Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
  • A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
  • A61M1/15—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit
  • A61M1/152—Details related to the interface between cassette and machine
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
  • A61M1/15—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit
  • A61M1/154—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit with sensing means or components thereof
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
  • A61M1/15—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit
  • A61M1/155—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit with treatment-fluid pumping means or components thereof
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
  • A61M1/15—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit
  • A61M1/156—Constructional details of the cassette, e.g. specific details on material or shape
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
  • A61M1/15—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit
  • A61M1/156—Constructional details of the cassette, e.g. specific details on material or shape
  • A61M1/1562—Details of incorporated reservoirs
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
  • A61M1/15—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit
  • A61M1/156—Constructional details of the cassette, e.g. specific details on material or shape
  • A61M1/1565—Details of valves
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
  • A61M1/15—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit
  • A61M1/159—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit specially adapted for peritoneal dialysis
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
  • A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
  • A61M1/288—Priming
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
  • A61M1/15—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit
  • A61M1/153—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit the cassette being adapted for heating or cooling the treating fluid, e.g. the dialysate or the treating gas
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/12—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
  • A61M2205/123—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit with incorporated reservoirs
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/12—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
  • A61M2205/127—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit with provisions for heating or cooling
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/12—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
  • A61M2205/128—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit with incorporated valves
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/33—Controlling, regulating or measuring
  • A61M2205/3331—Pressure; Flow
  • A61M2205/3344—Measuring or controlling pressure at the body treatment site

Definitions

• the present invention relates to processes of medical treatment, and apparatus for use therein. More specifically, it relates to processes of peritoneal dialysis (PD) conducted on human patients, apparatus for use therein, component parts for assembly into such an apparatus, and procedures for manipulating and adjusting processes using such an apparatus.
• PD peritoneal dialysis
• dialysis is the standard treatment for replicating the function of a normal human kidney.
• There are two types of dialysis procedures in use hemodialysis (HD), which circulates the patient's blood through filters located outside the body, and peritoneal dialysis (PD), which uses the peritoneal membrane of the patient's abdominal cavity as a filter to remove toxins via specialized solutions (dialysates).
• HD hemodialysis
• PD peritoneal dialysis
• PD a very gentle modality, with its slow corrective action more resembling that of the natural kidney. It is operationally simple, eliminates the need for venipunctures and has lower operational costs.
• APD APD modalities of: [0005] (i) Continuous Cycling Peritoneal Dialysis (CCPD); a method of performing PD in which an automated cycler performs 4 to 6 regular exchanges every night;
• CCPD Continuous Cycling Peritoneal Dialysis
• IPD Intermittent Peritoneal Dialysis
• NPD Nightly Peritoneal Dialysis
• TPD Tidal Peritoneal Dialysis
• Automatic PD machines of the type generally described in the aforementioned Dadson patent comprise a number of inter-connected sections and parts, some of which are used over again with the same or even with different patients, in different PD processes, and others of which are used once only or a few times only. In each case, there is a requirement for assembly and connection of the various parts prior to the commencement of a PD process, either by the health care professional or by the patient.
• peritoneal cavity pressure changes can provide valuable diagnostic information about the patient under test. Such changes, although significant when properly read and interpreted, are relatively small and need to be obtained with high accuracy. If peritoneal cavity pressure readings of the necessary
• the present invention seeks to provide automatic PD machines, and processes for their operation, which at least in their preferred embodiments fulfill one or more of these requirements.
• the invention in one aspect comprises a cartridge for a peritoneal dialysis system, including a defined fluid region within the cartridge where the volume of fluid within the fluid region reflects one or more of the physical, chemical and biological natures of the liquid in the peritoneal cavity.
