Valve system.

(54) Title: VALVE SYSTEM.

(54) Title: VALVE SYSTEM.

(57) Summary

The present invention is directed to a valve having a port closure member adjacent to a port through which fluid can flow, a displacement member having a first portion and a second portion, wherein the first portion is adjacent to the orifice closure member when the valve is in an open position, a first magnet and a second magnet, wherein the first and second magnets are close enough to the displacement member to exert a magnetic force on the displacement member, and an actuator to generate a magnetic field to move the displacement member towards the first magnet, causing the First portion is pressed against the hole closure member and cause the hole closure member to close the hole.

(57) Abstract

The present invention is directed to a valve that has an orifice closing member adjacent to an orifice through which fluid can flow, a displacement member having a first portion and a second portion, where the first portion is adjacent to the orifice closing member when the valve is in an open position, a first magnet and a second magnet where the first and second magnets are sufficiently proximate to the displacement member to exert a magnetic force on the displacement member, and an actuator for generating a magnetic field to move the displacement member toward the first magnet, cause the first portion to press against the orifice closing member, and cause the orifice closing member to cióse the orifice.

VALVE SYSTEM

Field of the Invention

The present invention relates generally to the valve field and more specifically to an electrically actuated magnetic valve for use in kidney dialysis systems, where low power consumption, low heat generation, high ' Reliability and light size are functional requirements.

Background of the Invention

Valves are widely used to control the flow of fluids through some systems. Valve requirements vary dramatically depending on the nature and scope of the application. In¹ A kidney dialysis system, particularly portable kidney dialysis systems, functional requirements for a valve include low power consumption, low heat generation, high reliability, and a small lightweight size.

Typically, automated valves for kidney dialysis systems require an energy input to maintain at least one state, namely a closed state or an open state. However, the increasing need for energy input to maintain the state has significant disadvantages. First, the system requires a higher amount of energy, which decreases the mobility of the system. Second, failure of the system can cause a cut in the power supply, which affects the condition of the valve and causes a more serious secondary failure in the system, which can harm the kidney dialysis patient.

Valves operating between two states (open and closed) where power input is required to change the state, but not to maintain the state, are well known. For example, United States Patents No. 6,836,201, No, 5,322,258; No. 6,517,045 and No. 7,314,208, all incorporated herein by reference in their entirety, describe a valve where the power input is required to change the state, but not to maintain the state. However, these valve systems have not been applied, or their application was suggested, in the field of kidney dialysis. Furthermore, they are typically not appropriate to reliably maintain the valve's closed state with the dimensions, reliability, and force levels required by kidney dialysis systems.

In summary, the valves described in the medical field and specifically in the kidney dialysis fields of the art are not appropriate to effectively meet the functional needs described above. Accordingly, there is a need in the art for an improved valve with the aforementioned attributes.

Brief Description of the Invention

In one embodiment, the present invention is directed to a valve having an open position and a closed position comprising an orifice closure member adjacent to an orifice through which fluid can flow, a displacement member having a first portion and a second portion, wherein the first portion is adjacent to the orifice closure member, when the valve is said to be in the open position, a first magnet and a second magnet, wherein the first and second magnets are close enough to the displacement member to exert a magnetic force on the displacement member and an actuator to generate a magnetic field to move the displacement member towards the first magnet, causing the first portion presses against the orifice closure member and causes the orifice closure member to close the orifice.

Optionally, the first portion comprises a housing, of an adaptable material, such as a spring, a bar, and a gap between the compatible material and the bar. The valve also comprises an optical sensor positioned to detect whether the gap in the valve is present or absent. The first portion comprises a bar and the second portion of the displacement member is a metal body with a diameter greater than that of the bar. The bar is attached to a cylinder. The first magnet is larger than the second magnet. The orifice closure member comprises at least one diaphragm, an elastic material, a compatible material, and a compressible material. The hole is part of a manifold for the kidney dialysis system. The orifice closure member is compressed against a valve seat to close the orifice. The valve seat is part of a manifold for the kidney dialysis system. The orifice closure member is part of a manifold for the kidney dialysis system.

