Modular, portable dialysis system

[Cross Reference to Related Applications] This application is a priority claim application based on US Provisional Patent Application Nos. 61/109, 834 filed on October 30, 2008. The present application also applies to US Patent Application Nos. 12/575, 450 filed October 7, 2009, US Patent Application Nos. 12/575, 449 filed October 7, 2009, 2009 1. US Patent Application Nos. 12/355, 102 filed on 16th March, US Patent Application 12/355, 128 filed on 16th January 2009, US filed on 12th January 2009 Patent Application Nos. 12/351,969 US Patent Application Nos. 12/324,924 filed on November 28, 2008 US Patent Application Nos. 12/210,080 filed on September 12, 2008 No. US Patent Application No. 12 / 238,055 filed on September 25, 2008, US Patent Application No. 12 / 237,914 filed on September 25, 2008, October 10, 2008 It relates to US Patent Application No. 12/249,090 filed in, and US Patent Application No. 12/245, 397 filed on October 3, 2008. The contents of all these applications are incorporated by reference.

The present invention relates to a dialysis system with improved structural and functional features. In particular, the dialysis system according to the invention relates to a portable dialysis system with improved modularity, ease of use, and safety.

Hemodialysis is performed to remove harmful waste products from the body of patients with renal failure. The patient's blood is temporarily removed from the body via a tube and passed through at least one semipermeable membrane in the dialysis machine. The semipermeable membrane is composed of, for example, a collection of hollow fibers, and partitions the dialysate and blood. Impurities in the blood move through the membrane into the dialysate, mainly due to osmotic pressure. The purified blood is then returned to the body.

Normal dialysis therapy using equipment installed in a hospital has two stages: (A) Dialysis. Here, harmful substances and scoria (usually small molecules) move from the blood through the semipermeable membrane to the dialysate. (B) Ultrafiltration. Here, the pressure difference between the blood circuit and the dialysate circuit, more specifically, the decompression in the latter circuit reduces the water content in the blood by a predetermined amount.

Dialysis treatment using ordinary equipment is troublesome and tends to be costly. In addition, the patient is detained in the dialysis center for an extended period of time. A portable dialysis system is being developed. U.S. Pat. No. 4,083,777 provides a blood permeation system comprising a dialysis means through which blood and dialysate containing waste impurities pass by an indirect material transfer dialysis relationship in order to transfer waste impurities from the blood into the dialysate. It is disclosed. This device includes means for pumping blood containing waste impurities from the patient to the dialysis means, and means for forming a blood flow circuit and returning blood from which waste impurities have been removed to the patient. The dialysis means has a flexible elastic tube pump drive section for pumping blood. The peristaltic pump means is provided with a rotatable pump head assembly. This assembly has a base member that is rotatably provided about a fixed shaft, to which a plurality of rollers spaced apart in the circumferential direction are mounted. These rollers are independently rotatable about each axis parallel to the fixed axis of the base member.

U.S. Pat. Nos. 4,443,333 discloses a portable system for performing hemodialysis. Here, the blood passes through the exchange station, where the blood contacts one side of the semipermeable membrane and the dialysate contacts the other side of the semipermeable membrane. The system includes elastic tube means that are connected to a blood source to allow blood to pass through multiple stations and return blood to the blood source, as well as thrombosis detectors and bubble detectors that communicate with the blood tube means. Replace with elastic tube means connected to the dialysate source to allow dialysate to pass through multiple stations and means to measure and control dialysate flow, pressure, temperature, and conductivity. Means for keeping the dialysate pressure below the blood pressure as it passes through the station, and at least the peristaltic pumps and dialysate tube means for pumping blood to the stretchable blood means. One motor means having an output shaft connected to two pumps of the peristaltic pump for sending to, and a mechanism for maintaining the dialysate flow at about three times the blood flow in connection with the motor means and the peritable pump. To be equipped with. Each peristaltic pump has an inner arch surface. The blood pump has at least one roller associated with the medial arch bearing surface in between to capture the blood tube means. The dialysate pump has one roller associated with the medial arch bearing surface in between to capture the dialysate tube means. When the peristaltic blood pump is activated, the rollers generate a smooth laminar flow of blood in the blood tube means. When the peristaltic dialysate pump is operated, the vacuum generated by the roller 1 generates a dialysate flow, which causes the elastic dialysate tube means to be deformed and restored. This system also has a control mechanism. The control mechanism is operably connected to a blood leak detector and a bubble detector, a motor means, and a dialysis fluid flow / pressure / temperature / conductivity measuring means, and is pressure, temperature, or conductive. When the measured value of is out of the predetermined range, the dialysate roller is selectively stopped while maintaining the blood flow to allow the dialysate tube means and the permeation in the exchange station.

U.S. Pat. No. 6,168,578 discloses a portable renal dialysis system with a belt carrying a effluent bag. A pump is also mounted on the belt, which is connected between the user and the waste bag. When the pump receives the discharge signal, the pump sends the liquid from the user to the waste liquid bag. There is also a pressure switch that detects when the waste liquid bag is full. The control mechanism serves to send a discharge signal to the pump only if it has not been detected that the waste bag is full. As another conventional portable hemodialysis system, there is a portable dialysis system called System One manufactured by Nextage.

