Necking stents

• US 5,139,480 A
• Filed: 08/22/1990
• Issued: 08/18/1992
• Est. Priority Date: 08/22/1990
• Status: Expired due to Fees

• Current Assignee: Biotec Laboratories Ltd. (Novacyt SAS)
• Original Assignee: Biotec Laboratories Ltd. (Novacyt SAS)
• Inventors: Hickle, Randall S., Parker, Harry W.
• Primary Examiner(s): Hafer, Robert A.
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US07/570,907
• Time in Patent Office: 727 Days
• Field of Search: 604/8-10, 604/96, 600/36, 606/191, 623/1, 623/12
• US Class Current: 604/8
• 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 2002/9155 Adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61L 31/048 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• 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 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials

Abstract

A stent is made from a thermoplastic material having a glass transition temperature below the normal temperature of the human body. Therefore the thermoplastic polymer may be necked in situ. The stent is made with a series of circumferential strips.

Claims

1. A stent comprising:

a. a tube formed of unexpanded polymer sheet

b. a plurality of holes through the sheet,

c. said polymer sheet being a thermoplastic having

i. a glass transition temperature between 5 degrees and 39 degrees Celsius,

ii. a minimum tensile strength after necking of 15 MPa,

iii. a minimum yield strength after necking of 10 MPa,

iv. a maximum fractional cross-sectional area after necking of 0.5, and

v. a compatibility with human body fluids.

2. The invention as defined in claim 1 further comprising said maximum fractional cross-sectional area after necking is 0.33.

3. The invention as defined in claim 1 wherein said yield strength after necking is at least 15 MPa.

4. The invention as defined in claim 1 wherein said tensile strength after necking is at least 25 MPa.

5. The invention as defined in claim 1 wherein the glass transition temperature is between 20 degrees Celsius and 35 degrees Celsius.

6. The invention as defined in claim 1 wherein said sheet is about 0.5 mm wall thickness before necking.

7. The invention as defined in claim 1 wherein said polymer sheet is made of a material selected from the group of polymers consisting of polyethylene, polypropylene, polyacrylonitrile, polyehylene terephthalate, and polybutylene terephthalate.

8. The invention as defined in claim 1 wherein said holes are uniformly spaced and form circumferential bands with strips between the holes, said strips of uniform width and have tabs of greater width evenly spaced in the band between successive strips.

9. The invention as defined in claim 8 wherein said tabs in each circumferential band are connected to the tabs in the adjacent bands.

10. The invention as defined in claim 1 wherein said stent is for a blood vessel and the sheet material is compatible with blood.

11. The invention as defined in claim 10 wherein said sheet is conducive to endothelialization.

12. The invention as defined in claim 11 further comprising said maximum cross-sectional area after necking is 0.33.

13. The invention as defined in claim 12 wherein said yield strength is at least 15 MPa after necking.

14. The invention as defined in claim 13 wherein said tensile strength is at least 25 MPa after necking.

15. The invention as defined in claim 14 wherein the glass transition temperature is between 20 degrees Celsius and 35 degrees Celsius.

16. The invention as defined in claim 15 wherein said sheet is about 0.5 mm wall thickness before necking.

17. The invention as defined in claim 16 wherein said holes are uniformly spaced and form circumferential bands with strips between the holes, said strips of uniform width and have tabs of greater width evenly spaced in the band between successive strips.

18. The invention as defined in claim 17 wherein said tabs in each circumferential band are connected to the tabs in the adjacent bands.

19. A stent for blood vessels comprising:

a. a tube formed of an unexpanded polymer sheet having a wall thickness of about 0.5 mm,

b. a plurality of circumferential bands having strips of uniform width, and said bands having tabs of greater width evenly spaced between the strips,

c. said polymer sheet being a thermoplastic having

i. a glass transition temperature between 20 degrees and 35 degrees Celsius,

ii. a minimum tensile strength after necking of 25 MPa,

iii. a minimum yield strength after necking of 15 MPa,

iv. a maximum fractional cross-sectional area after necking of 0.33, and

v. a compatibility with human blood and being condusive to endothelialization, and

d. said thermoplastic selected from the group of polymers consisting of polyethylene, polypropylene, polyacrylonitrile, polyehylene terephthalate, and polybutylene terephthalate.

20. The process of inserting a stent into a vessel comprising:

A. inserting said stent into the vessel, said stent before insertion being

i. a tube formed of an unexpanded polymer sheet,

ii. a plurality of holes through the sheet,

iii. said polymer sheet being a thermoplastic having;

a. a glass transition temperature between 5 degrees and 39 degrees Celsius,

b. a minimum tensile strength after necking of 15MPa,

c. a minimum yield strength after necking of 10MPa,

d. a maximum fractional cross-sectional area after necking of 0.5, and

e. a compatibility with human body fluids,

B. expanding the stent until portions of the sheet forming stent are necked.