Polymeric stents and other surgical articles

• US 20030208259A1
• Filed: 12/30/2002
• Published: 11/06/2003
• Est. Priority Date: 06/29/2000
• Status: Active Grant

• Current Assignee: Pentech Medical Devices Limited
• Original Assignee: Pentech Medical Devices Limited
• Inventors: Penhasi, Adel
• Granted Patent: US 7,410,498 B2
• Time in Patent Office: Days
• 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 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body

Abstract

A biocompatible non-memory expandable polymeric article selected from stents, implantable prostheses, catheters, other surgical articles and sealants for implantable prostheses, and which is at least in part biodegradable and includes a combination where hollow cylindrical element (2) is depicted in cutaway form to reveal helical element (4), terminated schematically at (6) and where a combination of at least one thermoplastic elastomeric component and at least one thermoplastic non-elastomeric component, the article being either porous articles or having the potential to become porous by action of body fluids in situ), the thermoplastic non-elastomeric component being present in such an amount as will provide mechanical strength and rigidity to the article when in an expanded mode.

Claims

1. A biocompatible non-memory expandable polymeric stent which is at least in part biodegradable and which includes a combination of at least one thermoplastic elastomeric component and at least one thermoplastic non-elastomeric component which has a glass transition temperature above 40°

C., said stent being selected from the group of porous stents and stents which have the potential to become porous by action of body fluids in situ, said thermoplastic non-elastomeric component being present in such an amount as will provide mechanical strength and rigidity to the stent when in an expanded mode.

2. A stent according to claim 1, wherein said at least one thermoplastic elastomeric component and at least one thermoplastic non-elastomeric component are in integral combination.

3. A stent according to claim 2, and which is further characterized by at least one of the following features:

(a) it is adapted for drug delivery in situ;

(b) said thermoplastic elastomeric component includes both hard and soft segments and may comprise a block copolymer;

(c) at least one of said components, preferably said non-elastomeric component, is substantially completely biodegradable;

(d) said combination includes at least one block copolymer containing at least one elastomeric segment as said elastomeric component and at least one non-elastomeric segment as said non-elastomeric component;

(e) said combination includes at least one mixture of at least one elastomeric polymer and at least one non-elastomeric polymer which has a glass transition temperature above 40°

C.;

(f) it has a configuration selected from one of the following;

(1) an elongated hollow cylindrical configuration other than an open-mesh configuration;

(2) a helical configuration;

(3) an elongated hollow cylindrical configuration which encases as an additional mechanical element, a helix formed from at least one biodegradable thermoplastic non-elastomeric polymer which has a glass transition temperature above 40°

C.;

(4) an elongated hollow cylindrical configuration which is additionally corrugated, or has a circumferentially corrugated or pleated section;

(5) an elongated hollow cylindrical configuration having a hole in the cylinder wall remote from either end of the elongated cylinder;

(6) an elongated hollow cylindrical open-mesh configuration.

4. A stent according to claim 3, wherein said block copolymer has a structure selected from (AB)_n, (AB)_nA, B(AB)N and ABC, where A is said at least one elastomeric segment, B is said at least one non-elastomeric segment, C is a different elastomeric or non-elastomeric segment, and n is an integer of at least one.

5. A stent according to claim 1, which consists of at least two discrete mechanical elements, at least one of which is formed from said at least one thermoplastic elastomeric component and at least one of which is formed from said at least one thermoplastic non-elastomeric component.

6. A stent according to claim 5, which is further characterized by at least one of the following features:

(a) at least one of said discrete elements is adapted for drug delivery in situ;

(b) said thermoplastic elastomeric component includes both hard and soft segments and may comprise a block copolymer;

(c) at least one of said discrete elements preferably said non-elastomeric component, is substantially completely biodegradable.

7. A stent according to claim 5, which includes a first mechanical element of hollow cylindrical configuration, formed from said elastomeric polymer, and a second mechanical element of helical configuration formed from said non-elastomeric polymer which is biodegradable and is adapted to be encased within said first mechanical element.

8. A stent according to claim 6, which includes a first mechanical element of hollow cylindrical configuration, formed from said elastomeric polymer, and a second mechanical element of helical configuration formed from said non-elastomeric polymer which is biodegradable and is adapted to be encased within said first mechanical element.

9. A stent according to claim 1, which comprises at least one IPN polymer.

10. A biocompatible non-memory expandable polymeric article selected from implantable prostheses, catheters, other surgical articles and sealants for implantable prostheses, and which is at least in part biodegradable and includes a combination of at least one thermoplastic elastomeric component and at least one thermoplastic non-elastomeric component which preferably has a glass transition temperature above 40°

C., said article being selected from the group of porous articles and articles which have the potential to become porous by action of body fluids in situ, said thermoplastic non-elastomeric component being present in such an amount as will provide mechanical strength and rigidity to the article when in an expanded mode.

11. An article according to claim 10, which is characterized by at least one of the features defined for said stent in any one of claims 2 to 9.