Medical fluid therapy machine including readily accessible pneumatic manifold and valves therefore

Abstract

A connection apparatus for sealing to a pathway of a mounting structure includes a body; and a port including a threaded portion extending from the body and a non-threaded portion extending from the threaded portion, the non-threaded portion carrying a gasket, the gasket positioned along the non-threaded portion such that the mounting structure to which the connection apparatus is mounted contacts the gasket prior to the threaded portion engaging a mating threaded portion of the mounting structure, the port providing fluid communication between the body and the pathway of the mounting structure. The body may be that of a valve that supplies any of air, water or oil as an operating fluid to, for example, inlet and outlet valves and a pump chamber of a medical fluid pump of a medical fluid delivery machine.

Claims

1. A connection apparatus for sealing to a pathway of a mounting structure, the connection apparatus comprising: a body; and a port including a threaded portion extending from the body and a non-threaded portion extending from the threaded portion, the non-threaded portion carrying a gasket, the gasket positioned along the non-threaded portion such that the mounting structure to which the connection apparatus is mounted contacts the gasket prior to the threaded portion engaging a mating threaded portion of the mounting structure, the port providing fluid communication between the body and the pathway of the mounting structure, and wherein the gasket is configured to create a seal between the pathway and both the threaded portion and mating threaded portion after engagement.

2. The connection apparatus of claim 1, wherein the body is a valve body, the valve body configured to be electrically actuated to open or close a fluid passageway.

3. The connection apparatus of claim 1, wherein the non-threaded portion defines a groove that accepts the gasket.

4. The connection apparatus of claim 1, wherein the body includes a surface, the port extending from the surface, the surface defining an aperture spaced apart from the port, the gasket is a first gasket, and wherein the valve body includes a second gasket extending around the spaced-apart aperture.

5. The connection apparatus of claim 1, which is configured for use with a pneumatic system.

6. The connection apparatus of claim 1, wherein the body is a variable orifice valve body.

7. The connection apparatus of claim 1, which is configured for use with a water system.

8. The connection apparatus of claim 1, which is configured for use with an oil-based system.

9. The connection apparatus of claim 1, wherein the body is a binary valve body.

10. The connection apparatus of claim 1, wherein the body is a pressure gauge body.

11. The connection apparatus of claim 1, wherein the body is a pressure regulator body.

12. The connection apparatus of claim 1, wherein the body is a flowmeter body.

13. The connection apparatus of claim 1, wherein the body is a filter body.

14. The connection apparatus of claim 1, wherein the body is piping.

15. The connection apparatus of claim 1, wherein the body is tubing.

16. The connection apparatus of claim 1, wherein the body is a piping/tubing fitting.

Description

BRIEF DESCRIPTION OF THE FIGURES

(1) FIG. 1 is a schematic illustration of one embodiment of a renal failure therapy operated by a machine employing a pneumatic manifold mounting pneumatic valves of the present disclosure.

(2) FIG. 2 is a perspective view illustrating a blood set for use with the renal failure therapy machine of FIG. 1.

(3) FIG. 3A is a perspective view of one embodiment of the renal failure therapy machine of FIG. 1 with a pump box connected to a main chassis of the machine.

(4) FIG. 3B is a perspective view of the renal failure therapy machine of FIG. 3A, with the pump box removed so that a service door may be opened to allow for the electronics of the machine to rotate out of the machine for servicing.

(5) FIGS. 4A and 4B are front and bottom views, respectively, of one embodiment of a pneumatic manifold mounting regime that includes a removable faceplate to enable access to various pneumatic valves connected to the pneumatic manifold.

(6) FIGS. 5 to 8 illustrate a first embodiment for mounting pneumatic valves to a plate of the pneumatic manifold of the present disclosure.

(7) FIGS. 9A and 9B illustrate a second embodiment for mounting pneumatic valves to a plate of the pneumatic manifold of the present disclosure.

(8) FIG. 10 illustrates a third embodiment for mounting pneumatic valves to a plate of the pneumatic manifold of the present disclosure.

