CA2187611C - Bone cement preparation kit having a breakable mixing shaft forming an output port - Google Patents

Bone cement preparation kit having a breakable mixing shaft forming an output port Download PDF

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Publication number
CA2187611C
CA2187611C CA002187611A CA2187611A CA2187611C CA 2187611 C CA2187611 C CA 2187611C CA 002187611 A CA002187611 A CA 002187611A CA 2187611 A CA2187611 A CA 2187611A CA 2187611 C CA2187611 C CA 2187611C
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CA
Canada
Prior art keywords
cartridge
shaft
distal end
cap
cement
Prior art date
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Expired - Lifetime
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CA002187611A
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French (fr)
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CA2187611A1 (en
Inventor
Kwan-Ho Chan
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Individual
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Individual
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Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F33/00Other mixers; Mixing plants; Combinations of mixers
    • B01F33/70Mixers specially adapted for working at sub- or super-atmospheric pressure, e.g. combined with de-foaming
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802Equipment for handling bone cement or other fluid fillers
    • A61B17/8805Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • A61B17/8825Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by syringe details
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/20Holders specially adapted for surgical or diagnostic appliances or instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/20Holders specially adapted for surgical or diagnostic appliances or instruments
    • A61B50/22Racks
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F23/00Mixing according to the phases to be mixed, e.g. dispersing or emulsifying
    • B01F23/50Mixing liquids with solids
    • B01F23/565Mixing liquids with solids by introducing liquids in solid material, e.g. to obtain slurries
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F31/00Mixers with shaking, oscillating, or vibrating mechanisms
    • B01F31/44Mixers with shaking, oscillating, or vibrating mechanisms with stirrers performing an oscillatory, vibratory or shaking movement
    • B01F31/441Mixers with shaking, oscillating, or vibrating mechanisms with stirrers performing an oscillatory, vibratory or shaking movement performing a rectilinear reciprocating movement
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F33/00Other mixers; Mixing plants; Combinations of mixers
    • B01F33/50Movable or transportable mixing devices or plants
    • B01F33/501Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use
    • B01F33/5011Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use portable during use, e.g. hand-held
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F33/00Other mixers; Mixing plants; Combinations of mixers
    • B01F33/50Movable or transportable mixing devices or plants
    • B01F33/501Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use
    • B01F33/5012Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use adapted to be mounted during use on a standard, base or support
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/75Discharge mechanisms
    • B01F35/754Discharge mechanisms characterised by the means for discharging the components from the mixer
    • B01F35/75425Discharge mechanisms characterised by the means for discharging the components from the mixer using pistons or plungers
    • B01F35/754251Discharge mechanisms characterised by the means for discharging the components from the mixer using pistons or plungers reciprocating in the mixing receptacle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802Equipment for handling bone cement or other fluid fillers
    • A61B17/8805Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • A61B17/8827Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it with filtering, degassing, venting or pressure relief means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802Equipment for handling bone cement or other fluid fillers
    • A61B17/8833Osteosynthesis 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
    • A61B2017/8838Osteosynthesis 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 for mixing bone cement or fluid fillers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B2050/005Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover
    • A61B2050/0062Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover closable by a combination of rotation and translation
    • A61B2050/0064Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers with a lid or cover closable by a combination of rotation and translation by screwing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03Automatic limiting or abutting means, e.g. for safety
    • A61B2090/037Automatic limiting or abutting means, e.g. for safety with a frangible part, e.g. by reduced diameter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30561Special structural features of bone or joint prostheses not otherwise provided for breakable or frangible
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30667Features concerning an interaction with the environment or a particular use of the prosthesis
    • A61F2002/30716Features concerning an interaction with the environment or a particular use of the prosthesis for single use, e.g. having means for preventing re-use
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2002/4685Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor by means of vacuum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0071Additional features; Implant or prostheses properties not otherwise provided for breakable or frangible
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/009Additional features; Implant or prostheses properties not otherwise provided for for single use, e.g. having means for preventing re-use
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F2101/00Mixing characterised by the nature of the mixed materials or by the application field
    • B01F2101/20Mixing of ingredients for bone cement
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F2101/00Mixing characterised by the nature of the mixed materials or by the application field
    • B01F2101/23Mixing of laboratory samples e.g. in preparation of analysing or testing properties of materials
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/30Driving arrangements; Transmissions; Couplings; Brakes
    • B01F35/32Driving arrangements
    • B01F35/32005Type of drive
    • B01F35/3202Hand driven
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01FMIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/75Discharge mechanisms
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S366/00Agitating
    • Y10S366/602Amalgam mixer, e.g. dental filling

