Software Technology for “Manifold” includes a data carrier to a medical/surgical collection assembly.

Medical Device – Sean Murray, Stephen Isham, Stephen J. Reasoner, David E. Hershberger, Brent S. Lalomia, Stryker Corp

Abstract for “Manifold” includes a data carrier to a medical/surgical collection assembly.

A manifold to be used in a medical/surgical waste collection system. The manifold consists of a housing that can be removed from the manifold receiver for the medical/surgical collection assembly. The housing is fitted with an inlet fitting that can be connected to a suction line. The outlet fitting is in fluid communication to the housing. This allows for fluid communication from the suction line to an outlet opening through a filter. A data carrier is included in the manifold that stores data necessary to control operation of the medical/surgical refuse collection assembly. A radiofrequency identification tag with memory that stores data may be included in the data carrier. This data carrier can be used to determine whether the manifold can be used with the medical/surgical collection assembly. When the RFID tag is attached to the manifold receiver, the RFID tag can be used electronically with a data reader for transmitting the data from it.

Background for “Manifold” includes a data carrier to a medical/surgical collection assembly.

The generation of solid, semi-solid, and liquid waste is a byproduct of certain medical and surgical procedures. These fluids include blood and irrigating solutions that are introduced into the area where the procedure was performed. Some of the solid and semisolid waste that is generated during a procedure may include bits of tissue or small pieces of surgical material. The best way to ensure that the waste does not pollute the operating area or pose a risk to the health of the patients is to have it collected immediately after its generation.

There are many systems that can be used by surgeons to collect this waste as it’s generated. These units generally include a suction unit, tubing that extends from it, and a containment device between the tubing, the suction, and the suction. The system activates and waste is drawn through the tubing’s opening. The suction pulls the waste through the tubing, so it flows into the container unit and is stored there.

“Applicants’ Assignees NEPTUNE surgical refuse collection system is one such system. This system features a mobile unit with a suction pump, and a canister. The tubing is connected to a canister via a removable manifold. This unit can be moved around to be close to the patient where the procedure is taking place. This minimizes the amount of suction tubing that is around surgical personnel. The system has other features that limit the potential exposure of surgical and support personnel to the material collected by it. U.S. patent application Ser. No. No. No. No.

“The intake manifold is another feature of the system. The intake manifold has a filter element which traps large amounts of solid matter. This is important because solids could clog down-line components of the system. The manifold is made from material that can be used as a single-use item. The manifold can be sterilized with its narrow conduits or internal filter after use. Personnel handling the manifold should only touch the outer surface. This reduces the possibility that these people could come in contact with the waste material. U.S. Patent Application Ser. No. No. No. No.

The above system reduces the risk of medical/surgical personnel being exposed to potentially dangerous medical waste. There are however some drawbacks to the existing waste collection systems. The manifold in the current system extends into the waste canister. The manifold’s sides can be clogged by small droplets of waste. This liquid can be removed from the mobile unit and is considered uncontained waste. The liquid can become a hazardous substance if it is not removed from the mobile unit immediately.

“The filter of the manifold also traps small pieces of solid that could clog downstream components of the mobile unit. It also traps a significant amount of semi-solid waste. This is why it is important to take care when removing the filter.

“Medical personnel may also visually inspect the volume of material that has been collected by the mobile canister. This is done to give a rough estimate on the amount of fluid that was taken from a patient during a procedure. The accuracy of the quick visual estimation of stored fluid can be affected if there is an excessive amount of liquid left in the manifold.

“Further, after removing the manifold, the port in the canister where it was seated opens to the environment. The smells usually associated with unpleasant smells are known to be emitted by material stored in the canister. These odors are released into the environment when the manifold is removed.

“Also the noise can be generated by the fluids and air flowing through the waste collection system (both the manifolds and mobile units). This noise can cause unwanted background noise in an operating area.

“This invention aims to create a new, useful system for collecting medical and surgical waste. This invention includes an intake manifold, to which suction tubes can be connected. The manifold can be removed and connected to a manifold receiver. The manifold and the complementary receiver are designed so that there is minimal release of fluids after removal and replacement of manifold.

“The housing of the intake manifold in this invention is a housing. A number of inlet fittings extend from one end to the other. These fittings are equipped with suction tubes. An opening is found at the opposite end of the housing that allows for suction to be drawn. This opening is equipped with a drip stop. The manifold can be seated in the complement receiver by placing the opening in the boss tubular that is part the receiver. To prevent material from leaking around the boss, a portion of the drip stop should be placed against the outer boss.

“The drip stop can be further shaped to include a selectively openable valve that extends into any opening. The valve is normally shut. This head is normally closed once the manifold has been removed from the receiver. It prevents waste from leaking from the manifold. In one embodiment of the invention, flaps are integral to the drip stop. The flaps, which prevent suction loss between boss and surrounding manifold, are fitted to the receiver.

The receiver boss is located at the valve. This valve is used to close a fluid conduit, which extends into a canister where the waste is stored. The manifold must be properly installed in the receiver to prepare the system for operation. A geometric feature on the manifold engages an integral drive member with the valve. The manifold is placed in the receiver to displace the drip stop and valve into an open state. The fluid path between the manifold and the conduit connecting to the canister is unrestricted.

The valve will return to its closed state when the manifold has been removed. When the manifold is not removed from the system, the valve returns to its closed state. This prevents the release of any unpleasant vapors.

“Internal” to this invention’s manifold is a filter basket. The filter basket traps large amounts of solid matter in the waste stream and allows the majority of the liquid stream to flow through it. The manifold is empty of any liquid state waste that could be leaked after the procedure is completed.

“I. Overview”

“FIG. 1. illustrates a waste collection unit 30 built in accordance to this invention. The base 32 is part of system 30, also known as a mobile unit. FIG. 30 does not show the cover or door assemblies that usually conceal components. These components are visible in FIG. The system’s mobility is provided by wheels 34 that are attached to the base 32. Mounted to the base 32 are two canisters 36-38. The first canister, canister 36 has an interior volume of approximately 10 to 40 liters. Canister 38 is smaller, with an interior volume of approximately 1 to 10 liters. Each canister 38 and 36 have a cap 40, 42, and respectively.

“Attached each canister cap 40 or 42 is a manifold receive 44. FIGS. 2 and 3 show a manifold 46. The manifold 46, shown in FIGS. 2 and 3, can be removed from each manifold receiver 44. Each manifold 46 has a variety of fittings 48. Each fitting 48 is fitted with a suction line 50. (One shown in FIG. 3). Attached to the distal end of each suctionline 50 is a suction applicator52 (FIG. 1). (?Distal,? It refers to the surgical site where the suction is applied. ?Proximal? (meaning away from the surgical site. FIG. FIG. Sometimes, the suction applicator 52 can be integrated into another surgical tool such as an ablation tool or endoscope, which is used to apply suction to a surgical site.

“Internal to each manifold receive 44 is a conduit 56. (FIG. 3). Conduit 56 acts as a fluid communication path between the manifold 46 and the canister 36/38 with which the receiver has been associated.

“A suction pump 58 is also part of mobile unit 30, Conduits 59, 60 (shown in FIG. 1) Connect each canister 36, 38 and 58 to the suction pump’s inlet port 58. The suction pump 58 activates, drawing matter into the suction applicator52 and through the associated suction lines 50, 46, and 44. The associated canister 36 and 38 are filled with the waste stream. The stream flows into the canister 36 and 38 as liquids and solid particles of matter. This waste is then stored in the canisters 36 and 38 until it is empty. The flow stream is then drained of any gas and other small pieces of matter. Filters that are not shown and not part this invention trap viral- and bacterial-sized matter as well as some components of the gas in the fluid stream before it is drawn into and exhausted from the suction pump.

“II. “II.

“As shown in FIGS. A manifold receiver 44 is composed of three static primary components. The housing 62 houses the manifold 46’s proximal end. The receiver adaptor 64 connects the manifold receiver housing (62) to the canister cap (40 or 42). Adaptor 64 also contains conduit 56, which acts as the flow path between the manifold receiver housing 62 and the associated canister 36/38. The distal end of the manifold receiver housing is secured by a lock ring 66. Lock ring66 has geometric features that ensure the manifold’s alignment when fitted into receiver 44 with a manifold 46.

“From FIGS. “From FIGS. The top of the manifold receiver housing is 62 has a rib 61. The outer surface 63 at the proximal end is slightly stepped inwardly to the distal surface. This spacing allows for the fitting of the receiver 44 and the canister caps 40 or 42.

“Turning towards FIG. 6 shows that the manifold receiver housing (62) is designed to create a variety of bores, windows and void spaces. These voids create a path through housing 62 along its longitudinal axis. Housing 62’s distal end has a cylindrical bore number 68. The receiver housing 62’s distal end has a lip of 67. The distal end opening of housing 62 extends inwardly into lip 67, which is the distal opening of bore 68. A bore 70 is located immediately adjacent to bore 68’s proximal end. Bore 70 is formed by the manifold receiver housing (62) so its diameter decreases as it gets further away from bore 68. Bore 70 opens into bore 72, which is a second bore with a constant diameter. Bore 72 is the same diameter as bore 70’s smallest section. Bore 76 is the third constant bore. It is located proximal to the bore 72 manifold receiver Housing 62. Bore 76 is smaller than bore 72. There is a small transition bore, 74, between bores 72-76. The diameter of the transition bore 74 is approximately 0.4 inches. It tapers inwardly between bore 72 and bore 76. The counter bore 78 is located at the most proximal part of the manifold receiver housing (62). The diameter of counterbore 78 is greater than bore 76 and intersects with it.

The “Manifold receiver housing” 62 has a notch 80. Notch 80 is formed within rib 61. It extends rearwardly towards the housing’s distal end and is contiguous to the top of bore 64. Contiguous to notch 80 and proximally, there is also a proximally-extending void space (82), which is also defined by the interior surface of rib 61. Void space82 intersects bores 70, 72 and 74, and extends slightly beyond them. Void space 82 is generally rectangular in cross section. Two opposed through windows 84 are also included in manifold receiver housing (as shown in FIG. 6). Each window 84 leads into the middle and proximal portions of bore 68 and bore 70, bore 72 and bore 76, respectively.

“A bore 86 runs downwardly from bore 72 to the bottom of the manifold. Bore 86 has been designed to accept a fastener (not illustrated) to attach the manifold 46 and the associated canister caps 40 or 42. Plural bores 86 are included in some versions of the invention. Each bore can receive a fastener. Housing 62 has windows 84 that allow for easy access to the bores.

Closed end bores (88 and 89) extend inwardly from the respective distal, front and proximal rear faces of the manifold receiver Housing 62. Although only one bore 88 or 89 is shown, there are plural bores 88 or 89. Each bore 88 is equipped with a fastener, 92 that holds the lock ring 66 to its manifold receiver housing 62. Each bore 89 is fitted with a fastener (94) that attaches the manifold receiver housing to the adaptor 64.