DETAILED DESCRIPTION

(9) The examples described herein are applicable to any medical fluid delivery system that delivers a medical fluid, such as blood, dialysis fluid, substitution fluid or and intravenous drug (IV). The examples are particularly well suited for kidney failure therapies, such as all forms of hemodialysis (HD), hemofiltration (HF), hemodiafiltration (HDF), continuous renal replacement therapies (CRRT) and peritoneal dialysis (PD), referred to herein collectively or generally individually as renal failure therapy. Moreover, the machines and any of the pneumatically operated systems and methods described herein may be used in clinical or home settings. For example, a machine including a pneumatic manifold of the present disclosure may be employed in an in-center HD machine, which runs virtually continuously throughout the day. Alternatively, the pneumatic manifold and other features of the present disclosure may be used in a home HD machine, which can for example be run at night while the patient is sleeping. Moreover, each of the renal failure therapy examples described herein may employ a diffusion membrane or filter, such as a dialyzer, e.g., for HD or HDF, or a hemofilter, e.g., for HF.

(10) Referring now to FIG. 1, an example of an HD flow schematic for a medical fluid delivery system 10 employing a pneumatic manifold and other features of the present disclosure is illustrated. Because the HD system of FIG. 1 is relatively complicated, FIG. 1 and its discussion also provide support for any of the renal failure therapy modalities discussed above and for an IV machine. Generally, system 10 is shown having a very simplified version of a dialysis fluid or process fluid delivery circuit. The blood circuit is also simplified but not to the degree that the dialysis fluid circuit is simplified. It should be appreciated that the circuits have been simplified to make the description of the present disclosure easier, and that the systems if implemented would have additional structure and functionality, such as is found in the publications incorporated by reference above.

(11) System 10 of FIG. 1 includes a blood circuit 20. Blood circuit 20 pulls blood from and returns blood to a patient 12. Blood is pulled from patient 12 via an arterial line 14, and is returned to the patient via a venous line 16. Arterial line 14 includes an arterial line connector 14a that connects to an arterial needle 14b, which is in blood draw communication with patient 12. Venous line 16 includes a venous line connector 16a that connects to a venous needle 16b, which is in blood return communication with the patient. Arterial and venous lines 14 and 16 also include line clamps 18a and 18v, which can be spring-loaded, fail-safe mechanical pinch clamps. Line clamps 18a and 18v are closed automatically in an emergency situation in one embodiment.

(12) Arterial and venous lines 14 and 16 also include air or bubble detectors 22a and 22v, respectively, which can be ultrasonic air detectors. Air or bubble detectors 22a and 22v look for air in the arterial and venous lines 14 and 16, respectively. If air is detected by one of air detectors 22a and 22v, system 10 closes line clamps 18a and 18v, pauses the blood and dialysis fluid pumps, and provides instructions to the patient to clear the air so that treatment can resume. In an embodiment, air detectors 22a and 22v are made of aircraft grade materials that allow the sensors to operate in a high temperature environment. FIG. 2 illustrates arterial and venous lines 14 and 16, respectively, which between treatments receive high temperature disinfecting water in one embodiment. Air detectors 22a and 22v touch lines 14 and 16 for operation and thereby become heated upon disinfection. Forming air detectors 22a and 22v and associated electronics such that they my operate in heated environments of, e.g., 105 C., enables system 10 and machine 90 to consolidate several electronic assemblies into one small integrated assembly near detectors 22a and 22v, increasing the reliability of system 10, while reducing its cost.

(13) A blood pump 30 is located in arterial line 14 in the illustrated embodiment. In the illustrated embodiment, blood pump 30 includes a first blood pump pod 30a and a second blood pump pod 30b. Blood pump pod 30a operates with an inlet valve 32i and an outlet valve 32o. Blood pump pod 30b operates with an inlet valve 34i and an outlet valve 34o. In an embodiment, blood pump pods 30a and 30b are each blood receptacles that include a hard outer shell, e.g., spherical, with a flexible diaphragm located within the shell, forming a diaphragm pump. One side of each diaphragm receives blood, while the other side of each diaphragm is operated by negative and positive air pressure. Blood pump 30 is alternatively a peristaltic pump operating with the arterial line 14 tube.

(14) A heparin vial 24 and heparin pump 26 are located between blood pump 30 and blood filter 40 (e.g., dialyzer) in the illustrated embodiment. Heparin pump 26 may be a pneumatic pump or a syringe pump (e.g., stepper motor driven syringe pump). Supplying heparin upstream of blood filter 40 helps to prevent clotting of the filter's membranes.

