Abstract
A method and apparatus to direct a drug directly at the point needed for a specific duration for dialysis catheters which are made in standard sizes. Disclosed is a combination of a rate and duration-controlled infusion pump and reservoir and a pre-measured infusion catheter with a radiopaque distal tip. Along the length of the infusion catheter there is a luer lock connector and anti-leak valve. The invention is inserted into a dialysis catheter where the preset marking is aligned with the catheter hub and the distal infusion tip rest at or near the end of the dialysis catheter. The infusion unit is then activated, and the drug is delivered at the distal tip of the catheter, at or in the fibrin for maximum effect. The method of use and device saves time and resources as it can be deployed without the need for a surgical suite or heath care team.
Claims
1. A dialysis catheter clearance device comprising: outflow line having a first end and a second end; a medication injection device configured to connect to the first of the outflow line the medication reservoir connected to or be configured as part of the medication injection device; an infusion catheter having a first end and a second end, the first end of the infusion catheter connected to the outflow line, and the second end of the infusion catheter having a distal tip with a nozzle through which medication exits the infusion catheter, the infusion catheter also having one or more placement markers; and a radiopaque marker at the distal tip of the infusion catheter.
2. The dialysis catheter clearance device of claim 1 wherein the medication deliver device comprises a catheter clearance box configured to deliver medication to infusion catheter, the catheter clearance box having a port switch, a flow rate control selector, motor, a belt and infusion gear, a medication reservoir, and an infusion catheter connector; the port switch connected to the motor; the flow rate control selector also connected to the motor; and the motor connected to the belt and infusion gear.
3. The dialysis catheter clearance device of claim 1 wherein the length of the infusion catheter is premeasured.
4. The dialysis catheter clearance device of claim 3 wherein the length of the infusion catheter is adjustable.
5. The dialysis catheter clearance device of claim 1 wherein the infusion catheter connector is a luer lock connector.
6. The dialysis catheter clearance device of claim 1 wherein the medication deliver device comprises a syringe.
7. The catheter clearance device of claim 1, wherein the one or more placement markers on the infusion catheter correspond to lengths of one or more dialysis catheters.
8. The dialysis catheter clearance device of claim 1 wherein the nozzle is configured to establish a different medication outflow pattern based on a medication flow rate.
9. The dialysis catheter clearance device of claim 1 further comprising an anti-leak valve associated with the connector.
10. A method of clearing a blood clot in a dialysis catheter comprising: providing a medication injection device, a medication reservoir containing clot dissolving medication, and an infusion catheter; accessing the dialysis catheter; inserting a distal end of the infusion catheter into the dialysis catheter; monitoring progression of the distal end of the infusion catheter in the dialysis catheter by monitoring the location of a radiopaque marker, a placement marker, or both; advancing the infusion catheter to a clot in or at a distal end of the dialysis catheter; and providing medication through the infusion catheter to the distal end of the infusion catheter to the clot to dissolve the clot.
11. The method of claim 10 wherein the monitoring progression of the distal end of the infusion catheter includes monitoring the location of one or more placement markers instead or in addition to the radiopaque marker.
12. The method of claim 10 further comprising connecting the infusion catheter to an outflow line using a connector such that the outflow line connects to the medication reservoir.
13. The method of claim 10 wherein providing medication occur over the course of hours at a predetermined deliver rate.
14. The method of claim 10 wherein providing medication is performed by a catheter clearance box.
15. The method of claim 10 wherein the infusion catheter is pushed into the clot to disburse medication into the clot.
16. The method of claim 10, wherein infusion catheter is a two-prong infusion catheter which splits into a first infusion catheter and a second infusion catheter and the method further comprises placing the first infusion catheter into the aspiration tube and placing the second infusion catheter into the injection tube.
Description
DESCRIPTION OF THE DRAWINGS
[0012] The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. In the figures, like reference numerals designate corresponding parts throughout the different views
[0013] FIG. 1 illustrates a standard tunneled type dialysis catheter.
[0014] FIG. 2 illustrates a dialysis catheter with the distal tip positioned near the heart in the chest.
[0015] FIG. 3 illustrates an occluded dialysis catheter with development of fibrin and clot at the distal tip.
[0016] FIG. 4 illustrates an injection of medication into the dialysis catheter port with medication diffusion to the tip.
