Surgery – Means for introducing or removing material from body for... – Material introduced into and removed from body through...
Reexamination Certificate
2002-01-23
2004-06-15
Kennedy, Sharon (Department: 3762)
Surgery
Means for introducing or removing material from body for...
Material introduced into and removed from body through...
C604S284000
Reexamination Certificate
active
06749580
ABSTRACT:
BACKGROUND OF THE INVENTION
Continuous flow peritoneal dialysis is a technique which utilizes a certain amount of fluid, generally dialysate, which is constantly present in the abdomen. Continuous flow peritoneal dialysis previously known in the art has utilized two single lumen peritoneal dialysis catheters or a modified large bore hemodialysis catheter. The inflow and uptake catheters enable the inflow and outflow to remain constant. However, high dialysate flow rates and re-circulation due to channeling or poor mixing inside the peritoneal cavity are problems associated with continuous flow peritoneal dialysis.
In the continuous flow peritoneal dialysis technique, the peritoneal dialysis solution is either utilized in a single pass or a re-circulation loop. Various re-circulation systems, such as sorbent cartridges or dialyzers, are known. A problem has been the quick drainage of fresh solution before coming into contact with the peritoneal exchange surface.
Regeneration systems include utilizing a batch of moderate volume prepared fluid and re-circulating the fluid until it saturates. Another method provides an initial fixed volume of commercial dialysis solution for priming, followed by continuous regeneration of the spent dialysate. Regeneration can be performed either by a hemodialysis filter or by absorption. Another method is preparation of solutions from water in concentrate with on-line ultra-filtration.
The proximal ends of the two lumens are attached to a dialysate regeneration means. Regenerated dialysate, or fresh dialysate, are introduced into the abdomen through one of the catheters, which is connected to a means for providing regenerated or fresh dialysate, which is well known in the art.
For all of the aforementioned reasons, it is important to have a continuous flow peritoneal dialysis catheter and method which effectively allow the dialysate to mix into the peritoneum while reducing trauma to the peritoneal walls. In addition, it is important to have catheters, and diffusers for catheters, that gently dispense the matter flowing through the catheter.
SUMMARY OF THE INVENTION
The present invention relates generally to continuous flow catheters with at least two lumens, one of which is a short lumen, and the other of which is a long lumen. In this invention, the long lumen, which is the uptake lumen, is coiled. It may have a plurality of openings, generally located on the inside of the coil, for the intake of matter flowing through the catheter.
The catheter also may include a diffuser, which is located over the distal end of the short lumen, for dispensing matter into the body of the user. The long lumen may extend beyond, and/or through, the diffuser.
The catheter may also include a hub at the proximal ends of the at least two lumens. The hub may be passable subcutaneously through the body of the user of the catheter, or the hub may be detachable.
The catheter of the current invention may be used for peritoneal dialysis.
In addition, the catheter may include at least one cuff located proximally to the peritoneal membrane for the adherence of subcutaneous tissue. The catheter may contain lumens which are “D” shaped.
The current invention also relates to diffusers for a catheter, as well as catheters having a diffuser. The diffuser has an interior portion and an exterior portion and at least one opening for the dispensing of matter into the body of the user. In addition, the diffuser may have a plurality of openings through which the matter may be dispensed into the body of the user in a diffused manner. The plurality of openings may be located radially around the sides of the diffuser in a generally perpendicular manner to the longitudinal axis of the catheter. The shapes of the diffuser generally consist of cylindrical, teardrop, bell, round, oval, semi-round, semi-oval and a combination of shapes. The diffuser, and catheter having a diffuser, may be used on a catheter used for a continuous flow peritoneal dialysis.
The current invention also includes methods for continuous flow peritoneal dialysis which include the steps of creating an incision in the body of the user and separating the anatomical layers, making a circular suture in the peritoneal membrane, making an incision in the peritoneal membrane, inserting the catheter, and tightening the parietal peritoneum. The method also may include anesthetizing the skin and peritoneal surface. In addition, the method may include making a lateral incision in the skin of the user, creating a skin tunnel, passing the catheter through the skin tunnel, connecting attachments to the catheter, and suturing the skin incision. The method may also include providing a catheter having a diffuser.
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R. Amerling, C. Ronco and N.W. Levin; Continuous Flow Peritoneal Dialysis; Peritoneal Dialysis International; May 2000; p. S172-177; vol. 20, Supplement 2; Multimed, Inc., Milton, Ontario, Canada.
C. Ronco and J.A. Diaz-Buxo; Automated Peritoneal Dialysis; Nephron; Jan. 18, 2001; p. 1-7; vol. 87, No. 1; S. Karger AG, Basel, Switzerland.
C. Ronco, A. Gloukhoff, R. Dell'Aquila and N.W. Levin; Catheter Design for Continuous Flow Peritoneal Dialysis; Blood Purification; Jan. 17, 2002; pp. 40-44; vol. 20, No. 1; S. Karger AG, Basel, Switzerland.
International Preliminary Examining Authority Written Opinion mailed Aug. 29, 2003.
International Search Report mailed May 8, 2003.
Gloukhoff Angela
Ronco Claudio
Work Jack
Kennedy Sharon
Maenner Joseph E.
Medical Components Inc.
Monte & McGraw, P.C.
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