Medical fluid treatment machine including an easily accessible pneumatic manifold and valve therefor

Abstract

The present invention relates to a medical fluid therapy machine including an easily accessible pneumatic manifold and valves therefor. A connection device for sealing to a path 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 positioned along the non-threaded portion such that a mounting structure in which the connection device is mounted contacts the gasket before the threaded portion engages a mating threaded portion of the mounting structure, the port providing fluid communication between the body and the path of the mounting structure. The body can be a body of a valve that admits any one of air, water or oil as a working fluid to inlet and outlet valves and a pump chamber of a medical fluid pump of, for example, a medical fluid delivery machine.

Description

[0001] Divisional Application

[0002] This application is a divisional application of Chinese Patent Application No. 201780073441.6, filed on October 27, 2017, entitled "Medical Fluid Treatment Machine Including Easily Accessible Pneumatic Manifold and Valve Therefor."

[0003] Cross Reference to Related Applications

[0004] This application claims priority to U.S. Patent Application No. 15 / 336,247, filed on October 27, 2016, entitled "Medical Fluid Treatment Machine Including Easily Accessible Pneumatic Manifold and Valve Therefor," the entire contents of which are incorporated herein by reference. TECHNICAL FIELD

[0005] The present disclosure relates generally to apparatuses, systems, and methods for medical fluid delivery machines. More particularly, the present disclosure relates to medical fluid delivery machines, such as kidney failure treatment machines, that employ pneumatic pumping. BACKGROUND

[0006] With respect to kidney function failure treatment machines, a person's kidney system can deteriorate for various reasons. Kidney failure creates a variety of physiological disorders. The ability to balance water and minerals or to excrete the daily metabolic load is no longer possible. Toxic end products of nitrogen metabolism (urea, creatinine, uric acid, etc.) can accumulate in the blood and tissues.

[0007] Kidney failure and reduced kidney function have been treated with dialysis. Dialysis removes from the body the waste, toxins, and excess water that would otherwise be removed by the normally functioning kidneys. Dialysis treatment to replace kidney function is vital for many people because the treatment is life-saving.

[0008] One type of kidney failure therapy is hemodialysis ("HD"), which generally uses diffusion to remove waste from a patient's blood. The diffusion gradient arises across a semipermeable dialyzer between the blood and an electrolyte solution called dialysate or dialysis fluid to cause diffusion.

[0009] Hemofiltration ("HF") is an alternative kidney replacement therapy that relies on convective transport of toxins from a patient's blood. HF is accomplished by adding a replacement or substitution fluid (typically 10 to 90 liters of such fluid) to an extracorporeal circuit during treatment. During an HF treatment, the replacement fluid and fluid accumulated by the patient between treatments are ultrafiltered, thereby providing a convective transport mechanism that is particularly beneficial for removal of middle and large molecules (in hemodialysis, there is some removal of waste with the fluid gained during dialysis, however, the solute drag from this ultrafiltration fluid removal is insufficient to provide convective clearance). HF is accomplished by adding a replacement or substitution fluid (typically 10 to 90 liters of such fluid) to an extracorporeal circuit during treatment. During an HF treatment, the replacement fluid and fluid accumulated by the patient between treatments are ultrafiltered, thereby providing a convective transport mechanism that is particularly beneficial for removal of middle and large molecules (in hemodialysis, there is some removal of waste with the fluid gained during dialysis, however, the solute drag from this ultrafiltration fluid removal is insufficient to provide convective clearance).

[0010] Hemodiafiltration ("HDF") is a treatment modality that combines convective and diffusive clearances. Similar to standard hemodialysis, HDF uses dialysate that is flowed through a dialyzer to provide diffusive clearance. Additionally, substitution fluid is provided directly to the extracorporeal circuit, thereby providing convective clearance.

[0011] Most HD (HF, HDF) treatments occur in centers. There is a trend toward home hemodialysis ("HHD") currently, in part because HHD can be performed every day, thereby providing therapeutic benefits over center hemodialysis treatments that typically occur every two or three weeks. Studies have shown that more toxins and wastes are removed with frequent treatments than with patients who receive lower frequency but possibly longer treatment times. Patients who receive more frequent treatments do not experience a decline period as do patients in centers who have accumulated toxins for two or three days before treatment. In certain areas, the nearest dialysis center can be many miles from a patient's home, thereby causing door-to-door treatment times to consume a large portion of the day. HHD can occur at night or during the day when the patient is relaxed, working, or otherwise productive.

[0012] Another type of renal failure therapy is peritoneal dialysis, which involves the infusion of a dialysis solution, also referred to as dialysate, into a patient's abdominal cavity via a catheter. The dialysate contacts the peritoneum of the abdominal cavity. Due to diffusion and osmosis, waste products, toxins and excess water pass from the patient's blood stream through the peritoneum and into the dialysate, i.e., an osmotic gradient exists across the membrane. Osmotic agents in the dialysate provide the osmotic gradient. The used or spent dialysate is drained from the patient, thereby removing the waste products, toxins and excess water from the patient. The cycle is repeated, for example, multiple times.

[0013] There are various types of peritoneal dialysis therapies, including continuous ambulatory peritoneal dialysis ("CAPD"), automated peritoneal dialysis ("APD"), and tidal flow dialysis and continuous flow peritoneal dialysis ("CFPD"). CAPD is a manual dialysis treatment. Here, the patient manually connects an implanted catheter to a drain tube to allow used or spent dialysate to drain from the abdominal cavity. The patient then connects the catheter to a bag of fresh dialysate to infuse fresh dialysate through the catheter and into the patient. The patient disconnects the catheter from the fresh dialysate bag and allows the dialysate to dwell within the abdominal cavity, where transport of waste products, toxins and excess water occurs. After a period of time, the patient repeats the manual dialysis procedure, for example, four times a day with each treatment lasting about an hour. Manual peritoneal dialysis requires a significant amount of time and effort from the patient, thereby leaving room for improvement.

[0014] Automated peritoneal dialysis ("APD") is similar to CAPD in that the dialysis treatment includes drain, fill, and dwell cycles. However, the APD machine typically performs the cycle automatically while the patient is sleeping. The APD machine frees the patient from having to perform the treatment cycles manually and also frees the patient from having to transport supplies during the day. The APD machine is fluidly connected to an implanted catheter, a source of fresh dialysate, or a bag of fresh dialysate, and a fluid drain. The APD machine pumps fresh dialysate from the source, through the catheter, and into the patient's peritoneal cavity. The APD machine also allows the dialysate to dwell within the cavity and allows the transport of waste, toxins, and excess water to occur. The source can include a plurality of sterile dialysate solution bags.

[0015] The APD machine pumps used or spent dialysate from the peritoneal cavity, through the catheter, and to the drain. As with the manual process, several drain, fill, and dwell cycles occur during dialysis. A "last fill" occurs at the end of the APD and remains in the patient's peritoneal cavity until the next treatment.

[0016] Any of the above approaches performed by a machine can employ pneumatic pumping. Pneumatic pumping generally involves applying positive and / or negative air pressure to pump membranes or diaphragms and associated valve membranes or diaphragms. Positive pressure can be provided via a compressor feeding a positive pressure tank or positive pressure accumulator. Negative pressure can be provided via a vacuum pump feeding a negative pressure tank or negative pressure accumulator.

[0017] The positive and negative pressure tanks are separated from the pump and valve membranes via pneumatic valves, which are typically electrically actuated pneumatic valves. The pneumatic valves can be two-way solenoid valves or on / off solenoid valves that can be spring closed and electrically opened by energizing the windings of a solenoid. Alternatively, the pneumatic valves can be variable orifice valves that open or close in an analog fashion based on the electrical energy delivered to the valve.

