POLYMERIC STENTS AND OTHER SURGICAL ARTICLES

• US 20080300675A1
• Filed: 06/25/2008
• Published: 12/04/2008
• Est. Priority Date: 06/29/2000
• Status: Abandoned Application

• Current Assignee: Pentech Medical Devices Limited
• Original Assignee: Pentech Medical Devices Limited
• Inventors: PENHASI, Adel
• Application Number:
  US12/146,294
• Publication Number:
  US 20080300675A1
• Time in Patent Office: Days
• US Class Current: 623/1.49
• 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 polymer blend, which is adapted for making a surgical article intended for contact with body fluids, is at least in part biodegradable, and is either porous or has a potential to become porous by action of said body fluids in situ, said polymer blend comprising or consisting of polymeric components (A) and (B) defined as follows:

(A) at least one thermoplastic elastomeric polymer having a glass transition temperature below 37°

C. and

(B) at least one thermoplastic non-elastomeric polymer that has a glass transition temperature greater than 40°

C., component (B) being present in such an amount as will provide per se mechanical strength and rigidity to said blend when in an expanded mode.

2. A polymeric blend according to claim 1, wherein components (A) and (B) are mutually miscible or immiscible, and which is further characterized by at least one of the following features:

(i) component (B) constitutes at least 10% of the total weight of components (A) and (B),

(ii) components (A) and (B) form at least in part an interpenetration polymer network (IPN),

(iii) at least one said elastomeric polymer and/or said non-elastomeric polymer is a plasticized polymer,

(iv) said blend incorporates one or more drugs within the interstices and/or on the surface of at least one polymer in the polymer blend.

11. A surgical article formed from the polymer blend of claim 1.

16. A polymeric stent adapted to be positioned in a body lumen, which is formed exclusively from the polymer blend of claim 1.

3. A biocompatible non-memory expandable polymer blend, which is adapted for making a surgical article intended for contact with body fluids, is at least in part biodegradable, and is either porous or has a potential to become porous by action of said body fluids in situ, said polymer blend comprising or consisting of polymeric components (A) and (B) defined as follows:

(A) at least one thermoplastic elastomeric polymer having a glass transition temperature below 37°

C. and

(B) at least one thermoplastic non-elastomeric polymer that has a glass transition temperature greater than 40°

C., component (B) being present in such an amount as will provide per se mechanical strength and rigidity to said blend when in an expanded mode;

wherein component (A) is selected from the group consisting of segmented polyurethane, segmented polyurethane urea, segmented polyurethane amide, segmented polyetherester, polydimethylsiloxane, di-block polystyrene polybutadiene, tri-block polystyrene polybutadiene, poly(acrylene ether sulfone)-poly(acryl carbonate) block copolymers, di-block copolymers of polybutadiene and polyisoprene, copolymer of ethylene vinyl acetate (EVA), segmented block co-polystyrene polyethylene oxide, di-block co-polystyrene polyethylene oxide, and tri-block co-polystyrene polyethylene oxide.

4. A polymeric blend according to claim 3, wherein components (A) and (B) are mutually miscible or immiscible, and which is further characterized by at least one of the following features:

(i) component (B) constitutes at least 10% of the total weight of components (A) and (B),

(ii) components (A) and (B) form at least in part an interpenetration polymer network (IPN),

(iii) at least one said elastomeric polymer and/or said non-elastomeric polymer is a plasticized polymer,

(iv) said blend incorporates one or more drugs within the interstices and/or on the surface of at least one polymer in the polymer blend.

12. A surgical article formed from the polymer blend of claim 3.

17. A polymeric stent adapted to be positioned in a body lumen, which is formed exclusively from the polymer blend of claim 3.

5. A biocompatible non-memory expandable polymer blend, which is adapted for making a surgical article intended for contact with body fluids, is at least in part biodegradable, and is either porous or has a potential to become porous by action of said body fluids in situ, said polymer blend comprising or consisting of polymeric components (A) and (B) defined as follows:

(A) at least one thermoplastic elastomeric polymer having a glass transition temperature below 37°

C. and

(B) at least one thermoplastic non-elastomeric polymer that has a glass transition temperature greater than 40°

