News Column

"Peritoneal Dialysis Systems and Related Devices and Methods" in Patent Application Approval Process

August 2, 2014



By a News Reporter-Staff News Editor at Obesity, Fitness & Wellness Week -- A patent application by the inventors Plahey, Kulwinder S. (Martinez, CA); Farrell, Sean (Walnut Creek, CA), filed on January 10, 2013, was made available online on July 17, 2014, according to news reporting originating from Washington, D.C., by NewsRx correspondents (see also Fresenius Medical Care Holdings, Inc.).

This patent application is assigned to Fresenius Medical Care Holdings, Inc.

The following quote was obtained by the news editors from the background information supplied by the inventors: "Dialysis is a treatment used to support a patient with insufficient renal function. The two principal dialysis methods are hemodialysis and peritoneal dialysis.

"During hemodialysis ('HD'), the patient's blood is passed through a dialyzer of a dialysis machine while also passing a dialysis solution or dialysate through the dialyzer. A semi-permeable membrane in the dialyzer separates the blood from the dialysate within the dialyzer and allows diffusion and osmosis exchanges to take place between the dialysate and the blood stream. These exchanges across the membrane result in the removal of waste products, including solutes like urea and creatinine, from the blood. These exchanges also regulate the levels of other substances, such as sodium and water, in the blood. In this way, the dialysis machine acts as an artificial kidney for cleansing the blood.

"During peritoneal dialysis ('PD'), a patient's peritoneal cavity is periodically infused with dialysis solution or dialysate. The membranous lining of the patient's peritoneum acts as a natural semi-permeable membrane that allows diffusion and osmosis exchanges to take place between the solution and the blood stream. These exchanges across the patient's peritoneum, like the continuous exchange across the dialyzer in HD, result in the removal of waste products, including solutes like urea and creatinine, from the blood, and regulate the levels of other substances, such as sodium and water, in the blood.

"Many PD machines, commonly referred to as 'cyclers', are designed to automatically infuse, dwell, and drain dialysate to and from the patient's peritoneal cavity in a process referred to as 'continuous cycler-assisted peritoneal dialysis' (CCPD). The treatment typically lasts for several hours, often beginning with an initial drain procedure to empty the peritoneal cavity of used or spent dialysate. The sequence then proceeds through the succession of infusion, dwell, and drain phases that follow one after the other. Each phase is called a cycle.

"Due to the length of the treatment, the large size of the PD machine and the large volume of dialysate required for the treatment, the treatment may be performed at home while the patient sleeps. Although nighttime CCPD treatments are sufficient for some patients, other patients require one or more additional fluid exchanges during the daytime. To permit the patient to participate in normal daily activities outside of the home, continuous ambulatory peritoneal dialysis (CAPD) is performed by connecting a bag of dialysis fluid to the patient's peritoneal catheter, and delivering about 1-3 liters of dialysate to the peritoneal cavity. After permitting the dialysate to dwell in the peritoneal cavity for a predetermined period of time, the dialysate is drained from the peritoneal cavity. The patient typically monitors and records the number of daytime exchanges and the amounts of dialysate used during the daytime exchanges."

In addition to the background information obtained for this patent application, NewsRx journalists also obtained the inventors' summary information for this patent application: "In one aspect, a peritoneal dialysis system includes a base peritoneal dialysis system and a peritoneal dialysis fluid exchange system that operates independently of the base peritoneal dialysis system. The base peritoneal dialysis system includes a first disposable unit including a first patient line configured to be connected to a patient, and a peritoneal dialysis device. The peritoneal dialysis device includes a compartment configured to receive the first disposable unit, and at least one pump arranged so that when the first disposable unit is disposed within the compartment. The pump cooperates with the first disposable unit to deliver dialysate to and drain dialysate from a peritoneal cavity of the patient via the first patient line of the first disposable unit. The peritoneal dialysis fluid exchange system includes a second disposable unit including a second patient line configured to be connected to the patient such that fluid can be delivered to and drained from the peritoneal cavity of the patient via the second patient line, and a fluid exchange device. The fluid exchange device includes a compartment configured to receive the second disposable unit, and a data exchange interface operable to transfer patient treatment data from the peritoneal dialysis fluid exchange system to the base peritoneal dialysis system.