“Receiver adaptor 64, best seen in FIGS. 4. and 5. Also included is a front plate 96. Plate 96 is designed to fit against the proximal receiver housing 62, including the open ends at bore 76 and counterbore 78. Plate 96’s through bores, in which fasteners extend to 94, are not identified. Plate 96 covers the receiver housing counterbore (78) in its entirety, but it does not completely cover it. Instead, a small amount of counterbore78 is visible at the bottom of receiver housing 62.

A bracket 98 can be extended proximally to and integratedly formed with plate 64 adapter 64. Bracket 98 features a triangular profile so that the overall width of the bracket increases along the length 96. The tab 102 is located proximally rearwardly of the bracket base 98. Tab 102 has an opening 104. Opening 104 is fitted with a fastener (not shown) which secures the receiver adapter 64 to canister cap 40, 42.

“Receiver adapter 64” is further formed as shown in FIG. 5A shows an annular slot 110 formed in the distally-directed face of plate. Slot 110 surrounds, is concentric with and is spaced from conduit 56 through plate 96. For reasons that are obvious below, a seal 112 is placed in slot 110.

“Lock ring number 66” is now described using FIGS. The lock ring 66 is generally a ring-shaped. The lock ring 66 has a central opening that is located at 114. Numerous bores 116 run longitudinally through the ring. Bores 116 are equipped with fasteners 92 to attach the lock ring to the receiver housing 62.

The lock ring 66 can also be shaped to create a pair slots 118-120. The slots 118 and 120 are adjacent to through opening 114. They extend radially outwardly starting at opening 114 until the proximal edge of the lock rings 66. Slots 118 and 120 may be diametrically opposite, but they have different arcuate profiles. Slot 118 (FIG. Slot 118 (FIG. 5). The length of lock ring number 66 is extended by the slots 118 and 120. Lock ring 66 also has a pair grooves 122 at its proximal end. Each groove is arcuately formed and is located in the lock ring’s inner portion that defines opening 114. Each groove 122 is also adjacent to one of the slots 118 and 120. Grooves 120 and 122 are usually diametrically opposite each other. The grooves 122 act as slots through the manifold 46, which are connected to the distal end of the lock rings 66 by the abutment of their distal faces.

“The interior arcuate-stepped interior surfaces 123, 124 that are internal to the lock rings 66 define the distal end bases of each groove 122. Surface 123 extends from the slot 118 and 120 adjacent surfaces. Surface 123 is not perpendicular to the slot 118 and 120. Surface 123 is instead angled so that it extends proximally towards adjacent receiver housing 62. Surface 124 extends beyond surface 123. Surface 124 runs parallel to the adjacent proximal face of lock ring number 66.

“Manifold receiver 44 contains two main moving parts. A valve disk 132 covers the conduit 56 opening in the front end plate of the distally receiver adapter 96. If a manifold has not been attached, a door 134 covers the distal end of the manifold receiver housing.

“Valve disk 132, seen best in FIG. 5 is a disk-shaped member that is located in the manifold receiver housing. 62. The valve disk 132 is placed in the counterbore 78-defined cylindrical space. The manifold receiver housing counterbore78 and the valve disc 132 have been designed so that the valve can rotate in the counterbore.

“Valve disc 132 is designed to have cylindrical boss136 that extends distally into the manifold receiver housing bore. 76. Bore 138 (shown in Phantom) runs through boss 136 as well as the portion of valve disk that the boss extends. The boss of the valve disk 132 is placed along an axis offset from the longitudinal axis through it, which is the axis on which the valve disc rotates. Also, the valve disk 132 is shaped so that it has a notch number 139. The notch 139 extends inwardly beyond the outer perimeter of a valve disk. Referring to the center axis on the valve disk 132. Notch 139 is located on opposite side of disk from which boss 136 extends.

“Thus, manifold-receiver 44 is designed so that the valve disk covers conduit 56’s receiver adapter front plate when it is in a particular rotational position within manifold receiver housing. The valve disk 132 in its closed position is further shaped to ensure that the counterbore 78 of the receiver housing base 139 is covered by the disk. Valve disk 132 can be rotated to align bore 138 and the conduit opening.

“When the manifold receiver44 is assembled seal 112, best seen at FIG. 5A is located at the valve disk 132’s proximally-directed face. Seal 112 can be either a C-, or U-shaped seal in one version. The opposite sides of the seal are pressed outwardly by spring 113. The one-side of seal 112 is pressed against the manifold receiver plate, which forms the base of slot 110. The opposite side of seal 112 is located against the valve disk 132’s proximally-directed face. Seal 112 prevents material from flowing into the interstitial space between the receiver adaptor plate (96) and the valve disk (132).

“The force generated from spring 113 also drives valve disc 132 against the proximally directed inner surface of receiver housing 62, which defines the base for counterbore 78. The valve disk’s free rotation is blocked by spring 113. But, spring 113 and seal 112 are chosen so that the anti-rotational force they collectively exert on valve disk 132 can be overcome with manual force.

“As shown in FIG. 7 door 134 has the cylindrical head 144. Head 144 is surrounded by diametrically opposite ears 146, 148 that extend outwardly. Ear 146, the first ear, is located a considerable distance from the center. Through hole 150 is formed in ear 146. Through hole 150 runs through the top end of an ear146 along an axis perpendicular with the axis through door head. The slot 152 is located on the plate’s proximally-directed side of door 134. Slot 152 runs from the outer edge of ear 146 to the width of the ear, intersecting through hole 150. Slot 152 is found along a line perpendicular the axis on which through hole 150 is centered. Slot 152 extends partly into door head number 144 in addition to passing through ear 146.

The door is further shaped so that the sides of ear146 extend outwardly to the left; there are notches 152 in the head 144. Ear 148 is located closer to the center of the door head 144 than does ear 146. Ear 148, a solid arcuate structure, is located a short distance from the door head 134.

“Door 144 is pivotally attached to manifold receiver housings 62, as best seen in FIG. 5. Door ear 146 is located in notch 80. The pivotal hold for the door to the housing is a pin 154, which extends through the manifold receiver 62 and door hole 150. The pin 154 section that passes through the door slot 152 is covered by a torsion spring 156. The receiver housing rib 61.1 defines the top of the void space 82. One leg of this torsion spring rests against the interior of the receiver housing. This leg is static. The second leg is the torsion spring and it meets the surface of the door, which defines the base slot 150.

“Collectively, the manifold receiver housing (62) and door 134 have been dimensioned so that the door can be positioned in void space 82, when the manifold 46 has been seated in the housing. The manifold 46 must be removed from the manifold 44 so that there is enough clearance between the interior surfaces of receiver housing. This will allow the door to pivot downwardly. The doors 134 pivot through windows number 84. Further, the manifold receiver housing (62) and the door 134 have been shaped so that when the plate pivots downwardly the plate ear148 meets the inner, proximally directed receiver housing lip (67).

“FIG. 8 shows the canister cap 42 section to which the manifold receive 44 is attached. Cap 42 also includes a boss 155 that extends upwardly. Boss 155 is the opening 177 where O-ring 108 and receiver boss 106 are seated. From cap 42, posts 156 extend upwardly. The posts are the support members on which the receiver housing 64 and adaptor 64 are mounted. Fasteners 145 attach the receiver housing 64 and the receiver adapter 64 to posts 156.

“Cap 42 is a dome-type profile. The cap’s perimeter is lower than its center. The cap’s perimeter is surrounded by an arcuate web 147. It extends upwardly. Web 147 runs between the outermost posts. Web 147 extends thus around boss 155. From the post 156, a small web 149 extends upwardly. Web 149 is then spaced from boss 15.5. The downwardly inclined surface at cap 42, webs web 147 and web 149, and webs 156 to either side of web147 create a pocket 151 at the top of cap 42. Boss 155 is partially enclosed by pocket 151.”

“III. Manifold”

“FIGS. 9 and 10 show the basic components of manifold 46. The most proximal portion of the manifold’s manifold is the open-ended shell 158. The shell 158’s open distal end is covered by a cap 164. Together, shell 158 & cap 164 make up the manifold housing. A void space (not yet identified) is located inside this housing. Cap 164 is where fittings 48 extend. The manifold void space is home to a filter basket 166. Filter basket 166 stops large pieces of solid matter flowing downstream.

“It is clear that the manifold shell (158) has a cylindrical shape. The shell 158 has a circular proximal base 168, from which a tubular-shaped side wall of 159 extends upwardly. The open top of the side wall 160 is covered by a lip 160. Lip 160 extends radially outwardly. From the top of sidewall 159, two fingers 161-162 extend distally upwardly. Each finger 161 or 162 has an arcuate cross-sectional profile. The fingers 161 and 162 are parallel along the longitudinal axis, and are diametrically opposite each other. Finger 161 has a large arc. Finger 162 has a shorter arc.

“A shell base 168 has an opening 170. The opening can accommodate the valve disk boss 136. The shell is designed so that opening 170 is located along an axis which is not in line with the longitudinal axis of shell 158. The shell base 168 surrounds opening 170 with a circular lip 172. The outer perimeter of opening 170 is defined by lip 172, which is spaced radially from the annular shell base 168. Manifold shell 158 in one version of the invention is designed so that a small section of the lip is flush with a section adjacent to the shell sidewall 159.

“A drip stop174” is now described in FIGS. 11, 12 are fitted into manifold opening 170. Drip stop 174 is made from a compressible material like polyisoprene. The base of drip stop 174 is a ring-shaped 176. Base 176 is designed so that it has a slot 178 around its outer perimeter. The drip stop 174 seats are created when manifold 46 has been assembled. This is the section of base that defines slot 178’s perimeter. Section of stop base 176 that is below slot. This defines section seats within the enclosed space defined shell lip 172.

“Drip stop base 176, is further shaped to have the first, second, and third inwardly tapered annular surfaces 180-182 and 184, respectively, as it extends forward from its proximal ends. Surface 180 has a greater taper than surface 182 and surface 184 relative to the drip stop’s longitudinal axis. Surface 180 is longer along the entire length of the valve base than surfaces 182 or 184 combined. Just above the tapered top surface surface 184 valve base 176 has a constant diameter inner surface of 186. The surface extends across the entire valve base 186, where slot 178 is made.

“The inner diameter of inner surface 186, is approximately 0.5 mm larger than that of valve boss 136. The drip stop base can be used as a lead-in for the valve boss 136 because of its relatively large diameters 180-186. This leads in corrects minor misalignments of the valve disk 132.

“Drip stop174 has a head 188, with a concavoconvex profile. It is integrated with base 176 and projects distally forward. Two lips make up the drip stop head 188. Normaly, lips 187 are abutted so that a slot of 190 is created. Slot 190 runs along two diametrically opposite radial lines. Slot 190 doesn’t extend across the entire width of the valve head. Slot 190 is shorter than the outside diameter of the valve boss to allow the drip stop to seal. The usual abutment of the opposed lips is 187. The 188 blocks flow from manifold opening 170.”

