WO2007103842A2 - Surgical waste collection system including a collection unit that has a removable manifold, the manifold having a memory with data that controls the operation of the collection unit - Google Patents

Abstract

A surgical waste collection system (30) including a collection unit (31) to which a manifold (42) is removably attached. The manifold is the components through which waste is drawn into the unit. The manifold includes a memory (280); the collection unit has a reader (298) capable of reading the data in the memory. The collection unit is operated based on the data read from the manifold memory.

Description

SURGICAL WASTE COLLECTION SYSTEM INCLUDING A COLLECTION

UNIT THAT HAS A REMOVABLE MANIFOLD,

THE MANIFOLD HAVING A MEMORY WITH DATA

THAT CONTROLS THE OPERATION OF THE COLLECTION UNIT

FIELD OF THE INVENTION

[0001] This invention is related generally to a system for collecting the liquid and semi-solid material generated during a medical or surgical procedure. More particularly, this invention is related to a waste collection system with a collection unit that has a removable manifold, the manifold having a memory in which are stored for regulating operation of the system. This invention is also related to a waste collection system that pre-filters the air that serves as the transport media that collects the waste.

BACKGROUND OF THE INVENTION

[0002] A waste collection system is sometimes used in a medical or surgical procedure to collect the liquid and semi-solid material generated as a byproduct of the procedure. A typical waste collection system includes at least a suction tube. The suction tube has a conduit through which the waste liquid or semi-solids generated at the surgical site are removed. The proximal end of the suction tube is connected to a collection unit. More specifically the suction tube is attached to a container, the collection unit member in which the waste material is collected. A suction source, also part of the collection unit, is connected to the container. More particularly, the plumbing is arranged so that the suction source draws a suction through the container and, then, from the suction tube conduit. This suction force draws the waste material from the site at which the procedure is being performed into the container. The material is discharged into the container and remains there until the container is cleaned. This system thus evacuates waste away from the surgical site so the waste does not interfere with the performance of the procedure or become a potential hazard to either the patient or the medical personnel.

[0003] Another feature of many medical/surgical waste collection systems is that the suction draws gases away from the surgical site. The smells associated with these gases can be displeasing to the nose. By drawing these gases away from the surgical site and surrounding space, the degradation of the operating room environment is minimized. [0004] One surgical waste collection system is sold by the Applicants' Assignee under the trademark NEPTUNE. United States patents US 6,180,000 Bl, SURGICAL WASTE LIQUID AND SMOKE DISPOSAL SYSTEM, and US 6,331,246 Bl, WASTE FILTER AND MANIFOLD SYSTEM, both of which are incorporated herein by reference, disclose features of this system. An enhanced version of this type of waste collection system is disclosed in the Applicants' Assignee's U.S. Pat. App . No. 11/601,071, U.S. Pat. Pub. No. 11/554,616 and its U.S. Pat.

App. No. 11/601,071, U.S. Pat. Pub. No. , both of these documents also incorporated herein by reference. The waste collection systems of these documents each includes a removable manifold. The manifold serves as the interface between the suction tube and the collection container. The use of this manifold eliminates the tedious and time consuming effort required to, after each use of the system, clean small-sized inlet ports to appropriate sanitary and hygiene standards suitable for an operating room. [0005] Some waste collection systems, including some versions of the NEPTUNE system, include their own vacuum pumps. This system eliminates the need to require another component in the operating room, a relatively long suction tube to a static, wall-mounted suction source. These systems sometimes include a HEPA type filter. The HEPA filter traps viral and bacterial sized particulates in the gas stream to prevent their recirculation in the operating room.

[0006] However, this type of system introduces its own design consideration; the system exhausts the air drawn into the system back into the operating room. The recirculation of this air can result in the like recirculation of the unpleasant gases entrained in the air stream. To avoid the discharge of these gases, this type of waste collection system typically includes a filter element in the vacuum line between the container and the suction pump. The filter element is formed from material that adsorbs the components of the gas stream responsible for the disagreeable odors. [0007] A problem with the known waste collection systems is that not all the liquid-state material drawn into the system falls out into the container. This is because some of this material is in form of small, aerosol-sized, droplets. When aerosolized liquid enters the container, gravity does not provide sufficient force to overcome the suction force that draws the aerosol through the vacuum line towards the suction pump. Consequently, the aerosolized material is trapped in the vacuum line filter element, the filter designed to absorb the odor-causing molecules. Liquid collected in this filter, in a relatively short amount of time, can reduce the effectiveness of the filter. There is also possibility this liquid material can be drawn through this first filter onto the second filter, the HEPA filter. When this material collects on the HEPA filter, the pressure drop across this filter increases. The continual increase of this pressure drop, over time, results in a decrease in the overall efficiency of the waste collection system.

[0008] Further, known medical/surgical waste collection systems are designed so that the user is always responsible for establishing the suction level. The suction draw through individual manifolds is a function of both the collection unit suction level and manifold size and geometry. Thus, presently, it is the responsibility of the person operating the system to establish the correct suction level for the manifold through which the waste material is being drawn. If this level is not set accurately, there is a possibility that, at least when the system is initially actuated, the suction flow will be too low or too high for the procedure being performed. [0009]

SUMMARY OF THE INVENTION

[00010] This invention is directed to a new and useful waste collection system especially designed for use during a medical or surgical procedure. The waste collection system of this invention has a filter system designed to remove liquids, semi-liquid material and noxious gases from a surgical site and aerosolized material entrained in the suction flow.

[00011] The waste collection system of this invention includes a canister for collecting the liquids and semi- liquid material. A suction pump connected to the canister draws a suction from the handpiece through the canister. A filter in line with the vacuum line from the canister traps the noxious gases.

[00012] The waste collection system of this invention further includes a manifold that serves as the component for connecting suction lines through which waste is collected from the surgical site. Integral with the manifold is a pre-filter. Internal to the canister is tubing. A first tube extends from the void space internal to the canister to the manifold pre-filter. A second tube extends from the outlet of the manifold pre-filter to the port to which the vacuum line to the suction pump is connected.

[00013] When the waste collection system of this invention is in use, the gas stream from the handpiece initially flows through the manifold into the canister. Droplet sized liquid waste and semisolid waste falls out of the gas stream into the canister. The gas stream then flows into the pre- filter integral with the manifold. Aerosolized liquid in the gas stream is trapped by pre-filter. The substantially liquid free gas stream then flows through the vacuum line filter before being drawn through the HEPA filter and into the suction pump.

[00014] The system of this invention is thus constructed so that, prior to the gas stream flowing into the vacuum line filter, the HEPA filter and the suction pump, aerosolized liquids are removed from the gas stream. Since this gas stream is substantially liquid free, liquid does not become entrapped in and consequently reduce the efficiency of the vacuum line filter element. Similarly, since there is substantially no liquid in this gas stream, the likelihood that liquid can collect on the HEPA filter so as to reduce the overall efficiency of the waste collection system. [00015] Another feature of the system of this invention is that the pre-filter is built into the manifold. Standard protocol is for the manifold to be replaced each time the system is used in a new procedure. Thus, the system is designed to prevent the possibility that, due to repetitive use, a pre-filter can become so clogged with liquid that it blocks the downstream flow of the gas stream or allows the passage downstream of liquid to the vacuum line filter element and to the HEPA filter.

[00016] Still another feature of the waste collection system of this invention is that the manifold includes a memory device in which data describing the manifold are stored. The collection unit has a device capable of retrieving and reading the data in the manifold memory. Internal to the collection unit is a processor that regulates the actuation of the vacuum pump. This processor receives the data that are read from the manifold memory. Based on these data, the processor determines whether or not the manifold is suitable for operation with the collection unit. If this evaluation is positive, the processor initially regulates the vacuum pump so that the drawn vacuum is appropriate for the manifold.

