Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1997-11-25
2001-10-09
Nguyen, Anthuan T. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S101050
Reexamination Certificate
active
06299597
ABSTRACT:
BACKGROUND OF THE INVENTION
The incidence of vascular aneurysms is increasing due to improved longevity of the population as well as improvements in the methods of diagnosing for these afflictions. Hertzer recently reported in
Vascular Surgery
that approximately 3% of the general population may be afflicted with aortic aneurysms. Further, specific incidence of aortic aneurysm correlates to a great degree with related risk factors. For instance, approximately 53% of all patients demonstrating femoral or popliteal aneurysms also were indicated to have aortic aneurysms. The prevalence of aneurysms increase rapidly after 55 years of age. Akkerselijk et al reported a AAA rate of 11.4% in men over 60.
Health care costs for the repair of aneurysms and dissections of the aorta, iliac, femoral and popliteal arteries is presently assumed to be in the vicinity of 150-200 million dollars annually and is rising at a significant level due to greater ability to diagnose and treat these afflictions, as well as because of the aging of the general population.
The repair of aneurysms and dissections found in the cardiovascular tree has to a great degree reflected the numerous advancements occurring in the fields of surgery, anesthetics and bio-devices. Since the 1950's successful repair of aneurysms has been possible through surgical treatment and to the present day standard treatment for aneurysms, dissection and septal defects includes surgical intervention typically resulting in the implant of a prosthesis to replace the dissected diseased tissue or span the gap of a septal defect. There are several prosthetic devices available for the repair of these anomalies. However, in spite of the relatively high degree of success being indicated by the surgical repair of vascular aneurysms (actuarial rates for the repair of aortic aneurysms indicate less than 3% morbidity being associated with this procedure) there exists numerous reasons for improvement of the processes used. For example, there is the need to further minimize trauma to the patients. There is also the need to minimize hospitalization time. There is a need to minimize expense associated with the repair procedure.
SUMMARY OF THE INVENTION
The present invention is directed towards the use of fluid polymer compositions for vascular repair and an accompanying catheter system which is applicable to the percutaneous repair of vascular aneurysms, dissections and the like.
Specifically, this invention relates to vascular diseases and anomalies such as aneurysms, dissections, lesions and septal defects in which the afflicted area is not surgically excised and replaced but rather is repaired by the localized delivery of a fluid polymerizable or crosslinkable material to the diseased site and the following stabilization of the polymer by photo-activation, heat activation or chemical means of this material in situ, resulting in a solid repair material at the site. The pre-polymer is delivered to the site by accessing the vasculature via the percutaneous introduction of a catheter (specifically designed for this application) into a vessel such as the femoral, brachial or carotid artery. Following delivery to the afflicted area, the fluid polymer may be molded via the use of the catheter. The pre-polymer is stabilized i.e. solidified in situ either by polymerization or crosslinking via the introduction of light or heat energy, chemicals, or chemical initiators. A relatively smooth transition between the polymer network and the natural vessel may be achieved either by shaping the proximal and distal portion of the implant generated or by controlling the physical and material properties of the polymer. Lastly, the catheter system is removed thus leaving behind a crosslinked polymeric network affecting the repair of the diseased site.
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Bilge Fertac
Buscemi Paul J.
Holman Thomas J.
Nguyen Anthuan T.
Sci-Med Life Systems, Inc.
Thissell Jeremy
Vidas Arrett & Steinkraus P.A.
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