In another embodiment, the valve comprises: a) an orifice closure member adjacent to an orifice through which a fluid can flow, wherein the orifice closure member is compressed against a valve seat when the valve is in a closed position; b) a movable member that can be physically moved relative to the orifice closure member, wherein the movable member moves from a first position when the valve is in the open position, to a second position when the valve is in the position closed and wherein, in the second position, the movable member is pressed against the orifice closure member to cause the orifice closure member to compress against the valve seat; c) a first magnet and a second magnet having a gap, where the first magnet and the second magnet generate a magnetic field at the gap and where the magnetic field has a direction and d) an actuator with the ability to generate a force electromagnetic, where the electromagnetic force reverses the direction of the magnetic field.

Optionally, the valve also comprises an optical sensor positioned to detect if a gap is present or absent. The movable member comprises a bar and a cylinder with a diameter greater than that of the bar, together with a compatible material, such as a spring. The first magnet is larger than the second magnet. The orifice closure member and valve seat are part of a disposable manifold for the kidney dialysis system.

In another embodiment, the valve comprises: a) a diaphragm; b) a valve seat adjacent to the diaphragm, where when the valve is in the closed state, the diaphragm compresses against the valve seat and causes the orifice through which fluid can flow to seal and when the valve is in the open state, the diaphragm does not compress against the valve seat; c) a displacement member comprising a bar attached to a cylinder, where the displacement member can move relative to the diaphragm, where the bar does not compress the diaphragm when the valve is in the open position, and where the rod compresses the diaphragm when the valve is in the closed position; d) a first magnet and a second magnet, where the first magnet is larger than the second magnet, where the first magnet exerts a greater magnetic force on the cylinder than the second magnet when the valve is in the closed position and in where the second magnet exerts a greater magnetic force on the cylinder than the first magnet when the valve is in the open position, and e) an actuator to generate the magnetic force exerted by the first magnet on the cylinder.

Brief Description of Drawings

These and other features and advantages of the present invention will become apparent as they may be better understood by reference to the following detailed description when considered in connection with the accompanying drawings, in which:

Figure 1 illustrates an embodiment of a valve of the present invention, wherein the valve is in an open state.

Figure 2 illustrates an embodiment of a valve of the present invention, wherein the valve is in the closed state.

Figure 3 is a diaphragm of one embodiment of the actuator.

Figure 4 shows a schematic diagram of another embodiment of a displacement member and a mechanism of the present invention.

Figure 5 is a schematic illustration of one embodiment of the displacement system of the present invention, when the valve is in the open state.

Figure 6 is a diagram showing the exemplary relationship between the force in one embodiment of an orifice compression member and its displacement.

Figure 7 is a schematic illustration of one embodiment of the displacement system of the present invention, when the valve is in the closed state; and

Figure 8 is a flow chart that describes the steps to show how the valve closes and opens.

Detailed description of the invention

Although the present invention can be incorporated in many different ways, for the purpose of promoting an understanding of the principles of the invention, reference will be made to the embodiments illustrated in the drawings and specific language will be used to describe them. However, it should be understood that no limitation on the scope of the invention is proposed. Any alteration and modification in the described embodiments and any other application of the principles of the invention are described as contemplated by persons experienced in the art to which the invention relates.

The present invention comprises a system that functions as a fluid valve in a kidney dialysis system, such as a portable kidney dialysis system. The system comprises a magnetic displacement system that is lightweight and consumes very little energy, making it ideal for the portable kidney dialysis system when using a disposable manifold for fluid circuits. The system can be used in conjunction with a hole in any structure. In particular, the hole is a hole, opening, hole or division of any type of material. This includes pipelines, manifolds, multiple disposables, channels, and other trajectories. United States Patents No. 12 / 324,924; No. 12 / 237,914 and No. 12 / 245,397, co-owned by the present applicant, describe multiple examples with which the present invention can be implemented and are incorporated herein by reference in their entirety. Those skilled in the art will appreciate that the described valve system will be implemented with a disposable manifold by placing the displacement member and magnets, as described below, external to the manifold at the desired location of the valve. The actuator is also separate and different from the disposable manifold and is generally part of the non-disposable portion of the kidney dialysis system.

In operation, the valve of the present invention has two stable states: open and closed. The valve operates by using magnetic forces to move a displacement member against a diaphragm and thus create enough force to press the diaphragm against the valve seat and cause the diaphragm to close the orifice. Closing the hole stops fluid flow. The reversed process, viz., Using magnetic forces to move the displacement member away from the diaphragm and thus, release the diaphragm from compression against the valve seat, opens the orifice and allows fluid to flow.