BRIEF DESCRIPTION OF THE DRAWINGS

[00017] The invention is pointed out with particularity in the claims. The above and further features and benefits of this invention are better understood by the following Detailed Description taken in conjunction with the accompanying drawings in which:

[00018] Figure 1 is a perspective view of a waste collection system constructed in accordance with this invention; [00019] Figure 2 is a plan view of the components internal to the cap of the system canister;

[00020] Figure 3 is a cross sectional view of the manifold receiver, and the manifold seated in the receiver, taken along line 3-3 of Figure 2 ;

[00021] Figure 4 is a cross sectional view of the manifold receiver, and the manifold seated in the receiver, taken along line 4-4 of Figure 2 ;

[00022] Figure 5 is a cross sectional view of the overflow check valve taken along line 5-5 of Figure 2 ; [00023] Figure 6 is a cross sectional view of the base of the overflow check valve taken along line 6-6 of Figure 2 ; [00024] Figure 7 is an exploded view of the integrated manifold and pre-filter of this invention; [00025] Figure 8 is a cross sectional view of an alternative manifold of this invention;

[00026] Figure 9 is a cross sectional view of a second alternative manifold of this invention;

[00027] Figure 10 is cross sectional view of a third alternative manifold of this invention;

[00028] Figure 11 is a cross sectional view of a fourth alternative manifold of this invention;

[00029] Figure 12 is a cross sectional view of an fifth alternative manifold of this invention;

[00030] Figure 13 is a cross sectional view of sixth alternative manifold of this invention with a complementary adapter;

[00031] Figure 14 is a diagrammatic and block diagram of how a manifold of this invention is provided with an identification tag and how the collection unit, the rover, is provided with a circuit to read the data contained in the tag. [00032] Figure 15 is a block representation of the memory integral with a manifold of this invention and the types of data stored in the memory; and

[00033] Figures 16A-16C collectively form a flow chart of the process steps performed by the collection unit of this invention when a manifold with a data tag is attached.

DETAILED DESCRIPTION

[00034] Figure 1 depicts the basic components of a waste collection system 30 designed for medical/surgical use of this invention. System 30 includes a mobile collection unit 31 that has a base 32. Casters 34 attached to the bottom of the base 32 provide collection unit 31 with its mobility. Extending above the base 32 is a cylindrical canister 36. Canister 36 functions as the container for holding the liquids and semi-solids collected by the system 30. A cap 38 is disposed over the top end of the canister 36. Waste material and noxious gases removed from the surgical site are drawn into the system 30 through a handpiece a suction tube 40. Sometimes the distal end of the suction tube, the end closest to the surgical site, is attached to a handpiece with a cannula (handpiece not illustrated) . The open end of the cannula functions as the port through which waste material and noxious gases are drawn into system 30.

[00035] The proximal end of suction tube 40 is connected to a manifold 42. The manifold 42, which is removably mounted to canister cap 38, defines the fluid flow path from the suction tube 40 to the inside of the canister 36.

[00036] A vacuum pump 57, shown in phantom as a cylinder, is disposed in the base 32. Pump 57 produces the suction that draws the waste material through the suction tube 40 and manifold 42 into the canister 36. A vacuum line 50 extends from canister cap 38 to the vacuum pump 57. Vacuum line 50 serves as the conduit through which vacuum pump 57 draws a suction on the inside of the canister and the upstream components. Filter material 52, shown as phantom cross hatching, is disposed in vacuum line 50. The filter material 52 adsorbs molecular-level components of the gas stream. These are the components that, if returned to the environment, generate disagreeable odors.

[00037] Also part of the system is a HEPA filter 56, shown in phantom in the base 32. The HEPA filter 56 is in series between vacuum line 50 and the inlet to pump 57. HEPA filter 56 traps viral and bacterial-sized particulate matter from the gas stream to prevent their circulation in the space in which system 30 is employed.

[00038] As described below with respect to Figure 3, integral with manifold 42 of system 30 of this invention is a pre-filter 48. Pre-filter 48 filters the gas drawn from canister 36 prior to the gas stream flowing into vacuum line 50. More specifically, pre-filter 48 inhibits downstream flow of aerosolized liquid material in the gas stream. The presence of pre-filter 48 ensures that the gas stream that flows through filters 52 and 56 and into vacuum pump 57 is substantially liquid free.

[00039] System 30 also has a tower 58 that rises upwardly from base 32. Tower 58 contains a smoke evacuator, not illustrated and not part of this invention. (In some surgical procedures, the smoke evacuator is employed to, through a separate inlet line, evacuate smoke from the surgical site.) A control panel 62 with control members 64 is mounted to the top of the tower 58. Control members 64, in combination with control members 68 mounted to tower 58, regulate operation of the waste collection system of this invention as well as the operation of smoke evacuator. [00040] A more detailed understanding of fluid (gas and liquid) flow through canister 36 is obtained by reference to Figures 2-4. A manifold receiver 70 is mounted to the canister cap 38. Manifold receiver 70 is formed with a number of bore with coaxial sections 88, 94 and 99 for receiving the manifold 42 including the pre-filter 48. The bottommost bore of the manifold receiver 70, bore section 99, the bore section through which a stem section 72 of the manifold 42 extends, opens into the void space internal to the canister 36. A flapper valve 74 moveably mounted to the receiver 70 normally closes the open bottom end of the receiver. The seating of the manifold 42 in the receiver 70 results in the opening of valve 74. [00041] Also mounted to the canister cap 38 are an inlet tube 76 and an outlet tube 78, both shown only in Figure 2. Inlet tube 76 has a first end that extends from an overflow check valve 73, fully shown in Figure 5, that extends downwardly from the cap 38. The opposed end of inlet tube 76 is connected to a tubular boss integral with the manifold receiver 70 that opens into inlet openings of the manifold pre-filter 48. Outlet tube 78 extends from a second tubular boss integral with the manifold receiver 70 into which the gas stream is discharged from the pre- filter 48. The opposed end of outlet tube 78 is connected to an open ended tubular sleeve 80 that extends upwardly from the canister cap 38. Sleeve 80 is the fluid coupling member of canister 36 from which vacuum line 50 extends. [00042] The illustrated version of the manifold receiver 70 has three generally circular coaxial sections. The top most section is a head 86. Receiver head 86 is shaped to define a first bore section 88. An 0-ring 90, seen only in Figure 3, is mounted to the inner wall of the receiver head 86 that defines bore section 88. More particularly, 0-ring 90 is seated in a groove 91, identified in Figure 11, that extends circumferentially around the inner wall of the head 86. Head 86 is the section of the manifold receiver 70 that extends through canister cap 38. Adhesives, mechanical fasteners, a welded joint or other suitable means secure the head 86 to the cap 38. It should be appreciated that whatever means is used to secure manifold receiver 70 to the cap 38, there should be a seal between the components to substantially reduce, if not eliminate the loss of suction flow through the canister-cap interface .

[00043] Immediately below head 86, manifold receiver 70 has a base 92. Base 92 has a diameter less than that of the head 86. The base 92 is further formed to define bore section 94. Bore section 94 is coaxial and contiguous with bore section 88 that has a diameter less than that of bore section 88. The manifold receiver 70 is further formed to have a cylindrical, tubular inlet boss 96 that extends perpendicularly away from head 90 and base 92. Receiver bore section 88 is in fluid communication with the center conduit through boss 96 through an opening in the annular step internal the receiver head that defines the base of the bore section 88. Receiver 70 is shaped so that the inlet boss 96 projects beyond the outer perimeter of receiver head 86. Inlet tube 76 is connected to the free end of the inlet boss 96 by a clamp (not illustrated) or other appropriate fastening unit.

