Surgery – Instruments – Surgical mesh – connector – clip – clamp or band
Reexamination Certificate
2001-04-23
2003-02-25
Huson, Gregory (Department: 3751)
Surgery
Instruments
Surgical mesh, connector, clip, clamp or band
Reexamination Certificate
active
06524322
ABSTRACT:
The present invention relates to an anastomotic device for joining a graft vessel to a target vessel at a connection opening present therein.
Anastomoses can in the general sense be subdivided into three types: so-called “end-to-side anastomoses” (abbreviated as ETS anastomoses), so-called “side-to-side anastomoses” (abbreviated as STS anastomoses) and so-called “end-to-end anastomoses” (abbreviated as ETE anastomoses). The anastomotic device according to the invention can be used with any of these three types of anastomoses. An ETS anastomotic is understood to be an anastomotic where one end of one vessel, the graft vessel, is joined to an opening formed in the wall of another vessel, the target vessel. A sort of T-join is thus produced. An STS anastomotic is understood to be an anastomotic where the two vessels to be joined each have an opening formed in their wall, which openings are joined to one another. A so-called ETE anastomotic is understood to be an anastomotic where t-o vessels are joined to one another by joining two vessel ends to one another. This is, as it were, a continuous join where the vessels are located in the extension of one another, for example straight or obliquely at an angle with respect to one another.
According to the invention, the connection opening can thus be either a side opening made in the wall of the target vessel in the case of an ETS or STS anastomotic or an end opening in the case of an ETE anastomotic. The end opening will then be determined by the cutting plane along which the target vessel has been cut through at its end.
According to the invention, the graft vessel and target vessel in this context are in particular blood vessels, but they can also be other hollow tubular organs, such as the urethra, Fallopian tubes, etc. Within the framework of the present invention, the terms graft vessel and target vessel are used as distinguishing terms which serve to distinguish between a first vessel (the graft vessel) and a second vessel (the target vessel). The terms graft vessel and target vessel are thus in no way intended to restrict the invention. Throughout this entire application the terms target vessel and graft vessel can in many cases be interchanged without going beyond the scope of the invention.
Graft vessels which are used in practice and can also be used according to the invention are, inter alia:
the vena saphena magna, which is usually completely detached as a free graft (transplant), but in peripheral vascular surgery is also left in the anatomical position as a so-called in situ graft and joined to neighbouring leg arteries;
the vena saphena parva, which is usually used for transplant purposes and to this end is completely detached;
veins from the arms, which are usually used for transplant purposes;
the arteria thoracica interna, which is usually detached only caudally and is sometimes used as a free graft;
the arteria radialis from the arm, which is used as a free graft;
the arteria gastro-epiploica dextra, which usually is detached only caudally on the spleen side (transponate) and sometimes is used as a free graft;
arteria epigastrica inferior, which in general is used as a free graft;
vessel prostheses made of plastic;
veins or arteries of animal or human material, which in general are stored in the frozen state.
An anastomotic device according to the invention can, for example, be used when making a by-pass in the case of, for example, a blocked coronary artery of the heart. By-pass operations of this type are carried out on a large scale and to date the graft vessel has been attached to the target vessel entirely by hand. In this case in general an opening is made in the aorta wall, where one end of the graft vessel is attached to the edges of the opening by stitching by hand. This join is termed the proximal anastomotic with the aorta. The other end of the graft vessel is joined by hand to the coronary artery beyond the blockage in a corresponding manner by means of suturing. The latter join is also termed the distal anastomotic with the coronary artery. An experienced surgeon is able to complete one anastomotic by suturing in approximately 10 minutes.
Most by-pass operations are also performed using a heart-lung machine, the heart then being temporarily stopped. Since stopping the heart in this way can not only be harmful for the heart itself (after all, the heart no longer has a blood supply) but also for other organs and bodily functions it is important that the time for which the heart is stopped is as short as possible. According to a recent development attempts are being made to perform an increasing number of operations on the beating heart, that is to say without heart-lung machine and without stopping the heart. The reason for this is that operations on the beating heart should be less harmful to the heart and other organs and are much less expensive. In the case of such by-pass operations on the beating heart, the bloodstream is temporarily interrupted at the location of a coronary artery to be by-passed. Also in the case of such a by-pass operation on the beating heart it is extremely important that the interruption to the bloodstream lasts for as short a time as possible, since otherwise a cardiac infarction can occur at this site. An ancillary problem in the case of by-pass operations on a beating heart is that the heart usually has to be lifted in order to be able to reach coronary arteries at the side and bottom of the heart, which in general is poorly tolerated by the heart and can lead to a fall in blood pressure or stoppage of the heart. An anastomotic which can be completed rapidly would make such an operation much more possible.
In addition to the recent development for performing an increasing number of heart operations, such as by-pass operations, on the beating heart, there is also an increasing number of operations which are performed via a small access route or thoracoscopically, there then being little or no possibility for suturing by hand. The aim of the present invention is to provide an aid with which joining of a graft vessel onto a target vessel can be completed in a reliable and reproducible manner, efficiently and with minimum stress on the patient. Said aim is achieved by the provision of accessories with which the conventional, relatively labour-intensive, lengthy and, as far as the result is concerned, less predictable suturing carried out by the surgeon on the body of the patient can be avoided or at least restricted to a minimum.
WO 96/25886, which discloses an anastomotic device of the type mentioned at the beginning, proposes a large number of diverse accessories for the same purpose. The starting point here is the philosophy that there must be no contact between the blood and foreign materials, the corollary of which is the aim to shield all accessories as far as possible by vascular wall material towards the interior of the vessels. However, the measures taken for this purpose—i.e. covering all or as many as possible internal, foreign parts with the aid of the wall of the graft vessel—result in a decrease/constriction in the flow aperture available for blood.
The accessories from WO 96/25886 each also have numerous other disadvantages. In many cases the graft vessel has to be stretched, which is possible to only a limited extent or is not possible or is possible only by constricting the graft vessel in another location. Furthermore, with many accessories the wall of the target vessel is punctured by so-called staples. These staples can be driven through the wall of the target vessel from the outside to the inside or driven through the wall of the graft vessel from the inside to the outside by folding arms outwards. Instruments for bending the staples are needed for driving the staples through the wall, both from the inside to the outside and from the outside to the inside. The requisite forces are exerted during this operation, inter alia on the target vessel. When a staple has to be driven through the wall from the outside to the inside in the case of a calcified diseased
Handal & Morofsky
Huson Gregory
Kontos Lina
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