Dilation catheter with an inflatable balloon

Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...

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Details

606194, A61M 2510

Patent

active

050025317

DESCRIPTION:

BRIEF SUMMARY
The invention concerns a dilation catheter with an inflatable balloon which along a guide wire can be advanced into a constricted coronary artery and is connected with an inflating, tubular body through which a medium can be forced into the interior of the balloon for inflating it.
Such a dilation catheter is previously known from the German patent disclosure 34 42 736 and serves specifically the widening of constrictions in coronary arteries. For that purpose, a guide catheter with a wide interior lumen is advanced from the groin or the angle of the elbow of a patient through the large body arteries up to shortly before the exit of the coronary arteries in the aortic arch, with a radiological presentation of the coronary artery and the constriction being made under x-ray with intermittent administration of a contrast agent through the guide catheter. For guidance of the dilation catheter to be inserted, a fine guide wire with a soft point is advanced through the guide catheter into the coronary artery beyond the constriction. A control of the guide wire is possible through rotation, with a variably bent point.
The dilation catheter is in a next step advanced from outside, by way of a guide wire which serves as a guide rail, and through the guide catheter until the balloon of the dilation catheter lies in the constriction. The dilation then takes place through a one-time or repeated inflation of the balloon at a pressure of about 500 to 1200 kPa. Clinical experience has shown that longer dilation times are more favorable than shorter dilation times for stabilization of the expanded arterial constriction. During dilation, however, the flow of blood is interrupted in the artery when using the known dilation catheter, which interruption of the blood flow in the hard muscle should not exceed 30 to 120 seconds.
As the constriction in the coronary artery is widened under the pressure of the balloon, the laminar structure of the arterial wall might be damaged, leading to complications. These consist in an occlusion of the artery after dilation, by separation and prolapse of the inner wall layers and, in rare cases, a wall rupture with bleeding. If one of the above complications with arterial occlusion occurs after dilation and removal of the balloon, such results in individual cases in an immediate surgical intervention and an increased risk for the patient. Therefore, dilations of larger coronary arteries are performed under acute surgical readiness, whereby the organizational expense and the cost of an operation using a dilation catheter are increased considerably.
Another disadvantage of the prior dilation catheters is that during the dilation process the blood supply in the artery is interrupted, which leads to an insufficient perfusion of the adjacent tissue. Basing on this prior art, the problem underlying the invention is to provide a dilation catheter which makes it possible to assure during dilation and in the case of a complication a sufficient and continuous blood flow for a sufficient period of time so as to enable a prolongation of the dilation time.
This problem is inventionally solved in that the balloon features a tubular outer skin and, connected with it at least on the edges pointing in the axial direction, a tubular inner balloon skin between which a cross-sectionally essentially annular balloon interior is formed which is connected with the inflating tubular body and which surrounds a central lumen which in axial direction is open on both ends.
Due to the fact that the balloon interior forms an arrangement of annular swell bodies with a central lumen, the blood flow in the artery is not interrupted during dilation when using the inventional dilation catheter, so that the dilation time can be considerably prolonged. In this way it is possible to achieve a better stabilization of the wall and, in the case of a complication, prolong the period of time up to the surgical intervention, or even omit a surgical intervention, after stabilization of the arterial wall.
In a suitable embodiment of the in

REFERENCES:
patent: 3731692 (1973-05-01), Goodyear
patent: 3833004 (1974-09-01), Vazquez
patent: 4141364 (1979-02-01), Schultze
patent: 4183102 (1980-01-01), Guiset
patent: 4198981 (1980-04-01), Sinnreich
patent: 4403612 (1983-09-01), Fogarty
patent: 4585000 (1986-04-01), Hershenson
patent: 4762129 (1988-08-01), Bonzel

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