[00044] A stem 98, below base 92, forms the bottommost section of the manifold receiver 70. Stem 98 defines bore section 99, the bottommost bore section of the receiver 70, the bore section that opens into the canister void space. An 0-ring 101, seen in Figures 3 and 11, fitted to stem 98 extends into bore section 99. The 0-ring 101 is seated in a groove 102 formed in the inner wall of the stem 98 that defines the bore section 99.

[00045] The flapper valve 74 is pivotally connected to the manifold receiver stem 98. The flapper valve 74 has a disk shaped head 106 from which a hinge plate 108 extends perpendicularly. Flapper valve 74 is positioned so that head 106 extends over the open end of receiver bore section 99 and hinge plate 108 is adjacent receiver stem 98. A hinge pin 110 pivotally connects valve hinge plate 108 to parallel spaced apart fingers that project outwardly from the receiver stem 98 (fingers not illustrated. A coil spring disposed over hinge pin 110 (spring not illustrated) provides a biasing force that normally positions the valve so that the valve head 106 is positioned over the open end of the receiver stem 98.

[00046] An elongated, post-like nose 111 extends upwardly from the valve head 106. When flapper valve 74 is closed, nose 111 extends into receiver bore section 99. [00047] Flapper valve 74 is further formed to have a foot 112 that extends downwardly from the outer surface of the valve head 106. An elongated, rod like toe 113 is slidably mounted to the end of the foot 112 so as to extend perpendicularly away from the foot 112. A seal 114 is fixedly attached to one end of the toe 113, (attachment mechanism not illustrated) . A coil spring 115, seen in cross section only in Figure 4, extends over toe 113. Spring 115 extends between the static foot 112 and seal 114 to bias the toe and seal assembly away from the foot. A fastener clip, (not illustrated) extends around the end of the toe opposite the end to which seal 115 is mounted. The fastener clip holds toe 113 to foot 112 to prevent the spring 115 from forcing the toe off the foot. The purposes for toe 113, seal 114 and spring 115 are apparent below. [00048] Manifold receiver 70 is further formed to have a tubular outlet boss 116. Outlet boss 116 extends perpendicularly away from the receiver stem 98. The through bore that extends through the outlet boss extends from an opening that is primarily in communication with bore section 99 but that is partially in communication with bore section 88 (boss bore and opening not identified) . A ball valve assembly 118 is in line with outlet boss 116. Ball valve assembly 118 includes a cylindrical, hollow valve housing 120. A ball 122 is disposed in the valve housing 120. Ball 122 has an outer diameter greater than that of the bore that extends axially through the outlet boss 116 and less than that of the inner wall of housing 120 that defines the void space in which the ball is seated. [00049] Ball housing 120, it is appreciated, is sized so that void space in which ball 122 is seated extends above the opening that extends outwardly through the outlet boss 116. The ball housing 120 is further shaped so at the bottom end of the housing there is a through hole 124. Manifold receiver 70 is constructed so that, when the flapper valve 74 is moved to the open state, the toe 113 integral with the valve projects into ball housing hole 124. Hole 124 has a diameter less than that of seal 114. [00050] One end of outlet tube 78 is fitted over the end of the outlet boss 116 that projects away from valve assembly 118. Not shown is the clamp or other fastener used to hold outlet tube 78 to boss 116. [00051] Overflow valve 73 is now described by reference to Figures 5 and 6. The valve 73 includes a base 130. Valve base 130 is mounted to sleeve 80. The outer end of sleeve 80, the end that extends above the body of the cap 38, is the fitting to which vacuum line 50 is mounted. Not shown in the drawings is the clamp or other fastener used to hold vacuum line 50 to sleeve 80. [00052] Valve base 130 has a first opening ended section 136. Base open ended section 136 seats over and is sealingly secured to the end of sleeve 80 that projects into the interior of cap 38. The valve base section 136 defines a first void space 138 contiguous with the bore that extends through sleeve 80 (sleeve bore not identified) . A tubular boss 142 extends perpendicularly outwardly from valve base section 136. Boss 142 is the fitting internal to the canister to which the second end of the outlet tube 78 is connected. Not shown is the clamp other fastener that holds tube 78 to boss 142. Boss 142, has a through bore (not identified) that opens into the base first void space 138. [00053] The valve base 130 has a second open ended section 144 that is located below section 136. ("Below" is understood to mean towards casters 34.) Base 130 is formed so that section 144 is formed to define a second void space 146. A web 148 internal to the valve base 130 isolates the void spaces 138 and 146 from each other. Valve base 130 is further formed to have a second tubular boss, boss 150. Boss 150 extends away from base section 144 and has a through bore that extends from void space 146. Boss 150 is the valve fitting to which inlet tube 76 is connected. Not shown is the clamp, snap ring or other fastener used to secure inlet tube 76 to boss 150. [00054] A tube 152 extends downwardly from the open end of valve base section 144. Thus, the center bore through tube 152 is in direct fluid communication with the valve base second void space 146. A cage 153 is suspended below the open end of tube 152. A float ball 154 is disposed in cage 153. As is known in the art, float ball 154 has a diameter greater than that of the adjacent open end of tube 152.

[00055] The structure of the manifold 42 is now described by reference to Figures 3, 4, and 7. The manifold 42 is formed from plastic and shaped to have a wide diameter base 158. (The geometries of the base of the manifold of Figure 1 and of the manifold of Figures 3, 4 and 7 are different.) Manifold base 158 is formed in part by a circular bottom panel 159. A circular outer wall 160 extends upwardly from the outer perimeter of panel 159. Collectively, panel 159 and outer wall 160 define a center void space 162 that is open to the top. A lid 164, seen only in Figures 1 and 4, is snap fitted to the open end of outer wall 160 to enclose void space 162. One or more tubular inlet fingers 166, seen only as openings in Figure 4, extend outwardly from the lid 164. Each inlet finger 166 functions as a fitting to which a separate suction tube 40 (Figure 1) is connected. The inlet fingers 166 open into the manifold void space 162. [00056] Internal to manifold void space 162 are one or more filters, seen only in Figure 4. These filters trap relatively large solid and semi-solid material that is entrained in the gas stream drawn through suction tube 40. In one version of the invention one filter consists of a ring of open cell foam 170. Foam ring 170 traps bone chips, fats, coagulated blood other solid and semi-solid tissue and other debris, including surgical materials, immediately upon entry into the manifold 42. A second filter in the illustrated version of the invention consists of a porous web 172 formed integrally with the material forming the manifold 42. Web 172 is formed to extend across the base, bottom portion of the constant diameter section of void space 162. The pores in web 172 prevent material larger than approximately 0.045 inches in size from flowing downstream out of the manifold 42 into the canister 36. In some versions of the invention a reinforcing grid is formed integrally with the web.

[00057] While not illustrated, it should be appreciated the manifold base may be formed so that the structural member that defines void space 162 has one or more elongated grooves. These grooves establish flow paths around the perimeter of web 172, beyond the outer perimeter of foam ring 170. The grooves provide a means for liquid waste to flow along the inner wall of the manifold base, through void space 162, into stem 72.

[00058] Manifold stem 72 extends downwardly from the base 158. Stem 72 has a through bore 168 that is contiguous with the section of void space 162 internal to base 158 that is below web 172. Stem 72 is the portion of the manifold 42 that seats in bore sections 88, 94 and 99 of manifold receiver 70. While not illustrated, it should be understood that manifold 42 is further shaped so that when the manifold is inserted in receiver 70, stem 72 extends a sufficient distance below the receiver stem 98 to pivot flapper valve 74 open. Arcuately spaced apart reinforcing tabs 180 extend between the base bottom panel 159 and the adjacent upper end of the stem 72. [00059] Pre-filter 48 includes a shell 184 and a sleeve 186 both of which extend circumferentially around the manifold stem 72. Shell 184 has a cylindrical shape and is of relatively wide diameter. More particularly, the shell 184 is dimensioned to closely slip fit in manifold receiver bore section 88. The shell 184 has a length so that when the manifold 42 is seated in receiver 70, the shell occupies between approximately 50 to 80% of the upper outer section of bore section 88. The upper end of the shell 184 is secured to the exposed surface of manifold base panel 159. In the illustrated version of the invention, an outwardly directed reinforcing lip 188 extends around the outer perimeter of the shell 184. Lip 188 is the structural component of the pre-filter that physically abuts manifold base panel 159.