<p num="0008"> The portable dialysis system has drawbacks. First, they are not easy to assemble, move, ship, and maintain the system due to their lack of modularity. Second, these systems are not simplified enough for the patient to use them reliably and accurately. When used by the patient, the system interface and consumable parts may be misused. For a truly efficient portable dialysis system, it should be easy for non-healthcare individuals to use, with the installation of consumables and data entry forced to avoid misuse.</p><p num="0009"> Therefore, a portable dialysis system that facilitates system assembly, movement, shipping, and maintenance by having a structural design configured to optimize modularity is preferred. It is also preferred that the system interface for the patient to enter data and deploy consumables is sufficiently constrained to avoid inaccurate use and configured to prevent misuse.</p>

<p num="0010"> The present invention comprises a controller unit having a first outer housing having front, rear, left, right, upper, and lower sides, and a second having front, rear, left, right, upper, and lower sides. A storage unit comprising an outer housing, the front side of the first outer housing having a door configured to allow access to the internal volume of the controller unit, and a front side of the second outer housing. Has a door configured to allow access to the internal volume of the storage unit, the underside of the first outer housing being detachably secured to the upper side of the second outer housing. When the first outer housing is detachably fixed to the second outer housing, the controller unit is automatically brought into a telecommunications state with respect to the storage unit. The present invention relates to a modular dialysis system.</p><p num="0011"> The lower side of the first outer housing may have an electrical connection pad, and the upper side of the second outer housing may have a plurality of electric pins. The lower side of the first outer housing may have a plurality of electrical pins, and the upper side of the second outer housing may have an electrical connection pad. When the connection pad is aligned with respect to the plurality of push pins and put into a telecommunication state, the controller unit is automatically put into a telecommunication state with respect to the storage unit.</p><p num="0012"> When the first outer housing is detachably fixed to the second outer housing, the controller unit may be automatically put into a data communication state with respect to the storage unit. The lower side of the first outer housing includes a first infrared communication port having at least one LED light emitting part and at least one LED light receiving part, and the upper side of the second outer housing has at least one LED. It includes a second infrared communication port having a light emitting unit and at least one LED light receiving unit. When the first infrared communication port is aligned with the second infrared communication port and put into a data communication state, the controller unit is automatically put into a data communication state with respect to the storage unit.</p><p num="0013"> The internal volume of the controller unit may include a manifold, a hook, and a guard surrounding the manifold. The door that allows access to the internal volume of the controller unit has an inner surface that projects into the internal volume when the door is closed, with a plurality of pump shoes and latches. A case with a side is provided. When the door is closed, the latch mechanically engages with the hook. The modular dialysis system further comprises a controller configured to activate a motor that supplies a driving force to the hook, which closes the door with a force in the range of 90-110 lbs. The modular dialysis system further comprises a mechanical release button having a first state and a second state, the button being mechanically engageable with the hook when in the first state, said second state. When at, the button is mechanically incompatible with the hook.</p><p num="0014"> In other embodiments, the present invention comprises a controller unit comprising a first outer housing having front, rear, left, right, top, and bottom, and front, rear, left, right, top, and. A storage unit comprising a second outer housing having a lower side, the front side of the first outer housing having a door configured to allow access to the internal volume of the controller unit, said. The front side of the second outer housing has a door configured to allow access to the internal volume of the storage unit, and the upper side of the second outer housing communicates with at least one leak detector. The lower side of the first outer housing is configured to be detachably fixed to the upper side of the second outer housing. Regarding modular dialysis systems.</p><p num="0015"> The lower side of the first outer housing may be provided with an electrical connection pad, and the upper side of the second outer housing may be provided with a plurality of electric pins. When the connection pad is aligned with respect to the plurality of push pins and put into a telecommunications state, the controller unit is automatically put into a telecommunications state with respect to the storage unit. The lower side of the first outer housing includes a first infrared communication port having at least one LED light emitting part and at least one LED light receiving part, and the upper side of the second outer housing has at least one LED. It includes a second infrared communication port having a light emitting unit and at least one LED light receiving unit. When the first infrared communication port is aligned with the second infrared communication port and put into a data communication state, the controller unit is automatically put into a data communication state with respect to the storage unit.</p><p num="0016"> A hook is housed in the internal volume of the controller unit, and the door that allows access to the internal volume of the controller unit may have an inner surface with a latch. The modular dialysis system further comprises a controller that activates a motor to supply driving force to the hook in response to user input, which closes the door with a force in the range of 90-110 pounds. The modular dialysis system further comprises a mechanical release button having a first state and a second state, the button being mechanically engageable with the hook in the first state and on the hook in the second state. It cannot be mechanically engaged.</p><p num="0017"> These and other embodiments will be described in detail with reference to the drawings in the section "Best Embodiments for Carrying Out the Invention".</p>

<figref num="1">Front view of the dialysis system of the present invention.</figref><figref num="2">The figure which shows the modularity of a dialysis system.</figref><figref num="3">The figure which shows the rear of the dialysis system and shows the state which the door is open.</figref><figref num="4">The front view which shows 1st Embodiment of the dialysis system which has an open door and a U-shaped latch.</figref><figref num="5">The figure which shows the internal structure of the top unit in 1 Embodiment of this invention.</figref><figref num="6">The figure which shows the member of the scale-based liquid scale by this invention.</figref><figref num="7a">A side perspective view of the storage unit containing the balance.</figref><figref num="7b">Side perspective view of the flexed assembly.</figref><figref num="8">The front view which shows the example of the graphical user interface in this invention.</figref><figref num="9a">FIG. 1 shows the upper surface of a bottom unit having a leak channel and a leak detector inside.</figref><figref num="9b">FIG. 2 shows the upper surface of a bottom unit having a leak channel and a leak detector inside.</figref><figref num="9c">Front view of the bottom unit having a leak channel and a leak detector inside.</figref><figref num="10">FIG. 5 is a side view of an embodiment of a dialysis machine having a barcode reader.</figref><figref num="11a">The schematic diagram of 1 Embodiment of a door assembly.</figref><figref num="11b">The schematic diagram of 1 Embodiment of a door opening.</figref><figref num="12">The figure which shows the upper part of the dialysis system which has a modular form work space.</figref><figref num="13">A side perspective view showing one embodiment of a latch attached to an upper unit of a portable dialysis system.</figref><figref num="14">A first side perspective view showing one embodiment of a base unit of a portable dialysis system including a matching latch mechanism.</figref><figref num="15">A second side perspective view showing one embodiment of a base unit of a portable dialysis system including a matching latch mechanism.</figref><figref num="16">The plan view which shows the electric communication connection in 1 Embodiment of a portable dialysis system.</figref><figref num="17a">FIG. 5 is a plan view showing an embodiment of a portable dialysis system to which an example of dimensions is added.</figref><figref num="17b">The front view which shows 1st Embodiment of the portable dialysis system to which an example of a dimension is added.</figref><figref num="18a">The figure which shows 1st Embodiment of the base unit which has a containment cavity and an alignment pin.</figref><figref num="18b">The figure which shows 1st Embodiment of the top unit which has a leg pad.</figref>

Although the present invention can be implemented in various forms, in order to facilitate understanding of the basic features of the present invention, the embodiments shown in the drawings will be referred to and described using specific terms. It goes without saying that the scope of the present invention is not limited and various modifications are possible. In addition, further implementation of the basic features of the invention described herein is possible, as would normally be assumed by those skilled in the art.

