RECOMBINANT EXPRESSED BIOADSORBABLE POLYHYDROXYALKONATE MONOFILAMENT AND MULTI-FILAMENTS SELF-RETAINING SUTURES

• US 20090112259A1
• Filed: 10/31/2008
• Published: 04/30/2009
• Est. Priority Date: 10/31/2007
• Status: Abandoned Application

• Current Assignee: Ethicon Incorporated (Johnson & Johnson), Ethicon, LLC (Johnson & Johnson)
• Original Assignee: Angiotech Pharmaceuticals Incorporated
• Inventors: D'Agostino, William L.
• Application Number:
  US12/263,119
• Publication Number:
  US 20090112259A1
• Time in Patent Office: Days
• US Class Current: 606/230
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs
• CPC Class Codes: A61L 17/08 of animal origin, e.g. catgut, collagen
• CPC Class Codes: A61L 17/105 Polyesters not covered by A61L17/12
• CPC Class Codes: A61L 17/145 Coating
• CPC Class Codes: D01F 6/625 derived from hydroxy-carboxylic acids, e.g. lactones
• CPC Class Codes: D01F 8/14 with at least one polyester as constituent

Abstract

The present invention provides polymers made by genetically engineering microorganisms for making a self-retaining suture. In an embodiment of the present invention the genetically engineering microorganisms synthesize polyhydroxyalkanoate (PHA) polymers. In an alternate embodiment of the invention, the genetically engineering microorganisms synthesize polybetahydroxybutyrate (PHB) polymers. In an alternative embodiment of the invention, the self-retaining sutures can be made from a copolymer such as polyhydroxybutyratevalerate (PHBV), where the genetically engineering microorganisms produces PHA polymers as the monofilament base material and a different genetically engineering microorganisms produces polyhydroxybutyratevalerate (PHBV) polymers. In various embodiments of the invention, recombinant expressed self-retaining suture materials have a melting point in the range from between approximately 40° C. to approximately 180° C. In various embodiments of the invention, recombinant expressed self-retaining suture materials have extension-to-break strength of between approximately 8% and approximately 42%.

Claims

1. A self-retaining suture comprising at least one filament, wherein the at least one filament includes:

a recombinant polyhydroxyalkonate (rPHA) polymer; and

at least one tissue retainer, where the tissue retainer is introduced into at least one of the at least one filament to improve retention of the suture in tissue.

2. The self-retaining suture of claim 1, wherein the tissue retainer is a barb.

3. The self-retaining suture of claim 1, wherein the rPHA polymer filament has a melting point between:

a lower limit of approximately 40°

C.; and

an upper limit of approximately 180°

C.

4. The self-retaining suture of claim 1, wherein the rPHA polymer filament has an extension-to-break strength of between:

a lower limit of approximately 8%; and

an upper limit of approximately 42%.

5. The self-retaining suture of claim 1, wherein the suture induces a tissue specific reaction when the suture is inserted in vivo, wherein the tissue specific reaction induces collagen deposition around at least one tissue retainer insertion site to further improve retention of the suture in tissue.

6. The self-retaining suture of claim 1, wherein the rPHA polymer is selected from the group consisting of poly-3-hydroxybutyrate (PHB), poly-4-hydroxybutyrate (P4HB), poly-3-hydroxyvalerate (PHV), poly-3-hydroxypropionate (PHP), poly-2-hydroxybutyrate (P2HB), poly-4-hydroxyvalerate (P4HV), poly-5-hydroxyvalerate (P5HV), poly-3-hydroxyhexanoate (PHH), poly-3-hydroxyoctanoate (PHO), poly-3-hydroxyphenylvaleric acid (PHPV) and poly-3-hydroxyphenylhexanoic acid (PHPH).

7. A self-retaining suture comprising:

at least one filament, wherein at least one of the filaments includes a recombinant polyhydroxyalkonate (rPHA) copolymer; and

at least one tissue retainer, where the tissue retainer is introduced into the at least one rPHA filament to improve retention of the suture in tissue.

