Manifolds for medical waste collection assemblies and methods of collecting tissue samples therewith
The manifold assembly addresses inefficiencies in tissue sample collection by enabling a secondary suction path for safe and efficient sample removal, reducing the risk of loss and exposure to hazardous waste during surgical procedures.
Patent Information
- Application Number
- CN202411261071.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2018-10-17
- Filing Date
- 2019-05-17
- Publication Date
- 2024-12-13
AI Technical Summary
Existing surgical procedures for collecting tissue samples face challenges such as increased time, inconvenience, and potential exposure to hazardous medical waste, with existing systems often failing to efficiently collect multiple samples.
A manifold assembly with a housing, inlet port, accessory opening, and outlet opening, featuring a tray with a control surface and sealing surface that allows for a removable tray configuration to switch between sealed and deflated states, creating separate suction paths to facilitate efficient tissue sample collection and removal.
The manifold assembly minimizes the risk of tissue sample loss and exposure to hazardous waste by providing a secondary suction path for safe and efficient tissue sample collection and removal without interrupting the surgical procedure.
Smart Images

Figure CN119112253A_ABST
Abstract
Description
[0001] This application is a divisional application of an invention patent application with an application date of May 17, 2019, application number 201980047509.2, and invention name “Manifold for medical waste collection assembly and method for collecting tissue samples using the same”.
[0002] CROSS-REFERENCE TO RELATED APPLICATIONS
[0003] This patent application claims priority to and all the benefits of U.S. Provisional Patent Application No. 62 / 673,418 filed on May 18, 2018, U.S. Provisional Patent Application No. 62 / 685,792 filed on June 15, 2018, and U.S. Provisional Patent Application No. 62 / 746,802 filed on October 17, 2018, the entire contents of each of which are incorporated herein by reference. Technical Field
[0004] The present disclosure relates generally to apparatus, systems and methods for surgical procedures and, more particularly, but not exclusively, to surgical procedures utilizing a medical waste collection assembly to collect tissue samples under suction. Background Art
[0005] Certain surgical procedures involve the removal of tissue samples for evaluation. For example, a polypectomy procedure involves the removal of a polyp from a surgical site within a patient's body, such as the uterus or endometrial tissue of the colon. Typically, the polyp is aspirated out using suction applied to the surgical site using a medical waste collection assembly. Once the polyp is collected in the suction path, removal of the polyp is an area of particular interest and research. Many known systems and methods have several disadvantages, including increased time and inconvenience of the surgical procedure, potential exposure to hazardous medical waste, inability to collect multiple tissue samples, etc. Therefore, there is a need in the art for an improved manifold and method of collecting tissue samples using a manifold and a medical waste collection assembly. BRIEF DESCRIPTION OF THE DRAWINGS
[0006] Advantages of the present disclosure will become more readily understood by referring to the following detailed description when considered in conjunction with the accompanying drawings.
[0007] Figure 1 is a schematic diagram of a portion of a medical waste collection assembly with a manifold positioned within a manifold receiver of the medical waste collection assembly.
[0008] Figure 2 is a partial cross-sectional view of a manifold engaged with a manifold receiver including a suction inlet.
[0009] Figure 3 is a perspective view of the manifold.
[0010] Figure 4 yes Figure 3 A perspective view of the manifold with the tray removed from the accessory sleeve.
[0011] Figure 5 yes Figure 3 Exploded view of the manifold.
[0012] Figure 6 yes Figure 3 A cross-sectional view of the manifold taken along section line 6-6.
[0013] Figure 7 yes Figure 6 A cross-sectional view of the control surface where it is moved to the discharge configuration.
[0014] Figure 8 It is a top perspective view of the tray.
[0015] Fig. 9 This is a bottom-up perspective view of the tray.
[0016] Fig.10 is a rear view of the cap portion of the manifold.
[0017] Fig.11 is a front view of the body portion of the manifold.
[0018] Fig.12 is a perspective view of the manifold.
[0019] Fig.13 yes Fig.12 Exploded view of the manifold.
[0020] Fig.14 yes Fig.12 A cross-sectional view of the manifold taken along section line 5-5.
[0021] Fig.15 yes Fig.12 Exploded view of the cap portion of the manifold.
[0022] Fig.16 It is a rear perspective view of the cap head of the cap portion.
[0023] Fig.17 yes Fig.18 A rear perspective view of a cap panel of a cap portion.
[0024] Fig.18 is a perspective view of another cap panel and tray of a manifold, wherein the cap panel includes a magnifying lens.
[0025] Fig.19 yes Fig.12 A perspective view of a tray of a manifold, wherein the tray defines a tissue collection chamber and a bypass channel.
[0026] Fig. 20 is with Fig.12 A perspective view of another tray for use with a manifold, wherein the tray includes a magnifying lens.
[0027] Fig.21 is with Fig.12 A perspective view of another tray used in conjunction with the manifold.
[0028] Fig. 22 is with Fig.12 A perspective view of another tray used in conjunction with the manifold.
[0029] Fig.23 is a perspective view of the manifold.
[0030] Fig.24 yes Fig.23 Exploded view of the manifold.
[0031] Fig.25 yes Fig.23 A cross-sectional view of the manifold taken along section line 25-25.
[0032] Fig.26 yes Fig.23 A front view of a tray of a manifold, wherein the tray defines a tissue collection chamber and a bypass channel.
[0033] Fig. 27 is a perspective view of the manifold.
[0034] Fig.28 yes Fig. 27 Exploded view of the manifold.
[0035] Fig.29 is a perspective view of the manifold.
[0036] Fig.30 yes Fig.29 Exploded view of the manifold.
[0037] Fig.31 yes Fig.29 A cross-sectional view of the manifold taken along section line 31-31.
[0038] Fig.32 yes Fig.29 A rear perspective view of the cap portion of the manifold.
[0039] Fig.33 yes Fig.29 A perspective view of a tray of a manifold, wherein the tray defines a tissue collection chamber.
[0040] Fig.34 is a perspective view of the manifold.
[0041] Fig.35 yes Fig.34Exploded view of the manifold.
[0042] Fig.36 yes Fig.34 A cross-sectional view of the manifold taken along section line 36-36.
[0043] Fig.37 yes Fig.34 A front perspective view of the cap portion of the manifold.
[0044] Fig.38 yes Fig.37 Rear perspective view of the cap portion of the .
[0045] Fig.39 yes Fig.34 A perspective view of the sliding member of the manifold.
[0046] Fig.40 yes Fig.40 A perspective view of a tray of a manifold, wherein the tray defines a tissue collection chamber.
[0047] Fig.41 is a perspective view of the manifold.
[0048] Fig.42 yes Fig.41 Exploded view of the manifold.
[0049] Fig.43 yes Fig.41 Cross-sectional view of the manifold with the rotor in the tissue collection position.
[0050] Fig.44 yes Fig.41 A cross-sectional view of the manifold with the rotor in the bypass position.
[0051] Fig.45 yes Fig.41 A partial cross-sectional view of the manifold schematically illustrating the suction path when the rotor is in the tissue collection position.
[0052] Fig.46 yes Fig.41 A partial cross-sectional view of a manifold schematically illustrating the suction path when the rotor is in the bypass position.
[0053] Fig.47 yes Fig.41 A front perspective view of the cap portion of a manifold including a stator defining a window.
[0054] Fig.48 yes Fig.41 A first perspective view of a rotor of a manifold, wherein the rotor defines a tissue collection chamber.
[0055] Fig.49 yes Fig.44 A second perspective view of the rotor.
[0056] Fig.50 is a perspective view of the manifold.
[0057] Fig.51 yes Fig.50 Exploded view of the manifold.
[0058] Fig.52 yes Fig.50 A cross-sectional view of the manifold taken along section line 52-52.
[0059] Fig.53 yes Fig.50 A cross-sectional view of the manifold taken along section line 53-53.
[0060] Fig.54 yes Fig.50 Rear perspective view of the cap panel of the manifold.
[0061] Fig.55 is a perspective view of the manifold.
[0062] Fig.56 yes Fig.55 Exploded view of the manifold.
[0063] Fig.57 yes Fig.55 Rear perspective view of the cap panel of the manifold.
[0064] Fig.58 yes Fig.55 Rear perspective view of the cap head of the manifold.
[0065] Fig.59 yes Fig.55 A front view of a manifold schematically illustrating the manifold in a tissue collection position.
[0066] Fig.60 yes Fig.55 A front view of a manifold schematically illustrating the manifold in a bypass position.
[0067] Fig.61 yes Fig.55 A cross-sectional elevation view of a manifold schematically illustrating the flow path through the manifold in a tissue collection position.
[0068] Fig.62 yes Fig.55 A perspective view of a variation of a manifold.
[0069] Fig.63 yes Fig.55 A side view of the cap head of a manifold, including orientation and / or locating features.
[0070] Fig.64 yes Fig.62A tray for a manifold, wherein the tray includes complementary orientation and / or positioning features.
[0071] Fig.65 is a perspective view of the cap portion of the manifold.
[0072] Fig.66 yes Fig.65 Side view of the cap portion with the tray removed.
[0073] Fig.67 is a perspective view of the cap portion of the manifold.
[0074] Fig.68 yes Fig.66 Side view of the cap portion with the tray removed.
[0075] Fig.69 is a rear perspective view of a manifold including an access feature that will be permanently destroyed to provide access to a filter element within the manifold.
[0076] Fig.70 is a rear perspective view of a manifold including an access feature that will be permanently destroyed to provide access to a filter element within the manifold.
[0077] Fig.71 is a rear perspective view of a manifold including an access feature that will be permanently destroyed to provide access to a filter element within the manifold.
[0078] Fig.72 yes Fig.69 Rear perspective view of the body portion of .
[0079] Fig.73 is a rear perspective view of a filter element including a window that allows removal of a tissue sample through an access feature. Summary of the invention
[0080] A manifold for collecting tissue samples via an aspiration line. The housing defines a manifold volume, an inlet port in fluid communication with the manifold volume and adapted to be in fluid communication with the aspiration line, an accessory opening leading to an accessory sleeve in fluid communication with the manifold volume, and an outlet opening adapted to be in fluid communication with a suction source to provide a first suction path from the aspiration line through the accessory sleeve and the manifold volume to the outlet opening. The housing includes a locating feature disposed within the accessory sleeve. The manifold includes a tray including a control surface, a sealing surface coupled to the control surface, a base portion, and a side portion coupled to the base portion, wherein the base portion and the side portion extend from the sealing surface and define a tissue collection chamber, and the porous feature is within the base portion. The tray is adapted to be removably coupled to the housing such that (i) the sealing surface seals the accessory opening, (ii) the tissue collection cavity is positioned within the accessory sleeve and is open toward the inlet aperture, and (iii) the base portion and / or the side portion engages a locating feature within the accessory sleeve to provide a gap between the base portion of the tray and a lower barrier of the housing defining the accessory sleeve. The tray is adapted to receive input from a user to move the sealing surface away from a portion of the accessory opening proximate the lower barrier to provide and position a second suction path from the accessory opening through the gap between the base portion of the tray and the lower barrier of the housing defining the accessory sleeve to the outlet opening.
[0081] A manifold for collecting tissue samples via an aspiration line. The manifold includes a housing defining a manifold volume, an inlet port in fluid communication with the manifold volume and adapted to be in fluid communication with the aspiration line, an accessory opening leading to an accessory sleeve in fluid communication with the manifold volume, a slot in the accessory sleeve extending to the accessory opening, and an outlet opening adapted to be in fluid communication with a suction source to provide a suction path from the aspiration line through the accessory sleeve and the manifold volume to the outlet opening. The manifold includes a tray including a control surface, a sealing surface coupled to the control surface, a base portion, and a side portion coupled to the base portion, wherein the base portion and the side portion extend from the sealing surface and define a tissue collection cavity, and the porous feature is within the base portion. The tray is adapted to be removably coupled to the housing in a sealed configuration in which (i) the sealing surface seals the accessory opening, (ii) the tissue collection cavity is positioned within the accessory sleeve and is open toward the inlet aperture, and (iii) a gap is defined between a base portion of the tray and the slot within the accessory sleeve. A control surface of the tray is adapted to receive input from a user to actuate the manifold from the sealed configuration to a deflated configuration in which a portion of the sealing surface moves away from a portion of the accessory opening to provide and position a second suction path from the accessory opening through the slot and the manifold volume to the outlet opening.
[0082] A method for collecting tissue samples through an aspiration line coupled to a manifold. The manifold includes a housing defining a manifold volume, an inlet aperture in fluid communication with the manifold volume in fluid communication with the aspiration line, an accessory opening leading to an accessory sleeve in fluid communication with the manifold volume, a locating feature disposed within the accessory sleeve, and an outlet opening in fluid communication with a suction source. The manifold includes a tray including a control surface, a sealing surface coupled to the control surface, a base portion, and a side portion coupled to the base portion, wherein the base portion and the side portion extend from the sealing surface and define a tissue collection cavity, and the porous feature is within the base portion. The tray is coupled to the housing such that the tissue collection cavity is within the accessory sleeve and open toward the inlet aperture, the sealing surface seals the accessory opening, and the base portion and / or the side portion engage the locating feature within the accessory sleeve to provide a gap between the base portion of the tray and a lower stopper of the housing defining the accessory sleeve. A first suction path is provided from the aspiration line through the accessory sleeve and the manifold volume to the outlet opening. The suction source is operated to collect a tissue sample within the tissue collection cavity of the tray using the porous feature. An input is applied to the control surface of the tray to move at least a portion of the sealing surface away from a portion of the accessory opening adjacent the lower barrier to provide and position a second suction path from the accessory opening through a gap between the base portion of the tray and the lower barrier of the housing to the outlet opening. DETAILED DESCRIPTION
[0083] use Figure 1 The medical waste collection assembly 50 schematically shown in FIG. 5 can facilitate aspiration of tissue samples from a patient. An exemplary medical waste collection assembly suitable for aspiration is the Neptune 100 manufactured by Stryker Corporation (Kalamazoo, Michigan). and Neptune Waste management systems are 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, each of which is incorporated herein by reference in its entirety. In the broadest sense, the medical waste collection assembly 50 includes a vacuum pump adapted to be placed in fluid communication with the proximal end of the suction line 52. The distal end of the suction line 52 is coupled to an instrument located near the surgical site. The desired tissue sample is excised, for example, by a trapping technique, and the excised tissue sample is aspirated into the suction line 52 toward the medical waste collection assembly 50.
[0084] Aspirates of semi-solid and solid matter, including tissue samples, must be captured or properly filtered to avoid potential clogging of the medical waste collection assembly 50. Figure 2, the medical waste collection assembly 50 engages the manifold 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000, 1100 (hereinafter referred to as 100-1100). The medical waste collection assembly 50 includes a manifold receiver 54 adapted to be removably engaged with the manifold 100-1100. The manifold receiver 54 may define a void 56 sized to receive a proximal portion of the manifold 100-1100. The medical waste collection assembly 50 also includes a suction inlet 58 adapted to be in fluid communication with an outlet opening of the manifold 100-1100 when the manifold 100-1100 is engaged with the manifold receiver 54. The manifold receiver 54 may include a valve disc 60 that is rotatable to align the aperture 62 with the suction inlet 58 when the outlet opening engages and rotates a boss 64 defining the aperture 62. Details of the interface between the manifolds 100 - 1100 and the manifold receiver 54 are disclosed in commonly owned US 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.
[0085] like Figure 1 As shown, the manifold 100-1100 is adapted to receive the suction line 52. With the manifold 100-1100 engaged with the manifold receiver 54, a suction path is established from the suction line 52 through the manifold 100-1100 to the medical waste collection assembly 50. In addition to other functions to be described, the manifold 100-1100 captures semi-solid and solid matter entrained in the flow of suction from the surgical site.
[0086] Figure 3-7 An embodiment of a manifold 100 for collecting tissue samples is shown. The manifold 100 includes a housing 102 adapted to be removably engaged with a manifold receiver 54. The housing 102 may include a body portion 104 and a cap portion 106. The cap portion 106 is coupled to the body portion 104 by a removable or permanent connection, but it is contemplated that the body and cap portions 104, 106 may be formed as a one-piece unitary structure. Figure 6 and 7 As best shown, manifold 100 defines a manifold volume 108 and an outlet opening 110 in fluid communication with manifold volume 108. Body portion 104 may include a proximal base 126 and at least one side 128 extending distally therefrom to define a cavity 130 including a portion of manifold volume 108. Figure 3The body portion 104 is shown as being cylindrical and defining a cavity 130, but it should be understood that other geometries, including asymmetrical shapes, are contemplated. As used herein, proximal (P) refers to a direction toward the rear of the manifold 100 and toward the medical waste collection assembly 50 when the medical waste collection assembly 50 is engaged with the manifold 100, while distal (D) refers to a direction toward the front of the manifold 100 and toward the surgical site (see Figure 4 ) direction. The outlet opening 110 may be disposed within the proximal base 126. Alternatively, the outlet opening 110 may be positioned at any suitable location of the housing 102, including, but not limited to, the side 128 of the body portion 104 and the cap panel 140 of the cap portion 106 to be described. The housing 102 includes at least one inlet connector 112a, 112b adapted to receive the suction line 52. The inlet connectors 112a, 112b define corresponding inlet holes 114a, 114b that are in fluid communication with the manifold volume space 108. The outlet opening 110 is adapted to be in fluid communication with the suction inlet 58 of the medical waste collection assembly 50 when the housing 102 is engaged with the manifold receiver 54, thereby providing a suction path from the inlet holes 114a, 114b to the suction inlet 58.
[0087] The manifold 100 may include a drip valve 132 disposed within the outlet opening 110 to prevent fluid from flowing out of the outlet opening 110 when the housing 102 is disconnected from the manifold receiver 54, for example after a surgical procedure. The drip valve 132 may include a pair of deflectable wings 134 defining a slit 136 therebetween. In a manner further described in detail in previously incorporated U.S. Patent Nos. 7,615,037, 8,518,002, 8,915,897, and 9,579,428, the boss 64 (see Figure 2 ) causes the wing 134 to deflect and extend through the slit 136 of the drip valve 132 to provide fluid communication between the manifold volume space 108 and the suction inlet 58 of the medical waste collection assembly 50.
[0088] Refer to Figure 5 , the manifold 100 may include at least one valve 133 configured to prevent backflow from the manifold volume 108. Further reference Figure 5-7 , the valve 133 can be coupled to the cap portion 106 and disposed within a cavity of the cap portion 106 that defines at least a portion of the manifold volume 108. In particular, the inner or proximal surface of the cap portion 106 can include a coupler 107 (see Fig.10), such as a protrusion extending proximally. The valve 133 includes a coupling 137 that is complementary to the coupling 107 of the cap portion 106. The coupling 137 can be a slot disposed in the central hub 138 of the valve 133 and is sized to engage the protrusion in an interference structure. Additionally or alternatively, a suitable joining process such as bonding, mechanical fastening, etc. can be used to couple the valve 133 to the cap portion 106.
[0089] The valve 133 may include a pair of baffles 135 coupled to a central hub 138 via flexible wings 139. The length of the flexible wings 139 is sufficient to space each of the pair of baffles 135 from the central hub 138 by a distance equal to the distance between the coupler 107 of the cap portion 106 and: (i) between the accessory sleeve 113 and the manifold volume 108 (see FIG. Figure 6 and 7 (ii) a second inlet opening 114b. The baffle 135 is sized to cover the inlet opening 114, wherein Figure 5 The flapper 135 is shown to be circular. The valve 133 may be formed of an elastic material, such as rubber or other polymers having suitable viscoelastic properties. The size and material of the valve 133 are configured to facilitate elastic deformation about an axis transverse to the length of the valve 133. In other words, the size and material of the valve 133 are configured to facilitate elastic deformation of the wing 139 to allow movement of the flapper 135 in the proximal-distal direction. Figure 6 and Figure 7 The valve 133 is shown in a natural or unstressed state. The flexural characteristics of the wings 139 can be adjusted based on the desired amount of movement of the flap 135 at the expected vacuum level provided by the vacuum pump. Certain features of the valve 133 can be similar to those disclosed in U.S. Patent No. 7,715,037, issued November 10, 2009, the contents of which are incorporated herein by reference.
[0090] During assembly of the manifold 100, the valve 133 can be coupled to the housing 102, and more specifically to the cap portion 106. The complementary couplers 107, 137 are engaged, and the valve 133 is positioned directly adjacent to or abutting the inner or proximal surface of the cap portion 106. In particular, with the valve 133 in a natural or unstressed state, the baffle 135 abuts the inner or proximal surface of the cap portion 106 and covers the delivery aperture 125 and the second inlet aperture 114b. With the manifold 100 inserted into the manifold receptacle 54 and the medical waste collection system 50 operating, a vacuum is drawn on or through the manifold 100 in fluid communication with the suction inlet 58. Without the caps 151a, 151b sealing the respective inlet apertures 114a, 114b from fluid communication with the surrounding environment, the vacuum drawn on or through the manifold 100 is sufficient to elastically deform the wings 139 to allow the wings 139 of the flapper 135 to flex in the proximal direction. The movement of the flapper 135 away from the proximal end of one or both of the inlet apertures and delivery apertures 114, 125 establishes a suction path from the inlet apertures 114a, 114b to the manifold volume 108 and, therefore, to the suction inlet 58. Upon ceasing the drawing of vacuum on or through the manifold 100, the valve 133 returns to a natural or unstressed state in which the wings 139 elastically move the flapper 135 into abutment with the inner or proximal surface of the cap portion 106 to cover and seal the proximal end of the inlet 114 and the delivery aperture 125. Sealing the proximal end of the inlet and delivery apertures 114, 125 prevents backflow from the manifold volume 108 to the accessory sleeve 113 and inlet aperture 114b, respectively, thereby preventing possible waste outflow.
[0091] The manifold 100 may include a filter element 116 disposed in the housing 102 and in the suction path. The filter element 116 includes porous features or pores 118 that are suitable for capturing or otherwise filtering semi-solid and solid matter entrained in the flow being drawn along the suction path. In other words, the suction path is provided from the inlet holes 114a, 114b through each of the manifold volume 108, the filter element 116, and the outlet opening 110 to the suction inlet 58. The filter element 116 may include a base wall 120 and at least one side wall 121 extending distally from the base wall 120 to form a basket-like structure 119 defining a mouth. The porous features may be defined within the base wall 120, the side wall 121, and / or the rim 117 to be described. In order to maintain the rotational orientation of the filter element 116 relative to the body portion 104, the filter element 116 and the body portion 104 may include several features, including ribs 115, which are suitable for aligning the filter element 116 radially within the body portion 104. In addition, the filter element 116 can be disposed in a position separated from the manifold volume 108, but in fluid communication with the outlet opening 110 of the manifold 100. The shape and configuration of the filter element 116 suitable for certain embodiments of the manifold 100 are disclosed in the commonly owned international publication WO 2018 / 170233 filed on March 15, 2018, the entire contents of which are incorporated herein by reference. Further, the filter element 116 can be considered optional, and manifold designs that do not include a filter element can be considered.