"Period" and its variations mean the time course from the start to the end of a given treatment. Treatment ends when the condition recovers and is interrupted for other reasons. During the duration of treatment, multiple treatment times are defined, during which one or more predetermined stimuli are applied to the subject.

"Time" refers to the time during which a single dose of stimulation is given to the subject as part of a given treatment plan.

"And / or" refers to one or all of the listed elements, or a combination of two or three or more of the listed elements.

"Preparing" and its variations are used in the specification and claims, but have no limiting meaning.

Unless otherwise stated, "1", "corresponding", "1 or more", and "at least 1" are interchangeable and are used to mean "1 or more".

The method described herein has individual steps, but the order of these steps may be any order as long as it is feasible. Further, if necessary, two or more steps may be performed at the same time.

In addition, the numerical range includes all numbers included in the range (for example, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, 5 and the like. included). Unless otherwise specified, all numbers used in the specification and claims to represent the number of components, molecular weight, etc. should be understood as being modified by "about" in all cases. Is. Therefore, unless otherwise specified, the numerical parameters described in the specification and claims are approximate values and differ depending on the characteristics to be realized by using the present invention. At the very least, each numerical parameter should be interpreted in light of the reported significant figures by applying conventional rounding techniques and not with the intent of limiting the doctrine of equivalents of claims.

Numerical ranges and numerical parameters indicating a wide range of the invention are approximate values, but the numerical values shown in the specific examples are as accurate as possible. However, all numbers essentially include the region that is inevitably caused by the standard deviation seen in each test measurement.

The present invention relates to a dialysis unit that is modular, portable and has improved functionality. In FIGS. 1 and 2, in one embodiment, the dialysis systems 100, 200 include top units 101, 201 detachably attached to a base 202, the base 202 being a storage unit 122 for storing liquids. 222. Top units 101, 201, also referred to as main units or controller units, include graphical user interfaces 114, 214, a pump unit, and doors 110, 210 having an electromagnetic lock and a mechanical backup mechanism described below. On one side of the top units 101 and 201, a metal fitting 105 for detachably fixing the dialysis apparatus 103 is provided. Adsorbent cartridge fixing substrates 104 and 204 for detachably fixing the adsorbent cartridge 107 are provided on the other side of the top units 101 and 201. As shown in FIG. 3, the metal fitting 105, the blood filter 103, the adsorbent cartridge fixing substrate 104, and the adsorbent cartridge 107 may be provided on the same side with respect to the top unit 101. In either case, the shelves that support the adsorbent cartridge, support the injectable bottle, catch spills, and / or guide the spills to the leak detector are on the sides of the top unit. The bottom unit has a sufficiently larger area than the top unit so that it is formed in.

A syringe pump 190 as an anticoagulant pump is provided between the dialysis apparatus 103 and the door 110. The top unit 101 may include a bottle holder 190 having a spiked base for accommodating the bottle downward in the bottle holder housing. The infusion line is connected to the inlet of the blood pump, the outlet of the blood pump, or the outlet of the dialysis machine (on the blood side). The infusion line may pass through the bubble detector to detect when the anticoagulant is empty or clogged.

The dialysis system according to the present invention realizes functional parameters and operating parameters that are significantly superior to those of the prior art. Top units range from about 20-40 pounds, more specifically 30 pounds. The bottom unit ranges from about 15 to 30 pounds, more specifically 22 pounds. This is lighter than traditional systems. Top units range from about 1 to 4 cubic feet, more specifically 2.3 cubic feet. The bottom unit ranges from about 1 to 4 cubic feet, more specifically 2.8 cubic feet. It has a smaller volume than conventional systems.

In the first embodiment, as shown in FIG. 17, the top unit 1701 having a user interface and a controller has the same depth as the base unit 1702 having a storage unit containing a scale, but is different in length and height. .. In this embodiment, the depth D of the top unit 1701 and the bottom unit 1702 are both in the range of 10 to 30 inches, more preferably about 19 inches. In this embodiment, the length Lt of the top unit 1701 is in the range of 6 to 20 inches, more preferably about 14 inches. On the other hand, the length Lb of the bottom unit is in the range of 14 to 40 inches, more preferably 27 inches. In this embodiment, the height Ht of the top unit 1701 is in the range of 7 to 21 inches, more preferably about 14.5 inches. On the other hand, the height Hb of the bottom unit is in the range of 3 to 11 inches, more preferably 7 inches.

The base unit 1702 may also be further defined by a pair of shoulders 1704. Each shoulder 1704 extends outward from the side of the centrally located top unit 1701 along the length direction of the base unit 1702. The top unit is preferably located in the center of the length Lb of the base unit 1702. Therefore, the length of each shoulder 1704 is in the range of 4-10 inches, more preferably 7 inches. The lip 1703 extends upward from the surface of the base unit 1702 where the shoulder 1704 physically collides with the top unit 1701. The surface of lip 1703 is used to position the top unit 1701. The lip 1703 is continuous along the perimeter of the base of the top unit 1701 and has the same length and depth as the top unit 1701. Also, its height is H_t2And H_tIs equal to the difference with. In one embodiment, the lip height is in the range of 0.1 to 3.5 inches, more preferably 0.6 inches. Overall system height H_t3Is in the range of 10 to 35 inches, more preferably 22 inches.

The outer housing forming the top unit 1701 and the base unit 1702 is configured in a rectangular parallelepiped, a cubic body, or a box shape having four side surfaces, an upper surface, and a lower surface. In one embodiment, in each of the top unit 1701 and the base unit 1702, two of the four sides have an inner surface and an outer surface, respectively, and have the same height, length, and depth. Further, the upper surface and the lower surface each have an inner surface and an outer surface, and have the same height, length and depth.

