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05/31/07 - USPTO Class 623 |  21 views | #20070123972 | Prev - Next | About this Page  623 rss/xml feed  monitor keywords

Modular stent graft assembly and use thereof

USPTO Application #: 20070123972
Title: Modular stent graft assembly and use thereof
Abstract: A modular stent graft assembly (10) for repairing a ruptured abdominal aorta aneurysm (90) and having an aortic section tubular graft (12) and an iliac section tubular graft (14). The aortic section graft has a proximal attachment stent (32) thereon for suprarenal attachment of the assembly (10) to the aorta. A proximal end portion (50) of the iliac section graft (14) underlies the distal end portion (28) of the aortic graft (12) and presses outwardly thereagainst forming a friction fit, at a telescoping region (64). The assembly (10) can be selected from an inventory (300) containing a set of delivery systems (100) of four size aortic section grafts (12) and a set of delivery systems (200) of four size iliac section grafts (14), that together accommodate a large majority of aneurysm sizes, and delivery systems (250) containing four standard sizes of occluders (80). (end of abstract)



Agent: Cook Group Patent Office - Bloomington, IN, US
Inventors: Roy K. Greenberg, Jason A. Mead
USPTO Applicaton #: 20070123972 - Class: 623001130 (USPTO)

Related Patent Categories: Prosthesis (i.e., Artificial Body Members), Parts Thereof, Or Aids And Accessories Therefor, Arterial Prosthesis (i.e., Blood Vessel), Stent In Combination With Graft

Modular stent graft assembly and use thereof description/claims


The Patent Description & Claims data below is from USPTO Patent Application 20070123972, Modular stent graft assembly and use thereof.

Brief Patent Description - Full Patent Description - Patent Application Claims
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CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This is a continuation of application Ser. No. 10/104,672, filed Mar. 22, 2002, which claims priority of provisional application Ser. No. 60/279,329, filed Mar. 28, 2001, both of which are incorporated by reference.

TECHNICAL FIELD

[0002] The present invention relates to medical devices and more particularly to modular endovascular stent grafts.

BACKGROUND OF THE INVENTION

[0003] In recent years treatment of aneurysms has been performed prior to aneurysm rupture and has included the use of stent grafts that are implanted within the vascular system with minimally invasive surgical procedures and that include one or more stents affixed to graft material. The stent grafts are secured at a treatment site by endovascular insertion utilizing introducers and catheters, whereafter they are enlarged radially and remain in place by self-attachment to the vessel wall. In particular, stent grafts are known for use in treating descending thoracic and abdominal aortic aneurysms where the stent graft at one end defines a single lumen for placement within the aorta and at the other end is bifurcated to define two lumens, for extending into the branch arteries.

[0004] One example of such a stent graft is disclosed in PCT Publication No. WO 98/53761 in which the stent graft includes a sleeve or tube of biocompatible graft material such as Dacron.TM. polyester fabric (trademark of E. I. DuPont de Nemours and Co.) or polytetrafluoroethylene defining a lumen, and further includes several stents secured therealong, with the stent graft spanning the aneurysm extending along the aorta proximally from the two iliac arteries; the reference also discloses the manner of deploying the stent graft in the patient utilizing an introducer assembly. The graft material-covered portion of the single-lumen proximal end of the stent graft bears against the wall of the aorta above the aneurysm to seal the aneurysm at a location that is spaced distally of the entrances to the renal arteries. Thin wire struts of a proximal stent extension traverse the renal artery entrances without occluding them, since no graft material is utilized along the proximal stent while securing the stent graft in position within the aorta when the stent self-expands. An extension is affixed to one of the legs of the stent graft to extend along a respective iliac artery and, optionally, extensions may be affixed to both legs. Another known stent graft is the Zenith AAA.TM. stent graft sold by William A. Cook Australia Pty. Ltd., Brisbane, Queensland, Australia.

[0005] Because of life threatening time constraints, such conventional stent grafts are not practical to be utilized with ruptured aneurysms, which presently must be treated, if at all, by open surgery.

[0006] Despite the multitude of advances in surgical management and intensive care, the devastating physiological effects of emergency aortic surgery for either ruptured abdominal aortic aneurysms (RAAA) or symptomatic abdominal aortic aneurysms (SAAA), carry an unacceptably high morbidity and mortality rate. Most patients who suffer from RAAA and SAAA are typically unaware of their aneurysmal disease prior to the development of symptoms of actual or impending rupture. The acuity of an RAAA precludes complex radiographic evaluation, does not allow for adequate preoperative planning, and is compounded by the relative unavailability of endovascular stent grafts. Additionally, because of the rapid blood loss from the patient, any substantial surgical delay cannot be tolerated. Another complication stems from the statistical fact that most patients who suffer RAAA or SAAA are elderly and have factors that preclude repair of the rupture by open surgery, with the result that patient mortality from RAAA is very high. Approximately 15,000 deaths per year occur in the United States from ruptured abdominal aortic aneurysms.