It should be appreciated that although the present invention is to be described in terms of a preferred embodiment, illustrated in Figures 1 and 2, a non-preferred embodiment is illustrated in Figure 4, the present invention is generally directed to any use of a valve in a kidney dialysis system that has the following attributes: a) two stable states, open and closed; b) changing the states requires energy input; c) maintaining a state does not require energy input; d) a state is changed with the use of magnetic forces to modify the position of the displacement member, which when modified causes the valve to open or close.

In one embodiment, referring to Figure 1, the valve system of the present invention 100 is used to control the flow of fluid through a fluid flow channel 102, which is connected by valve seats 104 , to create an annular hole 103 of the valve. As described above, hole 101 can be any hole, opening, void, or partition of any type of material, in particular, multiple, multiple disposables, channels, and other trajectories

110. Valve 100 is shown in an open state. The components of the valve system include a port closure member, a displacement member, a mechanism for moving the displacement member, an optional optical sensor, a coil activator circuit, and an actuator having a coil.

In one embodiment, the orifice closure member comprises a diaphragm 106, which when compressed by the displacement member, as described below, presses against valve seats 104, causing the annular orifice 103 of the valve closes. In the open state, the main body of the diaphragm 106 is separated from the valve seats 104 by a gap 198. In one embodiment, the diaphragm 106 is made of a soft material, such as silicone rubber. Diaphragm 106 should maintain its shape with time, temperature, and activations. Valve 100 relies on diaphragm material 106 to return to its uncompressed form when the displacement member (compression force) is removed, to the open state.

Those skilled in the art will appreciate that the orifice closure member can comprise any combination of spring, compressible and non-compressible structures, which when pushed by the displacement member, close the orifice. In one embodiment, valve seats 104 can be molded into a manifold. Suitable materials for the valve seat are polycarbonate, ABS and similar plastics. Valve port 103 in the preferred embodiment ranges from about 0.25 cm to 0.76 cm in diameter (and more preferably, 0.48 cm). The orifice dimensions can be increased in order to increase the flow for alternative applications of the invention, or alternatively, they can be decreased to decrease the flow for alternative applications.

In one embodiment, the displacement member comprises a plunger cap, or housing 110 that when the valve is in the open state, is aligned against diaphragm 106, but does not essentially compress diaphragm 106. Placed within plunger cap 110 a compatible component is found, such as a spring 112 and a plunger head 199, which are separated by an air gap 114. The plunger cap 110 is attached on the outer side by a fluid seal 120, which in one embodiment is a thin, smooth silicone rubber washer. In one embodiment, the plunger cap 110 is forced against the silicone rubber washer and compresses the washer to form the fluid seal 120. When in the closed position, the plunger cap 110 is not forced against the washer, therefore it is not compressed and loosely positioned with the end cap 130. Spring 112 is any elastic or compatible material and in one embodiment comprises a wave spring.

Plunger cap 110, inner spring 112, air gap, plunger head 199, plunger body 140 and core 142 are the components of the preferred displacement member of the present invention. In one embodiment, the plunger body 140 has an outer diameter within the range of 0.25 cm to 0.50 cm (more particularly, 0.30 cm) and is approximately 1.27 cm to 6.35 cm in length. It should be appreciated that the plunger body 140 is any rod structure of any length, depending on the application. Plunger body 140 is placed within an annular core 142, which has a larger end and a smaller end, and is coupled to the core by any method known to those of skill in the art, including epoxy, screw coupling , bolted or welded. The outer diameter of the largest end of core 142 is within the range of 0.76 cm to 1.27 cm (and more particularly 1.00 cm), the thickness is within the range of 0.76 cm to 0.38 cm, (and more particularly of. 012 cm to 0.25 cm), and the length is within the range of 1.27 cm to 4.44 cm (and more particularly, 2.66 cm. The small end of the core 142 has a diameter of 0.02 cm to 1.01 cm and more particularly of 0.63 cm.

At least encompassing the small end of the core is a coil 195, which holds coil 148 in place and provides dimensional stability to coil 148. Preferably, there is a gap between coil coil 195 and core 142. The gap size is approximately 0.02 cm to 0.76 cm (and more particularly 0.04 cm). The coil case 195 in one embodiment is a glass filled nylon structure, which may be non-metallic and non-ferromagnetic. Coil case 195 is an annular structure with an extreme diameter of sufficient size to provide a tight fit within the housing bore and sufficient diameter to enclose the core so that it has no room to move and experience some degree of expansion thermal. The two end caps 130, 160 wedge the coil

195 in place and hold it steady to move or slide, particularly when exposed to electromagnetic forces.