The system configurations shown in FIGS. 1, 2, 17a, and 17b are merely examples, and the present invention is not limited thereto. For example, in FIG. 3, the top unit 301 is above the base unit 302 and is central to the overall length of the base unit 302 (base is symmetrical), as opposed to one of the base units 302. It may be placed on the side of (the base is asymmetric). Placing the top unit 301 on one side of the base unit 302 has the advantage that all tube connections and consumables can be located on the same side of the system, but the adsorbent cartridges 317 and dialysis machine 313 are unnecessarily crowded. This makes the device less convenient to use.

This dialysis system uses less water than conventional systems. In the conventional system, about 120 liters were used per treatment. In the system of one embodiment, 3 to 8 liters, more specifically 5 to 6 liters, are used. Moreover, the system does not require any household drainage facilities, supply connections, or separate outlets to treat excess water.

In addition, in the embodiment of the present invention, a multiple path adsorption system is adopted. The system is disclosed and incorporated herein by reference in XCORP212. Therefore, this system does not require a separate purified water supply device by a reverse osmosis system, and instead, ordinary tap water can be purified and used by an adsorption system.

Moreover, this system design is small and energy-saving (up to 300, only 50-200W during the procedure) and does not require a built-in pump or a separate liquid bag for movement or priming. The device operates with a blood flow in the range of 20-600 Qb (ml / min) and a dialysate stream of 50-500 Qd (ml / min). Volume accuracy is accurate, less than ± 30 ml / hour.

As shown in FIG. 2, the dialysis system is modular. In one embodiment, the top unit 201 can be physically separated from the bottom unit 202. The top unit 201 houses the main electronic device of the system, which has a graphical user interface integrally formed as a self-sufficient housing, a controller, and a pump. The larger bottom unit 202 houses the storage 222. By separating the system's electronics and storage, the portable dialysis system can be disassembled into multiple units for assembly, inspection, or portability, making it easier to handle, pack, and carry each subunit. .. In this design, the size of each part is specifically set so that it can be shipped by UPS or other courier companies. It is also flexible in terms of production growth. For example, if a controller unit or reservoir (decrease in liquid volume or change in volume measurement) is made separately, existing customers do not need to upgrade for both of these two components, but on the one hand. You only have to do it against. Similarly, if only one of the two components fails (eg, the pump is depleted), the customer may request or purchase only one component for repair.

In order to enable such modularity, a latch mechanism is adopted in the embodiment of the present invention. In the configuration of 1, the latch mechanism firmly fixes the bottom unit 202 to the top unit 201, and the bottom unit 202 can be removed from the top unit 201 by operating the latch mechanism. It is possible to simply stack these two systems one above the other without using a latch, but using a latch can prevent them from being accidentally disengaged. Further, if it is fixed with a latch, the device can be easily moved. It is preferable that this latch mechanism simply employs a male female connector provided on the upper member and the lower member and does not require a tool. Further, it is more preferable that the latch mechanism is designed so that the upper member and the lower member can be reliably aligned with each other. As a result, when these units are properly aligned, they are automatically connected to the power supply circuit to complete the circuit (exposed to the lower side of the top unit and the upper side of the bottom unit as described later). Things) can be used. This allows the use of a single power supply and simple connection / disconnection.

In FIG. 14, the bottom unit 1402 has four sides 1405a, 1405b, 1405c, 1405d, a base, an upper surface 1406, and a storage portion 1422 accessible from the first side 1405d. A plurality of latch coupling structures 1420 are provided on the upper surface 1406 of the bottom unit 1402. In the first embodiment, two latch coupling structures 1420a and 1420b are provided, which are arranged at the center of the bottom unit 1402 in the length direction so that the weight distribution is even. The first latch coupling structure 1420a is preferably arranged at a position separated from the side 1405d by a distance equal to 1/3 of the width of the bottom unit 1402. The second latch coupling structure 1420b is preferably arranged at a position separated from the side 1405b by a distance equal to 1/3 of the width of the bottom unit 1402.

As shown in FIG. 15, the latch mechanism includes a metal frame 1501 fixed to the upper surface of the bottom unit 1505 by, for example, bolts, screws, or other fasteners 1502. The frame 1501 supports a protrusion or long member 1503 that is detachably and flexibly inserted into the latch.

In order to detachably and firmly secure the bottom unit to the top unit, the top unit is provided with an auxiliary mechanical slide latch that is firmly fixed to the base of the top unit. In the first embodiment, the base of the top unit is provided with a first latch. The first latch is preferably located at the center in the length direction of the top unit and at a distance of 1/3 of the width of the top unit from the first side. The base is also provided with a second latch, which is centered in the length direction of the top unit and is 1 of the width of the top unit from the second side opposite and parallel to the first side. It is preferable that they are arranged at a distance of 3/3.

As shown in FIG. 13, the top unit includes a latch 1300 with a metallic flat slide base 1315. The rail 1330 slidably engages with the lower surface of the top unit. A coupling member for holding the rail 1330 in a predetermined position is provided on the lower surface of the top unit. Latch 1300 coupled structure is physically attached to the upper surface of the base unit 1406 has two latching tabs 1315 to slide toward the inside and the outside of the concrete.

The latch 1300 attached to the top unit is coupled to the latch coupling structures 1420a and 1420b on the upper surface of the bottom unit 1406. When the slide latch 1300 is in the first position during operation, the slide latch 1300 does not physically engage with the latch coupling structures 1420a and 1420b, so that the top unit does not fit snugly on the base unit or the base unit. The position is not aligned with respect to. In order for the top unit to be properly mounted on the top surface of the base unit 1406, the slide latch is moved to a second position within the member support structure located at the bottom of the top unit.

In the second position, the handle of the latch 1311 protrudes, which allows the tab 1315 to move away from the latch coupling structures 1420a, 1420b so that the top unit can be correctly placed on the base unit. In FIGS. 18a and 18b, the top unit 1801 with the slide latch 1880 is positioned relative to the bottom unit 1802 by four small rubber legs or foot pads 1840 provided on the bottom of the top unit 1801. These pads 1840 are configured to fit snugly and securely into four cavities or recesses 1830 provided near the upper corners of the bottom unit 1802. In addition, the top unit 1801 is accurately positioned with respect to the bottom unit 1802 by pins 1860 or protrusions provided on the top surface of the base unit 1802. These pins 1860 are configured to fit snugly and securely into the cavities 1890 provided on the underside of the top unit 1801. The bottom unit further has a latch coupling structure 1863, as described above.

