Devices and methods for mixing and extruding medically useful compositions

• US 7,135,027 B2
• Filed: 10/04/2002
• Issued: 11/14/2006
• 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:
  US10/265,076
• Publication Number:
  US 20040068266A1
• Time in Patent Office: 1,502 Days
• Field of Search: 606/92, 606/93, 606/94
• 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 method for mixing and extruding a bone replacement material comprising the steps of:

providing a device comprising one container wherein at least two chemically reactive components of the bone replacement material are mixed and extruded after mixing;

sequentially placing the components of the bone replacement material into such container, at least one of such components is frozen during replacement and prior to mixing in such container;

mixing the components by thawing such component that is frozen to form the bone replacement material in said at least one container; and

extruding the bone replacement materials from the device.

2. The method of claim 1, wherein the bone replacement material comprises fibrin glue.

3. The method of claim 1, wherein the bone replacement material comprises a calcium based mineral.

4. A method for mixing and extruding a composite material comprising the steps of:

providing a syringe having a hollow cylindrical tube with a forward opening, and a rear opening through which a piston is fitted;

the forward opening being fitted such that a removable cap can cover the forward opening; and

the removable cap containing a removable cover that covers a port into which a luer tip can be inserted;

sequentially placing at least two chemically reactive substances in the tube, at least one of such substances being frozen during placement and prior to reaction between such substances in such tube;

causing the substances to react in said hollow cylindrical tube by thawing such substance that is frozen so as to form a composition; and

extruding the composition from the tube.

5. The method of claim 4, wherein the first and second chemically reactive substances can react to form a glue-like composition.

6. The method of claim 4, where the first chemically reactive substance is frozen after being placed in the tube but before the second chemically reactive substance is placed in the tube.

7. The method of claim 4, wherein the first chemically reactive substance is frozen at a temperature of 0°

C. or below.

8. The method of claim 4, wherein at least one mineral substance is placed in the syringe prior to causing the first and second chemically reactive substances to react.

9. The method of claim 5, 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.

10. The method of claim 8, wherein the second substance is adsorbed onto the mineral substance prior to the step of causing the first and second chemically reactive substances to react in the tube.

11. The method of claim 4, wherein the composition extruded from the syringe is a bone replacement material.

12. The method of claim 4, wherein the composition extruded from the syringe is a composite of the first chemically reactive substance, the second chemically reactive substance, and the mineral substance.

13. A method for mixing a first reactive substance and a second reactive substance comprising the steps of:

providing a syringe having a hollow cylindrical tube with a forward opening, and a rear opening through which a piston is fitted;

the forward opening being fitted such that a removable cap can cover the forward opening; and

the removable cap containing a removable cover that covers a port into which a luer tip can be inserted;

placing a first reactive component having a first volume into the syringe;

placing a second reactive component having a second volume into the syringe, at least one of such components being frozen during placement and prior to mixing of such components in such tube;

causing the first and second reactive components to react in such tube by thawing such substance that is frozen; and

mixing the first and second components together in said hollow cylindrical tube by advancing the piston, whereby the first and second reactive components mix to form a composition having a total volume approximate to one of the first and second volumes.

14. The method of claim 13, wherein the first reactive component is a solid and the second reactive component is a liquid.

15. The method of claim 14, wherein the first reactive component 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.

16. The method of claim 13, wherein the first and second reactive substances can react to form a glue-like composition.

17. The method of claim 13 wherein the respective volume of one of such components has a sufficient density to accommodate the volume of the other of such components when such components are mixed.

18. The method of claim 17 wherein one of such components comprises thrombin and the other of such components comprises fibrinogen.

19. The method of claim 14 wherein the first reactive component comprises thrombin and the second reactive component comprises fibrinogen.

20. The method of claim 13 wherein mixing is performed while the cap covers the forward opening.

21. The method of claim 13 further comprising;

removing the cap; and

extruding the composition through the forward opening.