The piston body is made of a metal or non-metal material, such as bronze or fiberglass, and the core is also made of metal, in particular 1018 or 1117 steel. Preferably, the piston body is not magnetic and the core body is ferrous-magnetic. As described above, the plunger body 140 and core 142 are moved by the mechanism to move the displacement member, as described in detail below.

The mechanism for moving the displacement member comprises a large magnet component, a small magnet component, and a housing within which the magnets and a portion of the displacement member are contained, namely the plunger body 140 and the core 142 More particularly, referring to Figure 1, the mechanism for moving the displacement member comprises one. large magnet end cap to hold and align large magnet 130, large magnet 132, an elastic material 134, a gap 197, a coil 148, a small magnet component 162, a magnet end and mounting cap 160 small and a material 164 elastic.

The large magnet end cap 130 holds and aligns the large magnet component 132 and the coil case 195 in place within the housing 170, referred to as the actuator body having a hole through which the components described herein are placed . Large magnet component 132 needs to be properly aligned with core 142, plunger body 140, and small magnetic component 162 to ensure proper movement of the displacement member. Both end caps 130 and 160 secure coil case 195 and coil 148 in position. Also, a mounting plate can be used to capture and hold the end cap 130. In one embodiment, the mounting plate is positioned vertically and flush against the side of the end cap and between the end cap and the hole. The mounting plate has a hole in it, almost the same size as the smaller diameter of the end cap. A clamping mechanism holds the body against the plate, alternatively the plate can be permanently fixed, using a bonding technique known to those of skill in the art. Unlike the prior art, such as in US Patent No. 6,836,201, in a preferred embodiment, the magnets are located inside, not outside, the bore and provide supports for the plunger, as described below. .

The large magnet component 132 is separated from the core 142 by a gap 197 and the elastic material 134, such as a silicone washer, which in one embodiment, has an outer diameter of about 0.76 cm to 1.27 cm (and more particularly, 0.93 cm), an internal diameter of 0.25 cm to 0.76 cm (and more particularly, 0.47 cm), a thickness of 0.012 cm to 0.038 cm (and more particularly 0.025 cm), and a durometer of 35 to 45 ( and more in particular 40). Small magnet component 162 is separated from the core by an elastic material 164, such as a silicone washer, which in one embodiment has an outer diameter of 0.25 cm to 1.01 cm (and more particularly 0.60 cm), a diameter internal from 0.25 cm to 0.76 cm (and more particularly from 0.025 cm), a thickness from 0.012 to 0.038 cm (and more particularly from 0.025 cm) and a durometer from 35 to 45 (and more particularly from 40). Small magnet component 162 is kept properly aligned within housing 170 by a small magnet mount and end cap 160. The small magnet end cap screws 172 also serve to capture and hold the small magnet end caps 160 in place.

Referring to Figure 1, the valve system of the present invention also comprises a coil activator circuit board 150, which activates the actuator, which comprises a coil 148 and is preferably mounted on the actuator body 170 by small screws, a coil activator connector 154 and an optical sensor 152, which detects the position of the large end of the core 196. Coil 148 serves to effect changes in the magnetic fields to cause movement of core 142 and plunger body 140. In one embodiment, the coil is approximately 0.12 cm to 3.70 cm long (and more particularly 2.54 cm long), has an outer diameter of 0.88 cm to 1.39 cm (and more particularly 1.16 cm), and an internal diameter of 0.38 cm to 0.88 cm (and more particularly 0.66 cm), with six layers of 29 AWG wire. The different elastic materials used in the displacement member and the mechanism for moving the displacement member to provide a "smooth" stop of movement of the bar 140 when the valve is opened or closed. In particular, it serves to ensure that core movement does not damage the magnets.