[00060] A planar ring 190 extends inwardly from lower open end of shell 184. Ring 190 is formed with a circular center opening (not identified) in which sleeve 186 is seated. Ring 190 is further formed with a number of arcuately spaced apart openings 192. Openings 192 thus open into the outer perimeter of the void space internal to pre-filter shell 184.

[00061] Pre-filter sleeve 186 is shaped to have an outer diameter less than that of the inner diameter of the surrounding pre-filter shell 184. Sleeve 186 has an inner diameter that is greater than the outer diameter of section of the manifold stem 72. Sleeve 186 surrounds approximately the upper two-thirds of manifold stem 72.

[00062] More particularly, sleeve 186 extends around the inner circumferential edge of ring 190 that defines the center opening. Sleeve 186 is positioned so that a portion of the sleeve extends above ring 190 and a portion of the sleeve extends below the ring. In one version of the invention, approximately 50 to 60% of the overall length of the sleeve extends below ring 190. Pre-filter 48 is further constructed so that top open end of sleeve 186 is spaced below reinforcing tabs 180. Teeth 196 extend radially inward from the bottom open end of sleeve 186 to manifold stem 72. Teeth 196 are circumferentially spaced apart from each other so as to define openings 198 therebetween. [00063] Pre-filter 48 is further formed to have a number of arcuately spaced apart stand offs 202 that are disposed around sleeve 186. The stand offs 202 extend downwardly from ring 190. Each stand off 202 is located below and inward of a separate one of the ring openings 192. Stand offs 202 are provided so that, when manifold 42 is seated in receiver 70, the standoffs suspend the pre-filter ring 190 above the base of bore section 94.

[00064] A filter element 204, seen only in Figure 3, is disposed in the pre-filter shell 184. Filter element 204 is formed from open cell foam or other material capable of trapping aerosolized liquid. The filter element 204 is generally sleeved shaped and disposed in the annular space within the shell between the inner cylindrical surface of the shell and the outer cylindrical surface of sleeve 186. In some versions of the invention, the overall height of the filter element 204 is less than the height of the annular space in which the element is seated. Often manifold 42 is constructed so that filter element 204 is positioned below reinforcing tabs 180.

[00065] Prior to the seating of manifold 42 in complementary receiver 70, the coil spring holds the flapper valve 74 in the closed position over the open end of receiver stem 98. As a consequence of the flapper valve 74 being in this position, valve toe 113 is spaced away from the housing 120 integral with ball valve assembly 118. Ball 122 thus seats in the bottom of the housing. In the event vacuum pump 57 is inadvertently actuated, the suction is drawn first through vacuum line 50 and secondly through canister cap sleeve 80 and base section 136 of the overflow valve 73. The suction is then drawn through outlet tube 78. The suction force through outlet draws ball 122 against the adjacent end of the bore internal to the outlet boss 116. Ball 122 thus acts as a stop valve to prevent the continued suction draw from the canister 36 to the vacuum pump 57. [00066] System 30 of this invention is prepared for use by inserting manifold 42 in the complementary receiver 70 integral with the canister cap 38. As a consequence of the mating of the manifold 42 to the receiver 70, manifold stem 72 abuts flapper valve nose 111. The pressing of the manifold stem 72 against flapper valve nose 111 overcomes the biasing force of the spring that holds the valve closed. Flapper valve head 106 pivots into the open position, away from the receiver stem 98. The pivoting of the flapper valve 74 open causes toe 113 to pivot into hole 124 of ball valve assembly 118. The tip of the toe 113 abuts and displaces ball 122 upwardly, away from the opening into boss 116. Thus, the seating of the manifold 42 in receiver 42 opens the suction path into outlet tube 78. [00067] As a consequence of toe 113 rotating into valve housing 120, seal 114 undergoes a like rotational motion. This motion positions the seal over hole 124 formed in the housing. Spring 115 presses seal 114 against the surface of the housing 120 so that the seal forms a barrier around hole 124. The spring 115 thus compensates for manufacturing tolerances in the positioning of seal 114. The barrier established by seal 114 minimizes, if not eliminates suction draw through hole 124.

[00068] As a result of the seating of the manifold 42 in position, 0-ring 90 establishes a seal between receiver head 86 and pre-filter shell 184. 0-ring 101 establishes a seal between the end of the manifold stem 72 and the surrounding receiver stem 98.

[00069] Once manifold 42 is seated in receiver 70, system 30 and the handpiece is connected to the manifold by a suction tube 40, system 30 is ready for use. The system 30 is activated by actuating vacuum pump 57. The generation of the suction head by the vacuum pump 57 causes the fluid stream to flow from the handpiece through the suction tube 40 into the manifold 42. In the manifold, foam ring 170 and web 172 trap larger solid and semi-solid waste material entrained in the fluid stream withdrawn from the surgical site. The partially filtered fluid stream then flows through the manifold stem 72 from which the stream is discharged into the canister 36. Gravity causes large volumes of liquid material entrained in the fluid stream to collect in the canister 36.

[00070] From canister 36, the suction pressure causes the fluid, now gas, small particulate matter and aerosolized liquid, to be drawn through overflow valve 73 into inlet tube 76. The fluid stream is discharged from inlet tube 76 and receiver inlet boss 96 into receiver bore sections 88 and 94. O-ring 90 prevents suction leakage from between the receiver head 86 and the filter shell 184. Instead, the suction pressure causes the fluid stream to flow through filter openings 192 and into the center of the filter shell 184. In the filter shell 184, the fluid stream flows through filter element 204. [00071] Filter element 204 traps the aerosol sized liquid still in the fluid stream. Downstream of filter element 204, the suction force causes the substantially liquid-free fluid stream to flow into the annular space between the manifold stem 72 and filter sleeve 186. From this annular space, the fluid stream flows out of the pre- filter 48 through the openings 198 at the base of the filter. The fluid stream is discharged into the annular section of receiver bore section 99 that surrounds the manifold stem 72. 0-ring 101 prevents the leakage of the suction from around the interface between the manifold stem 72 and the surrounding receiver stem 98. Consequently, the suction force draws the fluid in bore section 99 through the outlet boss 116, the open ball valve assembly 118 and the outlet tube 78.

[00072] (It should be understood that there may be some suction leakage in the unsealed interstitial separation above the outlet boss 116 between the inner wall of the receiver 70 that defines bore section 94 and the adjacent pre-filter sleeve 186. This suction leakage is not believed to adversely affect operation of system 30. In some versions of the invention a seal, (not illustrated) is fitted to either the receiver 70 or the pre-filter 48 to prevent suction leakage at this interface.) [00073] From outlet tube 78, the fluid stream flows through the void space internal to the valve base section 136 and sleeve 80 into vacuum line 50. The filter material 52 in vacuum line 50 adsorbs the odor causing components of the fluid stream. From the vacuum line 50, the fluid stream is discharged onto HEPA filter 56. The HEPA filter 56 traps the viral and bacterial sized particulate matter. This essentially liquid-free fluid stream is finally drawn into vacuum pump 57. From pump 57, the filtered fluid stream is discharged into the ambient environment .