By aligning the rubber legs 1840 and pins 1860 with the cavities 1830 and 1880, respectively, the latch 1880 of the top unit 1801 can be easily aligned with the latch coupling structure 1863 without repeated failures. Can be combined. Once aligned, the latch 1880 can be coupled to the latch coupling structure 1863 by simply sliding the latch 1880 into the latch coupling structure 1863, thereby firmly fixing the two units. Returning to FIGS. 13 and 14, in order to release the coupling, the latch handle 1311 is pulled or operated to open the tab 1315 from the base unit slots 1420a, 1420b. As a result, the upper top unit can be lifted from the lower bottom unit.

Further, in order to realize the above-mentioned modularity, a telecommunications connection mechanism is adopted in the embodiment of the present invention. This ensures that a telecommunications and / or data communication connection between the bottom unit and the top unit is established in one configuration, and telecommunications and / or between the bottom unit and the top unit in the other configuration. It cuts off the data communication connection.

In FIG. 16, the electrical connection between the top unit and the bottom unit is established when the top unit is installed on the bottom unit. These connections are firmly secured to the top surface of the bottom unit 1605 with fasteners 1601 and are established by a non-contact infrared communication port 1603 and a pushpin power port 1603 integrally configured as a plate 1602. The lower surface of the top unit has an electric conductor pad aligned with the push pin. Further, the push pin and the conductor pad may be arranged in the opposite direction. That is, the push pin may be arranged on the lower surface of the top unit, and the conductor pad may be arranged on the upper surface of the bottom unit.

In the first embodiment, a high current power connection is established by electrically connecting six spring-loaded pins integrally provided on the lower surface of the top unit to the conductor pad. Three pins are for +24 volt DC current and the other three pins are for grounding. In one embodiment, the pin or probe has the following characteristics: a) Centers are at least 0.175 inches, b) 15 amps rated current (steady), c) travel between 0.06 inches and 0.067 inches, ranging from 6.2 ounces to 9.0 ounces. Spring force, d) resistance less than 10 mΩ as standard, e) maximum travel amount in the range of 0.09 to 0.1 inch, f) work travel amount in the range of 0.06 inch to 0.067 inch, g) gold plating Nickel / silver barrel, h) stainless steel spring (optional gold plated), i) hard beryllium copper gold plated plunger, j) optional stainless steel bias ball. The spring force of the pin prevents damage by absorbing bending and twisting. The electric pin indicates any protrusion capable of transmitting electric power, and the electric contact pad indicates any surface capable of supporting the electric pin.

The non-contact infrared communication port 1603 employs two LED light emitting parts provided on the lower surface of the top unit, two LED light emitting parts arranged and connected to the two LED light receiving parts, and two LED light receiving parts. To do. The distance between the light emitting port and the light receiving port is less than 0.3 inches. On both the top surface of the bottom unit and the bottom surface of the top unit, the four LED units consist of a control pair (including 1 light emitting unit and 1 light receiving unit) and a safety pair (1 light emitting unit and 1 light receiving unit). It is divided into two pairs. These ports are put into a data communication state when the top unit and the bottom unit are properly arranged. In the first embodiment, the LED light emitting unit is a 870 nm high-speed infrared light emitting diode having a GaA1As double heterostructure. The LED light emitting unit is a high-speed diode having the following features. a) Ultra-high radiation, b) Low forward voltage, c) Suitable for high pulse current operation, d) Angle of half Intensity) is about 17 degrees, e) peak wavelength is about 870 nm, f) reverse voltage is about 5 V, g) forward current is about 100 mA, h) peak forward current is about 200 mA, i) forward surge current is about 0. .8A, j) Watt loss is about 190mW, junction temperature is about 100 ° C, l) Operating temperature range is -40 to 85 ° C. The non-contact infrared communication port can be arranged in any functional manner over the upper surface of the bottom unit or the lower surface of the top unit. It is also possible to adopt different well-known communication ports and structures.

In the first embodiment, the LED light receiving unit is a high-speed silicon light diode, has an ultra-high-speed response time, and has a radiation-sensitive region of about 0.25 mm.^２, The half-strength angle is about 15 degrees.

The LED light receiving unit has the following features. a) Reverse voltage is about 60V, b) Watt loss is about 75mW, c) Joint temperature is about 100 ° C, d) Operating temperature range is -40 to 85 ° C, e) Forward voltage is about 1V, f) Minimum yield The voltage is 60V, g) The diode capacity is 1.8pF.

Returning to FIGS. 1, 2 and 3, handles 211 and 311 and usable shelves 112 and 212 as work spaces are provided above the controller units 101 and 201. A handle provided on the upper pump section of the system is directly connected to the inner frame or internal structure of the system and simply projects from the plastic outer formation, housing, or outer panel surrounding the top units 101, 201. Not a translation. By connecting directly to the inner frame of the system, the handle can be used to safely move the system, especially when the instrument operates with 6 liters of water (additional about 40 pounds). Can handle the load reliably.

In FIG. 5, in one embodiment, the top unit 501 comprises an inner metal case, frame, or housing 510 in which an electronic device, a controller, and other top unit components are housed. The inner case 510 includes a horizontal protrusion arm 507 that extends rearward of the top unit 501. The substantially horizontal top shelf 505 includes at least one handle 520 integrally formed with the top shelf structure 505, a base bracket 530, and a vertical arm 506, thereby forming one continuous piece of metal or molded plastic. ing. The base bracket 530 is firmly attached to the inner case 510 at the front of the top unit 501, and the vertical arm 506 is firmly attached to the protrusion arm 507 at point 508 by screws. By firmly attaching the shelf 505 and handle 520 structure to the inner case 510 of the top unit 501, potential damage or damage caused by a heavy load on the connection between the outer case of the top unit and the handle can be prevented. Can be prevented.

