Methods and systems for delivering substances into luminal walls

• US 9,586,031 B2
• Filed: 03/15/2013
• Issued: 03/07/2017
• Est. Priority Date: 05/11/2005
• Status: Active Grant

• Current Assignee: Spectranetics LLC (Koninklijke Philips N.V.)
• Original Assignee: Angioscore Incorporated (Koninklijke Philips N.V.)
• Inventors: Konstantino, Eitan, Konstantino, Michal
• Primary Examiner(s): Nguyen, Victor
• Application Number:
  US13/842,080
• Publication Number:
  US 20130226071A1
• Time in Patent Office: 1,453 Days
• Field of Search: 606/108, 606/159, 606/194, 606/198, 623/1.11
• US Class Current: 1/1
• 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 catheter for delivering substances to a luminal wall comprising:

a catheter body having a proximal end and a distal end;

an expandable shell;

a scoring structure having a proximal end and a distal end, comprising at least one scoring element disposed near the distal end of the catheter body and over the expandable shell, wherein one of the proximal end and the distal end of the scoring structure is axially slidable relative to the expandable shell; and

an active substance carried by the at least one scoring element, wherein the active substance is configured to be delivered to the luminal wall by the scoring element; and

wherein one of the proximal end and the distal end of the scoring structure is fixed to the catheter body and the other of the proximal end and the distal end of the scoring structure is axially slidable with respect to the expandable shell.

2. The catheter according to claim 1, wherein at least a portion of an exposed surface of the at least one scoring element is coated by a coating including the active substance.

3. The catheter according to claim 2, wherein the at least one scoring element is coated by a polymeric carrier, wherein the active substance is incorporated in the polymeric carrier.

4. The catheter according to claim 3, wherein the polymeric carrier is resorbable in a vascular environment.

5. The catheter according to claim 3, wherein the polymeric carrier is non-resorbable in a vascular environment.

6. The catheter according to claim 2, wherein the coating is applied without a polymeric carrier.

7. The catheter according to claim 1, wherein the active substance is carried in holes or wells formed in the at least one scoring element.

8. The catheter according to claim 1, wherein the at least one scoring element comprises a plurality of generally linear and axially aligned scoring elements positioned over the expandable shell.

9. The catheter according to claim 1, wherein the scoring structure is formed as a resilient cage that expands with the expandable shell and collapses over the expandable shell.

10. The catheter according to claim 1, wherein the at least one scoring element comprises at least one helical scoring element.

11. The catheter according to 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/CKD inhibitor, an HMG co-enzyme reductase inhibitor, and a protease inhibitor.

12. The catheter according to claim 1, wherein the active substance is incorporated within a hydrogel, wherein the release of the active substance is enhanced by a swelling of the hydrogel.

13. The catheter according to claim 1, wherein the active substance is a hydrophobic drug.

14. The catheter according to claim 1, wherein the at least one scoring element has a flat surface configured to provide an initial contact between the at least one scoring element and the luminal wall when the expandable shell is expanded.

15. The catheter according to claim 1, wherein the at least one scoring element has a rectangular cross-section.

16. The catheter according to claim 1, wherein the active substance comprises an antiproliferative drug.

17. The catheter according to claim 1, wherein the active substance comprises paclitaxel.

18. The catheter according to claim 1, wherein the at least one scoring element further comprises a suitable carrier that facilitates a release of the active substance immediately upon expansion of the at least one scoring element.

19. The catheter of claim 1, wherein the distal end of the scoring structure is fixed to the catheter body and the proximal end of the scoring structure is axially slidable with respect to the expandable shell.