Large magnet component 132 may be a unitary magnet or, in a preferred embodiment, may be comprised of a plurality of magnets, such as three. Small magnet component 162 may also be unitary or may be comprised of a plurality of magnets. In one embodiment, the magnets are preferably made of Alnico, Samarium Cobalt, Neodymium, Rare Earth, or Ceramic Magnets. In one embodiment, the large magnet 132 is a neodymium ring magnet with an outer diameter of 0.050 cm to 1.27 cm (and more particularly 0.95 cm), an internal diameter of 0.12 cm to 0.76 cm (and more particularly of 0.31 cm), and a length of 0.50 cm to 0.12 cm (and more particularly 0.95 cm). In one embodiment the small 162 magnet is made of a neodymium ring magnet with an outer diameter of 0.38 cm to 1.01 cm (and more particularly 0.63 cm), an internal diameter of 0.12 cm to 0.76 cm (and more in particular of 0.31 cm), and a length of 0.38 cm to 1.01 cm (and more in particular of 0.63 cm). The large magnet 132 is used closer to the orifice closure member because its size is necessary to generate sufficient opposing force with the valve seat. Furthermore, the activation force caused by the activation coil is essentially the same even though the magnets are of different sizes, allowing for a simple coil activator circuit.

In one embodiment, the rod, plunger, or other elongated member 140 uses the central holes of the magnets as the linear support. Accordingly, the center holes of the magnets preferably should have a support surface, such as chrome or any hard, smooth surface with minimal friction. A gap is placed between the coil case 195 and the core 142, due to the thermal expansion of the coil, the shrinkage of the coil over time, and the tolerances of the coil, core, and magnets. However, under all operating conditions, the gap must be sufficient for the plunger body 140 to be able to move freely and not to join the magnet and coil openings. In a preferred embodiment, the gap is approximately 0.025 cm to 0.15 cm (and more particularly 0.50 cm) at room temperature.

When the valve is closed, referring to Figure 2, the valve system of the present invention 200 controls the flow of fluids through the fluid flow channel 202, which is joined by the valve seats 204, by compressing the orifice closure member, eg diaphragm 206 and thus obstruct annular valve orifice 203. In the closed state, the main body of the diaphragm 206 is pressed against the valve seats 204, and accordingly, essentially eliminates the gap 198 (seen in Figure 1).

Once adjacent to diaphragm 206, the displacement member now compresses diaphragm 206. In particular, plunger cap 210 has been moved to compress diaphragm 206. Plunger cap 210 has moved due to a change in magnetic fields causing the core body 242 to move towards the large magnet component 232. The core body 242 stops its movement when the core head 296 passes through the gap 197 (in Figure 1) and stops on the elastic material 234 positioned adjacent to the large magnet component 232. The movement of the core 242 causes the piston body 240, with which the core 242 is attached, to move as well. Movement of the plunger body 240 causes the plunger head 299 to move within the plunger cap 210, pass through the gap 114 (in Figure 1), and compress the spring 212. After exerting some compression, the cap The piston 210 moves and compresses the diaphragm 206. The movement of the piston cap 210 creates a new gap 292 between the cap body 210 and the elastic material 220 which is positioned adjacent to the end cap 230 of the large magnet.

As shown in Figure 2, the other valve components remain the same, including the actuator body 270, coil trigger circuit 250, coil connector 254, coil case 293, end cap screws 272 small, optical sensor 252, small magnet end cap 260. However, it should be appreciated that by virtue of the movement of the core 242, a gap 295 is created between the small end of the core 294 and the elastic material 264, which is placed adjacent to the small magnet component 262.

It should be appreciated that to close the valve, the displacement member applies a force to the orifice closure member, eg, diaphragm 206. The force required from the displacement member to deform the diaphragm to the point where the diaphragm The valve seat is essentially linear and can be modeled as a linear spring. However, the force requirements increase exponentially as the diaphragm compresses into the valve seat. In this way, the force profile for the displacement member becomes nonlinear and is much more complex. Accordingly, there are several unique challenges associated with valve design and tolerances between the different components of the displacement member, the orifice closure member, and the hard stop of the displacement mechanism. The displacement mechanism may have the ability to deliver the nonlinear force profile without permanently deforming the diaphragm. This means that the mechanism must deliver just the right amount of force.

As described above, the displacement member comprises a rod, plunger, or other elongated member that is attached to another structure, referred to as the core, which has a larger diameter and can function as a stop, when forced up against another structure, such as a face of the magnet. Those skilled in the art should appreciate that the displacement member or movable member is not limited to a bar and cylinder configuration. Rather, it may include non-cylindrical structures, unit parts, or multiple parts that are welded or joined in any other way. In summary, the displacement member can comprise many different structures, since the movement of the member can exert the necessary force on the orifice compression member in a way that is reliable and consistent.