“The filter basket 166, now explained using FIGS. 10, and 13. The filter basket 166 has a cylindrical trunk 194. The trunk 194 has a ring at its proximal base. The ring 196’s inner surface is surrounded by a series of ribs that extend upwardly. The ribs 198 are spaced so that they can be separated by a minimum distance of 10mm, and more preferably, by a maximum of 5mm. The filter basket 166 blocks the downstream flow of large-sized solid particles in the waste stream. The filter basket 166 is designed so that the ribs of 198 are at least one mm apart. This keeps small pieces of solid and semisolid waste from getting trapped in the basket 166, and clogging manifold 46.

“Above trunk 194, filter bag 166 has an inwardly tapered neck of 202. Neck 202 is generally shaped like a slice through a cone. The base of the neck is covered by a round, inwardly tapered web. The structural component of web 203 extends from the distal ends ribs 198. From web 203, a set of arcuately separated ribs (204) extends upwardly and inwardly. The filter basket head 206 is formed by the ribs 204 that terminate at a member with a disc shape.

“A pair diametrically opposing arms 208 extend outwardly towards the filters basket neck 202. Each arm 208 has a general planar structure. The arms intersect the filter basket 166’s longitudinal axis in a common plane. The top surfaces of arms 208 and filter basket head206 are coplanar. Each arm has a hand 210 at its free end. The hand 210 is generally perpendicular with the arm 208. Each hand 210 has an external surface (not identified), that has an arcuate profile. Each hand is connected to its associated arm 208 by strengthening webs 211 located at the hand’s top.

“Two parallel, elongated ears 212 extend distally from the top filter basket head 206. The ear 214 generally looks like a rectangularly-shaped post. The tip of each ear 212 has a 214-degree projection towards the arm 208. The ears are slightly flexible relative to the rest 166 filter basket, as shown below.

“The manifold caps 164 are now described in reference to FIGS. 14-15 and 16 are made from one piece of polypropylene, or another similar plastic. The manifold cap 164 is designed to have a tube-shaped skirt 220. Two tabs 222 & 224 extend radially from the skirt 220’s proximal base. The tabs 222 and 234 are diametrically opposite each other. However, the arcs of tabs 222, 224 are different. Tab 222 has a large arc and can be slipped into the manifold receiver lock slot 118. Tab 224 has a shorter arc and is made to fit into the manifold receiver lock slot 120.

Cap skirt 220 has a rim 217 which defines the proximal opening of the skirt. This rim is inwardly tapered. The skirt 220, above rim 215, has an outwardly directed 218 that runs circumferentially around the interior. Cap 164 is designed so that skirt 220’s inner diameter is approximately 0.5mm smaller than shell lip 160’s outer diameter. When the manifold 46 has been assembled, the shell can be inserted into cap 164. The lip will then fit on skirt step 218, thus the shell fits in cap 164. The cap skirt 220 is compressed around the cap lip 160 to reduce suction loss.

“A few ribs extend inwardly beyond the inner surface manifold cap skirt 221. These ribs are believed to start at step 218. There are two pairs of adjacent ribs 226, and one pair of adjacent 228 ribs. The centerline around which the ribs 226, 226 and 228 are centered is diametrically opposite to that around which the ribs 228, 228 are centered. The distance between ribs 226 and ribs 228 is relatively short relative to ribs 226, so they are spaced quite arcuately. Particularly, ribs 226, 228 and 226 are separated at a sufficient distance so that shell finger 161 may be slip fitted between them. Ribs 228 can be separated from enough distance that finger 162, and not finger 161, may be slip fitted between them. When these components are assembled, the shell fingers 161-162 and the cap rib pairs 226-228 and 228 facilitate proper alignment of the manifold shells 158 and 164.

“Manifold cap skirt 220 also includes two pairs of ribs, 230 (one pair is shown in FIG. 14). The ribs 230 are spaced at an arcuate distance so that one of filter basket hands 210 can be slipped between them.

“A head 234 with a disk-shaped shape extends above the top of the manifold cap skirt 221. Head 234 is shaped so that it has a centrally located through hole 236. Through hole 236 has a rectangular shape. Further, the cap 164 has a rectangular post 238 which extends upwardly from head 234. Post 238 is located around through hole 236. It is hollow to allow for access to the through hole.

“Fittings 48 extend upwardly to head 234. Each fitting 48 takes the shape of a hollow tube. The ports 237 and 234 in the cap head 234 allow fluid communication between each fitting, as well as the interior void space of manifold 46. The cap head’s inner face is covered by a circular rib 239 that extends around each port 239. FIG. 16 Each rib 239 has an outer surface of 240 that curves away from the cap head 234, which is located proximally. The outer surface 240 transitions into an inner surface of constant height 241. The associated port 237 is defined by the perimeter by the rib inner surface.

“A fence 245, seen best in FIGS. 2, and 9 extend upwardly from cap 234. The fence 245 can be divided into four sections (sections are not identified). Each section of fence is between two adjoining fittings 48. The fence 245 is located just inwardly of the cap head 234. The fence 245 is the manifold member that an individual can hold onto to insert, rotate, or remove the manifold as described below.

Two adjacent fittings 48 in the illustrated embodiment of the invention are of short length. The fittings 48 that are not adjacent to each other are longer. The fittings 48 have been designed to make it easier to attach a suction line 50 each fitting.

Each fitting 48 is supplied with a removable cap 246. A tether 247 attaches each fitting cap 246 to the manifold caps. The fitting caps 246 & tethers 247 form part of the same plastic part that forms the rest of manifold cap 164.

“Manifold 46” of this invention also contains a flapper valve unit 248, which is now described in reference to FIGS. 10, 17, and 18. Flapper valve unit 248, is made from one piece of compressible, flexible material like polyisoprene and other elastomeric materials. Flapper valve unit 248, has a hub 250 with a disc shape. Hub 250 has a 252 center hole. Hole 252 has been sized to accommodate filter basket ears 212. There are also a few annular ribs 254-256 on the flapper unit hub 250. One rib 254 extends from hub 250’s opposed distal and proximally-directed faces. A rib 256 extends outwardly also from the opposing faces of hub 250. Through hole 252, ribs 254 can be found proximal of hub 254. Ribs 254 and 256 are surrounded by ribs 256. The cross sectional profile of each rib 254 or 256 is inwardly angled. Each rib 254 or 256 is extended outwardly from hub face and is angled to point to longitudinal axis through the hub hole 252.

Flapper valves 262 pivotally connect to and extend from hub 254. Each flapper valve 262 is designed to cover a different fitting port 237. Each flapper valve 262 is connected to the hub 250 by a hinge 260. This hinge is also an integral part the flapper unit 248 The hinges 260 are made from sections of the material used to make the valve. They have a thinner cross-sectional thickness than the hub 250 and flapper va 262 adjacent.

“Every flapper valve 262 has a disk-shaped design. Each flapper valve 262 has a dimension that covers both the associated port 237 as well as the area surrounding the port, rib 239 in the center. Each flapper valve 262 generally has a diameter approximately 4 mm larger than the inner diameter the port-defining rib 239.

“As we will see, the flapper valve unit hub 250 of manifold 46 is compressed between filter basket 166 and manifold cap 164. This causes slight expansion of hub 250. When designing the flapper unit 248, it is important to ensure that the flapper vales 262 are still seated over the complementing cap ribs 239 when the hub expands. The flapper valves 262 shouldn’t be touching the inner surface 220 of the cap skirt when they are in the expanded state. This could hinder the valves’ ability to quickly open and close.

“Also the design of manifold 46 components should be such that flapper valves 262 are not too close to or slightly above the adjacent ribs 239 when assembled. The flapper valves 262 may press too hard against the ribs 239. This could lead to a static condition where they are not pivoted open. This will reduce the valve’s ability to prevent reverse flow from the manifold 46 through the fitting 48.

The valve unit 248 is first fitted over the filter basket ears 212 to make the manifold 46. Filter valve unit 248 cannot rotate due to the identical rectangular shapes of the ears 212, and the hub through hole 252 where they are seated. Cap 166 is fitted with filter basket 166. By pressing the filter basket ears 236 through the cap hole 236, and the hollow of the post 238, this is done. The ear tips 214 extend beyond the top walls of post 238 to secure the filter basket 166 to cap 164.

“Flapper valve unit hub 250 will be compressed between the components of the filter basket 166 and cap 164 after they have been secured. The seals of the ribs 254 and 258 prevent vacuum loss through the manifold cap hole 236, which is located on each side. Two ribs (or seals) are located on each side flapper valve unit 248. To create the fluid-tight barrier, only minimal compressive pressure must be between the ribs 254 & 256 and adjacent static surfaces. This force is smaller than the force needed to compress the solid seal hub 250 body. It should be noted that the filter basket ears 238 and cap post 238 have been collectively dimensioned so the ribs 254 & 256, when assembled, are compressed but not compressed too much between the cap & filter basket.

“Moreover, ribs 254 & 256, as we have already discussed, are inwardly directed. The vacuum created by drawing a vacuum will create an ambient atmosphere through the cap through hole 236, which is located around filter basket ears 212. This pressure head forms around the inner surfaces 254 and 262. The pressure head pushes the inwardly oriented ribs 254 & 256 outwardly. The ribs 254 & 256 are then flexed against an adjacent static surface, either the distally directed filter basket head 206 face or the proximally directed cap head 234. The fluid barrier created by these ribs is strengthened by the abutment of the 254 and256 against the adjacent surfaces.

“Further the filter unit is prevented from rotating by the square ears 212 in-square hole 252 during assembly. This prevents each flapper valve 262 from rotating during assembly.

“Also manifold 46 is designed so that the filter basket lip 196’s outer diameter is smaller than the shell side wall of the manifold shell 159. These two dimensions are equal or less than width of filter basket ribs198. As a result, manifold 46 is assembled with a small gap between side wall 159’s inner surface and filter basket lip. This gap acts as a flow path for liquids and other small particles of matter, which allows them to pass through the manifold.

“IV. Operation”

“Prior use, before the manifold46 is fitted to mobile unit 30, the manifold receiver44 is in the condition depicted in FIG. 5. Valve disk 132 is placed in the index position, so that the body is covered by plate 96 to receive adapter conduit 56. Spring 156 holds door 144 closed. Together, spring 156 and door 144 keep curious fingers out of the receiver housing 62.

The mobile unit 30 can be prepared by attaching the manifold 46 and the complement receiver 46, which are both associated with the canisters 36 and 38. This will allow the waste from the surgical site to be collected. The manifold 46 is then inserted into the receiver. To allow mobile unit 30’s function, the valve disk boss 136 must be seated in the shell opening 170. The alignment of the manifold 46 and valve disk 132 is ensured by the cooperation between the lock ring slots 120 and 118, and the manifold tabs 226 and 224. These components are placed so that manifold tab 224, located in receiver slot 118, is rotated so that the shell opening 170 aligns with valve disk boss 135. Shell base fitting over the valve boss 136 is possible after the manifold has been properly positioned.

