Bioabsorbable polymeric medical device

• US 7,846,197 B2
• Filed: 07/20/2007
• Issued: 12/07/2010
• Est. Priority Date: 07/20/2006
• Status: Expired due to Fees

• Current Assignee: OrbusNeich Medical Pte Ltd
• Original Assignee: Orbusneich Medical Incorporated (Orbusneich Medical)
• Inventors: Ye, Shusheng, Pazienza, John, Cottone, Robert J.
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US11/781,232
• Publication Number:
  US 20080051868A1
• Time in Patent Office: 1,236 Days
• Field of Search: 623/1.12, 623/1.15, 623/1.1, 623/1.17, 623/1.18, 623/1.19, 623/1.2, D25/155
• US Class Current: 623/1.15
• 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 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/9155 Adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/91566 connected trough to trough
• CPC Class Codes: A61F 2002/91583 by a bridge, whereby at least one of its ends is connected along the length of a strut between two consecutive apices within a band
• CPC Class Codes: A61F 2002/91591 Locking connectors, e.g. using male-female connections
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61F 2250/0071 breakable or frangible
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

In embodiments there is described a cardiovascular tube-shaped lockable and expandable bioabsorbable scaffold having a low immunogenicity manufactured from a crystallizable bioabsorbable polymer composition or blend.

Claims

1. An expandable tube-shaped scaffold having a proximal end and a distal end defined about a longitudinal axis, said scaffold comprising:

a) a plurality of first meandering strut elements interconnected with one another at least one point in such a manner to form a circumferential tube-shaped structure, said first meandering strut elements forming a tubular mesh which is crimpable and expandable;

b) a second meandering strut element which is operatively configured to be crimpable and expandable and configured to form a hoop-shaped strut of said scaffold after expansion; and

c) a locking means at the proximal and distal ends permitting the scaffold to be locked in a crimped position;

wherein said scaffold comprises an expansion crystallizable bioabsorbable racemate polymer composition or blend.

2. The tube-shaped scaffold of claim 1, wherein the locking means is a two-part portion of one or different meandering strut elements.

3. The tube-shaped scaffold of claim 2, wherein the two-part portion of the locking means entails snap-fit engagement in the crimped position of the scaffold.

4. The tube-shaped scaffold of claim 2, wherein the locking means is disengaged by scaffold expansion.

5. The tube-shaped scaffold of claim 2, wherein the locking means comprises a snap-fit key-in-lock configuration wherein the design resembles a dovetail type interlocking means.

6. The tube-shaped scaffold of claim 2, wherein the locking means comprises a snap-fit key-in-lock configuration resembling a ball-joint type interlocking means.

7. The tube-shaped scaffold of claim 2, wherein the locking means comprises a cantilever arm hooking an oppositely shaped end piece of the plastic scaffold.

8. The tube-shaped scaffold of claim 2 carried on an expandable balloon carrier device.

9. The tube-shaped scaffold of claim 2, wherein said scaffold can be sized to stretch from a crimped tube diameter to a diameter sufficient for implantation inside the lumen of a vascular system.

10. The tube-shaped scaffold of claim 2, wherein the expandable scaffold comprises a set of interlocking meandering struts stabilizing the implanted scaffold in an expanded or implanted configuration.

11. The tube-shaped scaffold of claim 2, wherein said scaffold polymer undergoes a molecular reorientation and crystallization during the radial strain of expansion.

12. The tube-shaped scaffold of claim 2, wherein said scaffold can vary from a cylindrical to a conal shape or combination thereof.

13. The tube-shaped scaffold of claim 2, wherein the biodegradable polymer displays breakdown kinetics sufficiently slow to avoid tissue overload or other inflammatory reactions.

14. The tube-shaped scaffold of claim 2, wherein said scaffold comprises a polymer core material comprising at least one encapsulated drug for localized treatment of the vascular wall and lumen.

15. The tube-shaped scaffold of claim 14, wherein the at least one encapsulated drug is for the treatment and prevention of tissue inflammation and platelet aggregation.

16. The tube-shaped scaffold of claim 2, wherein said scaffold comprises at least one attached or embedded identification marker.

17. The tube-shaped scaffold of claim 16, wherein said at least one attached or embedded identification marker comprises a spot radioopacity or a diffuse radioopacity.

18. The tube-shaped scaffold of claim 2, wherein the meandering struts are interlocked by means of ringlet connectors comprising configurations selected from one or more of the groups consisting of:

shaped-like an H, shaped-like an X, perforated circle, double adjacent H, two adjacent parallel connections, sinusoidal connect of parallel struts.

