Patent ID: 12186465

DETAILED DESCRIPTION

Hemodialysis patients require routine large volume blood exchange to survive and our bodies fight off efforts to allow this access. For many dialysis patients a permanent, indwelling catheter is the means of providing such access. Dialysis catheters have advantages over other methods of access however also have a limited time in which they will stay open and function mainly because of fibrin and clot forming on the tip. This invention and the method of use describe a means to direct a drug, a thrombolytic, directly at the point needed for a specific duration for dialysis catheters which are made in specific standard sizes.

FIG.1illustrates a standard dialysis catheter11consisting of an aspiration tube12, an injection tube13held together by a cuff14and a catheter15. The aspiration tube12is attached to an aspiration port16on one end, and a distal tip on the other end. The injection tube13is attached to an injection port17on one end, and a distal tip on the other end. The arrows3,4,5,6represent the direction of the blood flow. Specifically, the patient's blood exits the patient's body by entering3the distal tip of the aspiration tube12, flowing through the aspiration tube12, and exiting4the aspiration port16to become filtered. Once filtered, the patient's blood is returned to the patient's body by entering5through the injection port17, flowing through the injection tube13, and exiting6the distal tip of the injection tube19.

FIG.2illustrates the standard dialysis catheter11implanted in a patient's1chest near the heart, with the distal tips of the aspiration tube18and the injection tube19inserted into the patient's chest1superior vena cava blood vessel2.

FIG.3illustrates how the fibrin and clot7developed on the distal tips of the aspiration tube18and the injection tube19restricting the flow of the patient's blood through the standard dialysis catheter11. The patient's blood exiting6the distal tip of the injection tube19may be able to break the fibrin and clot7forming around the distal tip of the injection tube19due to pressure. However, the patient's blood entering3the distal tip of the aspiration tube18cannot pass through the fibrin and clot7forming around the distal tip of the aspiration tube18due to the ball-valve mechanism.

FIG.4illustrates the standard method of restoring patency in the standard dialysis catheter11. A syringe31containing medication50attaches to the aspiration port16using a standard luer lock attachment32. The syringe31injects33the medication50in the aspiration port16. Pressure from the injection33pushes the medication50into the aspiration tube12. This method intends the medication50to reach the distal tip of the aspiration tube18, where the medication50breaks down the fibrin and clot7to allow the patient's blood to enter3the distal tip of the aspiration tube18. However, this method is ineffective because the injection33does not produce enough pressure, resulting in most of the injected medication50to remain in the aspiration tube12without reaching the distal tip of the aspiration tube18. The small amount of medication50reaching the distal tip of the aspiration tube18is not sufficient to break down enough fibrin and clot7to allow the patient's blood to enter3the distal tip of the aspiration tube18.

FIG.5illustrates an embodiment of the catheter clearance device100, consisting of a catheter clearance box110connected to a medication injection port111on one end, and an infusion catheter connector195on the other end. The infusion catheter connector195connects the catheter clearance box110to an infusion catheter200.

The infusion catheter200is connected to the catheter clearance box110on one end and has a distal tip on the other end. A connector and valve300attaches to the infusion catheter200. The infusion catheter200displays placement markers measuring 19 centimeters210, 23 centimeters211, and 27 centimeters212respectively from the distal tip of the infusion catheter220. The distal tip of the infusion catheter220contains a radiopaque marker221, which can be detected by x-ray.

A port switch120on the catheter clearance box110turns the catheter clearance device100on and off. A flow rate control selector130on the catheter clearance box110controls the speed at which medication travels from the catheter clearance box110to the distal tip of the infusion catheter220.

FIG.6illustrates the connector and valve300, which is attached to the infusion catheter200and can be moved along the length of the infusion catheter200for proper placement of the infusion catheter200inside standard dialysis catheters. The connector and valve300consists of a female luer lock connector310and an anti-leak valve320. The female luer lock connector310can attach to the aspiration port16of a standard dialysis catheter11. The anti-leak valve320can seal the outer portion of the infusion catheter200. When fully sealed, the anti-leak valve320prevents the flow of medication inside the infusion catheter200from escaping, thus directing the medication to the clot.

FIG.7illustrates the placement of the catheter clearance device100inside the aspiration tube12of a standard dialysis catheter11. Specifically, the infusion catheter200is inserted into the catheter15of the standard dialysis catheter11through the aspiration port16. The catheter clearance device100is correctly placed inside a standard dialysis catheter11when the distal tip of the infusion catheter220reaches the distal tip of the aspiration tube18. In this illustration, the first placement marker210confirms this correct placement when the placement marker210is positioned directly underneath the aspiration port16of the standard dialysis catheter11. The correct placement can also be confirmed by an x-ray showing the radiopaque marker221is aligned with the distal tip of the aspiration tube18of the standard dialysis catheter11. The connector and valve300attaches to the aspiration port16to secure the infusion catheter200inside the catheter15of the standard dialysis catheter11once correct placement is confirmed. The catheter clearance device100can also be placed inside the injection tube13of the standard dialysis catheter11using the same method described above.

FIG.8illustrates the placement of the catheter clearance device100inside a standard dialysis catheter11with a longer catheter15, such that the infusion catheter200is advanced until the second placement marker211.

