Biodegradable device

• US 8,100,963 B2
• Filed: 12/28/2006
• Issued: 01/24/2012
• Est. Priority Date: 10/26/2001
• Status: Active Grant

• Current Assignee: Mirus LLC
• Original Assignee: Icon Medical Corp. (ICON Interventional Systems, Inc.)
• Inventors: Roth, Noah M., Kondabatni, Kishore, Karnati, Chandana, Brodbeck, William
• Primary Examiner(s): BUI, VY Q
• Application Number:
  US11/646,890
• Publication Number:
  US 20070123973A1
• Time in Patent Office: 1,853 Days
• Field of Search: 623/1.15, 623/1.42, 623/1.46, 606/191, 606/194, 606/195, 606/198
• US Class Current: 623/1.42
• CPC Class Codes: A61B 2017/2945 Curved jaws
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2002/30064 Coating or prosthesis-covering structure made of biodegradable material
• CPC Class Codes: A61F 2002/91516 the meander having a change in frequency along the band
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0014 having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
• CPC Class Codes: A61F 2250/0031 made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61F 2310/0097 Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: A61F 2310/00976 Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 31/10 : Macromolecular materials
• 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

A device that is at least partially formed of a biodegradable polymer. The device can be at least partially formed by MEMS technology. The device can include one or more micro-structures that are also formed by MEMS technology. The device can include one or more agents that can be controllably and/or uncontrollably released from the device.

Claims

1. An expandable medical device for insertion in a body passageway that is used in treating dissected blood vessels, vascular malformations, vulnerable plaque by encapsulation, vulnerable plaque by passivation, nerve dissection of the central nervous system, incompetent valves, pulmonary embolism, narrowing of a body passageway, and combinations thereof, said expandable medical device including a body having an unexpanded and expanded cross-section area and a biological agent coated or impregnated on an other surface of said body, majority of said body is formed of a biodegradable polymer system designed to degrade when exposed to fluids in the body passageway so that at least a portion of said body degrades over time and removes itself from a treatment site in said body passageway, a portion of an outer surface of said medical device including a plurality of microstructures that extend upwardly from and above said outer surface of said body, said plurality of microstructures at least partially formed of said biological agent, said plurality of microstructures having a shape and size that is designed to penetrate into said body passageway at the treatment site when said body is expanded to said expanded cross-sectional area and to deliver said biological agent in said penetrated region of said body passageway, said plurality of microstructures having a height of less than 1000 microns.

2. The expandable medical device as defined in claim 1, wherein said body is in the form of a stent.

3. The expandable medical device as defined in claim 2, wherein said body is formed of about 100 percent biodegradable material.

4. The expandable medical device as defined in claim 3, wherein said outer surface of said body including a body coating, said plurality of microstructures extending upwardly from said body coating, said body coating including biodegradable polymer, biological agent, and combinations thereof, said body coating having a different composition from said biodegradable polymer system of said body, said body coating having a thickness of at least about 0.01 μ

m to less than about less than about 150 μ

m.

5. The expandable medical device as defined in claim 1, wherein said body is formed of about 100 percent biodegradable material.

6. The expandable medical device as defined in claim 1, wherein said outer surface of said body including a body coating, said plurality of microstructures extending upwardly from said body coating, said body coating including biodegradable polymer, biological agent, and combinations thereof, said body coating having a different composition from said biodegradable polymer system of said body, said body coating having a thickness of at least about 0.01 μ

m to less than about less than about 150 μ

m.

7. The expandable medical device as defined in claim 6, including a protective outer polymer coating on said body coating, said protective outer polymer coating including a) one or more polymers selected from the group consisting of parylene, PLGA, PEVA, PBMA, PLA, POE, PGA, PLLA, PAA, PEG and chitosan, b) one or more derivatives of polymers selected from the group consisting of parylene, PLGA, PEVA, PBMA, PLA, POE, PGA, PLLA, PAA, PEG and chitosan, or c) a combination of a) and b).

8. The expandable medical device as defined in claim 6, wherein said protective outer polymer coating controls a rate of degradation of said biodegradable polymer on said body.

