Patent Application
20100217179
The present disclosure relates to medical fluid delivery and in particular to peritoneal dialysis fluid delivery.
Due to disease, insult or other causes, a person's renal system can fail. In renal failure of any cause, there are several physiological derangements. The balance of water, minerals and the excretion of daily metabolic load is no longer possible in renal failure. During renal failure, toxic end products of nitrogen metabolism (urea, creatinine, uric acid, and others) can accumulate in blood and tissues.
Kidney failure and reduced kidney function have been treated with dialysis. Dialysis removes waste, toxins and excess water from the body that would otherwise have been removed by normal functioning kidneys. Dialysis treatment for replacement of kidney functions is critical to many people because the treatment is life saving. One who has failed kidneys could not continue to live without replacing at least the filtration functions of the kidneys.
One type of dialysis is peritoneal dialysis. Peritoneal dialysis uses a dialysis solution or “dialysate”, which is infused into a patient's peritoneal cavity through a catheter implanted in the cavity. The dialysate contacts the patient's peritoneal membrane in the peritoneal cavity. Waste, toxins and excess water pass from the patient's bloodstream through the peritoneal membrane and into the dialysate. The transfer of waste, toxins, and water from the bloodstream into the dialysate occurs due to diffusion and osmosis, i.e., an osmotic gradient occurs across the membrane. The spent dialysate drains from the patient's peritoneal cavity and removes the waste, toxins and excess water from the patient. This cycle is repeated.
There are various types of peritoneal dialysis therapies, including continuous ambulatory peritoneal dialysis (“CAPD”) and automated peritoneal dialysis (“APD”). CAPD is a manual dialysis treatment, in which the patient connects an implanted catheter to a drain and allows a spent dialysate fluid to drain from the patient's peritoneal cavity. The patient then connects the catheter to a bag of fresh dialysate and manually infuses fresh dialysate through the catheter and into the patient's peritoneal cavity. The patient disconnects the catheter from the fresh dialysate bag and allows the dialysate to dwell within the cavity to transfer waste, toxins and excess water from the patient's bloodstream to the dialysate solution. After a dwell period, the patient repeats the manual dialysis procedure.
In CAPD the patient performs several drain, fill, and dwell cycles during the day, for example, about four times per day. Each treatment cycle typically takes about four hours. APD is similar to CAPD in that the dialysis treatment includes a drain, fill, and dwell cycle. APD machines, however, perform three to four cycles of peritoneal dialysis treatment automatically, typically overnight while the patient sleeps. Like CAPD, APD machines connect fluidly to an implanted catheter, to one or more sources or bags of fresh dialysate and to a fluid drain.
The APD machines pump fresh dialysate from the dialysate source, through the catheter, into the patient's peritoneal cavity and allow the dialysate to dwell within the cavity so that the transfer of waste, toxins and excess water from the patient's bloodstream to the dialysate solution can take place. The APD machines then pump spent dialysate from the peritoneal cavity, though the catheter, to the drain. APD machines are typically computer controlled so that the dialysis treatment occurs automatically when the patient is connected to the dialysis machine, for example, when the patient sleeps. That is, the APD systems automatically and sequentially pump fluid into the peritoneal cavity, allow for a dwell, pump fluid out of the peritoneal cavity and repeat the procedure. As with the manual process, several drain, fill, and dwell cycles will occur during APD. A “last fill” is typically used at the end of APD, which remains in the peritoneal cavity of the patient when the patient disconnects from the dialysis machine for the day.
While, APD frees the patient from having to manually performing the drain, dwell, and fill steps, a need still exists for CAPD. Some patients prefer the control that CAPD offers. Since the patient is awake during CAPD, the patient can adjust himself/herself during drain to produce more complete drains. Further, many patients who perform APD also perform a midday exchange using a CAPD technique. A continued need therefore exists for simple (for example, for patients performing exchanges at work) and effective CAPD systems.
The present disclosure sets forth a peritoneal dialysis set and corresponding system and method for performing peritoneal dialysis. As seen below, the set requires relatively little apparatus, and the method involves relatively simple clamping and unclamping steps in combination with the movement of a small, e.g., two liter, supply bag. The set and treatment are intended for patients who prefer continuous ambulatory peritoneal dialysis (“CAPD”) or who need to perform one or more manual midday exchange in combination with nightly automated peritoneal dialysis (“APD”).
The set includes a larger supply bag, e.g., six liters, that is connected fluidly to a smaller, e.g., two liter, supply bag via a supply tube. The larger and smaller supply bags are both initially full and hold the patient's prescribed total treatment volume collectively in one embodiment (plus a small amount used for flushing). The smaller supply bag is provided with two ports, one port for connecting to the larger supply bag via a supply line and a second port for connecting to a three-way connector or junction, such as a Y-junction or T-junction via a fill tube.
