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WO2008086619A1 - System and method for peritoneal dialysis - Google Patents

System and method for peritoneal dialysis

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Publication number
WO2008086619A1
WO2008086619A1 PCT/CA2008/000098 CA2008000098W WO2008086619A1 WO 2008086619 A1 WO2008086619 A1 WO 2008086619A1 CA 2008000098 W CA2008000098 W CA 2008000098W WO 2008086619 A1 WO2008086619 A1 WO 2008086619A1
Authority
WO
Grant status
Application
Patent type
Prior art keywords
pressure
cartridge
chamber
fluid
peritoneal
Prior art date
Application number
PCT/CA2008/000098
Other languages
French (fr)
Inventor
Joseph E. Dadson
Belinda Y. H. Wong
Orson L. Bourne
Original Assignee
Newsol Technologies Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators; Reciprocating systems for treatment of body fluids, e.g. single needle systems for haemofiltration, pheris
    • A61M1/28Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators; Reciprocating systems for treatment of body fluids, e.g. single needle systems for haemofiltration, pheris
    • A61M1/28Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
    • A61M1/288Priming
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/12General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
    • A61M2205/123General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit with incorporated reservoirs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/12General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
    • A61M2205/127General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit with provisions for heating or cooling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/12General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
    • A61M2205/128General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit with incorporated valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3331Pressure; Flow
    • A61M2205/3344Measuring or controlling pressure at the body treatment site

Abstract

The invention consists of 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 line, wherein said pressure sensing region enables measurement of pressure changes in said cartridge. The invention further consists of a peritoneal dialysis system using the aforementioned cartridge, and a method of performing peritoneal dialysis using the aforementioned system or cartridge.

Description

SYSTEM AND METHOD FOR PERTTONEAT, DIALVSTS Field of the Invention

[0001] 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.

Background of the Invention

[0002] For patients suffering from low kidney functions, 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). [0003] Compared with HD, PD is 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. Because the system is not an extracorporeal one, there is no need for a high degree of heparinization, a factor that is especially important in the case of diabetic patients. However, to date HD has continued to dominate in the treatment of End-Stage Renal Disease (ESRD) patients.

[0004] In a continuing effort to provide adequate PD treatment for the varied population of patients in need, clinicians have developed a number of different forms of the APD modality of treatment. These include the 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;

[0006] (ii) Intermittent Peritoneal Dialysis (IPD); a method of performing PD in hospitals or at home with an automatic cycler two or three times a week for a period of about eight to twenty hours each time;

. j . 73927-14 (ODV) [00071 (iϋ) Nightly Peritoneal Dialysis (NPD); a method of performing nightly peritoneal dialysis at home for patients with high efficiency peritoneal membranes. Such patients do not fare well with long dialysate dwell times.

[0008] (iv) Tidal Peritoneal Dialysis (TPD); This modality utilizes an initial maximum dialysate fill volume (usually three liters) and periodically, during a long and continuous dwell time, drains a fraction of the infused volume (usually one-third, the tidal volume) and re-infuses about a similar amount, adjusting for ultrafiltration (excess fluid removed from the patient's body during kidney dialysis) into the patient. [0009] These modalities all involve an infusion phase ("Fill sequence"), during which the dialysate (normally glucose) is introduced into the peritoneal cavity, a dwell phase ("Dwell sequence") during which the dialysate is essentially at rest in the peritoneal cavity, and a draining phase following the dwell phase, when the dialysate is expelled from the peritoneal cavity.

Brief Reference to the Prior Art

[0010] United States Patent 6,228,047 to Dadson, issued May 2001, describes an automated PD machine which is capable of monitoring the interperitoneal pressure during the PD process. Such pressure monitoring is very advantageous in practice. For example, it allows diagnostic information to be obtained from the patient in real time during the dialysis process, so that process conditions can be adjusted and optimized as the process proceeds.

