallel to one another. The base portion can be arcuate in shape and concave between the opposing sides. The ribs can be arcuate and contoured complementary to the arcuate shape of the base portion. The plurality of hole features can be arranged in at least two groups. Each group may include at least two rows of the holes oriented longitudinally along the base. A plurality of ribs may separate the groups. The above embodiment may be included in any one or more of the first to thirteenth aspects of the tray.
[0019] A fourteenth aspect of the present disclosure is directed to a manifold for collecting tissue samples through a suction tube. The manifold includes a housing having a sleeve defining an opening. The sleeve includes an inlet fitting defining an inlet bore opening into the sleeve. The manifold includes a tray. The tray may be any one or more of the first through thirteenth aspects of the tray.
[0020] A fourteenth aspect of the present disclosure is directed to a method for collecting a sample under vacuum from a medical waste collection assembly including a receiver. A suction tube is coupled to an inlet fitting of a manifold defining an inlet bore. The manifold is positioned within an opening of the receiver. A tray is removably disposed within the sleeve in a first position such that (i) a seal member of the tray is disposed in sealing engagement with the opening, (ii) a distal portion of the tray is disposed distal to the inlet bore, and (iii) a tissue collection cavity of the tray is open toward the inlet bore. The medical waste collection assembly interacts with the tray in the first position, and a sample is drawn into the tissue collection cavity through a first suction path. An input force is applied to the first and second adjustment members to resiliently move the first and second adjustment members toward each other. A lower portion of the seal member moves away from the opening to provide a second suction path. The input to the first and second adjustment members is maintained while moving the tray from the first position to the second position, where the seal member moves away from the opening and the sealing edge of the tray remains in sealing engagement with the upper barrier defining the sleeve. The distal portion of the tray remains disposed distal to the inlet bore in the second position. The input to the first and second adjustment members is maintained while moving the tray from the second position to a third position, where the seal member moves further away from the opening and the sealing edge of the tray disengages the upper barrier defining the sleeve to provide a third suction path. The distal portion of the tray moves proximal to the inlet bore in the third position to eliminate the first suction path and provide a fourth suction path.
[0021] Advantages of the present disclosure will be readily appreciated as the same becomes better understood by reference to the following detailed description when considered in conjunction with the accompanying drawings, in which: [Brief explanation of the drawings]
[0022] [Figure 1] FIG. [Figure 2] FIG. 10 is a perspective view of the manifold with the tray removed from the sleeve. [Figure 3] FIG. 10 is a near-front elevation view of the manifold without the tray showing the internal features of the sleeve. [Figure 4] FIG. [Figure 5] FIG. [Figure 6] FIG. [Figure 7] FIG. 1 is a cross-sectional view of a manifold including a tray disposed within a sleeve, the tray being in a sealing configuration. [Figure 8] FIG. 1 is a cross-sectional view of a manifold including a tray disposed within a sleeve, the tray being in a bleed configuration. [Figure 9] FIG. [Figure 10] FIG. 10 is a top front perspective view of the tray of FIG. [Figure 11] FIG. 10 is a top plan view of the tray of FIG. 9. [Figure 12] 1 is a cross-sectional view of a portion of a manifold with a tray disposed within a sleeve in a first position and in a sealed configuration. [Figure 13] 1 is a cross-sectional view of a portion of the manifold with the tray disposed within 14 in a second position. [Figure 14] FIG. 10 is a cross-sectional view of a portion of a manifold with a tray disposed within a sleeve in a second position. [Figure 15] FIG. 15 is a detailed view of the portion of the manifold within detail 15-15 in FIG. DETAILED DESCRIPTION OF THE INVENTION
[0023] The withdrawal (aspiration) of tissue samples from within a patient can be facilitated using a medical waste collection assembly, such as the Neptune 2® and Neptune 3® waste management systems manufactured by Stryker Corporation (Kalamazoo, Michigan) and disclosed in commonly owned U.S. Patent Nos. 7,621,898, 8,216,199, 8,740,866, 8,915,897, 9,579,428, and 9,782,524 (the entire contents of each are incorporated herein by reference). In its broadest sense, the medical waste collection assembly includes a vacuum pump adapted to be placed in fluid communication with the proximal end of a suction tube. The distal end of the suction tube is coupled to an instrument positioned near the surgical site. As used herein, proximal refers to the direction toward the rear of manifold 100 and the medical waste collection assembly when engaged with manifold 100, and distal refers to the direction toward the front of manifold 100 and the surgical site (see FIG. 1). The desired tissue sample is excised, for example, using a snare technique, and the excised tissue sample is aspirated into a suction tube toward the medical waste collection assembly.
[0024] Aspirated semi-solid and solid matter, including tissue samples, must be captured or appropriately filtered to avoid potential clogging of components of the medical waste collection assembly. The medical waste collection assembly includes a manifold receiver adapted to be removably engaged with the manifold 100. The medical waste collection assembly further includes a suction inlet adapted to be in fluid communication with the outlet opening of the manifold 100 when the manifold 100 is engaged with the manifold receiver. In one embodiment, the manifold receiver can include a valve body that is rotatable to align a bore with the suction inlet when the outlet opening engages and rotates a boss defining the bore, as disclosed in commonly owned U.S. Patent Nos. 7,615,037, 8,518,002, 8,915,897, and 9,579,428 (the entire contents of each of which are incorporated herein by reference). In another embodiment, the manifold receiver can include a translatable inlet mechanism and a suction fitting configured to engage the outlet opening, as disclosed in commonly owned U.S. Patent No. 10,471,188, issued November 12, 2019, the entire contents of which are incorporated herein by reference. The manifold 100 is adapted to receive a suction tube, such that a suction path is established through the manifold 100 from the suction tube to the medical waste collection assembly. Among other functions, the manifold 100 captures semi-solid and solid materials entrained in the stream aspirated from the surgical site.
[0025] 1 and 2 illustrate an embodiment of a manifold 100 for collecting tissue samples. The manifold 100 includes a housing 102 adapted to be removably engaged with a manifold receiver. The housing 102 can include a body 104 and a cap portion 106. The manifold 100 can define a manifold volume 108 and an outlet opening 109 in fluid communication with the manifold volume 108. A seal 110 can be coupled to the housing 102 and sized to cover the outlet opening 109. The manifold volume 108 can be defined by the body 104 and / or the cap portion 106; in some embodiments, the housing 102 can be an adapter for a suction tube and not define a manifold volume 108. The body 104 can include features configured to engage complementary features of a manifold receiver of a medical waste collection assembly. Features of the housing 102, which are described in more detail in the aforementioned U.S. Patent No. 10,471,188, may include an arm 116, a locking element 117, a spine 118, and / or a catch 119. The body 104 may include a first leg 126 and a second leg 128 spaced apart from the first leg 126 to define a cavity 130.
[0026] The housing 102 includes at least one inlet fitting 112a, 112b adapted to receive a suction tube. The inlet fittings 112a, 112b define respective inlet bores 114a, 114b in fluid communication with the manifold volume 108. The valve 132 can be coupled to the housing 102 and configured to prevent backflow from the manifold volume 108. The valve 132 can be coupled to the cap portion 106. Specifically, an inner or proximal surface of the cap portion 106 can include a connector 107, such as a proximally extending protrusion. The valve 132 includes a connector 137 complementary to the connector 107 of the cap portion 106. The connector 137 can be a slot sized to engage the protrusion in an interference-fit configuration. Additionally or alternatively, a suitable joining process, such as adhesives, mechanical fastening, or the like, can be used to couple the valve 132 to the cap portion 106. The valve 132 can include a pair of flappers 135, one configured to selectively cover a transfer bore 125 that establishes communication between the described accessory sleeve 113 and the manifold volume 108, and the other flapper 135 configured to selectively cover a second one of the inlet bores 114b. The valve 132 can be formed of a resilient material so that it resiliently deforms proximally-to-distal under a vacuum provided by a vacuum pump. Some features of the valve 132 can be similar to those disclosed in U.S. Patent No. 7,715,037, issued November 10, 2009, the entire contents of which are incorporated herein by reference. Seals at the proximal ends of the inlet and transfer bores 114b, 125, prevent backflow from the manifold volume 108 into the accessory sleeve 113 and inlet bore 114b, respectively, thereby preventing possible waste material spillage.
[0027] The manifold 100 may include a filter element 133 disposed within the housing 102 and the suction path. The filter element 133, in its broadest sense, includes a structure configured to capture or collect semi-solid or solid waste entrained within liquid waste drawn through the manifold 100 under the vacuum provided by the medical waste collection system. The filter element 133 includes a plurality of porous features or apertures, such as holes, pores, and / or slots, among others. In other words, a suction path is provided from the inlet bores 114a, 114b through each of the manifold volume 108, the filter element 133, and the outlet opening 109 to the suction inlet of the receiver. The filter element 133 may form a basket-like structure. The filter element 133 may be disposed within the manifold volume 108 or at a location remote from the manifold volume 108. Shapes and configurations of filter element 133 suitable for certain embodiments of manifold 100 are disclosed in commonly owned International Publication Nos. WO 2018 / 170233, filed March 15, 2018, and PCT / US2019 / 060732, filed November 11, 2019, the entire contents of each of which are incorporated herein by reference. Furthermore, filter element 133 may be considered optional, and manifold designs that do not include filter element 133 are contemplated.
