Vacuum mixing/bone cement cartridge and kit

• US 5,100,241 A
• Filed: 09/21/1990
• Issued: 03/31/1992
• Est. Priority Date: 01/13/1989
• Status: Expired due to Term

• Current Assignee: Zimmer Technology Incorporated (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Kwan-Ho Chan
• Inventors: Chan, Kwan-Ho
• Primary Examiner(s): Stinson, Frankie L.
• Application Number:
  US07/586,198
• Time in Patent Office: 557 Days
• Field of Search: 366/139, 366/189, 366/197, 366/76, 366/96, 366/154, 366/130, 366/256, 366/258, 366/602, 366/332, 366/255, 366/167, 366/333
• US Class Current: 366/139
• 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 17/8808 with sealing collar for bone cavity
• CPC Class Codes: A61B 17/8811 characterised by the introducer tip, i.e. the part inserted into or onto the bone
• CPC Class Codes: A61B 17/8827 with filtering, degassing, venting or pressure relief means
• CPC Class Codes: A61B 2017/883 Means for indicating hardening of bone cement
• CPC Class Codes: A61F 2002/30561 breakable or frangible
• CPC Class Codes: A61F 2002/4685 by means of vacuum
• CPC Class Codes: A61F 2250/0071 breakable or frangible
• CPC Class Codes: B01F 2101/20 Mixing of ingredients for bone cement
• CPC Class Codes: B01F 33/50 Movable or transportable mixing devices or plants
• CPC Class Codes: B01F 33/5011 portable during use, e.g. hand-held

Abstract

A two-component bone cement mixing system comprises a cartridge mixer having an interior volume containing a first predetermined quantity of a free-flowing, powdery, solid bone cement component under vacuum pressure; an ampoule containing a second predetermined quantity of a liquid bone cement component; a fluid transfer element for fluidically connecting the cartridge mixer and the ampoule for transfer of the liquid bone cement component to the cartridge mixer; and a plug element, receivable within the ampoule, for automatically hermetically sealing the fluid transfer element against passage of a material therethrough upon completion of the transfer of the second predetermined quantity of the liquid bone cement component into the cartridge mixer. The two-component bone cement mixing system allows in vacuo mixing of liquid monomeric and solid polymeric bone cement components without air being incorporated into the mixture and insures the prevention of air passage into the cartridge mixer during and/or after monomer transfer. In order to ensure transfer of all of the liquid monomer into the cartridge mixer, solely by vacuum pressure, the ratio of the interior volume of the cartridge mixer (Vcm), measured in cubic centimeters, to the volume of the first predetermined quantity of a free-flowing, powdery, solid bone cement component (Vbc), measured in cubic centimeters, should be in the range of Vcm/Vbc of about 1.5 to 3.5.

Claims

1. A two-component bone cement mixing system comprising:

(A) a cartridge mixer means, having an interior volume containing a first predetermined quantity of a free-flowing, powdery, solid bone cement component under vacuum pressure, for mixing said first predetermined quantity of a solid bone cement component with a second predetermined quantity of a liquid bone cement component in the substantial absence of air to form a third predetermined quantity of a fluid two-component bone cement, wherein the interior volume of said cartridge mixer means, measured in cubic centimeters, is represented by Vcm, said first predetermined quantity of a free-flowing, powdery solid bone cement component has a volume, measured in cubic centimeters, represented by Vbc and Vcm/Vbc is about 1.5 to 3.5;

(B) container means, containing said second predetermined quantity of a liquid bone cement component, for holding a liquid bone cement component;

(C) fluid transfer means, operably connectable to said cartridge mixer means and said container means, for fluidically connecting said container means and said cartridge mixer means to transfer said second predetermined quantity of a liquid bone cement component from said container means to said cartridge mixer means;

(D) plug means, receivable within said container means, for automatically hermetically sealing said fluid transfer means against passage of a material therethrough upon completion of the transfer of said second predetermined quantity of a liquid bone cement component from said container means to said cartridge mixer means therethrough.