[0018] Pneumatic valves operate with air passages. It is important to first seal the valve around the passage so that air does not leak from the atmosphere into the passage or from the passage to the atmosphere. However, in sealing the valve around the passage, care should be taken to not have material from the valve or from the valve mount fall into or otherwise enter the passage, which can negatively affect the operation of the valve and / or cause damage.

[0019] Additionally, the pneumatic valves can wear out or need replacement over time, e.g., due to a maintenance schedule. While it is generally a goal to have a compact machine, the valves should be easily accessible so that they can be individually removed and replaced when needed. SUMMARY

[0020] In one primary embodiment, a connection device is provided. The connection device is formed with a body. The body can be the body of any type of fluid control component including, but not limited to, a variable orifice valve body, a binary valve body, a pressure gauge body, a pressure regulator body, a flow meter body, a filter body, a piece of tubing, piping, and / or associated fittings. The fluid can be any type of working fluid including air, liquid such as water, hydraulic or oil. In each case, the connection device prevents the introduction of particulate during attachment of the connection device and associated body to a mounting structure such as a pneumatic pressure manifold.

[0021] The connection device in the embodiment includes a port having a threaded portion extending from the body and a non-threaded portion (e.g., smooth) extending from the threaded portion. The non-threaded portion carries a gasket such as an O-ring gasket positioned along the non-threaded portion such that the mounting structure to which the connection device is installed contacts the gasket before the threaded portion engages a mating threaded portion of the mounting structure. In this way, the threaded connection is sealed off from the fluid path prior to making the connection. In this way, any swarf or debris loosened as the connection device is threaded onto the mounting structure is captured by the O-ring and does not fall into the fluid path. Thereafter, the port allows fluid communication between the fluid path and the body.

[0022] The above connection device and the like disclosed herein can be used with, for example, pneumatic manifolds for medical fluid therapy such as: plasmapheresis therapy, hemodialysis ("HD"), hemofiltration ("HF"), hemodiafiltration ("HDF"), and continuous renal replacement therapy ("CRRT") treatments. The devices, manifolds, systems, and methods described herein are also applicable to peritoneal dialysis ("PD") and intravenous drug delivery. These modalities can be referred to collectively or individually herein as medical fluid delivery.

[0023] Further, each of the devices, systems, and methods described herein can be used with a clinical or home-based machine. For example, the system can be used with a center HD, HF, or HDF machine that operates all day. Alternatively, the system can be used with a home HD, HF, or HDF machine that operates when it is convenient for the patient. One such home system is described in U.S. Patent No. 8,029,454 (“the ‘454 patent”), filed November 4, 2004, issued October 4, 2011, entitled “High Convection Home Hemodialysis / Hemofiltration and Sorbent System,” which is assigned to the assignee of the present application. Another such home system is described in U.S. Patent No. 8,393,690 (“the ‘690 patent”), filed August 27, 2008, issued March 12, 2013, entitled “Enclosure for a Portable Hemodialysis System.” The entire contents of each of the above-referenced documents are incorporated herein by reference and relied upon.

[0024] In one embodiment, a medical fluid delivery machine is provided that includes a medical fluid delivery chassis. The medical fluid delivery chassis houses components required to deliver medical fluid, such as one or more pumps, valves, a heater (if needed), an on-line medical fluid generation device (if needed and desired), a plurality of sensors (such as any one or more, or all, of a pressure sensor, a conductivity sensor, a temperature sensor, an air detector, a blood leak detector, etc.), a user interface, and a control unit that can employ one or more processors and memory to control the above-mentioned devices.

[0025] Various components, such as fluid pumps and valves, can be pneumatically actuated. In this case, it is envisioned that a pneumatic manifold is provided that houses binary solenoid valves and / or variable pneumatic valves that selectively allow either positive pressure air or negative pressure air to reach a desired location, such as the air side of a pump or valve membrane. “Air” as used herein refers to naturally occurring air, which is composed of individual gases, such as nitrogen, oxygen, argon, and carbon dioxide. “Air” can also include a desired modified atmosphere, such as a larger percentage of a gas such as nitrogen or carbon dioxide or a pure gas such as nitrogen or carbon dioxide. The term “pneumatic” also refers to naturally occurring air and / or any type of modified atmosphere.

[0026] The pneumatic valves of the manifold receive positive pressure air and / or negative pressure air from one or more positive pressure air accumulators and / or negative pressure air accumulators. For example, the machine can include a high positive pressure accumulator, a low positive pressure accumulator, and one or more negative pressure accumulators. The positive pressure accumulators are pressurized via a compressor that runs air through a dryer. The one or more negative pressure accumulators are pressurized via a vacuum pump.

[0027] The manifold is mounted inside the chassis of the machine via a mounting assembly. The outside of the manifold is a faceplate that, in one embodiment, is connected to the mounting assembly. In one embodiment, the faceplate provides quick pneumatic coupling between the positive and negative pressure accumulators and the pneumatic manifold. To this end, the faceplate can be connected to the pneumatic manifold via pneumatic lines or activation conduits, which can be flexible or rigid, as even rigid pneumatic conduits are sufficiently flexible to allow for the movement of the faceplate described below. In embodiments, the faceplate also includes quick connections to power connections, such as alternating current ("AC") power connections and direct current ("DC") power connections. To this end, the faceplate can be further connected to flexible electrical wires leading to necessary locations within the machine.

[0028] In one embodiment, the mounting assembly includes a fixed portion that is secured to the machine and the faceplate, which are removable portions that are secured to the fixed portion. The fixed portion may, for example, include first and second flanges that are bolted to the machine chassis and the pneumatic manifold to support the manifold. In one embodiment, the removable portion or faceplate is positioned between the first and second flanges and is bolted thereto. In embodiments, quick connections to the accumulators and electrical wires are provided on the outward-facing surface of the removable faceplate, while pneumatic lines to the pneumatic manifold and flexible power wires to the machine are provided on the inward-facing surface of the removable faceplate.

[0029] If necessary, the removable faceplate can be detached from the fixed portion and swung away, enabling a service technician to access the pneumatic valves attached to the pneumatic manifold. By providing ready access to the pneumatic manifold, the pneumatic valves can be easily replaced without having to remove or move the pneumatic manifold itself. Once replaced, the removable faceplate can be swung back into position against the fixed portion and reattached.

[0030] As discussed above, there can be different types of pneumatic valves connected to the pneumatic manifold, such as binary (on-off) valves and variable orifice valves (variable valves). The valves, and in particular the variable valves, can be sealed to the surface of the plate of the pneumatic manifold. The seal typically involves sealing around two holes in the plate and two orifices in the valve, i.e. around the air inlet hole / orifice and the air outlet hole / orifice. In embodiments, the valve includes two O-rings, a central O-ring that seals the centrally located valve orifice and an outer O-ring that seals the offset valve orifice in combination with the centrally located O-ring. The present disclosure provides different embodiments for sealing the pneumatic valve to the plate of the pneumatic manifold.

[0031] In one embodiment, a clamping bracket is provided that compresses the valve to the plate of the pneumatic manifold, thereby compressing the inner and outer O-rings. The clamping bracket can be made of metal or hard plastic, such as Teflon. In embodiments, the clamping bracket fits around and in contact with the valve diameter located approximately in the middle of the valve, thereby exposing the top electrical contact portion of the valve to receive the electrical wires. Thus, the clamping bracket can be provided in two or more pieces or members that come together from opposite sides of the valve and extend around the valve diameter. In this way, the force from the clamping bracket is evenly distributed on the valve so that the valve does not tilt during compression and so that the O-rings are evenly compressed.