[0028] 1 and 2, the cap portion 106 includes a cap head 142 and a support frame 143 disposed distally of the cap head 142. The support frame 143 may be removably coupled to the cap face plate 140 of the cap head 142 or may be integrally formed with the cap face plate 140 of the cap head 142. The cap portion 106 further includes an accessory sleeve 113, a first inlet fitting 112a, and a second inlet fitting 112b. More specifically, the accessory sleeve 113 may be coupled to the support frame 143, the first inlet fitting 112a may extend upwardly from the upper barrier 103, and the first inlet bore 114a may extend through the upper barrier 103. A second inlet fitting 112b extends distally from the cap faceplate 140, and a second inlet bore 114b (also referred to herein as a bypass bore) extends through the cap faceplate 140. The housing 102 of the manifold 100 further defines an accessory opening 111 that opens into an accessory sleeve 113. As best shown in FIG. 3 , the accessory sleeve 113 can be at least partially defined by an upper barrier 103, a lower barrier 122, and a plurality of opposed side barriers 123 extending between the upper barrier 103 and the lower barrier 122. The accessory sleeve 113 can further be defined by an end barrier 124 opposite the accessory opening 111. The accessory sleeve 113 is in fluid communication with the manifold volume 108 through a transfer bore 125 and an aperture 158 extending through the cap faceplate 140. More specifically, transfer bore 125 is defined between a first end of at least one of lower barrier 122 and side barrier 123 and a second end that opens into the manifold volume, e.g., aperture 158. Accessory sleeve 113 can include positioning feature 145 that defines trough 127 as described, and orientation feature 189.
[0029] The manifold 100 may include a first cover 151a and a second cover 151b configured to selectively cover the accessory opening 111 and the second inlet bore 114b, respectively. With reference to FIGS. 1-3 , the first cover 151a is molded to the contours of the accessory opening 111. The first cover 151a may be coupled to the housing 102 using a hinge or tether 149a. More particularly, the first cover 151a may be coupled to the accessory sleeve 113 near its distal end. The first cover 151a may include a grip configured to be manipulated by a user to selectively position the first cover 151a over the accessory opening 111. The first cover 151a may include an inner seal rim configured to engage the accessory opening 111 via an interference fit engagement. When the first cover 151a selectively covers the accessory opening 111, the manifold 100 can be operable with the medical waste collection assembly to provide a suction path from a suction tube coupled to the first inlet fitting 112a through the first inlet bore 114a. In such a configuration, the tray 176 cannot be removably positioned within the accessory sleeve 113, and the first cover 151a maintains suction (vacuum) through the manifold 100. Disengaging the first cover 151a from the accessory opening 111 during operation of the medical waste collection assembly effectively discontinues suction without having to terminate operation of the medical waste collection assembly. A second cover 151b may be coupled to the housing 102 using a tether 149b. In examples where the second inlet fitting 112 is not utilized, the second cover 151b is sized to be coupled by friction or interference fit engagement with the second inlet fitting 112b to selectively cover the second inlet bore 114b.
[0030] The manifold 100 includes the aforementioned tray 176 configured to be removably positioned within the accessory sleeve 113. The tray 176 includes a basket 180 defining a tissue collection cavity 182 and a plurality of pore features 186 within the tissue collection cavity 182. When the tray 176 is positioned within the accessory sleeve 113, the plurality of pore features 186 are within the aspiration path for collecting tissue samples. The tray 176 further includes a seal member 154 adapted to sealingly engage the accessory opening 111 when the tray 176 is within the accessory sleeve 113. The seal member 154 may include a ledge 155 and a flange 156. The ledge 155 extends distally from the flange 156 and includes an outer periphery sized slightly smaller than the accessory opening 111. Similarly, the outer periphery of the flange 156 is complementarily shaped relative to the accessory opening 111. Specifically, when the accessory opening 111 is collectively defined by the upper surface, lower surface, and opposed side barriers 103, 122, 123, the perimeter is adapted to fit snugly against the adjacent edges of each of the upper surface, lower surface, and barriers 103, 122, 123. The ledge 155 aids in locating the tray 176 within the accessory sleeve 113 and also helps prevent loss of suction through the accessory opening 111. The flange 156 defines a sealing surface 157 that is adapted to contact the perimeter of the accessory opening 111. When the tray 176 is within the accessory sleeve 113 and the sealing surface 157 contacts the accessory sleeve 113, suction is maintained through the suction path during operation of the medical waste collection assembly.
[0031] The seal member 154 includes a resilient, flexible portion 160. The flexible portion 160 is configured to resiliently and pivotally move at least a portion of the seal member 154 away from the accessory opening 111 to provide a second suction path in a manner to be described further. As shown in FIG. 6 , the seal member 154 can include an upper region 170 and a lower region 172, and in some configurations, the flexible portion 160 is at least partially disposed between the upper region 170 and the lower region 172. In one example, the flexible portion 160 is a living hinge 174 that is a reduced thickness portion of the seal member 154, allowing the lower region 172 to pivot relative to the upper region 170 about the living hinge 174.
[0032] 4-6, basket 180 extends in a distal or first direction from seal member 154. Basket 180 includes a base portion 184 and side portions 185 (also referred to herein as lateral sides) coupled to base portion 184. Base portion 184 may be arcuate in shape and concave between opposing side portions 185, as shown, but may alternatively be planar or of any suitable profile. Base portion and side portions 184, 185 extend from seal member 154 and may be arranged to define tissue collection cavity 182. For purposes of convention, tissue collection cavity 182 is considered to open away from base portion 184 in a direction parallel to side portions 185. A plurality of hole features 186 are defined in base portion 184. It is contemplated that a plurality of hole features 186 may also be defined in opposing side portions 185. Additionally, basket 180 can include a distal portion 190 extending between opposed sides 185 and further defining tissue collection cavity 182. Distal portion 190 can include a plurality of hole features 186. The plurality of hole features 186 in distal portion 190 is optional.
[0033] The tray 176 includes first and second adjustment members 188a, 188b adapted to receive input from a user. The first and second adjustment members 188a, 188b extend from the seal member 154 in a second direction opposite the basket 180. The second adjustment member 188b can be spaced apart from the first adjustment member 188a such that the first and second adjustment members 188a, 188b are configured to be gripped between a user's fingers. More specifically, the grips can be positioned to be gripped by a user to move the first adjustment member 188a toward the second adjustment member 188b for the described functions.
[0034] 6, a first adjustment member 188a can extend from the upper region 170 of the seal member 154, and a second adjustment member 188b can extend from the lower region 170 of the seal member 154. In such a configuration, the first and second adjustment members 188a, 188b can be disposed on opposite sides of the flexible portion 160 of the seal member 154. For example, FIG. 6 shows the first and second adjustment members 188a, 188b disposed on opposite sides of the living hinge 174. As a result, when the first and second adjustment members 188a, 188b are pinched between a user's fingers, the second adjustment member 188b can be moved toward the first adjustment member 188a with a corresponding movement of the sealing surface 157 of the seal member 154.
[0035] The configuration of the basket 180 is further configured to facilitate movement of the second adjustment member 188b toward the first adjustment member 188a (as opposed to, for example, the first adjustment member 188a toward the second adjustment member 188b) while the first adjustment member 188a remains substantially stationary, thus pivoting the lower region 172 of the seal member 154 away from the accessory opening 111. Specifically, the basket 180 extends from the upper region 170, and no portion of the basket 180 extends from the lower region 172. The basket 180 may be snugly disposed within the accessory sleeve 113, such that pinching the first and second adjustment members 188a, 188a in consideration of positioning the flexible portion 160, results in pivoting of the lower region 172 of the seal member 154 away from the accessory opening 111 (see FIG. 8 ). FIG. 6 illustrates a depth of the tissue-collecting cavity 182 that is greater than the height of the upper region 170 of the seal member 154 (approximating the height of the basket 180). To accommodate the above-described configuration, the basket 180 can include a neck region 192 with a reduced cross-sectional profile such that a void space 194 is defined between the tissue-collecting cavity 182 and the lower region 172 of the seal member 154. In other words, the main portion of the basket 180 has a first cross-sectional profile (in a plane transverse to the longitudinal axis of the tray 176), and the neck region 172 has a second cross-sectional profile that is smaller than the first cross-sectional profile. The first cross-sectional profile can be defined by the base portion 184 and the opposing sides 185 (and the boundary extending between the upper surfaces of the opposing sides 185). The second cross-sectional profile can be defined by a lower connecting surface 196 of the neck region 192 and the opposing sides 185 (and the boundary extending between the upper surfaces of the opposing sides 185). 6, the interface between the basket 180 and the seal member 154 is at the upper region 170. The lower mating surface 196 and wall 198 may slope downward in the distal direction such that the depth of the tissue collection cavity 182 is generally maximized.
[0036] The tray 176 can include legs 131 extending from a base 184, more particularly extending from the base 184 in a direction opposite the tissue collection cavity 182. The legs 131 can be generally U-shaped and, when viewed from the bottom, define a plurality of hole features 186 within the base 184. In some embodiments, the legs 131 can be a plurality of opposed rails 136 extending from the base 184 near the sides 185. FIGS. 4-6 show each opposed rail 136 having a slot 138. It will be appreciated that the generally U-shaped legs 131 also define a bore 125 in communication with the manifold volume 108 to form a second suction pathway, as described, when the tray 176 is fully positioned within the accessory sleeve 113.