C., component (B) being present in such an amount as will provide per se mechanical strength and rigidity to said blend when in an expanded mode;

wherein component (B) is selected from the group consisting of polyhydroxy acids such as poly-L-lactic acid (PLLA), poly-DL-lactic acid (POLLA), poly(L-lactide), poly(D-lactide), poly(D,L-lactide), poly(glycolide), poly(L-lactide-co-D,L-lactide), poly(L-lactide-co-glycolide), poly(D,L-co-glycolide), poly(1,3-propylenemalonate-co-glycolide), polymalic acid, polydioxanone, poly(1,3-propylenemalonate-co-lactide), poly(1,3-propylenemalonate-co-dioxanone), polyhydroxybutyrate, polyhydroxyvalerate, polycarbonates, poly(glycolide-co-trimethylene carbonate), poly(glycolide-co-β

-propiolactone), poly(glycolide-co-γ

-butyrolactone), poly(glycolide-co-δ

-valerolactone), poly(glycolide-co-ε

-caprolactone), poly(lactide-cotrimethylenecarbonate), poly(lactide-co-δ

-propiolactone), poly(lactide-co-δ

-butyrolactone), poly(lactide-co-δ

-valerolactone), poly(lactide-co-δ

-caprolactone), poly[O—

(CH₂)x-O—

CO—

(CH₂)y-OC—

], where x=1-8 and y=1-8, polyethylene adipate (PEA), polyethylene carboxylates;

polyethylene succinate, polyethyleneoxalate, polyethlene subarate, polyethlene azelate, polyethylene sebacate, polytetramethylene carboxylates;

polyteteramethylene succinate, polyhexamethylene carboxylates, polydiethylene oxide carboxylates polyanhydrides, polytrimethylene carbonate, polyiminocarbonate, polyethylene carbonate, polypropylene carbonate, polyorthoesters, polyaminoacids, poly(hydroxyalkanoate)s, poly(pseudo amino acids), polyesteramides, and blends and copolymers thereof, shellac, polysaccharide such as pectin and polygalactronic acid, alginate and alginic acid, starch, cellulose, guar gum, dextrans, chitosan, chitin, pullulane, polyhyaluronic acids, heparin, proteins such as gelatin, collagen, albumin, zein and modified zein, casein, gluten, synthetic gel forming polymers such as polyvinyl alcohols, polyacrylamides, polyvinyl pyrrolidone, polyacrylic acid, polymethacrylic acid, polyacrylates such as polyhydroxy ethyl acrylate, polyhydroxy methyl acrylate, polyhydroxy ethyl methacrylate, polyhydroxy methyl methacrylate, and blends and copolymers thereof.

6. A polymeric blend according to claim 5, wherein components (A) and (B) are mutually miscible or immiscible, and which is further characterized by at least one of the following features:

(i) component (B) constitutes at least 10% of the total weight of components (A) and (B),

(ii) components (A) and (B) form at least in part an interpenetration polymer network (IPN),

(iii) at least one said elastomeric polymer and/or said non-elastomeric polymer is a plasticized polymer,

(iv) said blend incorporates one or more drugs within the interstices and/or on the surface of at least one polymer in the polymer blend.

13. A surgical article formed from the polymer blend of claim 5.

18. A polymeric stent adapted to be positioned in a body lumen, which is formed exclusively from the polymer blend of claim 5.

7. A biocompatible non-memory expandable polymer blend, which is adapted for making a surgical article intended for contact with body fluids, is at least in part biodegradable, and is either porous or has a potential to become porous by action of said body fluids in situ, said polymer blend comprising or consisting of polymeric components (A) and (B) defined as follows:

component (A) is selected from the group consisting of segmented polyurethane, segmented polyurethane urea, segmented polyurethane amide, segmented polyetherester, polydimethylsiloxane, di-block polystyrene polybutadiene, tri-block polystyrene polybutadiene, poly(acrylene ether sulfone)-poly(acryl carbonate) block copolymers, di-block copolymers of polybutadiene and polyisoprene, copolymer of ethylene vinyl acetate (EVA), segmented block co-polystyrene polyethylene oxide, di-block co-polystyrene polyethylene oxide, and tri-block co-polystyrene polyethylene oxide; and

component (B) is selected from the group consisting of polyhydroxy acids such as poly-L-lactic acid (PLLA), poly-DL-lactic acid (PDLLA), poly(L-lactide), poly(D-lactide), poly(D,L-lactide), poly(glycolide), poly(L-lactide-co-D,L-lactide), poly(L-lactide-co-glycolide), poly(D,L-co-glycolide), poly(1,3-propylenemalonate-co-glycolide), polymalic acid, polydioxanone, poly(1,3-propylenemalonate-co-lactide), poly(1,3-propylenemalonate-co-dioxanone), polyhydroxybutyrate, polyhydroxyvalerate, polycarbonates, poly(glycolide-co-trimethylene carbonate), poly(glycolide-co-β