[0092] The filter element 116 can include a rim 117 coupled to the basket 119. The rim 117 can extend radially outward distally from the basket 119. The outer diameter or size of the rim 117 can be greater than or larger than the outer diameter or size of the basket 119. Figure 6 and 7, the length of basket 119 can be such that basket 119 is disposed within body portion 104, and the length of rim 117 can be such that rim 117 is disposed within neck 105 of body portion 104. Step 109 extends radially inward from the inner surface of neck 105. An expanded wall of filter element 116 defined at a portion of rim 117 can be positioned adjacent to or abutting step 109 of body portion 104. The resulting structure includes basket 119 secured within manifold volume 108 by an interference engagement when body portion 104 is coupled to cap portion 106. In other words, during assembly of manifold 100, rim 117 of filter element 116 can be positioned abutting the inner surface of cap portion 106, and body portion 104 is advanced over basket 119 of filter element 116. Body portion 104 is coupled to cap portion 106 in a manner to be described, and step 109 of body portion 104 engages the flared wall defining the proximal side of rim 117 to secure filter basket 116 axially within manifold volume 108. Ribs 115 engaging slots (not shown) in body portion 104 radially align filter element 116 within body portion 104, as previously described.
[0093] In the broadest sense, the filter element 116 comprises a structure configured to capture or collect semi-solid or solid waste entrained in the liquid waste sucked through the manifold 100 under the influence of the vacuum provided by the medical waste collection system 50. The pores of the filter element 116 can be formed as holes, orifices and / or slots. These holes, orifices and / or slots can be defined in any one or more of the base wall 120, the side wall 121 and the edge 117. In type and position, the pores are arranged in a manner to minimize the clogging of the filter element 116. For example, the slot defined in the side wall 121 is positioned closer to the upper part of the filter element 116 than the lower part of the filter element 116. When the semi-solid or solid waste is collected, it will accumulate at the bottom of the basket 119 under the influence of gravity, and then the subsequent waste flow passes over the accumulation. After a sufficient amount of semi-solid or solid waste has accumulated, it may be desirable for the waste to encounter a slot having a minimum dimension approximately equal to the size of the orifice (to capture semi-solid or solid waste of the same size as the orifice) and a larger area of the opening to allow a greater volume to flow through the slot. In addition, the vertical arrangement of the slots is transverse to the suction path and parallel to gravity. Thus, as the semi-solid or solid waste further accumulates, at least a portion of the slots remain unobstructed until substantially the entire basket 119 is consumed by waste, thereby maximizing the useful life of the manifold 100.
[0094] The filter element 116 may include at least one overflow port (not shown) positioned on the upper side of the filter element 116. The overflow port is configured to maximize the operating cycle of the manifold 100. As previously described, when semi-solid or solid waste is collected, it will accumulate at the bottom of the basket 119 under the influence of gravity. Due to the direction of the suction path (i.e., in the proximal direction), the semi-solid or solid waste will accumulate on the base wall 120 of the basket 119. If a sufficient amount of semi-solid or solid waste is generated during the surgical procedure, the entire basket 119 may be consumed by the accumulated semi-solid or solid waste. In other words, most or all of the holes, orifices and / or slits of the filter element 116 may be blocked by semi-solid or solid waste. The size and position of the overflow port are set to allow the suction path to pass through the overflow port and extend outside the basket 119. In other words, understanding the fluid dynamics principle that fluid takes the path of least resistance, in the above case, the suction path begins from the inlet holes 114a, 114b, through the cap portion 106, through the overflow port, within the body portion 104, between the basket portion 119 and the inner surface of the body portion 104, and extends to the outlet opening 110 to be described.
[0095] Reference now Figure 5 , the cap portion 106 includes a cap head 142 and a support frame 143. The support frame 143 can be formed integrally with the cap head 142. The support frame 143 is positioned distally of the cap head 142 and generally defines the front of the manifold 100. The cap portion 106 includes an upper blocker 103, a first inlet joint 112a and a second inlet joint 112b. More specifically, an accessory sleeve 113 coupled to the support frame 143 includes the first inlet joint 112a, and the cap head 142 includes the second inlet joint 112b. The first inlet joint 112a extends upward from the distal blocker 103, while the first inlet hole 114a extends through the distal blocker 103. The second inlet joint 112b extends distally from the cap head 142, while the second inlet hole 114b (also referred to herein as a bypass opening) extends through the cap head 142.
[0096] The housing of the manifold 100 also defines an accessory opening 111 leading to an accessory sleeve 113. The accessory sleeve 113 may be at least partially defined by the upper block 103, the lower block 122, and opposing side blocks 123 extending between the upper block 103 and the lower block 122. The accessory sleeve 113 may be further defined by an end block 124 opposite the accessory opening 111. The accessory sleeve 113 is in fluid communication with the manifold volume 108 through a hole 125 (also referred to herein as a delivery hole) and an aperture 158 extending through the cap panel 140. More particularly, the hole 125 is defined between a first end within at least one of the lower block 122 and the side block 123 and a second end opening, such as the aperture 158, leading to the manifold volume.
[0097] The manifold 100 includes a tray 176 configured to be removably positioned within the accessory sleeve 113. The tray 176 defines a tissue collection cavity 182 and a porous feature 186 within the tissue collection cavity 182. With the tray 176 positioned within the accessory sleeve 113, the porous feature 186 is positioned in the suction path to collect tissue samples. The tray 176 also includes a sealing surface 155 adapted to be sealingly engaged with the accessory opening 111 when the tray 176 is within the accessory sleeve 113. In particular, the tray 176 may include a flange defining the sealing surface 155, wherein the sealing surface 155 is adapted to contact the perimeter of the accessory opening 111. Even more particularly, with the accessory opening 111 being defined by the upper, lower, and opposing side barriers 103, 122, 123, the sealing surface 155 is adapted to contact an end of each of the upper, lower, and opposing side barriers 103, 122, 123. With the tray 176 positioned within the accessory sleeve 113 and the sealing surface 155 covering the accessory opening 111 , suction is maintained through the suction path during operation of the medical waste collection assembly 50 .
[0098] Once it is desired to remove the collected tissue sample, the tray 176 can be slidably removed from the accessory sleeve 113, at which point the tissue sample is placed in the tissue collection chamber 182. However, when the sealing surface 155 is moved away from the sealing engagement with the accessory opening 111, a second suction path can be created based on fluid dynamics. The first suction path from the suction line through the accessory sleeve 113 and the manifold volume to the outlet opening can be reduced or eliminated, generating a second suction path from the accessory opening 111 through the accessory sleeve 113 and the manifold volume to the outlet opening. In other words, the aperture 125 is common to the first and second suction paths, and depending on the fluid itself (e.g., air and fluid waste) and the relative resistance encountered by the fluid in the first and second suction paths, when the tray 176 is slidably removed from the accessory sleeve 113, the second suction path can include a strong volume flow of fluid (typically, air) through the accessory opening 111 and the accessory sleeve 113. In known systems, tissue samples may encounter the fluid volume flow and associated forces, and the tissue sample may be undesirably swept along the fluid flow and ejected from the tray. In other cases, it may be necessary to "bleed" or reduce the suction through the first suction path, perhaps temporarily, without removing the manifold from the medical waste collection assembly and / or stopping operation of the medical waste collection assembly. Known systems do not adequately meet this need.
[0099] Advantageously, manifold 100 positions the second suction path in a manner that minimizes the likelihood of accidental loss of tissue samples. Additionally, manifold 100 advantageously provides a second suction path with sufficient volume flow such that the first suction path can be temporarily restricted or eliminated.
[0100] Reference now Figure 6 and 7 , the housing of the manifold 100 includes a locating feature 145 disposed within the accessory sleeve 113. In the broadest sense, the locating feature 145 is configured to appropriately position the tray 176 so that a gap (G) is defined between a base portion 184 (also referred to herein as a screen surface) of the tray 176 and at least a portion of the lower barrier 122 that at least partially defines the accessory sleeve 113. As will be further explained, the size of the gap (G) is set so that the second suction path (SSP) is guided through the gap (G) due to fluid dynamics without encountering the tissue collection cavity 182 of the tray 176 to minimize the possibility of tissue sample loss. The locating feature 145 shown is a platform 147 defining a groove 127 therebetween. It should be understood that the groove 127 defines at least a portion of the accessory sleeve 113 and extends to the accessory opening 111.
[0101] Figure 8 and 9A tray 176 including a base portion 184 is shown. As shown, the base portion 184 can be slightly arched, but can alternatively be planar or have any suitable profile. The tray 176 also includes a side portion 185 (also referred to herein as a side portion) coupled to the base portion 184. The base and side portions 184, 185 can extend from the sealing surface 155 and are arranged to define a tissue collection chamber 182. For convention, the tissue collection chamber 182 is considered to be open away from the base portion 184 in a direction parallel to the side portions 185. Porous features 186 are defined in the base portion 184.
[0102] The tray 176 includes one or more control surfaces 188a, 188b adapted to receive input from a user. Figure 8 and 9 Two control surfaces 188a, 188b are shown extending from the flange in a direction opposite to the sealing surface 155. The control surfaces 188a, 188b can be formed as a grip that is pinched between the fingers of a user. More specifically, the grip can include a first portion 188a and a second portion 188b that are collectively arranged to be pinched by a user to move the first portion 188a toward the second portion 188b for the functions to be described.
[0103] like Figure 5 As shown, with the tray 176 removably coupled to the housing, (i) the sealing member 155 seals the accessory opening 111, (ii) the tissue collection chamber 182 is located within the accessory sleeve 113 and is open toward the entry hole 112a, and (iii) the base portion 184 and / or the side portion 185 engage with the positioning features 145 within the accessory sleeve 113 to provide the above-mentioned gap (G) between the base portion 184 of the tray 176 and the lower barrier 122. More specifically, the base portion 184 of the tray 176 can be arranged to rest on or otherwise supported by the platform 147 so that the gap (G) is defined between the bottom side of the base portion 184 of the tray 176 and the upper surface of the groove 127. The gap (G) can be considered to be below the tray 176 (i.e., opposite the tissue collection chamber 182 in the aforementioned convention). With the tray 176 positioned within the accessory sleeve 113, the gap (G) communicates with the aperture 125 extending to the manifold volume 108. It should also be noted that the upper portion of the tray 176 is positioned adjacent the upper stop 103 with a small distance therebetween.
[0104] At least a portion of the sealing surface 155 can be formed of a resilient, flexible material. In particular, the lower portion of the sealing surface 155 (i.e., the portion of the sealing surface 155 that contacts the end of the lower barrier 122 that at least partially defines the accessory opening 111) can be formed of a resilient, flexible material. The resilient, flexible material is rigidly coupled to the control surface 188, for example, via the gusset 129. Also refer to Fig. 9 The gusset 129 is a triangular structure that rigidly connects the flange defining the sealing surface 155 with the second portion 188b defining the control surface 188 of the grip portion.
[0105] In operation, if a user wishes to reduce or eliminate the first suction path through the first inlet aperture 114a, the accessory sleeve 113 and the aperture 125, the user provides input to the control surface 188. In particular, the user may pinch the first and second portions 188a, 188b of the grip defining the control surface 188. Figure 6 and Figure 7 , the first portion 188a moves or pivots (P) toward the second portion 188b to move the manifold 100 from the sealed configuration to the deflated configuration. Due to the resiliently flexible material of the flange defining the sealing surface 155 and the rigid connection from the gusset 129, at least a portion of the sealing surface 155 moves away from a portion of the accessory opening 111 adjacent the lower barrier 122. The groove 127 extending to the accessory opening 111 is exposed to the atmosphere and provides a second suction path (SSP). Figure 7 As shown, the second suction path (SSP) is positioned from the accessory opening 111, through the gap (G) between the base portion 184 of the tray 176 and the lower stopper 122 of the housing defining the accessory sleeve 113 to the hole 125. Due to the lower resistance to fluid (e.g., air) entering the second suction path (SSP) relative to the end of the suction line disposed upstream of the surgical site (and the density of waste in the suction line relative to air), fluid dynamics dictate that the second suction path (SSP) becomes the primary suction path in the deflated configuration, and negligible suction can be maintained through the suction line 52. If the user wishes to quickly re-establish the first suction path (FSP) as the primary suction path, the user simply releases the input provided to the control surface 188. The elastic nature of the sealing surface 155 and the second suction path (SSP) adjacent to the sealing surface 155 cause the sealing surface 155 to re-engage with the accessory opening 111, and the manifold 100 resumes the sealed configuration. Moving the manifold 100 between the sealed configuration and the deflated configuration may be performed as many times as desired without causing undue difficulty and without requiring cessation of operation of the medical waste collection assembly 50 .
[0106] Moreover, as described above, the second suction path (SSP) is located below the tray 176 (i.e., opposite the tissue collection chamber 182 in the above convention). Thus, if the user wishes to remove the tissue sample collected in the tissue collection chamber 182, the user maintains input to the control surface 188 while withdrawing the tray 176 from the accessory sleeve 113. Because the gap (G) is relatively larger than any distance between the upper portion of the tray 176 positioned adjacent to the upper stop 103, almost the entire second suction path (SSP) remains below the tray 176 when the tray 176 is removed. It should be understood that any fluid in the second suction path (SSP) flowing above the tray 176 and being sucked into the tissue collection chamber 182 is negligible. Thus, the user can confidently remove the tray 176 without jeopardizing critical aspects of the surgical procedure by accidentally losing the collected tissue sample.
[0107] return Figure 8 and Fig. 9 , the tray 176 may include a foot 131 extending from the base portion 184, and more specifically, extending from the base portion 184 in a direction opposite to the tissue collection chamber 182. Fig. 9 ), the foot 131 can be generally U-shaped and confine the porous feature 186 within the base portion 184. Alternatively, for example, the foot 131 can be a series of discontinuous protrusions extending from the base portion 184 near the side portion 185. It should be understood that when the tray 176 is fully positioned within the accessory sleeve 113, the generally U-shaped foot 131 also defines the hole 125 that communicates with the manifold volume 108. In other words, each side portion of the foot 131 can be supported on one of the platforms 147, and the distal portion of the foot 131 can be supported on the lower stop 122 near the end stop 124 opposite the accessory opening 111. When the manifold 100 is in the deflated configuration, the relatively minimal clearance between the legs 131 and the lower barrier 122, particularly at the boundaries of the apertures 125, substantially isolates the second suction path (SSP) from the first suction path (FSP) (except by the porous features 186). This arrangement can further increase the difference in resistance between the second suction path (SSP) and the first suction path (FSP) when the manifold 100 is in the deflated configuration, such that the second suction path (SSP) becomes the primary suction path in the deflated configuration, and the suction maintained through the suction line 52 is negligible.
[0108] The feet 131 are also configured to further position the base portion 184 of the tray 176 within the accessory sleeve 113. More specifically, as mentioned, the feet 131 can be supported on or positioned adjacent to the platform 147 and can provide additional clearance between the base portion 184 and the lower stop 122 defining the gap (G). Figure 7 The distal portion of the foot 131 is shown positioned on the lower barrier 122 such that the gap (G) extends above the level of the platform 147 to the base portion 184 of the tray 176. The gap (G) (i.e., the distance from the base portion 184 to the lower barrier 122 defining the slot 127) increases the effectiveness of the deflation function and further reduces the likelihood that the fluid flow of the second suction path (SSP) above the tray 176 will dislodge or eject the collected tissue sample.
[0109] Continue to refer Figure 8 and 9 , the tray 176 may include an orientation feature 187 configured to mate with a complementary orientation feature 189 ( Figure 4 The tray 176 is engaged with the side portions 185 and the side portions 186 (shown) to position the tray 176 in a single relative orientation relative to the upper barrier 103 within the accessory sleeve 113, particularly to open the tissue collection chamber 182 toward the upper barrier 103. The orientation feature 189 of the accessory sleeve 113 can be considered as a groove defined in each of the opposing side barriers 123. In other words, each of the side barriers 123 flares outward near the upper barrier 103 to define the groove. The orientation feature 187 of the tray 176 can be considered as a guide extending from the side portion 185, particularly a guide extending near the upper portion of the tray 176. The complementary orientation features 187, 189 can be configured to be movably engaged by sliding the guide rails within the groove. It should be understood that the orientation feature 187 of the tray 176 can also be used as a positioning feature to define the vertical position of the base portion 184 relative to the lower barrier 122, and thus at least partially affect the size of the gap (G).
[0110] In certain embodiments, the cap portion 106 and the body portion 104 are removably coupled to each other. Figure 3-5 , the cap portion 106 includes at least one key 146 or a head coupler configured to be removably coupled to at least one keyway 148 or a trunk coupler of the body portion 104. The key 146 may be two keys 146 arranged opposite each other in the diametrical direction and extending proximally from the cap portion 106. The keyway 148 may be two keyways 148 arranged opposite each other in the diametrical direction and defined between at least one lip 149 extending radially outward from the neck 105 of the body portion 104. In another embodiment, the key 146 and the keyway 148 may be three keys 146 and three keyways 148, respectively, and spaced approximately 120 degrees from each other. The keyway 148 may include an insertion portion 152 and a locking portion 153 communicating with the insertion portion 152. Fig.11As best shown, the insertion portion 152 can be wider than the locking portion 153. In other words, the portion of the lip 149 that defines the locking portion 153 can be thinner than the portion of the lip 149 that defines the insertion portion 152. The key 146 can include a shank 162 and a hook 164 extending from the shank 162. The hook 164 can be thicker than the shank 162. The width of the insertion portion 152 is greater than or larger than the thickness of the hook 164 and greater than or larger than the thickness of the shank 162, and the width of the locking portion 153 is less than the thickness of the hook 164 and greater than or larger than the thickness of the shank 162. In addition, the length of the shank 162 can be at least equal to the length of the lip 149. More specifically, the length of the shank 162 can be greater than or larger than the length of the portion of the lip 149 that defines the insertion portion 152, and the length of the shank 162 can be approximately equal to the length of the portion of the lip 149 that defines the locking portion 153. Thus, during assembly of the manifold 100 or when it is desired to couple the cap portion 106 and the body portion 104, the cap portion 106 is oriented relative to the body portion 104 such that the hook portion 164 is rotationally aligned with the insert portion 152. The cap portion 106 is moved toward the body portion 104 such that the hook portion 164 extends through the insert portion 152 to pass through the lip 149 and the handle 162 is positioned within the insert portion 152. The cap portion 106 is rotated relative to the body portion 104, for example, Fig.11 14 to move the key 146 within the keyway 148. The handle 162 moves from within the insertion portion 152 into the locking portion 153, while the hook 164 is positioned in an interfering arrangement with the portion of the lip 166 that defines the locking portion 153. This interference prevents axial movement of the cap portion 106 relative to the body portion 104, and the cap portion 106 can be considered to be fixed to the body portion 104 to form the housing 102 of the manifold 100.
[0111] The removable connection between the cap portion 106 and the body portion 104 can provide access to the manifold volume 108 in which the filter element 116 is disposed. Among other advantages, access to the filter element 116 can allow a user to retrieve waste collected within the filter element 116 during certain surgical procedures, particularly polyps or tissue samples, for further examination and processing. Commonly owned International Publication WO 2013 / 090579, published on June 20, 2013, discloses a manifold including a tissue capturer for collecting polyps or tissue samples, the entire contents of which are incorporated herein by reference. In certain embodiments, the manifold 100 including the cap portion 106 can include other features for facilitating tissue sample collection.
[0112] When it is desired to separate the cap portion 106 from the body portion 104, the above method steps are reversed. The cap portion 106 is rotated relative to the body portion 104. Fig.11 148. The shank 162 is moved from within the locking portion 153 into the insertion portion 152, while the hook 164 is moved out of the interfering arrangement with the portion of the lip 149 that defines the locking portion 153. The cap portion 106 is moved away from the body portion 104 so that the hook 164 passes the lip 149 and the key 146 can be considered to be disengaged from the keyway 148. The cavity 130 of the cap portion 106 can be accessible, and / or the manifold volume 108 of the body portion 104 can be accessed, as shown. Figure 5 shown.
[0113] In some embodiments, the cap portion 106 and the body portion 104 are rigidly connected by an appropriate connection process, such as spin welding, solvent bonding, bonding, mechanical fastening, etc. As previously described, the housing 102 can be a monolithic or integral structure so that there is no discrete head and trunk. Suitable manufacturing processes for forming the housing 102 can include injection molding, three-dimensional printing, computer numerical control (CNC) machining, polymer casting, vacuum forming, blow molding, etc. Suitable materials for forming the housing 102 may include polymers, composite materials, metals, ceramics, and combinations thereof. These materials include anticorrosive properties sufficient to avoid degradation when exposed to waste, and mechanical properties sufficient to maintain integrity at the vacuum level provided by the medical waste collection system. Polymers of polyethylene, polypropylene, polyvinyl chloride, polyethylene terephthalate (PET, PETE), polystyrene, polycarbonate, and poly (methyl methacrylate) can be particularly well suited for manifolds 100 in low-cost and disposable embodiments.
[0114] Reference now Figure 12 to Figure 14 , another manifold 200 is shown that is similar in at least some respects to the previously described manifolds (certain similar components are indicated by the same numerals plus one hundred (100)). The manifold 200 includes a housing 202 adapted to removably engage the manifold receiver 54. The housing 202 includes a body portion 204 and a cap portion 206 coupled to the body portion 204. Fig.14 As best shown in FIG. 1 , the housing 202 defines a manifold volume 208 and an outlet opening 210 in fluid communication with the manifold volume 208. The body portion 204 may include a proximal base 226 and a side 228 extending distally from the proximal base 226 to define a cavity 230 that includes a portion of the manifold volume 208. The outlet opening 210 may be positioned within the proximal base 226. The cap portion 206 includes an inlet fitting 212 that defines an inlet hole 214 in fluid communication with the manifold volume 208. A drip valve 232 may be disposed within the outlet opening 210 in the manner previously described.
[0115] Figure 15-17The cap portion 206 is shown to include a cap panel 240 and a cap head 242. The cap head 242 can be coupled to the body portion 204. The cap head 242 may include an annular inclined surface terminating at an annular platform 246. The shape of the annular inclined surface 244 is formed to give the flange 248 of the body portion 204 elastic deflection when the body portion and the cap portion 204, 206 are assembled. The flange 248 is guided into the cap head 242 until the hook feature 250 moves through the annular platform 246 and elastically deflects outward to the interference engagement with the annular platform 246. In this structure, the body portion and the cap portion 204, 206 are usually prevented from being disengaged. In addition, the cap head 242 includes one or more directional features 252, such as one or more pairs of ribs extending radially inward from the inner annular surface. These ribs receive the flange 248 between them to prevent the cap head 242 from rotating relative to the body portion 204. The ribs may also receive protrusions 227 of the filter element 216 to prevent the filter element 216 from rotating relative to the cap portion 206 .