Abstract

A disposable telescoping mixing cartridge for mixing and delivering a quantity of bone cement. The cartridge cap includes a break-away agitator which opens an outlet port for the flow of cement. Therefore, the single opening serves as both an outlet port for the cement and the opening through which the agitator is reciprocated.

Description

- - . ~ ~:,.,..~, ' ~:
1~7~11 BONE CEMENT PREPARATION KIT PIAVING A
BREA1~ABLB IYIIYING SHArT rORMING AN OUTPUT PORT
This invention relates to a disposable preassembled collection of preparation apparatus and various cement components used ill the preparation of bone cement. The collection of disposable apparatus and constituent components being packaged as a single sterile kit for convenience and includes a telescoping mixing cartridge with a vacuum release mechanism and a break-away agitator. The break-away agitator f01'1115 all Ol-lLpllt for the ejection of the bone cement.
BACKGROUND OF THE INVENTION
In many orthopaedic surgical procedures, bone cements axe used to fix implants to the bone. Conventional bone cements are generally polymeric materials, which are prepared by copolymerization of its components as needed. Bone cement is prepared by c.opolymerizing a liquid I110nOIller and a powdered copolymer, such as methyl methacryiatc and polymethyl rrlethaerylate or methyl lnetllacrylate-styrene.
During 2 5 mi::ing of t't7e COilSilhtelll CO111pO11Ci7tS Of LIIC CCIllent, air bubbles may be formed 'vVitilin the cerrlent. It is thought that to improve the resultant strength of the cement, the ;iir bubbles must be evacuated li'om the mixture to ensure a uniform reaction product. .
Conscquentiy, the mixing of the constituent conlpon°nts is ideally perfornled in a vacuum.
2 U 1'he sepal'ate constituent COIIIpOl1e11tS play be mixed Wlthlll a 1111X1ng cartridge as is well known in the art. The mixing cartridge, when fully extended, provides a larger volume for mixing the constituent components to ensure that the constituent components are adeduately lilixed. Such 1111X1ng cartridges are generally enclosed by removable caps, WIllCh 111C~L1OP c~, valued port for COnIleCtIUII t0 a VaCLtLllll plllllp.
VaCllllm plilllpS dl'aW' el 2 S VaC11L111WV1111711 tl7e Cat'tl'lCIgCS Cllll'lllg ihC llllx117g prUCeSS t0 TedUCe the occurrences of all' bllbbICS Wlthlil ihC CelllCilt. ~hllC Caps llaVC all O~f-SCt Outlet port through which the llllxed Ceillellt COlllpOlli7Cl is Cx17Cl1Cd alld a CClItI'al opening through whlCl7 all agltatOr 1S
reciprocally disposed. 1'hc agitator has an elongated shaft and a mixing paddle for .
1711X1118 the COllStltllel7t CO111pU11C11tS. rlle: yltat0l' shaft is broken off aflet'~1171XIIlg aI7C~ the 3 G Of~Set OLltlet l7Crt 1S Upell°,Cl tU Cxl7Cl tl7e CClnellt. I11 a prior art V aClllllll C'dI'tl'ld5e mi inb , , , t . ~ .
2 ~~~7b~ 1 device, an end plunger is released after mixing yet while the cartridge is still under a vacuum. The vacuum pressure within the cartridge causes the plunger to be drawn into the cartridge to collect the cement. The plunger stops moving within the cartridge when the force exerted by the vacuum equalizes. After the cement is throughly mixed, the S agitator shaft is broken off and the cartridge is inserted into a conventional cement applicator gLm. Cement applicator guns are well known in the art. Generally, a variety of cement nozzles are affixed to the outlet port to aid in the application of the cement within the bone cavity. Because the outlet port is off center, a certain amount of cement cazmot be expelled from the cartridge, and is discarded with the disposal of the cartridge.
heretofore, the various cement constituent components and mixing apparatus have been individually packaged and provided to the user. Since the cement sets rapidly, the preparation and application of bone cement is time critical. Preparation of bone cement is generally pcrforzned in the sterile field of the operating room.
Consequently, etch piece of apparatus must be provided in a sterile package. Providing all of the various mixing apparatus and cement constituent components as a single preassc;rnb!ed collection or kit would be more convenient for the users in the operating room.
SUMMARY OI~ THE INVENTION
This invention provides a preassembled collection of disposable mixing apparatus and various cement constituent components needed for the preparation of bone cement 2 0 in a convenient disposable kit. The kit includes a contoured storage tray, ampules of liquid cement monomer; packets of powder cement copolymer, a vacuum pump, connecting tubing with a vacuum indicator, a mixing caz-tridge, a cartridge cap and agitator, an assortment of connectable cement nozzles, and a funnel attachment. The kit can be packaged as a single unit for convenient and efficient use in the sterile 2 5 environment of an operating room. In addition the contoured tray holds the various items in convenient positions to assist the user during the preparation of the bone cement. Por example, the tray holds the mixing cartridge in a stable upright position so that the user does not have to hold the caz-tridge, leaving his hands free to operate the agitator or the . . - ~. .. ... .'. ~....'~ .' ~._'..~. ,. .. ,'.,. ''. ' .. .'; .' .' '.~,'.
' . , ;Wr .v,. :.,..... ... ~ ~.. .