• the invention from another aspect comprises a cartridge for a peritoneal dialysis (PD) system, comprising: a) a pressure-sealed cartridge containing a mixing chamber, an entrance chamber and a ballast chamber; b) one or more inlet/outlet ports in said entrance chamber, said ports being fully pressure-sealed when closed; c) a pressure- sensing region in the entrance chamber, capable of measuring total pressure and pressure fluctuations within the cartridge; and d) an outlet from the mixing chamber to a patient
• PD peritoneal dialysis
• Other aspects of the invention further comprise a peritoneal dialysis system using the aforementioned cartridge, and a method of performing peritoneal dialysis using the aforementioned system or cartridge.
• Figure 1 is a top perspective view of the cartridge of the preferred embodiment of the present invention.
• Figure 2 is a bottom perspective view of the cartridge of Figure 1 with the casing removed;
• Figure 3 is a schematic of the inlet port sealing mechanism
• Figure 4 is a schematic of one embodiment of the sealing mechanism.
• Figure 5 is a schematic of another embodiment of the sealing mechanism.
• the inventive system presented herein comprises a disposable cartridge for use in a complete peritoneal dialysis system.
• the cartridge provides for the input of dialysate solution components, the mixing of these components and the transmission of the mixed solution to the patient, all within a pressure-sealed unit.
• the operating features of the cartridge according to the preferred embodiment are set out in more detail in the following description.
• a peritoneal dialysis system as known in the art, consists essentially of a set of fluid bags to hold the dialysate solution(s), a dialysis machine for pumping fluid into and out of the patient, and an outlet to deliver solution to and from the patient with a catheter in the peritoneal cavity.
• the inventive cartridge presentedjierein forms part of the dialysis machine and acts as the pumping and fluid delivery portion of the dialysis machine.
• Other elements, such as a power supply, operator controls, etc. are assumed to be consistent with the known art of dialysis machines, subject to any modifications required for operation of the cartridge.
• the cartridge 10 has a number of discrete chambers. There is a mixing chamber 20, with a series of input/output ports 22a-g and a pressure-sensing region 24 at one end.
• the mixing chamber 20 is connected to a ballast chamber 30, which preferably has a heating element (not visible) and a corrugated fluid path 32 (shown in Figure 2) to provide time for the fluid to be heated to a suitable entry temperature on a continuous basis.
• the ballast chamber 30 is coupled to an external supply of dialysate fluid (not shown) via an inlet port 26.
• a top view of the cartridge 10 as shown in Figure 1 indicates the orientation of the input/output ports 22 and pressure sensing region 24.
• Fluid movement in the cartridge 10 is produced by a syringe 40 is provided to drive fluid in and out of the mixing chamber 20 in conjunction with the opening and closing of input/output ports 22a-g. Syringe 40 also acts to mix and store fluid in cooperation with mixing chamber 20.
• Input/output port 22a is located at one end of mixing chamber 20, to provide, direct fluid communication between syringe 40 and mixing chamber 20. By locating port 22a in a position whereby syringe 40 can be directly connected the possibility of trapping air in the system between syringe 40 and mixing chamber 20 is significantly reduced.
• Input/output ports 22b-e are used for fluid connection between cartridge 10 and other sources. One port, using 22b as an example, although any of 22b-e can be used, is connected to the patient for fluid transfer to and from the patient. The others, 22c-e herein, are used to supply various additives and medicaments to the dialysate from external sources (not shown).
• Input/output port 22f is used for fluid communication between ballast chamber 30 and mixing chamber 20.
• Input/output port 22g is the drain port for cartridge 10.
• the input/output ports 22a-g contain compressible sealing elements 50 to ensure that the ports are completely closed when not in use, and properly opened when in use.
• the sealing elements 50 are shown in greater detail in Figure 3, with specific embodiments in Figures 4 and 5.
• the sealing element 50 comprises a compressible seal 58, a spring-loaded anchor point 60 for compressing the seal 58, a plunger 52 coupled to a cam 51 to open and close the seal 58, extremity detectors 53 to monitor the position of the plunger 52 and a force detector 57 and a motor 59 to drive the cam 51.
• Components such as motor 59, force detector 57 and extremity detectors 53 can be provided as off-the-shelf components.