(15) A control unit 50 includes one or more processor and memory. Control unit 50 receives air detection signals from air detectors 22a and 22v (and other sensors of system 10, such as temperature sensors, blood leak detectors, conductivity sensors, pressure sensors, and access disconnection transducers 102, 104), and controls components such as line clamps 18a and 18v, blood pump 30, heparin pump 26, and the dialysis fluid pumps. Blood that exits blood filter 40 via venous line 16 flows through an airtrap 110. Airtrap 110 removes air from the blood before the dialyzed blood is returned to patient 12 via venous line 16.

(16) With the hemodialysis version of system 10 of FIG. 1, dialysis fluid or dialysate is pumped along the outside of the membranes of blood filter 40, while blood is pumped through the insides of the blood filter membranes. Dialysis fluid or dialysate is prepared beginning with the purification of water via a water purification unit 60. One suitable water purification unit is set forth in U.S. Patent Publication No. 2011/0197971, entitled, Water Purification System and Method, filed Apr. 25, 2011, the entire contents of which are incorporated herein by reference and relied upon. In one embodiment, water purification unit includes filters and other structures to purify tap water (e.g., remove pathogens and ions such as chlorine), so that the water is in one implementation below 0.03 endotoxin units/ml (EU/ml) and below 0.1 colony forming units/ml (CFU/ml). Water purification unit 60 may be provided in a housing separate from the housing or chassis of the hemodialysis machine, which includes blood circuit 20 and a dialysis fluid circuit 70.

(17) Dialysis fluid circuit 70 is again highly simplified in FIG. 1 to ease illustration. Dialysis fluid circuit 70 in actuality may include all of the relevant structure and functionality set forth in the publications incorporated by reference above. Certain features of dialysis fluid circuit 70 are illustrated in FIG. 1. In the illustrated embodiment, dialysis fluid circuit 70 includes a to-blood filter dialysis fluid pump 64. Pump 64 is in one embodiment configured the same as blood pump 30. Pump 64, like pump 30, includes a pair of pump pods, which again may be spherically configured. The two pump pods, like with blood pump 30, are operated alternatingly so that one pump pod is filling with HD dialysis fluid, while the other pump pod is expelling HD dialysis fluid.

(18) Pump 64 is a to-blood filter dialysis fluid pump. There is another dual pod pump chamber 96 operating with valves 98i and 98o located in drain line 82 to push used dialysis fluid to drain. There is a third pod pump (not illustrated) for pumping pump purified water through a bicarbonate cartridge 72. There is a fourth pod pump (not illustrated) used to pump acid from acid container 74 into mixing line 62. The third and fourth pumps, the concentrate pumps, may be single pod pumps because continuous pumping is not as important in mixing line 62 because there is a buffering dialysis fluid tank (not illustrated) between mixing line 62 and to-blood filter dialysis fluid pump 64 in one embodiment.

(19) A fifth pod pump (not illustrated) provided in drain line 82 is used to remove a known amount of ultrafiltration (UF) when an HD therapy is provided. System 10 keeps track of the UF pump to control and know how much ultrafiltrate has been removed from the patient. System 10 ensures that the necessary amount of ultrafiltrate is removed from the patient by the end of treatment.

(20) Each of the above-described pumps may alternatively be a peristaltic pump operating with a tube. If so, the system valves may still be actuated pneumatically according to the features of the present disclosure.

(21) In one embodiment, purified water from water purification unit 60 is pumped along mixing line 62 though bicarbonate cartridge 72. Acid from container 74 is pumped along mixing line 62 into the bicarbonated water flowing from bicarbonate cartridge 72 to form an electrolytically and physiologically compatible dialysis fluid solution. The pumps and temperature-compensated conductivity sensors used to properly mix the purified water with the bicarbonate and acid are not illustrated but are disclosed in detail in the publications incorporated by reference above.

(22) FIG. 1 also illustrates that dialysis fluid is pumped along a fresh dialysis fluid line 76, through a heater 78 and an ultrafilter 80, before reaching blood filter 40, after which used dialysis fluid is pumped to drain via drain line 82. Heater 78 heats the dialysis fluid to body temperature or about 37 C. Ultrafilter 80 further cleans and purifies the dialysis fluid before reaching blood filter 40, filtering bugs or contaminants introduced for example via bicarbonate cartridge 72 or acid container 74 from the dialysis fluid.

(23) Dialysis fluid circuit 70 also includes a sample port 84 in the illustrated embodiment. Dialysis fluid circuit 70 will further include a blood leak detector (not illustrated but used to detect if a blood filter 40 fiber is torn) and other components that are not illustrated, such as balance chambers, plural dialysis fluid valves, and a dialysis fluid holding tank, all illustrated and described in detail in the publications incorporated by reference above.