' I I

. 215761 1 VlCtlllln pump.
The disposable telescoping Illlxlllg cartridge of the kit employs a vacuum release mechanism which releases the vacuu In within the cement cartridge as the telescoping tubes are being compressed. The cartridge includes t~vo telescoping tubular cylinders.
The ilmer cylinder is shiftably received within the outer cylinder. The inner cylinder has , an L-shaped longitudinal channel, and the outer cylinder includes a protrusion or key which is seated within the channel to provide for the lock and release of the inner cartridge relative to the outer cartridge. Alternatively, the channel may be stepped thereby allowing the inner cylinder to be rotated and axially moved within the outer l0 cylinder between tlu-ee selective positions: a fully extended mixing position, an i.ntermeciiate vacuum release position, and a retracted applicator position.
The cal-tridge cap includes a break-away agitator which also serves as an outlet port after breaking. There:(ore, the cap has a single opelung to serve as both an outlet pol-t for tl'le CeilleIlt ~lld the Opening tln'otigh WhlCi1 the agitator is reciprocated. Tll~~ agitator il?Chides ~ handle and an elongated shaft reciprocally disposed v.~itr~in the cutlet port of tine cap. The shaft includes a tubular outer sleeve and an timer rocl axially disposed within the sleeve. T he sleeve has a frangible hollow distal end. Agitator paddles extend radially from the distal end of the sleeve for assisting in the mixing of the constituent components of the bone cement. The distal end of the rod tel-Ininates in an integral 2 0 dumbbell shaped end plug. The small diameter of the middle se~,~li.ent of the dumbbell shaped end plug is positioned approximate to an almular notch formed in the sleeve. The distal end of the sleeve can be detached from the shaft so that the mixed cement compound cars be expelled therethrough. The configuration of the dumbbell shaped end plug allows the rod to be bent at the middle section of the end plug while the sleeve is 2 5 fractured at the notch. The hollow distal end of the sleeve remains seated within the outlet port of the cap to provide a passage for the mixed cement compound to be expelled.
Accordingly, an advantage of this invention is to provide, collection of disposable mixing apparatus and cement COIIStlttlellt components fOr VaCL1uI11 n11x1I1g and cartridge delivery in a single sterile kit for convenient use.
3 o Another advantage of this invention is that the tray included in the kit holds the -- ~ - 4 - 2i 8761 i mixing cartridge while the constituent C0117pO11eI1tS are mixed so that the cartridge does not have to be manually supported during the preparation of the cement con npound.
Another advantage of this invention is that the telescoping llllx117g cartridge has a vacuum release mechanism which releases tile VaCU11111 during collapsing of the telescoping cartridge.
Another advantage of this invention is that the cap includes a single outlet port through which the agitator is reciprocated during the mixing process and cement is expelled during cement application.
Other advantages will become apparent upon a reading of the following description.
BRIEF DESCRIPTION OF THE DRAWINGS
A preferred embodiment of the invention has been depicted for illustrative purposes only wherein:
Fig. 1 is a perspective view of the kit of this invention;
Fig. 2 is a side view of the mixing cartridge and the connected cap with a portion;.
cut away to illustrate the mixing of the constituent components;
Fig. 3 is a perspective view of the mixing cartridge of this invention with a portion cut away to illustrate its vacuum release mechanism;
Fig. 3A is a perspective view of the mixing cartridge of this invention with a 2 o portion cut away to illustrate its two stage vacuum release mechanism;
Fig. 4 is a sectional view of the mixing cartridge taken along line 4-4 of Fig. 3;
Fig. 5 is a sectional view of the mixing cartridge taken along line 5-5 of Fig. 3;
Fig. G is a sectional view of the cap and breakaway agitator cf this invention .
showing the dilmbbell shaped end plug of the rod bent to sever the distal end of the outer 5 sleeve;
Fig. 7 is a sectional view of the cap and breakaway agitator of thlS
ll1ve11tlUn showing the shaft and dumb bell shaped end plug withdrawn from the distal end of the sleeve;
Fig. 7A is a sectional view of an alternative embodiment of the agitator of the . . I ~~wvr ( .
_5_ X187611 Invention.
Fig. 8 is a perspective view of the kit of this invention showing the liduid and powder constituent components being poured into the mixing cartridge through a funnel attach111eI1t C01111eCted to the cartridge;
Fig. 9 is a perspective view of the kit of this invention showing the cap cotmected to the mixing cartridge for facilitating mixing of the constituent components and the vacuum pump corrected to the cap for drawing a vacuum in the cartridge;
Fig. 10 is a perspective view of the mixing cartridge of this invention sho~.ving the manipulation of the inner cylinder within the outer cylinder to release the vacuum pressure and to collapse the cal-tridge; and Fig. 11 is a side view of the mixing cartridge of this invention and a cotu~ected cement nozzle with a poI't1011 Cut away to show the position of the ir~lter alld outer cylinders.
5 DESC1RPTIOi'd r TrI~ Pr.F.F~P,P,~D r~.WODIP~ r~,T;
The preferred embodiments herein described are not intended to be exhaustive or to limit the invention to the precise for111S disclosed. Rather, they are chosen and described to best e>:plain the invention so that others skilled in t:he art nllgllt utilize their teachings.
2 0 Fig. 1 shows the collection of disposable items of kit 2 of tlus invention tbr use in the preparation of bone cement. Kit 2 consists of the following items: a contoured storage tray 10, ampules 12 of liquid cement monomer, packets 14 of powdered cement polymer, vacuum pump 20, colrtecting tubing 26 having a vacuum indicator 23, a nllxmg cartridge 30, a cal-tridge cap 60 and break-away agitator 70, an assortment of corl:ectable 25 cement nozzles 80, and a funnel attaclunent 90. Preferably, tray 10.1S
COllStrllCted ~'roIll a molded plastic, which has a plurality of contoured recesses 11 (Figs. l, S
and 9) within which tile Val'IOiIS illlXlllg apparatus and constituent COI11pO11e11tS 4 of the CelllentS are ,' stored. As shown in big. 1, tray 10 allows all of the kit items to be stored and packaged in a single sterile covering (not shown). Lach of the kit items are held in their individual 3 U contoured recesses 11 forllled in tray 10. In addition, tray 10 holds the various items at '. .: . . . ; .
:, v ~ . . :; . . . . , . . , ,1': ,, .; .
~~ ~~, .: : ..