[0116] The cap head 242 includes at least one sidewall 254 extending distally and terminating at a distal side 256. An aperture 258 extends through the distal side 256 of the cap head 242. The cap head 242 includes a mandrel 260 extending distally from the distal side 256, the mandrel 260 defining a cavity 262 and a coupling feature 264. The coupling feature 264 is a pair of slots arranged to provide a bayonet-type installation with a complementary coupling feature 266 of the cap panel 240. The complementary coupling feature 266 of the cap panel 240 is a column circumferentially arranged to be received in the slot. The complementary coupling feature 266 extends radially from a tubular portion 268 adapted to be received in the cavity 242 of the mandrel 260. The cap panel 240 may be disc-shaped, including a proximal side 270 and a distal side 272 opposite to the proximal side 270. The tubular portion 268 extends proximally from the proximal side 270. To facilitate detachment of the cap panel 240 detachably coupled to the cap head 242 , the cap panel 240 may include a grip 274 adapted to be manipulated (eg, pinched) by a user.
[0117] The cap panel 240 of the cap portion 206 includes an inlet connector 212. Fig.15 As shown, the inlet fitting 212 extends distally from the distal side 272 of the cap panel 240, and the inlet aperture 214 extends through the cap panel 240. Thus, the inlet fitting 212 is rotatably fixed relative to the body portion 204 when the manifold 200 is assembled.
[0118] During operation of the medical waste collection assembly 50 with the manifold 200, tissue samples may be collected using the porous feature 218 of the filter element 216. However, removing the tissue sample from the filter element 216 may be cumbersome. Thus, the present manifold advantageously provides for efficient retrieval of tissue samples from the manifold 200, and also provides for efficient collection of a variety of tissue samples and selective operation of the system without collecting tissue samples (i.e., without the need to replace parts). Referring again to Fig.12 and Fig.13 , the manifold 200 includes a tray 276 rotatably coupled to the housing 202. In particular and with reference to Fig.19 , the tray 276 defines a central lumen 280, the size of the central inner tube is set to receive the mandrel 260 of the cap head 242. When the tray 276 is rotatably arranged around the mandrel 260, the tray 276 is positioned between the cap panel 240 and the cap head 242, in particular, between the proximal side 270 of the cap panel 240 and the distal side 256 of the cap head 242. It should be understood that the tray 276 can be integral or composed of multiple parts to form a tray assembly. The tray 276 can be movably arranged in the housing 202 in other ways besides being rotatable.
[0119] The tray 276 defines a plurality of tissue collection chambers 282. Each tissue collection chamber 282 may extend at least partially through the tray 276. The tray 276 further defines a porous feature 286 within each tissue collection chamber 282. Four tissue collection chambers 282 are shown, but it is conceivable that the tray 276 may include one, two, three, five or six or more tissue collection chambers 282. The tissue collection chambers 282 may be spaced equiangularly around an axis A extending coaxially through the tray 276. Alternative forms of the tray 276 may include unequal intervals, or a combination of equal and unequal intervals. Although the tissue collection chamber 282 is shown as being integral with the tray 276, the tissue collection chamber 282 may be constructed as a modular plug-in for the tray 276. The tray 276 includes a control surface 288 adapted to receive input from a user. Fig.19 A control surface 288 is shown, which is generally defined by an outer annular surface 290 opposite the central lumen 280 to provide a generally cylindrical shape to the tray 276. Input to the control surface 288 causes the tray 276 to rotate about the axis A to selectively provide fluid communication between one of the tissue collection cavities 282 and the inlet aperture 214 so that the porous feature 286 is in the aspiration path to collect tissue samples during operation of the medical waste collection assembly 50.
[0120] The distal side 256 of the cap head 242 can define the previously mentioned aperture 258. The cap panel 240 is rotatably fixed relative to the cap head 242, while the inlet hole 214 is aligned with the aperture 258. The tray 276 is axially positioned between the inlet hole 214 and the aperture 258. If the user wishes to collect tissue samples using one of the tissue collection chambers 282, the user provides input to the control surface 288 to move (i.e., rotate) the tray 276 around the axis A so that one of the tissue collection chambers 282 is aligned with the inlet hole 214 (and the aperture 258). The tissue collection chamber 282 is located in the suction path, and the tissue sample sucked by the suction path encounters the porous feature 286 in the tissue collection chamber 282. If another tissue sample is needed, the user can simply provide another input to the control surface 288 to rotate the tray 276 around the axis A to align another tissue collection chamber 282 with the inlet hole 214. The method can be repeated until the number of tissue collection chambers 282.
[0121] For a variety of reasons, a user may prefer to wait until a certain point during a surgical procedure to operate manifold 200 to collect a tissue sample, but may also wish to maintain aspiration of the surgical site for other reasons (e.g., visualization). Additionally, once a tissue sample has been collected, the user may prefer to continue aspiration of the surgical site without first retrieving the tissue sample from manifold 200. However, directing flow over a previously collected tissue sample for any length of time may degrade the tissue sample itself. Manifold 200 advantageously accommodates the above considerations. Again, referring to Fig.19 , the tray 276 also defines at least one bypass channel 292 separated from the tissue collection chamber 282. Each bypass channel 292 can be formed to extend axially through the inner hole of the tray 276. The illustrated embodiment shows four bypass channels 292, but it is contemplated that the tray 276 can define one, two, three, five or six or more bypass channels 292. The tissue collection chamber 282 and the bypass channel 292 can be arranged in an alternating manner and spaced equiangularly around the axis A. Alternative forms of the tray 276 can include grouping the tissue collection chamber 282 and / or the bypass channel 292, as well as unequal intervals or a combination of equal and unequal intervals. It is also envisioned that the tray 276 can be formed to define only the tissue collection chamber 282, while the bypass channel 292 is defined between the outer surface of the tray 276 and the inner surface of the housing 202. For example, the tray 276 can be triangular to define the tissue collection chamber 282. The inner surface of the housing 202 circumscribes the triangle, and the area between the triangular tray 276 and the inner surface of the housing 302 constitutes the bypass channel 292.
[0122] The tray 276 is adapted to rotate about the axis A to selectively align the bypass channel 292 with the inlet hole 214 and the aperture 258 to allow fluid to flow through the manifold 200 without collecting tissue samples during operation of the medical waste collection assembly 50. In particular, the user provides input to the control surface 288 to rotate the tray 276 about the axis A to align one of the bypass channels 292 with the inlet hole 214 and the aperture 258. In the case where the bypass channel 292 is in the suction path, the tissue collection chamber is not in the suction path, so the flow does not encounter the porous feature 286. In other words, when the bypass channel 292 is in fluid communication with the inlet hole 214, the tissue collection chamber 282 is considered not to be in fluid communication with the inlet hole 214. It should be understood that regardless of whether the tissue sample is collected with the tray 276, the flow is filtered by the filter element 216 of the manifold 200.
[0123] The tray 276 of the manifold 200 may include an alignment feature 294 adapted to provide a visual marker to the user regarding the angular position of the tissue collection chamber 282 . Fig.19 and Fig. 20 The alignment feature 294 is shown as a protrusion extending radially from the outer annular surface 290 of the tray 276. The alignment feature 294 is shown as being coplanar with a plane extending through the axis A and dividing each tissue collection chamber 282 into two. When providing input to the control surface 288, the alignment feature 294 can also conveniently play a role in improving the manipulation of the control surface 288. The user provides input to the control surface 288 (and / or the alignment feature 294) until one of the alignment features 294 is roughly aligned with the radial center of the inlet hole 214. The grip 274 can divide the distal side 272 of the cap panel 240 into two, so that a pair of relative alignment features 294 are coplanar with the grip 274 when the tissue collection chamber 282 is aligned with the inlet hole 214. This increased alignment can provide further visual confirmation to the user. It is contemplated that additional or alternative markings can be provided at appropriate locations on the manifold 200 to facilitate the accurate orientation of the tray 276.
[0124] The manifold 200 may include one or more lenses 296 positioned to provide magnification within the one or more tissue collection cavities 282. Fig.18 , lens 296 is disposed on cap panel 240 of cap portion 206. Lens 296 is positioned near inlet connector 212 to provide visualization within tissue collection chamber 282 that is fluidly connected to inlet port 214. In another embodiment (see Fig. 20), lens 296 is disposed on tray 276. Since the size of tissue samples is typically on the order of a few millimeters, and lens 296 provides magnification in one or more tissue collection chambers 282, a user can more efficiently and effectively determine whether a satisfactory tissue sample has been collected in one of the tissue collection chambers 282. It is contemplated that illumination may be provided to illuminate the one or more tissue collection chambers 282. A light source (not shown) may be appropriately positioned on manifold receiver 54 and / or manifold 200 to direct light into tissue collection chamber 282.
[0125] As mentioned, bypass channel 292 allows the user to continue to aspirate the surgical site without first retrieving tissue samples from manifold 200 and without compromising the quality of the tissue samples initially collected. Thus, manifold 200 can remain engaged with medical waste collection assembly 50 until the end of the surgical procedure. Thereafter, manifold 200 facilitates efficient retrieval of tissue samples. Cap portion 206 is detachably coupled to tray 276 to provide access to tissue collection chamber 282. The user can support manifold 200 with one hand and engage grip 274 with the other hand. The user manipulates grip 274 to disengage complementary coupling features 266, 267 (e.g., bayonet mounting) between cap panel 240 and cap head 242. Cap panel 240 is separated from cap head 242, thereby exposing tissue collection chamber 282. In addition, tray 276 can be slidably removed from mandrel 260 of cap head 242 to require the user to manage only tray 276 during retrieval of tissue samples. Additionally, where the tray 276 is detachable from the remainder of the manifold 200 , the tray 276 may allow the tissue sample to be further processed prior to retrieval (eg, placing the tray 276 with the tissue sample in a container of formalin).
[0126] Figure 20-22 An alternative form of tray 277, 278, 279 is shown for use with manifold 200. In many respects, trays 277, 278, 279 are identical to tray 276 previously described, with like numerals representing like parts. Fig. 20 Lenses 296 are shown disposed on and circumferentially around control surface 288. Each lens 296 is angularly aligned with one of tissue collection cavities 282. Fig.21 In FIG. 2 , the alignment feature 294 is angularly aligned with the bypass channel 292 rather than with the tissue collection cavity 282 to provide appropriate space for the lens 296 on the outer annular surface 290 . Fig.21An outer annular surface 290 is shown that includes different contours to improve user manipulability of the control surface 288. In particular, the outer annular surface 290 includes a plurality of valleys that separate a plurality of peaks corresponding to the angular positions of the tissue collection chamber 282 and the bypass channel 292. Alignment features 294 are arranged on every other peak and correspond to the angular positions of the tissue collection chamber 282. It should be noted that the alignment features 294 are not as distinct as previously described. Fig. 22 The tray 278 particularly shows an alternative geometry of the tissue collection cavity 282 and the bypass channel 292. Fig. 22 The tissue collection cavity 282 and the bypass channel 292 are defined by sectors of a generally fan-shaped shape. In addition, the tray 278 includes a channel 295 that extends radially from the central lumen 280 to the outer annular surface 290. The channel 295 includes a width defined between opposite sides that is approximately equal to or greater than the diameter of the mandrel 260 of the cap portion 206. It is contemplated that the width of the channel 295 can be slightly less than the diameter of the mandrel 260 to provide an surmountable interference fit between the tray 278 and a portion of the central lumen 280. The channel 295 allows the tray 278 to be disengaged from the rest of the manifold 200 without disengaging the cap panel 240 from the cap head 242.
[0127] Reference now Figure 23-25 , another manifold 300 is shown that is similar in at least some respects to the previously described manifolds (and certain similar components are indicated by the same numerals plus one hundred (100)). The manifold 300 includes a housing 302 adapted to removably engage the manifold receiver 54. The housing 302 includes a body portion 304 and a cap portion 306 coupled to the body portion 304. Fig.25 As best shown, the housing 302 defines a manifold volume 308, and an outlet opening 310 in fluid communication with the manifold volume 308. The body portion 304 may include a proximal base 326 and a side 328 extending distally from the proximal base 326 to define a cavity 230 that includes a portion of the manifold volume 308. The outlet opening 310 may be positioned within the proximal base 326. The cap portion 306 includes an inlet fitting 312 that defines an inlet hole 314 in fluid communication with the manifold volume 308. A drip valve (not shown) may be disposed within the outlet opening 310 in the manner previously described.
[0128] The cap portion 306 can be removably coupled to the body portion 304. Fig.23 and 24, the cap portion 306 includes a flange 307 positioned circumferentially near the edge of the cap panel 340. Each flange 307 includes an inclined surface 309 located at the proximal end of the flange 307. The inclined surface 309 of the flange 307 is formed to give the flange 307 elastic deflection when the body and the cap portion 304, 306 are assembled. The flange 307 is guided to the side wall 328 of the body portion 304 until the hook feature 350 moves through the annular platform 346 of the body portion 304 and elastically deflects inward to interfere with the annular platform 346. In addition, the body portion 304 includes one or more directional features 352, such as one or more surfaces extending radially from the side wall 328 to engage the flange 307 and prevent the cap portion 306 from rotating relative to the body portion 304. In other words, the cap portion 306 is rotatably fixed relative to the body portion 304.
[0129] Manifold 300 may include a filter element 316 disposed within housing 302 and in the suction path. Filter element 316 defines a porous feature 318 adapted to capture semi-solid and solid matter entrained within the flow drawn along the suction path. Filter element 316 is shown as a sector, wherein an outer annular rim 317 opposite an inner annular rim 319 defines an inner cavity 321. Fig.24 and 25 As shown, the tray 376 includes a shaft 377 extending proximally from the proximal side of the tray 376. The size of the inner cavity 321 of the filter element 316 is determined to receive the shaft 377 of the tray 376. In addition, each of the tray 376 and the filter element 316 includes a complementary orientation feature 379 adapted to prevent the filter element 316 from rotating relative to the tray 376. In other words, when the tray 376 rotates about the axis A in a manner to be described, the filter element 316 rotates accordingly. The orientation feature 379 may include a key disposed on the shaft 377 and a corresponding key hole (not shown) appropriately disposed on the filter element 316.
[0130] The manifold 300 includes a tray 376 rotatably coupled to the housing 302. The tray 376 is positioned adjacent to the cap panel 340 of the cap portion 306. Fig.26 , the tray 376 defines a tissue collection cavity 382. Each tissue collection cavity 382 can be formed as a sector and define a porous feature 386 within each tissue collection cavity 382. The sector can be generally pancake-shaped. Fig.26 Five tissue collection chambers 382 are also shown, but it is contemplated that the tray 376 may include one, two, three, four, or six or more tissue collection chambers 382. Furthermore, the tissue collection chambers 382 may be of equal size, but alternatives may include unequal size arrangements, or a combination of equal and unequal size arrangements.
[0131] Manifold 300 includes a control surface 388 adapted to receive input from a user. Figure 23-25 A control surface 388 is shown defined on a knob 389 positioned distally of the cap portion 306. In particular, the cap panel 340 of the cap portion 306 includes an opening 305 through which the control surface 388 is arranged to be manipulated. Depending on the location of the tray 376, the body portion 304 may alternatively include such an opening. The knob 389 is coupled to the tray 376 by a complementary orientation feature 381. Fig.24 The complementary orientation feature 381 is shown to include a keyway defined in the tray 376 adjacent the central cavity 380. Fig.25 The complementary orientation feature is shown to include a key extending from a proximal region of the knob 389. The complementary orientation feature 381 is adapted to maintain relative rotation between the control surface 388 and the tray 376 such that when the knob 389 is rotated about the axis A, the tray 376 rotates accordingly.
[0132] In operation, if the user wishes to collect a tissue sample in one of the tissue collection chambers 382, the user provides input to the control surface 388 to rotate the knob 389 and the tray 376 about the axis A to align one of the tissue collection chambers 382 with the inlet hole 314. The aligned tissue collection chamber 382 is in the suction path, and the tissue sample aspirated through the suction path encounters the porous feature 386 within the tissue collection chamber 382. If another tissue sample is desired, the user can simply provide another input to the control surface 388 to rotate the knob 389 and the tray 376 about the axis A to align another tissue collection chamber 382 with the inlet hole 314. This method can be repeated until the number of tissue collection chambers 382 is reached.
[0133] For the reasons previously expressed, the tray 376 defines a bypass channel 392 that is separate from the tissue collection chamber 382. Fig.26 As shown, the bypass channel 392 allows fluid to flow through the manifold 300 during operation of the medical waste collection assembly 50, but does not collect tissue samples. The tray 376 is adapted to rotate about the axis A to selectively align the bypass channel 392 with the inlet hole 314. In particular, the user provides input to the control surface 388 to rotate the knob 389 and the tray 376 about the axis A to align the bypass channel 392 with the inlet hole 314. As described above, when the bypass channel 392 is in fluid communication with the inlet hole 314, it can be considered that the tissue collection chamber 382 is not in fluid communication with the inlet hole 314. The manifold 300 may include the previously described (one or more) lenses (not shown) and / or lighting to provide magnification and improved visibility in one or more tissue collection chambers 382.
[0134] The manifold 300 facilitates efficient retrieval of tissue samples from the manifold 300. The manifold 300 is most typically detached from the medical waste collection assembly 50 after completing the relevant aspects of the surgical procedure. The user supports the body portion 304 with one hand and overcomes the interference engagement between the hook feature 350 at the proximal end of the flange 307 of the cap portion 306 and the annular platform 346 of the body portion 304. The cap portion 306 is detached from the body portion 304, thereby exposing the tissue sample collected in the tissue receiving cavity 382 of the tray 376.
[0135] Reference now Fig. 27 and 28 , another manifold 400 is shown that is similar in at least some respects to the previously described manifolds (and certain similar components are represented by the same numerals plus one hundred (100)), and for the sake of brevity, only certain features are explicitly described. Manifold 400 includes a cap portion 406 rotatably coupled to a body portion 404, and a tray 476 is rotatably fixed relative to the body portion 404. Fig.28 Axle 477 is shown extending proximally from tray 476 and defining an orientation feature 479 adapted to engage a complementary orientation feature (not shown) of body portion 404. Engagement of complementary orientation feature 479 prevents tray 476 from rotating relative to body portion 404.
[0136] The cap portion 406 includes a flange 407 positioned circumferentially near the edge of the cap panel 440. Each flange 407 includes an inclined surface 409, which is shaped to give the flange 407 elastic deflection when the body and the cap portion 404, 406 are assembled. The flange 407 is guided onto the side wall 408 of the body portion 404 until the hook feature 450 moves through the annular platform 446 of the body portion 404 and elastically deflects inward to interfere with the annular platform 446. The body portion 404 may not include an orientation feature so that once the body and the cap portion 404, 406 are coupled in the above manner, the cap portion 406 can be rotated relative to the body portion 404. In particular, the hook feature 450 can move along the annular platform 446 while maintaining the axial position of the cap portion 406 relative to the body portion 404.
[0137] The cap portion 406 includes an inlet connector 412, and thus rotation of the cap portion 404 results in corresponding rotation of the inlet aperture 414 of the inlet connector 412, and particularly relative to the tray 476 that is rotatably fixed relative to the body portion 404. The tray 476 defines tissue collection chambers 482, porous features 486 within the tissue collection chambers 482, and a bypass channel 492 that is separable from the tissue collection chambers 482. In operation, if a user wishes to collect a tissue sample in one of the tissue collection chambers 482, the user provides an input to the control surface 488 to rotate the cap portion 406 and the inlet connector 412 about the axis A to align the inlet aperture 414 with one of the tissue collection chambers 482. The aligned tissue collection chamber 482 is in the aspiration path, and the porous features 486 are encountered by the tissue sample aspirated through the aspiration path. If another tissue sample is desired, the user can simply provide another input to the control surface 488 to rotate the cap portion 406 and the inlet connector 412 about the axis A to align the inlet hole 414 with another one of the tissue collection chambers 482. This method can be repeated until the number of tissue collection chambers 482 is reached. Similarly, the cap portion 406 can be rotated about the axis A to selectively align the inlet hole 414 with the bypass channel 492 to allow fluid to flow through the manifold 400 during operation of the medical waste collection assembly 50, but without collecting tissue samples. The manifold 400 may include the previously described (one or more) lenses (not shown) and / or lighting to provide magnification and visualization in one or more tissue collection chambers 482.
[0138] Reference now Figure 29-31 , another manifold 500 is shown that is similar in at least some respects to the manifolds previously described (and certain similar components are represented by the same numerals plus one hundred (100)). The manifold 500 includes a housing 502 adapted to removably engage with the manifold receiver 54. The housing 502 includes a body portion 504 and a cap portion 506. As previously expressed, the cap portion 506 can be coupled to the body portion 504 by a removable or permanent connection device, or the body and cap portions 504, 506 can be formed as a one-piece, unitary structure. In one example, the body and cap portions 504, 506 are spin welded at the interface to prevent reuse. As shown in FIG. Fig.31As best shown, the housing 502 defines a manifold volume 508, and an outlet opening 510 in fluid communication with the manifold volume 508. The body portion 504 may include a proximal base 526 and a side 528 extending distally from the proximal base 526 to define a cavity 530 that includes a portion of the manifold volume 508. The housing 502 includes an inlet connector 512 that defines an inlet aperture 514 in fluid communication with the manifold volume 508. As previously described, the outlet opening 510 is adapted to be in fluid communication with the suction inlet 58 of the medical waste collection assembly 50 when the housing 502 is engaged with the manifold receiver 54, thereby providing a suction path from the inlet aperture 514 to the suction inlet 58.
[0139] The manifold 500 may include a drip valve 532 positioned within the outlet opening 510 to prevent the flow of material from the outlet opening 510 when the housing 502 is disengaged from the manifold receiver 54. The drip valve 532 may include a pair of deflectable wings 534 defining a slit 536, wherein the boss 64 (see FIG. Figure 2 ) is adapted to deflect the wing 534 and extend through the slit 536 of the drip valve 532. This arrangement provides fluid communication between the manifold volume 508 and the suction inlet 58 of the medical waste collection assembly 50.
[0140] Manifold 500 may include a filter element 516 disposed within housing 502 and in the suction path. Filter element 516 defines a porous feature 518, which is suitable for capturing semi-solid and solid materials entrained in the flow sucked along the suction path. The suction path is provided from inlet hole 514 through each of manifold volume space 508, filter element 516 and outlet opening 510 to suction inlet 52. Filter element 516 may include a base wall 520 and a side wall 522 extending from base wall 520 to form a basket-shaped portion defining a mouth 524. Filter element 516 may include certain features (e.g., window 715) that will be described in detail later. It should be understood that filter elements 216, 316 of the previously described embodiments may be used.
[0141] Also refer to Fig.32 , the cap portion 506 includes a cap head 542 and a support frame 543. The cap head 542 may include one or more orientation features 552, such as one or more pairs of guide rails extending radially inward from the inner annular surface. The guide rails receive a protrusion 552 disposed near the mouth 524 of the filter element 516 to prevent the filter element 516 from rotating relative to the cap portion 506. The cap head 542 includes at least one sidewall extending distally and terminating at a distal surface 556. A pore 558 extends through the distal surface 556.
