Fluidic media introduction apparatus

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

Reexamination Certificate

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Details

C604S096010, C604S191000, C606S214000

Reexamination Certificate

active

06475182

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a fluidic media introduction apparatus, and more particularly to a fluidic media introduction apparatus for closing an opening in a vessel wall.
2. Description of Related Art
Various surgical procedures utilize percutaneous entry into a blood vessel or body cavity. Examples of such procedures include different techniques to recanalize atherosclerotic blood vessels, such as balloon angioplasty or atherectomy.
These procedures generally involve the percutaneous puncture with a thin walled needle into a blood vessel. Following this, a guidewire is placed through the needle into the blood vessel and the needle is withdrawn. An intravascular sheath of variable size is then advanced over the guidewire, percutaneously, into the lumen of the blood vessel. The introducer sheath is then used as an ingress/egress means during the procedure. Following completion of the procedure, the introducer sheath may be removed, but this requires the application of prolonged manual pressure over the puncture site by a physician or other suitably trained medical personnel. The time involved here is frequently extensive since patients are often treated with a variety of anticoagulant and thrombolytic agents, particularly in the setting of a heart attach. Alternatively, the sheath may be left in the puncture site for a prolonged period of time until the patient's coagulation status has returned to normal. Depending on the size of the size of the vascular sheath, there may be an increased risk of bleeding to the patient, which may require blood transfusion. in addition, there is a significant risk for injury to the blood vessel upon removal of the sheath, particularly if the sheath has been in place for a prolonged period of time. This includes the possible development of a pseudo-aneurysm or severe hematoma. Current methods for removal of introducer sheaths are painful to the patient and requires prolonged bed rest after removal. This adds to the discomfort for the patient, as well as prolonging hospitalization, and costs.
Many of the intra-vascular procedures are performed in patients who are clinically unstable or who have the potential to become so, following completion of the procedure. Following removal of the vascular access sheath, it could be cumbersome and sometimes difficult to re-enter the blood vessel if necessary. Thus, with the current technique for removal of the sheath following the procedure, no easy, reliable method is available to allow re-access to the lumen of the blood vessel, if necessary.
It would desirable to provide a fluid delivery device which provides vascular sealing and easy re-access to the lumen of the blood vessel. It would be further desirable to provide a fluid delivery device which provides vascular sealing and includes a mixing chamber for mixing a fluidic media.
SUMMARY OF THE INVENTION
Accordingly, an object of the invention is to provide a fluid delivery device.
Another object of the invention is to provide a fluid delivery device used for vascular sealing.
A further object of the invention is to provide a fluid delivery device that delivers a fluidic media to a vascular puncture site.
Still another object of the invention is to provide a fluid delivery device with a mixing chamber and a guide wire lumen, where the fluid delivery device is used for vascular sealing.
These and other objects of the invention are achieved in a fluidic media delivery apparatus for closing an opening in a vessel wall. The apparatus includes an elongated member with a fluidic media introduction port and a guide wire lumen. The guide wire lumen extends from a proximal portion to a distal portion of the elongated member. A fluidic media mixing chamber is positioned in the elongated member and coupled to a fluidic media introduction port. A fluidic media delivery lumen is coupled to the mixing chamber. A fluidic media advancement port is positioned at the distal portion of the elongated member. An inflatable member is coupled to the distal portion of the elongated member.


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