Further, a metal door 562 constituting the inner frame of the door 110 shown in FIG. 1 is attached to the inner frame or the inner case 510 by a hinge 565. The door 562 is firmly attached to the plate 561, which is part of the inner frame 510. Structures 563 and 572 are structures that hold the inner motor / pulley assembly and / or indicate protrusions of the assembly. The protrusion 583 extending from the rear of the frame 510 is used for connecting various electronic components including a power entry module and a USB connection 582.

The top or shelf 505 of the controller unit is flat and has side walls, ideal for accommodating replenishers and temporary work surfaces. In FIG. 12, in one embodiment, the consumables 1206 used in the system are packed and shipped assembled on tray 1205. The tray 1205 is placed on the work space of the controller unit 1201. This facilitates access to the required consumables and management of the consumables. This is especially important for home users. The controller unit 1201 is waterproofed in preparation for liquid leakage so that the leaked liquid does not permeate into the top controller unit 1201 and damage it.

Other structural features of the controller unit 1001 are shown in FIG. The unit 1001 preferably has a built-in exposure reader 1005 such as a barcode reader or an RFID tag reader that reads codes and tags of consumable parts. During operation, the user preferably passes all the cords or tags attached to the consumable parts through the reader. In the first GUI dialysis setup step, the user can be instructed to pass each consumable part through a reader to encourage the user to perform the task.

As a result, the reader acquires the identification information of the consumables, sends the identification information to the internal table stored in the memory, compares the contents of the internal table with the identification information, and makes an appropriate consumable part (particularly, the dialysate). Certified (or not certified) as an additive). The contents of the internal table may be generated by manually entering the name and quantity of consumables, or by remote access to a prescription detailing the name and quantity of consumables. This authentication step has at least two advantages. The first is to ensure that the user owns all the parts they need, and the second is that the correct parts (not counterfeit or inappropriate consumables) are used. Can be confirmed.

In another embodiment, the reader 1005 mounted on the side of the top unit is a special multifunctional infrared camera that can read barcodes in one mode and changes the level in the infusion container in another mode. It is detectable. This camera outputs an infrared signal, which is reflected by the liquid surface. The reflected signal is received by the infrared receiver of the camera and processed by a processor to detect the position of the meniscus on the liquid level. In one embodiment, the camera detects and monitors changes in the liquid level at a resolution of 0.02 mm. In one embodiment, the camera is a 1.3 megapixel single chip camera module, which has one or more of the following features: a) 1280H x 1024V active pixel, b) 3.0μm size, c) 1/3 inch optical format, d) RGB Bayer color filter array, e) integrated 10-bit ADC, f) defect correction, lens shading correction, image scaling , Integrated digital image processing function including demoizing, sharpening, gamma correction, and color space correction, g) Built-in camera control for automatic exposure control, automatic white balance control, black level correction, h) Programmable frame ratio And output reduction function, i) maximum 15 ft / sec SXGA sequential scan, j) low output 30 ft / sec VGA sequential scan, k) 8-bit parallel video interface, l) 2-wire serial control interface, m) on-chip PLL, n) 2.4-3.0V analog power supply, o) independent I / O power supply, p) integrated power management with power switch, q) 24-pin shield socket option. In one embodiment, the camera is a 1.3 megapixel camera (model number VL6624 / VS6624) manufactured by STMicroelectronics.

The top unit or bottom unit of the dialysis system preferably further includes an electronic interface such as an Ethernet connection or a USB port so that it can be directly connected to the network. This can facilitate remote prescription authentication, compliance alerts, and other remote service operations. The USB port allows direct connection to accessories such as blood pressure monitors and hematocrit / saturation monitors. The interface is electronically isolated, which ensures patient safety regardless of the quality of the interface device.

A graphical user interface 114 is provided at the front of the top unit to provide a simple user interface for the system 100. At home, it is important that the device is easy to use. Maximum use of color and touch screen is desirable from a useful point of view. The touch screen allows for multiple user input structures, is compatible with multiple languages, and is easy to see even at night (especially by using brightness adjustment and night vision color). The GUI also has automatic door opening and closing and automatic locking functions during operation. In one embodiment, the GUI opens the door to the first latch position, and then the user presses the physical door open button to fully open the door. In another embodiment, the device is provided with a manual override that allows the user to open the door (by pressing the door open button twice or by pressing hard) in order to manually open the door. In FIG. 8, it is preferable that one machine button 805 having a visible instruction with a light bulb is provided in the vicinity of the GUI 800. It provides a central stop button that, when activated, has normal function (eg, system stop function) regardless of operating state.

In FIG. 1, the storage system 102 has a door 118. When the door 118 is pulled, the storage unit 122 is pulled out and access to the storage unit is possible. The capacity of the reservoir is monitored by a scale system. The scale-based liquid scale 600 is shown in FIG. 6 and in more detail in FIGS. 7a and 7b. The scale 600 is integrally formed with a storage unit, which provides accurate liquid consumption data and enables accurate remaining amount calculation. This prevents hypotension and other illnesses caused by fluid imbalances. A more robust system can be provided by integrally forming the scale and the storage and completely surrounding them.

FIG. 7a shows the internal structure 700 of the storage system. The metal inner frame 720 has two lateral 721s, a rear 722, an open front 723, and a bottom 724. Although the internal structure or the inner frame is shown, the outer housing shown as the member 102 in FIG. 1 is omitted here. The scale 718 is integrally formed with the internal structure 700 of the storage portion. The lower surface 715 of the scale 718 comprises a metal surface or pan, which, along with the rest of the scale 718, is suspended from the outer storage housing (102 in FIG. 1) by four bends 705. It is preferable that a heating pad is provided below the lower surface 715 of the scale. The heating pad has a square, rectangular, circular, or other shaped surface that can raise the temperature and transfer it as heat to the surface 715. A conduction coil 770 having a field and capable of measuring conductivity using changes in the field is integrally formed on the bottom surface 715. Therefore, when the storage bag (not shown) is placed on the lower surface 715, the storage bag comes into contact with the coil 770 and is heated by the heating pad to monitor its conductivity.