[0142] The support frame 543 may be integrally formed with the cap head 542. The support frame 543 is positioned distally of the cap head 542 and defines the front of the manifold 500. Fig.29 and 30 As shown, the cap portion 506 of the housing 502 defines a distal barrier 503 located near the front of the manifold 500. The housing 502 includes an inlet fitting 512, and more specifically, the support frame 543 of the cap portion 506 includes the inlet fitting 512. The inlet fitting 512 extends distally from the distal barrier 503, and the inlet aperture 514 extends through the distal barrier 503.
[0143] The housing 502 also defines an accessory opening 511 leading to an accessory sleeve 513. The accessory sleeve 513 is in fluid communication with the manifold volume 508 via an aperture 558 extending through the distal surface 556. The accessory sleeve 513 is disposed within a support frame 543 of the cap body 506. Fig.29 An accessory opening 511 is shown positioned at an upper portion of the support frame 543, wherein an accessory sleeve 513 opens downwardly within the support frame 543. The accessory sleeve 513 may be oriented at an axis A. s The accessory sleeve 513 is angularly inclined upward, away from the longitudinal axis of the housing 502, and more specifically, away from the front of the housing toward the proximal side. With the tray 576 removably positioned within the accessory sleeve 513 in a manner to be described, the orientation of the accessory sleeve 513 limits or prevents accidental "splashing" of medical waste from within the accessory sleeve 513 after the tray 576 is removed from the suction path. In one example, the axis A of the accessory sleeve 513 is oriented such that the medical waste is not "splashed" out of the accessory sleeve 513. s Relative to the longitudinal axis of the housing 502, approximately in the range of 45 degrees to 75 degrees, and more specifically in the range of 55 degrees to 65 degrees.
[0144] The inlet hole 514 of the inlet connector 512 can be tilted relative to the horizontal. In particular, the inlet hole 514 is oriented on an axis Ab that is tilted angularly upward toward the distal side relative to the longitudinal axis of the housing 502. The tilt of the inlet hole 514 limits or prevents accidental "dripping" of medical waste from the inlet hole 514 after the suction line 52 is removed. Any remaining fluid in the inlet hole 514 flows to the accessory sleeve 513 under the influence of gravity. The valve 541 can be coupled to the housing 502 and positioned within the accessory sleeve 513, as shown in FIG. Fig.30 The valve 541 may be a flapper valve adapted to be positioned on the proximal end of the inlet aperture 514 to prevent fluid from flowing back from the accessory sleeve 513 to the inlet aperture 514. Other suitable valves are contemplated, such as a duckbill valve.
[0145] As mentioned, the manifold 500 includes a tray 576 configured to be removably positioned within the accessory sleeve 513. The tray 576 defines a tissue collection chamber 582 and a porous feature 586 within the tissue collection chamber 582. When the tray 576 is located within the accessory sleeve 513, the porous feature 582 is in the suction path to collect tissue samples. Once it is desired to retrieve the collected tissue sample, the tray 576 can be slidably removed from the accessory sleeve 513 when the tissue sample is placed in the tissue collection chamber 582. It should be understood that the tray 576 is optional, and the manifold 500 can operate without the tray 576 within the accessory sleeve 513. The manifold 500 can include a cap 545 sized to seal and engage with the accessory opening 511. The cap 545 can be coupled to the housing 502 by a tether 547. Fig.29 Another cap 549 is shown that is adapted to sealingly engage the inlet fitting 512 to cover the inlet aperture 514. The cap 549 may also be coupled to the housing 502 by a tether 551.
[0146] Also refer to Fig.33 , the tray 576 can be formed from a single piece or multiple pieces. The tray 576 includes a control surface 588 adapted to receive input from a user. The control surface 588 can be formed as a handle that is pinched between the user's fingers. Fig.33 A square-shaped handle is shown with gripping features 553 disposed on one or more of the faces of the square-shaped handle. The tray 576 also includes a sealing surface 555 adapted to sealably engage the housing 502 when the tray 576 is located within the accessory sleeve 513. In particular, the tray 576 may include a flange defining the sealing surface 555, wherein the sealing surface 555 is adapted to contact the periphery of the accessory opening 511. With the tray 576 located within the accessory sleeve 513 and the sealing surface 555 covering the accessory opening 511, suction through the suction path is maintained during operation of the medical waste collection assembly 50. Likewise, the cap 545 is sized to cover the accessory opening 511 to maintain suction through the suction path.
[0147] The tray 576 can include a retaining feature 559 adapted to defeatably engage a complementary retaining feature of the housing 502. The retaining feature 559 is adapted to simultaneously engage a sealing surface 555 positioned adjacent a perimeter of the accessory opening 511. Fig.31The holding feature 559 is shown to include a stopper positioned on the lower side of the tissue collection chamber 582. The holding feature 559 engages a groove in the housing 502, i.e., an upper portion of the aperture 558 of the cap head 542. When the holding feature 559 engages with a complementary holding feature, tactile and / or auditory feedback can be provided to the user, so that the user is assured that the tray 576 is fully placed or placed in the accessory sleeve 513. In addition, when the holding feature 559 is engaged, the sealing surface 555 is adjacent to the periphery of the accessory opening 511, so that once the medical waste collection assembly 50 is actuated, a suction path is successfully established. Once the tissue sample is collected in the tissue collection chamber 582 and the user wishes to remove the tray 576, sufficient force input is provided to the control surface 588 of the tray 576 to disengage the holding feature 559 and the complementary holding feature (e.g., to overcome the interference engagement between the stopper and the housing 502).
[0148] The tray 576 may include a second retaining feature (not shown) to engage a second complementary retaining feature (not shown) of the housing 502. The second complementary retaining feature is located in an appropriate position on the tray 576 and the housing 502 so that the tray 576 can be only partially placed or seated within the accessory sleeve 513. In the case where the tray 576 is only partially arranged within the accessory sleeve 513, an additional sealing surface can be provided to cover the accessory opening 511 to maintain suction. Therefore, the tray 576 can be placed in a bypass position and define a bypass channel 592 between the distal one of the sides 585 and the bottom of the accessory sleeve 513. The medical waste collection assembly 50 can be operated with the tray 576 in the bypass position, thereby allowing fluid to flow through the suction path without the tray 576 collecting tissue samples. Once the user wishes to collect a tissue sample, the user provides further input to the control surface 588 (i.e., pushes downward on the tray 576) to disengage the second complementary retaining feature, moving the tray 576 from the bypass position to a tissue collection position in which the tissue collection chamber 582 is fully positioned within the accessory sleeve 513, such that the porous feature 586 is in the suction path to collect the tissue sample.
[0149] As previously mentioned, it is desirable to visualize the tissue collection cavity 582 during the collection of tissue samples. The quick visual confirmation provided to the user when the tissue sample is located within the tissue collection cavity 582 allows the user to move on to any other aspects of the surgical procedure. When the tray 576 is within the accessory sleeve 513, the tissue collection cavity 582 of the tray 576 is open toward the front of the manifold 500, and the distal barrier 503 includes a lens 596 that provides magnification within the tissue collection cavity when the tray is within the accessory sleeve 513.
[0150] refer to Fig.33, the tray 576 may include a pair of opposing side portions 585 extending from a screen surface 584 defining a porous feature 586. The side portions 585 and the screen surface 584 together define a tissue collection cavity 582 of the tray 576. As is conventional, Fig.33 The tissue collection cavity 582 is considered to be open away from the screen surface 584 in a direction parallel to the side 585. The tray 576 further includes an orientation feature 587, which is configured to engage a complementary orientation feature 589 of the accessory sleeve 513 for positioning the tray 576 in the accessory sleeve 513 in a predetermined orientation relative to the distal barrier 503, particularly when the tissue collection cavity 582 is open toward the distal barrier 503. Fig.33 The orientation feature 587 is shown to include a tapered portion of the side 585 of the tray 576. The orientation feature 587 tapers the side 585 of the tray 576 to a designed thickness. The complementary orientation feature 589 includes a protrusion positioned within the accessory sleeve 513 so that the tray 576 can only be fully seated within the accessory sleeve 513 in one orientation of the tray 576 relative to the distal stop 503. Fig.31 As best shown, one of the protrusions is spaced apart from the proximal surface of the accessory sleeve 513 by a distance slightly greater than the designed thickness of the side 585 of the tray 576. Thus, when the tray 576 is slidably moved downwardly in the accessory sleeve 513 in a predetermined orientation, the distal portion of the tray 576 is disposed within a portion of the accessory sleeve 513 between the protrusion and the proximal surface defining the accessory sleeve 513. Fig.31 Another protrusion is shown therein, which blocks the distal portion of the accessory sleeve 513 to prevent the tray 576 from being placed in the accessory sleeve 513 in any orientation other than the predetermined orientation described above. When the tray 576 is arranged in the accessory sleeve 513 in the predetermined orientation, the tissue collection cavity 582 opens toward the front of the manifold 500, such as toward the distal stop 503 that defines the distal surface of the accessory sleeve 513.
[0151] Figure 29-31 A distal stopper 503 including a lens 596 is shown. The lens 596 is shown as an oval, but other suitable geometries are contemplated. The lens 596 is shaped to maximize visualization of the tissue collection chamber 582 and provide magnification therefor. The angled arrangement of the accessory sleeve 513, the forwardly open tissue collection chamber 582 of the tray 576, and the lens 596 of the distal stopper 503 work together to provide the user with a glance at the manifold 500 from a reasonable distance and without improper manipulation of the manifold 500 to quickly determine whether a suitable tissue sample has been captured. In addition, inserting the tray 576 into the manifold 500 on a different face of the manifold 500 from the inlet aperture 514 further aids in visualization. It is contemplated that illumination may be provided to illuminate the tissue collection chamber 582.
[0152] Reference now Figure 34-36 , another manifold 600 is shown that is similar in at least some respects to the manifolds previously described (and certain identical components are represented by the same numerals plus one hundred (100)). The manifold 600 includes a housing 602 adapted to removably engage with the manifold receiver 54. The housing 602 includes a body portion 604 and a cap portion 606. As previously expressed, the cap portion 606 can be coupled to the body portion 604 by a removable or permanent coupling device, or the body and cap portions 604, 606 can be formed as a one-piece, unitary structure. In one example, the body and cap portions 604, 606 are spin welded at the interface to prevent reuse. As shown in FIG. Fig.36 As best shown, the housing 602 defines a manifold volume 608, and an outlet opening 610 in fluid communication with the manifold volume 608. The body portion 604 may include a proximal base 626 and a side 628 extending distally from the proximal base 626 to define a cavity 630 that includes a portion of the manifold volume 608. A drip valve 632 may be positioned within the outlet opening 610 to, in the manner previously described, prevent fluid from flowing out of the outlet opening 610 when the housing 602 is disengaged from the manifold receiver 54, and to provide fluid communication between the manifold volume 608 and the suction inlet 52 of the medical waste collection assembly 50 when the housing 602 is engaged with the manifold receiver 54.
[0153] The manifold 600 may include a filter element 616 disposed within the housing 602 and in the suction path. The filter element 616 defines a porous feature 618 adapted to capture semi-solid and solid matter entrained within the flow drawn along the suction path. Fig.37 and 38 , the cap portion 606 includes a cap head 642 and a support frame 643. The cap head 642 may include one or more directional features 652, such as one or more pairs of guide rails extending radially inward from the inner annular surface. The guide rail receives the protrusion 627 of the filter element 616 to prevent the filter element 616 from rotating relative to the cap portion 606. The cap head 642 includes at least one sidewall 654 extending distally and terminating at a distal side 656. The first aperture 658 and the second aperture 657 extend through the distal side 656 and have a function to be described. The valve 641 can be disposed in the cap head 642 and disposed on the first and second apertures 657, 658 to prevent fluid from flowing back from the cap head 642.
[0154] The support frame 643 can be integrally formed with the cap head 642 or removably connected to the cap head 642. The support frame 643 includes opposite lateral sides 661 and a front side 663 separated by an upper surface and a lower surface. The housing 602 also defines an accessory opening 611 leading to an accessory sleeve 613. The accessory sleeve 613 is in fluid communication with the manifold volume space 608 through the first and second apertures 657, 658 extending through the distal side 656. The accessory sleeve 613 is disposed in the support frame 643 of the cap body 606. More specifically, the accessory opening 611 is in one of the opposite sides 661 of the support frame 643, and the accessory sleeve 613 extends inwardly from the accessory opening 611. The shape of the accessory sleeve 613 is formed to complement the side profile of the tray 676 so that the accessory sleeve 613 removably receives the tray 676 in a manner to be described. The front side 663 of the support frame 643 further defines a first opening 665 and a bypass opening 667 separated from the first opening 665. Fig.37 As shown, the first opening 665 may be coaxial and in fluid communication with the first aperture 658 and separated by the accessory sleeve 613 , and the bypass opening 667 may be coaxial and in fluid communication with the second aperture 657 to define a bypass passage 692 .
[0155] Manifold 600 includes a slide member 669 slidably coupled to support frame 643. Slide member 669 includes an upper surface 671 and a lower surface 673 separated by a gap of a size approximately equal to the thickness of support frame 643 defined between the upper and lower surfaces of support frame 643. The gap between upper surface 671 and lower surface 673 slidably receives support frame 643. Each of support frame 643 and slide member 669 includes complementary rail features 675 to restrict movement of slide member 669 relative to support frame 643 to one degree of freedom. In particular, rail features 675 of support frame 643 include elongated slots oriented parallel to front side 663, and rail features 675 of slide member 669 are elongated rails oriented to engage these slots. When viewing the front of manifold 600, movement of slide member 669 relative to support frame 643 can be considered as lateral movement.
[0156] Sliding member 669 includes an inlet fitting 612 defining an inlet aperture 614 . Fig.39The inlet fitting 612 is shown extending distally from the front surface 672 of the sliding member 669, thereby separating the upper surface 671 and the lower surface 673. The inlet fitting 612 is adapted to receive the suction line 52. The sliding member 669 also includes a control surface 688 adapted to receive input from a user, which has a resulting function to be described. The control surface 688 may include the above-mentioned upper surface 671 and lower surface 673, which are adapted to be grasped or pinched by the user's fingers to impart sliding movement of the sliding member 669 relative to the support frame 643.
[0157] As mentioned, the accessory socket 613 of the support frame 643 is configured to removably receive the tray 676. Fig.40 , the tray 676 can be generally box-shaped, but other suitable geometric shapes can be considered. The tray 676 includes a screen surface 684 and a pair of opposite side portions 685 extending from the screen surface 684 to define the tissue collection chamber 682. One of the pair of opposite side portions 685 can define a front wall opposite to the rear wall. The screen surface 684 of the tray 676 defines a porous feature 686. The screen surface 684 may include a first screen surface 684a and a second screen surface 684b inclined relative to the first screen surface 684a. The second screen surface 684b is inclined upward toward the rear wall. In addition to being more effectively positioned in the suction path, the inclined second screen surface 684b can also provide a trapezoidal shape for the side profile of the tray 676 to serve as a directional feature for inserting and removing the tray 676 from the accessory sleeve 613. In other words, the side profile of the tray 676 and the corresponding shape of the accessory opening 611 require the tray 676 to be in a predetermined orientation to be arranged or placed in the accessory sleeve 613. Fig.40 The tray 676 is also shown to include a cutout 699 in the front wall, and a grip 674 extending from a side portion 685 thereof. When the tray 676 is disposed within the accessory sleeve 613, the cutout 699 is aligned with the inlet hole 614 (and the first aperture 688) of the inlet adapter 612. The grip 674 may include a gripping feature 653 to facilitate secure manipulation of the tray 676.
[0158] In operation, if the user wishes to collect tissue samples in the tissue collection chamber 682 of the tray 676, the user provides input to the control surface 688 to move the sliding member 669 to the tissue collection position. When the tray 676 is disposed in the accessory sleeve 613, the sliding member 669 is moved so that the inlet hole 614 of the inlet connector 612 is positioned to be in fluid communication with the tissue collection chamber 682. A suction path is established from the inlet hole 614 through each of the first opening 665, the tissue collection chamber 682, the first aperture 658, the manifold volume space 608, the filter element 616, and the outlet opening 610 to the suction inlet 52. The porous feature 686 of the tray 676 is in the suction path and collects tissue samples. In one example, moving the inlet hole 614 in fluid communication with the tissue collection chamber 682 includes axially aligning the inlet hole 614 with the first opening 665. It should be understood that when the tissue collection chamber 682 is in the suction path, the bypass channel 692 is not in the suction path.
[0159] Once the desired tissue sample is collected and / or the user prefers to operate the manifold 600 without collecting a tissue sample, another input is provided to the control surface 688 to move the sliding member 669 to the bypass position. The sliding member 669 is moved so that the inlet hole 614 of the inlet connector 612 is positioned to be in fluid communication with the bypass channel 692. A suction path is established from the inlet hole 614 through each of the bypass opening 667, the bypass channel 692, the second aperture 657, the manifold volume 608, the filter element 616, and the outlet opening 610 to the suction inlet 52. In one example, moving the inlet hole 614 in fluid communication with the bypass channel 692 includes axially aligning the inlet hole 614 with the bypass opening 667. It should be understood that when the bypass channel 692 is in the suction path, the tissue collection chamber 682 is not in the suction path.
[0160] With the slide member 669 in the bypass position and the tissue collection cavity 682 not within the path of suction, the tray 676 can be removed from the accessory sleeve 613 without interrupting the operation of the medical waste collection assembly 50. For example, a user can remove the tray 676 to retrieve a collected tissue sample while another user continues other aspects of a surgical procedure that requires suction provided by the medical waste collection assembly 50. If the retrieved tissue sample is not satisfactory and / or another tissue sample is desired, another tray 676 can be quickly placed within the accessory sleeve 613 without undue interruption, such as loss of suction.
[0161] Manifold 600 accommodates visualization to provide the user with an improved tissue collection experience. Fig.34 and 39, the slide member 669 includes a lens 696 that provides magnification within the tissue collection cavity 682 when the tray 676 is within the accessory sleeve 613 and when the slide member 669 is in the tissue collection position. It is contemplated that illumination may be provided to illuminate the tissue collection cavity 682.
[0162] An exemplary method of collecting tissue samples with the manifold 600 is also contemplated. The manifold 600 is coupled to the medical waste collection assembly 50 so that the outlet opening 610 is in fluid communication with the suction inlet 58 of the medical waste collection assembly 50. The suction line 52 is coupled to the inlet connector 612 of the manifold 600. The medical waste collection assembly 50 is operated with the slide member 669 in the bypass position. The inlet hole 614 of the inlet connector 612 is in fluid communication with the bypass channel 692 so that fluid is allowed to flow through the suction path without the tray 676 collecting tissue samples. The user applies input to the control surface 688 to move the slide member 669 from the bypass position to the tissue collection position. In the tissue collection position, the inlet hole 614 of the inlet connector 612 is in fluid communication with the tissue collection chamber 682 so that the porous feature 686 is in the suction path. The medical waste collection assembly 50 is operated to collect tissue samples with the slide member 669 in the tissue collection position. For example, after collecting a tissue sample into the tissue collection chamber 682, another input may be applied to the control surface 688 to return the sliding member 669 to the bypass position. The previous input may include applying a lateral force along a first linear direction to the control surface 688, and the latter input may include applying another lateral force along a second linear direction opposite to the first linear direction to the control surface 688 to return the sliding member 669 to the bypass position. When the sliding member 669 is in the tissue collection position, the tissue collection chamber can be observed through the lens 696. The tray 676 can be removed from the accessory sleeve 613 when the sliding member 669 is in the bypass position. Another tray (not shown) can be provided and placed into the accessory sleeve 613 of the sliding member 669 when the sliding member 669 is in the bypass position.
[0163] Reference now Figures 41-46 , another manifold 700 is shown that is similar in at least some respects to the manifolds previously described (and certain identical components are represented by the same numerals plus one hundred (100)). Manifold 700 includes a housing 702 adapted to removably engage with manifold receiver 54. Housing 702 includes a body portion 704 and a cap portion 706. As previously expressed, cap portion 706 may be coupled to body portion 704 by a removable or permanent coupling arrangement, or body and cap portions 704, 706 may be formed as a one-piece, unitary structure. In one example, body and cap portions 704, 706 are spin welded at the interface to prevent reuse. As shown in FIG. Fig.43As best shown, the housing 702 defines a manifold volume 708 and an outlet opening 710 in fluid communication with the manifold volume 708. The body portion 704 may include a proximal base 726 and a side 728 extending distally from the proximal base 726 to define a cavity 730 that includes a portion of the manifold volume 708. A drip valve (not shown) may be positioned within the outlet opening 710 to, in the manner previously described, prevent fluid from flowing out of the outlet opening 710 when the housing 702 is disengaged from the manifold receiver 54 and to provide fluid communication between the manifold volume 708 and the suction inlet 58 of the medical waste collection assembly 50 when the housing 702 is engaged with the manifold receiver 54.
[0164] The manifold 700 may include a filter element 716 disposed within the housing 702 and in the suction path to be described. The filter element 716 defines a porous feature 718 adapted to capture semi-solid and solid matter entrained within the flow drawn along the suction path. Fig.41 , the cap portion 706 includes a cap head 742 and a support frame 743. The support frame 743 of the manifold 700 is a stator and is hereinafter referred to as a stator. The cap head 742 is coupled to the body portion 704. The cap head 742 includes at least one sidewall 754 extending distally and terminating at a distal side 756. A pore 758 extends through the distal side 756.
[0165] The stator 743 may be integrally formed with the cap head 742 , or the stator 743 may be coupled to the cap head 742 by a suitable connection process. Fig.47 The stator 743 is shown coupled to the cap head 742 via a throat member 729. The throat member 729 extends distally from the distal surface 756 of the cap head 742 and extends proximally from a portion of the stator 743. The stator 743 defines a void space 731 that communicates with the aperture 758 through the lumen defined by the throat member 729. Fig.42 and Fig.47 , the void space 731 of the stator 734 can be defined by a base 733 and at least one sidewall 735 extending from the base 733. The void space 731 is shown as cylindrical, but other suitable geometric shapes are contemplated. The stator 743 of the housing 702 includes an inlet fitting 712 adapted to receive the suction line 52. The inlet fitting 712 defines an inlet hole 714 in fluid communication with the void space 731.
[0166] Manifold 700 includes a rotor 737 rotatably disposed within stator 743. When disposed within void space 731, rotor 737 is supported on base 733 of stator 743. Fig.48 and 49The rotor 737 includes an annular outer wall 739 having an outer diameter that is approximately the same as but slightly smaller than the inner diameter of the inner annular wall of the rotor 737. The rotor 737 defines a pair of first openings 765a, 765b and a pair of bypass openings 767a, 767b. Each of the pair of first openings 765a, 765b is defined by the outer wall 739 and is in fluid communication with each other to define a tissue channel 791, and each of the pair of bypass openings 767a, 767b is defined by the outer wall 739 and is in fluid communication with each other to define a bypass channel 792 (see FIG. Fig.45 and 46 ). One of the first openings 765a can be considered as the entrance of the tissue channel 791, and the other first opening 765b can be considered as the exit of the tissue channel 791. Similarly, one of the bypass openings 767a can be considered as the entrance of the bypass channel 792, and the other bypass opening 767b can be considered as the exit of the bypass channel 792. The bypass channel 792 is separated from the tissue channel 791 and the tissue collection chamber 782.