[0037] 1 and 2 simultaneously, the tray 176 can include an orientation feature 187 configured to engage an orientation feature 189 of the accessory sleeve 113 to position the tray 176 within the accessory sleeve 113 in a single orientation relative to the upper barrier 103, specifically with the tissue collection cavity 182 open toward the upper barrier 103. The orientation feature 189 of the accessory sleeve 113 can be thought of as a groove defined in each of the opposing side barriers 123. In other words, each side barrier 123 near the upper barrier 103 flares outward to define a groove. The orientation feature 187 of the tray 176 can extend outward from the side 185, specifically near the upper surface of the tray 176. The complementary orientation features 187, 189 can be configured to be movably engaged by sliding rails within the grooves.
[0038] 7 and 8 , when the tray 176 is removably disposed within the accessory sleeve 113, (i) the seal member 154 seals the accessory opening 111, (ii) the tissue collection cavity 182 is disposed within the accessory sleeve 113 and opens toward the inlet bore 112a, and (iii) the base portion 184 and / or side portion 185 engage the positioning feature 145 within the accessory sleeve 113 to provide a gap G between the base portion 184 of the tray 176 and the lower barrier 122. In such a configuration, during operation of the medical waste collection assembly, a first suction path FSP is created through the suction tube, the inlet bore 114a, the tissue collection cavity 182, the transfer bore 125, and into the manifold volume 108 to the outlet opening 109. Tissue samples traveling through the first suction path are collected within the tray 176.
[0039] The presence of the wall 198, e.g., a sloped surface, causes the collected tissue sample to settle on the base portion 184 at a position away from the seal member 154. Additionally, as noted, and as shown in FIGS. 1 and 2, the upper barrier 103 can be transparent. As a result, a user viewing the manifold 100 from above, which is typical based on the operational height of the manifold 100 when coupled to a medical waste collection assembly, can quickly ascertain whether a tissue sample has been collected and / or the quality of the collected tissue sample. In contrast, without the wall 198 to allow the collected tissue sample to settle away from the seal member 154, the user would need to approach the manifold 100 to determine whether a tissue sample has been collected. And, of course, without the upper barrier 103 being transparent, the user would need to at least partially remove the tray 176 from the manifold 100 to determine whether a tissue sample has been collected.
[0040] The base 184 of the tray 176 may be positioned to rest on, or otherwise supported by, the ledge 147 such that a gap G is defined between the lower surface of the base 184 of the tray 176 and the upper surface of the valley 127. Gap G may be considered to be below the tray 176 (i.e., opposite the tissue collection cavity 182 in the aforementioned convention). When the tray 176 is placed within the accessory sleeve 113, gap G is in communication with the transfer bore 125 extending to the manifold volume 108. The orientation feature 187 of the tray 176 may further serve as a positioning feature for defining the vertical position of the base 184 relative to the lower barrier 122, thus at least partially influencing the size of gap G. It is further noted that the upper surface of the tray 176 is positioned adjacent to the upper barrier 103 with a small distance therebetween.
[0041] When it is desired to retrieve the collected tissue sample, the tray 176, along with the tissue sample disposed within the tissue collection cavity 182, can be slidably removed from the accessory sleeve 113. In known systems, the tissue specimen may encounter fluid flow (and associated forces), which can undesirably sweep the tissue sample along the fluid flow and eject it from the tray. Known systems do not adequately address this issue. The manifold 100 of the present disclosure advantageously provides for the creation of a second suction path SSP that is provided in a manner that minimizes the possibility of inadvertent loss of a tissue sample. For example, the aforementioned gap G provides a second suction path below the tray 176. Furthermore, the manifold 100 advantageously provides a second suction path of sufficient volumetric flow so that the first suction path can be temporarily limited or eliminated. In other words, the manifold 100 advantageously provides for a reduction or "bleeding" of suction through the first suction path, perhaps temporarily, without having to remove the manifold 100 from the medical waste collection assembly and / or without having to stop operation of the medical waste collection assembly.
[0042] In operation, if a user desires to reduce or eliminate the first suction path, the user provides an input to the first and second adjustment members 188a, 188b. Specifically, the user can pinch the first and second adjustment members 188a, 188b. With particular reference to FIGS. 7 and 8 , the second adjustment member 188b moves or pivots (P) toward the first adjustment member 188a to move the manifold 100 from the sealed configuration to the bleed configuration. More specifically, movement of the second adjustment member 188b causes at least a portion of the seal member 154 to move away from a portion of the accessory opening 111 near the lower barrier 122. For example, the lower region 172 of the seal member 154 can be pivoted relative to the upper region 170 of the seal member 154 to move the lower region 172 away from the accessory opening 111 and provide the second suction path SSP without disturbing the collected tissue sample. This pivoting may be about living hinge 174 .
[0043] A valley 127 extending into the accessory opening 111 is exposed to the atmosphere and provides a second suction path SSP. A gap G can be at least partially defined by the valley 127, and the second suction path SSP is fluidically directed through the gap G without encountering (directing toward) the tissue collection cavity 182 of the tray 176. As shown in FIG. 7 , the second suction path SSP is provided from the accessory opening 111 to the bore 125 through the gap G between the base 184 of the tray 176 and the lower barrier 122 of the housing that defines the accessory sleeve 113. Additionally, the legs 131 route the second suction path SSP toward the transfer bore 125, and the slots 138 in the rails 136 provide the desired flow characteristics for the second suction path SSP. For example, legs 131 can increase the difference in resistance between second aspiration path SSP and first aspiration path FSP when manifold 100 is in the bleed configuration, such that second aspiration path SSP becomes the primary aspiration path in the bleed configuration and negligible suction is maintained through the aspiration tubing. It is understood that maximizing the size of gap G (i.e., the distance from base 184 to lower barrier 122 defining valley 127) increases the effectiveness of the bleed function and also further reduces the likelihood of fluid flow in second aspiration path SSP above tray 176 that could dislodge or expel collected tissue samples.
[0044] Due to the lower resistance of the fluid (e.g., air) entering the second suction path SSP (as well as the density of the waste material in the suction path relative to air) to the end of the suction tubing disposed significantly upstream at the surgical site, fluid dynamics dictate that the second suction path SSP becomes the primary suction path in the bleed configuration, and negligible suction can be maintained through the suction tubing. If the user desires to immediately restore the first suction path FSP as the primary (and only) suction path, the user simply releases the input power applied to the first and / or second adjustment members 188a, 188b. The resilience of the seal member 154 and the second suction path SSP adjacent to the seal member 154 results in the seal member 154 reengaging the accessory opening 111, and the manifold 100 resumes the sealed configuration. Transitioning the manifold 100 between the sealed and bleed configurations can be done as many times as necessary without undue difficulty and without having to stop operation of the medical waste collection assembly.
[0045] Also, as mentioned, the second suction path SSP is provided below the tray 176 (i.e., on the opposite side from the tissue collection cavity 182 in the previously described practice). As a result, when a user desires to retrieve a tissue sample collected in the tissue collection cavity 182, the user maintains input to the first and second adjustment members 188a, 188b while removing the tray 176 from the accessory sleeve 113. Because the gap G is relatively larger than any distance between the upper sides of the tray 176 disposed adjacent to the upper barrier 103, substantially the entire second suction path SSP remains below the tray 176 when the tray 176 is removed. It is understood that the fluid flow of the second suction path SSP moving above the tray 176 to be drawn into the tissue collection cavity 182 is reduced. As a result, the user can more confidently remove the tray 176 without risk of unintentionally losing the collected tissue sample.
[0046] Inadvertent loss of collected tissue samples during removal of tray 176 from accessory sleeve 113 can be further minimized by a plurality of ribs 200 disposed within basket 180. Referring now to Figures 9-15, tray 176 is shown with like numbers indicating like components as compared to the previously described embodiment, and any aspects not repeated are for the sake of brevity and should not be considered limiting.
[0047] The tray 176 includes a basket 180 defining a tissue collection cavity 182 and a plurality of aperture features 186 within the tissue collection cavity 182. The tray 176 further includes a seal member 154 adapted to be in sealing engagement with the accessory opening 111 when the tray 176 is within the accessory sleeve 113. The seal member 154 includes a resiliently flexible portion 160 configured to resiliently and pivotally move at least a portion of the seal member 154 away from the accessory opening 111 to provide a second suction path. The flexible portion 160 may be a living hinge 174 configured to facilitate pivoting of the lower region 172 relative to the upper region 170. The first and second adjustment members 188 a, 188 b are capable of being grasped between a user's fingers to move the second adjustment member 188 b toward the first adjustment member 188 a with corresponding movement of the sealing surface 157 of the seal member 154. The basket 180 may include a neck region 192 to define a void space 194 between the tissue collection cavity 182 and the lower region 172 of the seal member 154 .
[0048] The basket 180 includes a base portion 184 and a plurality of opposed sides 185 (also referred to herein as sides) arranged to define a tissue collection cavity 182. A plurality of hole features 186 are defined in the base portion 184. It is contemplated that the plurality of hole features 186 may also be defined in the opposed sides 185. Additionally, the basket 180 may include a distal portion 190 extending between the opposed sides 185 and further defining the tissue collection cavity 182. The tray 176 may include legs 131 extending from the base portion 184, e.g., a plurality of opposed rails 136 extending from the base portion 184 near the sides 185. The opposed rails 136 may have slots 138.
