Stent having a programmed pattern of in vivo degradation

• US 5,957,975 A
• Filed: 12/15/1997
• Issued: 09/28/1999
• Est. Priority Date: 12/15/1997
• Status: Expired due to Term

• Current Assignee: Centre National De La Recherche Scientifique, Cleveland Clinic Foundation, The University Paris V Faculte Necker, Universite Montpellier II
• Original Assignee: Centre National De La Recherche Scientifique, Cleveland Clinic Foundation, The University Paris V Faculte Necker, Universite Montpellier II
• Inventors: Li, Suming, Vert, Michel R., Garreau, Henri L., Cornhill, Fredrick, Lafont, Antoine
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US08/990,401
• Time in Patent Office: 652 Days
• Field of Search: 623/1, 623/12
• US Class Current: 623/1.16
• CPC Class Codes: A61F 2/92 Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• 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: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

The present invention provides a biodegradable polymeric stent having a programmed pattern of in vivo degradation. When deployed, the stent comprises a substantially cylindrical element having two open ends and a plurality of regions circumferentially spaced around the cylindrical element and extending from one open end to the other open end of the cylindrical element. Each of the regions is configured to have a desired in vivo lifetime. One region is designed to have a shorter in vivo lifetime than the other region or regions so that when the stent is deployed within the lumen of a vessel of a patient, the cylindrical element breaks apart from one open end of the cylindrical element to the other open end of the cylindrical element within a predetermined period of time after the stent is deployed in the patient. In one preferred embodiment the stent is a formed from a biodegradable polymeric band. The band includes a head having a slot and a tongue having a catch mechanism. The cylindrical element is formed by inserting a portion of the tongue through the slot to provide a cylindrical element having a first reduced diameter configuration. Following deployment, the cylindrical element is in a second expanded diameter configuration wherein the distal catch mechanism engages the inner surface of the head and prevents radial collapse or recoil of the polymeric stent. In a second preferred embodiment, the stent is formed from a plurality of interconnected polymeric bands.

Claims

1. A biodegradable polymeric stent having a programmed pattern of in vivo degradation, said stent comprising:

a substantially cylindrical element having two open ends and comprising a plurality of regions circumferentially spaced around the cylindrical element, each region of said plurality of regions extending from one open end to the other open end of said cylindrical element, wherein at least two adjacent regions of said plurality of regions are configured to have different predetermined in vivo lifetimes;

a first region of said plurality of regions having a first in vivo lifetime;

a second region of said plurality of regions having a second in vivo lifetime, said second region being juxtaposed to said first region and;

wherein the first in vivo lifetime of said first region is shorter than the second in vivo lifetime of said second region such that said cylindrical element selectively breaks apart within said first region within a predetermined period of time following deployment of the stent in a vessel of a patient.

2. The stent of claim 1 wherein the stent comprises a plurality of spaced apart first regions having a first in vivo lifetime and a plurality of spaced apart second regions having a second in vivo lifetime.

3. The stent of claim 1 wherein the stent comprises a plurality of said substantially cylindrical elements, said plurality of said substantially cylindrical elements being interconnected.

4. The stent of claim 1 wherein the stent is an intravascular stent;

wherein the first in vivo lifetime of said first region is from about 8 to about 12 weeks; and

wherein the second in vivo lifetime of said second region is from about 16 to about 52 weeks.

5. The stent of claim 3 wherein the stent is an intravascular stent;

wherein the first in vivo lifetime of said first region is from about 8 to about 12 weeks; and

wherein the second in vivo lifetime of said second region is from about 16 to about 52 weeks.

6. The stent of claim 3 wherein the plurality of cylindrical elements are interconnected by an interconnecting element, and wherein said interconnecting element or a region thereof is configured to have an in vivo lifetime substantially the same as or less than the first in vivo lifetime of said first region.

7. The stent of claim 3 and wherein the plurality of cylindrical elements are interconnected by an interconnecting element, and wherein said interconnecting element or a region thereof is configured to have an in vivo lifetime substantially the same as or greater than the second in vivo lifetime of said second region.

8. The stent of claim 3 wherein the plurality of cylindrical elements are interconnected by an interconnecting element, and wherein said interconnecting element or a region thereof is configured to have an in vivo lifetime intermittent the first in vivo lifetime of said first region and the second in vivo lifetime of said second region.

9. The stent of claim 1 wherein the stent is formed from one or more amorphous polymers that are free from crystalline residues upon degradation in vivo.

10. The stent of claim 1 wherein the stent is formed from a polylactic acid polymer produced from L and DL-lactides, and wherein the percentage of L-lactic acid units in the mixture of monomers used to prepare said lactides ranges from about 10 to about 90%.

11. The stent of claim 10 wherein the percentage of L-lactic acid units in the mixture of monomers used to prepare said lactides ranges from about 25 to about 75%.

