Stent and living organ dilator

• US 8,801,770 B2
• Filed: 03/26/2010
• Issued: 08/12/2014
• Est. Priority Date: 09/27/2007
• Status: Active Grant

• Current Assignee: Terumo Kabushiki Kaisha
• Original Assignee: Terumo Kabushiki Kaisha
• Inventors: Takayuki, Kito, Hiroki, Goto
• Primary Examiner(s): Severson, Ryan
• Assistant Examiner(s): SHI, KATHERINE MENGLIN
• Application Number:
  US12/732,984
• Publication Number:
  US 20100249904A1
• Time in Patent Office: 1,600 Days
• Field of Search: 623/1.11, 623 115- 12, 623/1.22, 606/108, 606/191, 606/194, 606/198, 606/200
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• 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 2002/91508 the meander having a difference in amplitude 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 2002/9155 Adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped
• 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
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/128 containing other specific inorganic fillers not covered by A61L31/126 or A61L31/127
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00

Abstract

A stent, composed of linear components, comes into close contact with a tissue in vivo upon being deformed when set indwelling in vivo. The stent has linear components which are deformed to exhibit a force for maintaining dilation when the stent is set indwelling in vivo. The linear components deformed when the stent is set indwelling in vivo are composed of non-biodegradable metallic linear components and a plurality of biodegradable material-made linear components which are bonded to the non-biodegradable metallic linear components. Furthermore, when set indwelling in vivo, the stent exhibits the force for maintaining the dilation owing to both the non-biodegradable metallic linear components and the biodegradable material-made linear components. After a predetermined period of time, biodegradation of the biodegradable material-made linear components proceeds, which results in a lowering of the force for maintaining the dilation.

Claims

1. A stent configured to closely contact tissue in vivo by being deformed when set indwelling in vivo, the stent comprising:

a plurality of linear components configured to deform and exhibit a force for maintaining dilation when the stent is set indwelling in vivo, the linear components comprising a plurality of non-biodegradable metallic linear components and a plurality of biodegradable material-made linear components, the biodegradable material-made linear components being bonded to the non-biodegradable metallic linear components;

both the non-biodegradable metallic linear components and the biodegradable material-made linear components contributing to the stent exhibiting the force for maintaining the dilation when the stent is left indwelling in vivo; and

after a predetermined period of time following the stent being left indwelling in vivo, biodegradation of the biodegradable material-made linear components proceeds so that the force for maintaining the dilation is lowered; and

wherein the non-biodegradable metallic linear components have at least one joint part which protrudes from a side portion of a rectilinear portion of the non-biodegradable metallic liner components, and the biodegradable material-made linear components envelop only a free end of the at least one joint part.

2. The stent according to claim 1, wherein the non-biodegradable metallic linear components are zigzag in shape and the biodegradable material-made linear components are zigzag in shape, the non-biodegradable metallic linear components comprising a plurality of metallic linear spiral members extending in a spiral manner in relation to an axial direction of the stent, the plurality of metallic linear spiral members being interconnected by the biodegradable material-made linear components.

3. The stent according to claim 2, wherein the metallic linear spiral members extending in a spiral direction, the biodegradable material-made linear components each extending in a direction different from the spiral direction in which the metallic linear spiral members extend.

4. The stent according to claim 2, wherein the at least one joint part of the non-biodegradable metallic linear components partly protrudes from the zigzag shape such that the upper and lower surfaces of the zigzag shape are exposed.

5. The stent according to claim 1, further comprising a metallic wavy-linear endless annular part positioned at opposite ends of the stent.

6. The stent according to claim 1, wherein the linear components form a plurality of axially arranged annular members, with axially adjacent annular members interconnected by at least one link part, and a metallic wavy-linear annular member positioned at each end of the stent, the link part being composed of one of the metallic linear components.

7. The stent according to claim 1, wherein the biodegradable material is a biodegradable metal or a biodegradable polymer.

8. The stent according to claim 7, wherein the biodegradable metal is pure magnesium or a magnesium alloy.

9. The stent according to claim 8, wherein the magnesium alloy contains at least one element selected from a biocompatible element group consisting of Zr, Y, Ti, Ta, Nd, Nb, Zn, Ca, Al, Li, and Mn.

10. The stent according to claim 7, wherein the biodegradable polymer is at least one selected from the group consisting of polyglycolic acid, polylactic acid, polycaprolactone, polyhydroxybutyric acid, cellulose, polyhydroxybutylate valeric acid, and polyorthoester, or a copolymer, mixture, or composites of these.

11. The stent according to claim 1, wherein the non-biodegradable metallic linear component is a plastically deformable metallic linear component, the stent is a tubular body possessing a diameter permitting insertion into a lumen in vivo, and the stent is expanded when a radially outwardly directed dilating force is exerted on the stent from inside the stent.

12. A living organ dilator comprising a tubular shaft body part, a foldable and dilatable balloon provided at a distal portion of the shaft body part, and the stent according to claim 11 which is positioned to cover the balloon in a folded state and which is expandable by expansion of the balloon.

13. The stent according to claim 1, wherein the non-biodegradable metallic linear component is a superelastic metallic linear component, the stent possesses a hollow cylindrical shape and is compressed in a direction of a center axis of the stent when inserted into a living body, and the stent expands externally to restore a pre-compression shape when left indwelling in vivo.

14. A living organ dilator comprising a sheath and the stent according to claim 13 which is accommodated in a distal portion of the sheath, and an inner tube for pushing out the stent from a distal end of the sheath, the inner tube being slidably inserted in the sheath.

15. A stent configured to closely contact tissue in vivo by being deformed when set indwelling in vivo, the stent comprising:

a plurality of linear components configured to deform and exhibit a force for maintaining dilation when the stent is set indwelling in vivo, the linear components comprising a plurality of non-biodegradable metallic linear components and a plurality of biodegradable material-made linear components, the biodegradable material-made linear components being bonded to the non-biodegradable metallic linear components;

both the non-biodegradable metallic linear components and the biodegradable material-made linear components contributing to the stent exhibiting the force for maintaining the dilation when the stent is left indwelling in vivo; and

after a predetermined period of time following the stent being left indwelling in vivo, biodegradation of the biodegradable material-made linear components proceeds so that the force for maintaining the dilation is lowered,

wherein the biodegradable material-made linear components are connected to the metallic linear components at respective joints, the biodegradable material-made liner components crossing the non-biodegradable metallic linear components such that they intersect each other at the joint, the biodegradable material-made linear components covering an outer surface and an inner surface of the metallic linear component at the joint; and

wherein the non-biodegradable metallic linear components include zigzag shaped portions and the biodegradable material-made linear components include zigzag shaped portions, the non-biodegradable metallic linear components comprising a plurality of metallic linear spiral members extending in a spiral manner in relation to an axial direction of the stent, the plurality of metallic linear spiral members being interconnected by the biodegradable material-made linear components.

16. The stent according to claim 15, wherein the joints of the non-biodegradable metallic linear components partly protrude from the zigzag shaped portions such that the biodegradable material-made linear components cover the outer surface and the inner surface of the metallic linear component only at the protruding joints and the upper and lower surfaces of the zigzag shaped portions remain exposed.

17. The stent according to claim 15, wherein the biodegradable material-made linear components are continuous along a given longitudinal length and the non-biodegradable metallic linear components are continuous along a given longitudinal length such that the biodegradable material-made linear components intersect opposing transverse sides of the non-biodegradable metallic linear components at the joint.