Devices for mixing and extruding medically useful compositions

• US 7,766,919 B2
• Filed: 11/02/2006
• Issued: 08/03/2010
• Est. Priority Date: 10/04/2002
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: Delmotte, Yves
• Primary Examiner(s): Philogene; Pedro
• Application Number:
  US11/555,942
• Publication Number:
  US 20080109002A1
• Time in Patent Office: 1,370 Days
• Field of Search: 606/92, 606/93, 606/94, 604/191, 604/82, 604/85, 604/89, 424/94.64, 424/443, 424/423
• US Class Current: 606/93
• CPC Class Codes: A61B 17/8816 characterised by the conduit, e.g. tube, along which fluid flows into the body or by conduit connections
• CPC Class Codes: A61B 17/8833 Osteosynthesis tools specially adapted for handling bone cement or fluid fillers; Means for supplying bone cement or fluid fillers to introducing tools, e.g. cartridge handling means
• CPC Class Codes: A61B 2017/00495 for two-component glue
• CPC Class Codes: A61B 2017/8838 for mixing bone cement or fluid fillers
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2310/00293 containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61F 2310/00377 Fibrin
• CPC Class Codes: A61J 1/2058 having multiple connecting ports
• CPC Class Codes: A61J 1/2075 for external venting
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61M 5/1782 Devices aiding filling of syringes in situ combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003
• CPC Class Codes: A61M 5/19 having more than one chamber , e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly surgical glue applicators A61B17/00491

Abstract

This invention provides devices and methods for mixing and extruding compositions which are medically and non-medically useful. The devices are particularly useful for mixing substances which are relatively inert when alone but become reactive when mixed. A common feature of all of the devices is that they allow the user to mix and ultimately extrude a composition from a single device which includes a single container or multiple interconnected containers.

Claims

1. A medical device for mixing and extruding a bone replacement material comprising:

a syringe comprising a single hollow cylindrical chamber having an upward opening and a downward opening, and a movable member configured to slide within the chamber;

a first chemically reactive substance that is located within the syringe, said substance being liquid above approximately zero degree centigrade and being maintained in a frozen state at a first temperature and disposed at a lower location; and

a second chemically reactive substance that is solid at room temperature and located in the syringe atop the first substance without mixing with the first substance when the syringe is maintained at the first temperature, such second chemically reactive substance having a plurality of pores;

wherein, the first substance thaws to a liquid state upon the syringe being exposed to room temperature such that actuation of the movable member pushes the thawed first chemically reactive substance upward into the pores of the second chemically reactive substance, the volume of the first substance being sufficient to immerse the second substance to allow for mixing of such first and second substances within the hollow cylindrical chamber prior to extrusion through the upward opening.

2. The medical device of claim 1 wherein the syringe includes a removable cap that is attached to the forward opening.

3. The medical device of claim 1 wherein the movable member is slidably mounted within the chamber.

4. The medical device of claim 1 wherein the first chemically reactive substance includes fibrinogen.

5. The medical device of claim 1 wherein the second substance includes thrombin.

6. The medical device of claim 5 wherein the second substance includes at least one mineral substance.

7. The medical device of claim 6, wherein the mineral substance is selected from the group consisting of hydroxyapatite, calcium carbonate, calcium sulfate, biphasic materials constituted of hydroxyapatite and calcium based minerals, ion substituted hydroxyapatite, polarized hydroxyapatite, and blend corn starch with hydroxyapatite.

8. The medical device of claim 6 wherein the thrombin is adsorbed onto the mineral substance prior to placement in the syringe.

9. The medical device of claim 1 wherein the movable member is a plunger having two stop ends for preventing the plunger from being pushed out of the syringe when a composite is extruded.

10. The medical device of claim 7 wherein the mineral substance includes MBCP.

11. The medical device of claim 1 wherein the volume of the second chemically reactive substance is substantially equal to the volume of the first and second chemically reactive substances.

12. The medical device of claim 1 wherein the second chemically reactive substance has a porosity of about 80.5%.

13. The medical device of claim 1, wherein the syringe comprises a single movable member configured to slide within the chamber.

14. The medical device of claim 13, wherein the single moveable member comprises a single piston disposed in the single hollow cylindrical chamber and a pusher member with a first end attached to the single piston and a second end depending from the single hollow cylindrical chamber.