[00074] System 30 of this invention removes liquid, semisolid and odor causing material from a surgical site during the performance of a surgical procedure. Most of the liquid material is contained in the canister 36. Odor-causing components in the evacuated gas stream are absorbed by filter material 52. Viral and bacterial sized particulates are trapped by the HEPA filter 56. System 30 also has a pre-filter 48. Pre-filter 48 traps aerosolized liquid entrained in the gas flow downstream from the canister 36. This reduction, if not elimination, of liquid-state fluid results in a like reduction in the extent liquid is absorbed by and thereby reduces the effectiveness of filter material 52. The minimization of the flow of liquid-state material similarly reduces the extent to which liquid is trapped by HEPA filter 56. This eliminates the reduction in system efficiency caused by such liquid collection. [00075] Pre-filter 48 of this invention is integral with manifold 42. Standard protocol is for a new manifold 42 to be fitted to the collection unit 31 at the start of each procedure. Thus, system 30 of this invention is constructed so that each time the system is readied for use, a new pre- filter 48 with an empty filter element 204 is installed. This feature of system 30 of this invention reduces the likelihood that, due to extended use, filter element 204 becomes so clogged with liquid that it blocks suction flow through the pre-filter 48 or it allows through flow or aerosolized liquid.

[00076] It should further be understood that system 30 of this invention is designed so that the fluid stream only flows through pre-filter 48 after gravity has been given the opportunity to remove large liquid droplets from the stream. This arrangement reduces the likelihood that, during any one procedure, filter element 204 can become so saturated with liquid that it clogs.

[00077] Still another feature of system 30 of this invention is that, as the manifold 42 is removed from the complementary receiver, the base of the manifold stem 72 moves away from the nose 111 integral with the flapper valve 74. This displacement results in the spring integral with the flapper valve returning the valve head 106 to the closed position. Thus, before the manifold 42 is completely removed from the receiver 70, the end of the receiver extending into the canister is closed. Also as a consequence of the return of the flapper valve 74 to the closed state, the valve toe 113 spaces away from ball valve housing 120.

[00078] One advantage of the above arrangement is that this automatic closure of the flapper valve reduces the extent to which noxious gases trapped in the canister can escape through manifold receiver 70 into the environment. [00079] Another benefit of the above construction of system 30 of this invention becomes apparent if, while vacuum pump 57 is running, manifold 42 is inadvertently removed. In this situation, the suction pressure drawn by the vacuum pump draws ball 122 of valve assembly 118 into the adjacent open end of the bore integral with manifold receiver outlet boss 116. The movement of ball 122 around this bore effectively stops the suction draw through receiver bore sections 88, 94 and 99. The termination of this suction draw results in a like termination of the extent to which this draw pulls liquid adhering to the outer surface of the manifold and pre-filter assembly off this unit as the unit is moved away from the receiver. By stopping this suction draw, the extent to which material on the manifold and pre-filter unit forms a spray is likewise substantially eliminated.

[00080] It should be appreciated that the above description is directed to one specific construction of the system of this invention. Other versions of the system may have features different from what has been described. The arrangements of the components may be different from what has been described. There is no requirement in all versions of the invention, filter material 52, HEPA filter 56 and vacuum pump 57 are arranged in the described sequence. In alternative versions of the invention, these components may be arranged in alternative sequences. One or more of these components may not even be present in some versions of the invention .

[00081] Further, the fluid conduits internal to the canister 36 may be different from what has been described. In some versions of the invention, a single member mounted to the canister may contain all the conduits: the discharge port from the manifold; the inlet conduit to the pre-filter; and the outlet conduit from the pre-filter to the vacuum line .

[00082] Also, there may be reasons in alternative versions of the invention to have the manifold and pre-filter be separate units. In these versions of the invention, the pre-filter may comprise a cartridge that is constructed to be removably inserted and removed between canister cap sleeve 80 and vacuum line 50.

[00083] Alternative assemblies for blocking gas flow through the outlet tube 78 may be provided. For example, in one alternative valve assembly, a lever arm is pivoted as a result of the insertion/removal of the manifold to/from the receiver 78. This lever arm controls the open/closed state of the valve member that leads to the outlet tube 78. This assembly is thus configured so that there is no relationship between the flapper valve 74 and the outlet tube valve assembly. This eliminates the need to provide seal 114. [00084] Further, the illustrated overflow valve assembly is understood to be exemplary, not limiting. Some versions of the invention may not even include an overflow valve. For example, some versions of the invention may have a sensor that monitors the extent to which the canister is filled. When the quantity of material in the canister reaches a select level, the control system deactivates vacuum pump 57.

[00085] In some procedures in which the described version of system 30 is employed, it may be decided that there is no need to provide manifold 42 with the associated pre-filter. This may be done for cost reasons if, for a given procedure it is known by experience the fluid stream evacuated from the surgical site does not contain an appreciable amount of aerosolized fluid.

[00086] One such alternative manifold 220 is shown in Figure 8. In Figure 8 and subsequent Figures 9-11, only the bottom portions of the manifolds are shown. In Figure 8, manifold 220 is shown to have a bottom panel 221. Bottom panel 221 is more conical in shape than bottom panel 159 of manifold 42. Extending downwardly from the outer perimeter of bottom panel 221 is a ring 222. Ring 222 is positioned so that when manifold 220 is fitted in complementary receiver 70, O-ring 90 forms a seal between the inner wall of manifold the defines bore section 88 and the ring. This sealing arrangement prevents leakage of the suction pressure from the open top end of the receiver 70.

[00087] Tubular stem 224 extends downwardly from the nadir of bottom panel 221. Manifold 220 is formed so that stem 224 has an upper section 226 with a relatively thick wall and a lower section 228 with a narrower outer wall. More specifically, manifold 220 is constructed so that the stem 224 has an outer diameter less than the diameter of the receiver bore sections 88, 94 and 99 in which the stem is seated. More particularly, manifold 220 is constructed so that when the manifold is in the receiver 70, there is a gap between the outer wall of stem lower section 228 and the adjacent wall of the receiver 70 that defines bore section 99. This arrangement ensures the fluid stream is able to flow from canister 36 into the receiver inlet boss 96, through bore section 99, and therefore around the manifold stem 226, into the outlet boss 116. Curved arrow 227 illustrates this flow path. Straight arrow 229 illustrates the flow through the manifold 220 into the canister 36.

[00088] Manifold 230 of Figure 9 has a second alternative bottom panel 232. Bottom panel 232 is generally planar so as to be disk shaped. A ring shaped seal 234 is seated in a groove 236 in bottom panel 232. Seal 234 is positioned so that when manifold 230 is seated in receiver 70, the seal sits over the open end of the receiver. When vacuum pump 57 is actuated to apply a suction pressure to the system, the pressure urges manifold bottom panel downwardly, against the adjacent rim of the receiver 70. This force causes seal 234 to form a fluid barrier around the receiver-manifold interface . [00089] Manifold 230 has a stem 238 that extends downwardly from the center of the bottom panel 232. Stem 238 is physically and functionally similar to stem 226 of manifold 220.

[00090] Figure 10 illustrates an alternative manifold 240. Manifold 240 has a bottom panel 242 geometrically similar to bottom panel 232 of manifold 230. Bottom panel 242 includes seal 234. A ring 244, geometrically and functionally similar to ring 222 of manifold 220 extends downwardly from bottom panel 242. Thus, in this version of the invention, O-ring 90 and seal 234 define two independent barriers between the suction draw and the ambient environment. [00091] Manifold 240 is provided with stem 246. Stem 246 has an outer diameter appreciably less than receiver bore section 92 and slightly less than receiver bore section 99. Thus, upon the fitting of manifold 240 to receiver 70, O-ring 101 forms a seal between the inner cylindrical wall of the receiver stem 98 and the manifold stem 246. When system 30 is actuated, the resultant fluid stream still flows from inlet boss 96, through receiver bore section 94, around the manifold stem 246, into the outlet boss 116. This flow is represented by winding arrow 245. [00092] In some versions of the invention, a specific seal component may not be employed to create a barrier between the manifold and receiver 70. For example, the manifold 250 of Figure 11 includes a circular neck 253. While neck 253 is circular in cross sectional profile along its length, the neck is further formed to be outwardly tapered. More particularly, manifold 250 is formed so that neck 253 can be compression fitted in the open end of receiver bore section 88. As consequence of its tapered profile, this seating of the manifold neck 253 in the receiver results in a taper seal forming along the interface between the outer surface of the neck and the bore section-defining inner wall of the receiver 70.