a convenient position to assist the user in preparing the bone cement. For example, tray 10 holds mixing cartridge 30 in a stable upright position so that the user does not have to hold the cartridge, leaving his hands free to pour in the constituent components, operate vacuum pump 20, or agitator 70.
Preferably, the constituent components 4 of the cements are individually packaged in premetered portions. The liquid monomer components are provided in ampules 12 and the powder copolymers are provided in sealed packets 14, although any suitable packaging for the components may be provided with the kit of this invention. Ampules 12 of the liquid monomer and packets 14 of powder copolymer are well known in the art and are commercially available from a variety of sources. Vacuum pump 20 uses a reciprocated piston design, although any suitable vacuum pump may be included as part of kit 2. Vacuum pump 20 includes a cylindrical body 22 and reciprocating shaft 24, which drives an internal piston (not shown). Vacuum pump also includes a check valve (not shown) to permit air flow in one direction only through the pump orifice. The length of tubing 26 is used to connect pump 20 to cap 60 when connected to 15 mixing cartridge 30. Preferably tubing 26 includes vacuum indicator 28.
Vacuum indicator 28 is a plastic or rubber bulb, which collapses under the negative pressure of the vacuum drawn by pump 20.
Mixing cartridge 30 is preferably constructed of a disposable semi-transparent plastic, which allows the admixture of the constituent components 4 to be viewed.
Cartridge 30 includes 20 two telescoping tubular cylinders 40, 50. Both cylinders, 40, 50 have open proximal and distal ends. Outer cylinder 40 axially receives inner cylinder 50 in a telescoping configuration. The outer diameter of inner cylinder 50 is concentrically seated against the inner diameter of outer cylinder 40. The outer peripheral surface of inner cylinder 50 is in a tight but not hermetically sealed engagement with the inner peripheral surface of outer cylinder 40 in a piston like manner.
An air impermeable piston plug 32 is disposed within inner cylinder 50 approximate its distal end, so as to close the distal end of inner cylinder 50. Plug 32 is axially slidable within inner cylinder 50 for expelling the mixed cement compound 6 from cartridge 30 when the cartridge is connected to a cement gun.