The three-way connector or junction is also coupled to a drain line and has a patient connector for patient connection. The drain line runs to a house drain or drain container, such as a reusable drain container. The patient connector connects to a patient's transfer set, which leads to a catheter implanted inside the patient's peritoneum. Both the patient connector and the patient's transfer set are sealed originally with a cap that is removed for therapy.
In one embodiment, the patient performs treatment using just two manually operated clamps, such as external/removable clamps, or fixed clamps such as Roberts™ clamps. To perform a first exchange, the patient uses a first clamp to prevent fresh dialysate from flowing from the larger supply container to the smaller supply container and a second clamp to prevent fresh dialysate from flowing from the smaller supply container to the three-way connector or junction. The patient also secures the drain line to the three-way connector or junction. For example, the patient can remove a cap from the drain line and secure the drain line to a drain container, e.g., reusable container, or run the drain line to a house drain, such as a toilet or bathtub. All of the above can be done before the patient connects the three-way connector or junction to the patient's transfer set.
To accomplish the drain phase, the patient removes disposable caps from both the patient's transfer set and the patient connector of the three-way connector or junction and connects the patient connector to the patient's set (which is closed). The patient stands or sits above the house or reusable drain and opens the transfer set so that the spent dialysis fluid residing already in the patient's peritoneum from the last therapy is allowed to gravity flow to drain. The patient can maneuver himself/herself to allow the spent fluid to drain from the patient effectively. The supply and fill tubes remain clamped, and while the patient is waiting for the drain phase to be completed, the patient can hang the smaller supply container above the larger supply container to ready for the next step.
To accomplish a flush step, the patient closes the transfer set valve and opens the manual clamp on the fill tube, allowing fresh dialysate to gravity flow from the smaller supply container to the house or reusable drain. The clamp on the supply tube between the larger and smaller supply containers remains clamped. The patient allows fresh dialysate to gravity flow through the fill tube, though the three-way connector or junction, and through the drain line to drain, flushing the fill tube, junction and drain tube. The patient allows the flush to continue for a specified period of time or until visual inspection indicates that the flush is finished.
To accomplish a fill phase, the patient moves the opened clamp on the fill tube to the drain tube and clamps the drain tube. The patient opens the transfer set valve, so that fresh fluid can gravity flow from the smaller supply container, through the fill tube, though the junction, the patient's transfer set and into the patient's peritoneal cavity. The patient allows the smaller supply container to empty the remainder of its contents into the peritoneal cavity or until the patient feels full.
To accomplish a dwell phase, the patient opens and moves the closed clamp on the supply tube to the fill tube and clamps the fill tube, such that the fill and drain tubes are both clamped. The patient then disconnects the patient's transfer set from the patient connector of the junction and recaps both the transfer set and the patient connector using fresh caps. In one embodiment, the smaller supply container is left held elevationally above the larger supply container during dwell, such that the smaller container is not refilled at this time. In the one embodiment, the larger supply container is left in place, e.g., on a table so as to be at approximately a same height as the patient's access, during the entire therapy. The patient can then leave and perform whatever task the patient wishes during the dwell period.
For a second exchange, the patient moves the smaller supply container from the elevated fill position to a low elevational refill position, below the larger supply container, which is laid on a table above the smaller supply container. If the supply tube is clamped, the clamp is opened to allow fresh dialysate to gravity flow from the larger supply container to refill the smaller supply container. All above steps can be done during the dwell phase after disconnecting the transfer set from the patient connectors. That is, the patient does not have to wait for the second exchange to begin before preparing for the next exchange.
During the next exchange, The patient moves the second clamp from the drain tube to the fill tube to ready the set for the next drain. The patient then removes the caps from the transfer set and patient connector and connects the patient transfer set (which is closed) to the connector of the junction of the dialysis set. The patient moves the refilled smaller supply container to the elevated position above the larger supply container, while ensuring that the supply tube is clamped to prevent dialysate from flowing back from the smaller supply container to the larger supply container. A second clamp is used to prevent dialysate from flowing from the supply bag to the patient because the patient needs to drain first before beginning the next fill. The set is now ready for a second drain, which is initiated when the patient opens his/her transfer set.
When all exchanges, e.g., four exchanges, have been completed, the patient recaps the transfer set with a new cap, removes and saves the manual clamps. The patient removes the drain line from the drain and empties the reusable container if one is used and discards the peritoneal dialysis set. The clamps and drain can be reused until they need too be replaced.
It is accordingly an advantage of the present disclosure to provide a continuous ambulatory peritoneal dialysis (“CAPD”) set that requires little apparatus.
It is another advantage of the present disclosure to provide a continuous ambulatory peritoneal dialysis (“CAPD”) set that is easy to use.
Additional features and advantages are described herein, and will be apparent from the following Detailed Description and the figures.