[0007] Conventional surgical repair of ruptured and symptomatic aneurysms is itself associated with significant complications. Cardiopulmonary complications as a result of a prolonged abdominal operation, significant blood loss and aortic cross clamping, multiple blood transfusions, and hypothermia are most frequently encountered. Mortality of ruptured aneurysms is currently estimated to be between 50% and 75%.

[0008] It is thus desired to provide medical devices enabling emergency endovascular treatment of RAAA and SAAA. It is further desired to provide such devices in a manner not requiring, on site at a surgical treatment center, a large inventory of different size devices while still enabling immediate treatment of a large range of aneurysm sizes, nor in a manner requiring preoperative study of the treatment site taking a substantial length of time in order to optimize the selection of an appropriate device. It is yet further desired to provide a medical device that is quickly deliverable and effectively deployable at the treatment site.

SUMMARY OF THE INVENTION

[0009] The foregoing problems are solved and a technical advance is achieved in an illustrative modular stent graft assembly of the present invention. The stent graft assembly is to be a life-saving device first, and a permanent implant second. Each stent graft assembly comprises at least two components or sections, thus allowing for quick deployment; extensions can be added if necessary. The cranial or aortic section has a diameter corresponding to the normal or undiseased diameter of the aorta of the patient, and the caudal or iliac section has a diameter corresponding to the normal or undiseased diameter of the common iliac artery. The diameter of the aortic section of the assembly is sized to be at least 10 percent larger than the aortic artery for leakproof engagement therewith, while the diameter of the iliac section of the assembly is sized to be at least about 10 percent larger than the ipsilateral iliac artery, both thus assuring no deficiency in diameter that could otherwise result in leakage around the assembly or migration of the assembly following placement. Preferably, each section has an assembly interconnection portion with a constant diameter of, for example, 12 mm for at least a predetermined length of, for example about 56 mm to facilitate interconnection in a wide range of overall assembly lengths. The overall length of the implanted stent graft assembly is adjustable intraoperatively by varying the amount of overlap at the interconnection. An iliac occluder can also be utilized for occluding the contralateral iliac artery, with a conventional crossover connection to be made between the ipsilateral and contralateral iliac arteries, if possible.

[0010] A preferred inventory of components or devices includes a set of aortic assembly sections of a common length (exclusive of the attachment stent length) with proximal end portions having one of a standard set (four) of proximal diameters (34, 30, 26 and 22 mm); and iliac sections of a common length with distal end portions having one of a standard set (four) of different distal diameters (24, 20, 16 and 12 mm). In addition, occluders having one of a standard set (four) of different diameters (24, 20, 16 and 14 mm) could be included in the inventory. Such inventory provides for the largest coverage of the different patient anatomy with the fewest number of components or devices; however, the lengths of the assembled devices can be varied to accommodate different patient anatomy.

[0011] This invention is designed to perform a compromise operation which can be performed with a maximum of safety and yet produce a satisfactory and safe result. No time is spent on accurately measuring the dimensions of a patient's aorta, and no time is spent on manipulating a second graft down a second iliac artery and to thereby connect a second iliac leg thereto.

[0012] The method of use includes inserting the aortic section of the assembly into the aortic artery and engaging the proximal end with portion thereof the aorta just below the renals with the distal end portion extending distally into the aorta. The iliac section is inserted into the ipsilateral artery with engagement thereagainst at the distal end portion thereof. The proximal end portion of the iliac section interconnects with the distal end portion of the aortic assembly section to provide an overlapping interconnection that can be adjusted to accommodate the patient's anatomy. An occluder is then implanted in the contralateral iliac to isolate the ruptured aneurysm.

[0013] When an elderly patient is suffering from a rupture or dissection of an aortic aneurysm, all of the blood is immediately bypassed to one of the iliac arteries such as the ipsilateral iliac artery and the patient's life is saved. The provision of the contrailiac occluder and the bypass graft between the contrailiac artery and the ipsilateral iliac artery is a relatively unimportant detail and not too relevant to the life of the patient. Furthermore, the latter detail can be attended to after the ruptured vessel is isolated. The above operation may seem to be somewhat crude, but it is designed to protect the lives of elderly and very ill patients who would otherwise die. Each of the above steps has been performed separately for various reasons, but this is the first time that they have all been performed in sequence in a single permanent operation. One would not be expected to perform such an operation in a single procedure since it seems impractical and clumsy and yet it works and saves lives.

BRIEF DESCRIPTION OF THE DRAWING

[0014] An embodiment of the present invention will now be described by way of example with reference to the accompanying drawings, in which:

[0015] FIG. 1 diagrammatically illustrates the stent graft assembly of the present invention deployed within a ruptured aneurysm, and an occluder in a selected iliac artery;

[0016] FIG. 2 is an exploded side view of the stent graft assembly of the present invention having an aortic section and an iliac section;

[0017] FIG. 3 shows an occluder plug to be used with the present invention;

[0018] FIG. 4 shows a first embodiment of a set of stent graft assembly components having an aortic section graft and two iliac section grafts;

[0019] FIG. 5 illustrates a second embodiment of aortic section grafts;

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