Surgery – Instruments – Sutureless closure
Reexamination Certificate
2001-11-07
2004-02-17
Jackson, Gary (Department: 3731)
Surgery
Instruments
Sutureless closure
Reexamination Certificate
active
06692515
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a surgical kit for repairing leaks in fluid carrying vessels and organs, and in particular, to a surgical kit for percutaneously repairing post-operative cerebrospinal fluid leaks associated with intraoperative rents of the dura mater of the spinal cord.
2. Description of the Related Art
Surgical procedures involving fluid carrying vessels and organs have risks associated with them that can extend beyond the actual surgery itself. Once the actual surgery is complete, the patient must be closely monitored to ensure that leaks at the surgical site do not develop. With the advent of many popular minimally invasive surgical procedures, such as laparoscopy, the vast benefits associated with the minimally invasive procedure may be lost if the patient must return to the operating room to close leaks that develop in fluid carrying vessels, particularly if the leak must be closed using traditional open surgical techniques.
Post-operative leaks are of particular concern following neurosurgical procedures. The human spine is comprised of the spinal column, having many vertebra which support the body and protect the delicate spinal cord. The vertebra are generally of pentagon shape, with the spinal processes (or “points”) extending posteriorly to the patient's back. The vertebra are separated and cushioned from each other by the discs, which act as pads between the vertebra to permit movement and shock absorption for the spine. The center of the vertebra are hollow, to permit the spinal cord to extend from the base of the spine to join with the medulla oblongata of the brain. Nerves extend outwardly from the spinal cord between the vertebra. The brain and the spinal cord itself are covered with three main layers: the pia mater, the arachnoid membrane, and the dura mater. The pia mater is a generally thin vascular membrane which is covered by the arachnoid membrane. The arachnoid membrane is in turn covered by the dura mater, which is a tough fibrous membrane that contains and provides a passageway for the cerebrospinal fluid (CSF) to flow. Following neurosurgery, the patient is closely monitored to determine if a rent in the dura mater has developed, which can have deleterious effects on the patient.
In the prior art, once a dural rent is identified, it is common to place a spinal drain at the site and the patient is placed in the Trendelenburg position, with his head positioned below the feet at about a 30-40 degree angle, with the knees bent. Typically, this will solve the problem; however, if the leak is not sealed, oftentimes surgery is necessary to close the rent and prevent further leakage of the CSF. This of course is traumatic to the recovering patient.
A need, therefore, exists for a kit having the instruments required for performing percutaneous procedures to repair leaks in fluid carrying vessels and organs without requiring the patient to undergo a traditional surgical procedure to repair the vessel or organ. A minimally invasive surgical technique is also needed to repair fluid leaks, such CSF leaks in the spinal cord, that may be accomplished quickly and efficiently, to reduce the recovery time of the patient and to minimize the trauma associated with such repair procedures.
SUMMARY OF THE INVENTION
It is, therefore, an object of the present invention to provide a surgical kit to facilitate the percutaneous repair of leaks in internal fluid carrying vessels and organs.
It is also an object of the present invention to provide a surgical kit for repairing post-operative CSF leaks in the dura mater following neurosurgery in a minimally invasive manner.
It is yet another object of the present invention to provide a minimally invasive method for repairing leaks in internal fluid carrying vessels and organs, particularly CSF leaks in the dura mater of the spinal cord.
The above and other objects are achieved by providing a surgical kit for repairing leaks in fluid carrying vessels and organs which includes a syringe and at least one marker in a sterile package, the syringe for containing fibrin glue for sealing the leak and the at least one marker for placement on the body of the patient to mark the location of the leak. In a preferred embodiment, the kit includes the syringe and at least one marker, and a package for containing the syringe and marker, where the package includes a top cover and a bottom cover for enclosing the syringe and marker. In another embodiment, the kit includes a syringe, a container carrying a bio-compatible fluid such as a fibrin glue, at least one marker, and a package having a top cover and a bottom cover for containing the syringe, container and marker. In another embodiment, the kit includes a syringe filled with a fluid such as a fibrin glue for sealing the leak, at least one marker, and a package including a top cover and a bottom cover for containing the syringe and marker. Preferably, the marker is adhesive-backed for maintaining its placement location on the body of the patient, and includes a hole in its center through which the needle of the syringe may pass, to guide the needle to the location of the leak. In addition, it is preferred that the syringe have calibrations or graduations on outer surface to enable the physician to gauge the depth of penetration of the needle to ensure accurate placement of the needle with respect to the leak site. The kit may also be provided with other items that will assist in the repair procedure, such as a container, or even a second syringe, containing a contrast agent to facilitate locating the leak under radiographic or magnetic imaging, such as fluoroscopy, CT scan and magnetic resonance imaging (MRI). A dual chamber syringe, a dual lumen needle attached to the syringe, and even two syringes each carrying the separate components of the fibrin glue are also contemplated. Sterile surgical drapes may also be included.
A method for repairing leaks in internal fluid carrying vessels and organs is also provided, which is minimally invasive and includes the steps of determining the location of the leak, placing a marker on the patient's body to mark the location of the leak, providing a syringe and a fibrin glue material, inserting the needle through a guide hole in the marker into the patient's body to a location adjacent the leak, and delivering the fibrin glue to seal the leak. It is contemplated that the method be performed under radiographic or magnetic imaging to confirm the accuracy of the location of the leak, the accuracy of the placement of the marker and the needle with respect to the leak site, and the accuracy of the delivery of the fibrin glue.
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patent: 5773418 (1998-06-01), Edwardson et al.
patent: 5951589 (1999-09-01), Epstein et al.
patent: 6045570 (2000-04-01), Epstein et al.
patent: 6056769 (2000-05-01), Epstein et al.
patent: 6183498 (2001-02-01), Devore et al.
patent: 6371975 (2002-04-01), Cruise et al.
Boehm, Jr. Frank H.
Melnick Benedetta Delorenzo
Dilworth & Barrese LLP
Jackson Gary
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