Device for delivering medical treatment
A medical device for the delivery of treatment fluid to body vessels is described. The device has a distal ( 21 ) and a proximal ( 20 ) end with a self-expanding, hollow tubular member ( 9 ) and a delivery catheter ( 10 ) suitable for deploying a self-expanding, tubular member ( 9 ). The tubular member ( 9 ) is configured to expand radially to form a central part ( 11 ) flanked by two annular ridges, which creates, in situ, an annular lumen that can apply treatment fluid locally to a vessel and a passageway that can maintain the flow of blood through the vessel. The device is particularly suited for minimally invasive and repeatable organ perfusion. A method for organ perfusion is also disclosed.
1. A retrievable medical device for the delivery of medical treatment fluid to body vessels, having a distal and a proximal end, comprising a self-expanding, hollow tubular member and a delivery catheter suitable for deploying a self-expanding tubular member, wherein:
the tubular member comprises a liner made from liquid-impermeable material and a liquid permeable carrier made of braided wire mesh,
the tubular member is configured to expand radially to form a central part flanked by two annular ridges—a distal annular ridge and a proximal annular ridge, which central part is adapted to form an annular lumen in the vessel, said tubular member has a dumbbell or hourglass shape in the expanded condition in which the central part radially expands to a lesser degree compared to the annular ridges,
the tubular member comprises a liquid-impermeable area, defined at least by the region flanked by the annular ridges,
the tubular member comprises two liquid-permeable regions, one distal to the distal annular ridge and one proximal to the proximal annular ridge, so forming a passageway between the distal end and the proximal end of the tubular member for the flow of fluid,
the proximal end of the tubular member is attached to the distal end of the delivery catheter,
the proximal end is closed but is disposed with a liquid-permeable region devoid of the liner,
the distal end of the tubular member is open-mouthed,
a wall of the tubular member, in the liquid-impermeable area is disposed with one or more fluid ports for the passage of treatment fluid, and
the catheter comprises an inner tube, an outer tube surrounding at least a portion of the length of the inner tube, and a pusher means for deployment of the tubular member, wherein said inner tube is in fluid connection with the one or more fluid ports.
2. Medical device according to claim 1 , wherein
the liquid-permeable carrier is configured to adopt an essentially cylindrical state when compressed, and to self-expand radially to form a central part flanked by two annular ridges,
the liner is attached to the wall of the tubular member, which provides the liquid impermeable area.
3. Medical device according to claim 2 , wherein the carrier is made from a surgical wire that is: an alloy comprising Cobalt, Chromium, Nickel, Molybdenum and Iron, or nitinol, or a surgical wire in accordance to the standard ASTM F 1058.
4. Medical device according to claim 2 , wherein the carrier is laser cut.
5. Medical device according to claim 2 , wherein the carrier is made from any of polycarbonate polyurethane formulation, polytetrafluoroethylene, polyurethane, silicone or polyethylene terephthalate polymer.
6. Medical device according to claim 1 , wherein the pusher means being:
a pusher rod disposed between the inner tube and the outer tube, or
formed from the wall of the inner tube,
the pusher means being adapted for axial movement relative to the outer tube, and
the proximal end of the tubular member being attached to the distal end of the pusher means, and disposed within the outer tube in the compressed state.
7. Medical device according to claim 1 , wherein the inner tube is configured for the passage of treatment fluid.
8. Medical device according to claim 1 , wherein the inner tube is further configured to receive a guidewire.
9. Medical device according to claim 1 , wherein the inner tube of the catheter is in fluid connection with the one or more ports, using a bridging tubing.
10. Medical device according to claim 1 , wherein the tubular member is configured to create a fluid impermeable annular cavity between said device and the inner wall of the vessel.
11. Medical device according to claim 1 , wherein the proximal end of the tubular member is non-releasably attached to the distal end of the delivery catheter.
12. A kit comprising:
a device as defined in claim 1 , and one of more of the following:
an occlusion device for the hepatic artery, optionally with perfusion capacity,
an occlusion device, with options for perfusion and shunting,
one or more perfusion lines,
one or more perfusion lines in fluid connection with a means for drawing medicament or perfusion fluid into a perfusion circuit, and
one or more perfusion lines in fluid connection with at least one connector for drawing medicament or perfusion fluid into a perfusion circuit, said connector being specific to a particular medicine container.
13. A method for minimal invasive and repeatable organ perfusion of a living being comprising positioning the device of claim 1 into the inferior vena cava, thereby:
a. blocking the flow path of blood in the inferior vena cava;
b. providing a flow path for the blood through the passageway of the device;
c. creating an isolated cavity between the medical device and the wall of the vena cava, which is in contact with the liver by the hepatic veins; and
d. delivering the perfusion fluid to or from this cavity by means of the delivery catheter.
14. The method according to claim 13 , further comprising the step of withdrawing the device after perfusion.