Endolumenal prosthesis

• US 8,870,940 B2
• Filed: 07/25/2005
• Issued: 10/28/2014
• Est. Priority Date: 07/25/2005
• Status: Active Grant

• Current Assignee: Invatec Technology Center GmbH (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Venturelli, Andrea, Schaffner, Silvio
• Primary Examiner(s): Dornbusch, Dianne
• Application Number:
  US11/996,378
• Publication Number:
  US 20080215129A1
• Time in Patent Office: 3,382 Days
• Field of Search: 623/1.1, 623/1.11, 623 115- 117, 623/1.19, 623/1.2, 623/1.23
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2002/9155 Adjacent bands being connected to each other
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0031 made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
• CPC Class Codes: A61F 2250/0071 breakable or frangible

Abstract

The present invention relates to an endolumenal prosthesis comprising a tubular body adapted to convert from a contracted condition to an expanded condition. The tubular body develops along a longitudinal axis and comprises: a plurality of coils and at least one bridge. The coils develop along a substantially circumferential direction and the bridge connects two coils. The coils are realized in a persistent material, while the bridge is realized in a bioabsorbable material.

Claims

1. An endolumenal prosthesis, comprising a tubular body adapted to convert from a contracted condition to an expanded condition, said tubular body being developed along a longitudinal axis, said tubular body comprising:

a plurality of coils made of a non-bioabsorbable material that develop in a substantially circumferential direction, and

at least two bridges connecting two coils of the plurality of coils, the two coils being adjacent to each other along the longitudinal axis, said at least two bridges comprising;

at least one bioabsorbable bridge connecting the two coils and made of a bioabsorbable material; and

at least one non-bioabsorbable bridge connecting the two coils and made of the non-bioabsorbable material, wherein said at least one non-bioabsorbable bridge and said at least one bioabsorbable bridge are spaced apart from each other along said substantially circumferential direction between the two coils.

2. An endolumenal prosthesis according to claim 1 wherein said endolumenal prosthesis is of the self-expandable type.

3. An endolumenal prosthesis according to claim 2 wherein at least one coil is made of superelastic material or in hardened pseudoelastic material.

4. An endolumenal prosthesis according to claim 2 wherein at least one coil is made of shape memory material.

5. An endolumenal prosthesis according to claim 4, wherein said shape memory material is NiTinol.

6. An endolumenal prosthesis according to claim 1 wherein said endolumenal prosthesis is of the balloon-expandable type.

7. An endolumenal prosthesis according to claim 6 wherein at least one coil is made of stainless steel.

8. An endolumenal prosthesis according to claim 7, wherein said stainless steel is of the type classified as AISI 316 L.

9. An endolumenal prosthesis according to claim 6 wherein at least one coil is made of Chromium-Cobalt alloy.

10. An endolumenal prosthesis according to claim 9, wherein said Chromium-Cobalt alloy is of the type classified as UNS R30035.

11. An endolumenal prosthesis according to claim 1 wherein said coils define closed courses.

12. An endolumenal prosthesis according to claim 1 wherein said coils develop according to said substantially circumferential direction.

13. An endolumenal prosthesis according to claim 1 wherein each bridge of said at least two bridges has a substantially straight line development and an extension oriented in an approximately axial direction.

14. An endolumenal prosthesis according to claim 1 wherein said at least two bridges develop in said substantially circumferential direction.

15. An endolumenal prosthesis according to claim 14, wherein said at least two bridges form a pseudo-coil.

16. An endolumenal prosthesis according to claim 1 wherein each bridge of said at least two bridges has a slightly sloping direction in relation to the axial direction.

17. An endolumenal prosthesis according to claim 1 wherein all of said at least two bridges included between two coils are parallel with each other.

18. An endolumenal prosthesis according to claim 1 wherein each bridge of said at least two bridges alternates in directions having opposite slopes in relation to the longitudinal axis direction.

19. An endolumenal prosthesis according to claim 1 wherein at least one of said coils comprises fixation actuators in a point wherein a bridge branches off.

20. An endolumenal prosthesis according to claim 19, wherein said fixation actuators comprise a hole made in the width of the coil.

21. An endolumenal prosthesis according to claim 20, wherein said bridge comprises a profile that locally replicates with great precision the contour of the profile of the coil and portions which are complementary to said fixation actuators, adapted to provide shape coupling between the coil and the respective bridge.

22. An endolumenal prosthesis according to claim 19, wherein said fixation actuators comprise shaped protrusions positioned externally on the width of the coil.

23. An endolumenal prosthesis according to claim 19, wherein said fixation actuators comprise an incised line on the surface of the coil.