[0032] The clamping bracket can be secured to the manifold plate by fastening the bracket members into the plate of the pneumatic manifold adjacent to the pneumatic valve. The bracket provides a flange with one or more mounting holes that align with one or more threaded holes in the plate. In this way, the pneumatic valve can be easily replaced by unfastening the bracket members or unfastening one bracket member and loosening the other bracket member. The fastening bracket allows the valve to be secured to the manifold, thereby compressing the sealing O-rings without introducing contaminants associated with mating with threaded components into the pneumatic path.

[0033] In other embodiments, the pneumatic valve is screwed into the plate of the pneumatic manifold. Here, problems can arise because the screwing has the potential to shear and introduce particulate material into the pneumatic path and lines. In certain embodiments, the threads of the pneumatic valve can be stainless steel, which can be a relatively hard material compared to the material of the manifold plate, which can be aluminum. Thus, the softer aluminum can shear. Introducing particulate material into the pneumatic path or lines can cause premature failure of components of the entire pneumatic system, such as the pneumatic valve, fluid valve chamber, or fluid pump chamber.

[0034] Accordingly, it is contemplated to provide a seal that seals the threaded engagement from the rest of the pneumatic system before the threaded engagement occurs. In one embodiment, a pneumatic valve is provided with a port that is threaded adjacent to the valve body and extends to a smooth portion. A mating aperture formed in a plate of a pneumatic manifold, likewise includes a mating threaded portion adjacent to a surface of the plate that extends to a mating smooth portion. A gasket, such as an O-ring gasket, is fitted onto the smooth portion of the valve port or is fitted in the smooth portion of the aperture formed in the pneumatic manifold plate. When the valve is fastened to the manifold, the mating smooth portions of the valve port and plate aperture compress the gasket prior to the threaded engagement between the port and the aperture. In this way, a protective seal is formed between the pneumatic system and the threaded connection before the male and female threaded portions come into contact. The protective seal prevents particles that can be generated by the contact of the male and female threaded portions from entering the pneumatic system.

[0035] If the gasket is fitted to the port of the valve, the smooth portion of the port can be provided with a groove in which the gasket is seated. If the gasket is instead placed into the aperture of the manifold plate, the gasket can be seated on a stopper formed or placed into the aperture. In either case, the gasket is securely held when compressed. The gasket is a first gasket. As discussed above, the valve body can be equipped with one or more additional gaskets to seal around one or more holes formed in the valve body.

[0036] In one embodiment, the medical fluid machine of the present disclosure places pneumatic pumping components, such as a compressor and associated dryer, a vacuum pump, at least one positive pressure accumulator, and at least one negative pressure accumulator, in a pneumatic pump box. The pneumatic pump box can be removably connected to the medical fluid delivery chassis so that the pump box can be moved away from the patient to reduce noise. A plurality of pneumatic lines and electrical wires can run from the pneumatic pump box to the medical fluid delivery chassis of the machine.

[0037] In an embodiment, the removed pump box exposes a back side of the medical fluid delivery chassis and an access door. The access door is removable to expose a removable electronics cage. The electronics cage holds a plurality of printed circuit boards ("PCBs") and other electrical equipment of the medical fluid machine. The electronics cage is structured to (i) provide physical shock support and vibration support for the unit's PCBs, and (ii) provide electromagnetic shielding for the electrical components. The electronics cage is positioned to prevent heat generated from the unit's internal heat elements from being transferred to the electronics cage. In one embodiment, the electronics cage is also structured to allow sufficient airflow to the PCBs to prevent them from prematurely failing due to overheating.

[0038] In embodiments, the electronics cage is electrically attached to the medical fluid machine such that the machine is able to continue to work even when the electronics cage is completely removed from the interior of the device. This functionality allows service personnel to better access the PCB and fluid components within the machine during servicing activities, such as diagnostic testing. Electrical components that are not held within the electronics cage include the power supply and other electrical equipment that generates heat, such as transformers (which can be part of the power supply). By doing so, heat generated by the power supply and the like is not trapped within the electronics cage.

[0039] Providing the electronics cage and hinging it on one side also enables the PCB and other electrical equipment of the machine to be securely held in place, thereby improving reliability. The movable electronics cage also improves the serviceability of the machine in terms of both the contents of the cage and by opening up the interior space within the machine, thereby allowing better access to other machine components.

[0040] In accordance with the disclosure herein and without limiting the disclosure in any way, in a first aspect of the disclosure, which can be combined with any other aspect listed herein unless otherwise stated, a medical fluid delivery machine comprises: a medical fluid pump comprising a pneumatic pump chamber and first and second pneumatic medical fluid valve chambers respectively upstream and downstream of the pneumatic pump chamber; at least one of a positive or negative air pressure source for supplying positive or negative pressure air to at least one of the pneumatic pump chamber, the first pneumatic medical fluid valve chamber or the second pneumatic medical fluid valve chamber; a pneumatic manifold comprising an air passage, the pneumatic manifold being in fluid communication with (i) at least one of the pneumatic pump chamber, the first pneumatic medical fluid valve chamber or the second pneumatic medical fluid valve chamber and (ii) the at least one positive or negative air pressure source, the pneumatic manifold defining a manifold aperture; and a pneumatic valve defining a valve aperture, the valve aperture being sized and arranged such that when the pneumatic valve is seated against the pneumatic manifold, the valve aperture mates with the manifold aperture, the pneumatic valve comprising: a gasket extending around the valve aperture and a bracket configured to clamp the pneumatic valve to the pneumatic manifold, thereby compressing the gasket to seal the pneumatic valve to the manifold.

[0041] In a second aspect of the disclosure, which can be combined with any other aspect listed herein unless otherwise stated, the bracket is removably fastened to the pneumatic manifold.

[0042] In a third aspect of the disclosure, which can be combined with any other aspect listed herein unless otherwise stated, the bracket fits around a diameter of the pneumatic valve so as to expose an upper electrical connection portion of the pneumatic valve.

[0043] In a fourth aspect of the disclosure, which can be combined with any of the other aspects listed herein unless otherwise stated, the bracket includes a plurality of members, each of which fits around a diameter of the pneumatic valve.

[0044] In a fifth aspect of the fourth aspect of the disclosure, which can be combined with any of the other aspects listed herein unless otherwise stated, the plurality of members abut one another when fitted around the diameter of the pneumatic valve.

[0045] In a sixth aspect of the fourth aspect of the disclosure, which can be combined with any of the other aspects listed herein unless otherwise stated, the plurality of members are configured to disperse a holding force around the pneumatic valve.

[0046] In a seventh aspect of the disclosure, which can be combined with any of the other aspects listed herein unless otherwise stated, the valve aperture is a first valve aperture, and it includes a second valve aperture and a second gasket, the first and second gaskets sealing around the second valve aperture via clamping of the bracket.

[0047] In an eighth aspect of the seventh aspect of the disclosure, which can be combined with any of the other aspects listed herein unless otherwise stated, the first valve aperture is positioned along a central axis of the pneumatic valve, and the second valve aperture is spaced apart from the central axis.

[0048] In a ninth aspect of the seventh aspect of the disclosure, which can be combined with any of the other aspects listed herein unless otherwise stated, the first and second gaskets are O-ring gaskets.