[0011] 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. [0012] It has been discovered that 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

_ 2 _ 73927-14 (ODV) accuracy for delivering worthwhile diagnostic information during the PD process are to be obtained, it is necessary that a high degree of leak-proof sealing of the various parts that communicate with the peritoneal cavity during the process, and their connection to one another, be achieved and maintained. It is in addition highly desirable that the operator should be able to check and confirm that the required degree of sealing has been achieved and maintained during the process. Otherwise, worthless or misleading diagnostic pressure readings may be obtained from the peritoneal cavity. [00131 Additionally, current techniques of PD afford no ability to monitor the pressure build-up in the peritoneum during either the Dwell sequence or during the Fill sequence. Also, current PD solutions are of fixed composition and cannot be systematically adjusted either in their constituent parts or in the concentration of each constituent during a treatment. The ability to monitor peritoneal pressure readings and dynamically adjust PD solution composition in response would be of great benefit and provide improved PD treatment. [0014] 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.

[0015] It is an object of this invention to partially or completely fulfill one or more of the above-mentioned needs.

Summary of the Invention

[0016] 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. [0017] 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

_ 3 _ 73927-14 (ODV) line, wherein said pressure sensing region enables measurement of pressure changes in said cartridge.

[0018] 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.

(00191 Other and further advantages and features of the invention will be apparent to those skilled in the art from the following detailed description of specific embodiments thereof, taken in conjunction with the accompanying drawings.

Brief Description of the Drawings

[0020] The invention will now be described in more detail, by way of example only, with reference to the accompanying drawings, in which like numbers refer to like elements, wherein:

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; and

Figure 5 is a schematic of another embodiment of the sealing mechanism.

Detailed Description of the Preferred Embodiments

[0021] 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.

. 4 _ 73927-14 (ODV) [0022] 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. [0023] As shown in Figures 1 and 2, 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.

[0024] 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. [0025] 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.

. 5 . 73927-14 (ODV) [0026] 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. Preferably, 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. [0027] The pressure-sensing region 24 in the entrance chamber 20 allows for continuous monitoring of the pressure in the cartridge 10. As the cartridge is completely pressure-sealed, 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. Additionally, the fluid composition in region 24 reflects the fluid composition in the peritoneal cavity. Thus, 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. This latter change is facilitated by the ability of the cartridge to mix the dialysate solution from components within the cartridge 10 itself, as opposed to the standard usage of pre-mixed dialysate solutions. Use of pre- mixed solutions is still possible, but will limit the changes that can be made during the PD process. [0028] Preferably, 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

. 5 . 73927-14 (ODV) mounted on the dialysis machine in which the cartridge is installed. For example, an optical sensor can be targeted through the window 26 to perform spectroscopic analysis of the fluid in the pressure sensing region.

[0029) Similarly, 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. Given that ballast chamber 30 preferably includes a heating element, the cartridge material should also be non-heat conductive as well. [0030] In summary, 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. [0031] 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). In operation, 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.

[0032] In this closed position, the input/output port 22 is completely closed and isolated from all input/output ports 22 in communication with the mixing chamber 20. [0033] To reach the open state, 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. Again, the extremity sensors 53 and the force sensor are monitored to confirm the sealing force has been removed. Hence, liquid can be transferred from or inputted into an attachment to the input/output port 22 accordingly. [0034] 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

_ 7 _ 73927-14 (ODV) port open, 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.

[0035] 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.

[0036] In this mode, 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. In this preferred embodiment, the relationships of the pressures could be expressed as follows;

P2 > |P1| (negative or positive) P5 > |P1| + P2 + P3 + P4 [0037] It is understood that other arrangements and other force applications such as springy plastic arm assemblies, air pressures and/or vacuums, could be used to achieve the same or similar outcomes as explained above.

