Surgery – Instruments – Sutureless closure
Reexamination Certificate
2000-03-22
2002-05-28
Reip, David O. (Department: 3731)
Surgery
Instruments
Sutureless closure
C606S215000, C606S153000
Reexamination Certificate
active
06395015
ABSTRACT:
BACKGROUND OF THE INVENTION
The invention relates to a medical device for insertion into a blood vessel through an opening in the wall of said blood vessel, the device comprising a flexible sheet material having a length dimension and a width dimension, the sheet material being foldable in the width direction for placing the sheet material into an insertion configuration and the sheet material being unfoldable to assume a sealing configuration inside the blood vessel for a traumatically contacting the blood vessel wall in a sealing manners the sheet material in the sealing configuration extending along an open contour, partly covering the vessel wall, the device further comprising a gripping element on its outer surface.
From WO 90/14796, an occlusion assembly for sealing puncture openings in blood vessels is described. After puncturing a blood vessel with a needle and introducer sheath and subsequent withdrawal of the needle, the known occlusion device can be inserted into the vessel via the introducer sheath. The known occlusion device comprises a flexible sheet material which is attached to a retaining element such as a thread. In the blood vessel, it unfolds to have a surface area which is larger than the surface area of the puncture opening to be occluded. Subsequently the introducer sheath is removed out of the opening in the vessel and by pulling the retaining thread, the sheet material of the occlusion element will come to lie against the inside of the blood vessel wall. Thereafter, a retainer ring is placed around the thread and engages with the outer surface of the blood vessel for a fixed positioning of the occluding device. The flexible sheet, the thread and the retainer ring are made of bio-absorbable material such that it is ensured that after the opening in the blood vessel has been occluded, these parts will disappear, for example after a few weeks.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide a vascular surgery device and method which enables formation of a connection (anastomosis) between a bypass graft and a donor or recipient blood vessel with little or no interruption of the blood flow in the donor or recipient vessel. It is an object of the present invention to provide a vascular surgery device which can be used for instance in coronary bypass surgery, preferably on the beating hart, as well as in peripheral bypass surgery, cerebral bypass surgery and plastic and reconstructive vascular surgery. It is a further object of the present invention to provide a vascular surgery device which can be easily and effectively applied and retrieved with a minimum of trauma to the blood vessel and within a very short period of time, preferably within about one minute.
Thereto the medical device according to the present invention is characterised in that the flexible sheet material in an untensioned state is curved in the width direction. After completion of the anastomosis, the device according to the invention can be easily and reliably retrieved from the recipient vessel as the sheet material is predisposed by its flexibility and its pre-formed curvature to be folded in the width direction upon exertion of a pulling force on the gripping element, directed generally in the length direction of the device. Upon retrieval the sheet material is folded when it is contacted by the sides of the opening in the vessel wall.
The present invention provides an intravascular arteriotomy seal which can be easily inserted into and retrieved from a donor or recipient vessel. During insertion into a recipient artery, occlusion of the artery is required only for a brief moment or is not required at all when intravascular pressure is low. When the seal according to the invention is in place, the blood flow in the opened artery can be resumed and the distal end of the bypass graft can be grafted onto the opening of the recipient vessel without leakage of blood along the seal. Prior to completion of the bonding, such as by tightening (securing) the sutures which connect the bypass graft to the recipient vessel, the sheet material of the device according to the present invention can be withdrawn from the opening in the recipient vessel wherein the device will easily bend in the width direction by contact with the sides of the opening in the vessel wall, due to its flexibility and preformed curvature in the width direction. Thereafter, the sutures can be tightened and the grafting can be completed. With the device according to the present invention only a very short or no occlusion of the blood vessel upon insertion or retrieval is required. Once properly positioned, the seal according to the invention provides a bloodless arteriotomy for precise (microsurgical) anastomosis suturing without interfering with recipient artery blood flow, with minimal damage to the wall of the vessel and without blocking of any side branches in the vessel. The seal according to the invention will be particularly useful for coronary artery bypass grafting on the beating heart, such as for instance described in co-pending patent application WO 97/10753 in the name of the applicant. Because the sheet material of the seal according to the present invention has a preformed curvature in the width direction, the material will have a natural tendency to fold easily in the width direction. Hereby the device can be easily retrieved through the insertion opening by pulling, contrary to the prior art puncture hole occlusion device that is described in WO 97/14796, which is maintained in its unfolded position after insertion into a blood vessel.
Bypass Grafting
To provide adequate blood supply to an organ or tissue with impaired blood supply, the end of an extra vessel (bypass graft) is connected end-to-side or side-to-side to the recipient artery downstream of the obstruction in the recipient artery.
To establish this connection, i.e. the distal anastomosis, blood flow in the recipient artery is interrupted by, for example, temporary ligation or clamping of the artery proximal and distal of the connection site. Once the blood flow is interrupted, the recipient artery is opened (arteriotomy). Next, the exit (distal end) of the bypass graft is connected by suturing (or other bonding method) to the recipient artery. This is achieved by suturing the inside of the bypass graft to the inside of the recipient artery. The rationale of this precise anastomosis suturing is that the inner lining of the vessels (the endothelial layer) is anti-thrombogenic, whereas the outer layer is highly thrombogenic. Thrombosis at the transition of donor to recipient vessel reduces the cross-sectional area of the lumen at the anastomosis and hence jeopardizes the quality of the distal anastomosis. Narrowing (stenosis) of the anastomosis limits the maximum blood flow through the bypass graft.
In a proximal anastomosis, the entrance (proximal end) of the bypass graft needs to be connected to an artery which serves as pressure source of oxygenated blood. If a natural artery can serve as bypass graft, like e.g. the internal mammary artery in coronary artery bypass grafting, only the distal anastomosis needs to be made. Sometimes, however, the internal mammary artery is used as free graft or the radial artery is used as arterial conduit and a proximal anastomosis has to be made. Venous bypass grafts always require a proximal anastomosis, because their transformation to an arterial conduit requires connection to a source of arterial blood. Similar to suturing the distal anastomosis of the bypass graft, suturing the proximal anastomosis requires interruption of the source blood flow in the vicinity of the proximal anastomosis site.
Interruption of Blood Flow in Vascular Surgery: Adverse Effects
Currently, all vascular surgery is performed during interrupted blood flow in the vicinity of the anastomosis, because suturing (or otherwise bonding the vessel edges) requires a bloodless surgical field for proper exposure of the vessel edges. The bloodless field, however, is obtained at a price.
Temporary interruption of blood fl
Borst Cornelius
Grundeman Paul Frederik
Heijmen Robin Henricus
Heikens Martijn
Mansvelt Beck Henricus Jacobus
Medtronic Inc.
Reip David O.
Woo Julian W.
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