The manifold 46 must be fitted against the valve disk 132 before it can be rotated. Manifold tabs 226 and 224 cannot rotate into the slots for lock rings 122. This is why the direction of rotation is determined. The rotation of the manifold causes the valve disk boss (136) and the entire valve disk 132 to undergo a similar rotation. This rotate places the valve bore 138 in alignment with the receiver adaptor distal opening into conduit. The manifold’s rotation 46 and the valve disc 132 resulted in the manifold being positioned so that the manifold opening 170 lies at the bottom of manifold.

“Thus, manifold open 170 acts as a keyhole to receive valve disk boss 135. Valve disk boss 13 functions as a drive member, rotating the valve disk 132 into the open position.

“The rotational movement of the manifold 46 causes more than a similar rotation of valve disk 132. As you can see, the valve lips 187 extend from the valve boss 136 to the manifold when it is in its receiver housing. The valve boss 136 is blocked by the initial abutment of manifold dripstop 174 against the valve disc boss 136. As the manifold 46 rotates, the surfaces 123 within the lock ring66 act as cam surfaces. These surfaces are against which the manifold tabs 223, 222, and 224 are abut. These surfaces 123 are directed proximally backward. As the manifold turns, the tabs 222, 224 and 123 are abutted against the proximally-directed surfaces 123, resulting in the manifold being driven in a similar proximal direction. This causes sufficient force to overcome the elastomeric forces that keep the drip stop lips 187 closed. Manifold 46 is pushed down on top of the valve boss 136.

“At the conclusion of this process drip stop base base 176 is placed over the base valve boss 136. The outer circumference of the valve disk boss 136 is pressed against the valve lips 187. The drip stop base 176, and lips 187 together form a fluid-tight barrier between boss 136 and the surrounding area of manifold shellbase 168 which defines opening 170. The boss 136’s distal end extends through the valve head slot 193. The bottom of the manifold shell, 158, contains the distal end boss 136. This is the end that defines bore 138.

The process of preparing the mobile device 30 for use involves the coupling of a Suction Applicator 52 to it by a Suction Line 50. The suction line 50 will be attached to the manifold fitting 48. It is not capped.

The suction pump 58 is activated to activate the mobile unit 30. The activation of the suction pump58 causes a waste stream to be drawn from the surgical site into the applicator 52 through the suction line 51 and into the manifold 26. The waste stream contains liquid and solid waste, to which the suction application 52 is applied. The filter basket 166 and the basket lip 196 trap solid waste that is larger than the spaces between the filter baskets ribs 198. The suction force pulls the components of the waste stream which flow past the filter basket 166, into the open proximal bore 138 integral with the valve disk 132. Boss 136 is the fitting through the which the waste stream flows into conduit 58 from the manifold 46. Vacuum between these components is prevented by the drip stop formed between valve boss 136 and manifold 46.

“From valve disc bore 138, the waste stream flows through receiver adapter conduit 56 into the associated canister 36 and 38. The stream’s liquid and solid components, which enter the canister 36/38, precipitate out and are stored in the canisters 36 and 38 for final disposal.

The fluid stream that flows from canister 36 and 38 is therefore essentially liquid-free. This fluid stream is then filtered prior to exhausting it from the suction pump.

“Manifold 46 will be removed once the medical/surgical procedure has been completed and the use of the mobile device 30 is no more required. Manifold tabs 222, 224 are not allowed to be pulled out of the receiver 44 by simply being seated in the lock rings slots 122. It is important to rotate the manifold 46 first so that tabs 222, 224 and 120 align in slots 118, 120. The manifold 46 must be rotated so that the tabs 222 and 224 align in slots 118 and 120, respectively. Rotating the valve disk 132 causes the disk to reorient so that it covers the open end 58 of the receiver adapter conduit.

Once manifold 46 has been properly placed, the manifold can be manually removed from the receiver 44. The slot 190 is closed when the valve head 188 crosses over the valve disk boss 130. The manifold is sealed off by the closing of the 170. This prevents any leakage of remaining waste material.

“Post-use, the mobile unit 30 can be coupled to a docker (not shown and not part this invention). The docker is used to transport the waste material from the canisters 36 and 38 to a treatment facility. The manifold is disposed as medical waste.”

“Vail disk 132 closes the conduit 58 opening that leads to the canister. System 30 requires that the manifold be correctly aligned before the suction can be drawn through it. This will allow the valve disk to move in the correct manner. After the manifold 46 is removed, valve disk 130 is returned to its original closed state. The flow path into the canister remains closed as a benefit of the invention. The opening can only be opened if a manifold is attached. This is done by rotating the manifold 46 in order to remove it from its receiver. The valve disk 132 then closes the opening. This arrangement prevents the release of gases that could be irritating to the nose via the manifold receiver 44.

“The valve disk 132 is not only closed to prevent the release of noxious gasses. Mobile unit 30 includes plural canisters 36, 38. The suction pump 58 can be actuated to draw suction on both canisters. When a manifold is absent, the valve disk 132 automatically closes. This prevents any suction loss through empty manifold receiver 44.

“The manifold receiver 44 of this invention and manifold 46 are further designed so that the manifold sits over the valve boss136. The opposed lip 187 188 of the valve head press against the boss’ outer surface. This displacement occurs due to the rotational?twisting’. The manifold is in its final position. The inserter’s arm and hand are not affected by the physical effort required to rotate the manifold in order to insert or remove it. The valve boss is also pressed against by the valve base 176. These seal-forming parts are surrounded by no airflow. These components don’t vibrate, which results in noise generation.

“Further in preferred embodiments of the invention, the cross-sectional area of valve disk bore 138 is less than the cumulative cross-sectional areas of manifold caps ports 237. The waste stream flows through manifold 46. This ensures that the gaseous components do not experience noise-generating compression. Furthermore, because the fluid flow is not compressed, there is no drop in flow rate when the fluid flows into bore 138.

“Mobile unit 30 of the invention and manifold 46 are further combined to significantly reduce leakage of collected refuse. Drip stop174 prevents waste from leaking into the manifold. When the manifold 46 has been removed, the receiver 44 is removed. Drip stop lips 187 then press against the distal end the valve boss within the manifold. After removing the manifold, valve lips are 187 wiped clean of any remaining waste.

The manifold receiver 44’s geometry and orientation reduce waste leakage from the mobile unit 30 as well as the manifold 46. The receiver adapter 64 was designed so that plate number 96 is offset from the vertical. Therefore, the receiver housing 62 is angled towards the horizontal. The manifold 46, which is also seated in receiver housing 62 is offset similarly from the horizontal. The shell base 168 is located below the manifold cap 164. When the manifold 46 has been set in its run position, the shell opening 170 is at the lowest elevation. This allows for the flow of most waste material from the manifold through the valve disc bore 138 and adapter conduit 56 into the canisters 36 or 38.

The side of the base-defining opening will be rotated upwardly when the manifold 46 has been removed from receiver 44. The manifold’s remaining waste material flows to the opposite side of the empty space within the manifold 46. This means that waste in the manifold remains away from the opening 170 after the receiver 44 has been removed. This reduces the likelihood of waste leaking from the opening.

“Also when valve disk 132 is removed from the manifold 46, the valve disk 132 will be rotated back into the closed position. Notch 139 can also be found in the bottom rotational location. Because of the inclined orientation the manifold receiver housing (62), liquid left in the housing will flow to the valve disk 132. This liquid flows out of the receiver 44 via notch 139 when it reaches the valve disc. The liquid is contained within the pocket 151 at the top of the canister caps 40 and 42. This invention’s manifold receiver 44, and manifold 46 are also designed to reduce the amount of waste that can be accumulated on the mobile unit 30,

Summary for “Manifold” includes a data carrier to a medical/surgical collection assembly.

The generation of solid, semi-solid, and liquid waste is a byproduct of certain medical and surgical procedures. These fluids include blood and irrigating solutions that are introduced into the area where the procedure was performed. Some of the solid and semisolid waste that is generated during a procedure may include bits of tissue or small pieces of surgical material. The best way to ensure that the waste does not pollute the operating area or pose a risk to the health of the patients is to have it collected immediately after its generation.

There are many systems that can be used by surgeons to collect this waste as it’s generated. These units generally include a suction unit, tubing that extends from it, and a containment device between the tubing, the suction, and the suction. The system activates and waste is drawn through the tubing’s opening. The suction pulls the waste through the tubing, so it flows into the container unit and is stored there.

“Applicants’ Assignees NEPTUNE surgical refuse collection system is one such system. This system features a mobile unit with a suction pump, and a canister. The tubing is connected to a canister via a removable manifold. This unit can be moved around to be close to the patient where the procedure is taking place. This minimizes the amount of suction tubing that is around surgical personnel. The system has other features that limit the potential exposure of surgical and support personnel to the material collected by it. U.S. patent application Ser. No. No. No. No.

“The intake manifold is another feature of the system. The intake manifold has a filter element which traps large amounts of solid matter. This is important because solids could clog down-line components of the system. The manifold is made from material that can be used as a single-use item. The manifold can be sterilized with its narrow conduits or internal filter after use. Personnel handling the manifold should only touch the outer surface. This reduces the possibility that these people could come in contact with the waste material. U.S. Patent Application Ser. No. No. No. No.

The above system reduces the risk of medical/surgical personnel being exposed to potentially dangerous medical waste. There are however some drawbacks to the existing waste collection systems. The manifold in the current system extends into the waste canister. The manifold’s sides can be clogged by small droplets of waste. This liquid can be removed from the mobile unit and is considered uncontained waste. The liquid can become a hazardous substance if it is not removed from the mobile unit immediately.

“The filter of the manifold also traps small pieces of solid that could clog downstream components of the mobile unit. It also traps a significant amount of semi-solid waste. This is why it is important to take care when removing the filter.

“Medical personnel may also visually inspect the volume of material that has been collected by the mobile canister. This is done to give a rough estimate on the amount of fluid that was taken from a patient during a procedure. The accuracy of the quick visual estimation of stored fluid can be affected if there is an excessive amount of liquid left in the manifold.

“Further, after removing the manifold, the port in the canister where it was seated opens to the environment. The smells usually associated with unpleasant smells are known to be emitted by material stored in the canister. These odors are released into the environment when the manifold is removed.

“Also the noise can be generated by the fluids and air flowing through the waste collection system (both the manifolds and mobile units). This noise can cause unwanted background noise in an operating area.

“This invention aims to create a new, useful system for collecting medical and surgical waste. This invention includes an intake manifold, to which suction tubes can be connected. The manifold can be removed and connected to a manifold receiver. The manifold and the complementary receiver are designed so that there is minimal release of fluids after removal and replacement of manifold.

“The housing of the intake manifold in this invention is a housing. A number of inlet fittings extend from one end to the other. These fittings are equipped with suction tubes. An opening is found at the opposite end of the housing that allows for suction to be drawn. This opening is equipped with a drip stop. The manifold can be seated in the complement receiver by placing the opening in the boss tubular that is part the receiver. To prevent material from leaking around the boss, a portion of the drip stop should be placed against the outer boss.

