Catheter Introducer – Novel peel-away sheath introducer set (PASIS) with integrated sealing system
The introduction of a device (e.g. a catheter) into a vessel of the human or animal body to accomplish a medical procedure is accompanied with some fundamental problems. The device must be inserted through a puncture site in the vessel wall into the lumen of the vessel what causes bleeding and maybe wall trauma. To minimize this risks sheath introducers and hemostatic agents are used. Despite these approaches the problems havn´t been fully solved yet and a reliable, safe and easy to use device and method are still needed.
The invention presented here overcomes the limitations of the prior art and provides a catheter introducing system by means of which bleeding can be prevented and wall trauma can be minimized. The innovative device combines a peel-away sheath introducer set with a splittable hemostasis valve and an integrated sealing system. The new peel-away introducer set is composed of three coaxial arranged peelable cannulae: an access cannula, a pusher and a sealing cannula. The pusher and the sealing cannula are mounted on the access cannula in a movable manner. A collagen cuff is integrated into the sealing cannula in such a way that the collagen can be positioned by the pusher at the puncture site where the collagen acts as a surgical sealant. This system allows an effective sealing of the puncture wound after removal of the access cannula. In addition, the introducer set contains a splittable hemostasis valve to prevent reflux of liquid (e.g. blood) from the punctured vessel during the implantation procedure. The present invention could be used for procedures where a device has to be introduced into a vessel of the human or animal body. As an example the sheath introducer can be applied to establish a fully implantable and telemetrically controlled blood pressure system comprising an implant with a sensor and a telemetry unit which is connected via micro-cable with the sensor.
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