8. The self-retaining suture of claim 7, wherein the tissue retainer is a barb.

9. The self-retaining suture of claim 7, wherein the rPHA copolymer is selected from the group consisting of poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHBV), poly(3-hydroxybutyrate-co-3-hydroxyhexanoate) (PHBH), poly(3-hydroxybutyrate-co-4-hydroxyhexanoate) (PHB4H), poly(3-hydroxybutyrate-co-6-hydroxyhexanoate) (PHB6H), poly(3-hydroxybutyrate-co-3-hydroxyoctanoate) (PHBO), poly(3-hydroxybutyrate-co-3-hydroxyphenylvaleric acid) (PHBPV), poly(3-hydroxybutyrate-co-3-hydroxyphenylhexanoic acid) (PHBPH), poly(4-hydroxybutyrate-co-3-hydroxyvalerate) (P4HBV), poly(4-hydroxybutyrate-co-3-hydroxyhexanoate) (P4HBH), poly(4-hydroxybutyrate-co-4-hydroxyhexanoate) (P4HB4H), poly(4-hydroxybutyrate-co-6-hydroxyhexanoate) (P4HB6H), poly(4-hydroxybutyrate-co-3-hydroxyoctanoate) (P4HBO), poly(4-hydroxybutyrate-co-3-hydroxyphenylvaleric acid) (P4HBPV), poly(4-hydroxybutyrate-co-3-hydroxyphenylhexanoic acid) (P4HBPH), poly(3-hydroxyvalerate-co-3-hydroxyhexanoate) (PHVH), poly(3-hydroxyvalerate-co-4-hydroxyhexanoate) (PHV4H), poly(3-hydroxyvalerate-co-6-hydroxyhexanoate) (PHV6H), poly (3-hydroxyvalerate-co-3-hydroxyoctanoate) (PHVO), poly(3-hydroxyvalerate-co-3-hydroxyphenylvaleric acid) (PHVPV), poly(3-hydroxyvalerate-co-3-hydroxyphenylhexanoic acid) (PHVPH), poly(3-hydroxyvalerate-co-3-hydroxyphenylvaleric acid) (PHVPV), poly(3-hydroxyvalerate-co-3-hydroxyphenylhexanoic acid) (PHVPH), poly(3-hydroxypropionate-co-3-hydroxyvalerate) (PHPV), poly(3-hydroxypropionate-co-3-hydroxyhexanoate) (PHPH), poly(3-hydroxypropionate-co-4-hydroxyhexanoate) (PHP4H), poly(3-hydroxypropionte-co-6-hydroxyhexanoate) (PHP6H), poly(3-hydroxypropionate-co-3-hydroxyoctanoate) (PHPO), poly (3-hydroxypropionate-co-3-hydroxyphenylvaleric acid) (PHPPV), poly(3-hydroxypropionate-co-3-hydroxyphenylhexanoic acid) (PHPPH), poly(2-hydroxybutyrate-co-3-hydroxyvalerate) (P2HBV), poly(2-hydroxybutyrate-co-3-hydroxyhexanoate) (P2HBH), poly(2-hydroxybutyrate-co-4-hydroxyhexanoate) (P2HB4H), poly(2-hydroxybutyrate-co-6-hydroxyhexanoate) (P2H6H), poly(2-hydroxybutyrate-co-3-hydroxyoctanoate) (P2HBO), poly (2-hydroxybutyrate-co-3-hydroxyphenylvaleric acid) (P2HBPV), poly(2-hydroxybutyrate-co-3-hydroxyphenylhexanoic acid) (P2HBPH), poly(4-hydroxyvalerate-co-3-hydroxyvalerate) (P4HVV), poly(4-hydroxyvalerate-co-3-hydroxyhexanoate) (P4HVH), poly(4-hydroxyvalerate-co-4-hydroxyhexanoate) (P4H4H), poly(4-hydroxyvalerate-co-6-hydroxyhexanoate) (P4HV6H), poly(4-hydroxyvalerate-co-3-hydroxyoctanoate) (P4HVO), poly(4-hydroxyvalerate-co-3-hydroxyphenylvaleric acid) (P4HVPV), poly(4-hydroxyvalerate-co-3-hydroxyphenylhexanoic acid) (P4HVPH), poly(5-hydroxyvalerate-co-3-hydroxyvalerate) (P5HVV), poly(5-hydroxyvalerate-co-3-hydroxyhexanoate) (P4HVH), poly(5-hydroxyvalerate-co-4-hydroxyhexanoate) (P5HV4H), poly(5-hydroxyvalerate-co-6-hydroxyhexanoate) (P5HV6H), poly(5-hydroxyvalerate-co-3-hydroxyoctanoate) (P5HVO), poly(5-hydroxyvalerate-co-3-hydroxyphenylvaleric acid) (P5HVPV) and poly(5-hydroxyvalerate-co-3-hydroxyphenylhexanoic acid) (P5HVPH).

10. The self-retaining suture of claim 7, wherein the rPHA copolymer filament has a melting point between:

a lower limit of approximately 40°

C.; and

an upper limit of approximately 180°

C.

11. The self-retaining suture of claim 7, wherein the suture has a melting point between:

a lower limit of approximately 40°

C.; and

an upper limit of approximately 180°

C.

12. The self-retaining suture of claim 7, wherein the rPHA copolymer filament has an extension-to-break strength of between:

a lower limit of approximately 8%; and

an upper limit of approximately 42%.

13. The self-retaining suture of claim 7, wherein the suture has an extension-to-break strength of between:

a lower limit of approximately 8%; and

an upper limit of approximately 42%.

14. The self-retaining suture of claim 7, wherein the rPHA polymer is produced through recombinant expression in plant cells.

15. The self-retaining suture of claim 7, further comprising a plurality of tissue retainers on at least one filament, wherein the tissue retainers are arranged bidirectionally.

16. The self-retaining suture of claim 7, wherein the tissue retainers on a first set of at least one filament are aligned in a first direction, wherein the tissue retainers on a second set of at least one filament are aligned in a second direction, wherein the filaments of the first set are distinct from the filaments of the second set, wherein the first direction is opposite in direction to the second direction.

17. The self-retaining suture of claim 7, further comprising at least a second filament and wherein at least two of the at least two filaments are braided together.

18. The self-retaining suture of claim 7, wherein the suture has an absorption rate that is compatible with human tissue repair and replacement.

19. The self-retaining suture of claim 7, wherein the suture has a degradation profile that is compatible with human tissue repair and replacement.

20. The self-retaining suture of claim 7, wherein the suture induces a tissue specific reaction when the suture is inserted in vivo, wherein the tissue specific reaction induces collagen deposition around at least one tissue retainer insertion site to improve retention of the suture in tissue.