19. A bioabsorbable and flexible scaffold circumferential about a longitudinal axis so as to form a tube, said tube having a proximal open end and a distal open end, and being crimpable and expandable, comprising:

a) a plurality of first meandering strut elements interconnected with one another at least one point in such a manner to form a circumferential tube-shaped structure, said first meandering strut elements forming a tubular mesh which is crimpable and expandable;

b) a second meandering strut element which is operatively configured to be crimpable and expandable, and configured to form a hoop-shaped strut of said scaffold after expansion, said hooped-shaped strut having an inner surface proximal to said longitudinal axis, an outer surface distal to said longitudinal axis, a top surface proximal to said proximal open end and a bottom surface proximal to said distal open end;

said second meandering strut element interconnected with said plurality of first meandering strut elements; and

c) at least a pair of locking structures located proximal to either of said inner surface or said outer surface of said second meandering strut element, said pair of locking structures being configured to operatively lock to one another when said scaffold is in an unexpanded state, but to separate from one another when said scaffold is in an expanded state.

20. The scaffold of claim 19 wherein said locking structures comprise a pair of cantilevered arms that interconnect with one another when said scaffold is in an unexpanded state.

21. The scaffold of claim 19 wherein said locking structures comprise opposing male and female connectors.

22. The scaffold of claim 19 wherein said locking structures comprise connectors adjoined to one another with a friable connection when said scaffold is in an unexpanded state, but separate connectors when said friable connection is broken when said scaffold is in an expanded state.

23. The scaffold of claim 19 wherein said locking structures comprise a ball and joint connector.

24. The scaffold of claim 23 wherein said locking structures comprise a dovetail-type interlocking connectors.

25. The scaffold of claim 23 wherein said locking structures comprise a cantilevered arm and a portion of said a second meandering strut element when said scaffold is in an unexpanded state.

26. The scaffold of claim 23 wherein said locking structures comprise a cantilevered arm extending from, and a recess in, said second meandering strut element when said scaffold is in an unexpanded state.

27. The scaffold of claim 23 wherein said locking structures are configured and positioned with respect to such tube to allow for locking of an unexpanded state.

28. The tube-shaped scaffold of claim 23 carried on a expandable balloon carrier device.

29. A crimpable bioabsorbable and flexible scaffold circumferential about a longitudinal axis so as to form a tube, said tube having a proximal open end and a distal open end, and being expandable from an unexpanded to an expanded form, and containing a locking structure at either end of the scaffold to lock one component of the scaffold to another, said scaffold having a patterned shape in expanded form comprising:

a) a plurality of first meandering strut patterns, each of said first meandering strut pattern being interconnected to one another to form an interconnected mesh pattern circumferential about said longitudinal axis;

b) at least two second strut patterns nested within said interconnected mesh pattern, each of said second strut pattern comprising a hoop circumferential about said longitudinal axis, said hoop having an inner surface proximal to said longitudinal axis and an outer surface distal to said longitudinal axis, said hoop inner and outer surfaces about their circumferences being orthogonal to said longitudinal axis and within substantially the same plane.

30. The expandable tubular scaffold of claim 29 wherein one or more of said first meanders include receptacle structure for lock-fit reception of corresponding lock structure.

31. The expandable tubular scaffold of claim 30 wherein said corresponding locking structure is part of said one or more of first meanders which incorporate thereon receptacle structure, and said corresponding locking structure is locked with respect to said receptacle structure.

32. The expandable tubular scaffold of claim 29 wherein one or more of said second meanders includes receptacle structure for lock-fit reception of corresponding lock structure.

33. The expandable tubular scaffold of claim 32 wherein one or more of said second meanders further includes said corresponding locking structure, and said corresponding locking structure is locked with respect to said receptacle structure.

34. The expandable tubular scaffold of claim 29 wherein one or more of said first meanders includes receptacle structure for lock-fit reception of corresponding lock structure.

35. The expandable tubular scaffold of claim 34 wherein one or more of said second meanders includes corresponding lock structure for said receptacle structure, and said corresponding locking structure is locked with respect to said receptacle structure.

36. The expandable tubular scaffold of claim 29 wherein one or more of said second meanders includes receptacle structure for lock-fit reception of corresponding lock structure.

37. The expandable tubular scaffold of claim 36 wherein one or more of said first meanders includes said corresponding lock structure, said corresponding locking structure is locked with respect to said receptacle structure.