Surgery – Means for introducing or removing material from body for... – Material introduced into and removed from body through...
Reexamination Certificate
1997-07-18
2001-02-27
Kennedy, Sharon (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Material introduced into and removed from body through...
C604S093010
Reexamination Certificate
active
06193684
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention is generally directed to delivering liquid compositions to an interior site in the body. More particularly, this invention relates to delivering and draining compositions to and from a human patient at high flow rates to perform peritoneal dialysis under sterile conditions.
Patients afflicted with end stage renal disease where kidney transplantation is unavailable may be treated by hemodialysis or peritoneal dialysis to remove toxic products from the patient's blood. Both techniques operate by the principles of diffusion across semipermeable membranes. In the case of peritoneal dialysis, the membrane that is used is the patient's peritoneal membrane. In order to perform dialysis, a dialyzing solution or dialysate is drained into the peritoneal cavity and remains in the cavity for a dwell period of usually four to six hours. The dialyzing solution typically comprises an electrolyte component to reduce loss of electrolytes and a sugar component which acts as an anosmotic ingredient, removing water from the patient along with normal metabolic products such as urea, uric acid and creatinine. At the end of the dwell period, spent dialyzing solution is drained from the cavity back to the bag and the cavity refilled with fresh solution.
One serious drawback to peritoneal dialysis, which has limited its use, is that the peritoneal cavity is particularly subject to infection. Conventional peritoneal dialysis systems usually employ catheters which are implanted transcutaneously through the patient's abdomen. This exposure naturally increases the risk of contamination through the exposed, exterior end of the catheter. The tubing sets used to infuse solution into the peritoneum may also be a source of contamination. While the use of subcutaneously implanted septum-type ports has been suggested (such ports would be accessed with needles which reduces the chance of infection), the access with small bore non-coring needles places a flow restriction in the system which reduces the flow rate below the rate achieved by transcutaneous catheters. Such small bore access needles with relatively low flow rates prolong the exchange time and create additional patient discomfort.
2. Description of the Background Art
Conventional peritoneal dialysis tubing sets and components are described in U.S. Pat. Nos. 4,306,976; 4,396,382; 5,250,041; 5,334,139; 5,338,293; and 5,423,768. U.S. Pat. No. 4,184,497 describes an implantable catheter having an enlarged hollow portion which can be punctured to receive a sterile access needle. U.S. Pat. No. 4,496,349 describes a septum-type transcutaneous access port.
SUMMARY OF THE INVENTION
The present invention is directed at reducing the time needed to exchange dialysis fluid and limiting the risk of infection to the peritoneal cavity. More particularly, the present invention allows the use of large bore, percutaneous access members to deliver and drain fluid from the peritoneal cavity at high volumetric flow rates under sterile conditions, typically above 100 ml/min, preferably 200 ml/min, or higher.
In a first aspect, the present invention provides an apparatus for use in peritoneal dialysis in combination with a first container and a second container. The apparatus comprises a junction connected to a first and a second tube which are connected and/or connectable to the first and second containers, respectively. At least one of the containers is filled with unused dialysis fluid. A single common tube, fluidly coupled to the junction, fluidly connects the first and second tubes to a percutaneous access member having a bore diameter of at least 1.16 mm. Preferably, the percutaneous access member is straight and has a length in the range from about 15 mm to 40 mm, preferably from about 18 mm to 26 mm. The access member usually has a relatively large bore, typically having a lumenal diameter in the range from about 1 mm to 5 mm, preferably from about 1.5 mm to 2.1 mm. In specific embodiments of the apparatus of the present invention, the percutaneous access member comprises a large bore needle, such as a fistula-type needle. The large bore access members are advantageous in minimizing flow resistance and allowing for higher volumetric flow rates to and from the patient.
In another aspect, the present invention provides a system for performing peritoneal dialysis comprising a peritoneal dialysis tubing set having an access member and a mechanical port. The port has an aperture for receiving the access member of the tubing set and a flexible conduit in the port disposed to establish fluid flow with the access member inserted through the first passage. A linkage assembly in the port opens the flexible conduit when the access member is present in the passage and closes the flexible conduit when the access member is absent from the passage. The system may further comprise a peritoneal dialysis catheter fluidly coupled to the flexible conduit. The port allows for the advantageous use of large bore access members which would otherwise core and damage conventional septum-type ports.
In a further aspect, the present invention provides a method for performing peritoneal dialysis comprising the step of accessing a mechanical valve port coupled to a patient with an access member. Unused dialysis solution is introduced to the patient's peritoneal cavity through the access member and the mechanical port. After the dialysis solution has been in the patient for a specified dwell period, the dialysis solution is withdrawn from the patient's peritoneal cavity through the port and the access member. Preferably, the access member has a minimum bore diameter of 1.16 mm.
These and other embodiments of the present invention, as well as its advantages and features, are described in more detail in conjunction with the text below and attached figures.
REFERENCES:
patent: 4190047 (1980-02-01), Jacobsen et al.
patent: 4239041 (1980-12-01), Popovich et al.
patent: 4493696 (1985-01-01), Uldall
patent: 4832054 (1989-05-01), Bark
patent: 5041098 (1991-08-01), Loiterman et al.
patent: 5336165 (1994-08-01), Twardowski
patent: 5782796 (1998-07-01), Din et al.
Brugger James M.
Burbank Jeffrey H.
Kennedy Sharon
Townsend and Townsend / and Crew LLP
Vasca, Inc.
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