2. The mixing system according to claim 1, wherein said cartridge mixer means containing said first predetermined quantity of a solid bone cement component under vacuum pressure is itself contained within a substantially air-impermeable container under vacuum pressure.

3. The mixing system according to claim 2, wherein said air-impermeable container is a plastic bag.

4. The mixing system according to claim 1, wherein said vacuum pressure in said cartridge mixer means is less than about 30 mm Hg.

5. The mixing system according to claim 1, wherein said cartridge mixer means comprises

cartridge means, receivable within a bone cement gun, for containing said third predetermined quantity of a fluid two-component bone cement, said cartridge means including piston means, operatively engageable by said bone cement gun and moveable within said cartridge means, for dispensing of said fluid two-component bone cement from said cartridge means;

mixer means, detachably connected to said cartridge means, for agitating the contents of said cartridge means, said mixer means including inlet port means, operably connectable to said fluid transfer means, for passage of said second predetermined quantity of a liquid bone cement component into said cartridge mixer means;

hermetic sealing means for sealing said connected cartridge means and mixer means against the ingress of air.

6. The mixing system according to claim 5, wherein said cartridge means comprises

a hollow cartridge body member having a longitudinal axis, and a first open end and a second open end spaced apart on said longitudinal axis;

a piston member, axially slidable within said hollow cartridge body member, disposed within said hollow cartridge body member proximate said first end of said cartridge body, to close said first end of said cartridge body.

7. The mixing system according to claim 6, wherein said mixer means comprises

a hollow mixer body member having a longitudinal axis, and a first open end and a second open end spaced apart on said longitudinal axis;

a cap member, disposed proximate said first end of said hollow mixer body, to close said first end of said hollow mixer body;

a self-sealing aperture, formed in said cap member, operably engageable by said fluid transfer means, for fluidic communication with said interior volume of said cartridge mixer means when engaged by said fluid transfer means and sealed closure of said interior volume when not engaged by said fluid transfer means;

a first aperture, formed in said cap member, receivable of a mixing element therethrough;

a movable mixing element, received in said first aperture and extending from said interior volume of said cartridge through said first aperture, movement of said mixing element causing agitation of the contents of said cartridge mixer means.

8. The mixing system according to claim 7, wherein said cartridge mixer means further comprises detachable connection means for detachably coaxially connecting said second end of said hollow cartridge body member to said second end of said hollow mixer body member.

9. The mixing system according to claim 8, wherein said detachable connection means comprises a first screw thread formed on an outer surface of said second end of said hollow cartridge body member and a second screw thread formed on an inner surface of said second end of said hollow mixer body member, said first screw thread and said second screw thread being threadingly engageable of one another.

10. The mixing system according to claim 7, wherein said first aperture has an axis substantially parallel to said longitudinal axis of said hollow mixer body member and said movable mixing element has an axis coaxial with said axis of said first aperture.

11. The mixing system according to claim 10, wherein said mixer element is rotatably movable about said axis of said first aperture.

12. The mixing system according to claim 11, wherein said movable mixing element is axially slidable in said first aperture.

13. The mixing system according to claim 1, wherein said container means comprises a hollow container body member having a longitudinal axis and a first end and a second end, said second end including a spout coaxial with said hollow body longitudinal axis and a removable closure member for said spout.

14. The mixing system according to claim 13, wherein said container means comprises an ampoule.

15. The mixing system of claim 14, wherein said ampoule is made of glass.

16. The mixing system according to claim 13, wherein said fluid transfer means comprises

a hollow injector body member having a longitudinal axis and a first open end and a second open end spaced apart on said longitudinal axis, said hollow injector body member slidingly receivable of said hollow container body member;

a cap member, disposed on said second open end of said hollow injector body member for closure thereof, said cap member including a fluid conduit for passage of a fluid through said cap member;

an elongate hollow tube, operably connectable to said cartridge mixer means and hermetically connectable to said fluid conduit;

support means, hermetically sealingly connecting said second end of said hollow injector body member and said cap member, for engagingly contacting said second end of said hollow container body member, said support means including a fluid passage fluidically connected to said fluid conduit and receivable of said spout of said hollow container body member.