"Implementations can include one or more of the following features:

"In some implementations, the base peritoneal dialysis system is configured to automatically deliver dialysate to and automatically drain dialysate from a peritoneal cavity of a patient based on a patient treatment plan, and modify the patient treatment plan based on the patient treatment data transferred from the peritoneal dialysis fluid exchange system.

"In some implementations, the data exchange interface is a transmitter, and the base peritoneal dialysis system further comprises a receiver.

"In some implementations, the data exchange interface is an input/output port configured to permit connection to a data communication line extending from the base peritoneal dialysis system.

"In some implementations, the peritoneal dialysis fluid exchange system comprises a fluid flow meter.

"In some implementations, the fluid exchange device further comprises a sensor disposed adjacent to the second disposable unit when the second disposable unit is disposed in the compartment of the fluid exchange device, the sensor being operable to obtain the patient treatment data.

"In some implementations, the patient treatment data includes a volume of fluid transferred to the patient and a volume of fluid drained from the patient.

"In some implementations, the peritoneal dialysis fluid exchange system includes a processor configured to calculate fluid flow rates through the peritoneal dialysis fluid exchange system, calculate the duration of fluid flow through the peritoneal dialysis fluid exchange system, and use the calculated fluid flow rates and calculated duration to determine at least one of a volume of fluid infused to the patient and a volume of fluid drained from the patient.

"In some implementations, the processor is further configured to store at least one of the calculated fluid flow rates, calculated duration, volume of fluid transferred to the patient and a volume of fluid drained from the patient.

"In some implementations, the second disposable unit comprises a base, and a flexible membrane attached to the base in such a way that the base and the flexible membrane cooperate to form a fluid passageway that can be placed in communication with the second patient line, wherein the fluid passageway includes a first pressure sensor seat, a second pressure sensor seat, and a localized region of reduced fluid passageway diameter disposed between the first pressure sensor seat and the second pressure sensor seat.

"In some implementations, the second disposable unit comprises a base, and a flexible membrane attached to the base in such a way that the base and the flexible membrane cooperate to form a fluid passageway that can be placed in communication with the second patient line. The second patient line has a patient line portion connected to an infusion line portion and a drain line portion, and the patient line portion includes a first pressure sensor seat, a second pressure sensor seat, and a localized region of reduced fluid passageway diameter disposed between the first pressure sensor seat and the second pressure sensor seat.

"In some implementations, the fluid exchange device includes a first pressure sensor and a second pressure sensor, the fluid exchange device is configured to receive the second disposable unit within the fluid exchange device compartment in a manner such that the first pressure sensor is disposed at a location corresponding to the first pressure sensor seat, and the second pressure sensor is disposed at a location corresponding to the second pressure sensor seat, and the fluid exchange device further includes a controller. The controller is configured to receive fluid pressure data detected by the first pressure sensor and the second pressure sensor, and calculate fluid flow data based on the received fluid pressure data, and transmit the fluid flow data to the data exchange interface.

"In some implementations, the infusion line portion includes an infusion line portion valve seat and the drain line portion includes a drain line portion valve seat. In addition, the second disposable unit includes a pump chamber disposed between the first pressure sensor seat and a region in which the infusion line portion and the drain line portion connect to the patient line portion. The fluid exchange device is configured to receive the second disposable unit within the fluid exchange device compartment in a manner such that an infusion line valve is disposed at a location corresponding to the infusion line portion valve seat, a drain line valve is disposed at a location corresponding to the drain line portion valve seat, and a fluid pump is disposed at a location corresponding to the pump chamber, the fluid pump configured to cooperate with the pump chamber to pump fluid within the fluid passageway.

"In some implementations, the infusion line portion includes an infusion line portion valve seat and the drain line portion includes a drain line portion valve seat. In addition, the second disposable unit includes a pump chamber disposed between the first pressure sensor seat and a region in which the infusion line portion and the drain line portion connect to the patient line portion, and a pump rotor disposed within the pump chamber. The fluid exchange device is configured to receive the second disposable unit within the fluid exchange device compartment in a manner such that an infusion line valve is disposed at a location corresponding to the infusion line portion valve seat, a drain line valve is disposed at a location corresponding to the drain line portion valve seat, and an induction coil is disposed at a location corresponding to the pump chamber, the induction coil configured to drive the pump rotor to pump fluid within the fluid passageway.