“The drip stop can be further shaped to include a selectively openable valve that extends into any opening. The valve is normally shut. This head is normally closed once the manifold has been removed from the receiver. It prevents waste from leaking from the manifold. In one embodiment of the invention, flaps are integral to the drip stop. The flaps, which prevent suction loss between boss and surrounding manifold, are fitted to the receiver.

The receiver boss is located at the valve. This valve is used to close a fluid conduit, which extends into a canister where the waste is stored. The manifold must be properly installed in the receiver to prepare the system for operation. A geometric feature on the manifold engages an integral drive member with the valve. The manifold is placed in the receiver to displace the drip stop and valve into an open state. The fluid path between the manifold and the conduit connecting to the canister is unrestricted.

The valve will return to its closed state when the manifold has been removed. When the manifold is not removed from the system, the valve returns to its closed state. This prevents the release of any unpleasant vapors.

“Internal” to this invention’s manifold is a filter basket. The filter basket traps large amounts of solid matter in the waste stream and allows the majority of the liquid stream to flow through it. The manifold is empty of any liquid state waste that could be leaked after the procedure is completed.

“I. Overview”

“FIG. 1. illustrates a waste collection unit 30 built in accordance to this invention. The base 32 is part of system 30, also known as a mobile unit. FIG. 30 does not show the cover or door assemblies that usually conceal components. These components are visible in FIG. The system’s mobility is provided by wheels 34 that are attached to the base 32. Mounted to the base 32 are two canisters 36-38. The first canister, canister 36 has an interior volume of approximately 10 to 40 liters. Canister 38 is smaller, with an interior volume of approximately 1 to 10 liters. Each canister 38 and 36 have a cap 40, 42, and respectively.

“Attached each canister cap 40 or 42 is a manifold receive 44. FIGS. 2 and 3 show a manifold 46. The manifold 46, shown in FIGS. 2 and 3, can be removed from each manifold receiver 44. Each manifold 46 has a variety of fittings 48. Each fitting 48 is fitted with a suction line 50. (One shown in FIG. 3). Attached to the distal end of each suctionline 50 is a suction applicator52 (FIG. 1). (?Distal,? It refers to the surgical site where the suction is applied. ?Proximal? (meaning away from the surgical site. FIG. FIG. Sometimes, the suction applicator 52 can be integrated into another surgical tool such as an ablation tool or endoscope, which is used to apply suction to a surgical site.

“Internal to each manifold receive 44 is a conduit 56. (FIG. 3). Conduit 56 acts as a fluid communication path between the manifold 46 and the canister 36/38 with which the receiver has been associated.

“A suction pump 58 is also part of mobile unit 30, Conduits 59, 60 (shown in FIG. 1) Connect each canister 36, 38 and 58 to the suction pump’s inlet port 58. The suction pump 58 activates, drawing matter into the suction applicator52 and through the associated suction lines 50, 46, and 44. The associated canister 36 and 38 are filled with the waste stream. The stream flows into the canister 36 and 38 as liquids and solid particles of matter. This waste is then stored in the canisters 36 and 38 until it is empty. The flow stream is then drained of any gas and other small pieces of matter. Filters that are not shown and not part this invention trap viral- and bacterial-sized matter as well as some components of the gas in the fluid stream before it is drawn into and exhausted from the suction pump.

“II. “II.

“As shown in FIGS. A manifold receiver 44 is composed of three static primary components. The housing 62 houses the manifold 46’s proximal end. The receiver adaptor 64 connects the manifold receiver housing (62) to the canister cap (40 or 42). Adaptor 64 also contains conduit 56, which acts as the flow path between the manifold receiver housing 62 and the associated canister 36/38. The distal end of the manifold receiver housing is secured by a lock ring 66. Lock ring66 has geometric features that ensure the manifold’s alignment when fitted into receiver 44 with a manifold 46.

“From FIGS. “From FIGS. The top of the manifold receiver housing is 62 has a rib 61. The outer surface 63 at the proximal end is slightly stepped inwardly to the distal surface. This spacing allows for the fitting of the receiver 44 and the canister caps 40 or 42.

“Turning towards FIG. 6 shows that the manifold receiver housing (62) is designed to create a variety of bores, windows and void spaces. These voids create a path through housing 62 along its longitudinal axis. Housing 62’s distal end has a cylindrical bore number 68. The receiver housing 62’s distal end has a lip of 67. The distal end opening of housing 62 extends inwardly into lip 67, which is the distal opening of bore 68. A bore 70 is located immediately adjacent to bore 68’s proximal end. Bore 70 is formed by the manifold receiver housing (62) so its diameter decreases as it gets further away from bore 68. Bore 70 opens into bore 72, which is a second bore with a constant diameter. Bore 72 is the same diameter as bore 70’s smallest section. Bore 76 is the third constant bore. It is located proximal to the bore 72 manifold receiver Housing 62. Bore 76 is smaller than bore 72. There is a small transition bore, 74, between bores 72-76. The diameter of the transition bore 74 is approximately 0.4 inches. It tapers inwardly between bore 72 and bore 76. The counter bore 78 is located at the most proximal part of the manifold receiver housing (62). The diameter of counterbore 78 is greater than bore 76 and intersects with it.

The “Manifold receiver housing” 62 has a notch 80. Notch 80 is formed within rib 61. It extends rearwardly towards the housing’s distal end and is contiguous to the top of bore 64. Contiguous to notch 80 and proximally, there is also a proximally-extending void space (82), which is also defined by the interior surface of rib 61. Void space82 intersects bores 70, 72 and 74, and extends slightly beyond them. Void space 82 is generally rectangular in cross section. Two opposed through windows 84 are also included in manifold receiver housing (as shown in FIG. 6). Each window 84 leads into the middle and proximal portions of bore 68 and bore 70, bore 72 and bore 76, respectively.

“A bore 86 runs downwardly from bore 72 to the bottom of the manifold. Bore 86 has been designed to accept a fastener (not illustrated) to attach the manifold 46 and the associated canister caps 40 or 42. Plural bores 86 are included in some versions of the invention. Each bore can receive a fastener. Housing 62 has windows 84 that allow for easy access to the bores.

Closed end bores (88 and 89) extend inwardly from the respective distal, front and proximal rear faces of the manifold receiver Housing 62. Although only one bore 88 or 89 is shown, there are plural bores 88 or 89. Each bore 88 is equipped with a fastener, 92 that holds the lock ring 66 to its manifold receiver housing 62. Each bore 89 is fitted with a fastener (94) that attaches the manifold receiver housing to the adaptor 64.

“Receiver adaptor 64, best seen in FIGS. 4. and 5. Also included is a front plate 96. Plate 96 is designed to fit against the proximal receiver housing 62, including the open ends at bore 76 and counterbore 78. Plate 96’s through bores, in which fasteners extend to 94, are not identified. Plate 96 covers the receiver housing counterbore (78) in its entirety, but it does not completely cover it. Instead, a small amount of counterbore78 is visible at the bottom of receiver housing 62.

A bracket 98 can be extended proximally to and integratedly formed with plate 64 adapter 64. Bracket 98 features a triangular profile so that the overall width of the bracket increases along the length 96. The tab 102 is located proximally rearwardly of the bracket base 98. Tab 102 has an opening 104. Opening 104 is fitted with a fastener (not shown) which secures the receiver adapter 64 to canister cap 40, 42.

“Receiver adapter 64” is further formed as shown in FIG. 5A shows an annular slot 110 formed in the distally-directed face of plate. Slot 110 surrounds, is concentric with and is spaced from conduit 56 through plate 96. For reasons that are obvious below, a seal 112 is placed in slot 110.

“Lock ring number 66” is now described using FIGS. The lock ring 66 is generally a ring-shaped. The lock ring 66 has a central opening that is located at 114. Numerous bores 116 run longitudinally through the ring. Bores 116 are equipped with fasteners 92 to attach the lock ring to the receiver housing 62.

The lock ring 66 can also be shaped to create a pair slots 118-120. The slots 118 and 120 are adjacent to through opening 114. They extend radially outwardly starting at opening 114 until the proximal edge of the lock rings 66. Slots 118 and 120 may be diametrically opposite, but they have different arcuate profiles. Slot 118 (FIG. Slot 118 (FIG. 5). The length of lock ring number 66 is extended by the slots 118 and 120. Lock ring 66 also has a pair grooves 122 at its proximal end. Each groove is arcuately formed and is located in the lock ring’s inner portion that defines opening 114. Each groove 122 is also adjacent to one of the slots 118 and 120. Grooves 120 and 122 are usually diametrically opposite each other. The grooves 122 act as slots through the manifold 46, which are connected to the distal end of the lock rings 66 by the abutment of their distal faces.

“The interior arcuate-stepped interior surfaces 123, 124 that are internal to the lock rings 66 define the distal end bases of each groove 122. Surface 123 extends from the slot 118 and 120 adjacent surfaces. Surface 123 is not perpendicular to the slot 118 and 120. Surface 123 is instead angled so that it extends proximally towards adjacent receiver housing 62. Surface 124 extends beyond surface 123. Surface 124 runs parallel to the adjacent proximal face of lock ring number 66.

“Manifold receiver 44 contains two main moving parts. A valve disk 132 covers the conduit 56 opening in the front end plate of the distally receiver adapter 96. If a manifold has not been attached, a door 134 covers the distal end of the manifold receiver housing.

“Valve disk 132, seen best in FIG. 5 is a disk-shaped member that is located in the manifold receiver housing. 62. The valve disk 132 is placed in the counterbore 78-defined cylindrical space. The manifold receiver housing counterbore78 and the valve disc 132 have been designed so that the valve can rotate in the counterbore.

“Valve disc 132 is designed to have cylindrical boss136 that extends distally into the manifold receiver housing bore. 76. Bore 138 (shown in Phantom) runs through boss 136 as well as the portion of valve disk that the boss extends. The boss of the valve disk 132 is placed along an axis offset from the longitudinal axis through it, which is the axis on which the valve disc rotates. Also, the valve disk 132 is shaped so that it has a notch number 139. The notch 139 extends inwardly beyond the outer perimeter of a valve disk. Referring to the center axis on the valve disk 132. Notch 139 is located on opposite side of disk from which boss 136 extends.

“Thus, manifold-receiver 44 is designed so that the valve disk covers conduit 56’s receiver adapter front plate when it is in a particular rotational position within manifold receiver housing. The valve disk 132 in its closed position is further shaped to ensure that the counterbore 78 of the receiver housing base 139 is covered by the disk. Valve disk 132 can be rotated to align bore 138 and the conduit opening.

“When the manifold receiver44 is assembled seal 112, best seen at FIG. 5A is located at the valve disk 132’s proximally-directed face. Seal 112 can be either a C-, or U-shaped seal in one version. The opposite sides of the seal are pressed outwardly by spring 113. The one-side of seal 112 is pressed against the manifold receiver plate, which forms the base of slot 110. The opposite side of seal 112 is located against the valve disk 132’s proximally-directed face. Seal 112 prevents material from flowing into the interstitial space between the receiver adaptor plate (96) and the valve disk (132).