[0049] When the tray 176 is removably disposed within the accessory sleeve 113, a gap G is present between the base 184 of the tray 176 and the lower barrier 122, such that a first suction path FSP is created through the suction tube, the inlet bore 114a, the tissue collection cavity 182, the transfer bore 125, and into the manifold volume 108 to the outlet opening 109. Tissue samples traveling through the first suction path are collected within the tray 176. When it is desired to retrieve the collected tissue sample, the tray 176 can be slidably removed from the accessory sleeve 113 along with the tissue sample disposed within the tissue collection cavity 182. As described in detail above, the manifold 100 creates a second suction path SSP beneath the tray 176 to transition the manifold 100 from the sealed configuration to the bleed configuration, shown in FIGS. 7 and 8, respectively.
[0050] The tray 176 is configured to be moved within the accessory sleeve 113 in a proximal-distal direction, and more particularly, to be inserted distally into the accessory sleeve 113 and removed proximally from the accessory sleeve 113. During removal of the tray 176 from the accessory sleeve 113, the second suction path SSP aids in the removal of the tray 176 from the accessory sleeve 113 with minimal disruption of the collected tissue sample. Although the majority of the air is directed through the second suction path SSP without encountering the tissue collection cavity 182 of the tray 176, some air may travel over or around the upper edge 202 of the seal member 154 into the tissue collection cavity 182.
[0051] The base portion 184 may include at least one rib 200 disposed within the tissue collection cavity 182. In the most general sense, the rib 200 separates (divides) a portion of the tissue collection cavity 182 near the base portion 184 into at least two pockets 204, at least one of which is a low-pressure area when the tray 176 is removed from the accessory sleeve 113. If the pocket 204 is a low-pressure area, any air encountering the tissue collection cavity 182 is unlikely to be associated with sufficient force to dislodge or eject the collected tissue sample. It is further understood that the rib 200 may also provide a barrier to prevent movement of the collected tissue sample along the base portion 184 before, during, and after removal of the tray 176 from the accessory sleeve 113.
[0052] The base portion 184 can include at least two ribs 200 disposed with the tissue collection cavity 182. The ribs 200 can extend between opposing sides 185. With continued reference to FIGS. 9-11 , the ribs 200 include ends joined or integrally formed with each opposing side 185. In one example, the ribs are elongated and oriented along an axis transverse to the longitudinal axis LA of the tray 176 (see FIG. 11 ). In other words, the longitudinal axis of the tray 176 is oriented in the proximal-distal direction, and the ribs 200 are oriented transverse to the longitudinal axis LA. This configuration provides the ribs 200 that are generally oriented perpendicular to the direction of removal of the tray 176 (and thus the direction of airflow entering through the accessory sleeve 113 during removal), thereby providing a low-pressure region within the plurality of pockets 204.
[0053] In some embodiments, multiple ribs 200 are provided. For example, the illustrated embodiment shows the base portion 184 including three ribs 200a-200c defining four pockets 204a-204d. While the subsequent disclosure is directed to three ribs 200a-200c, any number of ribs is contemplated. The ribs 200a-200c may be equally spaced from one another and / or oriented parallel to one another. The ribs 200a-200c may be generally linear and continuous in configuration, or may be irregular (e.g., zigzag), discontinuous, etc. The location and orientation of the ribs 200a-200c positions the pockets 204a-204d in series between the illustrated proximal portion 206 and distal portion 190. In other words, the pockets 204a-204d are positioned in a generally side-by-side arrangement in the proximal-distal direction. 11 illustrates a first pocket 204a defined between the proximal portion 206 and the first rib 200a, a second pocket 204b defined between the first rib 200a and the second rib 200b, a third pocket 204c defined between the second rib 200b and the third rib 200c, and a fourth pocket 204d defined between the third rib 200c and the distal portion 190. The pockets 204a-204d may be associated with regions I-IV of the tissue collection cavity 182. The proximal-distal arrangement may provide redundancy in the event that collected tissue samples are transferred between the pockets 204a-204d during removal of the tray 176 from the accessory sleeve 113. For example, if a collected tissue sample located in the first pocket 204a moves to the second pocket 204b, it remains within the low pressure region (region II) of the tissue collection cavity 182. Additional air within the tissue collection cavity 182 is unlikely to move the collected tissue sample further, such as from the second pocket 204b to the third pocket 204c, and is unlikely to be associated with sufficient force to dislodge or eject the collected tissue sample at all.
[0054] 9-11, the base portion 184 can be arcuate between opposing sides 185. The ribs 200a-200c can be arcuate and can be contoured to complement the arcuate shape of the base portion 184. The base portion 184 can include a lower arcuate surface (not specified) opposite an upper arcuate surface 208 that partially defines the tissue collection cavity 182. The ribs 200a-200c extend upwardly from the upper arcuate surface 208 and match the contour of the upper arcuate surface 208. In such an embodiment, the ribs 200a-200c can appear crescent-shaped when viewed at axial height and as generally understood from FIGS. 9 and 10. The ribs 200a-200c can extend upward from the upper arcuate surface 208 by 0.5, 1, 2, or 3 or more millimeters (as measured perpendicular to the longitudinal axis). In one embodiment, the ribs 200a-200c extend upward by approximately 1 millimeter. In another implementation, the ribs 200a-200c can extend upward from the upper arcuate surface 208 by less than 10% of the depth of the tissue collection cavity 182. Additionally or alternatively, the ribs 200a-200c can extend upward from the upper arcuate surface 208 such that at least substantially the entirety of the ribs 200a-200c is below the interface 210 (where the opposing side portions 185 transition to the base portion 184).
[0055] With further discussion regarding sealing edge 212, the effect of ribs 200a-200c on airflow AF will be introduced with reference to FIG. 15. In known systems, after the tray is partially removed, airflow assaults the tray in a distal direction and becomes turbulent within tray 176. The turbulent airflow often causes a pinball-like effect of collected tissue samples TS, such as polyps. The pinball-like effect of the tissue sample TS can cause it to exit the tray through exposed portions of the tray. As schematically represented in FIG. 15, when airflow AF assaults distally within tissue collection cavity 182, negligible airflow encounters a low-pressure region within pocket 204b defined between ribs 200b, 200c. Furthermore, in the illustrated example where only a portion of the tissue sample TS extends above the adjacent ribs 200c, the airflow AF is likely to contact the upper surface of the tissue sample TS, thereby making it unlikely to have the lift necessary to cause the pinball-like effect described above. Still further, the illustrated example shows the tissue sample TS adjacent the ribs 200c oriented transverse to the direction of the airflow AF, such that the ribs 200c can mechanically prevent movement of the collected tissue sample along the base portion 184 before, during, and after removal of the tray 176 from the accessory sleeve 113.
[0056] As previously described, the plurality of pore features 186 are defined within the base portion 184, and the plurality of pore features 186 are within the suction path for collecting tissue samples. The plurality of pore features 186 may be positioned to further limit or prevent movement of collected tissue samples along the base portion 184 before, during, and after removal of the tray 176 from the accessory sleeve 113. Referring again to FIGS. 9-11 , the plurality of pore features 186 can be disposed between the ribs 200a-200c. The plurality of pore features 186 can be disposed within the first pocket 204a, the second pocket 204b, the third pocket 204c, and / or the fourth pocket 204d. In the illustrated embodiment, the plurality of pore features 186 are disposed in each of the four pockets 204a-204d.
[0057] The plurality of hole features 186 may be arranged in a plurality of groups 214. As used herein, a group is defined to include two or more hole features spaced equally apart from one another by a first distance. The plurality of groups 214 themselves are spaced apart from one another by a second distance greater than the first distance. For illustrative purposes, FIG. 11 shows a dashed line defining the boundary of the first group 214a and another dashed line defining the boundary of the second group 214b. The first and second groups 214a, 214b are separated from one another by a center aspect 216 of the base portion 184. The width of the center aspect 216 is greater than the spacing between the hole features 186 in the first and second groups 214a, 214b. In the illustrated embodiment, the first and second groups 214a, 214b each include five rows of hole features 186 arranged longitudinally along the base portion 184. It should be understood that the groups 214 can include two, three, four, six, or more rows of hole features 186. Also, in the illustrated embodiment, there are two groups 214 per pocket 204a-d. Likewise, it should be understood that there may be three, four, five, or more groups within a pocket 204. Multiple pockets 204 need not include the same number of groups, and / or the groups per pocket may vary based, among other things, on providing the desired flow characteristics through the tissue collection cavity 182.
[0058] Because base portion 184 is arcuate and concave between opposing sides 185, tissue samples TS may fall under the force of gravity to central surface 216, as shown in FIG. 11 . The lack of hole features 186 in central surface 216 reduces the likelihood of airflow moving upward through hole features 186, which could cause tissue samples TS to lift off base portion 184 and potentially be entrained in distally moving airflow AF within tissue collection cavity 182 (see FIG. 15 ). At least in this regard, ribs 200 a-c and groups 214 cooperate to limit movement of tissue samples TS within basket 180 before, during, and after removal of tray 176 from accessory sleeve 113.