[0038] An alternate embodiment of the occlusion system is shown in the schematic of Figure 5. In this embodiment the body header 56 is expanded to form part of the sealing membrane 54 of the mixing chamber 20. There is further a locking head 72 extending beyond the sealing membrane 54 that engages with a slot 74 located in the modified head of the plunger 52. In this embodiment, 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. Again, this embodiment must be such that P5>P 1 is realized as discussed above. [0039] Other methods could be used to achieve the result created by these embodiments. As another example, corrugations may be built into a semi-rigid sealing

_ g _ 73927-14 (ODV) membrane, or the soft head glued or fastened to a semi-rigid sealing membrane. The criteria is that confirmation that the inlet/outlet port 22 is fully open or closed must be provided, and that, in the closed position, P5>P1 such that the closed port is completely pressure-sealed. [0040] In operation, 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. [0041] 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.

[0042] After insertion of the cartridge 10 into the dialysis machine, 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 initial 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 Vlintjai to Vl begin- 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.

[0043] 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,nai. Again, according to Boyle's law the pressure in the mixing chamber 20 volume V2 will increase from its value at Vbegin- The machine will then

_ 9 . 73927-14 (ODV) monitor this pressure. If it remains constant it implies (a) all of the ports can be opened and closed effectively and (b) there is no unintentional fluid path between the large ballast volume and the mixing volume. The next phase is to connect all of the liquids that will be used to constitute the dialysate and perform the "flush before fill" routine as follows.

[0044] The admission of air into the peritoneal cavity must be avoided. Air, if unsterilized, is a source of infection and if sterilized it is a source of discomfort for the patient. The first step in the flush before fill routine is to remove all air from the fluid paths that lead to the patient. [0045] The machine opens ports 22a and 22f and expands from Vl to Vbegin- This will draw sterile liquid from a solution bag connected to inlet 26 into V3. Port 22f is then closed and port 22g is opened. Port 22g, the drain port, is preferably located at the highest point of the cartridge when the cartridge is located in the machine. Therefore, any air is automatically channeled to this point. Volume Vbegin is changed to Vfinai 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.

[0046] The machine will then open ports 22a and 22e. Sterile liquid is drawn from a bag connected to 22e into Vl via V2. Port 22g is opened, Port 22e is closed and the liquid in Vl is expelled via V2. This can be repeated as often as required. The same process is repeated for all liquids connected to ports 22c and 22d. Using this process all of the fluid lines and the cartridge itself can be flushed (flush before fill) with sterile liquid to remove any trace contaminants that may have been deposited during the set up phase of the treatment. [0047] In operation of the dialysis machine, 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.

_ JQ . 73927-14 (ODV) [0048] During operation, the pressure of the fluid in the cartridge is measured. As the whole system is pressure-sealed, changes in the pressure-sensing region 24 of the cartridge 10 reflect changes in the pressure exerted upon/by the peritoneal membrane in the patient's body. Given that the fluid in the pressure sensing region 24 during the PD operation is representative of the fluid in the peritoneal cavity, other clinical parameters, such as the physical, chemical and biological composition of the fluid, which are relevant to the treatment can be remotely monitored at this point. By monitoring and measuring the peritoneal pressure and these other fluid parameters, adjustments to the treatment of the patient can be made immediately, rather than having to be delayed to the next course of dialysis, as with current methods.

[0049) This concludes the description of a presently preferred embodiment of the invention. The foregoing description has been presented for the purpose of illustration and is not intended to be exhaustive or to limit the invention to the precise form disclosed. Many modifications and variations are possible in light of the above teaching and will be apparent to those skilled in the art. It is intended the scope of the invention be limited not by this description but by the claims that follow.