9. The expandable medical device as defined in claim 1, including a protective outer polymer coating on said plurality of microstructures, said protective outer polymer coating including a biodegradable polymer, said protective coating designed to inhibit or prevent damage to said plurality of microstructures as said body is inserted into said body passageway and to said treatment site, said protective outer polymer coating having a thickness of less than about 300 μ

m.

10. The expandable medical device as defined in claim 4, including a protective outer polymer coating on said plurality of microstructures, said protective outer polymer coating including a biodegradable polymer, said protective coating designed to inhibit or prevent damage to said plurality of microstructures as said body is inserted into said body passageway and to said treatment site, said protective outer polymer coating having a thickness of less than about 300 μ

m.

11. The expandable medical device as defined in claim 10, including a protective outer polymer coating on said body coating, said protective outer polymer coating including a) one or more polymers selected from the group consisting of parylene, PLGA, PEVA, PBMA, PLA, POE, PGA, PLLA, PAA, PEG and chitosan, b) one or more derivatives of polymers selected from the group consisting of parylene, PLGA, PEVA, PBMA, PLA, POE, PGA, PLLA, PAA, PEG and chitosan, or c) a combination of a) and b).

12. The expandable medical device as defined in claim 11, wherein said protective outer polymer coating controls a rate of degradation of said biodegradable polymer on said body.

13. The expandable medical device as defined in claim 12, wherein said agent ranging from about 0.01-100 ug per mm², said agent at least about 0.01 weight percent of the device, and combinations thereof.

14. The expandable medical device as defined in claim 13, wherein said biological agent is used to promote the growth of an integral endothelial layer.

15. The expandable medical device as defined in claim 14, wherein said biological agent includes a) one or more agents selected from the group consisting of trapidil, taxol, cytochalasin, paclitaxel, rapamycin, and GM-CSF, b) one or more agents selected from the group consisting of trapidil derivative, taxol derivative, cytochalasin derivative, paclitaxel derivative, rapamycin derivative, and GM-CSF derivative, or c) a combination of a) and b).

16. The expandable medical device as defined in claim 15, wherein said body includes a plurality of high strain regions when said body is expanded from said unexpanded cross-sectional area and to said expanded cross-sectional area, a plurality of said high strain regions formed of biodegradable material so that such high strain regions degrade at a faster rate as compared to non-high strain regions on said body.

17. The expandable medical device as defined in claim 16, wherein said body contacts a balloon, a sheath, or combination thereof when inserted in to said body passageway, a plurality of said microstructures deigned to increase retention of said body to said balloon, said sheath, or combinations thereof.

18. The expandable medical device as defined in claim 17, wherein said biological agent is incorporated into said body.

19. The expandable medical device defined in claim 1, wherein said agent ranging from about 0.01-100 ug per mm², said agent at least about 0.01 weight percent of the device, and combinations thereof.

20. The expandable medical device as defined in claim 1, wherein said biological agent is used to promote the growth of an integral endothelial layer.

21. The expandable medical device as defined in claim 1, wherein said biological agent includes a) one or more agents selected from the group consisting of trapidil, taxol, cytochalasin, paclitaxel, rapamycin, and GM-CSF, b) one or more agents selected from the group consisting of trapidil derivative, taxol derivative, cytochalasin derivative, paclitaxel derivative, rapamycin derivative, and GM-CSF derivative, or c) a combination of a) and b).

22. The expandable medical device as defined in claim 1, wherein said body includes a plurality of high strain regions when said body is expanded from said unexpanded cross-sectional area and to said expanded cross-sectional area, a plurality of said high strain regions formed of biodegradable material so that such high strain regions degrade at a faster rate as compared to non-high strain regions on said body.

23. The expandable medical device as defined in claim 1, wherein said body contacts a balloon, a sheath, or combination thereof when inserted in to said body passageway, a plurality of said microstructures deigned to increase retention of said body to said balloon, said sheath, or combinations thereof.

24. The expandable medical device as defined in claim 1, wherein said biological agent is incorporated into said body.

25. The expandable medical device as defined in claim 1, wherein said plurality of biodegradable microstructures extend upwardly from said body having a height of at least about 0.01 μ

m to less than about 300 μ

m.