Expandable medical device for treating cardiac arrhythmias

• US 20040249443A1
• Filed: 07/01/2004
• Published: 12/09/2004
• Est. Priority Date: 08/20/2001
• Status: Abandoned Application

• Current Assignee: Innovational Holdings, LLC
• Original Assignee: Innovational Holdings, LLC
• Inventors: Shanley, John F., Markey, Micheline Lisa
• Application Number:
  US10/883,129
• Publication Number:
  US 20040249443A1
• Time in Patent Office: Days
• US Class Current: 623/1.15
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00256 Creating an electrical block
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2493 Transmyocardial revascularisation [TMR] devices
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/003 differing in adsorbability or resorbability, i.e. in adsorption or resorption time
• CPC Class Codes: A61F 2250/0031 made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
• CPC Class Codes: A61F 2250/0035 differing in release or diffusion time
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• 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 31/022 Metals or alloys
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

An expandable medical device has a plurality of elongated struts joined together to form a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter. At least one of the plurality of struts includes at least one opening extending at least partially through a thickness of said strut. A beneficial agent is loaded into the opening within the strut in layers to achieve desired temporal release kinetics of the agent. The beneficial agent can be a chemically ablative agent use to create a lesion to treat atrial fibrillation. A wide variety of delivery profiles can be achieved including zero order, pulsatile, increasing, decrease, sinusoidal, and other delivery profiles.

Claims

1. A medical device for treating cardiac arrhythmias, the device comprising:

a bioresorbable implantable device;

a plurality of openings in the implantable device; and

a chemically ablative agent provided in the openings, wherein the openings are configured to deliver the chemically ablative agent to tissue surrounding the expandable cylindrical device without permanently trapping any agent in the openings.

2. The medical device of claim 1, further comprising a biodegradable barrier layer provided in the opening substantially adjacent an innermost surface of the implantable device.

3. The medical device of claim 2, wherein the barrier layer prevents the chemically ablative agent from passing from the openings into a vessel lumen.

4. The medical device of claim 1, wherein the chemically ablative agent is provided in the openings in a biodegradable matrix.

5. The medical device of claim 1, wherein the openings are through openings.

6. The medical device of claim 4, wherein the bioerodible material of the expandable cylindrical device erodes at a rate slower than a rate of erosion of the biodegradable matrix.

7. The medical device of claim 1, wherein the chemically ablative agent is a cytotoxic agent.

8. The medical device of claim 1, wherein the chemically ablative agent is provided in the openings in a plurality of layers configured to release the chemically ablative agent at a programmed release rate and over a desired administration period.

9. The medical device of claim 1, further comprising a biodegradable cap layer provided in the opening substantially adjacent an outermost surface of the implantable device to prevent release of the chemically ablative agent during delivery of the device to an implantation location.

10. The medical device of claim 1, wherein the implantable device is a stent.

11. A method of treating atrial fibrillation comprising:

providing a stent having a chemically ablative agent in a biodegradable matrix;

determining an ablation location within a blood vessel of a patient where ablation is desired;

implanting the stent at the ablation location and delivering the chemically ablative agent to the wall of the blood vessel without substantially delivering the chemically ablative agent into the vessel lumen;

creating a lesion in the blood vessel wall which electrically isolates portions of tissue.

12. The method of claim 11, wherein the chemically ablative agent is located within openings in the stent.

13. The method of claim 12, wherein a biodegradable barrier layer is provided in the opening substantially adjacent an innermost surface of the implantable device to substantially prevent delivery of the chemically ablative agent into the vessel lumen.

14. The method of claim 12, wherein the openings are through openings.

15. The method of claim 11, wherein the stent is formed of a bioerodible material.

16. The method of claim 15, wherein the bioerodible material of the stent erodes at a rate slower than a rate of erosion of the biodegradable matrix.

17. The method of claim 11, wherein the chemically ablative agent is a cytotoxic agent.

18. The method of claim 12, wherein chemically ablative agent is provided in the openings in a plurality of layers configured to release the chemically ablative agent at a programmed release rate and over a desired administration period.

19. The method of claim 12, wherein the stent has a biodegradable cap layer provided in the opening substantially adjacent an outermost surface of the stent to prevent release of the chemically ablative agent during delivery of the device to an ablation location.

20. The method of claim 11, wherein the ablation location is determined by an electrical mapping procedure.

21. A method of treating atrial fibrillation comprising:

determining an ablation location within a blood vessel of a patient where ablation is desired;

implanting a resorbable stent at the ablation location;

creating a lesion in the blood vessel wall with the stent which electrically isolates portions of tissue; and

allowing the stent to be completely resorbed over time.