17. The mixing system according to claim 16, wherein said plug means comprises a float member having a specific gravity less than said liquid bone cement component, said float member sealingly receivable in said fluid passage in said support means.

18. The mixing system according to claim 17, wherein said float member is a polyethylene ball.

19. The mixing system according to claim 1, wherein Vcm/Vbc is about 2.0.

20. A cartridge mixer, having an interior volume, useful for the mixing of a first predetermined quantity of a free-flowing powdery, solid bone cement component with a second predetermined quantity of a liquid bone cement component to form a third predetermined quantity of a fluid two-component bone cement, wherein the interior volume of said cartridge mixer, measured in cubic centimeters, is represented by Vcm, said first predetermined quantity of a free-flowing, powdery solid bone cement component has a volume, measured in cubic centimeters, represented by Vbc and Vcm/Vbc is about 1.5 to 3.5, said cartridge mixer comprising

cartridge means, receivable within a bone cement gun, for containing said third predetermined quantity of a fluid two-component bone cement, said cartridge means including piston means, operatively engageable by said bone cement gun and movable within said cartridge means, for dispensing of said fluid two-component bone cement from said cartridge means;

mixer means, detachably connected to said cartridge means, for agitating the contents of said cartridge means, said mixer means including inlet port means for passage of a second predetermined quantity of a liquid bone cement component into said cartridge mixer;

hermetic sealing means for sealing said connected cartridge means and mixer means against the ingress of air.

21. The cartridge mixer according to claim 20, wherein said cartridge mixer contains a first predetermined quantity of said solid bone cement component under vacuum pressure.

22. The cartridge mixer according to claim 21, wherein said vacuum pressure is less than about 30 mm Hg.

23. The cartridge mixer according to claim 21, wherein said cartridge mixer is contained within a substantially air-impermeable container under vacuum pressure.

24. The cartridge mixer according to claim 23, wherein said air-impermeable container is a plastic bag.

25. The cartridge mixer according to claim 20, wherein said cartridge means comprises

a hollow cartridge body member having a longitudinal axis, and a first open end and a second open end spaced apart on said longitudinal axis;

a piston member, axially slidable within said hollow cartridge body member, disposed within said hollow cartridge body member proximate said first end of said cartridge body, to close said first end of said cartridge body.

26. The cartridge mixer according to claim 25, wherein said mixer means comprises

a hollow mixer body member having a longitudinal axis, and a first open end and a second open end spaced apart on said longitudinal axis;

a cap member, disposed proximate said first end of said hollow mixer body, to close said first end of said hollow mixer body;

a self-sealing aperture, formed in said cap member, for fluidic communication with said interior volume of said cartridge mixer means;

a first aperture, formed in said cap member, receivable of a mixing element therethrough;

a movable mixing element, received in said first aperture and extending from said interior volume of said cartridge through said first aperture, movement of said mixing element causing agitation of the contents of said cartridge mixer means.

27. The cartridge mixer according to claim 26, wherein said first aperture has an axis substantially parallel to said longitudinal axis of said hollow mixer body member and said movable mixing element has an axis coaxial with said axis of said first aperture.

28. The cartridge mixer according to claim 27, wherein said mixer element is rotatably movable about said axis of said first aperture.

29. The cartridge mixer according to claim 28, wherein said movable mixing element is axially slidable in said first aperture.

30. The cartridge mixer according to claim 29, wherein said mixer element comprises a plate member disposed substantially perpendicular to said axis of said first aperture, said plate element being axially movable within said hollow mixer body member, said plate element having a plurality of holes therethrough.