r ~.::.~: i ~;
- ~ - 218761 1 Outer cylinder 40 includes a threaded outer rim 42 adjacent its open proximal end. Threaded r1111 42 allows connection of cap 60 and fullllel attachment 90 to cartridge 30. ZVhile outer cylinder 40 is shown herein as including an outer thread rim, any suitable connection structure can be employed to provide the connection to fiumel S attachment and cap 60. Outer cylinder 40 also includes an almular end flange 44, which extends outwardly approximate its open distal end, and a block protrusion or key 46, which protnldes inwardly. As shown in figs 2 and 5, the ilmer surface of outer cylinder 40 has a plurality of pressure evacuation grooves 41, which extend longitudinally from 1tS pTOXllIlal elld.
Inner cylinder SO includes a pair of 0-rings 52, which are seated within an.nllal grooves 51 formed approximate its proXlmal end. O-rings 52 provide a hermetic Seal between cylinders 40, 50. As shown in Fig. 3, inner cylinder SO has an L-shaped longitudinal chalmel S 3. Chall?lel S3 lilChJdeS a short lateral section 57 which colmects to a major longitudinal section 54. The L-shaped cha!~s~el allows the ilmer c~~linder 50 to be rotationally a::d a~;ially movwble betv~re~n two positions: a fully extencled mi;:il;g position wherein key 46 is seated within lateral section 57, and a vacuum release and retracted position wherein the key is accon~lnodated within the major longitudinal section. AS shoWll 111 Fi ;s. 3, 10 and 1 l, key 46 of outer cylinder 40 is seated within chalmel 53 of inner cylinder 50. In an alternative embodiment; illustrated in Fig. 3A, the 2 0 chalmel 53' is formed in a stepped configuration and includes a short intermediate lateral section 55', which colmects the major longitudinal section 54' to the minor longitudinal section 56 and a short lateral end section 57'. Stepped channel 53' and key 4G
provide a two stage vacuum release mechanism for cartridge 30. Stepped channel 53' allows imler cylinder 50 to be rotationally and axially mo«ed between three positions: a fully extended mixing position, an intermediate vacuum release position, alld a retracted applicator position.
As shown in Figs. 2, G and 7, cartridge cap 60 includes an annular rim 62. The inner surface (not shown) of rim 62 is threaded to mate with the threaded rim 42 of outer cylinder 40 to provide a hermetically sealed connection over the proximal end of outer 3 0 cylinder 40. Cap GU includes a one way valve port 64, which is connectable to vacuum ~'' r ~:::i _ -8- 21876Ii .
pump 20. Cap 60 includes a centered cement outlet port 66. The outer surface of cement port 66 is threaded to allow conncctio:i of cement nozzles SO to cap 60.
As shown in Pigs. 6 and 7, agitator 70 includes a handle 71 and an elongated shaft 72 reciprocally disposed within outlet port 66 of cap 60. Shaft 72 includes a tubular outer sleeve 74 and an inner rod 76 axially disposed within sleeve 74. Shaft sleeve 74 is frangible and has a detachable distal end 75. Agitator paddles 79 extend radially from distal end 75 of shaft sleeve 74 for assisting in the mixing of the constituent components 4 of the bone cement. The distal end of inner rod 76 terminates in m integral dumbbell shaped end plug 78. The small diameter of the middle segment 77 of dumbbell shaped ezid plug 7~ is positioned approximate to an amular notch 7.i .formed lIl shaft sleeve 74.
As shown in Figs 6 and 7, distal end 75 of sleeve 74 can be detached from shaft 72 so that the mixed cement compound 6 can be expelled theretlwough. When shaft 72 is ~.vithc!rawn to its outer extreme from cartridge 30, paddles 79 abut against the inner wall cf c:rp 6U rind ;listal end 75 of sleeve 72 is fitted within outlet port 66 of cap 6C. The ~_ 5 cuuliouralioi~ of dumbbell :;liaipeu tnd plug 78 allows rod 76 to he L~o:n a: mid'le se;aim;