“The force generated from spring 113 also drives valve disc 132 against the proximally directed inner surface of receiver housing 62, which defines the base for counterbore 78. The valve disk’s free rotation is blocked by spring 113. But, spring 113 and seal 112 are chosen so that the anti-rotational force they collectively exert on valve disk 132 can be overcome with manual force.

“As shown in FIG. 7 door 134 has the cylindrical head 144. Head 144 is surrounded by diametrically opposite ears 146, 148 that extend outwardly. Ear 146, the first ear, is located a considerable distance from the center. Through hole 150 is formed in ear 146. Through hole 150 runs through the top end of an ear146 along an axis perpendicular with the axis through door head. The slot 152 is located on the plate’s proximally-directed side of door 134. Slot 152 runs from the outer edge of ear 146 to the width of the ear, intersecting through hole 150. Slot 152 is found along a line perpendicular the axis on which through hole 150 is centered. Slot 152 extends partly into door head number 144 in addition to passing through ear 146.

The door is further shaped so that the sides of ear146 extend outwardly to the left; there are notches 152 in the head 144. Ear 148 is located closer to the center of the door head 144 than does ear 146. Ear 148, a solid arcuate structure, is located a short distance from the door head 134.

“Door 144 is pivotally attached to manifold receiver housings 62, as best seen in FIG. 5. Door ear 146 is located in notch 80. The pivotal hold for the door to the housing is a pin 154, which extends through the manifold receiver 62 and door hole 150. The pin 154 section that passes through the door slot 152 is covered by a torsion spring 156. The receiver housing rib 61.1 defines the top of the void space 82. One leg of this torsion spring rests against the interior of the receiver housing. This leg is static. The second leg is the torsion spring and it meets the surface of the door, which defines the base slot 150.

“Collectively, the manifold receiver housing (62) and door 134 have been dimensioned so that the door can be positioned in void space 82, when the manifold 46 has been seated in the housing. The manifold 46 must be removed from the manifold 44 so that there is enough clearance between the interior surfaces of receiver housing. This will allow the door to pivot downwardly. The doors 134 pivot through windows number 84. Further, the manifold receiver housing (62) and the door 134 have been shaped so that when the plate pivots downwardly the plate ear148 meets the inner, proximally directed receiver housing lip (67).

“FIG. 8 shows the canister cap 42 section to which the manifold receive 44 is attached. Cap 42 also includes a boss 155 that extends upwardly. Boss 155 is the opening 177 where O-ring 108 and receiver boss 106 are seated. From cap 42, posts 156 extend upwardly. The posts are the support members on which the receiver housing 64 and adaptor 64 are mounted. Fasteners 145 attach the receiver housing 64 and the receiver adapter 64 to posts 156.

“Cap 42 is a dome-type profile. The cap’s perimeter is lower than its center. The cap’s perimeter is surrounded by an arcuate web 147. It extends upwardly. Web 147 runs between the outermost posts. Web 147 extends thus around boss 155. From the post 156, a small web 149 extends upwardly. Web 149 is then spaced from boss 15.5. The downwardly inclined surface at cap 42, webs web 147 and web 149, and webs 156 to either side of web147 create a pocket 151 at the top of cap 42. Boss 155 is partially enclosed by pocket 151.”

“III. Manifold”

“FIGS. 9 and 10 show the basic components of manifold 46. The most proximal portion of the manifold’s manifold is the open-ended shell 158. The shell 158’s open distal end is covered by a cap 164. Together, shell 158 & cap 164 make up the manifold housing. A void space (not yet identified) is located inside this housing. Cap 164 is where fittings 48 extend. The manifold void space is home to a filter basket 166. Filter basket 166 stops large pieces of solid matter flowing downstream.

“It is clear that the manifold shell (158) has a cylindrical shape. The shell 158 has a circular proximal base 168, from which a tubular-shaped side wall of 159 extends upwardly. The open top of the side wall 160 is covered by a lip 160. Lip 160 extends radially outwardly. From the top of sidewall 159, two fingers 161-162 extend distally upwardly. Each finger 161 or 162 has an arcuate cross-sectional profile. The fingers 161 and 162 are parallel along the longitudinal axis, and are diametrically opposite each other. Finger 161 has a large arc. Finger 162 has a shorter arc.

“A shell base 168 has an opening 170. The opening can accommodate the valve disk boss 136. The shell is designed so that opening 170 is located along an axis which is not in line with the longitudinal axis of shell 158. The shell base 168 surrounds opening 170 with a circular lip 172. The outer perimeter of opening 170 is defined by lip 172, which is spaced radially from the annular shell base 168. Manifold shell 158 in one version of the invention is designed so that a small section of the lip is flush with a section adjacent to the shell sidewall 159.

“A drip stop174” is now described in FIGS. 11, 12 are fitted into manifold opening 170. Drip stop 174 is made from a compressible material like polyisoprene. The base of drip stop 174 is a ring-shaped 176. Base 176 is designed so that it has a slot 178 around its outer perimeter. The drip stop 174 seats are created when manifold 46 has been assembled. This is the section of base that defines slot 178’s perimeter. Section of stop base 176 that is below slot. This defines section seats within the enclosed space defined shell lip 172.

“Drip stop base 176, is further shaped to have the first, second, and third inwardly tapered annular surfaces 180-182 and 184, respectively, as it extends forward from its proximal ends. Surface 180 has a greater taper than surface 182 and surface 184 relative to the drip stop’s longitudinal axis. Surface 180 is longer along the entire length of the valve base than surfaces 182 or 184 combined. Just above the tapered top surface surface 184 valve base 176 has a constant diameter inner surface of 186. The surface extends across the entire valve base 186, where slot 178 is made.

“The inner diameter of inner surface 186, is approximately 0.5 mm larger than that of valve boss 136. The drip stop base can be used as a lead-in for the valve boss 136 because of its relatively large diameters 180-186. This leads in corrects minor misalignments of the valve disk 132.

“Drip stop174 has a head 188, with a concavoconvex profile. It is integrated with base 176 and projects distally forward. Two lips make up the drip stop head 188. Normaly, lips 187 are abutted so that a slot of 190 is created. Slot 190 runs along two diametrically opposite radial lines. Slot 190 doesn’t extend across the entire width of the valve head. Slot 190 is shorter than the outside diameter of the valve boss to allow the drip stop to seal. The usual abutment of the opposed lips is 187. The 188 blocks flow from manifold opening 170.”

“The filter basket 166, now explained using FIGS. 10, and 13. The filter basket 166 has a cylindrical trunk 194. The trunk 194 has a ring at its proximal base. The ring 196’s inner surface is surrounded by a series of ribs that extend upwardly. The ribs 198 are spaced so that they can be separated by a minimum distance of 10mm, and more preferably, by a maximum of 5mm. The filter basket 166 blocks the downstream flow of large-sized solid particles in the waste stream. The filter basket 166 is designed so that the ribs of 198 are at least one mm apart. This keeps small pieces of solid and semisolid waste from getting trapped in the basket 166, and clogging manifold 46.

“Above trunk 194, filter bag 166 has an inwardly tapered neck of 202. Neck 202 is generally shaped like a slice through a cone. The base of the neck is covered by a round, inwardly tapered web. The structural component of web 203 extends from the distal ends ribs 198. From web 203, a set of arcuately separated ribs (204) extends upwardly and inwardly. The filter basket head 206 is formed by the ribs 204 that terminate at a member with a disc shape.

“A pair diametrically opposing arms 208 extend outwardly towards the filters basket neck 202. Each arm 208 has a general planar structure. The arms intersect the filter basket 166’s longitudinal axis in a common plane. The top surfaces of arms 208 and filter basket head206 are coplanar. Each arm has a hand 210 at its free end. The hand 210 is generally perpendicular with the arm 208. Each hand 210 has an external surface (not identified), that has an arcuate profile. Each hand is connected to its associated arm 208 by strengthening webs 211 located at the hand’s top.

“Two parallel, elongated ears 212 extend distally from the top filter basket head 206. The ear 214 generally looks like a rectangularly-shaped post. The tip of each ear 212 has a 214-degree projection towards the arm 208. The ears are slightly flexible relative to the rest 166 filter basket, as shown below.

“The manifold caps 164 are now described in reference to FIGS. 14-15 and 16 are made from one piece of polypropylene, or another similar plastic. The manifold cap 164 is designed to have a tube-shaped skirt 220. Two tabs 222 & 224 extend radially from the skirt 220’s proximal base. The tabs 222 and 234 are diametrically opposite each other. However, the arcs of tabs 222, 224 are different. Tab 222 has a large arc and can be slipped into the manifold receiver lock slot 118. Tab 224 has a shorter arc and is made to fit into the manifold receiver lock slot 120.

Cap skirt 220 has a rim 217 which defines the proximal opening of the skirt. This rim is inwardly tapered. The skirt 220, above rim 215, has an outwardly directed 218 that runs circumferentially around the interior. Cap 164 is designed so that skirt 220’s inner diameter is approximately 0.5mm smaller than shell lip 160’s outer diameter. When the manifold 46 has been assembled, the shell can be inserted into cap 164. The lip will then fit on skirt step 218, thus the shell fits in cap 164. The cap skirt 220 is compressed around the cap lip 160 to reduce suction loss.

“A few ribs extend inwardly beyond the inner surface manifold cap skirt 221. These ribs are believed to start at step 218. There are two pairs of adjacent ribs 226, and one pair of adjacent 228 ribs. The centerline around which the ribs 226, 226 and 228 are centered is diametrically opposite to that around which the ribs 228, 228 are centered. The distance between ribs 226 and ribs 228 is relatively short relative to ribs 226, so they are spaced quite arcuately. Particularly, ribs 226, 228 and 226 are separated at a sufficient distance so that shell finger 161 may be slip fitted between them. Ribs 228 can be separated from enough distance that finger 162, and not finger 161, may be slip fitted between them. When these components are assembled, the shell fingers 161-162 and the cap rib pairs 226-228 and 228 facilitate proper alignment of the manifold shells 158 and 164.

“Manifold cap skirt 220 also includes two pairs of ribs, 230 (one pair is shown in FIG. 14). The ribs 230 are spaced at an arcuate distance so that one of filter basket hands 210 can be slipped between them.

“A head 234 with a disk-shaped shape extends above the top of the manifold cap skirt 221. Head 234 is shaped so that it has a centrally located through hole 236. Through hole 236 has a rectangular shape. Further, the cap 164 has a rectangular post 238 which extends upwardly from head 234. Post 238 is located around through hole 236. It is hollow to allow for access to the through hole.

“Fittings 48 extend upwardly to head 234. Each fitting 48 takes the shape of a hollow tube. The ports 237 and 234 in the cap head 234 allow fluid communication between each fitting, as well as the interior void space of manifold 46. The cap head’s inner face is covered by a circular rib 239 that extends around each port 239. FIG. 16 Each rib 239 has an outer surface of 240 that curves away from the cap head 234, which is located proximally. The outer surface 240 transitions into an inner surface of constant height 241. The associated port 237 is defined by the perimeter by the rib inner surface.