"In some implementations, the second disposable unit comprises a bypass passageway that selectively permits fluid flow to be diverted past the pump chamber.

"In some implementations, the second disposable unit comprises a bypass passageway including a first end that communicates with the patient line portion at a location between the pump chamber and the region in which the infusion line portion and the drain line portion connect to the patient line portion, a second end that communicates with the patient line portion at a location between the pump chamber and the first pressure sensor seat, and a bypass valve seat.

"In some implementations, the fluid exchange device comprises a bypass valve at a location corresponding to the bypass valve seat.

"In some implementations, the localized region of reduced fluid passageway diameter includes an orifice plate disposed in the fluid passageway, the orifice plate including an opening having a smaller diameter than the inner diameter of portions of the fluid passageway on either side of the orifice plate.

"In some implementations, the transferred patient treatment data is synchronized with patient treatment data of the base peritoneal dialysis system.

"In some implementations, the peritoneal dialysis fluid exchange system has a size and a weight that are less than the size and the weight of the base peritoneal dialysis system.

"In some implementations, the peritoneal dialysis fluid exchange system has a weight that is less than 1 lb.

"In another aspect, a peritoneal dialysis device includes a compartment configured to receive a disposable unit that includes a patient line configured to be connected to a patient, at least one pump arranged so that when the disposable unit is disposed within the compartment, the pump cooperates with the disposable unit to deliver dialysate to and drain dialysate from a peritoneal cavity of the patient via the patient line of the disposable unit in accordance with a patient treatment plan, a data transfer interface configured to receive patient treatment data from an independent peritoneal dialysis system, the patient data having been obtained during peritoneal dialysis performed by the independent peritoneal dialysis system, and a controller that automatically modifies the patient treatment plan based on the received patient treatment data.

"In another aspect, a method of providing dialysis treatment includes obtaining patient treatment data during peritoneal dialysis performed by a first peritoneal dialysis system, transferring the obtained patient treatment data from the first peritoneal dialysis system to a second peritoneal dialysis system, and determining a modified patient treatment plan using the second peritoneal dialysis system based on the obtained patient treatment data transferred from the first peritoneal dialysis system, the modified patient treatment plan to be carried out by the second peritoneal dialysis system.

"Implementations can include one or more of the following features:

"In some implementations, the method includes performing peritoneal dialysis using the second peritoneal dialysis system based on the modified patient treatment plan.

"In some implementations, obtaining the patient treatment data includes measuring fluid flow rates through the first peritoneal dialysis system and measuring fluid flow durations through the first peritoneal dialysis system.

"In some implementations, obtaining the patient treatment data includes measuring fluid flow rates through the first peritoneal dialysis system and measuring fluid flow durations through the first peritoneal dialysis system, and using the measured fluid flow rates and measured fluid flow durations to determine at least one of a volume of fluid infused to the patient and a volume of fluid drained from the patient.

"In some implementations, determining the modified patient treatment plan includes adjusting at least one of an infusing volume and a draining volume in a dialysis treatment based on the volume of fluid infused to the patient and a volume of fluid drained from the patient using the first peritoneal dialysis system.

"In some implementations, transferring the obtained patient treatment data is achieved via a wireless connection between the first peritoneal dialysis system and the second peritoneal dialysis system.

"In some implementations, transferring the obtained patient treatment data is achieved via a wired connection between the first peritoneal dialysis system and the second peritoneal dialysis system.

"In other aspects, a peritoneal dialysis cassette includes a base, and a flexible membrane attached to the base in such a way that the base and the flexible membrane cooperate to form a fluid passageway, the fluid passageway having a patient line portion connected to an infusion line portion and a drain line portion. The fluid passageway includes a first pressure sensor seat, a second pressure sensor seat, and a localized region of reduced fluid passageway diameter disposed between the first pressure sensor seat and the second pressure sensor seat.

"Implementations can include one or more of the following features.

"In some implementations, the peritoneal dialysis cassette includes a pump chamber disposed along the fluid passageway between the first pressure sensor seat and a region in which the infusion line portion and the drain line portion connect to the patient line portion.