[00093] Neck 253 is further dimensioned it is understood to prevent the neck from being completely seated in receiver bore section 88. A manifold stem 246a, similar to previously described stem 246, extends downwardly from manifold neck 253.

[00094] As represented by winding arrow 251, when the system 30 with manifold 250 installed is actuated, the vacuum draw is through receiver inlet boss 96, into bore sections 88 and 94, around manifold stem 246a, and out through the receiver outlet boss 116.

[00095] Figure 12 represents still another alternative manifold 256 of this invention. Manifold 256 includes the previously described bottom panel 242. A first tubular- shaped stem 257 from the center of bottom panel 242. First stem 257 is dimensioned to extend completely through manifold bore section 88 and partially through bore section 94. An O-ring 258 extends around first stem 257. O-ring 258 is provided to and is positioned so that, when manifold 256 is seated in complementary receiver 70, the O- ring forms a barrier between the manifold first stem 257 and the inner wall of the receiver that defines bore section 94. This barrier is located between the inlet opening from inlet boss 96 and the outlet opening to outlet boss 116. [00096] Manifold 256 has a second stem 259 that is contiguous with and extends below the first stem 257. Second stem 259 has inner and outer diameters that are less than the corresponding dimensions of the first stem 257. The manifold is constructed so that second stem 259 extends completely through and slightly beyond the receiver bore section 99 and has an outer diameter less than that of the receiver bore section 99.

[00097] It should be appreciated that, in this version of the invention, the suction pressure drawn through the receiver outlet boss 116 is drawn through the void space in the receiver bore section 99 around the manifold second stem 259 directly from the canister 36. This flow is represented by curved arrow 255.

[00098] Still in some implementations of this invention, an adapter is fitted to the manifold receiver 70 if the pre- filter is not required. Figure 13 illustrates how both a manifold 260 and an adapter 262 are simultaneously seated in receiver 70. Here manifold 260 has a bottom panel 264 with a slightly downwardly tapered shape. Bottom panel 264 has a diameter larger than the diameter of receiver bore section 88. Accordingly, the base of manifold 260 cannot seat in the receiver bore section 88.

[00099] A stem 266 extends downwardly from the bottom panel 264. Stem 266 is similar in geometry and function to stem 246.

[000100] Adapter 262 has a disk shaped head 270. Adapter head 270 is dimensioned to fit in receiver bore section 88 so that O-ring 90 forms a seal between the inner wall of receiver head 86 and the outer wall of the adapter head 270. A hole 272, concentric with the longitudinal axis of the adapter, extends axially through adapter head 270. Hole 272 is dimensioned to accommodate manifold stem 266. [000101] An O-ring 274 is mounted to adapter head 270 so as to be disposed in hole 272. Not identified is the groove in the inner wall of the adapter head 270 in which O-ring 274 is seated. When manifold stem 266 is seated in adapter hole 272, 0-ring 274 forms a fluid barrier between the manifold stem 266 and the adapter head 270. [000102] In the illustrated version of the invention, a sleeve 275 extends downwardly from adapter head 270. Sleeve 275 is concentric with hole 272. Sleeve 275 is dimensioned to have an outer diameter less than the diameter of receiver bore section 92. This dimensioning ensures that the sleeve does not completely block fluid flow from the manifold inlet boss 96, through bore sections 88, 94 and 99 into outlet boss 116. The sleeve 275 is further dimensioned so that when adapter 264 is seated in the receiver 70 the end of the sleeve rests against the annular surface that defines the base of bore section 94. When manifold 260 is seated in receiver 70, the manifold stem 266 extends through the through bore internal to the sleeve 275 (sleeve bore not identified) .

[000103] In this version of the invention curved and phantom arrow 277 represents the air flow through the inlet boss 96, around the adaptor sleeve 275 and out through outlet boss 116.

[000104] In some versions of the invention, the adapter sleeve is omitted.

[000105] It should likewise be understood that there is no requirement that the manifold and complementary receiver of this invention are always constructed so that the portion of the manifold seated in the receiver through bore is centered in this bore. In some versions of the invention, these components may be constructed so that when the manifold is seated in the receiver it is centered around axis off center to the receiver bore. Further, there is no requirement that the sealing device that prevents suction leakage from the canister be always attached to the receiver. In some versions of the invention, this seal may be attached to the removable manifold. Similarly, the compressible member that forms the barrier between the top of the manifold and the adjacent surface of the receiver may likewise be attached to the manifold.

[000106] Likewise, it should be understood the features of the various manifolds of this invention can be combined as appropriate .

[000107] Thus, it should be appreciated the manifold of this invention, with or without the adapter, is constructed so that, when inserted in receiver 70, plural fluid flow paths are formed. A first fluid flow path is the one established by the manifold stem, from the manifold, through the opposed end openings into the receiver and into the canister 36. This fluid path is isolated from the inlet and outlet bosses 96 and 116, respectively. A second flow path is the one from the inlet boss 96, the receiver bore sections 88, 94 and 99, around the manifold stem, and out through the manifold outlet boss 116.

[000108] It should be appreciated that in some versions of the invention the manifold may carry plural separate pre- filters. In these and other versions of the invention, the manifold can be designed so that when inserted into the receiver, the manifold defines three or more separate fluid flow paths through the receiver 70.

[000109] Figure 14 illustrates how, in some versions of the invention, the manifold 42a is provided with an identification tag and the collection unit 31 is able to read the data contained in the tag and regulate system operation based on the data. Specifically in Figure 14, an RFID chip 280 is shown as being embedded in the plastic material that forms manifold base 158a. RFID 280 functions as the identification tag for the manifold. Also embedded in the manifold base 158a is a coil of wire 282. While not illustrated, it is understood that wire coil 282 is connected to RFID 280 and functions as the antenna for the RFID. Wire coil 282 extends circumferentially around manifold base 158a. One potential RFID is the icode-SLI available from Philips Semiconductor of Eindhoven, The Netherlands .

[000110] Internal to RFID 280 is a memory represented by data block 284 of Figure 15. The memory contains data describing the characteristics of the manifold with which RFID 280 is integral. These data include manufacturing identification data, represented by field 286, that identifies the manifold with specificity. The manufacturing identification data includes such data as: model of manifold; serial number; use authorization code; and lot number. In a field 288, data indicating a use by date for the manifold are stored. The data in field 288 are provided if the manifold and its components are constructed out components that may functionally degrade over time. [000111] Field 290 contains vacuum level data. These data are used to establish the vacuum level (iπmHg.) that the vacuum pump 57 should draw through the manifold. [000112] Field 292 is a use history field. The data in field 292 indicates the number of times the manifold has been used. In some versions of the invention, the use history field 292 is a single bit field. The bit is employed as a flag as discussed below.

[000113] Returning to Figure 14, a coil 296 is embedded in the receiver head 86a. Receiver head 86a is shaped and coil 296 is positioned in the receiver head 86a so that, when the manifold is fitted to the receiver, signals can be inductively exchanged between coils 282 and 296. Coil 296 is connected to an RFID interface 298 which is part of control circuit internal to the collection unit 31. RFID interface 298 can be constructed out of the SL RC400 I ^• CODE Reader available from Philips Semiconductor. RFID interface 298 reads data from and writes data to the memory internal to RFID 280.

