Apparatus and method for mixing and dispensing bone cement

• US 6,120,174 A
• Filed: 01/14/1999
• Issued: 09/19/2000
• Est. Priority Date: 01/14/1999
• Status: Expired due to Term

• Current Assignee: Zimmer Technology Incorporated (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Bristol-Myers Squibb Company
• Inventors: Hoag, Stephen H., Case, Kirt L., Boggs, Jeffrey B., Miller, Scott B., Finn, Christopher A., Chan, Kwan-Ho
• Primary Examiner(s): SOOHOO, TONY GLEN
• Application Number:
  US09/231,894
• Time in Patent Office: 614 Days
• Field of Search: 366/129, 366/130, 366/139, 366/255, 366/256, 604/416, 222/327
• US Class Current: 366/139
• CPC Class Codes: A61B 17/8825 characterised by syringe details A61B17/8822, A61B17/8827 take precedence
• CPC Class Codes: A61B 17/8827 with filtering, degassing, venting or pressure relief means
• CPC Class Codes: A61B 2017/8838 for mixing bone cement or fluid fillers
• CPC Class Codes: A61F 2002/30561 breakable or frangible
• CPC Class Codes: A61F 2002/30589 Sealing means
• CPC Class Codes: A61F 2002/4685 by means of vacuum
• CPC Class Codes: A61F 2250/007 O-rings
• 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 31/441 performing a rectilinear reciprocating movement
• CPC Class Codes: B01F 33/5011 portable during use, e.g. hand-held
• CPC Class Codes: B01F 33/70 Mixers specially adapted for working at sub- or super-atmospheric pressure, e.g. combined with de-foaming

Abstract

A method and apparatus for mixing bone cement which produces bone cement essentially free of entrained air. The apparatus includes a cartridge having two telescoping cylinders. The outer cylinder receives a cap thereon which hermetically seals the cartridge. The cap includes an outlet port in which a break-away agitator is installed and a port for connection of a vacuum pump. In use, a desired vacuum pressure is drawn on the cartridge and the inner cylinder is allowed to be drawn into the outer cylinder while the vacuum is being drawn, whereupon the inner cylinder automatically stops moving relative to the outer cylinder when the desired vacuum pressure is reached. Mixing of the bone cement is then performed under the partial vacuum thereby created. The agitator paddles provide a scraping action against both inner cylinder walls of the telescoping cylinders thereby improving mixing. After mixing, the agitator is broken away, an appropriate nozzle is attached to the cartridge and the cartridge is inserted into a cement gun. The leading portion of the bone cement develops a convex profile when axially advanced through the cartridge and the piston plug includes a tapered protrusion which generally corresponds to the profile of the bone cement. The cap and paddles are also shaped correspondingly to the convex profile developed by the bone cement, resulting in substantially all of the bone cement being squeezed from the cartridge. An air escape passage is also provided to vent air contained within an annular gap between the agitator shaft and the cap upon initial being essentially free from entrained air.

Claims

1. A bone cement mixing apparatus, comprising:

first and second telescopingly connected cylinders for mixing and dispensing bone cement, said first and second cylinders including respective inner cylinder walls wherein one of said inner walls has an inner diameter greater than an inner diameter of the other inner wall; and

a bone cement agitator having a portion of which is insertable within said cylinders and movable axially therein, said agitator comprising;

a shaft; and

a plurality of paddles connected to an end portion of said shaft and extending generally radially therefrom, said paddles being movable radially and resiliently biased radially outwardly into wiping engagement with said first and second inner walls, whereby said paddles can flex outwardly to wipe said inner walls when said agitator is reciprocated within said telescopingly connected cylinders.

2. The apparatus of claim 1, wherein said paddles form a frustoconical shape.

3. The apparatus of claim 1, wherein said paddles each includes an opening therein for passage of bone cement therethrough while mixing.

4. A method for mixing bone cement, said method comprising the steps of.

placing bone cement components in a cartridge, the cartridge including a first cylinder slidably disposed within a second cylinder, the first cylinder initially being extended from the second cylinder;

installing a cap on a proximal end of the second cylinder and connecting a vacuum pump to a vacuum port on the cap, whereby vacuum can be drawn within the cartridge;

drawing vacuum in the cartridge by operating the vacuum pump and thereby causing the first cylinder to be drawn into the second cylinder;

halting the operation of the vacuum pump when the pressure within the cartridge reaches a desired level, thereby stopping the first cylinder from being further drawn into the second cylinder; and

then mixing the bone cement components within the cartridge under the vacuum created within the cartridge.

5. The method according to claim 4, wherein the first cylinder automatically stops moving relative to the second cylinder upon the pressure within the cartridge reaching the predetermined level.

6. The method according to claim 4, further comprising the steps of.

releasing the vacuum within the cartridge;

installing a cement nozzle on the cap;

advancing the bone cement through an outlet port in the cap and through the nozzle; and

venting substantially all of the air contained within the cap to ambient.

7. An apparatus for mixing and delivering bone cement, said apparatus comprising:

a cylinder;

a cap on one end of said cylinder and defining an outlet port therethrough; and

a piston plug disposed in said cylinder for axial movement in said cylinder toward said cap to expel the bone cement in said cylinder through said outlet port;

said piston plug having a tapered protrusion thereon which is oriented toward said cap, wherein said cap includes a recess corresponding in shape to said protrusion, said recess matingly receiving said protrusion when said plug is moved axially toward said cap, whereby the bone cement is squeezed from said cylinder;

an agitator for mixing the bone cement, said agitator comprising a shaft extending through said outlet port, a first end of said shaft disposed within said cylinder; and

a plurality of paddles connected to said first end of said shaft and extending radially therefrom for mixing the bone cement, said paddles forming a shape which corresponds to said piston plug and said cap, whereby said cap and said piston plug matingly receive said paddles therebetween when said piston plug is moved axially toward said cap.

8. The apparatus of claim 7, wherein said cap, seid paddles and said toward said cape.