[0167] The rotor 737 defines a tissue collection chamber 782 and a porous feature 786 within the tissue collection chamber 782. The porous feature 786 can be defined by a screen surface 784 that is removably coupled to the rotor 737. In another form of the rotor 737, the screen surface 784 is integrally formed with the rotor 737. The tissue collection chamber 782 is associated with the inlet 765a, such that the inlet 765a of the tissue channel 791 leads to the tissue collection chamber 782.
[0168] The rotor 737 may also include a control surface 788 adapted to receive input from a user. The control surface 788 is associated with a handle 789 extending from an upper surface of the rotor 737. The control surface 788 receives input to switch the manifold 700 between a tissue collection position and a bypass position to be described. It is contemplated that the control surface may be an electronic input device (e.g., a button) that generates a signal that is sent to a controller to actuate the rotor 737.
[0169] In operation, if the user wishes to collect a tissue sample in the tissue collection cavity 782 of the tray 776, the user provides input to the control surface 788 to rotate the rotor 737 to the tissue collection position within the stator 743. The rotor 737 is rotated so that the tissue collection cavity 782 is in fluid communication with the inlet hole 714. The porous feature 786 is in the aspiration path to collect the tissue sample. Fig.43 and 44 FIG. 7 shows the manifold 700 with the rotor 737 in the tissue collection position. As can be seen, the suction path between the inlet hole 714 and the tissue collection chamber is somewhat tortuous for identification reasons. To facilitate the illustrated suction path, the rotor 737 includes a groove 793 in the outer wall 739. Fig.48As best shown in FIG. 7 , the groove 793 extends radially from the inlet 765a by a designed distance. The designed distance is such that when the rotor 737 is rotated to the tissue collection position, the end of the groove 793 opposite to the opening 765a is substantially aligned with the inlet hole 714. When the rotor 737 is in the tissue collection position, a suction path is established from the inlet hole 714 to the suction inlet 52 through each of the inlet 765a, the groove 793, the tissue collection chamber 782, the tissue channel 791, the outlet opening 765b, the pores 758, the manifold volume space 708, the filter element 716, and the outlet opening 710. It should be understood that when the tissue collection chamber 782 is in the suction path, the bypass channel 792 is not in the suction path.
[0170] Once the desired tissue sample has been collected and / or the user prefers to operate manifold 700 without collecting a tissue sample, another input is provided to control surface 788 to rotate rotor 737 within stator 743 to the bypass position. Fig.44 and 46 The manifold 700 is shown with the rotor 737 in the bypass position. The rotor 737 is rotated so that the bypass channel 792 is in fluid communication with the inlet hole 714 and the tissue collection chamber 782 is not in the suction path. A suction path is established from the inlet hole 714 to the suction inlet 52 through each of the inlet 767a, the bypass channel 792, the outlet opening 767b, the aperture 758, the manifold volume 708, the filter element 716 and the outlet opening 710.
[0171] With the rotor 737 in the bypass position such that the tissue collection chamber 682 is not within the aspiration path, the manifold 700 advantageously provides for retrieval of collected tissue samples without interrupting operation of the medical waste collection assembly 50. Fig.41 , stator 743 defines a window 715 extending through the sidewall 735. When rotor 737 is in the bypass position, window 715 can be positioned circumferentially around stator 743 to align with tissue collection chamber 782. In addition, window 715 includes a height and width for exposing tissue collection chamber 782 to allow tissue sample to be taken out. For example, a user can place a container (e.g., formalin jar) below the exposed tissue collection chamber 782, and use an instrument (e.g., a spatula) to scrape the tissue sample from the porous feature 786 and enter the container. The incision 799 below the tissue collection chamber 782 in rotor 737 provides a straight line drop from the tissue collection chamber 782 to the container. When the tissue sample is retrieved, another user can continue to perform other aspects of the surgical operation requiring medical waste collection assembly 50 to provide suction. If the retrieved tissue sample is not satisfied and / or another tissue sample is needed, rotor 737 can be quickly turned back to the tissue collection position.
[0172] Manifold 700 is adapted to visualization to provide an improved tissue collection experience for the user. Stator 743 may include lens 796, which is positioned to align with tissue collection chamber 782 when rotor 737 is in tissue collection position and provide magnification in tissue collection chamber 782. As previously mentioned, this is partially achieved by a slightly tortuous suction path between inlet hole 714 and tissue collection chamber. Inlet joint 712 is offset and has groove 793 in rotor 737, and lens 796 is coaxially aligned with tissue collection chamber 782 when rotor 737 is in tissue collection position. In addition, when lens 796 is located at the front of manifold 700, the user can scan manifold 700 from a reasonable distance and without improperly operating manifold 700 to quickly determine whether a suitable tissue sample has been captured. It is envisioned that lighting can be provided to illuminate tissue collection chamber 782.
[0173] An exemplary method of collecting tissue samples using the manifold 700 is also contemplated. The housing 702 of the manifold 700 is coupled to the medical waste collection assembly 50 so that the outlet opening 710 is in fluid communication with the suction inlet 58 of the medical waste collection assembly 50. The suction line 52 is coupled to the inlet connector 712 to provide a suction path from the inlet hole 714 of the inlet connector 712 to the suction inlet 58. The medical waste collection assembly 50 is operated when the manifold 700 is in the bypass position. The bypass channel 792 is in the suction path, and the tissue collection chamber 782 is not in the suction path. The control surface 788 is actuated to rotate the rotor 737 from the bypass position to the tissue collection position in the stator 743. For example, the control surface 788 is rotated in a first rotational direction. The tissue collection chamber 782 is in the suction path, and the bypass channel 792 moves away from the suction path. The medical waste collection assembly 50 is operated when the manifold 700 is in the tissue collection position to collect tissue samples using the porous features 786 of the tissue collection chamber 782. When the rotor 797 is in the tissue collection position, the tissue collection chamber 782 can be observed through the lens 796. After collecting the tissue sample, the control surface 788 can be actuated to return the rotor 737 to the bypass position. For example, the control surface 788 is rotated in a second rotational direction opposite to the first rotational direction. When the rotor 737 is in the bypass position, the tissue sample can be removed from the tissue collection chamber 782. For example, the tissue sample can be retrieved from the exposed tissue collection chamber 782 through the window 715 of the stator 743, for example, using an instrument that scrapes the porous features 786 to remove the tissue sample.
[0174] In the above-described embodiment of the manifold 700, the rotor 737 is rotatably disposed with the stator 743 fixed relative to the body portion 704. It is contemplated that the opposite configuration may be achieved, wherein the "rotor" is fixed relative to the body portion 704 and the "stator" rotates or pivots about the "rotor." Additionally, the above-described embodiment of the manifold 700 includes the rotor 737 rotating about a vertical axis. It is contemplated that each of the rotor 737 and the stator 743 may be oriented about a horizontal axis.
[0175] Reference now Fig.50 and 51 , another manifold 800 is shown that is similar in at least some respects to the manifolds previously described (and certain identical components are represented by the same numerals plus one hundred (100)). Manifold 800 includes a housing 802 adapted to removably engage with manifold receiver 54. Housing 802 includes a cap portion 806 and a body portion (not shown), which may include any of the components described in the present disclosure. As previously described, cap portion 806 may be coupled to the body portion by a removable or permanent connection means, or the body portion and cap portion 806 may be formed as a one-piece, unitary structure, for example, spin welded at an interface to prevent reuse. As previously described, Fig.52 As best shown, a manifold volume 808 is defined, and an outlet opening (not shown) is in fluid communication with the manifold volume 808. The housing 802 includes a first inlet fitting 812a defining a first inlet aperture 814a in fluid communication with the manifold volume 808. The housing 802 includes a second inlet fitting 812b defining a second inlet aperture 814b in fluid communication with the manifold volume 808 in a manner to be described. As previously described, the outlet opening is adapted to be in fluid communication with the suction inlet 52 of the medical waste collection assembly 50 when the housing 802 is engaged with the manifold receiver 54, thereby providing a suction path from the inlet aperture 514 to the suction inlet 58. A drip valve (not shown) may be positioned within the outlet opening to, in the manner previously described, prevent fluid from flowing out of the outlet opening when the housing 802 is disengaged from the manifold receiver 54, and provide fluid communication between the manifold volume 808 and the suction inlet 58 of the medical waste collection assembly 50 when the housing 802 is engaged with the manifold receiver 54. The manifold 800 may include a filter element (not shown) disposed within the housing 802 and in the suction path to be described. The filter element defines a porous feature that is suitable for capturing semi-solid and solid matter entrained in the flow drawn along the suction path.
[0176] Fig.51A cap portion 806 is shown including a cap panel 840 and a cap head 842. The cap head 842 includes at least one sidewall 854 extending distally and terminating at a distal side 856. Apertures 858a, 858b extend through the distal side 856 of the cap head 852 and lead to tissue collection channels 891 extending through the cap head 842, respectively. Fig.54 , the cap panel 840 can be disc-shaped, including a proximal side 870 and a distal side 872 opposite the proximal side 870. The coupling feature 864 can be a pair of slots arranged to provide a bayonet-type installation with a complementary coupling feature 866 of the cap panel 840, such as Fig.51 and 54 As shown. The complementary coupling features 866 of the cap panel 840 are posts arranged circumferentially to be received in the slots. Of course, other coupling features can be considered. The tubular portion 868 extends proximally from the proximal side 870. To facilitate operation of the manifold 800 in a manner to be described, the cap panel 840 may include a control surface 874 suitable for being manipulated (e.g., pinched) by a user.
[0177] The cap panel 840 of the cap portion 806 includes a first inlet connector 812a. Fig.50 and 51 As shown, the first inlet joint 812a extends distally from the distal side 872 of the cap panel 840, while the inlet hole 814a extends through the cap panel 840. In this way, when the manifold 800 is assembled, the first inlet joint 812a can be rotated relative to the body portion, that is, it rotates around the longitudinal axis of the shell. It is envisioned that the first inlet joint can be moved in other ways. The second inlet joint 812b can extend distally from the distal side 856 of the cap head 852. The second inlet joint 812b is not directly connected to the cap panel 840. The first inlet joint 812a is rotatable relative to the body portion, while the second inlet joint 812b is fixed relative to the cap head 852 and the body portion. The second inlet hole 814b defined by the second inlet joint 812b is connected to the second aperture 857b to be described to define one of the bypass channels 892. The second inlet joint can also be part of the shell.
[0178] The housing 802 further defines at least one accessory opening 811 that leads to an accessory sleeve 813, respectively. The accessory sleeve 813 is in fluid communication with the manifold volume 808. The accessory sleeve 813 is disposed within the cap body 806. Fig.50 One of the accessory openings 811 is shown positioned at a side portion of the cap head 842, with the accessory sleeve 813 opening radially inwardly into the manifold volume 808. Another of the accessory openings 811 may be positioned relative to the cap body 806 diametrically opposite the other accessory opening 811.
[0179] The manifold 800 includes at least one tray 876a, 876b configured to be removably positioned within the accessory sleeve 813. Fig.51 , the trays 876a, 876b define a tissue collection chamber 882 and a porous feature 886 within the tissue collection chamber 882. With the trays 876a, 876b positioned within the accessory sleeve 813, the porous feature 582 can be within the suction path to collect tissue samples, in a manner to be described below, which is further based on the rotatable position of the first inlet hole 814a. Once it is desired to retrieve the collected tissue sample, the trays 876a, 876b can be slidably removed from the accessory sleeve 813 with the tissue sample placed within the tissue collection chamber 882. It should be understood that the trays 876a, 876b are optional, and the manifold 800 can be operated without the trays 876 within the accessory sleeve 813.
[0180] The trays 876a, 876b may be formed from a single piece or multiple pieces. Fig.51, the tray 876a, 876b includes a pair of opposite side portions 885 extending from a screen surface 884 defining a porous feature 886. The side portions 885 and the screen surface 884 together define a tissue collection chamber 882 of the tray 876a, 876b. The tray 876a, 876b may further include an orientation feature (not shown) configured to engage a complementary orientation feature (not shown) of the accessory sleeve 813 to position the tray 876a, 876b within the accessory sleeve 813 in a predetermined orientation relative to the distal stop 803. The tray 876 includes a control surface 888 adapted to receive input from a user. The control surface 888 may be formed as a handle that is pinched between the user's fingers. The tray 876a, 876b further includes a sealing surface 855 adapted to sealably engage with the housing 802 when the tray 876a, 876b is located within the accessory sleeve 813. In particular, the tray 876 may include a flange defining a sealing surface 855, wherein the sealing surface 855 is adapted to contact the periphery of the accessory opening 811. With the trays 876a, 876b located within the accessory sleeve 813 and the sealing surface 855 covering the accessory opening 811, suction is maintained through the suction path during operation of the medical waste collection assembly 50. Similarly, a cap (not shown) may be provided that is sized to cover the accessory opening 811 to maintain suction through the suction path without the trays 876a, 876b. Further, the trays 876a, 876b may include a retaining feature (not shown), such as a latch, adapted to be destructibly engaged with a retaining feature complementary to the housing 802, for providing tactile and / or audible feedback to the user, so that the user is assured that the trays 876a, 876b have been fully placed or seated in the accessory sleeve 813. Once tissue samples are collected within the tissue collection cavity 882 and the user wishes to remove the trays 876a, 876b, sufficient force input is provided to the control surfaces 888 of the trays 876a, 876b to disengage the retaining features from the complementary retaining features (e.g., to overcome the interference engagement between the detents and the housing 802).
[0181] Also refer to Fig.51 , the cap head 842 of the housing 802 defines at least one of the apertures 858a, 858b and a second aperture 857. Each of the apertures 858a, 858b can lead to a corresponding one of the tissue collection channels 891. The tissue collection channel 891 can be coaxial with the accessory sleeve 813 and in fluid communication. The bypass opening 857 can lead to the bypass channel 892 ( Fig.51 The second inlet hole 814b is in fluid communication with another one of the bypass channels 892.
[0182] In operation, if the user wishes to collect tissue samples in one or both of the tissue collection chambers 882 of the tray 876, the user provides input to the control surface 874 to rotate the first inlet connector 812a to align the first inlet hole 814a with one of the apertures 858a, 858b. In addition, the user positions one of the trays 876a, 876b in one of the accessory sleeves 813. With the first inlet hole 814a aligned with one of the apertures 858a, 858b and the trays 876a, 876b positioned within the accessory sleeves 813, a corresponding one of the tissue collection chambers 882 is in the suction path, and the tissue sample drawn through the suction path encounters the porous feature 886 within the tissue collection chamber 882. The manifold 800 can be considered to be in the tissue collection position. If another tissue sample is desired, the user can simply provide another input to the control surface 844 to rotate the first inlet connector 812a to align the first inlet aperture 814a with one of the apertures 858a, 858b. The user places the other of the trays 876a, 876b in one of the accessory sleeves 813. With the first inlet aperture 814a aligned with the other of the apertures 858a, 858b and the trays 876a, 876b positioned within the other accessory sleeve 813, the other tissue collection cavity 882 is in the aspiration path, and the tissue sample aspirated through the aspiration path encounters the porous feature 886 within the tissue collection cavity 882.
[0183] During operation of the medical waste collection assembly 50, if the user does not want to collect tissue samples, but the manifold 800 keeps suction, the bypass channel 892 allows fluid to flow through the manifold 800 without collecting tissue samples. Two bypass channels 892 are shown. The first inlet hole 812a is suitable for being rotated to selectively align with the bypass opening 857. In particular, the user provides input to the control surface 844 to rotate the first inlet hole 814a to align with the bypass opening 857. The manifold 800 can be considered to be in a bypass position. When the bypass channel 892 is in fluid communication with the first inlet hole 814a, it can be considered that the tissue collection chamber 882 is not in fluid communication with the inlet hole 814. Additionally or alternatively, the second suction line can be connected to the second inlet joint 812b defining the second inlet hole 814b. In such an exemplary operation, the waste entering the second inlet hole 814b is guided through another one of the bypass channels 892. Of course, additional inlet connections, such as three or four inlet connections, are also contemplated while replicating some of the features described above.
[0184] In the case where the manifold 800 is in the bypass position so that the tissue collection chamber 882 is not in the suction path, the manifold 800 advantageously provides for the retrieval of the collected tissue sample without interrupting the operation of the medical waste collection assembly 50. The bypass channel 892 allows the user to continue to suction the surgical site without first retrieving the tissue sample from the manifold 800 and without compromising the quality of the tissue sample initially collected. In this way, the manifold 800 can remain engaged with the medical waste collection assembly 50 until the end of the surgical procedure. In the case where the manifold 800 is in the bypass position (or in the case where the manifold 800 is in the tissue collection position using another tray 876a, 876b), the user provides input to the control surface 888 of the tray 876a, 876b to remove the tray 876a, 876b from its corresponding accessory sleeve 813. A replacement tray in the tray 876a, 876b can be placed into the accessory sleeve 813 without interrupting the operation of the medical waste collection assembly 50.
[0185] As previously described, manifold 800 accommodates visualization to provide the user with an improved tissue collection experience. Fig.51 and Fig.53 , the tissue collection cavity 882 of the tray 876 is open toward the top of the manifold 800, and the manifold 800 includes a lens 896 that provides magnification within the tissue collection cavity when the tray is within the accessory sleeve 813. In addition, when the lens 896 at the top of the manifold 800 is positioned horizontally within the medical waste collection assembly 50, the user can glance at the manifold 800 from a reasonable distance and without improper manipulation of the manifold 800 to quickly determine whether a suitable tissue sample has been captured. It is contemplated that lighting can be provided to illuminate the tissue collection cavity 882.
[0186] Reference now Figure 55-61, another manifold 900 is shown that is similar in at least some respects to the manifolds previously described (and certain identical components are represented by the same numerals plus one hundred (100)). Manifold 900 includes a housing 902 adapted to be removably engaged with manifold receiver 54. Housing 902 includes a cap portion 906 and a body portion 904. As previously described, cap portion 906 may be coupled to the body portion by a removable or permanent connection, or the body portion and cap portion 904 may be formed as a one-piece, unitary structure, for example, spin welded at an interface to prevent reuse. Housing 902 defines a manifold volume space (not identified). An outlet opening (not shown) is in fluid communication with the manifold volume space. Housing 902 includes: a first inlet connector 912a defining a first inlet port 914a in fluid communication with the manifold volume space; and a second inlet connector 912b defining a second inlet port 914b in fluid communication with the manifold volume space. As previously described, the outlet opening is adapted to be in fluid communication with the suction inlet 52 of the medical waste collection assembly 50 when the housing 902 is engaged with the manifold receiver 54, thereby providing a suction path from the inlet holes 914a, 914b to the suction inlet 52. A drip valve (not shown) may be positioned within the outlet opening to, in a manner previously described, prevent fluid from flowing out of the outlet when the housing 902 is disengaged from the manifold receiver 54, and provide fluid communication between the manifold volume space and the suction inlet 52 of the medical waste collection assembly 50 when the housing 902 is engaged with the manifold receiver 54. The manifold 900 may include a filter element (not shown) disposed within the housing 902 and in the suction path to be described. The filter element defines a porous feature adapted to capture semi-solid and solid matter entrained in the flow drawn along the suction path.
[0187] Fig.55 The cap portion 906 is shown to include a cap panel 940 and a cap head 942. Fig.56 , the cap head 942 includes at least one sidewall 954 extending distally and terminating at a distal side 956. Fig.57 , the cap panel 940 can be disc-shaped, including a proximal side 970 and a distal side 972 opposite the proximal side 970. The coupling feature 964 can be arranged to provide a bayonet-type installation together with a complementary coupling feature 966 of the cap panel 940. The tubular portion 968 extends proximally from the proximal side 970. Of course, other coupling features can be used. To facilitate operation of the manifold 900 in a manner to be described, the cap panel 940 may include a control surface 974 suitable for manipulation by a user.
[0188] The cap panel 940 of the cap portion 906 includes a first inlet connection 912a. Fig.56As shown, each of the first inlet connector 912a and the second inlet connector 912b extends distally from the distal side 972 of the cap panel 940, and the inlet holes 914a, 914b extend through the cap panel 940. In this way, when the manifold 900 is assembled, the first inlet connector 912a and the second inlet connector 912b are rotatable relative to the body portion 904, that is, rotate relative to it around the longitudinal axis of the body portion, and are configured to rotate between a tissue collection position and a bypass position. It is also contemplated that the first and second inlet connectors can move in different ways relative to the housing. A marking 994 can be provided to indicate which is the first inlet connector 912a, because the first inlet connector 912a is used as a port for tissue collection. Fig.55 and 56 The marking 994 shown in FIG. 1 comprises a ring around the first inlet fitting 912a to provide a visual as well as a tactile indication without excessive effort. Other types of markings, such as tabs or protrusions, are also contemplated.
[0189] The housing 902 also defines an accessory opening 911 leading into an accessory sleeve 913. The accessory sleeve 913 is in fluid communication with the manifold volume 908. The accessory sleeve 913 is disposed within the cap body 906. Fig.56 An accessory opening 911 is shown positioned at a side portion of the cap head 942, with an accessory sleeve 913 angled upward in a manner to be described. It is contemplated that another accessory sleeve (not shown) may be positioned diametrically opposite relative to the cap body 806.
[0190] The manifold 900 includes a tray 976 configured to be removably positioned within the accessory sleeve 913. Fig.56 , the tray 976 defines a tissue collection cavity 982 and a porous feature 986 within the tissue collection cavity 982. With the tray 976 positioned within the accessory sleeve 913, the porous feature 986 can be used within the suction path to collect tissue samples, in a manner to be described below, which is further based on the rotatable position of the first inlet hole 914a. Once it is desired to retrieve the collected tissue sample, the tray 976 can be slidably removed from the accessory sleeve 913 with the tissue sample placed within the tissue collection cavity 982. It should be understood that the tray 976 is optional and the manifold 900 can be operated without the tray 976 within the accessory sleeve 913.
