Reduction of recirculation in catheters

Abstract

A catheter tip designed to reduce the outflow velocity and / or directional momentum of fluid being infused by a catheter having such a tip. In one variation, a plurality of channels is provided at the distal portion of the catheter to increase the outflow cross-sectional area. In another variation, the diameter of the catheter at its distal portion where the fluid exits is increased. In yet another variation, a bullet-shaped nose is implemented which may decrease turbulence at the distal end of catheter tip. The low velocity outflow catheter tip may also be implemented on a dual lumen catheter, such as a hemodialysis catheter, to reduce recirculation rate. Various device configurations and methods for such implementations are also disclosed.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] Not applicable. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT [0002] Not applicable. REFERENCE TO A COMPACT DISK APPENDIX [0003] Not applicable. BACKGROUND OF THE INVENTION [0004] In various medical situations there is a need to divert blood from the circulatory system and then later reintroduce the removed blood back into the circulatory system. For example, patients with renal problems may require hemodialysis to stay alive. In such a situation, due to the fact that the patient's kidney is not functioning properly to remove biological waste from the patient's circulatory system, the blood must be removed from the patient and treated outside the body to remove the biological wastes, and then returned to the circulatory system. A common approach is to introduce a dual lumen catheter into a blood vessel within the patient's body. The catheter has one lumen for removing blood and another lumen for reintroducing the proce...

AI Technical Summary

Benefits of technology

[0009] Accordingly, described herein is a catheter having a distal tip designed to decrease the outflow velocity of fluid being delivered by the catheter. In one variation, side holes are provided at the distal portion of the catheter to prevent jetting of fluids. In another variation, the distal portion of the catheter, where fluid exits the catheter, has an enlarged cross-sectional area relative to the cross-sectional area of a lumen in the proximal portion of the catheter. In yet another variation, the catheter has a bullet shaped nose at the distal end of the catheter tip. Radially patterned openings may also be provided on the bullet shaped nose to serve as outflow orifice.

[0010] The low outflow profile catheter tip may be implemented in a catheter having two or more lumens. For example, a low outflow profile catheter tip may be utilized in a hemodialysis catheter. In one variation, the hemodialysis catheter comprises two lumens where the orifice for each of the lumens at the distal portion of the catheter is staggered along the length of the catheter. The orifice at the distal end of the hemodialysis catheter may be configured with a low outflow profile tip. The low outflow profile tip may decrease the outflow velocity of fluid being infused through the catheter such that the infusion of fluid causes minimal disruption on the existing circulatory flow within the patient's circulatory system. For example, the distal end of the hemodialysis catheter may be positioned in or close to the atrium of the patient's heart. A low outflow profile tip may be implemented to decrease the outflow velocity of blood being infused through the catheter such that the outflow of blood from the catheter does not cause significant disruption on the vortex flow that naturally occurs within the atrium of the heart. By minimizing the disruption on the vortex flow in the atrium, one may decrease the mixing of newly infused blood with the existing venous blood (i.e., “dirty blood”), thus reducing the recirculation of the processed blood being infused by the catheter.

[0011] It has also been observed that a large flow velocity differential, between the velocity of the out flowing infused blood and the velocity of the natural blood flow in the vessel, may promote the formation of thrombosis at the distal tip of the catheter. By reducing the velocity of the blood flowing out of the catheter, the flow velocity differential between the natural and infused flow may be decreased, and this may decrease the thrombus formation at the distal tip of the catheter. Furthermore, the shape of the catheter tip may be configured to create a uniform flow velocity across the entire cross-section directly distal to the catheter tip. Having multiple branching with increasing lumen cross-section within the catheter tip, the outflow of fluids may be dispersed into a larger cross-sectional flow and thus decrease the flow velocity. It may be desirable to control the dispersion such that a uniform flow velocity may be achieved directly distal to the catheter tip. Preferably, the dispersion is wide enough to provide sufficient reduction in overall flow velocity, but not too wide as to create a dead spot at the nose of the bullet shaped catheter tip.

[0012] In addition, the aspiration lumen opening of the dual lumen hemodialysis catheter may also be configured in a radial-pattern having a cross-sectional area equal or greater than the proximal portion of the aspiration lumen. This design may reduce the peak velocities of the blood flow as it enters the catheter. One of ordinary skill in the art would appreciate that the “dirty blood” flowing down the major axis of the catheter must reverse direction as it enters the aspiration lumen of the catheter. This tends to cause high shear stress around the fluid entry point. In a traditional “staggered dual-D” design catheter, this high stress at the fluid entry point may lead to the formation of thrombosis. The thrombus formation may result in the occlusion of the lumen opening and reducing the effective life of the catheter. However, with a radial-pattern design and increased cross-sectional area at the aspiration lumen openings, one may reduced the peak velocities as the blood changes direction and enters the catheter. By decreasing the peak inflow velocity, one may decrease the likelihood of thrombus formation at the fluid entry point. Furthermore, a design having greater cross-sectional areas and / or multiple openings for the aspiration lumen may accommodate the occasion when the catheter comes into contact with the vessel / atrium wall and one or several openings are blocked. One of ordinary skilled in the art, having the benefit of the disclosure herein, will appreciate that the number, shape (e.g., tapered shaped, etc.), and size (e.g., length of the opening, etc.) of the lumen openings can be configured to achieve the desired maximum flow velocity and / or fluid shear stress.

Problems solved by technology

This tends to cause high shear stress around the fluid entry point.

In a traditional “staggered dual-D” design catheter, this high stress at the fluid entry point may lead to the formation of thrombosis.

The thrombus formation may result in the occlusion of the lumen opening and reducing the effective life of the catheter.

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