Methods and systems for delivering substances into luminal walls

• US 20060259005A1
• Filed: 04/26/2006
• Published: 11/16/2006
• Est. Priority Date: 05/11/2005
• Status: Active Grant

• Current Assignee: Spectranetics Corporation (Koninklijke Philips N.V.)
• Original Assignee: Angioscore Incorporated (Koninklijke Philips N.V.)
• Inventors: Konstantino, Michal, Konstantino, Eitan
• Granted Patent: US 10,076,641 B2
• Time in Patent Office: Days
• US Class Current: 604/500
• CPC Class Codes: A61B 17/22032 having inflatable gripping elements balloon catheters A61M25/10
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61K 31/337 having four-membered rings, e.g. taxol
• CPC Class Codes: A61L 2300/00 Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2420/06 Coatings containing a mixture of two or more compounds
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 5/00 Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests vaccination appliances for veterinary use A61D1/025 ; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00; combinations of vial and syringe for mixing or transferring their contents A61J1/20; holders for containers for collecting, storing or administering blood or medical fluids A61J1/16
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Abstract

Angioplasty and other dilatation devices are provided with scoring elements which incorporate a drug to be delivered to a body lumen, typically a blood vessel. The scoring elements have drugs and other active substances coated over a portion thereof or incorporated within internal structure of the element so that the drug is released into the luminal wall closely associated diseased regions of the body lumen as the scoring structure is radially expanded into the wall.

Claims

1. A method for delivering an active substance to a luminal site, said method comprising:

positioning a scoring element within a body lumen; and

advancing the scoring element to score or cut a wall of the body lumen,

wherein the scoring element comprises the active substance.

2. A method as in claim 1, wherein the body lumen is a blood vessel, a vein graft, a synthetic graft, or a lumen in the respiratory, urinary, reproductive or digestive systems.

3. A method as in claim 2, wherein the body lumen is a blood vessel

4. A method as in claim 3, wherein the luminal site is at least partly occluded with thrombus.

5. A method as in claim 3, wherein the luminal site is at least partly occluded with plaque or with hardened plaque.

6. A method as in claim 1, wherein positioning comprises intraluminally positioning a catheter which carries one or more scoring elements.

7. A method as in claim 6, wherein the catheter is positioned over a guide wire.

8. A method as in claim 1, wherein the advancing comprises radially advancing the scoring element.

9. A method as in claim 8, wherein the scoring element(s) is(are) elongate.

10. A method as in claim 8, wherein the elongate scoring element has a helical geometry.

11. A method as in claim 1, wherein radially advancing comprises expanding and expandable shell which carries at least one scoring element.

12. A method as in claim 11, wherein expanding the expandable shell comprises inflating an inflatable structure.

13. A method as in claim 1, wherein the active substance comprises one or more of an antiproliferative agent, an antimitotic agent, an antiplatelet agent, an alkylating agent, an antimetabolite, a platinum coordination complex, a hormone, an anticoagulant, a fibrinolytic agent, an antimigratory agent, an antisecretory agent, an anti-inflammatory agent, indole and acetic acids, an immunosuppressive agent, an angiogenic agent, an angiotensin receptor blocker, a nitric oxide donor, an anti-sense olignucleotide, a cell cycle inhibitor, a retinoid, a cyclin/CDK inhibitor, an HMG co-enzyme reductase inhibitor, and a protease inhibitor.

14. A catheter comprising a catheter body having a proximal end and a distal end;

a scoring element disposed near the distal end of the catheter body;

wherein the scoring element comprises an active substance that is delivered to a luminal wall scored by the scoring element.

15. A catheter as in claim 14, wherein the active substance is coated over at least a portion of an exposed surface of the scoring element.

16. A catheter as in claim 15, wherein the active substance is incorporated in a polymeric carrier.

17. A catheter as in claim 16, wherein the polymeric carrier is resorbable in a vascular environment.

18. A catheter as in claim 16, wherein the polymeric carrier is non-resorbable in a vascular environment.

19. A catheter as in claim 14, wherein the active substance is coated without a polymeric carrier.

20. A catheter as in claim 14, wherein the active substance is carried in holes or wells formed in the scoring element.

21. A catheter as in claim 14, wherein the scoring element(s) is(are) generally linear and axially aligned over an expandable shell.

22. A catheter as in claim 14, wherein the scoring elements are formed as a resilient cage which is disposed over an expandable shell.

23. A catheter as in claim 22, wherein the cage has a resilient structure which expands with the shell and collapses over the shell.

24. A catheter as in claim 23, wherein the cage comprises at least one helical scoring element.

25. A method as in claim 14, wherein the active substance comprises one or more of an antiproliferative agent, an antimitotic agent, an antiplatelet agent, an alkylating agent, an antimetabolite, a platinum coordination complex, a hormone, an anticoagulant, a fibrinolytic agent, an antimigratory agent, an antisecretory agent, an anti-inflammatory agent, indole and acetic acids, an immunosuppressive agent, an angiogenic agent, an angiotensin receptor blocker, a nitric oxide donor, an anti-sense olignucleotide, a cell cycle inhibitor, a retinoid, a cyclin/CDK inhibitor, an HMG co-enzyme reductase inhibitor, and a protease inhibitor.

26. A method as in claim 14, wherein the drug is incorporated within hydrogel and the release of the drug is enhanced by the swelling of the hydrogel.

27. A method with claim 14, wherein the active substance is hydrophobic drug.