FIG.9the infusion of the medication50to the distal tip of the aspiration tube18of the standard dialysis catheter11. The distal tip of the infusion catheter220ensures delivery of all injected medication50directly to the distal tip of the aspiration tube18. Thus, there will be sufficient medication50to dissolve the fibrin and clot7, restoring patency to the standard dialysis catheter11.

FIG.10illustrates the interior of the catheter clearance box110. The medication injection port111at the top of the catheter clearance box110is connected to a medication reservoir150. In one embodiment of the invention, the medication reservoir150is made of an evacuated compliant sac structure that expands as it accepts fluids. This embodiment eliminates air in the system. The other end of the medication reservoir150is connected to an outflow line190. The other end of the outflow line190is connected to the infusion catheter connector195. The infusion catheter200attaches to the other end of the infusion catheter connector195.

The port switch120is connected to the motor170. The motor is connected to the belt and infusion gear175.

The flow rate control selector130displays three flow rate options on the exterior of the catheter clearance box110. The three respective flow rate options are minimum131, medium132, and maximum133. On the interior of the catheter clearance box110, the flow rate control selector130is connected to the motor170.

FIG.11illustrates how medication50travels through the catheter clearance box110. Specifically, a syringe31injects33medication50through the medication injection port110. The medication50then flows into the medication reservoir150.

When the port switch120is on, the motor170powers the belt and infusion gear175to rotate. The belt and infusion gear175pushes the medication50in the medication reservoir150through the outflow line190to the infusion catheter connector195, where the medication50flows into the infusion catheter200.

FIG.12illustrates the catheter clearance device100operating on minimum131. Specifically, when the flow rate control selector130is set to minimum131and the port switch120is on, the motor170powers the belt and infusion gear175that rotates at a slow speed. As a result, the medication in the medication reservoir150is slowly pushed into the outflow line190, then through the infusion catheter connector195into the infusion catheter200, eventually reaching the distal tip of the infusion catheter220and exiting the infusion catheter200at a slow rate.

FIG.13illustrates the catheter clearance device100operating on medium132. Specifically, when the flow rate control selector130is set to medium132and the port switch120is on, the motor170powers the belt and infusion gear175that rotates at a medium speed. As a result, the medication in the medication reservoir150is pushed into the outflow line190at a medium speed, then through the infusion catheter connector195into the infusion catheter200, eventually reaching the distal tip of the infusion catheter220and exiting the infusion catheter200at a medium rate. The medication may exit the infusion catheter through a nozzle, which may comprise any type opening at the distal end of the infusion catheter through which medication pass out of the infusion catheter200.

FIG.14illustrates the catheter clearance device100operating on maximum133. Specifically, when the flow rate control selector130is set to maximum133and the port switch120is on, the motor170powers the belt and infusion gear175that rotates at a high speed. As a result, the medication in the medication reservoir150is pushed into the outflow line190at a high speed, then through the infusion catheter connector195into the infusion catheter200, eventually reaching the distal tip of the infusion catheter220and exiting the infusion catheter200at a fast rate.

FIG.15illustrates another embodiment of the catheter clearance device100using a premeasured infusion catheter201, which does not display placement markers210,211,212. The placement of the connector and valve300is preset such that the connector and valve300cannot move along the infusion catheter200. Such infusion catheters200vary in length and are based on the length of catheters on standard dialysis catheters11. Using this embodiment, the user would choose the appropriate length of a premeasured infusion catheter201to insert into the infusion catheter connector195.

FIG.16illustrates another embodiment of the catheter clearance device100where a 2-prong infusion catheter202is attached to the infusion catheter connector195. The 2-prong infusion catheter202splits into two tubes, each tube displaying three placement markers210,211,212. A connector and valve300is attached to each tube. This embodiment allows the catheter clearance device100to be placed inside both the aspiration tube12and the injection of a standard dialysis catheter11, such that a single catheter clearance device100can remove fibrin and clot7at the distal tips of the aspiration tube18and the injection tube13of the standard dialysis catheter11simultaneously.

FIG.17illustrates another embodiment of the catheter clearance device100where an Infusion catheter with measuring marks203is attached to the infusion catheter connector195. In this embodiment, measuring marks213are displayed between the placement markers210,211,212such that the catheter clearance device100can restore the patency of dialysis catheters with non-standard length catheters. The measuring marks213may also help adjust the placement of the Infusion catheter220inside the catheter15of a standard dialysis catheter11, should an x-ray of the radiopaque marker221indicate the radiopaque marker221is not fully aligned with the distal tip of the aspiration tube18or the injection tube13of a standard dialysis catheter11.

FIG.18illustrates another embodiment of the catheter clearance device100with no medication injection port111on the catheter clearance box110. In this embodiment, the medication reservoir150is preloaded with medication50. This embodiment allows the user to utilize the catheter clearance device100without the need to manually inject33medication50into the catheter clearance box110.

Other systems, methods, features and advantages of the invention will be or will become apparent to one with skill in the art upon examination of the following figures and detailed description. It is intended that all such additional systems, methods, features and advantages be included within this description, be within the scope of the invention, and be protected by the accompanying claims.

While various embodiments of the invention have been described, it will be apparent to those of ordinary skill in the art that many more embodiments and implementations are possible that are within the scope of this invention. In addition, the various features, elements, and embodiments described herein may be claimed or combined in any combination or arrangement.