• the combination of force detector 57 with extremity detectors 53 detects and confirms whether the sealing element 50 is in a fully closed or fully open position.
• the force detector 57 preferably operates by sensing the change in current in the motor driving the plunger 52 arising from the resistance created by the plunger 52 and seal 58 as they contact the closed position.
• the pressure-sensing region 24 in the entrance chamber 20 allows for continuous monitoring of the pressure in the cartridge 10.
• the pressure in the pressure-sensing region 24 of cartridge 10 reflects the pressure in the patient's peritoneal cavity if the physical environment in this region is made equivalent to that of the peritoneal cavity.
• the fluid composition in region 24 reflects the fluid composition in the peritoneal cavity.
• a parameter such as a pressure change in the cavity can be monitored non-invasively, and in real-time, enabling on-the-fly changes in the patient's treatment.
• These parameters can be monitored or adjusted. They can be as simple as adjustments to the flow rates, or more complex functions, such as real time monitoring of the composition of the drain fluid or changing the composition of the dialysate solution.
• pressure-sensing region 24 is made with a transparent window 26 in the casing to permit the operation of additional sensors in the same location for increased efficiency and improved monitoring of patient status. Such sensors would be
• OCV optical . 5 . 73927-14 mounted on the dialysis machine in which the cartridge is installed.
• OCV optical sensor
• an optical sensor can be targeted through the window 26 to perform spectroscopic analysis of the fluid in the pressure sensing region.
• the material of the cartridge should permit the operation of other sensing technologies, such as acoustic or photoacoustic readings, and is preferably non- electrically conductive to permit the use of capacitance plates or similar technology in the dialysis machine to monitor electrolyte conditions in the dialysate.
• the cartridge material should also be non-heat conductive as well.
• the cartridge 10 should have a defined region, preferably as part of or in close proximity to the pressure-sensing region 24, where the fluid in that defined region reflects the physical, chemical and biological nature of the fluid in the patient's peritoneal cavity.
• FIG. 4 A schematic of a preferred embodiment of the cassette and a plunger are shown in Figure 4. This is an illustration of a typical input/output port 22 that opens inside the mixing chamber 20 (see Figure 1).
• an upward movement of the plunger 52 pushes against the sealing membrane 54 which pushes the valve body header 56 upwards and causes the soft head 58 to compress the spring 60 into the port 22, thereby sealing the port 22.
• the extremity detectors 53 shown in Figure 3) and force sensors (not shown) are monitored to confirm sufficient force has been applied to soft head 58 to seal the port 22.
• the input/output port 22 is completely closed and isolated from all input/output ports 22 in communication with the mixing chamber 20.
• the plunger 52 moves down, allowing the spring 60 to apply a restoring force P2 to the soft head 58, pushing the soft head 58 away to open the input/output port 22, and allowing it to communicate with the inside of the mixing chamber 20.
• the extremity sensors 53 and the force sensor are monitored to confirm the sealing force has been removed.
• liquid can be transferred from or inputted into an attachment to the input/output port 22 accordingly.
• the syringe 40 When transferring solution through the input/output port, the syringe 40 generates a positive force Pl that pressurizes the mixing chamber 20. To maintain the
• the restoring force P2 generated by spring must be greater than force Pl generated by the syringe 40. Otherwise Pl will push in between the sealing membrane 54 and the body header 56, and push behind the body header to close the outlet of the input/output port. Thus, it is important that the restoring force P2 be greater than the induced force Pl from the syringe 40.
• the syringe 40 When withdrawing solution from a receptacle attached to the input/output port, the syringe 40 generates a negative force P'l that transmits equally into the occlusion chamber. This induced negative force P'l would attempt to collapse the mixing chamber. This would force the header head to move upwards to close and seal off the output of the input/output port 22.
• the restoring force P2 must be strong enough to overcome the induced negative pressure P'l and force the inlet of the input/output port opened.