[0191] like Fig.56 As best shown in FIG. 9 , the tray 976 may be formed from a single piece or multiple pieces. Fig.56, the tray 976 includes a pair of opposite side portions 985 extending from a screen surface 984 defining a porous feature 986. The side portions 985 and the screen surface 984 together define a tissue collection cavity 982 of the tray 976. The tray 976 may further include an orientation feature (not shown) configured to engage a complementary orientation feature (not shown) of the accessory sleeve 913 to position the tray 976 within the accessory sleeve 913 in a predetermined orientation relative to the distal stop 903. The tray 976 includes a control surface 988 adapted to receive input from a user. The control surface 988 may be formed as a handle that is pinched between the user's fingers. The tray 976 also includes a sealing surface 955 adapted to sealably engage with the housing 902 when the tray 976 is within the accessory sleeve 913. In particular, the tray 976 may include a flange defining the sealing surface 955, wherein the sealing surface 955 is adapted to contact the periphery of the accessory opening 911. During operation of the medical waste collection assembly 50, suction through the suction path is maintained when the tray 976 is located within the accessory sleeve 913 and the sealing surface 955 covers the accessory opening 911. Similarly, a cap can be provided (see, e.g. Fig.29 ) and is sized to cover the accessory opening 911 to maintain suction through the suction path in the absence of the tray 976. Further, the tray 976 can include a retaining feature (not shown) adapted to destructibly engage with a complementary retaining feature of the housing 902, such as a detent, for providing tactile and / or audible feedback to the user to assure the user that the tray 976 has been fully placed or seated in the accessory sleeve 913. Once the tissue sample is collected in the tissue collection cavity 982 and the user wishes to remove the tray 976, sufficient force input is provided to the control surface 988 of the tray 976 to disengage the retaining feature and the complementary retaining feature (e.g., to overcome the interference engagement between the detent and the housing 902).
[0192] Also refer to Fig.58 and 60 , the cap head 942 of the housing 902 may define an aperture 958 and at least one of the bypass openings 957. The aperture 958 leads to a tissue collection channel 991. The tissue collection channel 991 is in fluid communication with the accessory sleeve 913. Fig.58 Three bypass openings 957a, 957b, 957c are shown, each opening into a respective bypass passage 992 in a manner to be described. In a variation to be described, one of the bypass openings 957a may be removed to eliminate suction to the suction line 52 when the manifold 900 is in the bypass position.
[0193] In operation, if a user wishes to collect a tissue sample in the tissue collection cavity 982 of the tray 976, the user provides input to the control surface 974 to rotate the first inlet connector 912a (and thus the second inlet connector 912b) to the position as shown in FIG. Fig.59 The input may include providing a torque in a first rotational direction D1 to the control surface 974 of the cap panel 940. Fig.59 In the tissue collection position shown, the first inlet aperture 914a is in communication with (e.g., coaxially aligned with) the aperture 958 near which the tissue collection cavity 982 is aligned when the tray 976 is placed within the accessory sleeve 913. At the same time, the second inlet aperture 914b is in communication with, e.g., coaxially aligned with, the one of the bypass openings 957b that opens into the manifold volume 908.
[0194] The user places the tray 976 in the accessory sleeve 913. With the first entry hole 914a aligned with the aperture 958 and the tray 976 in the accessory sleeve 913, a Fig.49 In particular, the tissue collection chamber 982 is in the suction path, and the tissue sample being suctioned through the suction path encounters the porous feature 986 within the tissue collection chamber 982. The manifold 900 can be considered to be in a tissue collection position while providing separate suction of waste through the second inlet connector 912b that communicates with the bypass opening 957b described above.
[0195] If the user wishes to retrieve the tissue sample collected in the tray 976 and / or remove the tray 976 from the aspiration path, the user provides another input to the control surface 974 to rotate the first inlet connector 912a (and thus the second inlet connector 912b) to Fig.60 The input may include providing another torque to the control surface 974 in a second rotational direction D2 opposite to the first rotational direction. Fig.60 In the bypass position shown, the first inlet aperture 914a is in communication with, e.g., coaxially aligned with, one of the bypass openings 957a, and the second inlet aperture 914b is in communication with, e.g., coaxially aligned with, the other of the bypass openings 957c.
[0196] In the aforementioned variation, the bypass opening 957a is removed so that in the bypass position the first inlet aperture 914a is aligned with a portion of the distal surface 856 of the cap head 942. Suction through the first inlet aperture 914a is removed, thereby eliminating the risk of additional tissue sample or waste being aspirated through the aspiration line 52 and the first inlet aperture 914a.
[0197] The tray 976 can be removed from the accessory sleeve 913 with the manifold 900 in the tissue collection position and / or the bypass position. In doing so, a drop in suction may occur after the accessory opening 911 is no longer in sealing engagement with the sealing surface 955 of the tray 976. With the manifold 900 in the tissue collection and / or bypass position, the user provides input to the control surface 988 of the tray 976 to remove the tray 976 from the accessory sleeve 913. If another tissue sample is desired, a replacement tray 976 can be placed in the accessory sleeve 913 without interrupting operation of the medical waste collection assembly 50.
[0198] Manifold 900 is adapted for visualization to provide an improved tissue collection experience for the user. The tissue collection chamber 982 of the tray 976 is open to the distal blocker 903, and the manifold 900 includes a lens 996 that provides magnification in the tissue collection chamber when the tray is in the accessory sleeve 913. The distal blocker 903 and other blocks defining the exterior of the accessory sleeve 913 are "clocked" relative to the longitudinal axis of the manifold 900 so that the distal blocker 903 including the lens 996 is oriented distally and upward relative to the longitudinal axis. Based on the orientation of the manifold 900 in the medical waste collection assembly 50, the lens 996 is positioned at the top of the manifold 900. The user can glance at the manifold 900 from a reasonable distance and without improperly manipulating the manifold 900 to quickly determine whether a suitable tissue sample has been captured. It is expected that lighting can be provided to illuminate the tissue collection chamber 982.
[0199] Figure 62-64 Shows Figure 55-61 A variation of manifold 900 of the present invention may be described with certain alternative or additional features, particularly with respect to the orientation and / or positioning of tray 976 within accessory sleeve 913. Figure 55-61 The description of the manifold 900 will not be repeated, and those descriptions should be considered to be incorporated herein by reference. The manifold 900 includes a cap portion 906 and a body portion 904, which together form a housing 902. The housing 902 includes a first inlet connector 912a defining a first inlet hole 914a in fluid communication with the manifold volume space, and a second inlet connector 912b defining a second inlet hole 914b in fluid communication with the manifold volume space. The manifold 900 may include a filter element (not shown) disposed within the housing 902 and in the suction path.
[0200] Fig.62A cap portion 906 is shown including a cap panel 940 and a cap head 942′. The cap panel 940 of the cap portion 906 includes a first inlet connector 912a and a second inlet connector 912b, which are rotatable relative to the body portion 904, i.e., orbitally rotatable relative to the longitudinal axis of the body portion, and are configured to rotate between a tissue collection position and a bypass position.
[0201] Also refer to Fig.63 The cap head 942' includes at least one sidewall 954 extending distally and terminating at a distal side (not shown). The housing 902 further defines an accessory opening 911 leading to an accessory sleeve 913. The accessory sleeve 913 is in fluid communication with the manifold volume 908. The accessory sleeve 913 is disposed within the cap portion 906. Fig.63 The accessory opening 911 is shown positioned to the side of the cap head 942', with the accessory sleeve 913 tilted upwardly in a manner to be described.
[0202] The manifold 900 includes a tray 976 configured to be removably positioned within the accessory sleeve 913. Fig.64 , the tray 976 defines a tissue collection cavity 982 and a porous feature 986 within the tissue collection cavity 982. With the tray 976 positioned within the accessory sleeve 913, the porous feature 986 can be within the suction path to collect tissue samples, in the manner previously described, which is further based on the rotatable position of the first inlet hole 914a. Once it is desired to retrieve the collected tissue sample, the tray 976 can be slidably removed from the accessory sleeve 913 with the tissue sample placed within the tissue collection cavity 982.
[0203] Continue to refer Fig.64, the tray 976 may include a pair of opposing side portions 985 extending from a screen surface 984 defining a porous feature 986. The side portions 985 and the screen surface 984 together define a tissue collection chamber 982 of the tray 976. The tray 976 includes a control surface 988 adapted to receive input from a user. The control surface 988 may be formed as a handle to be pinched between the fingers of the user. The tray 976 also includes a sealing surface 955 adapted to sealably engage with the housing 902 when the tray 976 is within the accessory sleeve 913. In particular, the tray 976 may include a flange defining the sealing surface 955, wherein the sealing surface 955 is adapted to contact the periphery of the accessory opening 911. With the tray 976 located within the accessory sleeve 913 and the sealing surface 955 covering the accessory opening 911, suction is maintained through the suction path during operation of the medical waste collection assembly 50. Once tissue samples are collected in tissue collection cavity 982 and the user wishes to remove tray 976 , sufficient force input is provided to control surface 988 of tray 976 to remove tray 976 from accessory sleeve 913 .
[0204] Reference Fig.64 , the tray 976 may further include an orientation feature 987 configured to engage a complementary orientation feature 989 of the accessory sleeve 913 (in Fig.63 903) to position the tray 976 in a single relative orientation, particularly relative to the upper stop 903, within the accessory sleeve 913. The orientation feature 989 of the tray accessory sleeve 913 can be a protrusion. The protrusion extends inwardly from the relative stop that at least partially defines the accessory sleeve 913 and is oriented generally parallel to the direction of the accessory sleeve 913, for example, parallel to the upper stop 903. Fig.63 The projection is shown extending only partially between the accessory opening 911 and the interface opening in the side wall 954 of the cap head 942' opposite the accessory opening 911. It is contemplated that the orientation feature 989 may extend between them substantially along the entire accessory sleeve 913, so that the orientation feature 999 is more like an elongated rail. The orientation feature 989 is closer to the distal stopper 903 than to that stopper shape that at least partially defines the accessory sleeve 913 opposite the upper stopper 903, thereby requiring the tray 976 to be coupled to the housing 902 in a single orientation.
[0205] The complementary orientation feature 987 of the tray 976 may be a guide configured to movably engage a protrusion of the accessory socket 913 . Fig.64The guide rail is shown extending outwardly from the sealing surface 955 to a position near the end of the tray 976 opposite the sealing surface 955. More specifically, the orientation feature 987 extends laterally outwardly from the opposite side portions 985, at least partially defining the tissue collection chamber 982. The orientation feature 987 is located at the upper edge of the side portion 985, in other words, at the edge of the side portion 985 opposite the screen surface 984. The position of the orientation feature 987 relative to the screen surface 984 and the position of the orientation feature 989 relative to the upper stop 903 require that the tray 976 be inserted into the accessory sleeve 913 in a single orientation. The guide rail movably engages the protrusion so that the tissue collection chamber 982 opens toward the first inlet hole 914a.
[0206] The directional features 987, 989 can also be used as positioning features to provide a second suction path below the tray 976 (i.e., adjacent to the screen surface 984 opposite to the tissue collection chamber 982). The second suction path can be used to at least partially weaken or destroy the suction ("deflating") between the inlet holes 912a, 912b and the outlet opening, after which the accessory opening 911 is no longer sealed with the sealing surface 955 of the tray 976. The positioning features and the second suction path will be described in more detail. In short, based on fluid dynamics, once the tray 976 is removed from the accessory sleeve 913, the corresponding fluid flow occurs in the path of least resistance through the accessory sleeve 913. Because the second suction path is located below the tray 976 when the tray 976 is removed from the accessory sleeve 913, the possibility that the fluid flowing through the accessory sleeve 913 accidentally and undesirably ejects the tissue sample collected in the tissue collection chamber 982 is reduced. The orientation features 987, 989 can suspend the screen surface 984 above the lower barrier that at least partially defines the accessory sleeve 913 to define a gap. Because the upper surface of the orientation feature 987 (e.g., a guide) is positioned adjacent to the upper barrier 903 that at least partially defines the accessory sleeve 913, the gap can be the path of least resistance so that most of the fluid is directed below the tray 976 and does not contact the tissue sample collected in the tissue collection chamber 982. Because the fluid flow into the tissue collection chamber 982 is small and the associated forces are minimal, the possibility of the collected tissue sample being siphoned out of the tissue collection chamber 982 and into the manifold volume is reduced or eliminated.
[0207] Manifold 900 accommodates visualization to provide the user with an improved tissue collection experience. Fig.63 and Fig.64, the tissue collection cavity 982 of the tray 976 is open toward the upper barrier 903, and the manifold 900 includes a lens 996 that provides magnification within the tissue collection cavity when the tray is within the accessory sleeve 913. The upper barrier 903 and other baffles defining the exterior of the accessory sleeve 913 are "rotationally displaced" relative to the longitudinal axis of the manifold 900, so that the upper barrier 903 including the lens 996 is oriented distally and upwardly relative to the longitudinal axis. Specifically, Fig.63 An upper barrier 903 is shown with a lens 996 disposed thereon, the upper barrier being positioned at an angle γ relative to a plane including the longitudinal axis of the manifold 900. The angle γ may be between about 10 and 45 degrees, more particularly between about 20 and 35 degrees, and even more particularly about 25 degrees. Based on the orientation of the manifold 900 within the medical waste collection assembly 50, the lens 996 is positioned at the top of the manifold 900, oriented generally horizontally relative to the ground. The user may glance at the manifold 900 from a reasonable distance and without inappropriate manipulation of the manifold 900 to quickly determine whether a suitable tissue sample has been captured. It is contemplated that illumination may be provided to illuminate the tissue collection chamber 982.
[0208] Reference now Figures 65-68, the cap portion 1106, 1206 for the manifold 1100, 1200 includes a cap head 1142, 1242 and a support frame 1143, 1243. The cap portion 1106, 1206 defines an upper stopper 1103, 1203. The housing includes a first inlet connector 1112a, 1212a and a second inlet connector 1112b, 1212b. More specifically, the support frame 1143, 1243 of the cap portion 1106, 1206 includes a first inlet connector 1112a, 1212a, and the cap head 1142, 1242 includes a second inlet connector 1112b, 1212b. The first inlet fitting 1112a, 1212a extends upwardly away from the upper block 1103, 1203, and the first inlet aperture 1114a, 1214a extends through the first inlet fitting 1112a, 1212a and the upper block 1103, 1203. The second inlet fitting 1112b, 1212b extends distally from the cap head 1142, 1242, and the second inlet aperture 1114b, 1214b extends through the cap head 1142, 1242. The housing of the manifold 1100, 1200 also defines an accessory opening 1111, 1211 leading to the accessory sleeve 1113, 1213. The accessory sleeve 1113, 1213 may be at least partially defined by an upper barrier 1103, 1203, a lower barrier 1122, 1222, and opposing side barriers 1123, 1223 extending between the upper barrier 1103, 1203 and the lower barrier 1122, 1222. The accessory sleeve 1113, 1213 is in fluid communication with the manifold volume through the aperture 1125, 1225.
[0209] The manifolds 1100, 1200 include a tray 1176, 1276 configured to be removably positioned within the accessory sleeves 1113, 1213. The trays 1176, 1276 may be the same as previously described. Operation of the manifolds 1100, 1200 includes moving the manifolds 1100, 1200 between a sealing configuration and a venting configuration, the same as previously described.
[0210] from Fig.65 and 66 It will be readily appreciated that cap portion 1106 may be considered "side loaded" and cap portion 1206 may be considered "front loaded"; that is, trays 1176, 1276 are loaded from the front and sides of manifolds 1100, 1200, respectively. Fig.67 and 68 1 is a side view of the front load cap portion 1206. The cap portions 1106, 1206 include cap panels 1140, 1240 and cap heads 1142, 1242 coupled to the cap panels 1140, 1240. Fig.66 and 67As shown, the cap panel 1140, 1240 is oriented on a first axis (A1). The cap head 1142, 1242 includes an upper stopper 1103, 1203 that at least partially defines an accessory sleeve 1113, 1213, as previously described. The upper stopper 1103, 1203 is oriented on a second axis (A2) that is angularly inclined relative to the first axis (A1). Fig.62 and 63 As shown, a line perpendicular to the first axis (A1) is at an angle α, β relative to the second axis (A2). The angles α, β can be between about 10 and 45 degrees, more particularly between about 20 and 35 degrees, and even more particularly about 25 degrees. Therefore, in a configuration of the medical waste collection assembly 50 in which the void space 56 of the manifold receiver 54 is oriented at an angle, particularly angles α, β, the orientation of the upper blocking members 1103, 1203 relative to the cap panels 1140, 1240 (coupled to the body portions 1104, 1204 inserted into the void space 156) causes the upper blocking members 1103, 1203 to be substantially horizontal. In addition, similarly, the accessory sleeves 1113, 1213 are horizontal to facilitate easy use to insert and remove the trays 1176, 1276 into and from the accessory sleeves 1113, 1213, respectively. Still further, the apertures (not shown) extending between the accessory sleeves 1113, 1213 and the manifold volume are oriented at angles α, β relative to horizontal, which helps prevent waste from flowing back from the manifold volume into the accessory sleeves 1113, 1213. In other words, waste is less likely to move from the manifold volume to the accessory sleeves 1113, 1213 through the angled apertures 1125, 1225 against gravity.
[0211] Fig.65 The side load cap portion 1106 is shown positioned in the assembly axis (A) from the proximal to the distal direction. F ). More specifically, the first inlet fitting 1112a extends distally from the upper barrier 1103 near a distal one of the side portions 1125 that at least partially define the accessory sleeve 1113. The first inlet fitting 1112a can define a distal end of the manifold 1100. The accessory sleeve 1113 can be defined on a sleeve axis (A S ) on (considered to be Fig.67 Sleeve axis (A S ) can be aligned with the assembly axis (A F ) are orthogonal so that the accessory sleeve 1113 is oriented in a direction from side to side, thus "side loading" the cap portion 1106. When the cap portion 1106 is viewed from the front (see Fig.65), the accessory opening 1111 may be positioned on the right-hand side and define the lateral end of the manifold 1100. Such an arrangement may be more convenient for a right-handed user to access the manifold 1100 from the front. Of course, it should be understood that an alternative configuration is contemplated in which the accessory opening 1111 is positioned on the left-hand side. The cap portion 1106 may also include a second inlet fitting 1112b coupled to the cap panel 1140 and defining a second inlet aperture 1114b, providing a bypass suction path from the second inlet aperture 1114b to the manifold volume space without passing through the accessory sleeve 1113.
[0212] Fig.67 and 68 The front load cap portion 1206 is shown oriented vertically on the assembly axis (A F ) on the first inlet joint 1212a. More specifically, the first inlet joint 1212a extends upward from the upper stopper 1203 that at least partially defines the accessory sleeve 1113. The accessory sleeve 1213 can be defined by the sleeve axis (A S ) on which the attachment opening 1211 defines the distal end of the manifold 1200. The sleeve axis (A S ) can be perpendicular to the assembly axis (A F ), such that the accessory sleeve 1213 is oriented in a proximal to distal direction, thereby "front loading" the cap portion 1206. The cap portion 1206 may also include a second inlet fitting 1212b coupled to the cap panel 1240 and defining a second inlet aperture 1214b that provides a bypass suction path from the second inlet aperture 1214b to the manifold volume space without passing through the accessory sleeve 1213.
[0213] Complementary to the orientation of the upper block 1103, 1203 relative to the cap panel 1140, 1240 so that the upper block 1103, 1203 is generally horizontal during operation is the presence of lenses 1196, 1296. As mentioned, it is desirable to visualize the tissue collection chamber 1182, 1282 during the collection of the tissue sample. Once the tissue sample is in the tissue collection chamber 1182, 1382, the quick visual confirmation provided to the user allows the user to move on to any other aspects of the surgical procedure. The manifold 1100, 1200 accommodates visualization to provide the user with an improved tissue collection experience. When the tray 1176, 1276 is in the accessory sleeve 1113, 1213, the tissue collection chamber 1182, 1282 of the tray 1176, 1276 is open toward the upper block 1103, 1203. Lenses 1196, 1296 are disposed on upper blocking members 1103, 1203 to provide magnification within tissue collection chambers 1182, 1282, such as Figure 53-63As shown. Lenses 1196, 1296 are elliptical, but other suitable geometric shapes are contemplated. Lenses 1196, 1296 can be shaped to maximize visualization of tissue collection chambers 1182, 1282 and magnify them. Thus, the user glances at manifolds 1100, 1200 from a reasonable distance and without inappropriate manipulation of manifolds 1100, 1200 to quickly determine whether a suitable tissue sample has been captured. It is contemplated that illumination can be provided to illuminate tissue collection chambers 1182, 1282.
[0214] As mentioned above and as previously described, regardless of whether or not a tissue sample is collected, for example, using trays 176-676, 876, 976, 1176, 1276, the fluid flow is filtered through the filter element 216-716 of the manifold 100-900, 1100, 1200. Access to the filter element 216-716 may be desirable for a variety of reasons. In one example, when a desired tissue sample is aspirated from a patient, the manifold 100-900, 1100, 1200 is operated in a "bypass mode" with caution. Referring now to Figures 69-71 , Fig.69 One embodiment of the aforementioned manifold 500 is shown. Fig.70 and 71 A cap portion 506 of the manifold 500 is shown. Figures 69-71 Each manifold of the present invention includes an access feature 1040 that enables access to the filter element 1016 within the body portion 1004. In a manner to be described, the access feature 1040 is configured to receive a user input to permanently destroy the manifold to provide access to the filter element 1016. It should be understood that the access feature 1040 can be included in any embodiment of the manifolds 100-900, 1100, 1200, and compatible manifolds not described herein.
[0215] refer to Fig.72 , the body portion 1004 includes a proximal base 1026 and at least one side 1028 extending from the proximal base 1026. The exit opening 1010 is defined within the proximal base 1026. The access feature 1040 can include a frangible boundary 942. Fig.67 The frangible border 942 in the form of the illustrated access feature 1040 includes thinned material disposed at the interface between the side and top portions of the side portion 1028 to define an at least partially detachable portion 1046 of the side portion 1026. The access feature 1040 also includes a grip 1044. Fig.72The grip 1044 is shown to include a tab-like structure that defines a gap sized to receive at least one finger of a user. The user, for example, pinches the grip 1044 and peels off a portion 1046 of the side 1026, causing the frangible border 942 to rupture. The portion 1046 is peeled off to expose the filter element 1016 within the body portion 1004.
[0216] Fig.73 A filter element 1016 is shown that is well suited for use with the aforementioned access feature 1040. The filter element 1016 includes at least one side wall 1022 extending from a base wall 1020 to form a basket that defines a cavity 1025. Fig.73 Opposing side walls 1022 are shown separated by a top wall 1023 and a bottom wall 1025. The side walls 1022 may define a porous feature 1018, and in other forms, the base wall 1020 may also define a porous feature 1018. The filter element 1016 defines a window 1050 extending through at least one of the side walls 1022. Fig.73 Window 1050 is shown consuming almost the entire top wall 1023. When filter element 1016 is disposed within body portion 1004, window 1050 is aligned with access feature 1040, and in particular, detachable portion 1046. Thus, after permanently disrupting access feature 1040, such as peeling away portion 1046 to expose filter element 1016, window 1050 is sized to allow retrieval of a tissue sample from within filter element 1016. In one example, forceps can be introduced through window 1050 into cavity 1025 of filter element 1016 to retrieve a tissue sample without removing filter element 1016 from body portion 1004.
[0217] Reference now Fig.70 , another form of access feature 1040 is shown. Access feature 1040 includes a frangible border 1042, which is an at least partially detachable portion 1046, illustrated as a ring, coupled to a grip 1044. The user, for example, pinches the grip 1044 and peels off the removable ring 1044 around the circumference of the body portion 1004 to disrupt the interface between the cap portion 1006 and the body portion 1004. The cap portion 506 is disengaged from the body portion 1004, thereby exposing the mouth 1024 of the filter element 1016 in communication with the cavity 1025. In an example, forceps can be guided through the mouth 1024 into the cavity 1025 of the filter element 1016 to retrieve a tissue sample without removing the filter element 1016 from the body portion 1004.