(24) In the illustrated embodiment, hemodialysis system 10 is an online, pass-through system that pumps dialysis fluid through blood filter one time and then pumps the used dialysis fluid to drain. Both blood circuit 20 and dialysis fluid circuit 70 may be hot water disinfected after each treatment, such that blood circuit 20 and dialysis fluid circuit 70 may be reused. In one implementation, blood circuit 20 including blood filter 40 is hot water disinfected and reused daily for about one month, while dialysis fluid circuit 70 is hot water disinfected and reused for about six months.

(25) In alternative embodiments, or for CRRT for example, multiple bags of sterilized dialysis fluid or infusate are ganged together and used one after another. In such a case, the emptied supply bags can serve as drain or spent fluid bags.

(26) The machine 90 of system 10 includes an enclosure as indicated by the dotted line of FIG. 1. The enclosure of machine 90 varies depending upon the type of treatment, whether the treatment is in-center or a home treatment, and whether the dialysis fluid/infusate supply is a batch-type (e.g., bagged) or on-line.

(27) FIG. 2 illustrates that machine 90 of system 10 of FIG. 1 may operate with a blood set 100. Blood set 100 includes arterial line 14, venous line 16, heparin vial 24, heparin pump 26/blood pump 30 and blood filter 40 (e.g., dialyzer). An airtrap 110 may be located in venous line 16 to remove air from the blood before being returned to patient 12. As discussed herein, high temperature air detectors 22a and 22v contact and thereby operate with arterial and venous lines 14 and 16, respectively.

(28) In FIGS. 1 and 2, any of pumps 26, 30 (30a and 30b), 64, 96 (and other pumps not illustrated) and any of the valves, such as valves 32i, 32o, 34i, 34o, 68i, 68o, 98i, and 98o may be pneumatically actuated. In an embodiment, each of the pumps and valves has a fluid side and an air side, separated by a flexible membrane. Negative pneumatic pressure may be applied to the air side of the membrane to draw fluid into a pump chamber or to open a valve (or pump or valve could be opened by venting positive closing pressure to atmosphere and allowing fluid pressure to open). Positive pneumatic pressure is applied to the air side of the membrane to expel fluid from a pump chamber or to close a valve.

(29) Referring now to FIG. 3A, an embodiment of a medical fluid delivery machine 90, such as an HD machine, is illustrated. Medical fluid delivery machine 90 in the illustrated embodiment includes a medical fluid delivery chassis 120 connected to a pneumatic pump box 150. Pump box 150 holds pneumatic pumping equipment, such as a compressor and associated dryer, vacuum pump, at least one positive pressure accumulator and at least one negative pressure accumulator. In an embodiment, pneumatic pump box 150 is connected removeably to medical fluid delivery chassis 120, so that the pump box can be moved away from the patient (e.g., placed in a closet) to reduce noise in the treatment area near the patient. At least one positive pneumatic line, at least one negative pneumatic line, and at least one power line (FIG. 3B) run from pneumatic pump box 150 to medical fluid delivery chassis 120 to drive pumps 26, 30 (30a and 30b), 64, 96 (and other pumps not illustrated) and any of the valves, such as valves 32i, 32o, 34i, 34o, 68i, 68o, 98i and 98o, which are located within or are mounted onto medical fluid delivery chassis 120.

(30) Referring now to FIG. 3B, medical fluid delivery machine is illustrated with pump box 150 removed. As discussed above, removed pump box 150 remains in pneumatic and operable communication with medical fluid delivery chassis 120 via extended pneumatic lines 86 and extended power lines 88. The removed pump box exposes a backside 122 of medical fluid delivery chassis 120 and an access door 124. Access door 124 in the illustrated embodiment rotates open along a bottom hinge 126. In an alternative embodiment, access door 124 may be translated away from backside 122 via tracks in a drawer-like manner. In either case, removing access door 124 exposes an electronics cage 130 (shown with its door open to see inside).

