PATENCY MAINTENANCE SYSTEM

Abstract: This apparatus is intended for maintaining the patency of an indwelling vein access device (14). The apparatus includes a vein access device (14) such as a catheter (14) connected to a self-energized container (12) having a capacity to deliver an infusate to the vein access device (14) at a flow rate of approximately 0.01-1.0 ml per hour.

Description: PATENCY MAINTENANCE SYSTEM Background of the Invention F gld of the Invention The invention generally relates to a method and apparatus for maintaining the patency of an indwelling vein access device and, more particularly, to such a method and apparatus that utilizes a self- energized container to slowly deliver an infusate into a vein access device and which permits the adding of a medicament without disconnecting the container from the vein access device. Description of the Prior Art There are numerous approaches to patency maintenance currently being utilized in venipuncture practice. The most common approaches are the heparin lock procedure and KVO procedure. In the KVO procedure a KVO solution (generally a saline solution) is slowly directed through the vein access device (IV catheter) into the patient at a flow rate generally from about 1 ml/hour to about 10 ml/hour. While this procedure seems to maintain the patency of the vein access device, it has the disadvantage of infusing a large volume of fluid into the patient and it limits the mobility of the patient. In the widely used heparin lock procedure, a concentrated heparin solution is contained in a capped off segment of tubing in fluid communication with the vein access device. The concentration of the heparin is generally from about 10 to about 100 international heparin units per milliliter of diluent. At these concentrations of heparin, it is necessary to initiate a flush procedure of the heparin lock device and vein access device prior to infusion of most antibiotic drugs through the vein access device, in order to avoid contamination resulting from the incompatibility of the drug with heparin. Most heparin lock devices utilize the cumbersome SASH procedure in which (a) the device is flushed with a bolus dose of saline solution, (b) the medicament or drug is infused into the device, (c) the device is again flushed with a bolus dose of saline solution, and (d) the device is filled with the concentrated solution of heparin. While this procedure is widely regarded as effective to maintain patency of the vein access device, it is generally regarded as being time consuming, costly and increasing the risk of sepsis. There is a need for a method and apparatus for reliably maintaining the patency of a vein access device in a manner that minimizes manipulative steps, is economical, minimizes the volume of fluid that is infused into the patient, and does not inhibit patient mobility. Summary of the Invention Briefly stated, the invention provides a method and apparatus for maintaining the patency of a vein access device into which a solution of an infusate is slowly delivered. The patency device is preferably self-energized and includes a means for adding a medicament without disconnecting the patency device from the vein access device. In accordance with a preferred embodiment of the invention, the patency device includes a self-energized container that contains infusate. The self-energized container delivers the infusate solution to the vein access device at a substantially constant low flow rate. The flow rate is preferably from about .01 to about 1.0 milliliters per hour. The term "self-energized container", as used herein, is intended to include a wide range of known self-powered, compact pump devices that (a) include a container for storing a fluid and means for dispensing such fluid from the container at a controlled flow rate over a prolonged period of time, (b) do not require electricity or gravity to operate and (c) are wearable by the patient. Such devices may include, but are not limited to the following: osmotic infusion pumps; elastomeric membrane or bladder infusion pumps; vapor pressure delivery pumps; hydrogel driven osmotic pumps; and the like. Exemplary of such pump devices are those disclosed in U.S. Patent Nos. 4,692,151, 4,769,008, 4,838,862, 4,898,582, 4,410,328, 4,318,400, 4,419,096, 3,840,009, 4,223,061 and 4,203,440. The patency device includes an access site for directing a medicament or drug into the vein access device. In a preferred embodiment, a check valve is provided to preclude a medicament from mixing with the infusate solution in the self-energized container. The invention, both as to its method of operation and apparatus, will be best understood from the following description of specific embodiments when read in connection with the accompanying drawings. Brief Description of the Drawings FIGURE 1 is a perspective view of a preferred embodiment of a patency device in accordance with the invention during use; FIGURE 2 is an enlarged elevational view of the patency device shown in FIGURE 1; and FIGURE 3 is a schematic representation depicting the components in accordance with the invention. Description of the Preferred Embodiments In accordance with the method of the present invention, the patency of a vein access device, such as a catheter, is maintained by continuously delivering infusate solution at a low flow rate to the vein access device. The infusate may be any solution or mixture of liquids capable of maintaining the patency of the vein access device and may include, without limitation, sterile water, saline, aqueous solutions of alcohol or sugar, e.g. dextrose, lactose, mannitol solutions or emulsions, or mixtures thereof where appropriate, Ringer's solution, lactated Ringer's solution, trace metals, salts, e.g. metal chlorides, metal carbonates or bicarbonates, anticoagulants such as heparin, clot dissolvers, e.g. TPA and urokinase, drugs such as antibiotics, cardiotonics or any other therapeutic drug, parenteral nutritionals such as amino acids and fat emulsions, electrolytes, cardioplegia solutions, dextran and many others. Thus, any solution which is not harmful may be used so long as it is capable of maintaining patency. The delivery of such solution maintains the patency of the vein access device in a manner that minimizes the volume of fluid directed into the patient and the potential adverse effects associated therewith. The low concentration of the anticoagulant drug, if used, also reduces the risks associated with the incompatibility of the drug with certain antibiotics. The anticoagulant drug, if used, is preferably a heparin solution having a concentration from about .01 to about .99 international heparin units per milliliter of diluent, although lower or higher concentrations may be useful. The heparin, saline or other infusate solution is preferably delivered to the vein access device at a flow rate from about .01 to about 1.0 milliliters per hour, but could be higher or lower. Most preferably, the flow rate should be at the lower end of said range. Referring to FIG. 3, a schematic representation of a patency device 10, in accordance with the broad concepts of the invention, is shown as including a self-energized container 12 for directing a normal saline solution to a catheter 14 at the flow rate disclosed hereinabove. An access site 16 is preferably interposed between the container 12 and the catheter 14 to infuse a medicament or drug into the catheter. A check valve 18 is preferably interposed between the access site 16 and the container 12 to preclude the medicament or drug from mixing with the normal saline solution in the container. Referring to FIGS. 1 and 2, patency device 10 includes a self-energized container 12 having a holding means or reservoir 20 that contains a solution containing heparin, said solution having a concentration from about .01 to about .99 international heparin units per milliliter of diluent. The container 12 is designed to deliver the heparin solution from the reservoir 20 at a flow rate from about .01 to about 1.0 milliliters per hour. The device includes an outlet line 22 for directing the heparin solution from container 12 to catheter 14 or other vein access device. Catheter 14 and outlet line 22 are provided with suitable luer connectors or equivalent attachment means 24 to facilitate connection of the catheter to the outlet line. In accordance with the invention, a suitable access site 16 is provided in communication with outlet line 22 to selectively infuse a medicament or drug into the catheter without disconnecting the self- energized container from the catheter. A suitable regulating or selecting means, for example a check valve, 18 is positioned in outlet line 22 between access site 16 and the reservoir 20 to prevent the back flow of the drug into the infusate reservoir. As best seen in FIG. 1, the patency device 10 may be secured to the patient's arm or elsewhere by tape or other suitable means. The device is sufficiently small in size to facilitate mobility of the patient. The device preferably includes a sufficient supply of infusate solution to last about 1 to 3 days. Should it become necessary, the self-energized container may be replaced without removal of the catheter from the vein of the patient by disconnecting the container at the luer connection. The specific type and construction of the self-energized container 12 does not form a part of the invention. As alluded to hereinabove, there are many such devices well known in the art that may be utilized to deliver the infusate solution at the disclosed flow rates. The patency device 10 is compact, portable and requires little manipulation during use, which makes it particularly ideal for use by home care patients. The dilute nature and the low flow rate of the infusate solution avoids the necessity of saline flushes to avoid interaction with drugs and minimizes the quantity of fluid that is infused into the patient. The provision of the access site permits infusion of a medicament or drug into the patient without disconnecting the device. Although the invention has been described in terms of certain preferred embodiments, other embodiments that are apparent to those of ordinary skill in the art are also within the scope of the invention. Accordingly, the scope of the invention is entitled to be defined in accordance with the spirit and scope of the appended claims.