[0218] Fig.71 Another form of access feature 1040 is shown. Fig.71The access feature 1040 of the embodiment includes a closed perimeter of the frangible border 1024 to define a detachable portion 1046. The closed perimeter can be completely within one of the side walls 1028 of the body portion 1004. The access feature 1040 includes a grip 1044 coupled to the detachable portion 1026 (e.g., a ring). The user manipulates the handle 1044 and tears off a portion 1046 of the side 1026, causing the frangible border 942 to rupture. The closed perimeter of the frangible border 1024 can provide for complete removal of the detachable portion 1026. Similar to Fig.73 The filter element can be provided with a window 1050 aligned with a closed perimeter provided in the side wall 1028. It should be understood that those and other access features discussed above can be provided in the body portion 1004 (e.g. Figures 69-71 as shown) and at least one of the cap portion 106.
[0219] Example clauses
[0220] Item 1 - A manifold for collecting tissue samples using a medical waste collection assembly including a manifold receiver and a suction inlet, the manifold comprising: an inlet connector adapted to receive a suction line and define an inlet aperture; a shell adapted to be removably engaged with the manifold receiver and define a manifold volume space and an outlet opening, the outlet opening being adapted to be fluidly connected to the suction inlet of the medical waste collection assembly when the shell is engaged with the manifold receiver to provide a suction path from the inlet aperture through the manifold volume space to the suction inlet; a filter element disposed within the shell and in the suction path; and a flow diverter defining a tissue collection chamber and a porous feature within the tissue collection chamber and a bypass channel separated from the tissue collection chamber, and comprising a control surface adapted to receive input from a user to move the flow diverter between a tissue collection position and a bypass position, in which the tissue collection chamber is fluidly connected to the inlet aperture so that the porous feature is in the suction path and the bypass channel is not in the suction path, and in which the bypass channel is fluidly connected to the inlet aperture in the suction path and the tissue collection chamber is not in the suction path.
[0221] Item 2 - A manifold for collecting tissue samples utilizing a medical waste collection assembly including a manifold receiver and a suction inlet, the manifold comprising: a shell adapted to be removably engaged with the manifold receiver and defining a manifold volume space, wherein the shell includes an inlet connector defining an inlet hole and adapted to receive a suction line, and defines an outlet opening, wherein the outlet opening is adapted to be fluidly connected to the suction inlet of the medical waste collection assembly when the shell is engaged with the manifold receiver to provide a suction path from the inlet hole through the manifold volume space to the suction inlet; a filter element disposed within the shell and in the suction path; and a tray rotatably coupled to the shell and defining a plurality of tissue collection chambers and a porous feature within each tissue collection chamber, and comprising a control surface adapted to receive input from a user to rotate the tray about an axis to selectively align one of the tissue collection chambers with the inlet hole so that the porous feature is located in the suction path to collect tissue samples.
[0222] Item 3 - The manifold of Item 2, wherein the tray further defines a bypass channel separate from the tissue collection chamber, wherein the tray is further adapted to rotate about the axis to selectively align the bypass channel with the inlet aperture to allow fluid to flow through the aspiration path when the tray is not collecting tissue samples.
[0223] Clause 4 - The manifold of clause 3, wherein the bypass channel comprises a plurality of bypass channels, wherein the tissue collection lumens and the bypass channels are arranged in an angularly alternating manner about an axis.
[0224] Clause 5 - The manifold of clause 4, wherein the tissue collection lumen and the bypass channel are equiangularly spaced about the axis.
[0225] Clause 6 - The manifold of Clause 2, wherein the tray further comprises a plurality of lenses arranged circumferentially about the control surface, wherein each of the lenses is aligned with one of the tissue collection cavities and each lens is shaped to provide magnification within one of the tissue collection cavities.
[0226] Clause 7 - The manifold of Clause 2, wherein the housing further comprises a lens positioned to provide magnification within one of the tissue collection cavities.
[0227] Clause 8 - The manifold of Clause 2, wherein the housing further comprises: a cap portion, and a body portion coupled to the cap portion, wherein the cap portion with the tray is positioned proximal to a panel of the cap portion.
[0228] Clause 9 - The manifold of clause 8, wherein one of the cap portion and the body portion includes an orientation feature adapted to rotatably secure the cap portion relative to the body portion.
[0229] Clause 10 - The manifold of Clause 8, wherein the cap portion includes an opening, wherein the control surface is arranged to be manipulated through the opening.
[0230] Clause 11 - The manifold of Clause 2, further comprising a carrier defining a void space sized to removably receive the tray, wherein the carrier is removably coupled to the housing.
[0231] Clause 12 - The manifold of Clause 2, wherein the housing further comprises: a bypass inlet connector adapted to removably receive the aspiration line, wherein the bypass inlet connector defines a fluid passage that bypasses the tray without being in fluid communication with the tissue collection chamber.
[0232] Clause 13—The manifold of Clause 1 , wherein the housing further comprises: a cap portion including the inlet fitting, and a body portion coupled to the cap portion.
[0233] Item 14 - A manifold for collecting tissue samples using a medical waste collection assembly including a manifold receiver and a suction inlet, the manifold comprising: a cap portion including a cap panel and an inlet connector adapted to receive a suction line and define an inlet aperture; a body portion coupled to the cap portion and rotatably fixed relative to the cap portion to jointly define a manifold volume space, wherein the body portion is adapted to be removably engaged with the manifold receiver and define an outlet opening, the outlet opening being adapted to be in fluid communication with the suction inlet of the medical waste collection assembly when the body portion is engaged with the manifold receiver to provide suction from the inlet aperture through the manifold volume space to the suction inlet path; a filter element at least partially arranged within the body portion and in the suction path; and a tray, which is disposed proximal to the cap panel of the cap portion and defines a plurality of tissue collection cavities and a porous feature within each tissue collection cavity, and a bypass channel separated from the tissue collection cavity, wherein the manifold is adapted to operate in a tissue collection position and a bypass position, in which one of the tissue collection cavities is fluidly connected to the inlet hole to allow the porous feature to be in the suction path to collect tissue samples, and in the bypass position, the bypass channel is fluidly connected to the inlet hole in the suction path to allow fluid to flow through the suction path without the tray collecting tissue samples.
[0234] Item 15 - The manifold of Item 14, wherein the tray is rotatably coupled to the housing and adapted to receive input from a user to rotate about an axis relative to the cap portion and the body portion to selectively switch the manifold between a tissue collection position and a bypass position.
[0235] Clause 16 - The manifold of Clause 14, wherein the cap portion is removably coupled to the tray to provide access to the tissue collection cavity.
[0236] Item 17 - A manifold for collecting tissue samples using a medical waste collection assembly including a manifold receiver and a suction inlet, wherein the manifold includes a front portion and a rear portion, the manifold comprising: a housing defining a manifold volume space, including an inlet connector located on the front portion of the housing and defining an inlet aperture in fluid communication with the manifold volume space, wherein the inlet connector is adapted to removably receive a suction line, and further defines an outlet opening on the rear portion of the housing, the outlet opening being adapted to be in fluid communication with the suction inlet of the medical waste collection assembly when the housing is engaged with the manifold receiver to A suction path is provided from the inlet port through the manifold volume to the suction inlet; a filter element is disposed within the housing and in the suction path; the housing further defines an accessory sleeve in fluid communication with the manifold volume, wherein the accessory sleeve is oriented on an axis that is angled away from the longitudinal axis of the housing; and a tray adapted to be removably positioned within the accessory sleeve and defining a tissue collection cavity and a porous feature within the tissue collection cavity, wherein when the tray is within the accessory sleeve, the tissue collection cavity is open toward the front of the manifold so that the porous feature is in the suction path to collect a tissue sample.
[0237] Clause 18 - The manifold of clause 17, wherein the housing further comprises a distal barrier that at least partially defines the accessory sleeve, the distal barrier comprising a lens adapted to provide magnification within the tissue collection cavity when the tray is positioned within the accessory sleeve.
[0238] Clause 19 - The manifold of clause 17, wherein the tray further comprises a control surface adapted to receive input from a user, and a sealing surface adapted to sealingly engage the housing when the tray is positioned within the accessory sleeve.
[0239] Clause 20 - The manifold of clause 17, wherein the accessory sleeve is oriented on an axis that is angled proximally away from a front portion of the housing.
[0240] Clause 21 - The manifold of Clause 17, wherein the inlet aperture is oriented on an axis that is angled distally upward relative to a longitudinal axis of the housing.
[0241] Clause 22 - The manifold of clause 17, further comprising a valve coupled to the housing and positioned within the accessory sleeve.
[0242] Clause 23 - The manifold of Clause 17, wherein the tray further comprises a retaining feature adapted to destructibly engage a complementary retaining feature of the housing to facilitate retaining the tray within the accessory sleeve.
[0243] The manifold of clauses 24-17, wherein the housing further comprises: a body portion, wherein the filter element is at least partially disposed within the body portion; a cap portion coupled to the body portion and including the inlet connector, and an access feature adapted to receive user input to permanently destroy the manifold to access the filter element within the body portion.
[0244] Clause 25 - The manifold of Clause 24, wherein the access feature further comprises a frangible border, and a grip coupled to the frangible border and adapted to receive a user input to rupture the frangible border to access the filter element within the body portion.
[0245] Clause 26 - The manifold of clause 25, wherein the filter element comprises: at least one sidewall extending from a base wall; a porous feature extending through the sidewall; and a window extending through the sidewall, the window being aligned with the access feature and sized to allow removal of a tissue sample from within the filter element after the manifold is permanently breached to access the filter element.
[0246] Item 27 - A manifold for collecting tissue samples using a medical waste collection assembly including a manifold receiver and a suction inlet, wherein the manifold includes a front portion and a rear portion, the manifold comprising: a housing defining a manifold volume space, including an inlet connector on the front portion of the housing and defining an inlet hole in fluid communication with the manifold volume space, wherein the inlet connector is adapted to removably receive a suction line, and further defines an outlet opening on the rear portion of the housing, the outlet opening being adapted to be in fluid communication with the suction inlet of the medical waste collection assembly when the housing is engaged with the manifold receiver to provide a suction line from the manifold. an inlet port through the manifold volume to a suction inlet; a filter element disposed within the housing in the suction path; the housing also comprising a distal baffle defining an accessory sleeve in fluid communication with the manifold volume; a tray defining a tissue collection chamber and a porous feature within the tissue collection chamber, wherein the tray is adapted to be removably disposed within the accessory sleeve; and the distal baffle comprising a lens shaped to provide magnification within the tissue collection chamber when the tray is placed within the accessory sleeve with the porous feature in the suction path to collect a tissue sample.
[0247] Clause 28 - The manifold of clause 27, wherein the accessory sleeve further comprises an orientation feature adapted to engage with a complementary orientation feature of the tray to position the tray within the accessory sleeve in a predetermined orientation relative to the distal stop.
[0248] Item 29 - A manifold for collecting tissue samples utilizing a medical waste collection assembly including a manifold receiver and a suction inlet, the manifold comprising: a cap portion including an inlet connector adapted to receive a suction line; a body portion coupled to the cap portion to jointly define a manifold volume, wherein the body portion is adapted to be removably engaged with the manifold receiver and further defines an outlet opening adapted to be fluidly connected to the suction inlet of the medical waste collection assembly when the body portion is engaged with the manifold receiver to provide a suction path from the inlet connector through the manifold volume to the suction inlet; and a filter element at least partially disposed within the body portion and in the suction path, wherein at least one of the body portion and the cap portion includes an access feature adapted to receive user input to permanently destroy the manifold to enable access to the filter element.
[0249] Clause 30 - The manifold of clause 29, wherein the access feature further comprises a frangible border, and a grip coupled to the frangible border and adapted to receive a user input to rupture the frangible border.
[0250] Clause 31 - The manifold of clause 30, wherein the frangible boundary is a removable ring coupled to one of the body portion and the cap portion and adapted to rupture an interface between the cap portion and the body portion.
[0251] Clause 32 - The manifold of Clause 30, wherein the frangible boundary further comprises a closed perimeter within the body portion formed of thinned material such that the frangible boundary ruptures along the closed perimeter.
[0252] The manifold of clause 33-clause 29, wherein the filter element comprises at least one sidewall extending from the base wall, a porous feature extending through at least one sidewall, and a window extending through the sidewall, the window aligned with the access feature and sized to remove a tissue sample from within the filter element after the manifold is permanently disrupted to access the filter element.
[0253] The manifold of clause 34-clause 29, further comprising a tray adapted to be removably coupled to the manifold and defining a tissue collection cavity and a porous feature within the tissue collection cavity, the porous feature adapted to collect a tissue sample when the tray is positioned in the aspiration path.
[0254] Item 35 - A manifold for collecting tissue samples using a medical waste collection assembly including a manifold receiver and a suction inlet, the manifold comprising: a shell adapted to be removably engaged with the manifold receiver, the shell defining a manifold volume space, an outlet opening adapted to be in fluid communication with the suction inlet of the medical waste collection assembly when the shell is engaged in the manifold receiver, and a bypass channel, wherein the shell includes a support frame defining an accessory sleeve separated from the bypass channel; a filter element disposed within the shell; a tray defining a tissue collection chamber and a porous feature within the tissue collection chamber, wherein the tray is sized to be removably disposed within the support frame and a slide member adapted to be slidably coupled to the support frame and including an inlet connector defining an inlet aperture and adapted to removably receive an aspiration line, wherein the slide member includes a control surface adapted to receive input from a user to move the slide member between a tissue collection position and a bypass position, wherein when the tray is placed in the accessory sleeve such that the porous feature is located in the aspiration path to collect tissue samples, the slide member is in the tissue collection position, wherein the inlet aperture of the inlet connector is in fluid communication with the tissue collection chamber, and in the bypass position, the inlet aperture of the inlet connector is in fluid communication to allow fluid to flow through the aspiration path without the tray collecting tissue samples.
[0255] Clause 36 - The manifold of clause 35, wherein the sliding member further comprises a lens shaped to provide magnification within the tissue collection cavity when the tray is placed within the accessory sleeve and the sliding member is in the tissue collection position.
[0256] Clause 37—The manifold of clause 35, wherein the support frame further comprises two opposing sides separated by a front side, wherein the accessory sleeve extends inwardly from one of the opposing sides, and wherein the bypass channel extends inwardly from the front side.
[0257] Clause 38 - The manifold of clause 35, wherein the sliding member further comprises a guide track feature adapted to engage a complementary guide track feature of the support frame to restrict movement of the sliding member relative to the support frame to one degree of freedom.
[0258] Item 39 - The manifold of Item 35, wherein the tray further comprises a front wall opposite the rear wall and separated by opposing side walls, and a base comprising the porous feature, the front wall comprising a cutout adapted to align with the inlet hole of the inlet connector when the sliding member is in the tissue collection position.
[0259] Clause 40 - The manifold of Clause 39, wherein the base of the tray further comprises an inclined surface that slopes upward toward the rear wall.
[0260] Item 41 - A method for collecting tissue samples using a manifold for a medical waste collection assembly, the manifold comprising a housing defining a manifold volume space, an outlet opening and a support frame, the support frame defining an accessory sleeve and a bypass channel separate from the accessory sleeve, the manifold further comprising a filter element disposed within the housing, a sliding member slidably coupled to the support frame and comprising an inlet connector defining an inlet aperture, and a tray positionable within a tissue collection chamber and defining a tissue collection chamber and a porous feature within the tissue collection chamber, the method comprising the steps of: coupling the manifold to the medical waste collection assembly such that the outlet opening is in contact with the medical waste collection assembly The waste collection assembly is fluidly connected to a suction inlet; connecting the suction line to the inlet connector; operating the medical waste collection assembly with the sliding member in a bypass position, in which the inlet hole of the inlet connector is fluidly connected to the bypass channel, thereby allowing fluid to flow through the suction path without the tray collecting tissue samples; applying an input to the control surface to move the sliding member from the bypass position to the tissue collection position, in which the inlet hole of the inlet connector is fluidly connected to the tissue collection cavity, thereby positioning the porous feature in the suction path; and operating the medical waste collection assembly to collect tissue samples with the sliding member in the tissue collection position.
[0261] Clause 42 - The method of Clause 41 , further comprising applying another input to the control surface to return the slide member to the bypass position.
[0262] Clause 43 - The method of clause 41, wherein the sliding member further comprises a lens shaped to provide magnification, the method further comprising observing the tissue collection cavity through the lens when the sliding member is in the tissue collection position.
[0263] Clause 44-The method of Clause 41, further comprising removing the tray from the accessory sleeve with the sliding member in the bypass position.
[0264] The method of clause 45-clause 44, further comprising replacing another tray within the accessory sleeve of the sliding member when the sliding member is in the bypass position.
[0265] Clause 46 - The method of clause 41, wherein the step of applying an input to the control surface to move the slide member to the tissue collection position further comprises applying a lateral force in a first linear direction to the control surface.
[0266] The method of clause 47-clause 45, further comprising applying another lateral force to the control surface in a second linear direction opposite the first linear direction to return the sliding member to the bypass position.
[0267] Item 48 - A manifold for collecting tissue samples utilizing a medical waste collection assembly including a manifold receiver and a suction inlet, the manifold comprising: a shell adapted to be removably engaged with the manifold receiver and to define a manifold volume space, wherein the shell includes a stator including an inlet connector adapted to receive a suction line and define an inlet hole, and the shell defines an outlet opening adapted to be fluidly connected to the suction inlet of the medical waste collection assembly when the shell is engaged with the manifold receiver to provide a suction path from the inlet hole through the manifold volume space to the suction inlet; a filter element disposed within the shell and in the suction path; and a rotor rotatably disposed within the stator and defining a tissue collection chamber and a porous feature within the tissue collection chamber, and including a control surface adapted to receive input from a user to cause the rotor to rotate within the stator to selectively establish fluid communication between the inlet hole and the tissue collection chamber, thereby positioning the porous feature in the suction path to collect tissue samples.
[0268] The manifold of clauses 49-48, wherein the rotor further defines a bypass channel separate from the tissue collection chamber, and the control surface is further adapted to receive input from a user to rotate the rotor within the stator to selectively establish fluid communication between the inlet port and the bypass channel, thereby allowing fluid to flow through the suction path without collecting a tissue sample.
[0269] Clause 50 - The manifold of clause 48, wherein the stator further comprises a sidewall defining a window, the window positioned such that the tissue collection chamber is aligned with the window when the bypass channel of the rotor is in the suction path.
[0270] Clause 51 - The manifold of Clause 50, wherein the sidewall of the stator further comprises a lens shaped to provide magnification and positioned to align with the lens when the tissue collection cavity is in the aspiration path.
[0271] Clause 52 - The manifold of Clause 48, wherein the rotor further comprises a cylindrical outer wall, wherein the tissue collection cavity and the bypass channel are each defined between two openings in the outer wall.
[0272] Item 53 - A manifold for collecting tissue samples utilizing a medical waste collection assembly including a manifold receiver and a suction inlet, the manifold comprising: a shell adapted to be removably engaged with the manifold receiver and defining a manifold volume space, wherein the shell includes a stator, an inlet connector adapted to receive a suction line and define an inlet hole extending through the stator, and the shell defines an outlet opening adapted to be fluidly connected to the suction inlet of the medical waste collection assembly when the shell is engaged with the manifold receiver; and a rotor rotatably disposed within the stator and defining a tissue collection chamber and a porous feature within the tissue collection chamber adapted to collect tissue samples, and a bypass channel separate from the tissue collection chamber, wherein the manifold is adapted to operate in one of a tissue collection position and a bypass position, in which the tissue collection chamber is fluidly connected to the inlet hole so that the porous feature is in the suction path to collect tissue samples, and in the bypass position, the bypass channel is fluidly connected to the inlet hole so that fluid is allowed to flow through the suction path without collecting tissue samples.
[0273] Clause 54 - The manifold of clause 53, wherein the rotor comprises an outer wall, wherein the tissue collection chamber and bypass channel are each defined between two openings in the side wall.
[0274] Clause 55 - The manifold of clause 53, wherein the rotor further comprises a control surface adapted to receive input from a user to switch the manifold to be operated between the tissue collection position and the bypass position.
[0275] Clause 56 - The manifold of clause 53, wherein the stator further comprises a sidewall defining a window positioned to align with and expose the tissue collection lumen when the manifold is operated in the bypass position to allow retrieval of a tissue sample.
[0276] Clause 57 - The manifold of clause 53, wherein the stator further comprises a lens shaped to provide magnification and positioned to align with the tissue collection lumen when the manifold is operated in the tissue collection position.
[0277] Item 58 - A method for collecting tissue samples using a manifold for a medical waste collection assembly, wherein the manifold includes a shell defining a manifold volume space, an outlet opening, and a stator and an inlet connector, the manifold also including a filter element disposed within the shell, and a rotor rotatably disposed within the stator and including a control surface, the method comprising the following steps: connecting the shell to the medical waste collection assembly so that the outlet opening is in fluid communication with a suction inlet of the medical waste collection assembly; connecting the suction line to the inlet connector to provide a suction path from an inlet hole of the inlet connector to the suction inlet; operating the medical waste collection assembly with the manifold in a bypass position, in which a bypass channel defined within the rotor is in the suction path and a tissue collection chamber defined within the rotor is not in the suction path; actuating the control surface to rotate the rotor within the stator from the bypass position to a tissue collection position, in which the tissue collection chamber is located in the suction path and the bypass channel is removed from the suction path; and operating the medical waste collection assembly with the manifold in the tissue collection position to collect tissue samples utilizing the porous features of the tissue collection chamber.
[0278]
[00136] The method of clause 59-clause 58, further comprising actuating the control surface to return the rotor to the bypass position after collecting the tissue sample.
[0279] The method of clause 60-clause 59, further comprising retrieving a tissue sample from the tissue collection chamber when the rotor is in the bypass position.
[0280] The method of clauses 61-59, wherein the stator includes a side wall defining a window, wherein the step of actuating the control surface to return the rotor to the bypass position further includes aligning the tissue collection cavity with the window of the stator to expose the tissue collection cavity; and removing a tissue sample from the exposed tissue collection cavity through the window of the stator.
[0281] The method of clause 62-clause 58, wherein the stator further comprises a lens shaped to provide magnification, the method further comprising: observing the tissue collection cavity through the lens when the rotor is in the tissue collection position.
[0282] The method of clause 63-clause 60, wherein the step of removing the tissue sample from the tissue collection cavity further comprises scraping the porous feature with an instrument to dislodge the tissue sample.
[0283] The method of clause 64-clause 59, wherein the step of actuating the control surface to move the rotor from the bypass position to the tissue collection position further comprises rotating the control surface in the first rotational direction.
[0284] The method of clause 65-clause 64, wherein the step of actuating the control surface to return the rotor to the bypass position further comprises rotating the control surface in a second rotational direction opposite the first rotational direction.