(31) Electronics cage 130 holds multiple printed circuit boards (PCB's), such as PCB's 132, 134, 136 and 138, and other electrical equipment of machine 90. Electronics cage 130 is made of a material, such as, high temperature plastic, steel, or stainless steel, which shields PCB's 132, 134, 136 and 138, and other electrical equipment of machine 90 from the heat generated within the machine, e.g., from heater 78 and the fluid carrying equipment within machine 90 subjected to heat disinfection. One electrical component that is not held within electronics cage 130 is power supply 140 and associated transformers, which themselves generate heat. Power supply 140 in the illustrated embodiment (and associated transformers which may be internal to the power supply housing) is mounted instead to the top of electronics cage 130. By doing so, heat generated by power supply 140 does not become trapped within electronics cage 130. It has been found that elevating the temperature of components on a PCB by 10 C. may reduce their service life by half.

(32) Hinging electronics cage 130 out of the way as illustrated in FIG. 3B provides a number of benefits. First, electronics cage 130 enables PCB's 132, 134, 136 and 138, and other electrical equipment of machine 90 to be held in place firmly, increasing reliability. Removable electronics cage 130 also improves the serviceability of machine 90, regarding both the contents of cage 130 any by opening up an interior space 106 within machine 90, allowing better access to other machine components. The components of pump box 150 are also readily accessible due to its removability.

(33) Referring now to FIGS. 4A and 4B, in an embodiment, pneumatic components, such as, pneumatic regulators, electrically actuated binary solenoid valves, and electrically actuated variable pneumatic (vari-valves) are located on a pneumatic manifold 160. In the illustrated embodiment, manifold 160 pneumatically is sealed to electrically actuated binary solenoid valves 162, and electrically actuated variable pneumatic (vari-valves) 164.

(34) Pneumatic manifold 160 is mounted within machine 90 via a mounting assembly 170 fixed to frame 92 of machine 90. Mounting assembly 170 includes a fixed portion having first and second mounting flanges 172a and 172b. First and second mounting flanges 172a and 172b are fastened to frame 92 of machine 90 via fasteners 166a. Mounting assembly 170 includes a removable portion in the form of a faceplate 174, which mounts removeably to first and second mounting flanges 172a and 172b via fasteners 166b. Mounting flanges 172a and 172b and removable faceplate 174 may be made of metal, for example, stainless steel or aluminum. Mounting flanges 172a and 172b in turn mount to pneumatic manifold 160 from underneath via fasteners 166d.

(35) Removable faceplate 174 in turn supports one or more quick disconnect plate 180, which is attached to faceplate 174 via fasteners 166c. Quick disconnect plate 180 provides quick disconnect connections to machine 90 for first and second vacuum lines via sockets 182, low positive pressure via socket 184, high positive pressure via socket 186, AC power via sockets 188, and DC power via sockets 190. Pneumatic quick disconnect sockets 182, 184 and 186 are in pneumatic communication with various components of pneumatic manifold 160 via pneumatic lines 86 as illustrated in FIG. 4B. Electrical power quick disconnect sockets 188 and 190 are in electrical communication with multiple electrical components within machine 90, including components of pneumatic manifold 160, via electrical lines 88 as illustrated in FIG. 4B.

(36) Pneumatic lines 86 may be rigid or flexible. Regardless, they in combination with electrical lines 88 provide enough slack such that faceplate 174 and corresponding quick disconnect plate 180 may be moved out of the way of pneumatic manifold 160 if needed, e.g., to replace a binary valve 162. As illustrated in FIGS. 4A and 4B, binary valves 162 on the ends of pneumatic manifold 160 may be accessible with faceplate 174 in place, however, the binary valves 162 hidden behind faceplate 174 are not accessible. Without removable faceplate 174, If any of those valves 162 needs replacement, mounting assembly 170 and pneumatic manifold 160 have to be removed from frame 92 via removing fasteners 166a, and then mounting assembly 170 needs to be removed from pneumatic manifold 160 by removing fasteners 166d. Removable faceplate 174 instead allows any of binary valves 162 to be replaced easily, e.g., by pulling them in the direction of the arrow in FIG. 4B, while leaving mounting assembly 170 and pneumatic manifold 160 intact.

(37) Referring now to FIGS. 5 to 8, one embodiment for mounting vari-valves 164 to pneumatic manifold 160 (FIG. 4A) is illustrated. One goal for the mounting of any of the pneumatic valves is to prevent particulate from entering the pneumatic pathways 168 of pneumatic manifold 160. It has been found that attaching the valves, such as vari-valves 164, to pneumatic manifold 160 by threaded interfaces may cause particulate to shear off of the threads of pneumatic manifold 160 and fall into the pneumatic pathways 168, which are then pushed or pulled by air in the pathways into a pneumatic component, where the particulate can cause damage and/or malfunction. Especially where the threads of the valve are stainless steel and manifold 160 is a softer metal, such as aluminum (which is conducive to all of the machining involved with the plated of manifold), the threading action can shear particles, shavings or coatings from the threads of manifold 160.