The inner surface of the side 721 includes a plurality of rails, long members, or protrusions 719 for fixing, holding, packaging, or attaching to the disposable storage bag mounting surface 710 such as a plastic sheet to which the storage bag is attached. Specifically, the discharge port of the storage bag mounted on the surface 715 is attached to a conduit integrally provided on the seat 710. Bent portions 705 are mounted on the four corners of the scale surface 718, and each bent portion 705 includes a hall sensor and a magnet.

In FIG. 7b, the bent portion 705 has a plurality of fixing points where the bent portion is fixed to the external storage housing. The bent portion further includes a magnetic body 762 (for example, two magnets) and a Hall sensor 764. The base 767 of the bend 705 is attached to the top surface 715 of the scale 718. When the loaded scale 718 is displaced (eg, when the storage bag is filled with dialysate, the bag pushes down the surface 715 and displaces the scale 718 downwards), one end is connected to the scale and the other end is outward. The bent portion 705 connected to the housing moves, and the magnet 762 mounted on one end of the bent portion uses the change in the magnetic field of the magnetic body 762 to track this movement. Hall sensor 764 detects changes in magnetic field strength. The method for measuring the weight load based on the change in the magnetic field strength detected in this way is self-evident to those skilled in the art.

By arranging disposable members such as the dialysis machine 103, the adsorbent cartridge 107, and the injection solution outside the system in an easily accessible form, it becomes possible to use the adsorbent cartridge, the dialysis device, and the injection mixture of different sizes. , Flexibility in use and applicability of the system can be improved. In FIGS. 3 and 9, disposable components, particularly completely disposable blood and dialysate circuits, are included in the kit (including dialysate, manifold, tube, storage bag, ammonia sensor, and other components). Used by packing, opening the front door (above) 303 of the top unit 301 and installing the dialysis machine 313 and manifold 304 for proper alignment of pressure, sensors and other non-disposable parts. To. The plurality of pump shoes 305 integrally formed on the inner surface of the front door 303 makes it easy to mount disposable parts. All you have to do is insert the manifold and you don't have to pass the pump tube between the roller and the shoe 305. Such packaging and easy handling facilitate the installation of consumables and the cleaning of the system. Further, the liquid circuit shown in FIG. 11 is properly configured and ready for use. At the time of operation, the top unit 301 is attached to the bottom unit 302 including the storage unit 322.

The front door is wide open (about 100 degrees) for mounting consumables. By widening the door, the manifold can be easily attached and the device surface and the inside of the door can be easily cleaned. It can be made safe and sturdy by closing the door and covering the moving members of the device. This is especially important for home use. Furthermore, by accommodating the display in the front door, space can be saved and the important point that the device should not be operated unless the consumables are installed and the door is closed can be emphasized. The door applies the required closing force to the manifold and pump segments. The door surface also houses a touch screen, voice alarm, and manual stop button.

In one embodiment, the door is held in a completely closed state by an electric stepper motor. The motor is operated via a user interface, especially by the user pressing a button with the door fully closed and open. It is preferable to have an electronic mechanism capable of closing the door and generating sufficient door closing force so that the door and pump shoe exert appropriate pressure on the manifold configuration. In one embodiment, 90-110 lbs of door closing force is generated.

The electric door closing mechanism 1100 according to the first embodiment is shown in FIG. 11a. The stepping motor 1106 is mechanically connected to the main screw 1116, and when activated by the controller, the stepping motor 1106 turns the main screw 1116, whereby a driving force is applied from the rod 1118 to the hook. A hook located below the member 1140 is adapted to latch on the U-shaped latch 1130, and when pulled or rotated to move in the direction of the stepping motor 1106, it pulls the U-shaped latch 1130 in the closing direction. And give the necessary door closing force. The hook is physically engaged with the rod 1118, which can be operated to pull the U-shaped latch 1130 to close it tightly or loosen its engagement with the U-shaped latch 1130. The electrically closed system is mounted while being maintained in the proper orientation by the mounting bracket 1105.

Operationally, when the user closes the door sufficiently, the U-shaped latch 410 provided on the door engages with the hook 450 provided inside the controller unit as shown in FIG. The user then instructs the portable dialysis machine to close the door, preferably via a mechanical button or a graphical user interface. When a mechanical button or graphical user interface is pressed, a signal is sent to the controller, which activates the stepper motor 1106. The stepping motor 1106 supplies a driving force to the hook 450, and the hook 450 pulls the engaged U-shaped latches 1130 and 410 and closes them tightly. In the first embodiment, the controller monitors the talk imparted by the motor and stops the stepping motor when the value reaches a predetermined value. In another embodiment, a hole device arranged in the vicinity of the main screw detects the extension of the main screw and determines the amount of movement of the screw. When the screw moves sufficiently in the direction of increasing the door closing force, the Hall sensor outputs a signal to the controller to stop the motor. Alternatively, the sensor constantly outputs a signal indicating the extension of the screw, and the controller interprets this to determine whether or not sufficient driving force has been applied, and determines whether or not the stepping motor should be stopped. In any of the embodiments, if the motor talks excessively, exceeds a predetermined distance, or the door does not completely close within a predetermined time, the controller stops the motor and reaches the fully open state. It may be inverted. In addition, the controller may issue visual and / or audio alarms.

When the user opens the door, he activates a mechanical button or graphical user interface icon and signals the controller to activate the stepper motor 1106 in the opposite direction. Then, the engagement between the hook and the U-shaped latch is loosened. When the mechanical release button 1107 is pressed, the loose engagement with the U-shaped latch is disengaged.