-propiolactone), poly(glycolide-co-γ

-butyrolactone), poly(glycolide-co-δ

-valerolactone), poly(glycolide-co ε

-caprolactone), poly(lactide-cotrimethylenecarbonate), poly(lactide-co-δ

-propiolactone), poly(lactide-co-δ

-butyrolactone), poly(lactide-co-δ

-valerolactone), poly(lactide-co-δ

-caprolactone), poly[O—

(CH₂)x-O—

CO—

(CH₂)y-OC—

], where x=1-8 and y=1-8, polyethylene adipate (PEA), polyethylene carboxylates;

polyethylene succinate, polyethyleneoxalate, polyethlene subarate, polyethlene azelate, polyethylene sebacate, polytetramethylene carboxylates;

polyteteramethylene succinate, polyhexamethylene carboxylates, polydiethylene oxide carboxylates polyanhydrides, polytrimethylene carbonate, polyiminocarbonate, polyethylene carbonate, polypropylene carbonate, polyorthoesters, polyaminoacids, poly(hydroxyalkanoate)s, poly(pseudo amino acids), polyesteramides, and blends and copolymers thereof, shellac, polysaccharide such as pectin and polygalactronic acid, alginate and alginic acid, starch, cellulose, guar gum, dextrans, chitosan, chitin, pullulane, polyhyaluronic acids, heparin, proteins such as gelatin, collagen, albumin, zein and modified zein, casein, gluten, synthetic gel forming polymers such as polyvinyl alcohols, polyacrylamides, polyvinyl pyrrolidone, polyacrylic acid, polymethacrylic acid, polyacrylates such as polyhydroxy ethyl acrylate, polyhydroxy methyl acrylate, polyhydroxy ethyl methacrylate, polyhydroxy methyl methacrylate, and blends and copolymers thereof.

8. A polymeric blend according to claim 7, wherein components (A) and (B) are mutually miscible or immiscible, and which is further characterized by at least one of the following features:

(i) component (B) constitutes at least 10% of the total weight of components (A) and (B),

(ii) components (A) and (B) form at least in part an interpenetration polymer network (IPN),

(iii) at least one said elastomeric polymer and/or said non-elastomeric polymer is a plasticized polymer,

(iv) said blend incorporates one or more drugs within the interstices and/or on the surface of at least one polymer in the polymer blend.

14. A surgical article formed from the polymer blend of claim 7.

19. A polymeric stent adapted to be positioned in a body lumen, which is formed exclusively from the polymer blend of claim 7.

9. A biocompatible non-memory expandable polymer blend, which is adapted for making a surgical article intended for contact with body fluids, is at least in part biodegradable, and is either porous or has a potential to become porous by action of said body fluids in situ, said polymer blend comprising or consisting of polymeric components (A) and (B) defined as follows:

(A) at least one thermoplastic elastomeric block copolymer having a soft segment with a glass transition temperature below 37°

C. and

(B) at least one thermoplastic non-elastomeric polymer that has a glass transition temperature greater than 40°

C., component (B) being present in such an amount as will provide per se mechanical strength and rigidity to said blend when in an expanded mode.

10. A polymeric blend according to claim 9, wherein components (A) and (B) are mutually miscible or immiscible, and which is further characterized by at least one of the following features:

(a) said soft segment has a glass transition temperature below 0°

C.;

(b) said component (A) is a segmented polyurethane,

(c) said component (B) is a polylactide,

(d) component (B) constitutes at least 10% of the total weight of components (A) and

(B),

(e) components (A) and (B) form at least in part an interpenetration polymer network (IPN),

(f) component (B) constitutes at least 10% of the total weight of components (A) and (B),

(g) components (A) and (B) form at least in part an interpenetration polymer network (IPN),

(h) at least one said elastomeric polymer and/or said non-elastomeric polymer is a plasticized polymer,

(i) said blend incorporates one or more drugs within the interstices and/or on the surface of at least one polymer in the polymer blend.

15. A surgical article formed from the polymer blend of claim 9.

20. A polymeric stent adapted to be positioned in a body lumen, which is formed exclusively from the polymer blend of claim 9.