Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-01-18
2002-02-26
Brown, Michael A. (Department: 3764)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C514S222500
Reexamination Certificate
active
06350251
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to prosthetic devices for use internally in a patient (hereinafter “internal prosthetic devices”), especially catheters and ports, and to compositions and methods for their flushing and coating to prevent infection and blood coagulation. In accordance with the present invention, biocidal/anti-coagulant compositions are provided for use in flushing and coating internal prosthetic devices, especially ports and catheters.
2. Description of Related Art
Hemodialysis access systems for access to a human or animal patient's vascular system for exchange of blood between the vascular system and an external processing apparatus are well known in the art. One method comprises a catheter placed in the patient with one end extending into the central venous system and the other end affixed to one of several possible devices placed within the patient's body that are generally referred to as “ports.” Herein, “vessel” is defined as any conduit carrying a fluid within the patient's body. These devices generally comprise a chamber having an access opening sealed by means of a septum and having an egress from a second location leading to the catheter that is disposed within a fluid space or vessel. The septum allows a needle to pass into the chamber, but then closes when the needle is removed, thereby preventing leakage from within the space or vessel and also preventing anything from entering or exiting the chamber. These devices are usually implanted below the skin to prevent infection, other contamination, and mishandling.
Recently, an improved device of this class has been developed and described in U.S. Pat. No. 5,954,691 and U.S. patent application Ser. No. 09/083,078, filed May 21, 1998. These inventions are directed to a hemodialysis access system for access to a human or animal patient's vascular system for high fluid flow rate exchange of blood between the vascular system and an external processing apparatus at a volumetric flow rate in excess of 250 mL/minute, and comprising, in combination,
(a) a needle assembly comprising a lumen defined by an interior surface and constructed and arranged for puncturing the skin of the patient and for carrying blood therethrough at a flow rate consistent with the high blood flow requirement of the blood exchange process;
(b) a subcutaneously implantable access device permitting fluid connection to a vessel or space within a patient's body, the device comprising
(i) a channel structure providing a flowpath having a straight or gently changing flow direction and having an interior surface and a distal end and a proximal end with reference to the patient's skin puncture site and constructed and arranged for insertion of the needle through the proximal end of the channel and withdrawal of the needle therefrom,
(ii) a seal arranged within the channel and movable between first and second positions, where the seal, in the first position, with the needle not inserted through the seal, prevents fluids from passing the seal and, in the second position, with the needle inserted through the seal, allows fluids to pass through the needle and emerge substantially at the channel distal end, and where blood flowpath transitions between the needle interior surface and the channel interior surface are substantially continuous and smooth when the means for sealing is in the second position; and
the device further comprising structure for joining the channel distal end to a catheter that extends to an internal vessel of the patient's body, and wherein such joining is continuous and smooth along the interior surfaces of the channel and catheter.
As with any invasive procedure, prevention of infection has been a problem, particularly with a device that must remain in place over protracted periods of time. Coagulation of the blood in and around the catheter and/or port has also proven troublesome and methods are needed for its prevention, particularly with regard to inhibiting the clogging of the catheter, which can diminish or destroy its usefulness. A significant amount of research has been directed to the alleviation of these problems.
It is standard procedure to flush catheters and/or ports with an anticoagulant, such as heparin. However, heparin is not an antibacterial and, in addition, if not carefully controlled, it can carry the anti-coagulation process too far, thereby presenting a risk of hemorrhage. It is also known in the art to employ an antibiotic along with the anticoagulant, but if this is done, as is always the case with the use of antibiotics, the probability increases that hybrid microorganisms will be produced having immunity to the applied antibiotic. For this reason, it is desirable in the medical arts to minimize the use of antibiotics to as great an extent as possible in order to conserve their efficacy over a prolonged period.
U.S. Pat. No. 4,107,305 discloses a method of combating endotoxaemia by administering an effective amount of a taurolin composition.
U.S. Pat. No. 4,445,889 discloses a method for preventing an infection in a patient introduced through a indwelling catheter, the method comprising, connecting the patient to the catheter, connecting the catheter to a fluid receiving container, admitting into the container a biocidal dispensing device, and releasing a biocide into fluid in the container for inhibiting the growth of infectious bacteria in the container and concomitantly their introduction into the catheter and the patient.
U.S. Pat. No. 4,587,268 discloses a composition for the treatment of wounds comprising a resorbable aqueous gel having dissolved or dispersed therein one or more water-soluble medicaments, which are preferably an antibiotic or a methylol transfer antibacterial.
U.S. Pat. No. 4,626,536 discloses the use of taurolin compounds to combat toxic proteins or peptides, e.g., venoms, fungal toxins and bacterial exotoxins, in the bloodstream of humans or warm-blooded animals.
U.S. Pat. No. 4,797,282 discloses a drug depot, which can be implanted in the body, for the controlled, delayed release of cytostatics, comprising a synthetic material based on polyacrylates and/or polymethacrylates containing a cytostatic and at least one amino acid.
U.S. Pat. No. 4,853,225 discloses an implantable medicament depot useful for combating infections comprising physiologically acceptable excipients and at least one delayed release active compound that is a chemotherapeutic of the gyrase inhibitor type.
U.S. Pat. No. 4,960,415 discloses a device for inserting in wounds and wound cavities consisting of a container containing a pharmaceutically active substance, the walls of this container consisting at least partly of a membrane, preferably a semi-permeable membrane, which allows the active substance to escape into the wound area. The container is, more preferably, a dialysis tube. In order to drain off wound secretions, the container containing the pharmaceutically active substance, particularly taurolidine, is conveniently connected to a drainage tube. Preferably, a drainage tube is used in which the end that leads into the wound is split into filaments.
U.S. Pat. No. 5,077,281 discloses the use of taurolin compounds as blood coagulation-inhibiting agents and as abacterial inflammation-inhibiting agents. According to the patent, taurolin has outstanding coagulation-inhibiting action and is especially suitable for use in medical conditions requiring dialysis and for vascular prostheses. It is also disclosed that these compounds can be used together with other anti-coagulants such as coumarin or heparin.
U.S. Pat. No. 5,093,117 discloses pharmaceutical compositions that are said to be useful for the treatment or prophylaxis of Gram-negative bacteremia or septic shock. These compositions contain a bactericidal effective amount of polyclonal immunoglobulins against Gram-negative bacteria and a blood clot-dissolving effective amount of protein C. The compositions may further contain one or more protein C cofactors and mono
Estabrook Brian K.
Prosl Frank R.
Sodemann Klaus
Biolink Corporation
Brown Michael A.
Williams Frederick C.
Williams & Associates
LandOfFree
Biocidal locks does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Biocidal locks, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Biocidal locks will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2954943