Vacuum mixing/bone cement cartridge and kit
First Claim
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 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;
(B) container means for holding said second predetermined quantity of a liquid bone cement component, said container means comprising 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;
(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 liquid bone cement component from said container means to said cartridge mixer means, said fluid transfer means comprisinga 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;
(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, said plug means comprising 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.
1 Assignment
0 Petitions
Accused Products
Abstract
A two-component bone cement mixing system comprises a cartridge mixer having an interior volume containing a first predetermined quantity of a 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.
266 Citations
37 Claims
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1. A two-component bone cement mixing system comprising:
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(A) a cartridge mixer means, having an interior volume containing a first predetermined quantity of a 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; (B) container means for holding said second predetermined quantity of a liquid bone cement component, said container means comprising 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; (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 liquid bone cement component from said container means to said cartridge mixer means, said fluid transfer means 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 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; (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, said plug means comprising 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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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15. A cartridge mixer, having an interior volume, useful for the mixing of a first predetermined quantity of a 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, said cartridge mixer comprising
(A) 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; -
said cartridge means comprising 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;
said piston means comprisinga 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; (B) 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; said mixer means comprising 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 meter, 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 mixer means; (C) 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; and (D) hermetic sealing means for sealing said connected cartridge means and mixer means against the ingress of air. - View Dependent Claims (16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26)
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27. A two-component bone cement kit comprising:
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(A) a vacuum-packed cartridge mixer, defining an interior volume, containing a first predetermined quantity of a powdery bone cement component, 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. - View Dependent Claims (28)
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29. A method of preparing a bone cement comprising:
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providing a cartridge mixer means, having an interior volume containing a first predetermined quantity of a 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; providing container means, containing said second predetermined quantity of a liquid bone cement component, for holding a liquid bone cement component; cooling said cartridge mixer means containing said solid bone cement component and said container means containing said liquid bone cement component to a temperature less than 20°
C.;then admixing said liquid bone cement component and said solid bone cement component in said cartridge mixer means while maintaining said vacuum pressure in said cartridge mixer means. - View Dependent Claims (30, 31, 32)
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33. A two-component bone cement mixing system comprising:
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(A) a cartridge mixer means, having an interior volume containing a first predetermined quantity of a 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 substantially absence of air to form a third predetermined quantity of a fluid two-component bone cement; said cartridge mixer means comprising (a) 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; said cartridge means comprising 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;
said piston means comprisinga 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; (b) 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; said mixer means comprising 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; (c) 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; (d) hermetic sealing means for sealing said connected cartridge means and mixer means against the ingress of air; (B) container means for holding said second predetermined quantity of 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.
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34. A cartridge mixer, having an interior volume, useful for the mixing of a first predetermined quantity of a 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, said cartridge mixer comprising
(A) 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; -
said cartridge means comprising 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; said piston means comprising 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; (B) mixer means, detachably connected to said cartridge mans, 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; said mixer means comprising 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; 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, said mixer element is rotatably movable about said axis of said first aperture, said movable mixing element is axially slidable in said first aperture, and 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; (C) hermetic sealing means for sealing said connected cartridge means and mixer means against the ingress of air. - View Dependent Claims (35, 36, 37)
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Specification