[0049] In a tenth aspect of the disclosure, which can be combined with any of the other aspects listed herein unless otherwise stated, a medical fluid delivery machine includes: a medical fluid pump including a pneumatic pump chamber and first and second pneumatic medical fluid valve chambers positioned upstream and downstream, respectively, of the pneumatic pump chamber; at least one of a positive or negative air pressure source for supplying positive or negative pressure air, respectively, to at least one of the pneumatic pump chamber, the first pneumatic medical fluid valve chamber, or the second pneumatic medical fluid valve chamber; a pneumatic manifold including an air passageway, the pneumatic manifold being in fluid communication with (i) at least one of the pneumatic pump chamber, the first pneumatic medical fluid valve chamber, or the second pneumatic medical fluid valve chamber and (ii) the at least one positive or negative air pressure source, the pneumatic manifold defining an aperture including a threaded portion; a gasket; and a pneumatic valve including a pneumatic port having a mating threaded portion and a smooth portion, the pneumatic port being sized and arranged such that, when the pneumatic valve is connected to the pneumatic manifold, the smooth portion contacts the gasket before the mating threaded portion of the valve engages the threaded portion of the aperture.

[0050] In a eleventh aspect of the disclosure, which can be combined with any other aspect listed herein unless otherwise stated, the dimensions and arrangement of the smooth portion of the pneumatic port are adapted to seal to the inner diameter of the gasket, and the outer diameter of the gasket seals to the surface of the aperture.

[0051] In a twelfth aspect of the disclosure, which can be combined with any other aspect listed herein unless otherwise stated, the gasket is initially located in the aperture.

[0052] In a thirteenth aspect of the disclosure, which can be combined with any other aspect listed herein unless otherwise stated, the gasket is seated on a stop in the aperture, the inner diameter of the stop being smaller than the inner diameter of the threaded portion of the aperture.

[0053] In a fourteenth aspect of the disclosure, which can be combined with any other aspect listed herein unless otherwise stated, the gasket is initially located on the smooth portion of the pneumatic port.

[0054] In a fifteenth aspect of the disclosure, which can be combined with any other aspect listed herein unless otherwise stated, the gasket is located within a groove formed in the smooth portion of the pneumatic port.

[0055] In a sixteenth aspect of the disclosure, which can be combined with any other aspect listed herein unless otherwise stated, the aperture includes a threaded portion and a smooth portion, the gasket extends through the threaded portion, and the gasket seals against the smooth portion of the aperture when the pneumatic valve is connected to the pneumatic manifold.

[0056] In a seventeenth aspect of the disclosure, which can be combined with any other aspect listed herein unless otherwise stated, the pneumatic valve defines an aperture, the gasket is a first gasket, and it includes a second gasket extending around the outside of the aperture, the second gasket being compressed when the pneumatic valve is connected to the pneumatic manifold.

[0057] In a twenty-first aspect of the disclosure, which can be combined with any other aspect listed herein unless specified otherwise, the machine includes a machine frame and a mounting assembly attached to the machine frame and mounting the pneumatic manifold, and wherein the mounting assembly includes a fixed portion secured to the machine frame, the panel being removably attached to the fixed portion.

[0058] In a nineteenth aspect of the disclosure, which can be combined with any other aspect listed herein unless specified otherwise, the machine includes a machine frame and a mounting assembly attached to the machine frame and mounting the pneumatic manifold, and wherein the mounting assembly includes a fixed portion secured to the machine frame, the panel being removably attached to the fixed portion.

[0059] In a twentieth aspect of the disclosure, which can be combined with any other aspect listed herein unless specified otherwise, the fixed portion includes a first mounting flange and a second mounting flange, the panel being between the first mounting flange and the second mounting flange.

[0060] In a twenty-first aspect of the disclosure, which can be combined with any other aspect listed herein unless specified otherwise, the fixed portion is threaded to the frame, and the panel is threaded to the fixed portion.

[0061] In a twenty-second aspect of the disclosure, which can be combined with any other aspect listed herein unless specified otherwise, the panel is configured to provide quick pneumatic connections to a plurality of positive air pressure sources and a plurality of negative air pressure sources.

[0062] In a twenty-third aspect of the disclosure, which can be combined with any other aspect listed herein unless specified otherwise, the panel is configured to provide quick electrical connections, the panel being additionally connected to electrical wires running to the machine.

[0063] In a twenty-fourth aspect of the disclosure, which can be combined with any other aspect listed herein unless specified otherwise, a connection device 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 positioned along the non-threaded portion such that a mounting structure in which the connection device is mounted contacts the gasket before the threaded portion engages a mating threaded portion of the mounting structure, the port providing fluid communication between the body and the pathway of the mounting structure.

[0064] In a twenty-fifth aspect of the twenty-fourth aspect of the disclosure, which can be combined with any other aspect listed herein unless specified otherwise, the body is a valve body configured to be electrically actuated to move a member to open or close a fluid passage member, the member and passage being located within the valve body.

[0065] In a twenty-sixth aspect of the twenty-fourth aspect of the disclosure, which can be combined with any other aspect listed herein unless specified otherwise, the non-threaded portion defines a groove that receives the gasket.

[0066] In a twenty-seventh aspect of the twenty-fourth aspect of the disclosure, which can be combined with any other aspect listed herein unless specified otherwise, the body includes a surface from which the port extends, 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.

[0067] In a twenty-eighth aspect of the twenty-fourth aspect of the disclosure, which can be combined with any other aspect listed herein unless specified otherwise, the connection device is configured for use with a pneumatic system, a water-based or oil-based system.

[0068] In a twenty-ninth aspect of the twenty-fourth aspect of the disclosure, which can be combined with any other aspect listed herein unless specified otherwise, the body is a variable orifice valve body, a binary valve body, a pressure gauge body, a pressure regulator body, a flow meter body, a filter body, a piece of tubing, a piece of piping, or a tubing / piping fitting.

[0069] In a thirtieth aspect of the disclosure, in combination with Figures 1 to 10 Any of the structures and functions disclosed can be combined with Figures 1 to 10 Any other structures and functions disclosed.

[0070] According to the present disclosure and the above aspects, therefore, it is an advantage of the present disclosure to provide an improved medical fluid delivery apparatus.

[0071] Another advantage of the present disclosure is to provide an improved pneumatic manifold for a medical fluid delivery device.

[0072] A further advantage of the present disclosure is to provide a pneumatic manifold for a medical fluid delivery device that properly seals pneumatic valves to the manifold.

[0073] Yet another advantage of the present disclosure is to provide a pneumatic manifold for a medical fluid delivery device that attempts to maintain the air passages to and from pneumatic valves free of particulates.

[0074] Yet a further advantage of the present disclosure is to provide a pneumatic manifold that allows ready access to pneumatic valves for repair and replacement.

[0075] Still another advantage of the present disclosure is to maintain sensitive electronics in a cooler environment.

[0076] Still a further advantage of the present disclosure is to provide ready access to sensitive electronics and other components within the medical fluid machine chassis.

[0077] In addition, an advantage of the present disclosure is to provide a high temperature air detector with consolidated electronics.

[0078] The advantages discussed herein can be found in one or some, and possibly not all, of the embodiments disclosed herein. Additional features and advantages are described herein, and will be apparent from the following detailed description and the drawings. BRIEF DESCRIPTION OF DRAWINGS

[0079] Figure 1 is a schematic diagram of one embodiment of a kidney failure treatment operated by a machine that mounts pneumatic valves with the pneumatic manifold of the present disclosure.