[0285] Item 66 - A manifold for collecting tissue samples utilizing a medical waste collection assembly including a manifold receiver and a suction inlet, the manifold comprising: a shell adapted to be removably engaged with the manifold receiver and to define a manifold volume space, an accessory sleeve in fluid communication with the manifold volume space, a tissue collection channel, a bypass channel separated from the tissue collection channel, and an outlet opening adapted to be in fluid communication with the suction inlet of the medical waste collection assembly when the shell is engaged with the manifold receiver; a filter element disposed within the shell; and an inlet connector rotatable relative to the shell and adapted to receive a suction line and define an inlet aperture; a tray adapted to be removably positioned within the accessory sleeve and defining a tissue collection cavity and a porous feature in communication with the tissue collection channel when the tray is positioned within the accessory sleeve; and a control surface adapted to receive input from a user to rotate the inlet connector between a tissue collection configuration in which the inlet aperture is in communication with the tissue collection channel when the tray is positioned within the accessory sleeve, and a bypass configuration in which the inlet aperture is in communication with the bypass channel.
[0286] Clause 67 - The manifold of clause 66, wherein the housing further comprises a lens positioned to provide magnification within the tissue collection cavity.
[0287] Clause 68 - The manifold of Clause 66, wherein the housing further defines a second accessory sleeve in fluid communication with the manifold volume, the manifold further comprising a second tray removably positionable within the second accessory sleeve and defining a second tissue collection cavity and a second porous feature.
[0288] Clause 69 - The manifold of clause 68, wherein the first and second accessory sleeves are diametrically opposed relative to the housing.
[0289] The manifold of clause 70-clause 66, wherein the housing further comprises: a bypass inlet connector adapted to removably receive another aspiration line, the bypass inlet connector defining a fluid passage that bypasses the tray and is not in fluid communication with the tissue collection chamber.
[0290] Item 71 - A manifold for collecting tissue samples using a medical waste collection assembly including a manifold receiver and a suction inlet, the manifold comprising: a housing adapted to be removably engaged with the manifold receiver and defining a manifold volume space and an outlet opening, the outlet being adapted to be in fluid communication with the suction inlet of the medical waste collection assembly when the housing is engaged with the manifold receiver; a filter element disposed within the housing; and a first inlet connector movable relative to the housing and adapted to receive a first suction line and define a first inlet aperture; a a second inlet connector, wherein each of the first and second inlet holes are in fluid communication with the manifold volume space; a tray adapted to be removably coupled to the housing, defining a tissue collection chamber and a porous feature in communication with the tissue collection channel when the tray is positioned in the accessory sleeve; and a control surface adapted to receive input from a user to move the first inlet connector between a tissue collection configuration in which the first inlet hole is in communication with the porous feature when the tray is positioned in the accessory sleeve, and a bypass configuration in which the first inlet hole is not in communication with the porous feature.
[0291] Clause 72 - The manifold of clause 71 , wherein the second inlet aperture is not in fluid communication with the tissue collection chamber in the tissue collection configuration.
[0292] Clause 73—The manifold of clause 71 , wherein the housing further defines an accessory sleeve in fluid communication with the manifold volume, wherein the tray is configured to be removably positioned within the accessory sleeve.
[0293] Item 74 - A manifold for collecting tissue samples utilizing a medical waste collection assembly including a manifold receiver and a suction inlet, the manifold comprising: a shell adapted to be removably engaged with the manifold receiver and defining a manifold volume space, a pore, a bypass opening separated from the pore, and an outlet opening adapted to be fluidly connected to the suction inlet of the medical waste collection assembly when the shell is engaged with the manifold receiver; a filter element arranged within the shell; a first inlet connector rotatable relative to the shell and adapted to receive a first suction line and define a first inlet hole; a second inlet connector rotatable relative to the shell and adapted to receive a second suction line and define a second inlet hole; a control surface adapted to receive input from a user to rotate the first and second inlet connectors between a tissue collection configuration and a bypass configuration, in which the first inlet hole is connected to the pore and the second inlet hole is connected to one of the bypass openings, and in which the first inlet hole and the second inlet hole are respectively connected to a single one of the bypass openings.
[0294] Clause 75 - The manifold of clause 74, wherein the housing further defines an accessory sleeve in communication with the manifold volume, wherein the tray is configured to be removably positioned within the accessory sleeve.
[0295] Clause 76 - The manifold of Clause 75, wherein the tissue collection cavity of the tray is in communication with the aperture.
[0296] The manifold of clause 77-clause 66, wherein the housing further comprises an orientation feature within the accessory sleeve and the tray further comprises a complementary orientation feature configured to removably engage the orientation feature to allow the tray to be coupled to the housing in a single orientation.
[0297] Clause 78 - The manifold of clause 77, wherein the orientation feature of the housing is a protrusion and the complementary orientation feature of the tray is a guide extending from a side portion and configured to movably engage the protrusion.
[0298] Item 79 - A manifold for collecting tissue samples via a suction line, the manifold comprising: a shell defining a manifold volume space, an inlet port fluidly connected to the manifold volume space and adapted to be fluidly connected to the suction line, an accessory sleeve fluidly connected to the manifold volume space, and an outlet opening, the outlet opening being adapted to be fluidly connected to a suction source to provide a suction path from the suction line through the accessory sleeve and the manifold volume space to the outlet opening; a filter element disposed within the shell and in the suction path; a tray defining a tissue collection chamber and a porous feature within the tissue collection chamber, wherein the tray is adapted to be removably positioned within the accessory sleeve and the porous feature in the suction path is used to collect tissue samples; and a backflow prevention valve located between the tray and the filter element within the suction path.
[0299] The manifold of clauses 80-79, wherein the housing further defines a transfer aperture having a first end opening to the accessory sleeve and a second end opening to the manifold volume space, wherein the anti-backflow valve selectively covers the second end of the transfer aperture to allow waste to flow from the accessory opening to the manifold volume space.
[0300] The manifold of clauses 81-80, wherein the housing further defines a bypass hole which is fluidly connected to the outlet opening, bypassing the accessory sleeve to provide a bypass suction path from the bypass hole through the manifold volume space to the outlet opening, wherein the anti-backflow valve selectively covers the second end of the delivery hole and the end of the bypass hole.
[0301] Clause 82-The manifold of Clause 81, wherein the anti-drainback valve is a flapper valve unit.
[0302] Clause 83 - The manifold of Clause 82, wherein the flapper valve unit includes a first flapper that selectively covers the second end of the delivery hole and a second flapper that selectively covers the end of the bypass hole.
[0303] The manifold described in Clause 84-Clause 81, wherein the shell further includes a cap portion and a body portion connected to the cap portion, wherein the cap portion includes a cap panel that together with the body portion at least partially defines the manifold volume space, wherein the delivery hole extends through the cap panel and the anti-backflow valve is connected to the cap panel.
[0304] Clause 85 - The manifold of Clause 84, wherein the housing further comprises a bypass fitting defining a bypass aperture and adapted to receive another suction line, wherein the bypass fitting is coupled to the cap panel.
[0305] Item 86 - A manifold for collecting tissue samples via an aspiration line, the manifold comprising: a shell defining a manifold volume space, an inlet port in fluid communication with the manifold volume space and adapted to be in fluid communication with the aspiration line, an accessory sleeve in fluid communication with the manifold volume space, and an outlet opening, the outlet opening being adapted to be in fluid communication with a suction source to provide a suction path from the aspiration line through the accessory sleeve and the manifold volume space to the outlet opening, wherein the shell comprises a body portion, and a cap portion coupled to the body portion and at least partially defining the manifold volume space, wherein the cap portion comprises a cap panel oriented on a first axis, and an upper stopper coupled to the cap panel and at least partially defining the accessory sleeve, wherein the upper stopper is oriented on a second axis that is angled relative to the first axis; and a tray defining a tissue collection chamber and a porous feature within the tissue collection chamber, the tray being adapted to be removably positioned within the accessory sleeve and the porous feature in the aspiration path being used to collect tissue samples.
[0306] The manifold of clause 87-clause 86, further comprising a lens coupled to the upper barrier and shaped to provide magnification within the accessory sleeve.
[0307] The manifold of clauses 88-86 further comprises a filter element disposed within the manifold volume and in the suction path.
[0308] Clause 89 - The manifold of clause 86, wherein the housing further defines an accessory opening leading to the accessory sleeve, the accessory opening defining a distal end of the manifold such that the accessory sleeve is oriented in a proximal to distal direction.
[0309] Clause 90 - The manifold of Clause 89, wherein the housing further comprises an inlet fitting defining the inlet aperture, the inlet fitting being sized to receive the suction line, wherein the inlet fitting is coupled to the upper barrier and extends upwardly from the upper barrier.
[0310] The manifold of clauses 91-86, wherein the housing further defines an accessory opening leading to the accessory sleeve, the accessory opening defining a lateral end of the manifold such that the accessory sleeve is oriented in a direction from side to side.
[0311] The manifold of clause 92-clause 91, wherein the housing further comprises an inlet connector defining the inlet aperture, the inlet connector being sized to receive the suction line, wherein the inlet connector is coupled to the upper barrier and extends distally from the upper barrier to define a distal end of the manifold.
[0312] The manifold of clauses 93-86, wherein the housing further defines a bypass joint connected to the cap panel and defining a bypass hole, the bypass hole being in fluid communication with the outlet opening, bypassing the accessory sleeve to provide a bypass suction path from the bypass hole through the manifold volume space to the outlet opening.
[0313] Article 94 - A manifold for collecting tissue samples via an aspiration line, the manifold comprising: a housing defining a manifold volume, an inlet aperture in fluid communication with the manifold volume and adapted to be in fluid communication with the aspiration line, an accessory sleeve in fluid communication with the manifold volume, and an outlet opening adapted to be in fluid communication with a suction source to provide a suction path from the aspiration line through the accessory sleeve and the manifold volume to the outlet opening, wherein the housing comprises an inlet connector defining the inlet aperture, wherein the inlet connector is oriented on a first axis in a proximal to distal direction, and wherein the accessory sleeve is disposed about a second axis orthogonal to the first axis such that the accessory sleeve is oriented in a side-to-side direction; and a tray defining a tissue collection chamber and a porous feature within the tissue collection chamber, the tray being adapted to be removably positioned within the accessory sleeve, and the porous feature in the aspiration path being used to collect tissue samples.
[0314] The manifold of clauses 95-94 further includes a filter element disposed within the housing and in the suction path.
[0315] Item 96 - A manifold for collecting tissue samples via a suction line, the manifold comprising: a shell defining a manifold volume space, an inlet port fluidly connected to the manifold volume space and adapted to be fluidly connected to the suction line, and an outlet opening adapted to be fluidly connected to a suction source to provide a suction path from the suction line through the manifold volume space to the outlet opening; a tray defining a tissue collection chamber and a porous feature communicating with the tissue collection chamber, the tray adapted to be removably coupled to the shell; and a filter element disposed within the shell and in the suction path, wherein the shell comprises a cap portion and a body portion, the cap portion and the body portion being removably coupled to each other so that the filter element is accessible to retrieve the tissue sample.
[0316] Clause 97 - The manifold of Clause 96, wherein each of the cap portion and the body portion includes complementary coupling features for removably coupling the cap portion and the body portion.
[0317] Clause 98 - The manifold of Clause 97, wherein the complementary coupling features include at least one key and at least one keyway configured to removably engage one another via interference engagement.
[0318] Clause 99 - The manifold of Clause 98, wherein the at least one key and the at least one keyway comprise three keys and three keyways.
[0319] The manifold of clause 100-clause 98, wherein the at least one keyway includes an insert portion and a locking portion in communication with the insert portion, wherein the insert portion is wider than the locking portion.
[0320] Item 101 - A manifold for collecting tissue samples via an aspiration line, the manifold comprising: a housing defining a manifold volume, an inlet aperture in fluid communication with the manifold volume and adapted to be in fluid communication with the aspiration line, an accessory opening leading to an accessory sleeve in fluid communication with the manifold volume, and an outlet opening adapted to be in fluid communication with a suction source to provide a first suction path from the aspiration line through the accessory sleeve and the manifold volume to the outlet opening, wherein the housing includes a locating feature disposed within the accessory sleeve; and a tray including a control A control surface, a sealing surface coupled to the control surface, a base portion, and a side portion coupled to the base portion, wherein the base portion and the side portion extend from the sealing surface and define a tissue collection chamber, and a porous feature is in the base portion, wherein the control surface of the tray is adapted to receive input from a user to move the sealing surface away from a portion of the accessory opening proximate the lower barrier to provide and position a second suction path from the accessory opening through a gap between the base portion of the tray and a lower barrier of the housing defining the accessory sleeve to the outlet opening.
[0321] Item 102 - A manifold for collecting tissue samples via an aspiration line, the manifold comprising: a housing defining a manifold volume, an inlet aperture in fluid communication with the manifold volume and adapted to be in fluid communication with the aspiration line, an accessory opening leading to an accessory sleeve in fluid communication with the manifold volume, and an outlet opening adapted to be in fluid communication with a suction source to provide a first suction path from the aspiration line through the accessory sleeve and the manifold volume to the outlet opening, wherein the housing includes a locating feature disposed within the accessory sleeve; and a tray including a sealing surface, a base A tray having a plurality of side portions connected to the base portion and a plurality of side portions connected to the base portion, wherein the base portion and the side portions extend from the sealing surface and define a tissue collection cavity, and a porous feature is within the base portion, wherein the tray is adapted to be removably coupled to the shell so that (i) the sealing surface seals the accessory opening, (ii) the tissue collection cavity is positioned within the accessory sleeve and is open to the inlet hole, and (iii) the base portion and / or the side portion engage a positioning feature within the accessory sleeve to provide a gap between the base portion of the tray and a lower barrier of the shell defining the accessory sleeve.
[0322] The foregoing description is not intended to be exhaustive or to limit the present invention to any particular form. The terms used are intended to have the nature of descriptive, rather than restrictive, terms. In view of the above teachings, many modifications and variations are possible, and the present invention may be practiced in a manner different from that specifically described.
Claims
1. A manifold for collecting tissue samples via an aspiration line, the manifold comprising: a housing defining a manifold volume, an inlet aperture in fluid communication with the manifold volume and adapted to be in fluid communication with the suction line, and an outlet opening adapted to be in fluid communication with a suction source to provide a suction path from the suction line through the manifold volume to the outlet opening; a tray defining a tissue collection cavity and a porous feature in communication with the tissue collection cavity, the tray being adapted to be removably coupled to the housing; and a filter element disposed in the suction path within the housing, Wherein the housing includes a cap portion and a body portion, the cap portion and the body portion are removably coupled to each other such that the filter element is accessible to retrieve a tissue sample.
2. The manifold according to claim 1, wherein: The cap portion and the body portion include complementary couplings configured to facilitate disengagement by relative rotation between the cap portion and the body portion.
3. The manifold of claim 1, wherein: Each of the cap portion and the body portion includes complementary coupling features for removably coupling the cap portion and the body portion, wherein the complementary coupling features include at least one key and at least one keyway configured to removably engage each other by interference engagement.
4. The manifold of claim 3, wherein: The at least one key and the at least one keyway include three keys and three keyways.
5. The manifold of claim 3, wherein: The at least one keyway includes an insertion portion and a locking portion communicating with the insertion portion, wherein the insertion portion is wider than the locking portion.
6. The manifold of claim 5, wherein: The body portion includes a neck and a lip extending radially outward from the neck, a first portion of the lip defining an insertion portion of the keyway and a second portion of the lip defining a locking portion of the keyway.
7. The manifold of claim 6, wherein: The at least one key includes a hook portion, and the at least one keyway is sized to be smaller than a thickness of the hook portion.
8. The manifold of claim 7, wherein: The at least one key includes a shank and the hook extends from the shank.
9. The manifold of claim 8, wherein: The length of the shank is at least equal to the length of the lip.
10. The manifold of claim 8, wherein: The cap portion is for coupling with the body portion, the cap portion being oriented relative to the body portion such that the hook portion is rotationally aligned with the insertion portion.
11. The manifold according to any one of claims 1 to 10, wherein: The control surface is configured to receive input from a user to flex a lower portion of the sealing surface away from a lower portion of the accessory sleeve to provide a suction path in the deflated configuration.
12. A manifold for collecting tissue samples via an aspiration line, the manifold comprising: a housing including a body portion defining an outlet opening, and a cap portion removably coupled to the body portion to define a manifold volume in fluid communication with the outlet opening, wherein the cap portion includes an accessory sleeve in fluid communication with the manifold volume, and an inlet fitting coupled to the accessory sleeve and configured to removably couple with the aspiration line; and a tray configured to be removably positioned within the accessory sleeve and comprising a base portion defining a porous feature configured for collecting a tissue sample, wherein the tray further comprises a control surface, and a sealing surface coupled to the control surface; and a filter element disposed within the manifold volume, Wherein the filter element is configured to be accessed by detaching a cap portion from the body portion.
13. The manifold of claim 12, wherein: The cap portion and the body portion include complementary couplings configured to facilitate disengagement by relative rotation between the cap portion and the body portion.
14. The manifold of claim 13, wherein: The complementary coupler is a key including a hook portion, and a keyway, at least a portion of the keyway being sized to be smaller than a thickness of the hook portion.
15. The manifold according to any one of claims 12 to 14, wherein: The control surface is configured to receive input from a user to cause a lower portion of the sealing surface to flex away from a lower portion of the accessory sleeve to provide a suction path in the deflated configuration.
16. A manifold for collecting tissue samples via an aspiration line, the manifold comprising: a housing defining a manifold volume, and an outlet opening in fluid communication with the manifold volume, wherein the housing includes an accessory sleeve in fluid communication with the manifold volume, and an inlet fitting coupled to the accessory sleeve and configured to be removably coupled to the aspiration line, wherein the accessory sleeve includes a platform, the accessory sleeve and the platform defining a slot therebetween, and a bore extending between the slot and the manifold volume; a tray configured to be removably positioned within the accessory sleeve and comprising a base portion defining a porous feature for collecting a tissue sample, and a foot extending from the base portion, wherein the tray further comprises a control surface, and a sealing surface coupled to the control surface, the foot being configured to engage the platform when the tray is removably positioned within the accessory sleeve, Wherein the control surface is configured to receive input from a user to provide a suction path through the slot and into the manifold volume in the deflated configuration.
17. The manifold of claim 16, wherein: The legs are U-shaped and confine the porous feature within the base portion.
18. The manifold of claim 17, wherein: The U-shaped legs are configured to circumscribe the aperture when the tray is removably positioned within the accessory sleeve.
19. The manifold of any one of claims 16-18, further comprising a filter element disposed within the manifold volume, the housing being configured to allow access to the filter element for retrieval of a tissue sample.
20. A manifold for collecting tissue samples via an aspiration line, the manifold comprising: a housing defining a manifold volume, and an outlet opening in fluid communication with the manifold volume, wherein the housing includes an accessory sleeve in fluid communication with the manifold volume, and an inlet fitting coupled to the accessory sleeve and configured to be removably coupled to the aspiration line, wherein the accessory sleeve includes a platform, the accessory sleeve and the platform defining a slot therebetween; and a tray configured to be removably positioned within the accessory sleeve and including a base portion defining a porous feature for collecting a tissue sample, wherein the tray is configured to be supported above the well by the platform, and wherein the tray further includes a control surface, and a sealing surface coupled to the control surface, Wherein the control surface is configured to receive input from a user to cause a lower portion of the sealing surface to flex away from a lower portion of the accessory sleeve to provide a suction path through the slot and into the manifold volume in a deflated configuration.
21. The manifold of claim 20, wherein: An upper portion of the sealing surface is held in engagement with an upper portion of the accessory sleeve in the deflated configuration.
22. A manifold according to any one of claims 20 and 21, wherein: The housing also defines a bore having a first end that opens into the slot and a second end that opens into the manifold volume.
23. The manifold according to any one of claims 20 and 21, wherein: The inlet fitting extends upwardly from the accessory sleeve proximate a location where the first end of the bore opens into the slot.
24. The manifold according to any one of claims 20 and 21, wherein: The manifold includes a body portion defining the outlet opening, and a cap portion removably coupled to the body portion and including the accessory socket.
25. The manifold of claim 24, further comprising a filter element disposed within the body portion and configured to be accessed by detaching the cap portion from the body portion.
26. The manifold of claim 25, wherein: The cap portion and the body portion include complementary couplings configured to facilitate the disengagement by relative rotation between the cap portion and the body portion.
27. The manifold of claim 26, wherein: The complementary coupler is a key including a hook portion, and a keyway, at least a portion of the keyway being sized to be smaller than a thickness of the hook portion.
28. The manifold of any one of claims 20 and 21, wherein: The tray also includes a foot extending from the base portion, the foot being configured to engage the platform when the tray is removably positioned within the accessory sleeve.
29. The manifold of claim 28, wherein: The legs are U-shaped and confine the porous feature within the base portion.
30. The manifold of claim 29, wherein: The U-shaped legs are configured to constrain the slot when the tray is removably positioned within the accessory sleeve.
31. The manifold of any one of claims 20 and 21, wherein: The control surface is located on a grip that includes a first portion and a second portion extending from the sealing surface, the first portion and the second portion being configured to be pinched by a user to move the manifold to the deflated configuration.
32. A method for operating a manifold, the manifold comprising a housing defining a manifold volume, an inlet port in fluid communication with the manifold volume and in fluid communication with an aspiration line, an accessory opening leading to an accessory sleeve in fluid communication with the manifold volume, a locating feature disposed within the accessory sleeve, an outlet opening in fluid communication with a suction source, and a tray, the tray comprising a control surface, a sealing surface coupled to the control surface, a base portion, and a side portion coupled to the base portion, wherein the base portion and the side portion extend from the sealing surface and define a tissue collection cavity, and a porous feature within the base portion, the method comprising the steps of: coupling the tray to the housing such that the tissue collection cavity is within the accessory sleeve and open to the inlet aperture, the sealing surface sealing the accessory opening, and at least one of the base portion and the side portion engaging a locating feature within the accessory sleeve to provide a gap between the base portion of the tray and a lower barrier of the housing defining the accessory sleeve to provide a first suction path from the suction line through the accessory sleeve and the manifold volume to the outlet opening; as well as Applying an input to the control surface of the tray causes the lower portion of the sealing surface to pivot relative to the upper portion of the sealing surface and away from the accessory opening near the lower barrier to provide and position a second suction path from the accessory opening through a gap between the base portion of the tray and the lower barrier of the housing to the outlet opening.
33. The method according to claim 32, wherein: The tray also includes a grip portion that defines the control surface and includes a first portion and a second portion that are respectively coupled to the sealing surface, wherein the step of applying the input also includes moving the first portion toward the second portion to pivotally bend the portion of the sealing surface away from the portion of the accessory opening.
34. The method of claim 33, further comprising pinching the first portion and the second portion to move the first portion toward the second portion.
35. The method of any one of claims 32-34, further comprising operating a suction source to collect a tissue sample within a tissue collection cavity of the tray using the porous feature.