24. An endolumenal prosthesis according to claim 19, wherein said fixation actuators comprise a highly porous level on the surface of the coil.

25. An endolumenal prosthesis according to claim 1, wherein said at least one bioabsorbable bridge is made of a bioabsorbable polymer.

26. An endolumenal prosthesis according to claim 25, wherein said bioabsorbable polymer is selected from the group composed of PDLA or poly-(D-lactic acid), PLLA or poly-(L-lactic acid), and PGA or poly-(glycolic acid).

27. An endolumenal prosthesis according to claim 25 wherein said bioabsorbable polymer is selected from the group composed of:

poly-caprolactone, poly-(lactide-co-glycolide), poly-(ethylene-vinyl acetate), poly-(hydroxybutyrate-co-valerate), poly-dioxanone, poly-orthoester, poly-anhydride, poly-(glycolic acid-co-trimethylene carbonate), poly-phosphoester, poly-phosphoester urethane, poly(amino acids), cyanoacrylates, poly-(trimethylene carbonate), poly-(iminocarbonate), copoly-(ether-esters) (PEO/PLA), poly-alkylene oxalates, poly-phosphazenes and biomolecules such as fibrin, fibrinogen, cellulose, starch, collagen, hyaluronic acid, poly-N-alkylacrylamides, poly-depsi-peptide carbonate, and poly-ethylene-oxide based polyesters.

28. An endolumenal prosthesis according to claim 1, wherein said at least one bioabsorbable bridge is made of a bioabsorbable metallic material.

29. An endolumenal prosthesis according to claim 1, wherein at least one bioabsorbable bridge is made of a Magnesium alloy.

30. An endolumenal prosthesis according to claim 29, wherein said Magnesium alloy is of the type classified as UNS M18430.

31. An endolumenal prosthesis according to claim 1, wherein said at least one bioabsorbable bridge is made of a binary mixture Calcium oxide (CaO) and Phosphorous pentoxide (or Phosphoric anhydride)(P₂O₅).

32. An endolumenal prosthesis according to claim 1, wherein each bridge of said at least two bridges forms a loop adapted to enclose a loop of a coil in order to form a chain connection.

33. An endolumenal prosthesis according to claim 32 wherein each of the beams comprises at its distal end, a keel.

34. An endolumenal prosthesis according to claim 33 wherein, when the endolumenal prosthesis is in its contracted condition, and the beams are in contact with one another, the plurality of keels creates a tip.

35. An endolumenal prosthesis according to claim 1, wherein each bridge of said at least two bridges assumes the form of a beam having a mainly axial development and connected to more than two coils.

36. An endolumenal prosthesis according to claim 35 wherein said beam is positioned inside said coils and is connected to their radially internal surface.

37. An endolumenal prosthesis according to claim 36 wherein said radially internal surface of said coils comprises fixation actuators adapted to form a shape coupling with said beam.

38. An endolumenal prosthesis according to claim 35 wherein said endolumenal prosthesis comprises a plurality of beams which, when the endolumenal prosthesis is in its contracted condition, enter into contact with each other, thus forming a tubular structure positioned inside the coils.

39. An endolumenal prosthesis according to claim 38 wherein said tubular structure defines, at its distal end, an opening adapted to receive a guidewire.

40. Device for the transport and delivery of an endolumenal prosthesis according to claim 38, comprising a catheter and a sheath adapted to supply a radial containing system for the endolumenal prosthesis, wherein

said catheter comprises, at its distal end, a shoulder adapted to provide an axial support for the tubular structure of the endolumenal prosthesis;

and

the length of said sheath extends further than that of said catheter by a length substantially equal to that of the endolumenal prosthesis.

41. An endolumenal prosthesis according to claim 1, wherein at least one coil comprises a marker made of radiopaque material.

42. An endolumenal prosthesis according to claim 1, wherein the coils positioned at the distal end and proximal end respectively, comprise a marker made of radiopaque material.

43. An endolumenal prosthesis according to claim 1, wherein the parts made of bioabsorbable material are adapted to release a drug in a controlled manner over a prolonged period of time.

44. An endolumenal prosthesis according to claim 1, wherein each single loop of each single coil is connected by a bridge to the respective loop of the adjacent coil.

45. An endolumenal prosthesis according to claim 1, wherein said non-bioabsorbable material comprises a metallic material.

46. An endolumenal prosthesis according to claim 1, wherein said non-bioabsorbable material comprises a material selected from the group consisting of superelastic material, Nitinol, stainless steel, and Chromium-Cobalt alloy.