[0059] As described in detail above, the flexible portion 160, neck region 172, and gap G of the seal member 154 cause the second suction path SSP to be below the tray 176 when the manifold 100 is in the bleed configuration. The bleed configuration limits or eliminates the first suction path FSP when the upper region 170 of the seal member 154 remains engaged with the accessory opening 111. However, when the tray 176 is partially removed such that the tissue collection cavity 182 is exposed to the environment (e.g., positioned proximal to the accessory opening 111), airflow AF can enter the tissue collection cavity 182. An advantage of the tray 176 of the present disclosure includes a sealing edge 212 configured to delay the onset of any airflow AF entering the tissue collection cavity 182. The delayed onset of airflow AF within tissue collection cavity 182, particularly in combination with ribs 200a-200c and second suction path SSP below basket 180, prevents removal and ejection of collected tissue samples from tray 176.
[0060] The seal member 154 can include a ledge 155 extending distally from a flange 156, the flange 156 including a sealing surface 157. The ledge 155 includes an outer periphery sized slightly smaller than the accessory opening 111 so as to be disposed in sealing engagement with a plurality of inner surfaces defining the accessory sleeve 113, one of which is the lower surface 218 of the upper barrier 103 (see FIGS. 12-14 ). In some embodiments, a previously introduced proximal portion 206 extends from the ledge 155. The proximal portion 206 can at least partially define the tissue collection cavity 182. For example, FIG. 10 illustrates the proximal portion 206 including an upstanding surface 220 extending between opposed sides 185 and defining the proximal side of the tissue collection cavity 182. The wall 198 can slope downward in the distal direction, away from the upstanding surface 220.
[0061] Proximal portion 206 includes sealing edge 212. Sealing edge 212 may be considered the uppermost edge of upstanding surface 220. Additionally or alternatively, sealing edge 212 may be flush with upper surface 222 of shelf 155. In other words, shelf 155 and proximal portion 206 may be generally unitary in appearance, whereas shelf 155 and basket 180 may otherwise be distinct in appearance (but unitarily formed). Sealing edge 212 is spaced apart from flange 156 such that it extends a greater distance within accessory sleeve 113 relative to the shelf when tray 176 is removably positioned within accessory sleeve 113. Referring to FIG. 12 , sealing edge 212 is in sealing engagement with upper barrier 103 at a boundary line identified at 223 that is significantly more distal than the sealing engagement of shelf 155 and accessory opening 111. For example, the distance between flange portion 156 and sealing edge 212 can be at least 3 millimeters, 5 millimeters, 7 millimeters, or 9 millimeters, or more millimeters.
[0062] The sealing edge 212 delays the onset of any airflow AF into the tissue collection cavity 182 when the tray 176 is removed from the accessory sleeve 113. FIG. 12 shows the tray 176 in the first or fully inserted position and further illustrates the manifold 100 in the sealed configuration. The inner surface 224 of the distal portion 190 of the tray 176 is located distal to the distal-most portion 226 of the inlet bore 114a. Thus, a first suction path FSP extends through the suction tube, the inlet bore 114a, the tissue collection cavity 182, the transfer bore 125, and into the manifold volume 108 to the outlet opening 109. The collected tissue sample, i.e., the tissue sample TS, is collected in the second pocket 204b adjacent the second rib 200b. FIG. 13 shows the tray 176 in the second position, and FIG. 14 shows the tray 176 in the third position. To move the tray 176 from the first position to the second position, a user applies an input to the first and second adjustment members 118a, 118b, for example, by grasping the gripping portions and pulling the tray 176 proximally. The flexible region 160 of the seal member 154 allows the pinching input to momentarily transition the manifold 100 from the sealed configuration to the bleed configuration before or simultaneously with the tray 176 beginning to move proximally within the accessory sleeve 113 (see, e.g., FIG. 8 ).
[0063] FIG. 13 shows the tray 176 positioned more proximally in the second position than in the first position. In addition to the space between the sealing surface 157 and the accessory opening 111 created by moving the manifold 100 to the bleed configuration, additional clearance is provided by the proximal movement of the tray 176 within the accessory sleeve 113. Almost all of the airflow is allowed through the second suction path SSP, with minimal or negligible airflow through the first suction path FSP. The sealing edge 212 remains in sealing engagement with the lower surface 218 of the upper barrier 103. Thus, in the second position, airflow is prevented from entering the tissue collection cavity 182. In the illustrated example, the tissue sample TS remains within the second pocket 204b adjacent the second rib 200b, and the inner surface 224 of the distal portion 190 of the tray 176 remains positioned distal to the distal-most portion 226 of the inlet bore 114a.
[0064] 14 shows the tray 176 in a third position (more proximal than the first and second positions) where an even larger gap is provided between the sealing surface 157 and the accessory opening 111. The sealing edge 212 is no longer in sealing engagement with the lower surface 218 of the upper barrier 103. In other words, the sealing edge 212 has been moved proximal to the accessory opening 111, and at least a portion of the tissue collection cavity 182 is now exposed to the surroundings. A third suction path TSP may be provided, specifically, airflow into the tissue collection cavity 182 between the sealing edge 212 and the upper barrier 103. Regardless of the presence of the third suction path TSP, movement of the tissue sample TS can be minimized or eliminated based on any one or more of the following advantageous features: (i) the ribs 200a-200c define pockets 204a-204d that provide low-pressure regions (see FIG. 15 ); (ii) the ribs 200a-200c provide a barrier; and (iii) the base portion 184 is arcuate, with the central surface 216 located between multiple groups 214 of multiple hole features 186.
[0065] When the sealing edge 212 is no longer in sealing engagement with the upper barrier 103, the inner surface 224 of the distal portion 190 of the tray 176 is no longer located distal to the distal-most portion 226 of the inlet bore 114a. In other words, the distal portion 190 begins to traverse the inlet bore 114a as the tissue collection cavity 182 becomes exposed to the environment. Among other benefits, this configuration prevents the tissue sample TS from ejecting above the distal portion 190 if the tissue sample TS is moving within the tray 176. Furthermore, the distal portion 190 traversing the inlet bore 114a effectively eliminates the first suction path FSP and creates a fourth suction path XSP. The fourth suction path XSP extends through the suction tube, the inlet bore 114a, the accessory sleeve 113 distal to the tray 176, the transfer bore 125, and into the manifold volume 108 to the outlet opening 109. The tray 176 may include a distal slot 230 in the legs 131 to accommodate the fourth suction path XSP for movement from the accessory sleeve 113 to the transfer bore 125 (see FIG. 10 ). Thus, despite the presence of the third suction path TSP within the tissue collection cavity 182, the volumetric flow rates permitted by the second and fourth suction paths SSP and XSP are significantly greater than the third suction path TSP, and fluid dynamics dictate that the third suction path TSP has a relatively low volumetric flow rate and disruptive force on collected tissue samples (i.e., the path of least resistance). In particular, the combination of the ribs 200a-200c and the group 214 of the plurality of hole features 186 allows the user to confidently remove the tray 176 with minimal risk of unintentionally losing collected tissue samples.
[0066] In some embodiments, the cap portion 106 and the body 104 are removably coupled to one another. With reference to FIGS. 1 and 2 , the cap portion 106 includes at least one key 146 or head coupler configured to removably couple with at least one keyway 148 or body coupler of the body 104. The keys 146 may be multiple keys 146 diametrically opposed to one another and extending proximally from the cap portion 106. The keyway 148 may be multiple keyways 148 diametrically opposed to one another. The key may include a shank and a barb extending from the shank. The barb may be thicker than the shank. As a result, during assembly of the manifold 100, or when it is desired to couple the cap portion 106 to the body 104, the cap portion 106 is oriented relative to the body 104 such that the barb 164 is rotationally aligned with the insert of the keyway 148. After the barbs extend through the inserts, the cap portion 106 is rotated relative to the body 104 to move the keys 146 into an interference fit configuration within the keyways 148. This interference prevents axial movement of the cap portion 106 relative to the body 104, and the cap portion 106 may be considered to be fixed to the body 104 to form the housing 102 of the manifold 100.
[0067] The cap portion 106 and / or the body 104 may include indicia 150, 152 configured to indicate whether the cap portion 106 and the body 104 are in a locked configuration, in which the cap portion 106 is secured to the body 104, or an unlocked configuration, in which the cap portion 106 may be separated from the body 104. More specifically, in the locked configuration, the key 146 may engage the keyway 148 to prevent axial movement of the cap portion 106 relative to the body 104, as described above. The indicia 150 on the cap portion 106 may include a locked icon and an unlocked icon, as shown in FIGS. 1 and 2, and the indicia 150 on the body 104 may include an arrow configured to point adjacent one of the locked icon and the unlocked icon based on whether the manifold 100 is in the locked configuration or the manifold 100 is in the unlocked configuration. Of course, the reverse configuration is also contemplated. 1 and 2 show the manifold 100 in a locked configuration with an arrow adjacent to and pointing toward the lock icon. Upon relative rotation of the cap portion 106 and body 106 as previously described, the arrow is moved relative to the cap portion 106 so that it is positioned adjacent to and points toward the unlock icon.
