1. A method of treatment of the human or non-human body to combat an inflammatory disease, autoimmune disease or tissue rejection, wherein said method comprises administering to said body a compound of formula I.
wherein Ar1 and Ar2 are phenyl optionally substituted with hydroxy, thiol, C1-C6 alkoxy, cyano or halo and R2 is H or C1-C10 alkyl, provided that the relative weight ratio of any 3,5-pyrazoladine dione not having a 4-hydroxy group (impurity) to said compound of formula I is not more than 50 parts impunity to 50 parts formula I.
2. A method as claimed in claim 1 wherein said disease is selected from Addison’s disease, Bechet’s syndrome, diabetes mellitus, haemolytic anasmia, lupus erythematosus, multiple sclerosis, myasthenia gravis, pernicious anaemia, polyglandular deficiency, polymyositis, dermatomyositis, testicular failure, thrombocytopenic purpura, Crohns disease, ulcerative colitis and rheumatoid arthritis.
3. A method as claimed in claim 2 wherein said disease is diabetes mellitus or rheumatoid arthritis.
4. A method as claimed in claim 1 wherein Ar1 is phenyl, Ar2 is p-hydroxy phenyl, and R2 is C4H9.
5. A method as claimed in claim 1 wherein said relative weight ratio of any 3,5-pyrazoladine dione not having a 4-hydroxy group to said compound of formula I is not more than 10 parts impurity to 90 parts formula I.
The claims below are in addition to those above.
All refrences to claim(s) which appear below refer to the numbering after this setence.
1. A medical product, comprising:
a stentless valve having a plurality of membranes free from any separate support frame, the plurality of membranes implantable in a body lumen in the absence of a stent and thereupon movable between a first position and a second position, wherein the membranes are movable in response to fluid flow through the lumen; and
an endoluminally advanceable delivery device having an expandable member upon which said stentless valve is mounted, the expandable member configured for expansion in the lumen for forcing the valve against the wall of the lumen for delivery of the valve.
2. The medical product of claim 1, wherein said membranes are configured to flex in response to fluid flow in the body lumen.
3. The medical product of claim 1, wherein said membranes are configured to invert their shape in response to fluid flow in the body lumen.
4. The medical product of claim 3, wherein said inversion in shape is relative to the radial axis of the body lumen.
5. The medical product of claim 1, wherein the membranes are formed of a polymer.
6. The medical product of claim 5, wherein the polymer is polytetrafluoroethylene.
7. The medical product of claim 5, wherein the membranes are formed of Dacron.
8. The medical product of claim 1, wherein the membranes are formed of a collagenous material.
9. The medical product of claim 1, comprising two membranes.
10. The medical product of claim 1, wherein the membranes are generally triangular in shape.
11. The medical product of claim 1, wherein the valve lacks radial expandability sufficient to anchor itself to the wall of the body lumen.
12. The medical product of claim 1, wherein the expandable member is a balloon.
13. The medical product of claim 1 also comprising one or more barbs attached to the stentless valve for embedding in a wall of the body lumen.
14. A method of treating a patient, comprising:
delivering a medical product to a body lumen, the product including a stentless valve and further a catheter having an expandable member upon which the stentless valve is mounted, the stentless valve having a plurality of membranes free from any separate support frame, the plurality of membranes implantable in the body lumen in the absence of a stent and thereupon movable between a first position and a second position, wherein the membranes are movable in response to fluid flow through the lumen;
expanding the expandable member in the body lumen so as to force the valve against a wall of the body lumen; and
removing the catheter from the body lumen such that the valve remains anchored in the body lumen in the absence of a stent.
15. The method of claim 14, wherein the expandable member is a balloon.
16. The method of claim 14, wherein the anchored valve includes one or more barbs extending into a wall of the body lumen.
17. A medical product, comprising:
a balloon catheter;
a stentless valve removably mounted on the balloon catheter for percutaneous introduction into a body lumen of a patient, the valve comprising one or more leaflets and lacking radial expandability sufficient to anchor itself to the wall of the body lumen; and
one or more barbs attached to the stentless valve, wherein the balloon catheter is configured to expand in the body lumen to force the stentless valve against the wall of the lumen such that the one or more barbs become embedded in the wall to anchor the valve in the body lumen in the absence of a stent.
18. A method of controlling flow in a body lumen, the method comprising:
forcing a membrane of a stentless valve against a wall of a body lumen with a balloon such that a barb attached to the membrane extends into the wall and anchors the membrane in the body lumen in the absence of a stent, wherein the anchored membrane is thereupon moveable between a first position and a second position in response to the direction of fluid flow through the lumen, wherein said membrane in said first position restricts fluid flow through the lumen in a first direction alone or in combination with one or more additional membranes, and wherein said membrane in said second position permits fluid flow through the lumen in the first direction alone or in combination with one or more additional membranes.
19. The method of claim 18, wherein the membrane in said second position and a portion of the body lumen form a cup for trapping the fluid.
20. The method of claim 18, comprising forcing a plurality of membranes of a stentless valve against a wall of a body lumen with a balloon such that one or more barbs attached to the plurality of membranes extends into the wall and anchors the plurality of membranes in the body lumen in the absence of a stent, wherein the anchored membranes are thereupon movable between a first position and a second position in response to the direction of fluid flow through the lumen, wherein said membranes in said first position restrict fluid flow through the lumen in a first direction, and wherein said membranes in said second position permit fluid flow through the lumen in the first direction.
21. A method of controlling flow in a body lumen, the method comprising:
moving a membrane of a valve between a first position and a second position in response to the direction of fluid flow through the lumen, wherein the valve is percutaneously implanted in the body lumen and is free from any separate support frame, wherein said membrane in said first position restricts fluid flow through the lumen in a first direction alone or in combination with one or more additional leaflets, and wherein said membrane in said second position permits fluid flow through the lumen in the first direction alone or in combination with one or more additional leaflets.
22. A method for treating a patient comprising:
providing a percutaneously implanted valve anchored in a body lumen of the patient in the absence of a stent, the percutaneously implanted valve comprising one or more leaflets and lacking radial expandability sufficient to anchor itself to the wall of the body lumen.
23. The method of claim 22, wherein the valve is anchored in the body lumen by barbs extending into the vessel wall.
24. The method of claim 22, wherein the valve lacks any separate support frame.
25. The method of claim 22, wherein the valve comprises a frame integral with said leaflets.
26. The method of claim 22, wherein said valve lacks any separate support frame and said leaflets include edge portions incorporating one or more materials or agents that increase the stiffness or resiliency of the edge portions.