Kit and devices for organ perfusion

Abstract

The present invention provides a kit for the delivery a therapeutic agent to an organ blood flow and the removal of the excess of said therapeutic agent from said organ blood flow, said kit comprises: (a) the therapeutic agent, (b) a first retrievable medical device (26), for delivering said therapeutic agent into the organ inflow, (c) a second retrievable medical device for isolating the organ outflow vessel and (d) a separation device (25) comprising at least one filter able to separate the therapeutic agent excess from the organ outflow, having an inlet (38) for the organ outflow having a therapeutic agent excess and an outlet (39) for filtered organ outflow.

Description

FIELD OF THE INVENTION[0001]The present invention generally relates to the field of medical treatment systems. More particularly, the present invention relates to system, devices, kits and methods to deliver a therapeutic agent and remove its excess during an interventional procedure.BACKGROUND[0002]Embolization, chemo-embolization and radio-embolization therapy are often clinically used to treat a range of diseases, such as hypervascular liver tumors, uterine fibroids, secondary cancer metastasis in the liver, pre-operative treatment of hypervascular menangiomas in the brain and bronchial artery embolization for hemoptysis. An embolizing agent may be embodied in different forms, such as beads, liquid, foam, or glue placed into an arterial vasculature or any combination thereof. The beads may be uncoated or coated. Where the beads are coated, the coating may be a chemotherapy agent, a radiation agent or other therapeutic agent. When it is desirable to embolize a small blood vessel, ...

AI Technical Summary

Benefits of technology

[0028]The present invention allows collecting blood from an organ outflow and filtering the collected blood from any therapeutic and / or embolizing agent. The filtering can be performed in the vessel itself or in an external separation device to which the collected blood is directed. After filtering, the blood is returned from the external filter to the organ blood flow or systemic blood flow. The kit of the present allows the delivery of high dose drug regime in a local, isolated, environment. The devices of the kit can be placed percutaneously, thereby reducing operative trauma and shortening the operation procedure and the hospital stay or completely avoids a hospital stay.

Problems solved by technology

A common issue with RE is extrahepatic embolization to the gastric artery or the lungs.

Non-targeted delivery of the embolic agent may have significant unwanted effects on the human body.

For example, in liver treatment, a number of microspheres can inadvertently reach other non-targeted organs in the body.

This has undesirable impacts on other organs including the stomach, the gall bladder, the pancreas and the small intestine and can cause inflammation of the gall bladder (cholecystitis), stomach (gastritis) or intestine (duodenitis).

In uterine fibroid treatment, the non-targeted delivery of the embolic agent may embolize one or both ovaries leading to loss of menstrual cycle, subtle ovarian damage that may reduce fertility, early onset of menopause and in some cases substantial damage to the ovaries.

Other unintended adverse events including pain and necrosis might appear.

These complications require additional medical treatment and might be lethal for the patient which is an enormous disadvantage of RE.

For colorectal cancer liver metastasis, at least 20% of the patients may not benefit from RE due to the presence of an intolerable shunt to the lung and up to 38% of the patients may require a reduced dose (which may require an additional, costly treatment).

The use of occlusion devices in this system is disadvantageous as the systemic blood flow is interrupted during the treatment, which may not be well tolerated by the patient and can cause hypovolemia.

Another drawback of the system of WO 2011 / 05618 is the use of balloon type devices to occlude the vena cava.

These types of devices are highly prone to leakages and migration / rotation.

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