“A fence 245, seen best in FIGS. 2, and 9 extend upwardly from cap 234. The fence 245 can be divided into four sections (sections are not identified). Each section of fence is between two adjoining fittings 48. The fence 245 is located just inwardly of the cap head 234. The fence 245 is the manifold member that an individual can hold onto to insert, rotate, or remove the manifold as described below.

Two adjacent fittings 48 in the illustrated embodiment of the invention are of short length. The fittings 48 that are not adjacent to each other are longer. The fittings 48 have been designed to make it easier to attach a suction line 50 each fitting.

Each fitting 48 is supplied with a removable cap 246. A tether 247 attaches each fitting cap 246 to the manifold caps. The fitting caps 246 & tethers 247 form part of the same plastic part that forms the rest of manifold cap 164.

“Manifold 46” of this invention also contains a flapper valve unit 248, which is now described in reference to FIGS. 10, 17, and 18. Flapper valve unit 248, is made from one piece of compressible, flexible material like polyisoprene and other elastomeric materials. Flapper valve unit 248, has a hub 250 with a disc shape. Hub 250 has a 252 center hole. Hole 252 has been sized to accommodate filter basket ears 212. There are also a few annular ribs 254-256 on the flapper unit hub 250. One rib 254 extends from hub 250’s opposed distal and proximally-directed faces. A rib 256 extends outwardly also from the opposing faces of hub 250. Through hole 252, ribs 254 can be found proximal of hub 254. Ribs 254 and 256 are surrounded by ribs 256. The cross sectional profile of each rib 254 or 256 is inwardly angled. Each rib 254 or 256 is extended outwardly from hub face and is angled to point to longitudinal axis through the hub hole 252.

Flapper valves 262 pivotally connect to and extend from hub 254. Each flapper valve 262 is designed to cover a different fitting port 237. Each flapper valve 262 is connected to the hub 250 by a hinge 260. This hinge is also an integral part the flapper unit 248 The hinges 260 are made from sections of the material used to make the valve. They have a thinner cross-sectional thickness than the hub 250 and flapper va 262 adjacent.

“Every flapper valve 262 has a disk-shaped design. Each flapper valve 262 has a dimension that covers both the associated port 237 as well as the area surrounding the port, rib 239 in the center. Each flapper valve 262 generally has a diameter approximately 4 mm larger than the inner diameter the port-defining rib 239.

“As we will see, the flapper valve unit hub 250 of manifold 46 is compressed between filter basket 166 and manifold cap 164. This causes slight expansion of hub 250. When designing the flapper unit 248, it is important to ensure that the flapper vales 262 are still seated over the complementing cap ribs 239 when the hub expands. The flapper valves 262 shouldn’t be touching the inner surface 220 of the cap skirt when they are in the expanded state. This could hinder the valves’ ability to quickly open and close.

“Also the design of manifold 46 components should be such that flapper valves 262 are not too close to or slightly above the adjacent ribs 239 when assembled. The flapper valves 262 may press too hard against the ribs 239. This could lead to a static condition where they are not pivoted open. This will reduce the valve’s ability to prevent reverse flow from the manifold 46 through the fitting 48.

The valve unit 248 is first fitted over the filter basket ears 212 to make the manifold 46. Filter valve unit 248 cannot rotate due to the identical rectangular shapes of the ears 212, and the hub through hole 252 where they are seated. Cap 166 is fitted with filter basket 166. By pressing the filter basket ears 236 through the cap hole 236, and the hollow of the post 238, this is done. The ear tips 214 extend beyond the top walls of post 238 to secure the filter basket 166 to cap 164.

“Flapper valve unit hub 250 will be compressed between the components of the filter basket 166 and cap 164 after they have been secured. The seals of the ribs 254 and 258 prevent vacuum loss through the manifold cap hole 236, which is located on each side. Two ribs (or seals) are located on each side flapper valve unit 248. To create the fluid-tight barrier, only minimal compressive pressure must be between the ribs 254 & 256 and adjacent static surfaces. This force is smaller than the force needed to compress the solid seal hub 250 body. It should be noted that the filter basket ears 238 and cap post 238 have been collectively dimensioned so the ribs 254 & 256, when assembled, are compressed but not compressed too much between the cap & filter basket.

“Moreover, ribs 254 & 256, as we have already discussed, are inwardly directed. The vacuum created by drawing a vacuum will create an ambient atmosphere through the cap through hole 236, which is located around filter basket ears 212. This pressure head forms around the inner surfaces 254 and 262. The pressure head pushes the inwardly oriented ribs 254 & 256 outwardly. The ribs 254 & 256 are then flexed against an adjacent static surface, either the distally directed filter basket head 206 face or the proximally directed cap head 234. The fluid barrier created by these ribs is strengthened by the abutment of the 254 and256 against the adjacent surfaces.

“Further the filter unit is prevented from rotating by the square ears 212 in-square hole 252 during assembly. This prevents each flapper valve 262 from rotating during assembly.

“Also manifold 46 is designed so that the filter basket lip 196’s outer diameter is smaller than the shell side wall of the manifold shell 159. These two dimensions are equal or less than width of filter basket ribs198. As a result, manifold 46 is assembled with a small gap between side wall 159’s inner surface and filter basket lip. This gap acts as a flow path for liquids and other small particles of matter, which allows them to pass through the manifold.

“IV. Operation”

“Prior use, before the manifold46 is fitted to mobile unit 30, the manifold receiver44 is in the condition depicted in FIG. 5. Valve disk 132 is placed in the index position, so that the body is covered by plate 96 to receive adapter conduit 56. Spring 156 holds door 144 closed. Together, spring 156 and door 144 keep curious fingers out of the receiver housing 62.

The mobile unit 30 can be prepared by attaching the manifold 46 and the complement receiver 46, which are both associated with the canisters 36 and 38. This will allow the waste from the surgical site to be collected. The manifold 46 is then inserted into the receiver. To allow mobile unit 30’s function, the valve disk boss 136 must be seated in the shell opening 170. The alignment of the manifold 46 and valve disk 132 is ensured by the cooperation between the lock ring slots 120 and 118, and the manifold tabs 226 and 224. These components are placed so that manifold tab 224, located in receiver slot 118, is rotated so that the shell opening 170 aligns with valve disk boss 135. Shell base fitting over the valve boss 136 is possible after the manifold has been properly positioned.

The manifold 46 must be fitted against the valve disk 132 before it can be rotated. Manifold tabs 226 and 224 cannot rotate into the slots for lock rings 122. This is why the direction of rotation is determined. The rotation of the manifold causes the valve disk boss (136) and the entire valve disk 132 to undergo a similar rotation. This rotate places the valve bore 138 in alignment with the receiver adaptor distal opening into conduit. The manifold’s rotation 46 and the valve disc 132 resulted in the manifold being positioned so that the manifold opening 170 lies at the bottom of manifold.

“Thus, manifold open 170 acts as a keyhole to receive valve disk boss 135. Valve disk boss 13 functions as a drive member, rotating the valve disk 132 into the open position.

“The rotational movement of the manifold 46 causes more than a similar rotation of valve disk 132. As you can see, the valve lips 187 extend from the valve boss 136 to the manifold when it is in its receiver housing. The valve boss 136 is blocked by the initial abutment of manifold dripstop 174 against the valve disc boss 136. As the manifold 46 rotates, the surfaces 123 within the lock ring66 act as cam surfaces. These surfaces are against which the manifold tabs 223, 222, and 224 are abut. These surfaces 123 are directed proximally backward. As the manifold turns, the tabs 222, 224 and 123 are abutted against the proximally-directed surfaces 123, resulting in the manifold being driven in a similar proximal direction. This causes sufficient force to overcome the elastomeric forces that keep the drip stop lips 187 closed. Manifold 46 is pushed down on top of the valve boss 136.

“At the conclusion of this process drip stop base base 176 is placed over the base valve boss 136. The outer circumference of the valve disk boss 136 is pressed against the valve lips 187. The drip stop base 176, and lips 187 together form a fluid-tight barrier between boss 136 and the surrounding area of manifold shellbase 168 which defines opening 170. The boss 136’s distal end extends through the valve head slot 193. The bottom of the manifold shell, 158, contains the distal end boss 136. This is the end that defines bore 138.

The process of preparing the mobile device 30 for use involves the coupling of a Suction Applicator 52 to it by a Suction Line 50. The suction line 50 will be attached to the manifold fitting 48. It is not capped.

The suction pump 58 is activated to activate the mobile unit 30. The activation of the suction pump58 causes a waste stream to be drawn from the surgical site into the applicator 52 through the suction line 51 and into the manifold 26. The waste stream contains liquid and solid waste, to which the suction application 52 is applied. The filter basket 166 and the basket lip 196 trap solid waste that is larger than the spaces between the filter baskets ribs 198. The suction force pulls the components of the waste stream which flow past the filter basket 166, into the open proximal bore 138 integral with the valve disk 132. Boss 136 is the fitting through the which the waste stream flows into conduit 58 from the manifold 46. Vacuum between these components is prevented by the drip stop formed between valve boss 136 and manifold 46.

“From valve disc bore 138, the waste stream flows through receiver adapter conduit 56 into the associated canister 36 and 38. The stream’s liquid and solid components, which enter the canister 36/38, precipitate out and are stored in the canisters 36 and 38 for final disposal.

The fluid stream that flows from canister 36 and 38 is therefore essentially liquid-free. This fluid stream is then filtered prior to exhausting it from the suction pump.

“Manifold 46 will be removed once the medical/surgical procedure has been completed and the use of the mobile device 30 is no more required. Manifold tabs 222, 224 are not allowed to be pulled out of the receiver 44 by simply being seated in the lock rings slots 122. It is important to rotate the manifold 46 first so that tabs 222, 224 and 120 align in slots 118, 120. The manifold 46 must be rotated so that the tabs 222 and 224 align in slots 118 and 120, respectively. Rotating the valve disk 132 causes the disk to reorient so that it covers the open end 58 of the receiver adapter conduit.

Once manifold 46 has been properly placed, the manifold can be manually removed from the receiver 44. The slot 190 is closed when the valve head 188 crosses over the valve disk boss 130. The manifold is sealed off by the closing of the 170. This prevents any leakage of remaining waste material.

“Post-use, the mobile unit 30 can be coupled to a docker (not shown and not part this invention). The docker is used to transport the waste material from the canisters 36 and 38 to a treatment facility. The manifold is disposed as medical waste.”

“Vail disk 132 closes the conduit 58 opening that leads to the canister. System 30 requires that the manifold be correctly aligned before the suction can be drawn through it. This will allow the valve disk to move in the correct manner. After the manifold 46 is removed, valve disk 130 is returned to its original closed state. The flow path into the canister remains closed as a benefit of the invention. The opening can only be opened if a manifold is attached. This is done by rotating the manifold 46 in order to remove it from its receiver. The valve disk 132 then closes the opening. This arrangement prevents the release of gases that could be irritating to the nose via the manifold receiver 44.