In addition to providing the required closing force, this electric door closing mechanism has some important features. First, it prevents obstacles from getting caught in the door and is subject to large door closing forces. In FIG. 4, the manifold is surrounded by an edge guard. The edge guard engages the door latch with the latch receiver provided on the top unit when a human finger or an improperly mounted consumable or other obstruction is caught between the door and the bottom plate of the top unit. It is to prevent. The door 405 has an inner surface 406 to which the metal case 425 is attached. In the first embodiment, the upper surface of the inner surface 406 of the door 405 is fixed to the outer surface of the case 425. The case 425 is substantially rectangular and defines a cavity that forms an internal volume and has four sides 407 and a base 408. The cavity opens towards the manifold configuration of the dialysis system 400 and surrounds the manifold configuration 430 and guard 440. The guard 440 is preferably a plastic curtain that surrounds the upper and lateral sides of the manifold 430. A pump shoe 415 and at least one U-shaped latch projecting toward the rear plate are attached to the surface of the base 408. The hook 450 is integrally formed with the guard and protrudes outward from the guard. The hook 450 is firmly engaged with or disengaged from the U-shaped latch 410. When the door is properly closed and nothing is sandwiched between the door and the guard, an electric door lock hook mechanism is mechanically connected to the U-shaped latch. If an obstruction is caught, the metal case 425 cannot protrude into the internal volume of the top unit (cannot surround the guard) and the U-shaped latch cannot engage the hook. Therefore, in the presence of obstructions, mechanical connections and the doors are prevented from being inadvertently closed by electric power.

Next, the mechanical button release 1107 is activated only when the electric door closing force is released by the reverse rotation of the stepping motor. This prevents the door from opening carelessly or opening rapidly. In FIGS. 11a and 11b, when the door is closed and locked, the roller 1150 on the button shaft 1107 rotates 90 degrees to move the push pin away from the electric door lock hook. The roller 1150 is rotated by the rod 1121. The rod 1121 is connected to the roller at position 1145 and is mechanically connected to the main screw 1116. A spring is mounted on the roller 1150 and is locked by a small pin solenoid. When the user presses the button in the locked position, the button moves into the device, but is displaced by the rotation of the roller, so that the engagement with the hook is not disengaged. This prevents the door from opening. In the event of a power outage or an unintentional power cut, the pin solenoid opens, the rollers return 90 degrees, and the push pins are properly aligned. The next time the user presses a button, the push pin contacts the electric door hook and releases the door latch. This mechanism can provide a convenient and safe backup of the mechanical door release without the risk of the mechanical door release being inadvertently activated and the door being opened with excessive force. The term "hook" or "latch" is used in a broad sense to include any protrusion or member that can be physically or mechanically engaged with another protrusion or member. Further, the term "U-shaped latch" is used, but the present invention is not limited to this, and as described above, any latch mechanism or hook mechanism can be used.

As described above, the shelf space formed by the bottom knit and surrounding the top unit employs drainage channels provided with liquid sensors at a plurality of locations inside and outside the apparatus in order to enable division leakage detection. Specifically, by providing a drainage channel provided with an optical leakage sensor in an external member of the device, the system can capture the liquid leaked from the external member (adsorbent container or the like) and send it to the optical leakage sensor.

In one embodiment, at least three different optical leak detectors are provided inside the outer housing of the bottom unit. In FIG. 9a, the upper surface of the bottom unit 902 is slightly inclined, and the central 980 is located above the sides 981 and 982. In the first embodiment, the surface is tilted downward from the central region 980 toward the sides 981 and 982 at an angle of 1 to 10 degrees, preferably 3 degrees. Channel 987 surrounds the top surface of the bottom unit, extends along the outer circumference, through the center of the top surface, and / or through the rest of the top surface. Since the upper surface of the bottom unit 902 is inclined, the channel 987 is also inclined from the center 980 toward the sides 981 and 982. In another embodiment, the upper surface is slightly inclined downward even in the direction from the rear 991 to the front 990. The slanted channel 987 guides the liquid away from the center and / or rear of the system to the front and sides where the leak detector 988 is located and communicates with the channel 987.

The first optical leak detector 988a is located at the right front corner of the upper surface of the bottom unit 902. The second optical leak detector 988b is located at the front left corner of the upper surface of the bottom unit 902. Each leak detector comprises an optical sensor located inside the well or cavity and located on the side of the well. The optical sensor detects the leaked liquid and / or the liquid guided to the well, and transmits the detection signal to the controller of the top unit. The detection signal is processed by the processor to determine if a leak has occurred. The detection signal is then stored and, if necessary, the processor causes the GUI to display an alarm or warning. The bottom surface of the well or cavity is preferably rounded so that the user can easily wipe off the moisture. FIG. 9b shows the details of the upper surface of the bottom unit 902 including the leak detector 988a arranged in the channel 987 and the well 997.

In FIG. 9c, at least one additional leak detector is arranged inside the bottom unit 902, more specifically inside the storage section 903 containing the scale 904. It is preferable that the channel 905 is integrated with a storage structure such as an inner housing or a metal bag holder and is inclined from one side to the other side or from the center to both sides. In the first embodiment, the tilt angle is in the range of 1 to 10 degrees, more specifically 3 degrees. Well 910, which houses the leak detector, is built into the storage housing and communicates with channel 905 on one or both sides of the storage housing. When a leak occurs in the disposable bag, the liquid flows through the channel 905 into a metal dish or a corner of the storage housing and is guided to at least one well in which the leak sensor 910 is located.

The discharge channel has two functions. A) a function to prevent liquid from entering the inside of the device, and b) a function to immediately suppress leakage and ensure that the liquid is sent to a sensor that issues an alarm or warning. The device also preferably has a liquid drain channel leading to a well with an optical sensor inside the device. Thus, for example, if a leak occurs in the internal storage, the liquid is guided away from the critical member and the optical sensor signals the leak. When the sensor is activated, the GUI issues an alarm to the user based on this, and the liquid leakage location can be specifically specified. By dividing the leak detection into multiple independent areas (multiple liquid sensors and multiple drainage paths), the user can quickly find the leak. With multiple channels and sensors, the system can partially and automatically identify the source of the leak and provide the user with graphic assistance for problem solving.

Although the preferred embodiments of the present invention have been described, those skilled in the art can understand that various modifications and modifications can be made, and elements can be replaced with substitutes without exceeding the scope of the present invention. It is possible. In addition, the features of the present invention can be modified in various ways so that they can be applied to specific situations and materials without exceeding the scope of the present invention. Therefore, the present invention is not limited to the above embodiments, and the present invention includes all embodiments included in the claims.