Surgery – Instruments – Sutureless closure
Reexamination Certificate
1999-06-29
2004-01-20
Milano, Michael J. (Department: 3731)
Surgery
Instruments
Sutureless closure
C606S213000, C227S181100
Reexamination Certificate
active
06679904
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a device for locating and sealing a puncture wound in animal and human tissue and the related method. A particular example is a vascular puncture.
BACKGROUND OF THE INVENTION
An ever increasing number of vascular interventional procedures are being undertaken by cardiologists and radiologists. With the growing use of both diagnostic and therapeutic procedures requiring percutaneous vascular access, a real demand exists for a method and device for accurately locating and closing the puncture site in the blood vessel, post inter-ventional procedure.
Due to ease of access, the most common site selected for these percutaneous arterial inter-ventional procedures is the femoral artery. The normal procedure is to insert an angio-graphic needle into the femoral artery. This is followed by the insertion of a guide wire and over this guide wire successive dilators are passed percutaneously into the artery in order to widen the puncture in the artery sufficiently to allow the sheath of optimal diameter for the diagnostic or therapeutic procedure to be inserted. Through this sheath is then inserted the required catheter or intervengional device in order to perform the required diagnostic or therapeutic procedure on the patient.
At the end of the procedure above, the standard treatment on removal of the sheath involves digital pressure on the artery, supplemented with external compression such as sandbags, pneumatic extension cuffs, or adjustable vice-like devices which may be graduated to apply different degrees of pressure on the skin over the puncture site. This method results in the occlusion of the puncture site by thrombosis of blood in the wall of the puncture site and haemostasis in the percutaneous tract. It causes considerable discomfort for the patient and is associated with a long period of immobilisation. Unpredictable post-procedural haemorrhaging during time periods varying from hours to days after the intervention are not uncommon, and may even be fatal for the patient. The additional healthcare cost in dealing with this complication may be considerable.
A series of devices have been invented to address some of these problems by Datascope Corp. U.S.A., PerClose Corp. U.S.A., Kensey Nash Corp. U.S.A. and Bard Corp. U.S.A.
SUMMARY OF THE INVENTION
The present invention which is, however, independent of the exact procedure and of which type of wound is involved, discloses a new method and a new device for sealing a tissue wall puncture by approximating the walls of the tissue in such a way as to obliterate the puncture site. The present invention will find use for vascular puncture wounds, as well as in other medical procedures which rely on percutaneous access to hollow organs such as laparo-scopic procedures, arthroscopic procedures, and the like. It will also find use in closing body orifices approached directly by the device or approached through body cavities or organs.
The new method involves the use of a surgical stapler which includes means to permit use at visually inaccessible sites.
Accordingly, the invention proposes a surgical stapler having a stapler head at its distal end, comprising guide means which can be used to constrain the stapler to move along a pre-positioned guide wire to reach a location along the path of said guide wire. The invention is of particular use at visually inaccessible surgical sites.
The invention also proposes a surgical stapler, for use at visually inaccessible vascular sites, having a stapler head at its distal end, and comprising guide means which can be used to constrain the stapler to move along a pre-positioned guide wire to reach a location along the path of said guide wire, and locator means which project forwardly of the stapler head which enable blood flow to be sensed within a blood vessel with consequential location of the stapler head adjacent the exterior of said blood vessel.
After the intervention the guide wire may have an incremental marking measurement scale along its length, allowing the operator to estimate precisely the amount of guide wire which is placed within the blood vessel. After the interventional procedure serial dilators may be placed over the guide wire and used to dilate the subcutaneous tract down to the level of the external wall of the arterial puncture to allow access by the stapler. The dilator may contain a radio-opaque marker and also a measurement scale which allows the accurate measurement of the length of the percutaneous tract from the skin level to the outer surface of the blood vessel puncture site.
As an alternative method of locating the puncture accurately, the dilator may have a fine bore plastic tube running through its length which passes over the guidewire. The calibre of this plastic tubing is such that it will be sufficiently small to pass into the blood vessel. This tubing may be fixed to the dilator and protrudes for approximately 1-6 mm and preferably 2-4 mm beyond the distal end of the tissue tract dilator. When blood is observed pulsing back from the distal end of this tubing on to the skin, it can be taken to signify that the tube has entered the blood vessel and consequently the dilator has reached the outer surface of the blood vessel. When this occurs, the exact depth of the percutaneous tract may be measured. Transmission of a a pulsation via the dilator to operator may be taken as further evidence that the dilator is resting against the outer wall of the artery. After completion of dilation of the tract, the dilator is removed over the guidewire which itself is left in place so that the inventive stapler can then be used.
Alternatively, the fine bore tube may be fixed within the stapler itself with the same degree of projection. In either case, the distal end of the tube may have a longitudinal slit into which the guidewire may enter as it curves into the artery.
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Coleman James
Gleeson Malachy
Taylor James
Milano Michael J.
Nutter & McClennen & Fish LLP
Woo Julian W.
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