Methods and systems for delivering substances into luminal walls

• US 10,076,641 B2
• Filed: 04/26/2006
• Issued: 09/18/2018
• Est. Priority Date: 05/11/2005
• Status: Active Grant

• Current Assignee: Spectranetics Corporation (Koninklijke Philips N.V.)
• Original Assignee: Spectranetics Corporation (Koninklijke Philips N.V.)
• Inventors: Konstantino, Eitan, Konstantino, Michal
• Primary Examiner(s): Hall, Deanna K
• Application Number:
  US11/411,635
• Publication Number:
  US 20060259005A1
• Time in Patent Office: 4,528 Days
• Field of Search: 604508, 604509, 604 46, 604 73, 606159, 606194, 623 136, 623 142, 623 143
• 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 catheter within a body lumen, wherein the catheter comprises a catheter body, an expandable shell and a scoring structure positioned over the expandable shell, the scoring structure comprising a plurality of helical elements oriented in a similar configuration and coupled, wherein each helical element comprises an exposed, flat surface, wherein the active substance is coated over at least a portion of the exposed, flat surfaces, wherein an end of the scoring structure is axially slidable with respect to the catheter body and the expandable shell, wherein each of the exposed, flat surfaces comprise outward edges, wherein the exposed, flat surfaces are oriented in a direction away from the expandable shell to provide initial contact with the luminal site upon expansion of the expandable shell; and

penetrating and scoring a wall of the body lumen at said luminal site with the exposed, flat surfaces and the outward edges, thereby releasing the active substance from the coated portion of the flat surfaces into the wall at the luminal site.

2. The method of 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. The method of claim 2, wherein the body lumen is a blood vessel.

4. The method of claim 3, wherein the luminal site is at least partly occluded with thrombus.

5. The method of claim 3, wherein the luminal site is at least partly occluded with plaque or with hardened plaque.

6. The method of claim 1, wherein the catheter is positioned over a guide wire.

7. The method of claim 1, wherein penetrating comprises radially advancing the scoring element.

8. The method of claim 1, wherein penetrating comprises expanding the expandable shell to advance the scoring element into the wall.

9. The method of claim 8, wherein the expandable shell comprises an inflatable structure and expanding the expandable shell comprises inflating an inflatable structure, wherein the inflatable structure engages the scoring element.

10. The method of 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 indene acetic acids, an immunosuppressive agent, an angiogenic agent, an angiotensin receptor blocker, a nitric oxide donor, an anti-sense oligonucleotide, a cell cycle inhibitor, a retinoid, a cyclin/CDK inhibitor, an HMG co-enzyme reductase inhibitor, and a protease inhibitor.

11. The method of claim 3, wherein the active substance comprises an anti-proliferative drug.

12. The method of claim 3, wherein the active substance comprises a thrombolytic drug.

13. The method of claim 1, wherein the active substance is incorporated in a polymeric carrier, wherein the polymeric carrier is coated over the scoring element.

14. The method of claim 3, wherein the active substance comprises paclitaxel.

15. The method of claim 1, wherein the active substance is applied with a suitable carrier that facilitates release of the active substance immediately upon expansion of the scoring structure.

16. The method of claim 1, further comprising collapsing the scoring structure over the expandable shell and removing the expandable and the scoring structure from the body lumen.

17. The method of claim 1, wherein the scoring structure comprises a proximal end and a distal end, and wherein the axially slidable end of the scoring structure is the proximal end.

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

positioning a device within a body lumen, wherein the device comprises (i) an inflatable balloon, (ii) a plurality of scoring elements, wherein each scoring element has a helical geometry oriented in a similar configuration and coupled, wherein each helical element comprises an exposed, flat surface, and (iii) a catheter body carrying the inflatable balloon and the scoring elements, wherein respective end of the scoring element is axially slidable with respect to the catheter and the inflatable balloon, wherein the exposed, flat surfaces comprise outward edges, wherein the exposed, flat surfaces are oriented in a direction away from the inflatable balloon to provide initial contact between the scoring element and the wall of the lumen when the balloon is inflated, and the active substance is coated over at least a portion of the exposed, flat surfaces;

inflating the balloon to engage and drive the exposed, flat surface into a wall of the body lumen at said luminal site, thereby releasing the active substance from the exposed, flat surfaces into the wall at the luminal site.

19. The method of claim 18 wherein the scoring element has a rectangular cross-section.

20. The method of claim 18, wherein the scoring structure comprises a proximal end and a distal end, and wherein the axially slidable end of the scoring structure is the proximal end.