31. The cartridge mixer according to claim 30, wherein said hollow mixer body member is circular in cross-section, said plate member is circular in plan, said plurality of holes comprises a first plurality of pairs of holes, each of said pairs of holes comprising a hole with a first radius and a hole with a second radius, said first radius being larger than said second radius, each of said holes in a pair of holes being centered on a common diameter of said plate member and disposed on opposite sides of said plate center from one another.

32. The cartridge mixer according to claim 31, wherein each hole having said first radius is immediately adjacent and disposed between two holes having said second radius, in a circumferential direction.

33. The cartridge mixer according to claim 32, wherein said first plurality of pairs of holes comprises three pairs of holes and the common diameter of each pair of holes is offset 60°

of arc from adjacent common diameters of holes.

34. The cartridge mixer according to claim 20, wherein Vcm/Vbc is about 2.0.

35. A two-component bone cement kit comprising:

(A) a vacuum-packed cartridge mixer, defining an interior volume, containing a first predetermined quantity of a free-flowing, powdery, solid bone cement component, wherein the interior volume of said cartridge mixer, measured in cubic centimeters, is represented by Vcm, said first predetermined quantity of a free-flowing, powdery solid bone cement component has a volume, measured in cubic centimeters, represented by Vbc and Vcm/Vbc is about 1.5 to 3.5, said cartridge mixer comprising;

a cartridge member, receivable within a bone cement gun, comprising a hollow, air-impermeable cartridge body member having a longitudinal axis, and a first open end and a second open end spaced apart on said longitudinal axis.

an air-impermeable piston member, axially slidable within said hollow cartridge body, disposed within said cartridge body, proximate said first end of said cartridge body, to close said first end of said cartridge body,

releasable hermetic sealing means for releasably hermetically sealing said piston member to said cartridge body proximate said first end of said cartridge body,

a mixer member comprising a hollow, air-impermeable mixer body having a longitudinal axis, and a first open end and a second open end spaced apart on said longitudinal axis,

releasable connection means for releasably coaxially hermetically sealing connecting said second end of said cartridge body member to said second end of said mixer body for fluidic communication between said cartridge body member and said mixer body, and

cap means for hermetically sealing said first end of said mixer body, said cap means including

self-sealing aperture means, pierceable by a hollow needle, for fluidic communication with said interior volume of said cartridge mixer through said hollow needle when pierced by said hollow needle and hermetically sealed closure of said interior volume when said hollow needle is withdrawn, and

mixing means for agitating a material contained within said interior volume of said cartridge mixer;

(B) an ampoule, defining an interior volume, containing a second predetermined quantity of a liquid bone cement component, said ampoule comprising a liquid bone cement component impermeable body member having a longitudinal axis, spout means, having a predetermined diameter, for fluid communication with said interior volume of said ampoule and removable closure means for hermetically sealing said spout means;

(C) an injector comprising

a hollow injector body member having a longitudinal axis and a first open end and a second open end spaced apart on said longitudinal axis, said hollow injector body member slidingly, coaxially receivable of said ampoule,

a cap member, disposed on said second open end of said hollow injector body for closure thereof, said cap member including a fluid conduit, coaxial with said hollow body, for passage of a fluid through said cap member,

hollow needle means, pierceable of said self-sealing aperture means, hermetically connectable to said fluid conduit, for passage of fluid into said interior volume of said cartridge mixer,

resilient support means, hermetically sealingly connecting said second end of said hollow injector body and said cap member, for engagingly contacting said ampoule, said resilient support means including a fluid passage tapering toward and fluidically connected to said fluid conduit, said fluid passage coaxial with said hollow injector body and receivable of said ampoule spout means; and

(D) float means, having a specific gravity less than said liquid bone cement component, for hermetically sealingly closing said fluid passage in said resilient support means.

36. The bone cement kit according to claim 35, wherein said float means comprises a polyethylene ball.

37. The bone cement kit according to claim 35, wherein Vcm/Vbc is about 2.0.