(38) FIG. 6 illustrates the bottom side of vari-valve 164 having inner and outer o-rings 164a and 164b, a pneumatic inlet 164c, and an annular pneumatic outlet 164d. Inner o-ring 164a seals pneumatic inlet 164c, while inner and outer o-rings 164a and 164b collectively seal annular pneumatic outlet 164d. O-rings 164a and 164b accordingly need to be compressed to properly mount vari-valve 164.

(39) FIG. 5 illustrates one embodiment of a bracket 200 (referring collectively to brackets 200a and 200b in FIGS. 7 and 8), which clamps to and seals vari-valve 164 to pneumatic manifold 160. In the illustrated embodiment, bracket 200 includes a first bracket member 202 and a second bracket 204 (referring collectively to bracket members 202a/202b and 204a/204b in FIGS. 7 and 8). Bracket members 202 and 204 are bent or formed so as to fit over and around and engage the top of a larger, intermediate diameter portion 164e of vari-valve 164. Clamping bracket 200 to an intermediate diameter portion 164e of vari-valve 164 enables an upper, electrical connection portion 164f of vari-valve 164 to remain exposed for connection to associated electrical wiring.

(40) Bracket 200 may be made of metal, such as stainless steel or treated steel. Bracket 200 may be made alternatively of a touch plastic, such as teflon. Sidewalls of bracket 200 in FIG. 5 have been removed to show how bracket members 202 and 204 come together at least substantially all the way around the larger, intermediate diameter portion 164e of vari-valve 164. Bracket 200 (including brackets 200a and 200b) however may have sidewalls and/or gussets as necessary to prevent bracket 200 from bending when placed under mounting stress to compress o-rings 164a and 164b.

(41) Bracket 200 (including brackets 200a and 200b) includes flanges 206 and 208 (referring collectively to bracket member flanges 206a/206b and 208a/208b in FIGS. 7 and 8). Flanges 206 and 208 each define an aperture 210 for receiving a fastener 166e. In the illustrated embodiment of FIG. 5, fasteners 166e threadingly engage pneumatic manifold 160 to clamp flanges 206 and 208 and associated bracket members 202 and 204 to intermediate diameter portion 164e of vari-valve 164, thereby compressing o-rings 164a and 164b.

(42) FIGS. 7 and 8 illustrated different example shapes for bracket 200 (including brackets 200a and 200b). Bracket 200a is rounded with cylindrical sides (not seen) and may be more easily produced via molding, e.g., of tough plastic. Bracket 200b is square with straight sides (not seen) and may be formed easily from metal. It should be appreciated that each of brackets 200a and 200b is configured to distribute force evenly about intermediate diameter portion 164e of vari-valve 164. It should also be appreciated that brackets 200a and 200b are not limited to mounting valves, such as vari-valve 164, and may be used instead to mount other structures sealingly to a manifold, such as pneumatic manifold 160, including binary valves, pressure gauges, pressure regulators, flowmeters, filters, piping and tubing and associated fittings, and the like.

(43) Referring now to FIGS. 9A and 9B, other mounting scenarios for mounting vari-valve 164 are illustrated. Vari-valve 164 as discussed above includes inner and outer o-rings 164a and 164b, a pneumatic inlet 164c, and an annular pneumatic outlet 164d. Inner o-ring 164a seals pneumatic inlet 164c, while inner and outer o-rings 164a and 164b collectively seal annular pneumatic outlet 164d. Vari-valve includes a port 264 that extends into pneumatic pathway 168 of pneumatic manifold 160. Port 264 includes an upper threaded portion 266 and a lower smooth portion 268. Upper threaded portion 266 and a lower smooth portion 268 are made of stainless steel in one embodiment. Upper threaded portion 266 in the illustrated embodiment includes male threads 266a that thread up into the body of valve and male threads 266b angled in the reverse direction that thread down into pneumatic pathway 168 of pneumatic manifold 160.

