System for use in bone cement preparation and delivery

• US 10,039,584 B2
• Filed: 11/04/2015
• Issued: 08/07/2018
• Est. Priority Date: 04/21/2008
• Status: Active Grant

• Current Assignee: Dfine Incorporated (Merit Medical Systems, Inc.)
• Original Assignee: Dfine Incorporated (Merit Medical Systems, Inc.)
• Inventors: Phan, Christopher U., Kohm, Andrew
• Primary Examiner(s): SOOHOO, TONY GLEN
• Application Number:
  US14/932,714
• Publication Number:
  US 20160157910A1
• Time in Patent Office: 1,007 Days
• CPC Class Codes: A61B 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• CPC Class Codes: A61B 17/8822 characterised by means facilitating expulsion of fluid from the introducer, e.g. a screw pump plunger, hydraulic force transmissions, application of vibrations or a vacuum
• CPC Class Codes: A61B 17/8827 with filtering, degassing, venting or pressure relief means
• 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 2017/8838 for mixing bone cement or fluid fillers
• CPC Class Codes: A61L 24/0094 containing macromolecular fillers
• CPC Class Codes: B01F 2101/20 Mixing of ingredients for bone cement
• CPC Class Codes: B01F 23/511 characterised by the composition of the liquids or solids
• CPC Class Codes: B01F 23/565 by introducing liquids in solid material, e.g. to obtain slurries
• CPC Class Codes: B01F 31/65 the materials to be mixed being directly submitted to a pulsating movement, e.g. by means of an oscillating piston or air column
• CPC Class Codes: B01F 33/50112 of the syringe or cartridge type
• CPC Class Codes: B01F 35/2112 Level of material in a container or the position or shape of the upper surface of the material
• CPC Class Codes: B01F 35/717613 Piston pumps
• CPC Class Codes: B01F 35/718 using vacuum, under pressure in a closed receptacle or circuit system

Abstract

A system for use in combining two part preparations, such as bone cement, can include a chamber for intermixing liquid and powder components, a container, a vacuum channel, and a filter. The mixing chamber can be configured to hold a non-liquid, polymer powder component of a bone cement. The container can be configured to hold a liquid component of the bone cement. The vacuum channel can direct a partial vacuum to draw the liquid component from the container into the non-liquid component in the mixing chamber to intermix the components and to thereby provide a settable bone cement.

Claims

1. A method of preparing a bone cement, comprising:

forming a mixture of a monomer liquid and polymer beads in a chamber having an opening at one end and a porous member at another end;

applying a pressure to the mixture to mix the monomer liquid and the polymer beads, wherein applying the pressure comprises using a pressure applicator to remove air from the mixture through the porous member, wherein the pressure applicator comprises a syringe comprising a plunger configured to apply the pressure upon being displaced, the syringe further comprising a spring configured to resist being displaced; and

determining a level of mixing between the monomer liquid and the polymer beads by detecting a level of saturation of the porous member by the monomer liquid.

2. The method of claim 1, wherein determining the level of mixing comprises detecting that the porous member is fully saturated with the monomer liquid that has been in contact with the polymer beads.

3. The method of claim 1, wherein the porous member is configured to pass air therethrough and to selectively prevent the monomer liquid that has been in contact with the polymer beads and having a viscosity greater than a predetermined value from passing therethrough.

4. The method of claim 3, wherein the polymer beads and the monomer liquid are configured such that the monomer liquid attains a viscosity exceeding the predetermined value upon the polymer bead surfaces being substantially saturated with the monomer liquid, and wherein the method further comprises determining that the polymer bead surfaces are substantially saturated with the monomer liquid based on air being removed from the mixture while the contacted monomer liquid is prevented from passing through the porous member.

5. The method of claim 1, further comprising, after applying the pressure, allowing a mechanical equilibrium to be reached between a force exerted on the plunger by a pressurized mixture and an opposing spring force exerted on the plunger by the spring, and determining from the equilibrium that the porous member has been fully saturated.

6. The method of claim 1, wherein the chamber and the pressure applicator are fixed in an upright position and extend in a vertical direction.

7. The method of claim 1, wherein the chamber is at least partially formed of a transparent material such that determining the level of mixing comprises visually detecting the level of saturation of the porous member.

8. The method of claim 1, wherein the porous member has a mean pore dimension of about 0.05 to 10 microns.

9. A method of preparing a bone cement, comprising:

providing a bone cement preparation system comprising a chamber configured to pass air therethrough and to selectively prevent a monomer liquid that has been in contact with polymer beads from passing therethrough;

applying a pressure to remove air from the chamber and into a flow channel;

expelling the air from the flow channel through a one-way valve;

mixing polymer beads and a monomer liquid in the chamber; and

determining that the polymer bead surfaces are substantially saturated with the monomer liquid based on air being removed from the mixture while the monomer liquid that has been in contact with the polymer beads is prevented from passing through the chamber.

10. The method of claim 9, wherein the chamber is formed of a transparent material and determining that the polymer bead surfaces are substantially saturated comprises visually observing that the monomer liquid that has been in contact with the polymer beads is prevented from passing through the chamber.

11. The method of claim 9, wherein the chamber comprises a porous member at a bottom end of the chamber that is configured to pass air and to selectively prevent the monomer liquid that has been in contact with polymer beads from passing through.

12. The method of claim 11, further comprising determining a level of mixing between the monomer liquid and the polymer beads by detecting a level of saturation of the porous member.

13. The method of claim 12, wherein determining the level of mixing comprises detecting that the porous member is fully saturated with the monomer liquid.

14. The method of claim 9, wherein the polymer beads include a first volume of PMMA beads having an average cross section of less than about 100 microns and a second volume of PMMA beads having an average cross section of greater than about 100 microns.

15. The method of claim 14, wherein the polymer beads have less than 2.5 weight percent of an initiator on the basis of the total weight of the polymer beads.

16. The method of claim 15, wherein an initial volume ratio of the polymer beads to the monomer liquid is between 2:

1 and 5;

1.

17. The method of claim 9, wherein applying the pressure comprises applying a negative pressure to the chamber.

18. The method of claim 9, wherein applying the pressure comprises using a pressure source coupled to the chamber through a porous member.

19. The method of claim 18, wherein the pressure source comprises a syringe having a retractable plunger.

20. The method of claim 19, wherein detecting that the polymer bead surfaces are substantially saturated comprises detecting a change in position of the retractable plunger after applying the pressure.

21. A method of preparing a bone cement, comprising:

forming a mixture of a monomer liquid and polymer beads in a chamber having an opening at one end and a porous member at another end;

applying a pressure to the mixture to mix the monomer liquid and the polymer beads, wherein applying the pressure comprises using a pressure applicator to remove air from the mixture through the porous member, wherein the chamber and the pressure applicator are fixed in an upright position and extend in a vertical direction

wherein the pressure applicator comprises a syringe comprising a plunger configured to apply the pressure upon being displaced, the syringe further comprising a spring configured to resist being displaced.