• the additional springs 60 in Figure 4 are also designed to apply forces P3 and P4 to assist the restoring force P2 to keep the input/output port opened along with P5, the pressure exerted by the plunger 52.
• the relationships of the pressures could be expressed as follows;
• FIG. 5 An alternate embodiment of the occlusion system is shown in the schematic of Figure 5.
• the body header 56 is expanded to form part of the sealing membrane 54 of the mixing chamber 20.
• the head of plunger 52 moves up or down to apply the positive and the negative forces to close or open accordingly, the output of the input/output ports 22a-g.
• this embodiment must be such that P5>P 1 is realized as discussed above.
• Other methods could be used to achieve the result created by these embodiments.
• corrugations may be built into a semi-rigid sealing
• syringe 40 provides the pressure required to draw fluid through the input/output ports 22a-g. To drain the cartridge, input/output port 22g is opened, all others are closed, and syringe 40 is depressed to increase pressure in the cartridge and force fluid out through input/output port 22g.
• a desirable aspect of any PD system is the requirement for an absolute sterile environment.
• Disposable components are made sterile at the point of manufacture and supplied as a sterile packaged to the end user. Sterility is only broken at the point of use. It is well known that this sterility can now be inadvertently compromised at this stage, for example, by touch contamination by the user.
• a technique described in U.S. Patent No. 5,053,003 known as "flush before fill" is one method to protect against sterility compromise.
• the cartridge 10 is capable of sterilization according to this technique.
• the machine can check to see if the cartridge has been correctly inserted and all of its ports can be opened and closed on demand as follows.
• the cartridge 10 is inserted into the machine with syringe 40 having a fluid volume Vl preset at Vl i n i t i al prior to sterilization.
• the machine will open port 22f, the port that allows liquid flow between the volume in ballast chamber 30, V3 and Vl (see Figure 1) and then reduce Vli nt j a i to Vl beg i n - Since all of the other ports are closed the pressure in the cartridge will increase as the volume decreases in accordance with Boyle's law.
• a controller in the machine will watch this pressure for a preset time. If the pressure is unchanged during this set time then the operator is instructed to open all of the fluid line clamps and again the system will monitor the pressure. If the pressure is unchanged the machine will indicate that the system is air tight and hence liquid tight.
• the machine will then cycle all of the ports from closed to open and back to closed a number of times (at least three). Then all of the ports 22a-g are closed and Vlbegin is reduced to Vlf, na i. Again, according to Boyle's law the pressure in the mixing chamber 20 volume V2 will increase from its value at V be gi n - The machine will then
• Volume Vb eg in is changed to Vf ina i expelling any air that was removed from V3.
• Port 22g is closed and the cycle repeated. After approximately 5 or 6 such cycles all of the air in V3 and V2 will be removed and V3 and V2 will be filled with sterile fluid.
• fluid bags containing the components parts of a dialysate solution are coupled to the input/output ports 22c-e and the ports 22c- e are opened and closed in sequence to bring the various component solutions into the mixing chamber 20.
• the fluid then flows into the ballast chamber 30, preferably along a corrugated or similar path 32 to permit the fluid to be brought to temperature before it enters the mixing chamber 20 and is pushed out into the patient.

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• Health & Medical Sciences (AREA)
• Heart & Thoracic Surgery (AREA)
• Urology & Nephrology (AREA)
• Emergency Medicine (AREA)
• Anesthesiology (AREA)
• Engineering & Computer Science (AREA)
• Vascular Medicine (AREA)
• Biomedical Technology (AREA)
• Hematology (AREA)
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• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
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• External Artificial Organs (AREA)

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• 2007
  • 2007-01-19 CA CA2574537A patent/CA2574537C/en active Active
• 2008
  • 2008-01-21 EP EP08706245.1A patent/EP2111242A4/de not_active Withdrawn
  • 2008-01-21 WO PCT/CA2008/000098 patent/WO2008086619A1/en active Search and Examination

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