Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-12-04
2004-08-31
Casler, Brian L. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S174000, C604S533000, C606S151000, C128S912000, C024S543000, C024S336000, C024S339000
Reexamination Certificate
active
06783520
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to the field of connectors for extracorporeal medical tubing. Such extracorporeal medical tubing is used in dialysis procedures such as peritoneal dialysis and hemodialysis and in a variety of other medical procedures. Extracorporeal procedures are to be distinguished from intracorporeal procedures and uses such as prosthetic implants, urinary catheters and other implantable catheters, shunts and cannulation devices.
BACKGROUND OF THE INVENTION
Many modern medical procedures require the use of tubing sets of varying complexity to withdraw fluid from a patient, or to administer fluid to a patient, or to do both. Such procedures include intravenous feeding, blood transfusions and blood processing, and both peritoneal dialysis and hemodialysis. Typically, a catheter is temporarily or semi-permanently implanted in the patient such as by cannulating a vein in the case of hemodialysis or a catheter is implanted in a peritoneal cavity in the case of peritoneal dialysis. The catheter extends from the implant site to outside the body, where it is connected in some manner to the appropriate tubing set necessary for the procedure that is to be performed.
The configuration and complexity of tubing sets are vastly different depending upon the particular medical procedure for which they are designed and also depending on the manufacturer of the other extracorporeal elements used in the procedure. For example, a hemodialysis tubing set is much different from a peritoneal dialysis tubing set because of the different nature and requirements of hemodialysis as compared to peritoneal dialysis, and a peritoneal dialysis tubing set made by one manufacturer for use with its peritoneal dialysis cycler machine may be much different from a peritoneal dialysis tubing set made by another manufacturer for use with the other manufacturer'peritoneal dialysis cycler machine.
In hemodialysis, the patient'blood is cleansed by drawing it out of the patient though a catheter and passing it through an artificial kidney. The artificial kidney includes a semi-permeable membrane which removes impurities and toxins by a process of diffusion. The purified blood is then returned to the patient. A hemodialysis tubing set is used to transport the blood between the catheters and the artificial kidney. Patients in hemodialysis treatment typically require treatment several times a week for several hours each time.
In peritoneal dialysis, a peritoneal dialysis solution is infused into the patient'peritoneal cavity and allowed to reside there for a “dwell time” during which blood impurities diffuse through the puitoneal membrane into the dialysis solution. The dialysis solution with the collected impurities is then removed from the peritoneal cavity and discarded. In Continuous Ambulatory Peritoneal Dialysis (“CAPD”) the infusion of dialysis solution into and out of the peritoneal cavity is accomplished throughout the day while the patient goes about a fairly normal routine. In Intermittent Peritoneal Dialysis (“IPD”) large amounts of dialysis solution (up to 40 liters) are cycled through the patient'peritoneal cavity over a 4 to 24 hour period. In Continuous Cycling Peritoneal Dialysis (“CCPD”) the dialysis treatment is more or less continuous, with dwell times of 3 to 4 hours at night. Then, throughout the waking time of the patient, a single dose of dialysis solution is retained within the patient.
In both IPD and CCPD an automated dialysis apparatus operates in generally the same manner. The dialysis solution and “tubing administration set” or simply “tubing set” is integrated with the valving, heating and control functions associated with the automated apparatus. In many of the systems, premeasured amounts of dialysis solution are either pumped or delivered by gravity flow to a heating station. At the heating station the solution is warmed to body temperature in order to prevent the uncomfortable sensation of introducing room temperature or cooler solution into the peritoneal cavity. The warmed solution is then allowed to enter the patient via a catheter implanted in the patient'peritoneal cavity. After a period of time (the “dwell period”), the solution is drained from the patient into a spent solution container.
In IPD, a large amount of solution is cycled in this manner over a relatively short period of time. Once treatment is completed, the patient is unencumbered for at least a few days. A disadvantage is the large amount of dialysis solution that must be utilized. Bags cumulating to at least 40 liters of solution can be difficult to lift for a patient in a weakened condition.
In CCPD and CAPD methods, the same efficiency of results is obtained by increasing the dwell time of the dialysis solution within the peritoneal cavity. The total amount of solution required can therefore be significantly reduced. The obvious disadvantage, is that there is no “down time” for the treatment.
Many of the tubing sets used with these dialysis procedures or with other medical procedures involving extracorporeal treatment of fluid, use connection devices to connect two pieces of tubing together. For example, a hemodialysis patient or a peritoneal dialysis patient will often have a semi-permanent implanted catheter in the vascular system or peritoneal cavity, respectively, which extends to outside the patient. The exterior end may be attached to a tubing segment which in turn is usually attached to half of the connection device. The other half of the connection device is attached to another tubing segment which in turn may be attached to a pump or bag of fluid.
The system used for a medical procedure may require several connection devices that connect several tubing segments, thereby permitting fluid flow through the entire system and the patient. When it is time to begin the procedure, the two halves of each connection device are connected so that fluid can flow from one tubing segment to the other tubing segment. It is important for the connection devices between the tubing segments to be mechanically strong and secure to prevent accidental disconnection and maintain fluid flow during the procedure. For example, the two halves of the connection device usually have a set of interlocking threads and the mechanical connection between the two halves of the connection device is achieved by screwing the two halves together. This simply requires that one of the halves be rotated about its axis in relation to the other while a slight force is applied urging the two halves together. Once the connections have all been made, fluid can flow throughout the system and the medical procedure can begin.
To further prevent accidental disconnection of the connection device and maintain fluid flow through the system during the medical procedure, it is not uncommon for a medical practitioner to strengthen the connection device between two tubing segments by taping the two halves of the connection device together with medical tape. In the case of a connection device with two halves that have interlocking threads, this would help prevent the two halves from unscrewing or coming apart during the procedure.
However, taping together the two halves of the connection device can take time and is not necessarily easy to do. Furthermore, while the tape is effective in preventing accidental disconnection, this is not what medical tape was designed for and it is difficult and messy to remove the medical tape when it is necessary to disconnect the tubes after the procedure is completed.
Therefore, there still remains a need for an inexpensive connector holding device that is easy to connect and disconnect and will back up the connection device to prevent accidental disconnection of the tubing segments and maintain the connection so that fluid can flow through the tubing set during treatment.
SUMMARY OF THE INVENTION
The present invention is a connector holding device that has particular but not exclusive application in peritoneal dialysis and hemodialysis tubing sets. The holding device
Candray Adolfo M.
Curtin Conor
Hull Steven L.
Casler Brian L.
Fresenius USA, Inc.
Gibson Dunn & Crutcher, LLP
Rodriguez Cris L.
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