[0017] FIG. 5 illustrates the infusion system with the infusion pump and control 100 and the preset infusion catheter 200 and the associated components.
[0018] FIG. 6 illustrates an anti-leak connector 300 with internal luer lock connector 310 and anti-leak valve 320 sealing around the infusion catheter 200.
[0019] FIG. 7 illustrates an infusion system deployed with the tip in the dialysis catheter and medication infused directly at the dialysis catheter tip.
[0020] FIG. 8 illustrates the infusion system deployed within a longer dialysis catheter confirmed by the matched infusion catheter marker 211.
[0021] FIG. 9 illustrates the lysis process, from left to right wherein the medication 50 dissolves the fibrin and clot 4 and restored catheter patency.
[0022] FIG. 10 illustrates an inside view of the infusion pump system 101 with internal components visualized.
[0023] FIG. 11 illustrates the components housed within the Infusion system 100, a medication reservoir 150 and output catheter 190 and the infusion controls 120 with electronically controlled motor and pump mechanism 170 and 175.
[0024] FIG. 12 illustrates a flow rate control 130 sensory set on low with minimal medication 50 output.
[0025] FIG. 13 illustrates a flow rate control 130 sensory set on medium with moderate medication 50 output.
[0026] FIG. 14 illustrates a flow rate control 130 sensory set on high with maximum medication 50 output.
[0027] FIG. 15 illustrates an additional embodiment of the infusion system with a predetermined, non-adjustable catheter length and anti-leak connecter.
[0028] FIG. 16 illustrates an additional embodiment of the infusion system with two outflow catheters.
[0029] FIG. 17 illustrates an additional embodiment of the infusion system with measurement markers along the proximal infusion catheter.
[0030] FIG. 18 illustrates an infusion system 101 that is preloaded with a dose of the medication 50 therefore not requiring the infusion port.
DETAILED DESCRIPTION
[0031] 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.
[0032] FIG. 1 illustrates a standard dialysis catheter 11 consisting of an aspiration tube 12, an injection tube 13 held together by a cuff 14 and a catheter 15. The aspiration tube 12 is attached to an aspiration port 16 on one end, and a distal tip on the other end 18. The injection tube 13 is attached to an injection port 17 on one end, and a distal tip on the other end 19. The arrows 3, 4, 5, 6 represent the direction of the blood flow. Specifically, the patient's blood exits the patient's body by entering 3 the distal tip of the aspiration tube 12, flowing through the aspiration tube 12, and exiting 4 the aspiration port 16 to become filtered. Once filtered, the patient's blood is returned to the patient's body by entering 5 through the injection port 17, flowing through the injection tube 13, and exiting 6 the distal tip of the injection tube 19.
[0033] FIG. 2 illustrates the standard dialysis catheter 11 implanted in a patient's 1 chest near the heart, with the distal tips of the aspiration tube 18 and the injection tube 19 inserted into the patient's chest 1 superior vena cava blood vessel 2.
[0034] FIG. 3 illustrates how the fibrin and clot 7 developed on the distal tips of the aspiration tube 18 and the injection tube 19 restricting the flow of the patient's blood through the standard dialysis catheter 11. The patient's blood exiting 6 the distal tip of the injection tube 19 may be able to break the fibrin and clot 7 forming around the distal tip of the injection tube 19 due to pressure. However, the patient's blood entering 3 the distal tip of the aspiration tube 18 cannot pass through the fibrin and clot 7 forming around the distal tip of the aspiration tube 18 due to the ball-valve mechanism.
[0035] FIG. 4 illustrates the standard method of restoring patency in the standard dialysis catheter 11. A syringe 31 containing medication 50 attaches to the aspiration port 16 using a standard luer lock attachment 32. The syringe 31 injects 33 the medication 50 in the aspiration port 16. Pressure from the injection 33 pushes the medication 50 into the aspiration tube 12. This method intends the medication 50 to reach the distal tip of the aspiration tube 18, where the medication 50 breaks down the fibrin and clot 7 to allow the patient's blood to enter 3 the distal tip of the aspiration tube 18. However, this method is ineffective because the injection 33 does not produce enough pressure, resulting in most of the injected medication 50 to remain in the aspiration tube 12 without reaching the distal tip of the aspiration tube 18. The small amount of medication 50 reaching the distal tip of the aspiration tube 18 is not sufficient to break down enough fibrin and clot 7 to allow the patient's blood to enter 3 the distal tip of the aspiration tube 18.