"In some implementations, the peritoneal dialysis cassette includes an induction pump at least partially disposed within the pump chamber.

"In some implementations, the peritoneal dialysis cassette includes a bypass passageway that selectively permits fluid flow to be diverted past the pump chamber.

"In some implementations, the peritoneal dialysis cassette includes a bypass passageway including a first end that communicates with the patient line portion at a location between the pump chamber and the region in which the infusion line portion and the drain line portion connect to the patient line portion, a second end that communicates with the patient line portion at a location between the pump chamber and the first pressure sensor seat, and a bypass valve seat.

"In some implementations, the localized region includes an orifice plate disposed in the fluid passageway, the orifice plate including an opening having a smaller diameter than the inner diameter of portions of the fluid passageway on either side of the orifice plate.

"In other aspects, a peritoneal dialysis system includes a peritoneal dialysis cassette including a base, and a flexible membrane attached to the base in such a way that the base and the flexible membrane cooperate to form a fluid passageway, the fluid passageway having a patient line portion connected to an infusion line portion and a drain line portion. The fluid passageway includes a first pressure sensor seat, a second pressure sensor seat, and a localized region of reduced fluid passageway diameter disposed between the first pressure sensor seat and the second pressure sensor seat.

"Implementations can include one or more of the following features.

"In some implementations, the system further comprises a fluid exchange device that includes a first pressure sensor and a second pressure sensor. The fluid exchange device is configured to support the cassette in a manner such that the first fluid pressure sensor is disposed at a location corresponding to the first pressure sensor seat, and the second fluid pressure sensor is disposed at a location corresponding to the second pressure sensor seat. The fluid exchange device further includes a controller that is configured to receive fluid pressure data detected by the first fluid pressure sensor and the second fluid pressure sensor, and calculate fluid flow data based on the received fluid pressure data, and a data exchange interface that is configured to transmit fluid flow data to a location remote from the peritoneal dialysis device.

"In some implementations, the infusion line portion includes an infusion line portion valve seat, the drain line portion includes a drain line portion valve seat, and the peritoneal dialysis cassette includes a pump chamber disposed between the first pressure sensor seat and a region in which the infusion line portion and the drain line portion connect to the patient line portion. In addition, the fluid exchange device includes an infusion line valve at a location corresponding to the infusion line portion valve seat, a drain line valve at a location corresponding to the drain line portion valve seat, and a fluid pump at a location corresponding to the pump chamber, the fluid pump configured to cooperate with the pump chamber to pump fluid through the fluid passageway.

"In some implementations, the infusion line portion includes an infusion line portion valve seat, the drain line portion includes a drain line portion valve seat, and the peritoneal dialysis cassette further includes a pump chamber disposed between the first pressure sensor seat and a region in which the infusion line portion and the drain line portion connect to the patient line portion, and a pump rotor disposed within the pump chamber. In addition, the fluid exchange device includes an infusion line valve at a location corresponding to the infusion line portion valve seat, a drain line valve at a location corresponding to the drain line portion valve seat, and an induction coil at a location corresponding to the pump chamber, the induction coil configured to drive the pump rotor to pump fluid through the fluid passageway.

"In some implementations, the peritoneal dialysis cassette further comprises a bypass passageway that selectively permits fluid flow to be diverted past the pump chamber.

"In some implementations, the peritoneal dialysis cassette further comprises a bypass passageway including a first end that communicates with the patient line portion at a location between the pump chamber and the region in which the infusion line portion and the drain line portion connect to the patient line portion, a second end that communicates with the patient line portion at a location between the pump chamber and the first pressure sensor seat, and a bypass valve seat.

"In some implementations, the fluid exchange device includes a bypass valve at a location corresponding to the bypass valve seat.

"In some implementations, the localized region of reduced fluid passageway diameter includes an orifice plate disposed in the fluid passageway, the orifice plate including an opening having a smaller diameter than the inner diameter of portions of the fluid passageway on either side of the orifice plate.

"Implementations can include one or more of the following advantages:

"In some implementations, a peritoneal dialysis fluid exchange system permits CAPD while automatically measuring and recording the amount of fluid exchanged during the CAPD. For example, the peritoneal dialysis fluid exchange system determines the volume of fluid delivered to the peritoneal cavity and the volume of fluid drained from the peritoneal cavity during the CAPD. Since the peritoneal dialysis fluid exchange system automatically measures and records the amount of fluid exchanged during the CAPD, patient errors and measurement inaccuracies during data collection can be avoided.