77 of end plug 7S while sleeve 74 is fractured a t notch 73. The ho:low distal elld 75 of sleeve 74 remains within outlet port GG of cap 60 to provide a passal;e for the mixed cement compound 6 to be expelled.
An alternative embodiment of the break away sleeve 74 and dumbbell shaped 2 0 distal plug is illustrated in Fig. 7A. As illustrated in Fig. 7A, elongated shaft 72' includes a tubular outer sleeve 74' and an inner rod 76' axially disposed within the sleeve. Shaft sleeve 74' is frangible and has a detachable distal end 75'. In the embodiment of pig. 7A, the inner rod 76' is formed from a flexible polymer such as is conunonly used in medical tubing and is o.f a constant irL~ter and outer diameter. A plug 78' is secured within the 2 S distal end of inner rod 76' adjacent the detachable distal end 75' of the outer sleeve 74'.
Mixing paddle 79 is connected to the distal end 75' of sleeve 74' and functions in a similar mamer as described earlier. In use, after the constituent CO:I1pO11e11tS Of the bone cement are till'Oll~lll}' mixed as discussed earlier, the II11X1I1g l7addlc 1S
dra~,v to a position adj<:cent the cap 62. The outer sleeve is bent sufficiently to cause it to break at the score 3 C line or notch 7,'. During bending of the outer sleeve, the ixu~er rod 74' made of the . . . . ;.. :. ~ ~ . , .'':' : . .. .:. . ~;~ ,. .«. ,~ .v r _ -9- ~18761i flexible polymer tubing) flexes or compresses an amount sufficient to allow the outer sleeve to bleak. Once the outer rod is broken, the user pulls on handle 71' which is colmected t0 lllllel- rod 74' by an adapter as illustrated. As the handle, inner rod and the remaining outer sleeve are pulled away, the distal plug 78' i.s pulled from the center of mixing paddle 79 to allow cement to exit theretlu-ough.
as shown in Pigs. l, 10 and 11, cement nozzles 80 are of conventional design and include an elongated neck 82 and a coupling part, which is adapted to be fitted to outlet port 66 of cap 60. ~S ShoWll 111 Figs. 1 and 8, fulu~el attachment 90 includes a conical flange 92 and an ammlar neck 94. Neck 94 has a threaded ilmer surface (lot l0 shown), which allows the funnel to be connected to the proximal end of cartridge 30.
Figs. 8-11 demonstrate the use of kit 2 in the preparation of bone cement.
lCit 2.
is packaged in an external packaging (not shown) with funnel attachment 90 connected to cartridge 30. Cne will notice that cartridge 30 is packaged in tray 10 in its extended llllxillg position for the convenience of the user. As shown in Fig. e, the cement CUn;ititLiC'.llt ;.nlnpj~n;:nts 4 of tile ccn,.ent are poured into mixing cylinder 30 th;;.ugl~
f1i1:17e1 90. Once tl~e proper volumes of the various constituent components 4 of the cement have been poured into the cartridge, funnel attacl-unent 90 is removed and discarded. Cap GO is then removed from tray 10 and attached to cartridge 30.
Vacuun-1 pump 20, tubing 22, and vacuum indicator 24 are also removed from tray 10 and 2 G corlrlected to vacuum port 64 of cap G0. Once cap 60 and vacuum pump 20 are connected to cartridge 30 aS S110w11 111 Fig. 9, a vacuum is drawn within cartridge 30 by manually reciprocating shaft 24 of vacuum pump 20. Vacuum indicator 28 collapses to indicate that the cartridge is at the desired vacuum pressure. The vacuum pump may then be removed and the vacuwn is maintained by a one-way check valve (not shoe;.-n) w~itlii:u cap 2 5 6U. The constituent components 4 of the cement are then mixed by manually reciprocating agitator 70 in a manner well know in the art. When the COllstltll~llt components 4 of the cement have been thoroughly mixed, agitator part 70 is pulled to its outer limit so that agitator paddles 79 abut against cap 60.
AS ShOWll 111 Figs 10 and 11, the lJacl1L1I11 pressure within cartridge 30 is then 3 0 released and cartridge 30 is compressed for use in a cement injector gun (not shown). To .: ..,,. . , . , , . . ,.
:.::.. '.'~.~.. .,., ,. . ~.w '.; :.' .v..