(44) Pneumatic pathway 168 includes an upper mating female threaded portion 168a and a lower mating smooth portion 168b. In FIG. 9A, lower smooth portion 168b is formed in part by an insert press-fitted into pneumatic manifold 160. In FIG. 9B, lower smooth portion 168b is formed directly in one or more of the plates of pneumatic manifold 160. In either case, the top of lower smooth portion 168b forms a step upon which a third o-ring 270 is placed. The step prevents o-ring 270 from being pushed down into pneumatic pathway 168.

(45) The length of port 264 and its lower smooth portion 268 in combination with the placement of the step and o-ring 270 ensure that lower smooth portion 268 contacts and compresses o-ring 270 to lower smooth portion 168b prior to male threads 266b engaging upper mating female threaded portion 168a of pneumatic pathway 168. In this way, a sealed chamber is created prior to creation of, and that therefore catches, any chips or particulate that are sheared off of female threaded portion 168a of pneumatic pathway 168. The chips or particulate therefore cannot fall further into pneumatic pathway 168.

(46) FIG. 9A illustrates lower smooth portion 268 just beginning to contact and compress o-ring 270 against the wall of pneumatic pathway 168. FIG. 9B illustrates vari-valve 164 fully threaded into pneumatic manifold 160. In FIG. 9B, any chips or particulate that are sheared off of female threaded portion 168a of pneumatic pathway 168 due to the threaded connection fall on top of compressed o-ring 270 or against the small exposed section of lower smooth portion 268, but not further down into pneumatic pathway 168.

(47) It should be appreciates that while port 264 is illustrated as being part of vari-valve 164, port 264 may be used instead to mount other structures sealingly to a manifold, such as pneumatic manifold 160, including binary valves, pressure gauges, pressure regulators, flowmeters, filters, piping and tubing and associated fittings, and the like.

(48) Referring now to FIG. 10 a further alternative mounting scenario for any type of pneumatic component, such as vari-valves 164, binary valves, pressure gauges, pressure regulators, flowmeters, filters, piping and tubing and associated fittings, is illustrated. An attachment mechanism 220 includes a port 264 as described below that attaches to a body. The body may be a body of any of vari-valve 164, a binary valve body, a pressure gauge body, a pressure regulator body, a flowmeter body, a filter body, piping, tubing and/or associated fittings. For purposes of illustration, the body will be described hereafter as that of vari-valve 164

(49) Vari-valve 164 as discussed and illustrated above includes inner and outer o-rings 164a and 164b, a pneumatic inlet 164c, and an annular pneumatic outlet 164d. Inner o-ring 164a seals pneumatic inlet 164c, while inner and outer o-rings 164a and 164b collectively seal annular pneumatic outlet 164d. Vari-valve 164 again includes a port 264 that extends into pneumatic pathway 168 of pneumatic manifold 160. Port 264 includes an upper threaded portion 266 and a lower smooth portion 268 extending from upper threaded portion 266. Upper threaded portion 266 and lower smooth portion 268 are made of stainless steel, steel, titanium, aluminum, alloys and combinations thereof in various embodiments.

(50) Pneumatic pathway 168 includes an upper mating female threaded portion 168a and a lower mating smooth portion 168b. In FIG. 10, lower smooth portion 168b is formed directly in one or more of the plates of pneumatic manifold 160. As opposed to FIGS. 9A and 9B, o-ring 270 is here positioned into a mating groove of lower smooth portion 268 of valve 164.

(51) The length of port 264 and its lower smooth portion 268 in combination with the placement of o-ring 270 onto lower smooth portion 268 ensure that o-ring 270 passes through female threads 168a and contacts and compresses to lower smooth portion 168b prior to male threads 266 engaging upper mating female threaded portion 168a of pneumatic pathway 168. Here again, a sealed chamber is created prior to the creation of, and that therefore catches and traps, any chips or particulates that are sheared off of female threaded portion 168a of pneumatic pathway 168 or male threaded portion 266 of port 264. The chips or particulates therefore cannot fall further into pneumatic pathway 168.

(52) While the valves of FIGS. 9A, 9B and 10 are described as being pneumatic valves, the valves may alternatively operate with other types of systems, such as water, hydraulic or oil-based systems. The valves may alternatively be hydraulic valves, for example. The connection structures of FIGS. 6 to 10 may therefore be used to prevent the transfer of particulates created when threading mating elements of any pneumatic, hydraulic, water or oil-based system from entering the flow path of the system.

(53) It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present subject matter and without diminishing its intended advantages. It is therefore intended that such changes and modifications be covered by the appended claims.