“The valve disk 132 is not only closed to prevent the release of noxious gasses. Mobile unit 30 includes plural canisters 36, 38. The suction pump 58 can be actuated to draw suction on both canisters. When a manifold is absent, the valve disk 132 automatically closes. This prevents any suction loss through empty manifold receiver 44.

“The manifold receiver 44 of this invention and manifold 46 are further designed so that the manifold sits over the valve boss136. The opposed lip 187 188 of the valve head press against the boss’ outer surface. This displacement occurs due to the rotational?twisting’. The manifold is in its final position. The inserter’s arm and hand are not affected by the physical effort required to rotate the manifold in order to insert or remove it. The valve boss is also pressed against by the valve base 176. These seal-forming parts are surrounded by no airflow. These components don’t vibrate, which results in noise generation.

“Further in preferred embodiments of the invention, the cross-sectional area of valve disk bore 138 is less than the cumulative cross-sectional areas of manifold caps ports 237. The waste stream flows through manifold 46. This ensures that the gaseous components do not experience noise-generating compression. Furthermore, because the fluid flow is not compressed, there is no drop in flow rate when the fluid flows into bore 138.

“Mobile unit 30 of the invention and manifold 46 are further combined to significantly reduce leakage of collected refuse. Drip stop174 prevents waste from leaking into the manifold. When the manifold 46 has been removed, the receiver 44 is removed. Drip stop lips 187 then press against the distal end the valve boss within the manifold. After removing the manifold, valve lips are 187 wiped clean of any remaining waste.

The manifold receiver 44’s geometry and orientation reduce waste leakage from the mobile unit 30 as well as the manifold 46. The receiver adapter 64 was designed so that plate number 96 is offset from the vertical. Therefore, the receiver housing 62 is angled towards the horizontal. The manifold 46, which is also seated in receiver housing 62 is offset similarly from the horizontal. The shell base 168 is located below the manifold cap 164. When the manifold 46 has been set in its run position, the shell opening 170 is at the lowest elevation. This allows for the flow of most waste material from the manifold through the valve disc bore 138 and adapter conduit 56 into the canisters 36 or 38.

The side of the base-defining opening will be rotated upwardly when the manifold 46 has been removed from receiver 44. The manifold’s remaining waste material flows to the opposite side of the empty space within the manifold 46. This means that waste in the manifold remains away from the opening 170 after the receiver 44 has been removed. This reduces the likelihood of waste leaking from the opening.

“Also when valve disk 132 is removed from the manifold 46, the valve disk 132 will be rotated back into the closed position. Notch 139 can also be found in the bottom rotational location. Because of the inclined orientation the manifold receiver housing (62), liquid left in the housing will flow to the valve disk 132. This liquid flows out of the receiver 44 via notch 139 when it reaches the valve disc. The liquid is contained within the pocket 151 at the top of the canister caps 40 and 42. This invention’s manifold receiver 44, and manifold 46 are also designed to reduce the amount of waste that can be accumulated on the mobile unit 30,

Click here to view the patent on Google Patents.

What is a software medical device?

The FDA can refer to software functions that include ” Software As a Medical Device” and “Software in a Medical Device(SiMD)”, which are software functions that are integral to (embedded in a) a medical device.

Section 201(h),?21 U.S.C. 321(h),(1) defines a medical device to be?an apparatus, implements, machine, contrivances, implant, in vitro regulator, or other similar or related articles, as well as a component or accessory. . . (b) is intended for diagnosis or treatment of disease or other conditions in humans or animals. (c) Is intended to alter the structure or function of human bodies or animals. To be considered a medical device, and thus subject to FDA regulation, the software must meet at least one of these criteria:

• It must be used in diagnosing and treating patients.
• It must not be designed to alter the structure or function of the body.

If your software is designed to be used by healthcare professionals to diagnose, treat, or manage patient information in hospitals, the FDA will likely consider such software to be medical devices that are subject to regulatory review.

Is Your Software a Medical Device?

FDA’s current oversight, which puts more emphasis on the functionality of the software than the platform, will ensure that FDA does not regulate medical devices with functionality that could be dangerous to patient safety. Examples of Device Software and Mobile Medical Apps FDA is focused on

• Software functions that aid patients with diagnosed mental disorders (e.g., depression, anxiety, and post-traumatic stress disorder (PTSD), etc.) by providing “Skill of the Day”, a behavioral technique, or audio messages, that the user can access when they are experiencing anxiety.
• Software functions that offer periodic reminders, motivational guidance, and educational information to patients who are recovering from addiction or smokers trying to quit;
• Software functions that use GPS location data to alert asthmatics when they are near high-risk locations (substance abusers), or to alert them of potential environmental conditions that could cause symptoms.
• Software that uses video and games to encourage patients to exercise at home.
• Software functions that prompt users to choose which herb or drug they wish to take simultaneously. They also provide information about interactions and give a summary of the type of interaction reported.
• Software functions that take into account patient characteristics, such as gender, age, and risk factors, to offer patient-specific counseling, screening, and prevention recommendations from established and well-respected authorities.
• Software functions that use a list of common symptoms and signs to give advice about when to see a doctor and what to do next.
• Software functions that help users to navigate through a questionnaire about symptoms and to make a recommendation on the best type of healthcare facility for them.
• These mobile apps allow users to make pre-specified nurse calls or emergency calls using broadband or cell phone technology.
• Apps that allow patients or caregivers to send emergency notifications to first responders via mobile phones
• Software that tracks medications and provides user-configured reminders to improve medication adherence.
• Software functions that give patients access to their health information. This includes historical trending and comparisons of vital signs (e.g. body temperature, heart rate or blood pressure).
• Software functions that display trends in personal healthcare incidents (e.g. hospitalization rates or alert notification rate)
• Software functions allow users to electronically or manually enter blood pressure data, and to share it via e-mail, track it and trend it, and upload it to an electronic or personal health record.
• Apps that offer mobile apps for tracking and reminders about oral health or tools to track users suffering from gum disease.
• Apps that offer mobile guidance and tools for prediabetes patients;
• Apps that allow users to display images and other messages on their mobile devices, which can be used by substance abusers who want to quit addictive behaviors.
• Software functions that provide drug interaction and safety information (side effects and drug interactions, active ingredient, active ingredient) in a report based upon demographic data (age and gender), current diagnosis (current medications), and clinical information (current treatment).
• Software functions that allow the surgeon to determine the best intraocular lens powers for the patient and the axis of implantation. This information is based on the surgeon’s inputs (e.g., expected surgically induced astigmatism and patient’s axial length, preoperative corneal astigmatism etc.).
• Software, usually mobile apps, converts a mobile platform into a regulated medical device.
• Software that connects with a mobile platform via a sensor or lead to measure and display electrical signals from the heart (electrocardiograph; ECG).
• Software that attaches a sensor or other tools to the mobile platform to view, record and analyze eye movements to diagnose balance disorders
• Software that collects information about potential donors and transmits it to a blood collection facility. This software determines if a donor is eligible to collect blood or other components.
• Software that connects to an existing device type in order to control its operation, function, or energy source.
• Software that alters or disables the functions of an infusion pump
• Software that controls the inflation or deflation of a blood pressure cuff
• Software that calibrates hearing aids and assesses sound intensity characteristics and electroacoustic frequency of hearing aids.

What does it mean if your software/SaaS is classified as a medical device?

SaaS founders need to be aware of the compliance risks that medical devices pose. Data breaches are one of the biggest risks. Medical devices often contain sensitive patient data, which is why they are subject to strict regulations. This data could lead to devastating consequences if it were to become unprotected. SaaS companies who develop medical devices need to take extra precautions to ensure their products are safe.

So who needs to apply for FDA clearance? The FDA defines a ?mobile medical app manufacturer? is any person or entity who initiates specifications, designs, labels, or creates a software system or application for a regulated medical device in whole or from multiple software components. This term does not include persons who exclusively distribute mobile medical apps without engaging in manufacturing functions; examples of such distributors may include the app stores.

Software As Medical Device Patenting Considerations

The good news is that investors like medical device companies which have double exclusivity obtained through FDA and US Patent and Trademark Office (USPTO) approvals. As such, the exit point for many medical device companies is an acquisition by cash rich medical public companies. This approach enables medical devices to skip the large and risky go-to-market (GTM) spend and work required to put products in the hands of consumers.

Now that we have discussed the FDA review process, we will discuss IP issues for software medical device companies. Typically, IP includes Patents, Trademarks, Copyrights, and Trade secrets. All of these topics matter and should be considered carefully. However, we will concentrate on patents to demonstrate how careless drafting and lack of planning can lead to problems, namely unplanned disclosures of your design that can then be used as prior art against your patent application.

In general, you should file patent application(s) as soon as practicable to get the earliest priority dates. This will help you when you talk to investors, FDA consultants, prototyping firms, and government agencies, among others. Compliance or other documents filed with any government agency may be considered disclosure to third parties and could make the document public. In general, disclosures to third parties or public availability of an invention trigger a one year statutory bar during which you must file your patent application. Failure to file your application within the required time frame could result in you losing your right to protect your invention.

The information from your FDA application may find its way into FDA databases, including DeNovo, PMA and 510k databases and FDA summaries of orders, decisions, and other documents on products and devices currently being evaluated by the FDA. Your detailed information may be gleaned from Freedom of Information Act requests on your application. This risk mandates that you patent your invention quickly.

When you patent your medical device invention, have a global picture of FDA regulatory framework when you draft your patent application. Be mindful of whether your software/SaaS application discusses the diagnosing and treating patients or affecting the structure or function of the body and add language to indicate that such description in the patent application relates to only one embodiment and not to other embodiments. That way you have flexibility in subsequent discussions with the FDA if you want to avoid classification of your software/SaaS/software as a medical device. In this way, if you wish to avoid FDA registration and oversight, you have the flexibility to do so.

An experienced attorney can assist you in navigating the regulatory landscape and ensure that you comply with all applicable laws. This area of law is complex and constantly changing. It is important that you seek legal advice if you have any questions about whether or not your software should be registered with FDA.

Patent PC is an intellectual property and business law firm that was built to speed startups. We have internally developed AI tools to assist our patent workflow and to guide us in navigating through government agencies. Our business and patent lawyers are experienced in software, SaaS, and medical device technology. For a flat fee, we offer legal services to startups, businesses, and intellectual property. Our lawyers do not have to track time as there is no hourly billing and no charges for calls or emails. We just focus on getting you the best legal work for your needs.

Our expertise ranges from advising established businesses on regulatory and intellectual property issues to helping startups in their early years. Our lawyers are familiar with helping entrepreneurs and fast-moving companies in need of legal advice regarding company formation, liability, equity issuing, venture financing, IP asset security, infringement resolution, litigation, and equity issuance. For a confidential consultation, contact us at 800-234-3032 or make an appointment here.