12. The stent of claim 3 wherein the stent is formed from one or more amorphous polymers that are free from crystalline residues upon degradation in vivo.

13. The stent of claim 3 wherein the stent is formed from a polylactic acid polymer produced from L and DL-lactides, and wherein the percentage of L-lactic acid units in the mixture of monomers used to prepare said lactides ranges from about 10 to about 90%.

14. The stent of claim 13 wherein the percentage of L-lactic acid units in the mixture of monomers used to prepare said lactides ranges from about 25 to about 75%.

15. The stent of claim 13 wherein the stent is heated to a temperature above the glass transition temperature of the polymer prior to expansion of said stent to provide said stent with a memory of an expanded diameter configuration.

16. The stent of claim 1 wherein the stent is formed from a polylactic acid and glycolic acid copolymer produced from L-lactides, DL-lactides and glycides.

17. The stent of claim 3 wherein the stent is formed from a polylactic acid and glycolic acid copolymer produced from L-lactides, DL-lactides and glycides.

18. The stent of claim 1 wherein said substantially cylindrical element breaks apart within said first in vivo lifetime to allow remodeling of the vessel.

30. The stent of claim 1 wherein the width of said first region is less than the width of said second region.

31. The stent of claim 2 wherein the width of each of said first region is less than the width of each of said second region.

32. The stent of claim 1 wherein the overall surface area of said first region is less than the overall surface area of said second region.

33. The stent of claim 2 wherein each of said first regions has an overall surface area that is less than the overall surface area of each of said second regions.

34. The stent of claim 1 wherein said first region comprises polymeric chains that are shorter than the polymeric chains in said second region.

35. The stent of claim 1 wherein said first region comprises acidic ions.

36. The stent of claim 1 wherein said second region comprises a first bioresorbable polymer having a first in vivo degradation rate and wherein said first region comprises a second bioresorbable polymer having a second in vivo degradation rate;

said second in vivo degradation rate of said second polymer being faster than said first in vivo degradation rate of said first polymer.

19. A biodegradable stent for use in a vessel of a patient, said stent comprising:

a polymeric band having two longitudinal edges that overlap when said stent is formed into a cylinder, two lateral edges defining two open ends when said stent is formed into a cylinder, and an inner and outer surface when said stent is formed into a cylinder;

said band comprising;

a head and a tongue;

said head having a slot for receiving a distal portion of said tongue when said stent is formed into a cylinder;

said distal portion of said tongue comprising a catch mechanism for contacting the inner surface of said stent and preventing radial collapse of said stent following deployment of said stent in the vessel

wherein said polymeric band comprises a plurality of regions spaced across the band;

each region of said plurality of regions extending from one lateral edge to the other lateral edge of said polymeric band, wherein at least two adjacent regions of said plurality of regions are configured to have different predetermined in vivo lifetimes;

a first region of said plurality of regions having a first in vivo lifetime;

a second region of said plurality of regions having a second in vivo lifetime;

wherein the first in vivo lifetime of said first region is shorter than the second in vivo lifetime of said second region such that said polymeric band breaks apart within said first region following deployment of the stent in a vessel of a patient.

20. The stent of claim 19 wherein said stent comprises a plurality of polymeric bands, said plurality of polymeric bands being interconnected, each of said bands comprising a head having a slot and a tongue having a catch mechanism.

21. The stent of claim 19 wherein said catch mechanism comprises opposing projections on the lateral edges of the tongue.

22. The stent of claim 20 wherein the catch mechanism on each tongue comprises opposing projections of the lateral edges of the tongue.

23. The stent of claim 19 wherein the stent is formed from one or more amorphous polymers that are free from crystalline residues upon degradation in vivo.

24. The stent of claim 19 wherein the stent is formed from a poly-lactic acid polymer produced from L and DL-lactides, and wherein the percentage of L-lactic acid units in the mixture of monomers used to prepare said lactides ranges from about 10 to about 90%.

25. The stent of claim 24 wherein the percentage of L-lactic acid units in the mixture of monomers used to prepare said lactides ranges from about 25 to about 75%.

26. The stent of claim 20 wherein the stent is formed from one or more amorphous polymers that do not generate crystalline residues upon degradation in vivo.

27. The stent of claim 19 wherein the stent is formed from a poly-lactic acid polymer produced from L and DL-lactides, and wherein the percentage of L-lactic acid units in the mixture of monomers used to prepare said lactides ranges from about 10 to about 90%.

28. The stent of claim 27 wherein the percentage of L-lactic acid units in the mixture of monomers used to prepare said lactides ranges from about 25 to about 75%.

29. The stent of claim 19 wherein the stent is formed from a poly-lactic acid and glycolic acid copolymer produced from L-lactides, DL-lactides and glycides.