Surgery – Instruments – Surgical mesh – connector – clip – clamp or band
Reexamination Certificate
2000-04-05
2001-09-11
Jackson, Gary (Department: 3731)
Surgery
Instruments
Surgical mesh, connector, clip, clamp or band
C606S139000, C606S144000
Reexamination Certificate
active
06287317
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to medical devices and methods, and more particularly to intraluminal devices and methods for passing attachment apparatus (e.g., connector devices, staples, etc.) or connector material (e.g., suture thread, wire, cord, filament, monofilament, etc.) into or through the wall of a luminal anatomical structure (e.g., a blood vessel or other anatomical conduit) for the purpose of; i) closing the lumen of the anatomical structure, ii) forming an anastomotic junction between separate anatomical structures (or between approximated segments of the same anatomical structure), and/or iii) attaching an article (e.g., an endoluminal, extraluminal or transluminal graft) or other apparatus to the wall of the anatomical structure.
BACKGROUND OF THE INVENTION
In modern medical practice, it is sometimes desirable to pass attachment apparatus (e.g., connector devices, staples, etc.) or connector material (e.g., suture thread, wire, cord, filament, monofilament, etc.) into or through the wall of a luminal anatomical structure (e.g., a blood vessel or other anatomical conduit) for the purpose of; i) closing the lumen of the anatomical structure, ii) forming an anastomotic junction between separate anatomical structures (or between approximated segments of the same anatomical structure), and/or iii) attaching an article (e.g., an endoluminal, extraluminal or transluminal graft) or other apparatus to the wall of the anatomical structure. Some of these types of medical procedures are summarized as follows:
i. Procedures for Fully or Partially Closing of the Lumen of a Tubular Anatomical Structure Such As a Blood Vessel
Examples of medical procedures wherein it is desirable to close the lumen of a blood vessel include: a) procedures intended to diminish or block the flow of blood into vascular aneurysms (e.g., cerebral aneurysms); b) procedures intended to occlude the side branches which emanate from a segment of a peripheral vein (e.g., to prepare the vein segment for use as an in situ bypass conduit); c) procedures intended to occlude varicose veins; d) transvascular, catheter-based procedures for bypassing obstructed, diseased or injured arteries as described in U.S. patent application Ser. Nos. 08/730,327 and 08/730,496; e) procedures intended to block or diminish blood flow to a tumor; f) procedures intended to close congenital or acquired arteriovenous malformations; g) procedures intended to temporarily or permanently block blood flow through a vessel as an adjuvant to placement of an implant or apparatus within the blood vessel (e.g., placement of an endovascular graft for treatment of an aneurysm or other therapeutic intervention); and procedures intended to close an interstitial puncture tract or fistula which has been created for use in performing another medical procedure. Included among the catheter-based arterial bypass procedures described in co-pending application Ser. Nos. 08/730,327 and 08/730,496 is a coronary artery bypass procedure wherein a passageway-forming catheter is transluminally advanced into the coronary vasculature, and a tissue-penetrating element is passed out of the catheter and through the wall of the vessel in which the catheter is positioned to create at least one blood flow passageway (e.g., a puncture tract or interstitial tunnel) between an obstructed coronary artery and an adjacent coronary vein. Arterial blood then flows from the obstructed coronary artery into the adjacent coronary vein. In one variation of the procedure, a single arteriovenous passageway is formed (i.e., a “first” blood flow passageway) and the lumen of the coronary vein is blocked or closed off immediately proximal to such first blood flow passageway, such that arterial blood will enter the vein and will be forced to flow through the vein, in the retrograde direction. In this manner, the arterial blood from the obstructed artery may retroperfuse the myocardium through the coronary vein. In another variation of the procedure, one or more secondary arteriovenous passageways (e.g., puncture tracts or interstitial tunnels) may be formed between the coronary vein into which the arterial blood has been shunted, and the obstructed artery or another coronary artery. These secondary passageway(s) allow the rerouted arterial blood to re-enter the coronary arterial tree after having bypassed the arterial obstruction. In cases wherein such secondary blood flow passageways are formed, the lumen of the coronary vein may additionally be blocked or closed off at location(s) distal to such secondary passageway(s), to cause the rerouted arterial blood to re-enter the arterial vasculature, as desired.
ii. Procedures Which Require the Formation of an Anastomotic Connection to the Wall of a Luminal Anatomical Structure
Various types of anastomotic connections are frequently formed in luminal anatomical structures for the purpose of connecting opposing transected ends or openings formed in anatomical conduit(s) (e.g., blood vessel, intestine, etc.) or for connecting an opening formed in an anatomical conduit to another anatomical structure. When joining the juxtaposed ends or openings of a singular anatomical conduit which has been transected, or when joining the juxtaposed ends or openings of two (2) different anatomical conduits, such joinder(s) may be accomplished by either 1) end-to-end, 2) end-to-side, or 3) side to side anastomosis. Irrespective of which type of anastomotic connection is being formed, the usual surgical technique requires that the luminal anatomical conduit(s) be maneuvered into proximity and placed in abutting juxtaposition, such that the ends or openings of the anatomical conduit(s) are in alignment with one another. Thereafter, sutures, staples or other connecting apparatuses are passed through the walls of the juxtapositioned anatomical conduit(s) to form the desired anastomotic connection therebetween. Anastomotic connections of this type are frequently performed during surgical procedures wherein a diseased or injured segment of an anatomical conduit (e.g., blood vessel, intestine, etc.) has been resected and removed, and the opposing cut ends of the conduit are then reconnected (by end-to-end, side to side, or end to side anastomosis) to permit continued flow of bodily fluids or other matter through the conduit.
iii. Procedures Wherein Grafts or Other Articles are Attached to a Luminal Anatomical Structure
Examples of medical procedures wherein it is desirable to anchor or attach a graft or other apparatus to the wall of a blood vessel or other luminal anatomical conduit include certain endovascular grafting procedures wherein a tubular graft is placed within the lumen of an aneurysmic blood vessel to create a neo-lumen or artificial flow conduit through the aneurysm, thereby eliminating the exertion of blood pressure on the aneurysm and allowing the aneurysmic space to subsequently become filled in with granulation tissue. These endovascular grafting procedures have heretofore been used to treat aneurysms of the abdominal aorta, as well as aneurysms of the descending thoracic aorta. The endovascular grafts which have heretofore been used for these procedures typically incorporate or are combined with one or more radially expandable stents which are radially expanded in situ to anchor the tubular graft to the wall of the blood vessel at sites upstream and downstream of the aneurysm. However, in the event that these stent(s) fail to establish sound frictional engagement with the blood vessel wall, the graft may undergo undesirable migration or slippage, or blood may leak into the anneurysmic sac (sometimes referred to as an “endoleak”).
Thus, in view of the above-mentioned undesirable complications associated with the use of radially expandable stents to frictionally anchor a graft or other apparatus to the wall of a blood vessel (or other luminal anatomical structure) there exists a need in the art for the development of new endoluminal suturing devices which may be used to suture the opposite ends of a endoluminal tub
Flaherty J. Christopher
Garibotto John Thomas
MacHold Timothy R.
Makower Joshua
Whitt Jason Brian
Buyan Robert D.
Jackson Gary
Stout, Uxa Buyan & Mullins, LLP
TransVascular, Inc.
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