. J j _ 73927-14 (ODV)

Claims

What is claimed is:
1. A cartridge for a peritoneal dialysis system, said cartridge 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.
2. A cartridge according to claim 1, wherein the defined fluid region is a pressure- sensing region whereby the pressure in the pressure-sensing region reflects the pressure of the liquid in the peritoneal cavity.
3. A cartridge for a peritoneal dialysis (PD) system, comprising:
a) a pressure-sealed cartridge including a pumping syringe, a mixing chamber and a ballast chamber;
b) one or more inlet/outlet ports in said mixing 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 line,
wherein said pressure sensing region enables measurement of pressure changes in said cartridge that reflect pressure changes of fluid in a patient's peritoneal cavity..
4. The cartridge of claim 3, wherein said cartridge is disposable.
5. The cartridge of claims 3-4, wherein the inlet/outlet ports include one or more: extremity sensors, force sensors and a combination thereof to determine the open/closed status of the inlet/outlet ports.
. | 2 - 73927-14 (ODV)
6. The cartridge of claims 3-5, further including pressure sealing means for the inlet/outlet port, the pressure sealing means including a plunger which contacts a sealing membrane to drive a soft header into and out of the port.
7. The cartridge of any of claims 3-5, further including pressure sealing means for the inlet/outlet port, the pressure sealing means including a plunger which is locked to a soft header and drives said soft header into and out of the port without contact a sealing membrane.
8. The cartridge of any of claims 3-7, further including an optically transparent region of the cartridge located in a position aligned with the pressure sensing region.
9. The cartridge of any of claims 3-8, wherein the cartridge is made of a nonelectrical conductive material.
10. The cartridge of any of claims 3-9, wherein the cartridge is made of a non-heat conductive material.
11. A peritoneal dialysis system, comprising:
a) a pressure-sealed cartridge containing:
i) a mixing chamber, an entrance chamber and a ballast chamber;
ii) one or more inlet/outlet ports in said entrance chamber, said ports being fully pressure-sealed when closed;
iii) a pressure-sensing region in the entrance chamber, capable of measuring total pressure and pressure fluctuations within the cartridge;
iv) an outlet from the mixing chamber to a patient line;
v) a dialysate fluid supply reservoir coupled to said mixing chamber; and
vi) one or more fluid supply reservoirs coupled to said mixing chamber,
_ 13 . 73927-14 (ODV) wherein said pressure sensing region enables measurement of pressure changes in said cartridge; and
wherein said peritoneal dialysis system enables modification of treatment of the patient in response to pressure changes measured through the cartridge.
12. The peritoneal dialysis system of claim 11 , wherein the cartridge is disposable.
13. A method of performing peritoneal dialysis, comprising:
a) providing a peritoneal dialysis system with a cartridge according to any of claims 1-12;
b) measuring and monitoring pressure changes in said cartridge; and
c) modifying treatment of said patient in real-time in response to said pressure changes.
14. The method of claim 13, wherein said cartridge is disposed of after one course of peritoneal dialysis patient treatment.
15. The method of claims 13-14, further including steps of measuring the physical, chemical and biological parameters of fluid a defined fluid region within the cartridge and real-time modification of patient treatment in response to those measurements.
. 14 _ 73927-14 (ODV)
PCT/CA2008/000098 2007-01-19 2008-01-21 System and method for peritoneal dialysis WO2008086619A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CA2,574,537 2007-01-19
CA 2574537 CA2574537C (en) 2007-01-19 2007-01-19 System and method for peritoneal dialysis

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP20080706245 EP2111242A4 (en) 2007-01-19 2008-01-21 System and method for peritoneal dialysis

Publications (1)

Publication Number Publication Date
WO2008086619A1 true true WO2008086619A1 (en) 2008-07-24

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EP (1) EP2111242A4 (en)
CA (1) CA2574537C (en)
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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016095026A1 (en) * 2014-12-17 2016-06-23 Newsol Technologies Inc. System and method for peritoneal dialysis
US9861733B2 (en) 2012-03-23 2018-01-09 Nxstage Medical Inc. Peritoneal dialysis systems, devices, and methods
US9907897B2 (en) 2011-03-23 2018-03-06 Nxstage Medical, Inc. Peritoneal dialysis systems, devices, and methods

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