Apparatus and method of reacting polymers passing through metal ion chelated resin matrix to produce injectable medical devices

• US 9,039,979 B2
• Filed: 02/22/2010
• Issued: 05/26/2015
• Est. Priority Date: 02/21/2009
• Status: Expired due to Fees

• Current Assignee: Sofradim Production
• Original Assignee: Sofradim Production
• Inventors: Ladet, Sbastien, Gravagna, Philippe
• Primary Examiner(s): Krylova, Irina
• Application Number:
  US13/202,348
• Publication Number:
  US 20120035335A1
• Time in Patent Office: 1,919 Days
• Field of Search: 422/131, 422/135, 424/400
• US Class Current: 422/135
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 2017/00495 for two-component glue
• CPC Class Codes: B01F 25/43141 composed of consecutive sections of helical formed elements
• CPC Class Codes: B01F 25/451 characterised by means for moving the materials to be mixed or the mixture
• CPC Class Codes: B01F 25/4521 the components being pressed through orifices in elements, e.g. flat plates or cylinders, which obstruct the whole diameter of the tube
• CPC Class Codes: B01F 33/5011 portable during use, e.g. hand-held
• CPC Class Codes: B01F 33/50112 of the syringe or cartridge type
• CPC Class Codes: B01J 14/005 in the presence of catalytically active bodies, e.g. porous plates
• CPC Class Codes: B01J 19/0053 Details of the reactor
• CPC Class Codes: B01J 19/0066 Stirrers mixing per se B01F
• CPC Class Codes: B01J 19/18 Stationary reactors having moving elements inside B01J19/08, B01J19/26 take precedence
• CPC Class Codes: B01J 2219/00761 Details of the reactor
• CPC Class Codes: B01J 23/72 Copper
• CPC Class Codes: B01J 35/56 Foraminous structures having flow-through passages or channels, e.g. grids or three-dimensional monoliths
• CPC Class Codes: C08G 63/66 Polyesters containing oxygen in the form of ether groups C08G63/42, C08G63/58 take precedence

Abstract

The present disclosure relates to an apparatus and process for forming medical devices from an injectable composition. The apparatus includes a supply assembly configured to maintain and selective dispense a first precursor and a second precursor, a mixing assembly configured to mix the first and second precursors, and at least one catalyzing element including a transition metal ion to aid in the polymerization of the first and second precursors. The process includes dispensing a volume of the first precursor and a volume of the second precursor into a mixing assembly and mixing the first and second precursors. The first and second precursors each possess a core and at least one functional group known to have click reactivity with each other. The mixed precursors are contacted with a transition metal catalyst to produce a flowable composition for use as a medical device.

Claims

1. A process of forming an injectable medical device comprising:

dispensing a volume of a first precursor and a volume of a second precursor into a mixing assembly including at least one mixing element, the first precursor including a first core and at least one azide group and the second precursor including a second core and at least one alkyne group;

mixing the first and second precursors within the mixing assembly via the at least one mixing element wherein the mixing element further includes a transition metal ion chelating resin coating to catalyze a reaction between the at least one azide group and the at least one alkyne group to produce an injectable composition for use as an implantable medical device, wherein the mixing element is selected from the group consisting of a helical member, multiple planar blades, and multiple curved blades.

2. The process according to claim 1, wherein the first precursor and optionally the second precursor comprises a polyol core.

3. The process according to claim 2, wherein the polyol is selected from the group consisting of polyethers, polyesters, polyether-esters, polyalkanols, and combinations thereof.

4. The process according to claim 2, wherein the polyol core comprises a bioabsorbable material.

5. The process according to claim 1, wherein the transition metal catalyst is selected from copper, zinc, iron, aluminum, magnesium, and alloys thereof.

6. A medical device formed in accordance with the process of claim 1, selected from the group consisting of wound closure devices, sealants, tissue-bulking devices, and adhesion barriers.

7. The process according to claim 1, wherein the mixing element includes a plurality of openings to permit the flow of the first and second precursors therethrough.

8. The process according to claim 1, wherein the mixing element is a single helical screw.

9. The process of claim 1, wherein the transition metal ion chelating resin coating covers all of the mixing element.

10. A process of forming an injectable medical device comprising:

dispensing a volume of a first precursor and a volume of a second precursor into a mixing assembly including at least one mixing element, the first precursor including a first core and at least one alkyne group and the second precursor including a second core and at least one azide group;

mixing the first and second precursors within the mixing assembly via the at least one mixing element wherein the mixing element further includes a transition metal ion chelating resin coating to catalyze a reaction between the at least one alkyne group and the at least one azide group to produce an injectable composition for use as an implantable medical device, wherein the mixing element is selected from the group consisting of a helical member, multiple planar blades, and multiple curved blades.

11. The process according to claim 10, wherein the first precursor and optionally the second precursor comprises a polyol core.

12. The process according to claim 11, wherein the polyol is selected from the group consisting of polyethers, polyesters, polyether-esters, polyalkanols, and combinations thereof.

13. The process according to claim 11, wherein the polyol core comprises a bioabsorbable material.

14. The process according to claim 10, wherein the transition metal catalyst is selected from copper, zinc, iron, aluminum, magnesium, and alloys thereof.

15. A medical device formed in accordance with the process of claim 10, selected from the group consisting of wound closure devices, sealants, tissue-bulking devices, and adhesion barriers.

16. The process according to claim 10, wherein the mixing element includes a plurality of openings to permit the flow of the first and second precursors therethrough.

17. The process according to claim 10, wherein the mixing element is a single helical screw.

18. The process of claim 10, wherein the transition metal ion chelating resin coating covers all of the mixing element.