Infusion system with fixed occluding wire

Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...

Reexamination Certificate

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C604S256000, C604S533000

Reexamination Certificate

active

06179828

ABSTRACT:

BACKGROUND OF THE INVENTION
1. The Field of the Invention
This invention is in the field of catheters, including catheterization systems employing occluding wires for use in perfusion catheters.
2. The Relevant Technology
Perfusion catheters have become popular in recent years for use in anesthetizing tissues at an insertion site of a catheter and for treating clotted blood vessels, among other uses. Perfusion catheters typically feature a cannula having infusion holes in a wall thereof for enabling fluid to flow through the wall onto the sensitive tissues of a patient or adjacent an area in which the practitioner has discovered a clot. By positioning the holes of the catheter adjacent the area to be treated, a fluid may be applied to the area, thereby diffusing the clot or anesthetizing the tissues. Once the catheter is positioned at the site of the clot, for example, a thrombolytic fluid capable of dissolving the clot, such as urokinase or streptokinase, is delivered to the site of the clot.
Typical perfusion catheter assemblies comprise a catheter, a fluid supply port, and a hemostasis valve coupled to a proximal end of the catheter which substantially prevents fluid from flowing out a proximal end of the catheter assembly during use. Generally, the distal insertion end of the catheter assembly is open and must therefore be occluded prior to irrigating a liquid from a fluid source through the fluid supply port and into an infusion length of the catheter, where the infusion holes are located. Occlusion of the distal opening of the catheter assembly may be accomplished by inserting an occluding wire through the valve of the assembly and then inserting the wire further along the length of the catheter.
The occluding wire substantially seals the distal end of the infusion catheter during use in order to facilitate spray distribution through the holes. The occluding wire typically includes a wire body portion and a distal sealing ball portion. The sealing ball portion forms a substantially liquid-tight seal at the distal end of the catheter, thereby forcing liquid located proximal to the seal out of the infusion holes of the catheter. Because the inner diameter of the catheter is typically larger than the diameter of the wire body portion of the occluding wire, there is ample space within the infusion catheter for the passage of a liquid out of the infusion holes.
In certain catheters, such as typical 5 French catheters, the inner diameter of the catheter is reduced to a narrow neck at the distal end of the catheter. The sealing ball portion of the occluding wire seats against the inner, narrow neck wall portion of the catheter when inserted into the distal end and thereby substantially occludes the distal opening of the catheter. Consequently, substantially any liquid forced through the catheter is caused to exit through the infusion holes rather than through the opening.
In other catheters, such as typical 4 French catheters, the inner diameter of the catheter is constant throughout the catheter, but the diameter of the occluding ball is configured to substantially match the inner diameter of the catheter. Thus, the practitioner slides the occluding ball to the distal tip, thereby substantially occluding the passageway of the catheter and forcing fluid to flow out of the side perfusion holes proximal to the occluding ball.
When the distal end of the occluding wire is positioned in the catheter, the proximal end of the occluding wire is generally positioned within the hemostasis valve of the catheter assembly. The valve temporarily prevents the occluding wire from moving until the occluding wire is grasped, pushed, or otherwise moved by a practitioner. Consequently, it is generally possible to intentionally or accidentally slide the occluding wire with respect to the catheter, particularly when an adjustable valve is loosened.
Thus, one ramification of present occluding wire and catheter designs is that during use of the catheter system, the proximal end of the occluding wire is generally slidably movable with respect to the hemostasis valve. In addition, the proximal end of the occluding wire generally extends from the proximal end of the catheter assembly and remains exposed to the environment. This dynamic results in a variety of different complications.
For example, the occluding wire can be inadvertently inserted too far distally through the catheter or retracted proximally from a desired position in the catheter. Such inadvertent insertion of the occluding wire may occur when a practitioner accidentally contacts the proximal end of the wire or may be caused by an infusion of fluid under a significant amount of pressure. Such inadvertent actions can cause the occluding wire to lose its occluding effect, for example, by causing the occluding ball to exit the distal opening of the catheter or by inadvertently retracting the ball proximally to a distal set of holes, thereby occluding the fluid supply to the distal set of holes.
In addition to the aforementioned drawbacks associated with typical catheterization systems employing occluding wires, other elongate bodies, such as catheters and guidewires can also be inadvertently displaced from or moved within hemostasis valves.
There is therefore a need in the art for an improved catheterization system for percutaneous catheterization of a blood vessel. More specifically, there is a need in the art for a catheterization system having an improved occluding wire.
SUMMARY AND OBJECTS OF THE INVENTION
It is therefore an object of the invention to provide an improved occluding wire.
It is another object of the invention to provide an improved catheterization system.
It is another object of the invention to provide a catheterization system in which the occluding wire cannot be inadvertently pushed too far into or inadvertently retracted from a catheter.
It is another object of the invention to provide a catheterization system in which the longitudinal position of the occluding wire is fixed with respect to a catheter of the system.
It is another object of the invention to provide a catheterization system in which an elongate body of the system is maintained in a fixed position with respect to a hemostasis valve of the system.
The present invention relates to an improved catheterization system. In one embodiment, the improved catheterization system comprises a perfusion catheterization system comprising: (i) an occluding wire; (ii) a perfusion catheter, and (iii) a fluid supply port in fluid communication with the catheter.
The occluding wire comprises (i) an elongate wire body; (ii) an occluding tip (including an occluding ball or other structure which is larger in diameter than the wire body) coupled to a distal end of the elongate wire body; and (iii) a hub coupled to a proximal end of the elongate wire body. The hub of the occluding wire prevents the occluding tip from moving in a longitudinal direction with respect to the catheter once the hub has been coupled to the catheter.
The perfusion catheter comprises: (i) a hollow cannula having a cannula wall; and (ii) a hub coupled to the cannula. A lumen extends through the cannula from a proximal opening of the cannula to a distal opening of the cannula. The cannula wall has a plurality of infusion holes extending therethrough. The distal occluding tip of the occluding wire is configured to extend into the lumen of the cannula.
The perfusion catheterization system further comprises a fluid supply port. The fluid supply port supplies fluid to the cannula for delivery through the infusion holes. The fluid supply port can be integral with the catheter or the occluding wire. Optionally, an adaptor comprising a fluid supply port and preferably a hemostasis valve is selectively coupled to the catheter hub so as to be in fluid communication with the cannula.
The adaptor comprises a hollow tubular body having a proximal end and a distal end. The distal end is configured to be coupled to the hub of the catheter. A hollow secondary access tube is coupled at one end thereof in fluid communicatio

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