Claims: WHAT IS CLAIMED IS: 1. Apparatus for maintaining the patency of an indwelling vein access device, comprising: a. a vein access device; and b. a self-energized container means for delivering infusate solution to said vein access device at a low flow rate from about .01 to about 1.0 milliliters per hour. 2. The apparatus as defined in claim 1 further including means for preventing the medicament directed into said access device from flowing into said self-energized container means. 3. Apparatus for maintaining the patency of an indwelling vein access device, comprising: a. a vein access device; and b. means for delivering a heparin solution to said vein access device, said heparin solution having a concentration from about .01 to about .99 international heparin units per milliliter of diluent and a flow rate from about .01 to about 1.0 milliliters per hour. 4. The apparatus as defined in claim 3 wherein said means for delivering said heparin solution is a self-energized container. 5. The apparatus as defined in claim 4 including an access site for directing a medicament into said vein access device. 6. The apparatus as defined in claim 5 further including regulating or selecting means for preventing the medicament directed into said access device from flowing into said self-energized container. 7. The apparatus as defined in claim 4 wherein said vein access device is a catheter. 8. A method for maintaining the patency of an indwelling vein access device, comprising the step of delivering a dilute solution of an infusate into a vein access device at a flow rate from about .01 to about 1.0 milliliters per hour.

Inventors: KOLBER CHRIS M, KOLBER, CHRIS, M.
Applicants: ABBOTT LAB, ABBOTT LABORATORIES
Application year: 1995
Main classification: A61M5
IPC codes: A61M5, A61M25