Two-phase compositions for absorbable surgical devices

• US 4,744,365 A
• Filed: 09/22/1987
• Issued: 05/17/1988
• Est. Priority Date: 07/17/1986
• Status: Expired due to Term

• Current Assignee: United States Surgical Corporation (Medtronic Plc)
• Original Assignee: United States Surgical Corporation (Medtronic Plc)
• Inventors: Kennedy, John J., Hermes, Matthew E., Muth, Ross R., Kaplan, Donald S.
• Primary Examiner(s): Howard, Jacqueline V.
• Application Number:
  US07/099,635
• Time in Patent Office: 238 Days
• Field of Search: 128/335.5, 128/334 R, 528/354
• US Class Current: 606/230
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61L 31/041 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 31/048 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/129 containing macromolecular fillers
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

An absorbable, annealed surgical device made from a multi-phase, polymeric composition derived from lactide and glycolide is disclosed. Preferably, the composition has two phases, both phases are continuous, the first phase has about 0-about 25% m glycolide moieties, the overall composition has up to 45% m glycolide moieties, and the first phase constitute at least 50% (and preferably not more than about 95%) by weight of the composition. The device has a high distortion temperature, good resistance to hot-wet creep, but yet loses tensile strength in vivo quickly. The composition per se is injection-moldable, can be annealed, and is not brittle.

Claims

1. An absorbable, annealed surgical device of a multi-phase polymeric composition derived from lactide and glycolide, the first phase having about 0-about 25% m glycolide moieties and about 75-about 100% m lactide moieties and the other phase or phases having glycolide and lactide moieties in amounts such that the composition overall has up to 45% m glycolide moieties, wherein the first phase constitutes at least 50% by weight of the annealed surgical device.

2. The device of claim 1 wherein the first phase has 10-20% m glycolide moieties and the composition overall has 30-45% m glycolide moieties.

3. The device of claim 1 wherein the first phase has about 10% m glycolide moieties and the composition overall has about 35% m glycolide moieties.

4. The device of claim 1 wherein the composition has two phases.

5. The device of claim 4 wherein both phases are continuous.

6. The device of claim 5 wherein the first phase has 10-20% m glycolide moieties and the composition overall has 30-45% glycolide moieties.

7. The device of claim 5 wherein the first phase has about 10% m glycolide moieties and the composition overall has about 35% m glycolide moieties.

8. The device of claim 4 wherein the first phase is continuous and the second phase comprises discrete particles.

9. The device of claim 8 wherein the discrete phase contains about 100% m glycolide moieties.

19. The device of claim 1 wherein the device is injection molded.

20. The device of claim 19 wherein the device is an injection molded staple or an injection molded clip.

21. The device of claim 4 wherein the crystallinity of the first phase is about 10-20%, based on the total device, and the crystallinity of the second phase is less than about 10%, based on the total device.

10. An annealable, injection-moldable lactide/glycolide polymeric composition having at least two phases wherein the first phase contains about 0-about 25% m glycolide moieties and about 75-about 100% m lactide moieties and the other phase or phases contain glycolide moieties in amounts such that the overall composition contains up to 45% m glycolide moieties, wherein the first phase constitutes at least 50% by weight of the annealable polymeric composition.

11. The composition of claim 10 wherein the first phase contains 10-20% m glycolide moieties and the composition overall has 30-45% m glycolide moieties.

12. The composition of claim 10 wherein the first phase contains about 10% m glycolide moieties and the composition overall contains about 35% m glycolide moieties.

13. The composition of claim 10 wherein there are two phases.

14. The compostion of claim 13 wherein both phases are continuous.

15. The composition of claim 14 wherein the first phase has 10-20% m glycolide moieties and the composition overall has 30-45% glycolide moieties.

16. The composition of claim 14 wherein the first phase has about 10% m glycolide moieties and the composition overall has about 35% m glycolide moieties.

17. The composition of claim 13 wherein the first phase is continuous and the second phase comprises discrete particles.

18. The composition of claim 17 wherein the discrete phase contains about 100% m glycolide moieties.

22. The composition of claim 13 wherein the crystallinity of the first phase is about 5-10%, based on the total composition, and the crystallinity of the second phase is about 1-5%, based on the total composition.

23. An absorbable, injection moldable multi-phase polymeric composition containing lactide and glycolide moieties, comprising a matrix polymer phase and a discrete polymer phase dispersed therein, the matrix phase comprising a polymer composition which is lactide-rich and the discrete phase comprising a polymer composition which is glycolide-rich and having a melting point which is higher than the melting point of the lactide-rich phase, and the multi-phase polymer composition as a whole comprising predominantly lactide moieties.

24. The composition of claim 23 wherein the polymer of both the matrix and discrete phases comprise lactide and glycolide moieties.

25. The composition of claim 23 wherein the polymer of the matrix phase comprises lactide and glycolide moieties.

26. An absorbable, annealed surgical device of multi-phase polymeric composition containing lactide and glycolide moieties, comprising a matrix polymer phase and a discrete polymer phase dispersed therein, the matrix phase comprising a polymer composition which is lactide-rich and the discrete phase comprising a polymer composition which is glycolide-rich and having a melting point which is higher than the melting point of the lactide-rich phase, and the multi-phase polymer composition as a whole comprising predominantly lactide moieties.

27. The composition of claim 26 wherein the polymer of both the matrix and discrete phases comprise lactide and glycolide moieties.

28. The composition of claim 26 wherein the polymer of the matrix phase comprises lactide and glycolide moieties.