[0080] Figure 2 is a perspective view showing a blood assembly for use with the kidney failure treatment machine of Figure 1 is a perspective view of a blood assembly for use with the kidney failure treatment machine of

[0081] Figure 3A is a perspective view of one embodiment of the kidney failure treatment machine of Figure 1

[0082] Figure 3B is a perspective view of one embodiment of the kidney failure treatment machine of Figure 3A

[0083] Figure 4A and Figure 4B ​​are front and bottom views, respectively, of an embodiment of a pneumatic manifold installation scheme that includes removable panels to enable access to various pneumatic valves connected to the pneumatic manifold.

[0084] Figures 5 to 8 A first embodiment for mounting pneumatic valves to the plate of the pneumatic manifold of the present disclosure is shown.

[0085] Figure 9A and Figure 9B A second embodiment for mounting pneumatic valves to the plate of the pneumatic manifold of the present disclosure is shown.

[0086] Figure 10 A third embodiment for mounting pneumatic valves to the plate of the pneumatic manifold of the present disclosure is shown. DETAILED DESCRIPTION

[0087] The examples described herein can be adapted to any medical fluid delivery system that delivers medical fluids such as blood, dialysate, replacement fluid, and / or intravenous drugs ("IV"). The examples are particularly suitable for renal failure therapies such as all forms of hemodialysis ("HD"), hemofiltration ("HF"), hemodiafiltration ("HDF"), continuous renal replacement therapy ("CRRT"), and peritoneal dialysis ("PD"), which are collectively or individually referred to herein as renal failure therapies. Furthermore, the machines and any pneumatically operated systems and methods described herein can also be used in a clinical or home environment. For example, a machine including the pneumatic manifold of the present disclosure can be employed in a center HD machine that runs continuously almost around the clock. Alternatively, the pneumatic manifold and other features of the present disclosure can be used in a home use HD machine that is able to run overnight, for example, while the patient is sleeping. Furthermore, each of the renal failure therapy examples described herein can employ a diffusion membrane or filter such as, for example, a dialyzer for HD or HDF, or a hemofilter for HF.

[0088] Referring now to Figure 1 , an example of a HD flow schematic for a medical fluid delivery system 10 employing the pneumatic manifold and other features of the present disclosure is shown. Because Figure 1 HD systems are relatively complex, the Figure 1and the discussion thereof also provide support for any of the renal failure treatment modalities and IV machines discussed above. Generally, the system 10 is shown with a very simplified version of the dialysate or process fluid delivery circuit. While the blood circuit is also simplified, it is not to the extent that the dialysate circuit is simplified. It should be understood that the circuit has been simplified to make the description of the disclosure easier and that if implemented, the system will have additional structure and functionality such as found in the publications incorporated by reference above.

[0089] Figure 1 The system 10 includes a blood circuit 20. The blood circuit 20 draws blood from the patient 12 and returns blood to the patient 12. Blood is drawn from the patient 12 via an arterial line 14 and returned to the patient via a venous line 16. The arterial line 14 includes an arterial line connector 14a connected to an arterial needle 14b that is in blood draw communication with the patient 12. The venous line 16 includes a venous line connector 16a connected to a venous needle 16b that is in blood return communication with the patient. The arterial line 14 and the venous line 16 also include wire clamps 18a and 18v that can be spring loaded, fail-safe mechanical pinch clamps. In one embodiment, the wire clamps 18a and 18v automatically close in the event of an emergency.

[0090] The arterial line 14 and the venous line 16 also include air detectors or bubble detectors 22a and 22v, respectively, that can be ultrasonic air detectors. The air detectors or bubble detectors 22a and 22v look for air in the arterial line 14 and the venous line 16, respectively. If air is detected by one of the air detectors 22a and 22v, the system 10 closes the wire clamps 18a and 18v, pauses the blood pump and the dialysate pump, and provides instructions to the patient to clear the air so that treatment can be resumed. In one embodiment, the air detectors 22a and 22v are made of aircraft grade materials that allow the sensors to operate in high temperature environments. Figure 2 The arterial line 14 and the venous line 16 are shown in one embodiment receiving high temperature disinfecting water between treatments. The air detectors 22a and 22v contact the lines 14 and 16 to operate and are thereby heated when disinfected. The air detectors 22a and 22v and associated electronics are formed so that they can operate in a heated environment of, for example, 105°C, so that the system 10 and machine 90 can consolidate several electronic components into one small integrated package near the detectors 22a and 22v, thereby improving the reliability of the system 10 while reducing its cost.

[0091] In the illustrated embodiment, blood pump 30 is located in arterial line 14. In the illustrated embodiment, blood pump 30 includes a first blood pump chamber 30a and a second blood pump chamber 30b. Blood pump chamber 30a operates with inlet valve 32i and outlet valve 32o. Blood pump chamber 30b operates with inlet valve 34i and outlet valve 34o. In one embodiment, blood pump chambers 30a and 30b are each a blood container that includes a rigid outer shell, e.g., spherical, with a flexible diaphragm located within the shell, forming a diaphragm pump. One side of each diaphragm receives blood, and the other side of each diaphragm is operated by negative and positive air pressure. Blood pump 30 is alternatively a peristaltic pump that operates with the arterial line 14 tubing.

[0092] In the illustrated embodiment, heparin bottle 24 and heparin pump 26 are located between blood pump 30 and blood filter 40, e.g., a dialyzer. Heparin pump 26 can be a pneumatic pump or a syringe pump, e.g., a stepper motor driven syringe pump. Supplying heparin upstream of blood filter 40 helps prevent clotting of the filter membrane.

[0093] Control unit 50 includes one or more processors 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 disconnect sensors 102, 104) and controls components such as clamps 18a and 18v, blood pump 30, heparin pump 26, and dialysate pump. Blood exiting blood filter 40 via venous line 16 flows through air trap 110. Air trap 110 removes air from the blood before the dialyzed blood is returned to patient 12 via venous line 16.

[0094] For example, in one embodiment, control unit 50 is configured to control blood pump 30 to operate at a first speed when air detector 22a detects air in arterial line 14 and to operate at a second speed when air detector 22a does not detect air in arterial line 14. In one embodiment, the second speed is greater than the first speed. In one embodiment, the second speed is greater than the first speed by a factor of 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, or 100. Figure 1A hemodialysis version of the system 10 of FIG. 1, dialysate or dialysis fluid is pumped along the outside of the membrane of the hemofilter 40 while blood is pumped through the inside of the hemofilter membrane. The dialysate or dialysis fluid is prepared starting with 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, filed April 25, 2011, entitled "Water Purification System and Method," the entire contents of which are incorporated herein by reference and relied upon. In one embodiment, the water purification unit includes filters and other structures to purify tap water (e.g., to remove pathogens and ions such as chlorine) so that in one implementation, the water is less than 0.03 endotoxin units / ml ("EU / ml") and less than 0.1 colony forming units / ml ("CFU / ml"). The water purification unit 60 can be disposed in a housing separate from the housing or chassis of the hemodialysis machine that includes the blood circuit 20 and the dialysate circuit 70.

[0095] The dialysate circuit 70 is again highly simplified in FIG. 2 to facilitate illustration. The dialysate circuit 70 can actually include all of the relevant structures and functionality set forth in the publications incorporated by reference above. Certain features of the dialysate circuit 70 are illustrated in FIG. 3. Figure 1 Figure 1 The dialysate circuit 70 includes, in the illustrated embodiment, a hemofilter dialysate pump 64. In one embodiment, the pump 64 is constructed the same as the blood pump 30. The pump 64 includes a pair of pump chambers as does the blood pump 30, which can also be constructed to be spherical. As with the blood pump 30, the two pump chambers are operated alternately so that one pump chamber is filled with HD dialysate while the other pump chamber is expelling HD dialysate.