[0068] The removable connection between the cap portion 106 and the body 104 can provide access to the manifold volume 108 within which the filter element 133 is disposed. Among other benefits, access to the filter element 133 can allow a user to retrieve waste material, most notably polyps or tissue samples, collected within the filter element 133 for further examination and processing during certain surgical procedures. Co-owned International Publication WO 2013 / 090579, published June 20, 2013 (the entire contents of which are incorporated herein by reference), discloses a manifold including a tissue trap for collecting polyps or tissue samples. In some embodiments, the manifold 100 including the cap portion 106 can include additional features to aid in the collection of tissue samples. When it is desired to detach the cap portion 106 from the body 104, the steps of the aforementioned method can be reversed and the manifold volume 108 of the body 104 can be accessed.
[0069] In some embodiments, the cap portion 106 and the body 104 are rigidly connected by a suitable joining process, such as spin welding, solvent bonding, adhesives, mechanical fastening, or the like. As previously mentioned, the housing 102 may be of unitary or monolithic construction, such that there are no separate head and body components. Suitable manufacturing processes for forming the housing 102 may include injection molding, 3D printing, computer numerical control (CNC) machining, polymer casting, vacuum forming, and blow molding, among others. Suitable materials for forming the housing 102 may include polymers, composites, metals, ceramics, and combinations thereof. The materials include sufficient corrosion resistance to prevent degradation when exposed to waste materials and sufficient mechanical properties to maintain integrity under vacuum levels provided by medical waste collection systems. Polymers such as polyethylene, polypropylene, polyvinyl chloride, polyethylene terephthalate (PET, PETE), polystyrene, polycarbonate, and poly(methyl methacrylate) may be particularly well-suited for the manifold 100 in low-cost, disposable embodiments.
[0070] Some embodiments can be described with reference to the following exemplary clauses.
[0071] Clause 1 - A tray configured to be removably positioned within a sleeve having an opening and to collect tissue samples drawn through a first suction path, the tray including: a sealing member configured to be positioned in sealing engagement with the opening when the tray is removably positioned within the sleeve, the sealing member including a resilient, flexible portion; a first adjustment member extending from the sealing member; a second adjustment member extending from the sealing member and positioned away from the first adjustment member; and a basket extending from the sealing member in a direction opposite to the first and second adjustment members, the basket defining a plurality of hole features for collecting tissue samples from liquid drawn through the first suction path, the first and second adjustment members being positioned opposite the resilient, flexible portion and configured to receive an input to resiliently and pivotably move at least a portion of the sealing member away from the opening to provide a second suction path through the opening and the sleeve.
[0072] Clause 2 - The tray of clause 1, wherein the basket includes a neck region having a reduced cross-sectional profile of the basket such that a void space is defined between the basket and the seal member.
[0073] Clause 3 - A tray as described in Clause 1 or Clause 2, wherein the basket includes a base and opposing sides coupled to the base so as to collectively define a tissue collection cavity, a plurality of hole features defined within the base, and the base is arcuate in shape and concave between the opposing sides.
[0074] Clause 4 - A tray described in any one of clauses 1 to 3, further comprising a plurality of opposed rails extending along the base and configured to pass (form) a second suction path.
[0075] Clause 5 - The tray of clause 4, wherein each of the opposed rails defines a slot.
[0076] Clause 6 - A tray according to any one of clauses 1 to 5, wherein the elastically flexible portion includes a living hinge including a reduced thickness portion of the sealing member.
[0077] Clause 7 - A tray configured to be removably positioned within a sleeve having an opening and to collect tissue samples drawn through a first suction path, the tray including a sealing member configured to be positioned in sealing engagement with the opening when the tray is removably positioned within the sleeve, the sealing member including upper and lower regions, a first adjustment member extending from the upper region, a second adjustment member extending from the lower region and positioned away from the first adjustment member, and a basket extending from the upper region in a direction opposite to the first adjustment member, the basket defining a plurality of hole features for collecting tissue samples, no portion of the basket extending from the lower region of the seal member, the first and second adjustment members configured to accept an input for pivoting the lower region of the seal member relative to the upper region to move the lower region away from the opening to provide a second suction path through the opening and the sleeve without disturbing the collected tissue sample.
[0078] Clause 8 - The tray of clause 7, wherein the basket includes a neck region having a reduced cross-sectional profile of the basket such that a void space is defined between the basket and a lower region of the sealing member.
[0079] Clause 9 - A tray as described in Clause 7 or Clause 8, wherein the basket includes a base and opposing sides coupled to the base so as to collectively define a tissue collection cavity, a plurality of hole features defined within the base, and the tray further includes a plurality of opposing rails extending along the base and configured to pass a second suction path therethrough.
[0080] Clause 10 - The tray of clause 9, wherein each of the opposed rails defines a slot.
[0081] Clause 11 - A tray configured to be removably positioned within a sleeve having an opening and to collect tissue samples drawn through a first suction path, the tray including a sealing member configured to be positioned in sealing engagement with the opening when the tray is removably positioned within the sleeve, the sealing member including upper and lower regions separated by a living hinge including a reduced-metal portion of the seal member, an adjustment member extending from the upper region, and a basket extending from the seal member in a direction opposite to the adjustment member, the basket including a plurality of hole features for collecting tissue samples, the adjustment member configured to accept an input to pivot the lower region relative to the upper region about the living hinge to move the lower region of the seal member away from the opening to provide a second suction path through the opening and the sleeve.
[0082] Clause 12 - The tray of clause 11, wherein the basket includes a neck region having a reduced cross-sectional profile of the basket such that a void space is defined between the basket and the seal member.
[0083] Clause 13 - A tray as described in clause 11 or clause 12, wherein the basket includes a base and opposing sides coupled to the base so as to collectively define a tissue collection cavity, a plurality of hole features defined within the base, and the base is arcuate in shape and concave between the opposing sides.
[0084] Clause 14 - The tray of any one of clauses 11 to 13, further comprising a plurality of opposed rails extending along the base and configured to carry the second suction path.
[0085] Clause 15 - The tray of clause 14, wherein each of the opposed rails defines a slot.
[0086] Clause 16 - A tray for collecting tissue samples drawn under the action of suction (vacuum), the tray configured to be removably positioned within a sleeve having an opening, the tray including: a sealing member configured to be disposed in sealing engagement with the opening when the tray is removably positioned within the sleeve; an adjustment member extending from the sealing member; and a basket coupled to the sealing member, the basket including a base and opposing sides coupled to the base so as to collectively define a tissue collection cavity, and a plurality of hole features defined in the base for collecting tissue samples, the basket having a first cross-sectional profile defined by a boundary between the base, the opposing sides, and upper surfaces of the opposing sides, the basket further including a neck region extending from the seal member in a direction opposite to the adjustment member, the neck region having a second cross-sectional profile defined between a lower connecting surface of the neck region and an upper surface of the opposing side, the second cross-sectional profile being smaller than the first cross-sectional profile such that a void space is defined between the tissue collection cavity and the seal member.
[0087] Clause 17 - A tray according to clause 16, wherein the base is arcuate in shape and concave between the opposing sides.
[0088] Clause 18 - A tray as described in clause 16 or clause 17, further comprising a plurality of opposed rails extending along the base.
[0089] Clause 19 - The tray of clause 18, wherein each of the opposed rails defines a slot.
[0090] Clause 20 - A tray configured to be removably positioned within a sleeve having an opening and to collect tissue samples drawn through a first suction path, the tray including a sealing member configured to be disposed in sealing engagement with the opening when the tray is removably positioned within the sleeve, the sealing member including a resiliently flexible portion, an adjustment member extending from the sealing member and configured to receive an input to resiliently and pivotably move at least a portion of the seal member away from the opening to provide a second suction path through the opening and the sleeve, and a basket coupled to the sealing member, the basket including a base, opposing sides coupled to the base, a plurality of hole features in the base for collecting tissue samples, and legs including opposing rails extending along the base in a direction away from the tissue collection cavity so as to collectively define a tissue collection cavity, the legs configured to pass through the second suction path.
[0091] Clause 21 - The tray of clause 20, wherein each of the opposed rails defines a slot.
[0092] Clause 22 - A tray described in any one of clauses 1 to 21, wherein the basket further includes walls that collectively define a tissue collection cavity, the walls being configured to position the tissue sample away from the sealing member so that it is visible through the sleeve when viewed from above.
[0093] Clause 23 - A tray described in any one of clauses 1 to 22, further comprising a distal end extending from the base and extending between opposite sides, the distal end including an additional plurality of hole features.
[0094] Clause 24 - A manifold for collecting tissue samples through a suction tube, comprising: a sleeve including an upper barrier that is at least partially transparent; a tray including a sealing member configured to be disposed in sealing engagement with the opening when the tray is removably disposed within the sleeve; an adjustment member extending from the seal member; and a basket extending from the seal member in a direction opposite to the adjustment member, the basket including a base that is opaque and defines a plurality of hole features for collecting the tissue sample; opposed sides extending from the base; and a wall extending downwardly away from the seal member, the base, opposed sides, and wall collectively defining a tissue collection cavity, the wall configured to position the tissue sample away from the seal member as viewed through the upper barrier when viewed from above.
[0095] Clause 25 - The manifold of clause 24, wherein the wall is a ramp that slopes downwardly away from the seal member to force the tissue sample down towards the base.
[0096] Clause 26 - A manifold as described in clause 24 or clause 25, wherein the sleeve includes ledges defining valleys (recesses) between the ledges, the second suction path extending through the valleys.
[0097] Clause 27 - A manifold for collecting tissue samples through a suction tube, the manifold comprising a tray according to any one of clauses 1 to 22 and a sleeve.