[0036] FIG. 5 illustrates an embodiment of the catheter clearance device 100, consisting of a catheter clearance box 110 connected to a medication injection port 111 on one end, and an infusion catheter connector 195 on the other end. The infusion catheter connector 195 connects the catheter clearance box 110 to an infusion catheter 200.
[0037] The infusion catheter 200 is connected to the catheter clearance box 110 on one end and has a distal tip 220 on the other end. A connector and valve 300 attaches to the infusion catheter 200. The infusion catheter 200 displays placement markers measuring 19 centimeters 210, 23 centimeters 211, and 27 centimeters 212 respectively from the distal tip of the infusion catheter 220. The distal tip of the infusion catheter 220 contains a radiopaque marker 221, which can be detected by x-ray.
[0038] A port switch 120 on the catheter clearance box 110 turns the catheter clearance device 100 on and off. A flow rate control selector 130 on the catheter clearance box 110 controls the speed at which medication travels from the catheter clearance box 110 to the distal tip of the infusion catheter 220.
[0039] FIG. 6 illustrates the connector and valve 300, which is attached to the infusion catheter 200 and can be moved along the length of the infusion catheter 200 for proper placement of the infusion catheter 200 inside standard dialysis catheters. The connector and valve 300 consists of a female luer lock connector 310 and an anti-leak valve 320. The female luer lock connector 310 can attach to the aspiration port 16 of a standard dialysis catheter 11. The anti-leak valve 320 can seal the outer portion of the infusion catheter 200. When fully sealed, the anti-leak valve 320 prevents the flow of medication inside the infusion catheter 200 from escaping, thus directing the medication to the clot.
[0040] FIG. 7 illustrates the placement of the catheter clearance device 100 inside the aspiration tube 12 of a standard dialysis catheter 11. Specifically, the infusion catheter 200 is inserted into the catheter 15 of the standard dialysis catheter 11 through the aspiration port 16. The catheter clearance device 100 is correctly placed inside a standard dialysis catheter 11 when the distal tip of the infusion catheter 220 reaches the distal tip of the aspiration tube 18. In this illustration, the first placement marker 210 confirms this correct placement when the placement marker 210 is positioned directly underneath the aspiration port 16 of the standard dialysis catheter 11. The correct placement can also be confirmed by an x-ray showing the radiopaque marker 221 is aligned with the distal tip of the aspiration tube 18 of the standard dialysis catheter 11. The connector and valve 300 attaches to the aspiration port 16 to secure the infusion catheter 200 inside the catheter 15 of the standard dialysis catheter 11 once correct placement is confirmed. The catheter clearance device 100 can also be placed inside the injection tube 13 of the standard dialysis catheter 11 using the same method described above.
[0041] FIG. 8 illustrates the placement of the catheter clearance device 100 inside a standard dialysis catheter 11 with a longer catheter 15, such that the infusion catheter 200 is advanced until the second placement marker 211.
[0042] FIG. 9 the infusion of the medication 50 to the distal tip of the aspiration tube 18 of the standard dialysis catheter 11. The distal tip of the infusion catheter 220 ensures delivery of all injected medication 50 directly to the distal tip of the aspiration tube 18. Thus, there will be sufficient medication 50 to dissolve the fibrin and clot 7, restoring patency to the standard dialysis catheter 11.
[0043] FIG. 10 illustrates the interior of the catheter clearance box 110. The medication injection port 111 at the top of the catheter clearance box 110 is connected to a medication reservoir 150. In one embodiment of the invention, the medication reservoir 150 is 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 reservoir 150 is connected to an outflow line 190. The other end of the outflow line 190 is connected to the infusion catheter connector 195. The infusion catheter 200 attaches to the other end of the infusion catheter connector 195.
[0044] The port switch 120 is connected to the motor 170. The motor is connected to the belt and infusion gear 175.
[0045] The flow rate control selector 130 displays three flow rate options on the exterior of the catheter clearance box 110. The three respective flow rate options are minimum 131, medium 132, and maximum 133. On the interior of the catheter clearance box 110, the flow rate control selector 130 is connected to the motor 170.