[0096] The pump 64 is a hemofilter dialysate pump. There is another dual chamber pump chamber 96 that operates with valves 98i and 98o located in the drain line 82 to push used dialysate to drain. There is a third chamber pump (not shown) for pumping the pump purification water through the bicarbonate cartridge 72. There is a fourth chamber pump (not shown) for pumping acid from the acid container 74 into the mixing line 62. The third and fourth pumps are concentrate pumps, which can be single chamber pumps because continuous pumping is less important in the mixing line 62 because, in one embodiment, there is a buffer dialysate tank (not shown) between the mixing line 62 and the hemofilter dialysate pump 64.

[0097] ​A fifth chamber pump (not shown) disposed in drain line 82 is used to remove a known amount of ultrafiltrate ("UF") while providing HD therapy. System 10 tracks 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 at the end of therapy.

[0098] Each of the above-described pumps can alternatively be peristaltic pumps operated with tubing. If so, the system valves can still be pneumatically actuated in accordance with the features of the present disclosure.

[0099] In one embodiment, purified water from water purification unit 60 is pumped along mixing line 62 through bicarbonate cartridge 72. Acid from container 74 is pumped along mixing line 62 into the bicarbonated water flowing from bicarbonate cartridge 72 to form electrolyzed and physiologically compatible dialysate. Although pumps and temperature-compensated conductivity sensors for properly mixing the purified water with bicarbonate and acid are not shown, they are disclosed in detail in the disclosures incorporated by reference above.

[0100] Figure 1 It is also shown that dialysate is pumped along fresh dialysate line 76 through heater 78 and ultrafilter 80 before reaching blood filter 40, after which used dialysate is pumped to drain via drain line 82. Heater 78 heats the dialysate to body temperature or about 37°C. Ultrafilter 80 further cleans and purifies the dialysate before reaching blood filter 40, filtering for example germs or contaminants introduced into the dialysate via bicarbonate cartridge 72 or acid container 74.

[0101] In the illustrated embodiment, dialysate circuit 70 also includes sample port 84. Dialysate circuit 70 will further include a blood leak detector (although not shown, used to detect whether blood filter 40 fibers are torn) and other not shown components (such as a balance chamber, multiple dialysate valves, and a dialysate reservoir), all of which are shown and described in detail in the disclosures incorporated by reference above.

[0102] In the illustrated embodiment, hemodialysis system 10 is an online, straight-through system that pumps dialysate through blood filter once and then pumps used dialysate to drain. Both blood circuit 20 and dialysate circuit 70 can be heat water sterilized after each treatment, so that blood circuit 20 and dialysate circuit 70 can be reused. In one implementation, blood circuit 20 including blood filter 40 is heat water sterilized and reused daily for about one month, while dialysate circuit 70 is heat water sterilized and reused for about six months.

[0103] In alternative embodiments, or for example for CRRT, multiple bags of sterile dialysate or infusate are combined together and used one after the other. In this case, an empty supply bag can be used as a drain or waste bag.

[0104] The machine 90 of the system 10 includes a housing as shown by the dashed lines of Figure 1 The housing of the machine 90 varies depending on the type of treatment, whether the treatment is in-center or home treatment, and whether the dialysate / infusate supply is batch (e.g., bagged) or online.

[0105] Figure 2 The machine 90 of the system 10 is shown in Figure 1 Operation of the machine 90 of the system 10 can be with a blood set 100. The blood set 100 includes the arterial line 14, the venous line 16, the heparin bottle 24, the heparin pump 26 / blood pump 30, and the blood filter 40 (e.g., dialyzer). An air trap 110 can be located in the venous line 16 to remove air from the blood before the air returns to the patient 12. The high temperature air detectors 22a and 22v contact and thereby operate with the arterial line 14 and the venous line 16, respectively, as discussed herein.

[0106] In Figure 1 and 2 , any of the pumps 26, 30 (30a and 30b), 64, 96 (and other pumps not shown) and any of the valves (such as the valves 32i, 32o, 34i, 34o, 68i, 68o, 98i, and 98o) can be pneumatic. In one embodiment, each of the pumps and valves has a fluid side and an air side separated by a flexible membrane. Negative pneumatic pressure can be applied to the air side of the membrane to draw fluid into a pump chamber or open a valve (or a pump or valve can 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 close a valve.

[0107] Reference is now made to Figure 3A which shows an embodiment of a medical fluid delivery machine 90, such as an HD machine. The medical fluid delivery machine 90 in the embodiment shown includes a medical fluid delivery chassis 120 connected to a pneumatic pump box 150. The pump box 150 holds pneumatic pumping equipment, such as a compressor and associated dryer, a vacuum pump, at least one positive pressure accumulator, and at least one negative pressure accumulator. In one embodiment, the pneumatic pump box 150 is removably connected to the 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 electrical line Figure 3B) from the pneumatic pump box 150 to the medical fluid delivery chassis 120 to drive any of the pumps 26, 30 (30a and 30b), 64, 96 (and other not shown pumps) and valves (such as valves 32i, 32o, 34i, 34o, 68i, 68o, 98i, and 98o) located within or mounted to the medical fluid delivery chassis 120.

[0108] Reference is now made to Figure 3B which shows the medical fluid delivery machine with the pump box 150 removed. As discussed above, the removed pump box 150 remains in pneumatic and operable communication with the medical fluid delivery chassis 120 via the extended pneumatic lines 86 and the extended electrical lines 88. The removed pump box exposes the back side 122 and the access door 124 of the medical fluid delivery chassis 120. In the illustrated embodiment, the access door 124 rotates open along a bottom hinge 126. In alternative embodiments, the access door 124 can translate away from the back side 122 in a drawer-like manner via a track. In either case, removal of the access door 124 exposes the electronics cage 130 (shown with the door of the electronics cage 130 open to see the interior side).

[0109] The electronics cage 130 holds a plurality of printed circuit boards ("PCBs") such as PCBs 132, 134, 136, and 138, and other electrical equipment of the machine 90. The electronics cage 130 is made of a material such as high temperature plastic, steel, or stainless steel that shields the PCBs 132, 134, 136, and 138, and other electrical equipment of the machine 90 from heat generated within the machine (e.g., from the heater 78 and fluid carrying equipment within the machine 90 that is subjected to heat sterilization). One electrical component that is not held within the electronics cage 130 is the power supply 140 and associated transformer, which generate heat themselves. The power supply 140 (and associated transformer, which can be inside the power supply housing) in the illustrated embodiment is instead mounted to the top of the electronics cage 130. By doing so, heat generated by the power supply 140 is not trapped within the electronics cage 130. It has been found that a 10 °C increase in temperature of components on a PCB can cut its useful life in half.

[0110] As shown in Figure 3B hinged on one side provides a number of benefits. First, the electronics cage 130 enables the PCBs 132, 134, 136, and 138, and other electrical equipment of the machine 90 to be held securely in place, improving reliability. The removable electronics cage 130 also improves the serviceability of the machine 90 with respect to the two contents of the cage 130 by opening up the interior space 106 within the machine 90, allowing better access to other machine components. The components are also easily accessible due to the removability of the pump box 150.