[0098] Clause 28 - A method of collecting a sample under vacuum from a medical waste collection assembly including a receiver, comprising: coupling a suction tube to an inlet fitting of a manifold defining an inlet bore; and disposing the manifold within the opening of the receiver, the manifold having a tray removably disposed within a sleeve in a first position such that (i) a sealing member of the tray is disposed in sealing engagement with the opening, (ii) a distal portion of the tray is disposed distal to the inlet bore, and (iii) a tissue collection cavity of the tray is open to the inlet bore; activating the medical waste collection assembly with the tray in the first position, wherein the sample is drawn into the tissue collection cavity through a first suction path; and applying an input force to the first and second adjustment members to resiliently move the first and second adjustment members toward each other, the lower portion of the sealing member being configured to provide a second suction path. maintaining the input to the first and second adjustment members while moving the tray from the first position to a second position, where the sealing member moves away from the opening, a sealing edge of the tray remains in sealing engagement with the upper barrier defining a sleeve, and a distal portion of the tray remains disposed distally of the inlet bore at the second position; and maintaining the input to the first and second adjustment members while moving the tray from the second position to a third position, where the sealing member moves further away from the opening, the sealing edge of the tray disengages the upper barrier defining a sleeve to provide a third suction path, and the distal portion of the tray moves to the third position proximal to the inlet bore to eliminate the first suction path and provide a fourth suction path.
[0099] Clause 29 - The method of clause 28, wherein the steps of applying an input to the first and second adjustment members and moving the tray from the first position to the second position are performed simultaneously.
[0100] The foregoing description is not intended to be exhaustive or to 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 in other ways than as specifically described. The claims at the time of filing were as follows: [Claim 1] 1. A tray configured to collect tissue samples under the influence of a vacuum by being removably placed within a sleeve having an opening, a seal member configured to be disposed in sealing engagement with the opening when the tray is removably disposed within the sleeve; a basket extending from the seal member; Equipped with the basket comprising a base and opposing sides coupled to the base so as to collectively define a tissue collection cavity; the base portion defines, together with the tissue collection cavity, a plurality of hole features for collecting the tissue sample; The tray, wherein the base portion includes a plurality of ribs disposed within the tissue collection cavity. [Claim 2] 1. A tray configured to collect tissue samples under the influence of a vacuum by being removably placed within a sleeve having an opening, a seal member configured to be disposed in sealing engagement with the opening when the tray is removably disposed within the sleeve; a basket extending from the seal member; Equipped with the basket comprising a base and opposing sides coupled to the base so as to collectively define a tissue collection cavity; the base portion defines, together with the tissue collection cavity, a plurality of hole features for collecting the tissue sample; The base portion includes ribs extending between the opposing sides and dividing the tissue collection cavity into a plurality of pockets. [Claim 3] 1. A tray configured to collect tissue samples under the influence of a vacuum by being removably placed within a sleeve having an opening, a seal member configured to be disposed in sealing engagement with the opening when the tray is removably disposed within the sleeve; a basket extending from the seal member; Equipped with the basket having a length greater than a width such that the basket is elongated and has a longitudinal axis; the basket comprising a base and opposing sides coupled to the base so as to collectively define a tissue collection cavity; the base portion defines, together with the tissue collection cavity, a plurality of hole features for collecting the tissue sample; The tray, wherein the base portion includes ribs within the tissue collection cavity, the ribs being elongated and oriented in an axis transverse to the longitudinal axis. [Claim 4] 1. A tray configured to collect tissue samples under the influence of a vacuum by being removably placed within a sleeve having an opening, a seal member configured to be disposed in sealing engagement with the opening when the tray is removably disposed within the sleeve; a basket extending from the seal member; Equipped with the basket comprising a base and opposing sides coupled to the base so as to collectively define a tissue collection cavity; the base portion defines, together with the tissue collection cavity, a plurality of hole features for collecting the tissue sample; A tray, wherein the base portion is defined between an upper surface and an opposing lower surface, the base portion including ribs extending upwardly from the upper surface a distance sufficient to create a pocket that is a low pressure area when the tray is removed from within the sleeve. [Claim 5] 1. A tray configured to collect tissue samples under the influence of a vacuum by being removably placed within a sleeve having an opening, a seal member configured to be disposed in sealing engagement with the opening when the tray is removably disposed within the sleeve; a basket having a proximal portion extending from the seal member, opposing sides coupled to the proximal portion, a base portion coupled to the opposing sides, and a distal portion coupled to the base portion and the opposing sides, the proximal portion, the opposing sides, the base portion, and the distal portion collectively defining a tissue collection cavity, and the base portion together with the tissue collection cavity defining a plurality of hole features for collecting the tissue sample; a rib within the tissue collection cavity defining at least two pockets arranged in series between the proximal and distal portions; Equipped with The at least two pockets are associated with a low pressure region when the tray is removed from within the sleeve. [Claim 6 ] The tray of claim 5 , wherein the at least two pockets comprise four pockets. [Claim 7] 7. The tray of claim 5 or claim 6, wherein one of the pockets is defined between the rib and the proximal portion. [Claim 8] 7. The tray of claim 5 or claim 6, wherein one of the pockets is defined between the rib and the distal portion. [Claim 9] 6. A tray as claimed in any one of claims 2, 4 and 5, wherein the basket has a length greater than a width such that the basket is elongated and has a longitudinal axis, and the ribs are elongated and oriented along an axis transverse to the longitudinal axis. [Claim 10] The tray of claim 1 , wherein the plurality of hole features are disposed between the ribs. [Claim 11] The tray of claim 1 , wherein the ribs further comprise three ribs. [Claim 12] 6. The tray according to claim 2, wherein the ribs further include three ribs. [Claim 13] 13. The tray of claim 12, wherein the three ribs are equally spaced from one another. [Claim 14] 14. The tray of claim 12 or claim 13, wherein the three ribs define four pockets in the base portion, and a plurality of hole features are within each of the four pockets. [Claim 15] 15. The tray according to claim 12, wherein the three ribs are parallel to one another. [Claim 16] 14. A tray as described in any one of claims 2 to 13, wherein the base portion is arcuate in shape and concave between the opposing sides, and the ribs are arcuate and contoured complementary to the arcuate shape of the base portion. [Claim 17] 17. The tray according to claim 1, wherein the plurality of hole features are arranged in at least two groups. [Claim 18] 18. The tray of claim 17, wherein each of the at least two groups comprises at least two rows of holes oriented longitudinally along the base portion. [Claim 19] 18. The tray of claim 17, wherein the rib separates the at least two groups. [Claim 20] 1. A tray configured to collect tissue samples under the influence of a vacuum by being removably placed within a sleeve having an opening, a seal member configured to be disposed in sealing engagement with the opening when the tray is removably disposed within the sleeve; a basket extending from the seal member; Equipped with the basket comprising a base and opposing sides coupled to the base so as to collectively define a tissue collection cavity; the base portion includes ribs that divide the tissue collection cavity into a plurality of pockets; A tray, wherein the base defines a plurality of hole features in each pocket, each pocket including a plurality of groups of the hole features, the hole features being equally spaced apart from one another by a first distance, and the groups being spaced apart from one another by a second distance greater than the first distance. [Claim 21] 21. The tray of claim 20, wherein each of the plurality of groups comprises at least two rows of holes oriented longitudinally along the base portion. [Claim 22] 1. A tray configured to collect tissue samples under the influence of a vacuum by being removably placed within a sleeve having an opening, a seal member configured to be disposed in sealing engagement with the opening when the tray is removably disposed within the sleeve; a ledge extending from the seal member, the ledge being complementary in size and shape to the sleeve for placement within the sleeve when the seal member is in sealing engagement with the opening; a basket having a proximal portion extending from the shelf, opposing sides coupled to the proximal portion, a base portion coupled to the opposing sides, and a distal portion coupled to the base portion and the opposing sides; Equipped with the proximal portion, the opposed side portions, the base portion, and the distal portion collectively define a tissue collection cavity; the base portion defines, together with the tissue collection cavity, a plurality of hole features for collecting the tissue sample; A tray wherein the sealing edge of the proximal portion is flush with the upper surface of the shelf portion. [Claim 23] 23. The tray of claim 22, wherein a top surface of the proximal portion including the sealing edge is flush with a top surface of the shelf portion. [Claim 24] 1. A tray configured to collect tissue samples under the influence of a vacuum by being removably placed within a sleeve having an opening, a seal member configured to be disposed in sealing engagement with the opening when the tray is removably disposed within the sleeve; a ledge extending from the seal member, the ledge being complementary in size and shape to the sleeve for placement within the sleeve when the seal member is in sealing engagement with the opening; a basket having a proximal portion extending from the shelf, opposing sides coupled to the proximal portion, a base portion coupled to the opposing sides, and a distal portion coupled to the base portion and the opposing sides; Equipped with the proximal portion, the opposed side portions, the base portion, and the distal portion collectively define a tissue collection cavity; the base portion defines, together with the tissue collection cavity, a plurality of hole features for collecting the tissue sample; A tray wherein the proximal portion extends from the shelf portion by at least 5 millimeters so that when the tray begins to be removed from the sleeve, air ingress into the sleeve is prevented near the proximal portion while air ingress into the sleeve is permitted near the base portion. [Claim 25] 25. The tray of claim 24, wherein the