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

• US 9,550,164 B2
• Filed: 04/22/2015
• Issued: 01/24/2017
• Est. Priority Date: 02/21/2009
• Status: Active Grant

• Current Assignee: Sofradim Production
• Original Assignee: Sofradim Production
• Inventors: Ladet, Sbastien, Gravagna, Philippe
• Primary Examiner(s): Krylova, Irina
• Application Number:
  US14/692,776
• Publication Number:
  US 20150290617A1
• Time in Patent Office: 643 Days
• US Class Current: 1/1
• 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. An apparatus for forming an injectable composition comprising:

a supply assembly configured to maintain and selectively dispense a first precursor including a first core and at least one azide group and a second precursor including a second core and at least one alkyne group;

a mixing assembly configured to mix the first and the second precursors; and

at least one catalyzing element positioned within the mixing assembly and including 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 catalyzing element is selected from the group consisting of a helical member, multiple planar blades, and multiple curved blades.

2. The apparatus according to claim 1, wherein the transition metal ion chelating resin coating comprises transition metal ions selected from the group consisting of copper, zinc, iron, aluminum, magnesium, and alloys thereof.

3. The apparatus according to claim 2, wherein the transition metal ions are copper ions selected from the group consisting of copper sulfate, copper iodide, and combinations thereof.

4. The apparatus according to claim 1, wherein the transition metal ion chelating resin coating covers only a portion of the at least one catalyzing element.

5. The apparatus according to claim 1, wherein the transition metal ion chelating resin coating covers all of the at least one catalyzing element.

6. The apparatus according to claim 1, wherein the supply assembly includes a housing configured for operable handheld engagement by a user.

7. The apparatus according to claim 6, wherein the housing includes a flange member formed on a proximal end of the housing.

8. The apparatus according to claim 7, wherein the housing includes an extension formed on a distal end of the housing.

9. The apparatus according to claim 8, wherein the housing further includes a first component chamber configured to receive the first precursor and a second component chamber configured to receive the second precursor.

10. The apparatus according to claim 9, further comprising a plunger assembly including a first and a second plunger members operably engaging the housing and configured to selectively dispense the first and the second precursors from the first and the second component chambers.

11. The apparatus according to claim 10, further comprising a plunger cap member configured to fit about an end of the first and the second plunger members.

12. The apparatus according to claim 9, further comprising a first component conduit and a second component conduit that fluidly communicate the first and the second component chambers with the mixing assembly.

13. The apparatus according to claim 8, wherein the mixing assembly includes a substantially elongate member including a proximal end, a distal end, and a mixing cavity therebetween, wherein the proximal end is connected to the extension.

14. The apparatus according to claim 13, wherein the distal end of the mixing assembly further comprises an outlet configured for dispensing a mixture of the first and the second precursors.

15. The apparatus according to claim 13, wherein the at least one catalyzing element extends a length of the mixing cavity.

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

17. The apparatus according to claim 16, wherein the polyol is selected from the group consisting of polyethers, polyesters, polyether-esters, polyalkanols, and combinations thereof.