[0046] FIG. 11 illustrates how medication 50 travels through the catheter clearance box 110. Specifically, a syringe 31 injects 33 medication 50 through the medication injection port 110. The medication 50 then flows into the medication reservoir 150.
[0047] When the port switch 120 is on, the motor 170 powers the belt and infusion gear 175 to rotate. The belt and infusion gear 175 pushes the medication 50 in the medication reservoir 150 through the outflow line 190 to the infusion catheter connector 195, where the medication 50 flows into the infusion catheter 200.
[0048] FIG. 12 illustrates the catheter clearance device 100 operating on minimum 131. Specifically, when the flow rate control selector 130 is set to minimum 131 and the port switch 120 is on, the motor 170 powers the belt and infusion gear 175 that rotates at a slow speed. As a result, the medication in the medication reservoir 150 is slowly pushed into the outflow line 190, then through the infusion catheter connector 195 into the infusion catheter 200, eventually reaching the distal tip of the infusion catheter 220 and exiting the infusion catheter 200 at a slow rate.
[0049] FIG. 13 illustrates the catheter clearance device 100 operating on medium 132. Specifically, when the flow rate control selector 130 is set to medium 132 and the port switch 120 is on, the motor 170 powers the belt and infusion gear 175 that rotates at a medium speed. As a result, the medication in the medication reservoir 150 is pushed into the outflow line 190 at a medium speed, then through the infusion catheter connector 195 into the infusion catheter 200, eventually reaching the distal tip of the infusion catheter 220 and exiting the infusion catheter 200 at 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 catheter 200.
[0050] FIG. 14 illustrates the catheter clearance device 100 operating on maximum 133. Specifically, when the flow rate control selector 130 is set to maximum 133 and the port switch 120 is on, the motor 170 powers the belt and infusion gear 175 that rotates at a high speed. As a result, the medication in the medication reservoir 150 is pushed into the outflow line 190 at a high speed, then through the infusion catheter connector 195 into the infusion catheter 200, eventually reaching the distal tip of the infusion catheter 220 and exiting the infusion catheter 200 at a fast rate.
[0051] FIG. 15 illustrates another embodiment of the catheter clearance device 100 using a premeasured infusion catheter 201, which does not display placement markers 210, 211, 212. The placement of the connector and valve 300 is preset such that the connector and valve 300 cannot move along the infusion catheter 200. Such infusion catheters 200 vary in length and are based on the length of catheters on standard dialysis catheters 11. Using this embodiment, the user would choose the appropriate length of a premeasured infusion catheter 201 to insert into the infusion catheter connector 195.
[0052] FIG. 16 illustrates another embodiment of the catheter clearance device 100 where a 2-prong infusion catheter 202 is attached to the infusion catheter connector 195. The 2-prong infusion catheter 202 splits into two tubes, each tube displaying three placement markers 210, 211, 212. A connector and valve 300 is attached to each tube. This embodiment allows the catheter clearance device 100 to be placed inside both the aspiration tube 12 and the injection of a standard dialysis catheter 11, such that a single catheter clearance device 100 can remove fibrin and clot 7 at the distal tips of the aspiration tube 18 and the injection tube 13 of the standard dialysis catheter 11 simultaneously.
[0053] FIG. 17 illustrates another embodiment of the catheter clearance device 100 where an Infusion catheter with measuring marks 203 is attached to the infusion catheter connector 195. In this embodiment, measuring marks 213 are displayed between the placement markers 210, 211, 212 such that the catheter clearance device 100 can restore the patency of dialysis catheters with non-standard length catheters. The measuring marks 213 may also help adjust the placement of the Infusion catheter 220 inside the catheter 15 of a standard dialysis catheter 11, should an x-ray of the radiopaque marker 221 indicate the radiopaque marker 221 is not fully aligned with the distal tip of the aspiration tube 18 or the injection tube 13 of a standard dialysis catheter 11.
[0054] FIG. 18 illustrates another embodiment of the catheter clearance device 100 with no medication injection port 111 on the catheter clearance box 110. In this embodiment, the medication reservoir 150 is preloaded with medication 50. This embodiment allows the user to utilize the catheter clearance device 100 without the need to manually inject 33 medication 50 into the catheter clearance box 110.
[0055] 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.
[0056] 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.