shelf has a defined thickness between a distal surface and the seal member, the thickness being less than 5 millimeters. [Claim 26] 26. The tray of claim 24 or claim 25, wherein an upper surface of the proximal portion is flush with an upper surface of the shelf portion. [Claim 27] a manifold for collecting tissue samples through a suction tube, a housing having a sleeve defining an opening; Tray and Equipped with the sleeve includes an inlet fitting defining an inlet bore opening into the sleeve; The tray is a seal member configured to be disposed in sealing engagement with the opening when the tray is removably disposed within the sleeve; a basket having a proximal portion coupled to the seal member, opposing side portions coupled to the proximal portion, a base portion coupled to the opposing side portions, and a distal portion coupled to the base portion and the opposing side portions; Equipped with the proximal portion, the opposed side portions, the base portion, and the distal portion collectively define a tissue collection cavity; the base portion defines, together with the tissue collection cavity, a plurality of hole features for collecting the tissue sample; the proximal portion includes a sealing edge; The manifold, wherein the distance between the opening and the inlet bore is less than the distance between the sealing edge and the distal portion. [Claim 28] a manifold for collecting the tissue sample through a suction tube, A tray according to any one of claims 1 to 26, The sleeve; A manifold comprising: [Claim 29] a manifold for collecting tissue samples through a suction tube, a sleeve defining an opening; Tray and Equipped with The tray is a seal member configured to be disposed in sealing engagement with the opening when the tray is inserted into and removed from the sleeve in a proximal-distal direction; a basket extending from the seal member, the basket including a base and opposing sides coupled to the base so as to collectively define a tissue collection cavity; Equipped with the base portion defines, together with the tissue collection cavity, a plurality of hole features for collecting the tissue sample; the base portion includes a rib disposed within the tissue collection cavity, the rib defining a plurality of pockets disposed proximally and distally within the tissue collection cavity; The pockets are configured to provide a low pressure region to retain the tissue sample within one of the pockets when the tray is removed from the sleeve. [Claim 30] 30. The manifold of claim 29, wherein the ribs are oriented toward a longitudinal axis of the tray. [Claim 31] a manifold for collecting tissue samples through a suction tube, a sleeve defining an opening; Tray and Equipped with The tray is a seal member configured to be disposed in sealing engagement with the opening when the tray is inserted into and removed from the sleeve in a proximal-distal direction; a ledge extending from the seal member, the ledge being complementary in size and shape to the sleeve for placement within the sleeve when the seal member is in sealing engagement with the opening; a basket having a proximal portion extending from the shelf, opposing sides coupled to the proximal portion, a base portion coupled to the opposing sides, and a distal portion coupled to the base portion and the opposing sides; Equipped with the proximal portion, the opposed side portions, the base portion, and the distal portion collectively define a tissue collection cavity; the base portion defines, together with the tissue collection cavity, a plurality of hole features for collecting the tissue sample; A manifold configured such that when the sealing member is disengaged from the opening and the shelf is removed from the sleeve, the sealing edge of the proximal portion remains temporarily engaged with the upper surface of the sleeve. [Claim 32] 32. The manifold of claim 31, wherein the proximal portion extends from the shelf by at least 5 millimeters. [Claim 33] 1. A tray configured to collect tissue samples under the influence of a vacuum by being removably placed within a sleeve having an opening, a seal member configured to be disposed in sealing engagement with the opening when the tray is removably disposed within the sleeve; a basket coupled to the seal member; Equipped with the basket including a base and opposing sides coupled to the base so as to collectively define a tissue collection cavity; the base portion defines, together with the tissue collection cavity, a plurality of hole features for collecting the tissue sample; the base portion is arcuate in shape and concave between the opposed sides; The tray, wherein the base portion includes ribs within the tissue collection cavity, the ribs being arcuate in shape complementary to the arcuate shape of the base portion. [Claim 34] 34. The tray of claim 33, wherein the ribs are crescent-shaped.
Claims
1. 1. A tray configured to collect tissue samples under the influence of a vacuum by being removably placed within a sleeve having an opening, a seal member configured to be disposed in sealing engagement with the opening when the tray is removably disposed within the sleeve; a basket extending from the seal member; Equipped with the basket comprising a base and opposing sides coupled to the base so as to collectively define a tissue collection cavity; the base portion defines, together with the tissue collection cavity, a plurality of hole features for collecting the tissue sample; the base portion includes a plurality of ribs disposed within the tissue collection cavity, the plurality of ribs defining a plurality of pockets; the pocket comprises a low pressure region of air adjacent the tissue collection cavity to prevent the tissue sample from being expelled when the tray is removed from within the sleeve while a vacuum is being drawn through the tray; A tray wherein the base is arcuate in shape and concave between the opposing sides, and each of the plurality of ribs is arcuate and contoured complementary to the arcuate shape of the base.
2. 1. A tray configured to collect tissue samples under the influence of a vacuum by being removably placed within a sleeve having an opening, a seal member configured to be disposed in sealing engagement with the opening when the tray is removably disposed within the sleeve; a basket extending from the seal member; Equipped with the basket having a length greater than a width such that the basket is elongated and has a longitudinal axis; the basket comprising a base and opposing sides coupled to the base so as to collectively define a tissue collection cavity; the base portion defines, together with the tissue collection cavity, a plurality of hole features for collecting the tissue sample; the base portion includes a plurality of ribs within the tissue collection cavity, the ribs being elongated and oriented along an axis transverse to the longitudinal axis to define a plurality of pockets; the pocket comprises a low pressure region of air adjacent the tissue collection cavity to prevent the tissue sample from being expelled when the tray is removed from within the sleeve while a vacuum is being drawn through the tray; A tray wherein the base is arcuate in shape and concave between the opposing sides, and each of the plurality of ribs is arcuate and contoured complementary to the arcuate shape of the base.
3. 1. A tray configured to collect tissue samples under the influence of a vacuum by being removably placed within a sleeve having an opening, a seal member configured to be disposed in sealing engagement with the opening when the tray is removably disposed within the sleeve; a basket extending from the seal member; Equipped with the basket comprising a base and opposing sides coupled to the base so as to collectively define a tissue collection cavity; the base portion defines, together with the tissue collection cavity, a plurality of hole features for collecting the tissue sample; the base portion is defined between an upper surface and an opposed lower surface, the base portion comprising a plurality of ribs extending upwardly from the upper surface a distance sufficient to create a pocket that is a low pressure area when the tray is removed from within the sleeve while a vacuum is drawn through the tray; A tray wherein the base is arcuate in shape and concave between the opposing sides, and each of the plurality of ribs is arcuate and contoured complementary to the arcuate shape of the base.
4. 1. A tray configured to collect tissue samples under the influence of a vacuum by being removably placed within a sleeve having an opening, a seal member configured to be disposed in sealing engagement with the opening when the tray is removably disposed within the sleeve; a basket having a proximal portion extending from the seal member, opposing sides coupled to the proximal portion, a base portion coupled to the opposing sides, and a distal portion coupled to the base portion and the opposing sides, the proximal portion, the opposing sides, the base portion, and the distal portion collectively defining a tissue collection cavity, and the base portion together with the tissue collection cavity defining a plurality of hole features for collecting the tissue sample; a plurality of ribs within the tissue collection cavity and defining at least four pockets arranged in series between the proximal and distal portions; Equipped with the at least four pockets are associated with a low pressure region when the tray is removed from within the sleeve while a vacuum is drawn through the tray; A tray wherein the base is arcuate in shape and concave between the opposing sides, and each of the plurality of ribs is arcuate and contoured complementary to the arcuate shape of the base.
5. The tray of claim 4 , wherein one of the pockets is defined between one of the plurality of ribs and the proximal portion.
6. The tray of claim 4 , wherein one of the pockets is defined between one of the plurality of ribs and the distal portion.
7. 2. The tray of claim 1, wherein the basket has a length greater than a width such that the basket is elongated and has a longitudinal axis, and the plurality of ribs are elongated and oriented with an axis transverse to the longitudinal axis.
8. The tray of claim 1 , wherein the plurality of hole features are arranged in at least two groups.
9. 9. The tray of claim 8, wherein each of the at least two groups comprises at least two rows of holes oriented longitudinally along the base portion.
10. The tray of claim 8 , wherein the plurality of ribs separate the at least two groups.
11. 1. A tray configured to collect tissue samples under the influence of a vacuum by being removably placed within a sleeve having an opening, a seal member configured to be disposed in sealing engagement with the opening when the tray is removably disposed within the sleeve; a basket extending from the seal member; Equipped with the basket comprising a base and opposing sides coupled to the base so as to collectively define a tissue collection cavity; the base portion includes a plurality of ribs that divide the tissue collection cavity into a plurality of pockets; the pocket comprises a low pressure region of air adjacent the tissue collection cavity to prevent the tissue sample from being expelled when the tray is removed from within the sleeve while a vacuum is being drawn through the tray; the base is arcuate in shape and concave between the opposed sides, and each of the plurality of ribs is arcuate and contoured complementary to the arcuate shape of the base; A tray, wherein the base defines a plurality of hole features in each pocket, each pocket including a plurality of groups of the hole features, the hole features being equally spaced apart from one another by a first distance, and the groups being spaced apart from one another by a second distance greater than the first distance.
12. The tray according to any one of claims 1 to 11, wherein the plurality of ribs are crescent-shaped.
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