-lo- X187611 release the vacuum pressure within cartridge 30, imer cylinder 50 is rotated and axially compressed within outer cylinder 40 from its extended position to its intermediate vacuum release position. Inner cylinder 50 is rotated within outer cylinder 40 to move key 46 through lateral end section 57 into longitudinal section 54 so'that the inner cylinder can be compressed. With key 46 aligned with section 57, the izmer cartridge is in its vacuum release and collapsing position. In the vacuum release position, the position of izmer cylinder 50 within outer cylinder 40 locates 0-rings 52, which provide the hermetic seal between the inner and outer cylinder 40, 50, between the opposed ends of grooves 41 formed in the outer cylinder 40. Grooves 41 provide nrz air passage into the interior of cartridge 30 around 0-rings 52 through channels 41.
To release the vacuum pressure within cartridge 30 in the alternative embodiment of Figure 3A; inner cylinder 50 is rotated and axially compressed within ' outer cylinder 40 from its extended position to its intermediate vacuum release position.
Inner cylinder S0 is rotated within outer cylinder 40 to mope key 46 through lateral end SeCtlOll 57 into lUn~aL:d:Ilal section 56 se that the inner cylinder can be c~n:hress~~a. :'l;e axial conzhression of inner cylinder 50 within outer cylinder 40 is arrested as its intermediate vacuum release position when key 46 reaches intermediate lateral section 55. In the vacuum release position, the position of inner. cylinder 50 within outer cylinder 40 locates 0-rings 52, which provide the hermetic seal between the irzrzer and outer 2 0 cylinder 40, 50, between the opposed ends of grooves 41 formed in the outer cylinder 40.
Grooves 41 provide an air passage into the interior of cartridge 30 around O-rings 52 through channels 41. Once the pressure within cartridge 30 has been equalized, izmer cylinder 40 is rotated again to move key 46 along lateral, intermediate section 55~into longitzzdinal section 54. Now imier cylinder 50 can be completely compressed into outer Cy1111deI' 40 to its retracted position.
Once cartridge 30 is compressed into its retracted position, distal end 75 of sleeve 7~E of the agitator is broken off and discarded as shown in Figs. 6 and 7.
When agitator 70 is broken off, plug 7g is pulled from the cap and outlet port 66 is opened.
The suitable cement nozzle SO can now be afrxed to outlet port 66, and cartridge 30 inserted into the 3 0 applicator gun (not shown).
. , . ;, , ..,. : : . . :-;
... ... : .