[0111] Referring now to Figure 4A and 4B In one embodiment, pneumatic components such as pneumatic regulators, electrically actuated binary solenoid valves, and electrically actuated variable pneumatic valves (variable valves) are located on a pneumatic manifold 160. In the illustrated embodiment, the manifold 160 is pneumatically sealed to electrically actuated binary solenoid valves 162 and electrically actuated variable pneumatic valves (variable valves) 164.

[0112] The pneumatic manifold 160 is mounted within the machine 90 via a mounting assembly 170 that is secured to a frame 92 of the machine 90. The mounting assembly 170 includes a fixed portion having first and second mounting flanges 172a and 172b. The first and second mounting flanges 172a and 172b are secured to the frame 92 of the machine 90 via fasteners 166a. The mounting assembly 170 includes a removable portion in the form of a faceplate 174 that is removably mounted to the first and second mounting flanges 172a and 172b via fasteners 166b. The mounting flanges 172a and 172b and the removable faceplate 174 can be made of metal, such as stainless steel or aluminum. The mounting flanges 172a and 172b in turn mount the pneumatic manifold 160 from below via fasteners 166d.

[0113] The removable faceplate 174 in turn supports one or more quick disconnect plates 180 that are attached to the faceplate 174 via fasteners 166c. The quick disconnect plate 180 provides quick disconnect connections to the machine 90 for first and second vacuum lines via sockets 182, low positive pressure via sockets 184, high positive pressure via sockets 186, AC power via sockets 188, and DC power via sockets 190. As shown in Figure 4B The pneumatic quick disconnect sockets 182, 184, and 186 are in pneumatic communication with various components of the pneumatic manifold 160 via pneumatic lines 86, as shown in Figure 4B The electrical power quick disconnect sockets 188 and 190 are in electrical communication with a plurality of electrical components of the machine 90, including components of the pneumatic manifold 160, via electrical wires 88, as shown in

[0114] The pneumatic lines 86 can be rigid or flexible. Regardless, they combine with the electrical wires 88 to provide sufficient slack allowance so that the faceplate 174 and corresponding quick disconnect plate 180 can be moved out of the way of the pneumatic manifold 160 when needed, for example, to replace a binary valve 162. As shown in Figure 4A and 4BAs shown in FIG. 1 1, the binary valves 162 on the end of the pneumatic manifold 160 are accessible with the faceplate 174 in place, however, the binary valves 162 hidden behind the faceplate 174 are not accessible. Without the removable faceplate 174, if any of those valves 162 need to be replaced, the mounting assembly 170 and pneumatic manifold 160 must be removed from the frame 92 via the removal of fasteners 166a, and then the mounting assembly 170 needs to be removed from the pneumatic manifold 160 by removing fasteners 166d. For example, by pulling any of the binary valves 162 in the direction of the arrows in FIG. 1 1, the removable faceplate 174 instead allows any of the binary valves 162 to be easily replaced while leaving the mounting assembly 170 and pneumatic manifold 160 intact. Figure 4B

[0115] Reference is now made to FIG. 12, Figures 5 to 8 which shows one embodiment for mounting a variable valve 164 to a pneumatic manifold 160 Figure 4A The goal in mounting any of the pneumatic valves in FIG. 12 is to prevent particles from entering the pneumatic path 168 of the pneumatic manifold 160. It has been found that attaching a valve, such as the variable valve 164, to the pneumatic manifold 160 by a threaded interface can cause particles to shear off from the threads of the pneumatic manifold 160 and fall into the pneumatic path 168, which is then pushed or pulled by the air in the path into a pneumatic component where the particles can cause damage and / or failure. In particular, where the threads of the valve are stainless steel and the manifold 160 is a softer metal, such as aluminum, which facilitates all of the machining involved in the plating of the manifold, the threading action can shear particles, swarf, or plating off of the threads of the manifold 160.

[0116] Figure 6 The underside of the variable valve 164 is shown with an inner O-ring 164a and an outer O-ring 164b, a pneumatic inlet 164c, and an annular pneumatic outlet 164d. The inner O-ring 164a seals the pneumatic inlet 164c, while the inner O-ring 164a and the outer O-ring 164b collectively seal the annular pneumatic outlet 164d. Compression of the O-rings 164a and 164b is therefore required to properly mount the variable valve 164.

[0117] Figure 5 One embodiment of a cradle 200 (collectively for the cradles 200a and 200b in FIGS. 13 Figure 7 and 8 is shown, which clamps a variable valve 164 to a pneumatic manifold 160 and seals the pneumatic manifold 160. In the embodiment shown, the cradle 200 includes a first cradle member 202 and a second cradle 204 (collectively for the first cradle member 202a and 202b and the second cradle 204a and 204b in FIGS. 13 Figure 7 and 8 ​(collectively referred to as the support members 202a / 202b and 204a / 204b in ). The support members 202 and 204 are bent or formed so as to fit over and around the top of the larger intermediate diameter portion 164e of the variable valve 164 and engage with the top. The bracket 200 is clamped to the intermediate diameter portion 164e of the variable valve 164 such that the upper electrical connection portion 164f of the variable valve 164 remains exposed for connection to an associated electrical wire.

[0118] The bracket 200 can be made of metal (such as stainless steel or heat-treated steel). The bracket 200 can alternatively be made of a hard plastic (such as Teflon). The side walls of the bracket 200 in have been removed Figure 5 to show how the support members 202 and 204 gather together at least generally around the larger intermediate diameter portion 164e of the variable valve 164. However, the bracket 200 (including brackets 200a and 200b) can have side walls and / or gussets as necessary to prevent the bracket 200 from bending when placed under installation stress to compress the O-rings 164a and 164b.

[0119] The bracket 200 (including brackets 200a and 200b) includes flanges 206 and 208 (collectively referred to as Figure 7 and 8 the support member flanges 206a / 206b and 208a / 208b in ). Each of the flanges 206 and 208 defines a pore 210 for receiving a fastener 166e. In the Figure 5 illustrated embodiment, the fastener 166e threadedly engages the pneumatic manifold 160 to clamp the flanges 206 and 208 and the associated support members 202 and 204 to the intermediate diameter portion 164e of the variable valve 164, thereby compressing the O-rings 164a and 164b.

[0120] Figure 7 and 8 show different example shapes for the bracket 200 (including brackets 200a and 200b). The bracket 200a is circular with a cylindrical side wall (not shown) and can be more easily produced, for example, by molding a hard plastic. The bracket 200b is square with straight edges (not shown) and can be easily formed from metal. It should be understood that each of the brackets 200a and 200b is configured to distribute force evenly around the intermediate diameter portion 164e of the variable valve 164. It should also be understood that the brackets 200a and 200b are not limited to mounting valves (such as variable valves), but can instead be used to sealably mount other structures to a manifold (such as the pneumatic manifold 160), the other structures including binary valves, pressure gauges, pressure regulators, flow meters, filters, pipes and tubes, and associated fittings, etc.

[0121] Reference is now made to Figure 9A and 9B which shows another mounting scheme for mounting the variable valve 164. The variable valve 164, as discussed above, includes an inner O-ring 164a and an outer O-ring 164b, a pneumatic inlet 164c and an annular pneumatic outlet 164d. The inner O-ring 164a seals the pneumatic inlet 164c while the inner O-ring 164a and the outer O-ring 164b collectively seal the annular pneumatic outlet 164d. The variable valve includes a port 264 that extends into the pneumatic path 168 of the pneumatic manifold 160. The port 264 includes an upper threaded portion 266 and a lower smooth portion 268. In one embodiment, the upper threaded portion 266 and the lower smooth portion 268 are made of stainless steel. In the illustrated embodiment, the upper threaded portion 266 includes a male thread 266a that screws up into the body of the valve and a male thread 266b that screws down into the pneumatic path 168 of the pneumatic manifold 160 at an angle in the opposite direction.