Referring now to the drawings and in particular to
Set 10 includes a larger supply bag 12, e.g., six liters, that is connected fluidly to the smaller, e.g., two liter, supply bag 14 via a supply tube 16. The larger and smaller supply bags 12 and 14 are both initially full and hold the patient's prescribed total treatment volume (e.g., eight liters) collectively in one embodiment (plus an extra amount for flushing). Smaller supply bag 14 is provided with two ports 14a and 14b, one port 14a for connecting to larger supply bag 12 via supply line 16 and a second port 14b for connecting to a fill line 18 leading to a three-way connector or junction 20, such as a Y-junction or T-junction.
In an alternative embodiment, port 14a is fitted with a frangible. The frangible is unbroken for the first fill, which comes from smaller supply bag 14 and carries a first type of dialysate. After the first fill, the frangible is broken, so that a second dialysate type, different from the first can be delivered from larger supply bag 12 to smaller supply bag 14, and then delivered to the patient (process for delivering from container 12 to container 14 and then to the patient is discussed in detail below). The frangible accordingly allows different types of fluids to be delivered to the patient. For example, the first fill from smaller supply bag 14 could hold a more expensive type of dialysate. The assignee of the present disclosure makes a dialysate called Extraneal™, which is polyglucose-based as opposed to a dextrose-based dialysate (e.g., Dianeal™) and can thereby pull ultrafiltrate (“UF”) from the patient for a longer period of time, e.g., eight hours, than can the standard dextrose-based dialysate (which may lose UF removal capability after four hours). The Extraneal™ dialysate is initially filled into the patient just prior to a long day or overnight dwell. Afterwards, the Dianeal™ dialysate is filled from the larger supply bag 12 for shorter dwells.
In certain countries, a more expensive dialysate, such as Extraneal™ dialysate, is too expensive. It is expressly contemplated herein to offset the additional expense of the dialysate by reducing the disposable cost via set 10. Set 10 therefore yields an overall better therapy for the patient in such countries.
Three-way connector or junction 20 includes a first port 22a that is connected to fill tube 18. A second port 22b is connected to a drain tube 26. Junction 20 includes a third port or patient connector 24, which is configured to mate in a releasable and fluid tight manner (e.g., threaded with o-ring seal) with a patient's transfer set (shown below as set 40), which leads to a catheter implanted inside the patient's peritoneum.
Drain tube 26 runs to a house drain or drain container, such as a reusable drain container shown below as container 30. In the illustrated embodiment, drain tube 26 includes a removable handle and plug 28. Set 10 also includes reusable manual clamps 38a and 38b, such as reusable line clamps provided by Baxter International Inc., the use of which is described below. Reusable manual clamps 38a and 38b can be used over and over again until they need to be replaced.
In one implementation, supply bags 12 and 14 are made of medical grade polymers, e.g., PVC or polyolefin-based non-PVC material. Tubes 16, 18 and 26 are made of PVC or polyolefin-based non-PVC material. Junction 20 including connector 24 can be made of Hytrel, PVC or polycarbonate. Supply tube 16 can be about 2.5 feet in length. Fill and drain tubes 18 and 26 can be about three feet in length.
Referring now to
Patient connector 24 of junction 20 is capped via a removable cap 42a. Patient transfer set 40 is likewise sealed originally via a cap 42b that is removed for therapy. Patient transfer set 40 also includes a twistable valve 44 that allows patient 46 to open and occlude flow through transfer set 40.
Referring additionally to the therapy method 100 of
At block 104, patient 46 also secures drain line 26 to port 22b of three-way connector or junction 20. For example, the patient can remove plug cap 28 from drain line 26 and secure the drain line to drain container 30 (or secure the drain line to a house drain, such as a toilet or bathtub). As shown in
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In the embodiment illustrated in
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In an alternative embodiment, the manual clamping of fill line 18 and drain line 26 is replaced with a flow control device that the patient positions, e.g., turns, to perform the drain, flush, and fill steps. Many embodiments of such a flow control device are set forth in copending U.S. patent application Ser. No. 11/947,261 (“the '261 application”), entitled, “Flow Control Device For Peritoneal Dialysis”, filed Nov. 29, 2007, assigned to the assignee of the present disclosure, the entire contents of which are incorporated herein by reference and relied upon.
In particular, FIGS. 15 to 19 of the '261 application show a dial type device, which fit around fill tube 18 and drain tube just prior first port 22a and second port 22b of junction 20. The device eliminates the need for moving, clamping and unclamping individual clamps 38a and 38b at fill tube 18 and drain tube 26. It also eliminates the need for the patient to open and close valve 44 of transfer set 40, which is instead left in the open position unless the patient wants to disconnect from set 10. One of the individual clamps 38a or 38b will still be used to selectively open and close supply tube 16 as discussed above.
It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present subject matter and without diminishing its intended advantages. It is therefore intended that such changes and modifications be covered by the appended claims.