For example, referring to Figure 4, an alternative, less preferred embodiment is shown. For kidney dialysis applications, this modality typically does not reliably keep the valve in a closed state. The displacement member 400 comprises a housing 405 including an electromagnet 410 with an essentially cylindrical structure and a through hole 415 running therethrough. Electromagnet 410 is securely positioned centered within housing 405 by non-magnetic spacers 420, which in one embodiment are end caps. The end caps have two purposes - to hold the magnets in place and to sandwich the coil in place. In one embodiment, elements 431 and 420 comprise a first unitary piece and 405 and 420 comprise a second unitary piece. A ferromagnetic core 425, cylindrical in shape having a first face 423 and a second face 424, is positioned to allow a portion of the core 425, between the first face 423 and the second face 424 to have a sliding fit linearly with the hole 415. Second face 424 is larger than hole 415, which restricts linear movement of core 425. In one embodiment, the second face is different in size from the first face to generate enough magnetic force to keep the valve in the closed position. Core 425 has the ability to slide linearly to the left and right within hole 415.

Two magnets 430, 435 of different sizes are also fixed within the two end caps 431, 432 of the housing 405. The first face 423 of the core 425 contacts the first magnet 430 to form the first stable state of the system 400 of displacement and the second face 424 of the core 425 makes contact with the larger magnet 435 to form a second stable state of the displacement system 400. The placement of the permanent magnets 430, 435 is designed to fit within the diameter of the housing 405 as the size of the displacement system 400 is reduced. A first bar 440 connected to the first face 423 of the core 425 passes through the first magnet 430, which protrudes from the housing 405 at one end and a second bar 445 connected to the second face 424 of the core 425 passes through the second Magnet 435 therefore protrudes from housing 405 at the other end. Bars 440, 445 may be made of a non-magnetic, non-corrosive material known in the art, such as, without limitation, bronze. Although one embodiment has two bars connected to two faces of the core, in an alternative embodiment, there is only one bar connected to one of the faces of the magnet.

Those of skill in the art will appreciate that the magnetic force exerted by electromagnet 410 on core 425 is high enough to overcome the holding force of permanent magnets 430, 435 so that displacement system 400 can be changed from the first steady state to the second. Furthermore, those skilled in the art will appreciate that rod / plunger 445 moves with core 425, which eliminates the creation of a motive force to compress or decompress the orifice closure member. However, this modality has been determined as inferior compared to the first modality since it fails to maintain the closed state long enough.

Various features of the hole closure member design operate in conjunction with the member and the displacement mechanism. First, with reference to Figure 5, and as described above in relation to the

Figures 1 and 2, there is a gap between the plunger cover 504 and the orifice closing member 505, in particular the first face 505 of the diaphragm. The gap is within the range of 0.10 cm to 0.17 cm and more particularly 0.13 cm. The diaphragm preferably comprises silicone with a thickness of 0.10 cm and can be modeled as a spring (K_V2) which has a spring constant of 945 kg / cm. The second face 506 of the diaphragm is separated from the valve seat 507 and is actuated by modeled magnetic forces such as spring K_Vi which has a spring constant of approximately pounds and a thickness of approximately 78.75 kg / cm and approximately 1.18 cm.

The bar 504 transfers the force generated by the magnetic attraction of the core 501 to the magnet 503 modeled by the spring Kp, which is separated from the head 501 of the core by a washer, for example, 0.025 cm of silicone in a closed state and is separated from the head 501 of the nucleus by approximately 0.27 cm in an open state. Core 501 is attached with a bar 504. When the valve is activated, the bar 504 moves in the direction of the valve seat 507 due to the core, to which the bar is attached, and moves in the direction of the large magnet 503.

With reference to Figure 5, K_v2 and K_SL they correspond to the elastic material, such as silicone, which are modeled as rigid springs. It should be appreciated that when a valve is in the closed state, there are two important positions. First, the position of the bar against the diaphragm and the second is the position of the core face against the large magnet. When the valve is closed, the bar is pressed into the valve diaphragm with enough force to resist at least

600mmHg of back pressure generated within the fluid passage of the kidney dialysis system. In this mode, fluid pressures can reach up to 2,600mmHg and this system is designed to hold the diaphragm firmly pressed against the valve seat to seal the port up to and including 2600mmHg.