[0122] The pneumatic path 168 includes an upper mating female threaded portion 168a and a lower mating smooth portion 168b. In Figure 9A the lower smooth portion 168b is formed in part by an insert that is press fit into the pneumatic manifold 160. In Figure 9B the lower smooth portion 168b is formed directly in one or more plates of the pneumatic manifold 160. In either case, the top of the lower smooth portion 168b forms a step on which a third O-ring 270 is placed. The step prevents the O-ring 270 from being pushed down into the pneumatic path 168.

[0123] The length of the port 264 and its lower smooth portion 268, combined with the placement of the step and the O-ring 270, ensures that the lower smooth portion 268 contacts and compresses the O-ring 270 against the lower smooth portion 168b of the pneumatic path 168 before the male thread 266b engages the upper mating female threaded portion 168a of the pneumatic path 168. In this way, a sealed chamber is created before any debris or particles are created that shear off from the female threaded portion 168a of the pneumatic path 168 and this sealed chamber thus traps the debris or particles. As a result, the debris or particles cannot fall further into the pneumatic path 168.

[0124] Figure 9A The lower smooth portion 268 is shown just beginning to contact the O-ring 270 and compress the O-ring 270 against the wall of the pneumatic path 168. Figure 9B The variable valve 164 is shown fully screwed into the pneumatic manifold 160. In Figure 9BIn this regard, while any debris or particulate sheared off the female threaded portion 168a of the pneumatic path 168 due to the threaded connection falls on top of the compressed O-ring 270 or the small exposed portion of the lower smooth portion 268, it does not further fall down into the pneumatic path 168.

[0125] It should be appreciated that while the port 264 is shown as part of the variable valve 164, the port 264 can alternatively be used to sealingly mount other structures to a manifold, such as the pneumatic manifold 160, including binary valves, pressure gauges, pressure regulators, flow meters, filters, tubing and piping, and associated fittings, among others.

[0126] Reference is now made to Figure 10 which shows another alternative mounting scheme for any type of pneumatic component, such as the variable valve 164, binary valves, pressure gauges, pressure regulators, flow meters, filters, tubing and piping, and associated fittings. The attachment mechanism 220 includes the port 264 attached to a body as described below. The body can be the body of any variable valve 164, binary valve body, pressure gauge body, pressure regulator body, flow meter body, filter body, tubing, piping, and / or associated fittings. For purposes of illustration, the body will be described below as the body of the variable valve 164

[0127] The variable valve 164 as discussed and shown above includes an inner O-ring 164a and an outer O-ring 164b, a pneumatic inlet 164c, and an annular pneumatic outlet 164d. The inner O-ring 164a seals the pneumatic inlet 164c, while the inner O-ring 164a and the outer O-ring 164b collectively seal the annular pneumatic outlet 164d. The variable valve 164 likewise includes the port 264 extending into the pneumatic path 168 of the pneumatic manifold 160. The port 264 includes an upper threaded portion 266 and a lower smooth portion 268 extending from the upper threaded portion 266. The upper threaded portion 266 and the lower smooth portion 268 are in various embodiments made of stainless steel, steel, titanium, aluminum, alloys, and combinations thereof.

[0128] The pneumatic path 168 includes an upper mating female threaded portion 168a and a lower mating smooth portion 168b. In Figure 10 In this regard, the lower smooth portion 168b is formed directly in one or more plates of the pneumatic manifold 160. In contrast Figure 9A and 9B In contrast, the O-ring 270 is positioned here into the mating groove of the lower smooth portion 268 of the valve 164.

[0129] The length of the port 264 and its lower smooth portion 268 in combination with the placement of the O-ring 270 over the lower smooth portion 268 ensures that the O-ring 270 passes through the female thread 168a and contacts and compresses the lower smooth portion 168b before the male threaded portion 266 of the port 264 engages the upper mating female threaded portion 168a of the pneumatic path 168. As such, again, a sealed chamber is created before any debris or particulate is sheared off from either the female threaded portion 168a of the pneumatic path 168 or the male threaded portion 266 of the port 264 and the sealed chamber thus traps and captures the debris or particulate. As such, the debris or particulate cannot further fall into the pneumatic path 168.

[0130] While Figure 9A , 9B and 10 are described as pneumatic valves, the valves can alternatively operate with other types of systems, such as water, hydraulic, or oil based systems. The valves can alternatively be, for example, hydraulic valves. Thus, the connection structure of Figures 6 to 10 can be used to prevent the transfer of particulate created when threading together mating components of any pneumatic, hydraulic, water based, or oil based system into the flow path of the system.

[0131] 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.

Claims

1. A medical fluid delivery device, comprising: A medical fluid pump, comprising a pneumatic pump chamber and a first pneumatic medical fluid valve chamber and a second pneumatic medical fluid valve chamber located upstream and downstream of the pneumatic pump chamber, respectively; At least one of the positive or negative pressure sources is used to supply positive or negative pressure air to at least one of the pneumatic pump chamber, the first pneumatic medical fluid valve chamber, or the second pneumatic medical fluid valve chamber, respectively. A pneumatic manifold, the pneumatic manifold including an air passage fluidly connected to at least one of (i) the pneumatic pump chamber, the first pneumatic medical fluid valve chamber, or the second pneumatic medical fluid valve chamber, and (ii) at least one of the positive or negative pressure sources, the pneumatic manifold defining a manifold orifice; and A pneumatic valve including a port extending into a manifold orifice of a pneumatic manifold, the port including an upper threaded portion and a lower smooth portion, the manifold orifice including an upper mating female threaded portion and a lower mating smooth portion, the top of the lower mating smooth portion forming a step on which a third washer is placed, wherein the pneumatic valve defines a valve orifice, the valve orifice being sized and arranged such that when the pneumatic valve abuts against the pneumatic manifold, the pneumatic valve including a first washer extending about the valve orifice and the upper threaded portion of the port; and A bracket configured to clamp the pneumatic valve to the pneumatic manifold, thereby compressing the first washer to seal the pneumatic valve to the manifold.

2. The medical fluid delivery device according to claim 1, wherein, The bracket is removably secured to the pneumatic manifold.

3. The medical fluid delivery device according to claim 1, wherein, The bracket is assembled around the diameter of the pneumatic valve to expose the upper electrical connection portion of the pneumatic valve.

4. The medical fluid delivery device according to claim 1, wherein, The bracket includes multiple components, each of which is assembled around the diameter of the pneumatic valve.

5. The medical fluid delivery device according to claim 4, wherein, The plurality of components are adjacent to each other when assembled around the diameter of the pneumatic valve.

6. The medical fluid delivery device according to claim 4, wherein, The plurality of components are configured to distribute the holding force around the pneumatic valve.

7. The medical fluid delivery device according to claim 1, wherein, The valve orifice is the first valve orifice, and The medical fluid delivery device includes a second valve orifice and a second gasket, the first gasket and the second gasket being sealed around the second valve orifice by clamping of the support.

8. The medical fluid delivery device according to claim 7, wherein, The first valve orifice is positioned along the central axis of the pneumatic valve, while the second valve orifice is spaced apart from the central axis.

9. The medical fluid delivery device according to claim 7, wherein, The first washer, the second washer, and the third washer are O-ring washers.

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