, . i - 11 - 2i~761~
It is understood that the above description does not limit the invention to the details given, but play UL 1110d1~1cC1 within the scope of the following claims.
.. . .. . - . . ;

Claims (5)

1. An apparatus for manufacturing bone cement by mixing a plurality of constituent components, said apparatus comprising:
a cartridge including a tubular cylinder having an open proximal end and a distal end;
a cap connectable to said cylinder proximal end, said cap including means for connecting said cartridge to a vacuum pump to draw vacuum within said cartridge, said cap defining an opening therethrough;
a piston plug shiftably disposed within said cylinder for axial movement within said cylinder towards said cap to expel cement from said cartridge;
agitator means for mixing the constituent components of the bone cement within said cartridge;
said agitator means including an elongated shaft having a detachable tubular distal end reciprocally received through said opening of said cap, and connected to said shaft distal end for axial reciprocation within said cartridge;
end plug means extending from the shaft into the shaft distal end; and detachment means disposed in said detachable tubular shaft distal end for detaching said shaft distal end from said shaft and removing said end plug means from said shaft distal end;
whereby said cement can be expelled through said shaft distal end.
2. The apparatus of claim 1 wherein said end plug means comprises a dumbbell shaped end plug integrally connected to said shaft and disposed within said shaft distal end, said end plug including a flexible middle for permitting said shaft distal end to be axially bent, whereby said shaft distal end is severed from said shaft when said shaft distal end is disposed within said opening of said cap.
3. The apparatus of claim 1 wherein said detachment means includes a flexible inner rod axially carried within the elongated shaft wherein a distal end of the flexible inner rod constitutes said end plug means.
4. An apparatus for manufacturing bone cement by mixing a plurality of constituent components, said apparatus comprising:
a cartridge;
a cap connectable to said cartridge, said cap including means for connecting said cartridge to a vacuum pump to draw a vacuum within said cartridge;
said cap having an opening defined therein for expelling cement from said cartridge;
a piston plug shiftably disposed within said cartridge for axial movement within said cartridge towards said cap to expel said cement from said cartridge;
agitator means for mixing said constituent components of said bone cement within said cartridge, said agitator means including an elongated shaft having a detachable tubular distal end reciprocally received through said opening of said cap, and a paddle connected to said shaft for axial reciprocation within said cartridge; and detachment means within said shaft for detaching said shaft distal end from said shaft;
whereby said cement can be expelled through said shaft distal end.
5. The apparatus of claim 4 wherein said detachment means comprises a dumbbell shaped end plug integrally connected to said shaft and disposed within said shaft distal end, said end plug including a flexible middle for permitting said shaft distal end to be axially bent, whereby said shaft distal end is severed from said shaft when said shaft distal end is disposed within said opening of said cap.
CA002187611A 1995-10-10 1996-10-10 Bone cement preparation kit having a breakable mixing shaft forming an output port Expired - Lifetime CA2187611C (en)

Applications Claiming Priority (3)

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US08/541,543 US5624184A (en) 1995-10-10 1995-10-10 Bone cement preparation kit having a breakable mixing shaft forming an output port
US541,543 1995-10-10
US08/541,360 US5586821A (en) 1995-10-10 1995-10-10 Bone cement preparation kit

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CA2187611C true CA2187611C (en) 2005-01-18

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EP0768067A2 (en) 1997-04-16
CA2187611A1 (en) 1997-04-11
US5624184A (en) 1997-04-29
EP0768067A3 (en) 1998-02-11
US5586821A (en) 1996-12-24
EP0768067B1 (en) 2003-01-15

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