[000114] In the illustrated version of the invention manifold coil 282 and receiver coil 296, are wound circumferentially, respectfully, around the manifold and receiver. This arrangement eliminates the need to place the manifold in a select index position relative to the receiver in order to facilitate data transfer with the RFID 280. [000115] The RFID interface 298 is connected to a main controller 302 that provides overall control of the collection unit 31. In one version of the invention, an Atmel AT91SAM Smart ARM based microcontroller is employed as the microcontroller 302. Microcontroller 302 regulates the on/off operation of the vacuum pump 57. Microcontroller 302 also regulates the vacuum flow through vacuum line 50. (For ease of illustration, the HEPA filter is not shown.) In one version of the invention a regulator 304 is used to regulate the vacuum level. Regulator 304 is a three way valve. Both vacuum line 50 and the inlet to the vacuum pump 57 are connected to regulator 304. Regulator 304 also has a port to atmosphere. A transducer 306 connected to vacuum line 50 provides a signal to main controller 302 representative of the vacuum level.

[000116] Figure 13 also shows a display 303 connected to the main controller 302. Main controller 302 presents data regarding the operation of the system 30 on display 303. In some versions of the invention, display 303 is a touch screen display. Surgical personnel enter commands to regulate the system based on the depression of button images presented on the display. Not illustrated is a display I/O controller that is often used to regulate the generation of images on and the basic processing of commands received from the display 303.

[000117] An understanding of how system 30 with manifold RFID 280 operates is now explained by reference to Figures 16A-16C. Initially, as represented by step 312, the collection unit 31 is activated. As a result of the activation of the collection unit, main controller 302 instructions the RFID interface to repetitively emit a basic interrogation signal, a single interrogation signal being represented by step 314. If the manifold is not fitted to the receiver, no response is received to the basic interrogation signal, illustrated in Figure 16A as step 315. Main controller 302 and RFID interface 298 cooperate to continually reexecute step 314.

[000118] As long as steps 314 and 315 are being reexecuted, the main controller 302 also inhibits activation of the pump 57, represented as step 316. In some versions of the invention, this control may serve as a master override that prohibits the pump from being actuated unless, as described below, an appropriate manifold if fitted to the collection unit 31. In alternative versions of the invention, this control may be overridden by the user. Thus, in a version of the invention, wherein commands can be entered to regulate unit operation through touch screen display 303, if the user tries to actuate the pump without a manifold being present, controller 302 causes a warning message to be presented on the display 303. The user must acknowledge this warning before he/she is allowed to activate the pump. [000119] At some point in the process a manifold is seated in the receiver 70, (step not shown.) Once this event occurs, the manifold RFID 280, in a step not illustrated, sends back a basic response to the collection unit components. Thus, the evaluation of step 315 tests true. In response to this result, the RFID interface 298 and main controller 302 cooperate to send a full interrogation signal to the RFID 280, step 318. In response to this full interrogation signal, in a step 320 all the data in the RFID memory are forwarded through the RFID interface 298 to the main controller 302.

[000120] Upon receipt of the manifold RFID data, main controller 302, in a step 322, evaluates whether or not the manifold is useable with the collection unit 31. Step 322 comprises a number of individual evaluations. One such evaluation is whether or not the data in the use history field 292 indicates the manifold has been used the allowed number of times. In some versions of this system, each manifold is designed for a single use. A second evaluation of step 322 is whether or not the use by data in field 288 indicates that the data at which the manifold can be used has passed. Still another evaluation of step 322 is whether or not the data in field 286 indicate that the particular manifold is the subject of recall and should not be used. This evaluation is performed by comparing the manifold serial or lot number to a list of restricted serial or lot numbers stored in a memory accessible by main controller 302.

[000121] If in step 322, the test result is negative, the manifold cannot be used, a warning message is presented, step 324. This message is presented on display 303. Typically integral with this message is a statement indicating why the manifold is unusable. While not shown in the flow chart of Figure 16B, it should be appreciated that in some versions of system 30, the medical personnel are able to enter an override command to allow the use of a manifold tested as unusable.

[000122] If in step 322, the manifold tests useable, main controller 302, in a step 326, configures the collection unit for use. One aspect of step 326 is establishment of a vacuum level for the system. This level is based on the level data in field 290 from the manifold RFID 280. [000123] In a step 328, RFID interface 298 and main controller 302 write data to the RFID use history field 292 to reflect that the manifold is undergoing an additional use. For a single use manifold, step 328 comprises the setting of the single flag bite that constitutes the use history field 292.

[000124] The system is then actuated based on commands entered by the user, step 330. Step 330, it is appreciated, may be performed by the user actuating a control in order to activate the pump 57. Since an appropriate manifold 42a is now attached to the collection unit, there is no display of a warning message. The vacuum level as measured by the transducer 306 is, in step 332, monitored by transducer 306. As part of step 332, the main controller 302 compares the vacuum level to the target vacuum level. Based on the monitoring and comparison of step 332, in step 334, adjusts regulator to cause the vacuum level to be as close as possible to the target vacuum level. Not shown in Figure 16B is the feedback link indicating that steps 332 and 334 are continually reexcuted.

[000125] Also while the collection unit 31 is actuated, a basic interrogation signal is repetitively broadcast by the RFID interface, step 336. As represented by step 338 main controller 302 tests to determine if a response is received. As long as the manifold remains fitted to the receiver, the response is received in step 338.

[000126] However, the manifold may be inadvertently removed while system is actuated, (step not shown.) In this situation, RFID interface 298 does not receive a response to the interrogation of step 336. The absence of a response in step 338 is interpreted by the main controller 302 as indication that the manifold was removed. Accordingly the main controller 302 initiates a shut-down procedure. This procedure starts in step 340 with the deactivation of the vacuum pump 57. Then, in step 342, regulator 304 is set to fully vent vacuum line 50 to atmosphere.

[000127] One benefit of the above version of system is that notice is immediately provided if, for any one of a number of reasons, the manifold is unusable.

[000128] The above version of system 30 is further designed so that the vacuum level established for the collection unit 31 is the appropriate vacuum level for the specific manifold. Thus, a manifold intended for use during an optholmogical procedure may include data in its RFID that limits the vacuum draw of system 30 to a relatively low level. This would reduce the possibility that the vacuum level could be inadvertently being set too high for the procedure .

[000129] Another feature of the above construction of system 30 is that the presence/absence of the manifold is detected electronically and acted on electronically. In the event the manifold is removed while the pump 57 is actuated, main controller 302 causes the suction pressure to cease in the manner most efficient to minimize suction induced spray of waste material and continued use of the moving components of the system (pump 57) . This eliminates the need to provide an expensive valve unit that totally blocks the suction drawn from environment into the collection unit 31. [000130] It should be appreciated that alternative embodiments of the above construction of the system are possible. Not all embodiments of this version of the system require an RFID as the component for storing manifold- describing data. In some versions of the invention, one or more magnets or other pieces of ferrous metal may perform this function. In these versions of the invention, one or more complementary magnetic sensors, such as Hall sensors are mounted to the collection unit. These magnetic sensors generate signals as a function of the presence/absence of manifold magnets or ferrous components. Main controller 302 interprets the presence of a specific sequence of magnets as indicating a specific data regarding the manifold with which the magnets are integral.

[000131] Alternatively, a NOVRAM or EEPROM may function as the memory. It should be recognized that in this version of the invention, the collection unit memory reader is some sort of terminal device with contacts over which electrical connections can be established with the memory. [000132] Still in another version of the invention, the data tag is some form of optically readable data carrier. This tag can, for example, be a label on which a manifold specific bar code is printed. In these constructions of the invention, a bar code reader is built into the manifold receiver. Also in these versions of the invention, a means may be provided in the manifold receiver to physically or mechanically render the bar code unreadable. A printer that obliterates the code can serve this function. Alternatively a mechanical device can perform the same function. This device is actuated once a single-use manifold is fitted to the receiver to prevent the reuse for which the manifold is not designed.

