Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Arterial prosthesis – Including valve
Reexamination Certificate
1997-12-17
2001-09-11
Nguyen, Dinh X. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Arterial prosthesis
Including valve
C623S023640, C623S023680, C623S023700, C128S898000
Reexamination Certificate
active
06287334
ABSTRACT:
This application claims priority to Dutch Patent Application Number 1004827, filed Dec. 18, 1996.
The present invention relates to a device for regulating the flow of blood in blood vessels.
The blood system, and in particular the venal blood system of the legs and arms are provided with valves, at predetermined positions, which ensure that blood cannot flow back along the system in the direction from which it has just been pumped, to only be displaced in the direction of the heart.
In the arms and legs, there is a deep and a surface venal system.
Due to various causes, thrombosis can occur in especially the deep venal system. Following thinning of the blood, passage of the blood through the system is often again possible, but in this case the valves do not effectively close off the system and often leak. This causes an increased venal blood pressure in the direction of the ankles, which leads to many problems, such as varicose veins and the infamous “open leg”. This type of complaint, is wide spread among people who spend a vast majority of their working hours in a standing position, for instance surgeons.
The surface venal system of the leg is weaker than the deep system, and has the tendency to spontaneously widen, whereby the valves no longer function effectively, leading to varicose veins, which, apart from being highly unattractive, are also very painful. Major surgery is often required to deal with these blood vessel valve problems.
For example varicose veins are presently surgically operated on, by either closing off the vein, which leads to a reduced blood flow capacity and extra pressure on surrounding blood vessels in order to ensure blood supply, or by completely removing the varicose veins, which leads to the same problem.
An object of the present invention is to obviate one or more of these problems.
According to a first aspect, the present invention provides a device for regulating the flow of blood in blood vessels, comprising one or more flow stoppage elements, each comprising:
a flareable proximal end, flareable between a flared, flow stoppage configuration and a substantially flattened, flow permitting configuration, and
a middle section extending from the proximal end to terminate in a distal end.
By introducing a synthetic device which acts as a valve, the blood flow is now able to be regulated in substantially the normal manner.
The device preferably further comprises:
an opening associated with the proximal end, the middle section comprising one or more sidewalls extending from this proximal end opening to join together at the distal end, the sidewalls being displaceable, by the flow of blood through the device between the flared configuration, wherein the element encloses a temporary blood storage area, and the substantially flattened configuration wherein the one or more sidewalls lie substantially flat adjacent to each other.
When occupying the blood flow stoppage configuration, the flow stoppage element encloses a temporary blood storage area between its open proximal end and the closed distal end. In this way between heartbeats, which force the blood through the venal system, any blood flowing in the opposite direction to the blood stream opens the proximal end of the stoppage element thereby forcing the sidewalls apart to enter the temporary blood storage area, instead of passing through the device to leak back into the blood vessel in the direction from where it has just been pumped. Since opening of the blood flow stoppage element effectively closes off the blood vessel, a very effective valve is provided.
The flow stoppage element is preferably mounted on a support having such a form as to pass within a blood vessel. This provides extra stability.
Further, the support frame comprises a resilient wire and is biased toward an unrolled configuration.
The stoppage element is preferably substantially conical in shape when occupying the blood flow stoppage configuration, the closed distal end being synonymous with the tip of the cone and the proximal end opening being synonymous with the flared base of the cone. This yields a highly effective valve working.
The support is preferably adjustable between an introducing form, wherein the device is suitable for introducing into a blood vessel, and an expanded form suitable for supporting the stoppage element within a blood vessel at the desired working location thereof, and most preferably has such a form as to have substantially the same length when occupying its introducing form as when occupying its expanded form. Accordingly the device can be effectively introduced to a pre-desired location within a blood vessel, whereafter it is expandable to take up its working form. Since the support has substantially the same length when in its introducing form as in its expanded form, the stoppage elements remain effectively supported, and any damage ensuing from alteration of the length of the support within the blood system is effectively obviated.
In order to yield a very effective valve working, the support preferably comprises substantially separate frame sections for each of the one or more fluid passage stoppage elements.
According to another aspect of the present invention, there is provided a support for a fluid stoppage element as referred to above.
According to yet a further aspect of the resent invention there is provided a method for regulating the flow of blood in the blood stream comprising introducing the above device into a blood vessel, so that the distal end thereof is arranged downstream from the proximal end, wherein the proximal end opening is closed by the pressure of blood flowing through the device, as blood is pumped through the system by the heart, wherein blood flowing in the opposite direction to which it is pumped between beats, flows into the proximal end of the device, which is subsequently thereby opened to force the sidewalls of the device against the blood vessel walls, thereby closing off the passage of blood in the blood vessel, wherein blood is trapped in the temporary blood storage area enclosed by the sidewalls of the device before a subsequent volume of blood being pumped through the device claps said sidewalls shut, thereby expelling blood out of the temporary storage area and further through the system.
The introducer preferably comprises an elongated sliding member which is advanceable by a physician to forcibly displace the valve prosthesis from the hollow distal portion of said introducer into the blood vessel
The present invention will now be further clarified by way of the following specific description, which refers to
FIGS. 1
to
7
, wherein:
FIG. 1
is a perspective view of the device according to the present invention;
FIG. 2
is a side view of a support for a flow stoppage element according to the present invention,
FIG. 3
is a perspective view of the device from
FIG. 1
, when occupying its introducing form, as to be introducible into a blood vessel;
FIG. 4
is a perspective view showing the introduction of a device as shown in
FIG. 1
into a blood vessel;
FIG. 5
is a perspective view as in
FIG. 4
, showing the device when occupying its blood flow through put position;
FIG. 6
shows the device from
FIG. 1
, with the support (not shown) in order to provide maximum clarity, when occupying its blood flow stoppage position within a blood vessel; and
FIG. 7
is a perspective view of two devices as shown in
FIG. 1
, when placed in a vein in the leg.
REFERENCES:
patent: 4291420 (1981-09-01), Reul
patent: 4787901 (1988-11-01), Baykut
patent: 5141491 (1992-08-01), Bowald
patent: 5327774 (1994-07-01), Nguyen et al.
patent: 5332402 (1994-07-01), Teitelbaum
patent: 5411552 (1995-05-01), Andersen et al.
patent: 5480423 (1996-01-01), Ravenscroft et al.
patent: 5713953 (1998-02-01), Vallana et al.
patent: 5735859 (1998-04-01), Fischell et al.
patent: 5741326 (1998-04-01), Solovay
patent: 5741333 (1998-04-01), Frid
patent: 5800506 (1998-09-01), Perouse
patent: 5824061 (1998-10-01), Quijano et al.
patent: 1932817 (1970-01-01), None
patent: 19532846 (1997-03-01), None
Kalmann Menno
Moll Franciscus Laurens
Knobbe Martens Olson & Bear LLP
Nguyen Dinh X.
VenPro Corporation
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