"In some implementations, the peritoneal dialysis fluid exchange system includes a small, light-weight (e.g., hand-held) machine and a disposable fluid line set that is received within the machine. The peritoneal dialysis fluid exchange system is more portable than some conventional PD cyclers, and therefore is more convenient for daytime fluid exchanges that typically occur away from home.

"In some implementations, the peritoneal dialysis fluid exchange system includes a fluid pump and valves permitting improved control of dialysate flow during CAPD. Using the peritoneal dialysis fluid exchange system to perform CAPD can reduce the time required to perform fluid delivery to and drain fluid from the peritoneal cavity during CAPD, and help to ensure that all delivered fluid is subsequently drained during each CAPD cycle.

"In some implementations, a peritoneal dialysis system includes a base PD system that performs CCPD in accordance with a patient treatment plan, and a peritoneal dialysis fluid exchange system that performs CAPD at a location remote from the base PD system. The peritoneal dialysis fluid exchange system automatically measures and records patient treatment data including the amount of fluid exchanged during the CAPD, and automatically transfers the patient treatment data to the base PD system. Upon receipt of the transferred patient treatment data, the base PD system updates and modifies the patient treatment plan, and performs peritoneal dialysis based on the modified patient treatment plan. Since the peritoneal dialysis fluid exchange system transfers the patient treatment data obtained during CAPD to the base PD system, the quality of the CCPD performed by the base PD system is improved because the patient treatment plan is performed with more accuracy. In addition, there is reduced opportunity for human error during collection of patient treatment data during CAPD and transfer of the collected patient treatment data to the PD system. Other benefits include a reduced likelihood of chances of patient overfill during CCPD since daytime exchange volumes are automatically measured and recorded by the peritoneal dialysis fluid exchange system, transferred to the base PD system, and the patient treatment plan performed by the base PD system is modified to reflect the transferred data.

"Other aspects, features, and advantages will be apparent from the description and drawings, and from the claims.

DESCRIPTION OF DRAWINGS

"FIG. 1 is a perspective view of a peritoneal dialysis ('PD') system that includes a PD cycler and a PD fluid exchange device that can transmit data to the PD cycler.

"FIG. 2 is a perspective view of the PD cycler of FIG. 1 positioned atop a portable cart.

"FIG. 3 is an exploded perspective view of the PD fluid cassette used with the PD cycler shown in FIG. 2.

"FIG. 4 is a schematic diagram illustrating control and communication systems within the PD system of FIG. 1.

"FIG. 5 is an exploded perspective view of a gravity-fed PD fluid exchange system.

"FIG. 6 is a perspective view of the PD fluid exchange system of FIG. 5 illustrating the PD fluid exchange cassette disposed within an open PD fluid exchange device.

"FIG. 7 is a perspective view of the PD fluid exchange system of FIG. 5 illustrating the PD fluid exchange cassette disposed within the closed PD fluid exchange device.

"FIG. 8 is a perspective view of the PD fluid exchange cassette of FIG. 5.

"FIG. 9 is a side sectional view of the PD fluid exchange cassette of FIG. 5 as seen along line 9-9 of FIG. 8.

"FIG. 10 is an exploded perspective view of a pump-fed PD fluid exchange system.

"FIG. 11 is an exploded perspective view of a PD fluid exchange system that can be either gravity-fed or pump-fed."

URL and more information on this patent application, see: Plahey, Kulwinder S.; Farrell, Sean. Peritoneal Dialysis Systems and Related Devices and Methods. Filed January 10, 2013 and posted July 17, 2014. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=1378&p=28&f=G&l=50&d=PG01&S1=20140710.PD.&OS=PD/20140710&RS=PD/20140710

Keywords for this news article include: Dialysis Solutions, Fresenius Medical Care Holdings, Fresenius Medical Care Holdings Inc., Hemodialysis, Peritoneal Dialysis, Pharmaceutical Solutions, Renal Dialysis.

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Source: Obesity, Fitness & Wellness Week


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