Surgery – Instruments – Sutureless closure
Reexamination Certificate
2000-01-25
2001-10-02
Jackson, Gary (Department: 3731)
Surgery
Instruments
Sutureless closure
60
Reexamination Certificate
active
06296658
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to medical devices in general and, more particularly, to hemostatic devices. The device is particularly useful for arresting the flow of blood or hemorrhage from punctures of the vascular system.
2. Background Art
Various surgical procedures are performed by medical specialists such as cardiologists, utilizing 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. Recently, both the types and number of procedures performed utilizing the above mentioned percutaneous access to blood vessels have increased greatly.
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 Following this, a guidewire is placed through the needle into the blood vessel and the needle is withdrawn.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 attack. 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 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 an pseudo-aneurysm or severe hematoma. The current technique for removal of introducer sheaths is also 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 reaccess to the lumen of the blood vessel, if necessary.
In the past, various devices and methods have been used and proposed in an attempt to seal punctures in blood vessels by injection of a resorbable hemostatic plug into the puncture site, including U.S. Pat. Nos. 4744364 (Kensey), 4,852,568 (Kensey), and 4,890,612 (Kensey).
Despite the need for a device and method which overcome the imitations and problems of the prior art, none insofar as is known, has been proposed or developed.
SUMMARY OF THE INVENTION
This invention provides a device for sealing an opening or puncture in the wall of a blood vessel. The device includes a shaft section of small diameter, with an expandable balloon and guidewire tip at its distal end. The proximal end of the device has a low profile port which is utilized to inflate and deflate the distal balloon once it is in place within the blood vessel, and which permits removal of a standard hemostasis introducer which is preexisting in the puncture. The introducer is used to inject a procoagulant to the puncture site, proximally with respect to the balloon for sealing.
Unique aspects of this invention include: (1) the creation of immediate hemostasis at the puncture site for procoagulant delivery; (2) the device balloon acts as a marker for delivery of procoagulant; (3) balloon approach prevents injection of procoagulant into the bloodstream; and (4) the apparatus and method allow reaccess to the patient's vasculature. Other features, benefits and objects of this invention will become clear from the following description by reference to the drawings.
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Gershony Gary
Horzewski Michael J.
Kasprzyk Daniel J.
Fredrikson & Byron , P.A.
Jackson Gary
Vascular Solutions, Inc.
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