[000133] Likewise, there is no specific requirement where on the manifold the memory is located. [000134] It should likewise be understood that this invention is not limited to medical/surgical waste collection systems wherein the collection unit is mobile. One or more features of the system of this invention may be incorporated into a system having a static collection unit. [000135] Similarly, the pressure regulator used to control the level of the suction drawn on the canister may be something other than a valve with a port to atmosphere. Other regulators may include flow control orifices and/or devices that regulate operation of the vacuum pump 57 [000136] Likewise the components regulated by controller 302 may be different from what has been described. Thus, in some versions of the invention, the speed at which pump 57 may be set in order to establish the level of suction drawn by the system 30.

[000137] Likewise the process steps can similarly vary from what has been described. In some versions of the invention, for example, if the manifold is removed while the pump 57 is running, the interrogation inquiry of steps 336 and 338 tests false, the controller may not completely deactivate the pump 340. Instead, controller 302 may only reduce the level of the suction drawn by the pump. Alternatively, or in addition to the foregoing steps of resetting the pump operation, the controller 302 may reset a valve to prevent the vacuum from being drawn on the contents of the canister and/or through the manifold receiver. [000138] Similarly, in some versions of the invention, the data in memory vacuum level field 290 may only be used to set an initial vacuum level. The medical personnel would be available to reset the vacuum level up or down from this initial settings. Alternatively, in some versions of the invention, the memory integral with manifold contains data identifying two or more vacuum levels. The first vacuum level, for example, is an initial vacuum level setting. The second and third vacuum levels are, respectively, minimum and maximum vacuum levels. The controller 302 inhibits the persons operating the collection unit 31 from setting the vacuum level outside of the range specified by the minimum and maximum vacuum levels.

[000139] Therefore, it is an object of the appended claims to cover all such variations and modifications of the system as come within the true scope and spirit of the appended claims .

Claims

What is claimed is:

1. A medical/surgical waste collection system (30) comprising : a collection unit (31) including: a canister (36) for receiving medical/surgical waste; a pump (57) connected to the canister for drawing waste into the canister; and a controller (302) for regulating the operation of the collection unit; and a manifold (42a) adapted for releasable connection to the canister, the manifold formed with a through path through which waste from a suction tube (40) is drawn into the cannister; characterized in that: a memory (280) is attached to the manifold, the memory containing data (284) used to regulate operation of the collection unit; a data reader (296, 298) is attached to the collection unit for reading the data in the memory; and the controller is connected to the data reader for receiving the data read from the memory and to regulate operation of the collection unit based on the read data.

2. The medical/surgical waste collection system of Claim 1, wherein: a device (304) is connected to the collection unit for regulating the level of the vacuum drawn on the canister or manifold; and the controller sets said vacuum regulating device to establish the level of the vacuum drawn on the canister or manifold.

3. The medical/surgical waste collection system of Claims 1 or 2, wherein said controller is configured to regulate actuation of the pump based on the data read from the memory.

4. The medical/surgical waste collection system of Claims 1, 2 or 3, wherein: said memory is an RFID; and the collection unit includes an antenna (296) for reading data from the RFID.

5. The medical/surgical waste collection system of Claims 1, 2, 3, or 4, wherein said controller is configured to, after the pump is actuated: continually attempt to read data from the manifold memory; and if said controller is unable to read data from the manifold memory, inhibit/reduce the suction drawn by the pump .

6. A medical/surgical waste collection manifold (42a), said manifold including: a body (158) shaped to be removably fitted to a waste collection unit, the body having at least one inlet port (166) for receiving a waste stream and an outlet port (168) through which the waste stream flows into the collection unit, characterized in that: a memory (280) is attached to the body, said memory being storing data (284) that can be read by a reader integral with the collection unit, the data defining operating characteristics of the collection unit.

7. The medical/surgical waste collection manifold of Claim 6, wherein said memory contains data that are electronically readable.

8. The medical/surgical waste collection manifold of Claims 6 or 7, wherein said memory contains data indicating the level of the vacuum that should be drawn through the collection unit.

9. A manifold (42, 220, 230, 240, 250, 260) for insertion into a receiver (70) of a surgical waste collection unit, the receiver having: an inner wall that defines a bore (88, 94, 99) with opposed bore openings, one of which opens into a collection unit canister (36) ; an inlet opening (96) separate from the bore openings that opens into the bore; and an outlet opening (116) separate from the bore openings and the inlet opening that opens into the bore, said manifold comprising: a head (158, 220, 250) with at least one member (166) for receiving a suction tube, the head having an internal void space; and a stem (72, 224, 246, 246a, 266) that extends from said head, said stem having a through bore that extends from the head void space to an open end, the stem dimensioned so that said stem extends through the receiver bore and is spaced from the inner wall of the receiver so as to establish a flow path from the head into the collection unit canister, characterized in that: the stem is dimensioned to extends through the receiver bore and is spaced from the inner wall of the receiver so as to establish through said receiver bore: a first fluid flow path (229) in said stem from the manifold head into the collection unit canister, through that is isolated from the receiver inlet and outlet openings : and a second fluid flow path (227, 245, 251) from the receiver inlet opening, through the receiver bore and around said stem and to the receiver outlet opening.

10. The manifold of Claim 9, further including a filter unit (48) disposed over the stem (72) the filter unit having at least one inlet opening (192) and at least one outlet opening (198) spaced from the inlet opening, the filter unit constructed so that, when the manifold is fitted into the receiver: the filter unit inlet opening is in communication with the receiver inlet opening; and the filter unit outlet opening is in communication the receiver outlet opening.

11. The manifold of Claim 10, wherein a filter element (204) for trapping aerosolized liquid is disposed in said filter unit (48) .

12. The manifold of Claims 10 or 11, wherein said filter unit (48) is disposed circumferentially around the stem (72)

13. The manifold of Claims 9, 10, 11 or 12, wherein the manifold has a structural member (184, 222, 232, 242, 244, 250, 262) positioned to abut a static portion of the waste collection unit to establish a seal between the receiver bore and the ambient environment.

14. The manifold of Claim 13, wherein said structural member is an adapter (262) separate from the manifold head or stem that is dimensioned to seat in the waste collection unit receiver, the adapter having an opening (272) for receiving the manifold stem (266) .

15. The manifold of Claims 9, 10, 11, 12 or 13, wherein said stem (72, 246, 246a) is dimensioned to abut a section (98) of the waste collection unit receiver to establish a seal between the end of the receiver that opens into the collection unit canister and the receiver bore.

16. A manifold (256) for insertion into a receiver (70) of a surgical waste collection unit, the receiver having: an inner wall that defines a bore (88, 94, 99) with opposed bore openings including a bottom opening that opens into the waste collection unit; an inlet opening (96) separate from the bore openings that opens into the bore; and an outlet opening (116) separate from the bore openings and the inlet opening that opens into the bore, said manifold comprising: a head (242) with at least one member (166) for receiving a suction tube, the head having an internal void space; and a stem (257, 259) that extends from said head, said stem having a through bore that extends from the head internal void space to an open end, the stem dimensioned so that said stem extends through the receiver bore and is spaced from the inner wall of the receiver so as to establish a flow path from the head through said receiver bore; characterized in that: the stem has a first section (257) dimensioned to abut a section (92) of the receiver so as to isolate the receiver inlet opening and the receiver outlet opening from each other; and the stem has a second section (259) that extend from the first section, the second section being in a section (98) of the receiver that opens into waste collection unit and being dimensioned to define a first flow path from said stem first section into the waste collection unit and a second flow path from the waste collection unit into the receiver outlet opening.