Also, when the valve is closed, the large face of the core is pulled close to or directly against the large magnet. The magnetic attraction of the core with the large magnet generates the force that the rod applies to the hole closure member, for example the diaphragm. To generate a consistent and reliable force, the separation between the face of the core and the face of the large magnet must be consistent. Therefore, it is preferred to place an elastic material 502, 503 between face 501 of the core and face 504 of the magnet. The elastic material has a nonlinear spring constant and will compress until the resulting forces for the elastic material are equalized with the magnetic forces. When the bar applies force on the diaphragm through the core, the core will experience the resulting force. For a static condition to occur, the sum of these forces in the core must equal zero. In addition, the elastic material serves to protect the face of the magnet from breakage or fracture during activation.

Referring to Figure 7, when valve 700 is in the closed state, core head 705, 702 has moved away from face 701 of the small magnet (from position 702a to position 702). When in position 702, the core head is separated from the small magnet 701 by an elastic 717 material, such as a silicone washer that is approximately 0.038 cm thick. When in position 705, the core head will move approximately 0.35 cm +/- 0.50 cm, including a distance of 1.14 cm +/- 0.012 cm, during which bar 708 does not move, and stops against the material elastic 716 (for example, the silicone washer is about 0.038 cm thick), which separates the head 705 from the core from the large face 706 of the magnet. The large magnet 706, in turn, is separated from the head 707 of the bar.

When the valve is in an open state, the large magnet 706 is separated from the rod head 707 by an elastic 715 material, such as the silicone washer that is about 0.038 cm thick. When the valve is in a closed state, the large magnet 706 is separated from the magnet head 707 by an elastic 715 material, such as the silicone washer having a thickness of approximately 0.038 cm and at a distance of approximately 1.39 cm + / - 0.25 cm. When the valve is closed, the bar head 707 has moved from being close to the large magnet 706 and the elastic material 715 to be close to the valve seat 710. Specifically, the bar head 707 moves to compress the diaphragm 708 and thus presses against the elastic material 709 (eg, silicone having a thickness of about 0.10 cm) which in turn presses against the valve seat 710 . This causes the valve to close with a force of approximately 14 N.

It should be appreciated that the configuration of the displacement member and mechanism relative to the orifice closure member and the tolerances described herein provide a diaphragm displacement profile 600, as shown in Figure 6, which is appropriate for applications where they need to withstand at least 600mmHg of back pressure, just like in kidney dialysis systems. Referring to Figure 6, an exemplary diaphragm displacement profile is provided, wherein the force 602 exerted by the displacement member is provided on the y axis and the corresponding diaphragm displacement is provided on the x axis. The inflection point of this curve 603 indicates the moment when the diaphragm begins to compress against the valve seat. To the left of inflection 603, the diaphragm is forced to flex toward the valve seat, but there is no substantial compression against the valve seat. To the right of inflection point 603, the diaphragm flexes against the valve seat, deforming the diaphragm material and affecting the good seal against fluid pressure.

Another important component of the displacement mechanism system is an actuator system. Referring to Figure 3, during the activation process, the coils 305 are energized and the magnetic field is created, which creates a magnetic force opposite to the small magnetic attraction force. As the force builds up, the nucleus described above begins to move towards the closed position (large magnet). Once the core moves past the point of no return, the attractive forces on the large magnet core have exceeded the attractive forces of the small magnet. To ensure that the opposing forces caused by the valve diaphragm do not exceed the attractive force of the large magnet, a gap is provided, as described above.

The coil design is made of a coil shape and magnetic wire. The size of the coil is preferably based on commercially available coil shapes that form the impulse current capacity of the power supply, and in particular the required activation force and voltage of the power supply. The activation force is proportional to the rate of ampere turns of the coil. In one embodiment, it is preferred to limit the coil current to 6 amps or less.

Important factors in coil design include the number of layers, the packing factor, the wire diameter, and the coil resistance. In one embodiment, the present invention uses a coil with six layers of wire and a gap of approximately 0.25 cm between the diameter of the coil flange and the last layer. With a heavy polynylon insulation requirement, and a coil resistance of 3.5 +/- 0.5 Ohms, the wire size is approximately 29 AWG. Any size of coil shape can be used.

The circuit used to activate the coil is an H-bridge circuit that allows the current to be inverted for open and closed operations. The H-bridge circuit is activated through a single pulse width modulated (PWM) signal. The PWM signal is used to generate a pulse of cosine current through the coil. The period of the cosine impulse is related to the mass of the nucleus and the opposite force. Preferred mode does not use a power switch

Bipolar DC or detection switch, better, the optical sensor operates to determine the position of the core, conclude the state of the valve and generate an electronically activated cosine waveform to move the plunger in the desired direction, which changes the state of the valve.

Optionally, as shown in Figures 1 and 2, as elements 152, 252, the valve system uses a sensor, preferably an optical sensor, to determine the state of the valve (open or closed). This can be accomplished by placing the optical sensor in a location that has a sufficient difference in reflectivity, or other optical properties, between an open state of the valve and a closed state of the valve. For example, when the valve is closed, in one embodiment, the large end of the core 296 is placed against an elastic material 234 and the component 232 of the large magnet. The large end of the core 296 is wide enough to be detected by the reflective optical sensor, but not too wide for the optical sensor to have position resolution. The optical sensor will be placed on the outside of the displacement member / mechanism and will see through the body, which is preferably made of. a transparent polycarbonate. The wavelength of the optical sensor will not be within the near infrared range (NIR), in order to have a good transmission through the polycarbonate body. Those skilled in the art will appreciate that the sensor can be selected to suit any material structure, as it includes the appropriate filters. Here, preferably, the optical sensor has been incorporated into a long-pass optical filter for response

NIR.

Functionality, when the core is in the open position, as shown in Figure 1, the large end of the core 196 moves out of the field of view of the optical sensor 152, thus very little reflection will be seen by the sensor optical. When the large end of the core 296 is in the field of view, as shown in Figure 2, there will be a reflection that the sensor will see, indicating that the core is in the closed position. Those of skill in the art will appreciate that the sensor can be positioned so that it detects much of the reflection from the core when the valve is in the open position and much less reflection (because the core moves out of the field vision) when the valve is in the closed position. Furthermore, those skilled in the art will appreciate that the sensor can be placed near the gap to detect when the gap is present and when the gap is absent, indicating the condition of the valve.

Operationally, referring to Figure 8, a valve is initially in one of two states, open or closed. Assuming the valve is in the 801 open state, the first step in closing the valve is to energize the coil activator circuit 802, thereby causing the magnetic field generated by the coil to pass through the core, creating a magnetic force. opposite between the core and the small magnet and creates a weak attraction force between the large magnet and the large end of the core. As the displacement member 803 begins to move, the attractive force of the small magnet decreases as the attractive force of the large magnet increases. The displacement member 803 moves to a point of no return, after which the displacement member 804 closes a gap 804 and compresses the orifice closure member, namely the diaphragm · 805, against the valve seat 806. Compression of the diaphragm 806 causes the diaphragm to close port 807 and close valve 808.

Referring to Figure 8, assuming the valve is in a closed 809 state, the first step in opening the valve is to energize the coil activator circuit 810, create an opposite magnetic force between the core and the large magnet, and create a weak attraction force between the large magnet and the small end of the core. As the displacement member 811 begins to move, the attractive force of the large magnet decreases as the attractive forces of the small magnet increase. The displacement member moves 811 to a point of no return after which the displacement member decompresses the diaphragm 812 away from the valve seat 813. The hole is opened because it is no longer covered by the diaphragm 814. The displacement member returns to its original position and recreates hole 815.

Since the first and second stable states of the core are maintained even when the power of the electromagnet is suspended, this allows the displacement system to have low power consumption and low heat generation relative to prior art actuators, where a continuous energy supply is needed to maintain the states, it also results in high heat generation.

Although what is currently considered the preferred embodiment of the present invention have been shown and described, those skilled in the art will understand that various changes and modifications can be made, and equivalents can substitute for elements thereof without departing from the true scope and spirit of the invention. Furthermore, many modifications can be made in order to adapt to a particular situation or material in accordance with the teachings of the invention, without departing from the central focus thereof. Therefore, it is intended that this invention is not limited to the particular embodiment described herein, as the best contemplated mode for carrying out the invention, rather, the invention should include all the modalities that fall within the claims attached.