CA2266699A1

CA2266699A1 - Integrated bone cement mixing and dispensing system

Info

Publication number: CA2266699A1
Application number: CA002266699A
Authority: CA
Inventors: Donald Barker; James P. Seaton
Original assignee: Individual
Current assignee: Individual
Priority date: 1996-11-15
Filing date: 1997-11-07
Publication date: 1998-05-22
Also published as: US5961211A; DE69721291T2; EP0938368A1; DK0938368T3; DE69721291D1; US5876116A; AU5176898A; WO1998020963A1; EP0938368A4; ES2198597T3; PT938368E; EP0938368B1

Abstract

By providing a single housing comprising a mixing chamber (22) integrally combined with a delivery chamber or tube (23), a unitary, fully integrated bone cement mixing and dispensing system (20) is attained which eliminates user exposure or handling of the mixed bone cement. In the present invention, the two chambers (22, 23) of the integrated system of the present invention are movable between two alternate positions, a first position wherein each chamber is sealed from the other, and a second position wherein the two chambers (22, 23) are in direct communication with each other. In this way, the mixing chamber is operated independently of the delivery chamber for preparing the bone cement and, once prepared, easily transferred from the mixing chamber through the delivery chamber for immediate use.

Description

CA 02266699 1999-03-2~

INTEGRATED BONE CEMENT MIXING
- AND DISPENSING SYSTEM

TECHNICAL FIELD

This invention relates to a system or appal~lus for mixing a two-part bone cement, form~ ted for surgical applications in securing prosthetic devices to bones and joints, and more particularly, to a fully integrated, unitary system capable of providing mixing of the two-part bone cement, automatic transfer of the mixed cement to a dispensing zone, and dispensing of the cement directly to the desired site underpressure. In addition, this invention relates to a system or apparatus for dispensing a premixed bone cement, with the system providing for the removal of air in the mix and dispense the material into the dispensing zone with adequate pressure to asure a good interlock of the material to the bone and prothesis.

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W O 98/20963 PCTrUS97/20536 BACKGROUND ART

In many surgical procedures, particularly orthopedic procedures, it has now become common to affix a prosthesis to a bone or joint structure for improving the strength, rigidity, and movement of the bone/joint structure. Although such prosthetic devices have been widely used, hip joints and knee joints are the most common examples of areas where prosthetic devices are used to reduce or elimin~te pain and hlg that exists from typical leg movements.
As part of these operations, it has become common practice to secure the prosthesis to the bone or joint using a cement, formed by intermixing a powder and a liquid. Once intermixed, the two components must be thoroughly blended together to achieve the required consistency for the fully mixed cement, with the fully mixed cement then being loaded into a dispensing apparatus for placement in the desired area for affixing the prosthesis to the desired site.
In most applications, the two components forming the cement are mixed in a mixing vessel and, once fully mixed, are m~nn~11y transferred from the mixing vessel to a dispensing member. Typically, devices such as c~n1king guns are employed, for dispensing the fully mixed cement to the precisely desired location of the patient. This process is extremely unpleasant for individuals mixing the cement, since the mixed cement contains an offensive, noxious odor. Furthermore, removal of the mixed cement from the mixing vessel into the c~1llking gun is cumbersome, time con~uming, and has the potential for being mi~h~n-l1P~ and/or dropped.
Another problem typically encountered with prior art systems is the difficulty encountered with air being entrapped in the mixed cement. The presence of air pockets or air bubbles in the mixed cement is undesirable. Since it is important that the cement added to the bone area for affixing the prosthetic be virtually free of any e.ll~dpped air bubbles or air pockets, most prior art systems dem~n~ mixing of the powder and liquid under vacuum conditions. As a result, added lirnitations are incurred on the flexibility of the mixing vessel and the ability to mix the two-part cement mixture in any desired location.
Although a~ -lp~s have been made to reduce or elimin~te some of these prior art problems, no prior art systems has been developed which completely e1imin~tes the requirement for vacuum or the requirement for two separate components for mixing CA 02266699 1999-03-2~

WO 98nog63 PCT/US97/20536 and dispensing. At best, some prior art systems have enabled the mixing to be performed in one vessel which then is directly conn~cted to a feeding system forenabling the mixed cement to be added to a holding tube for use with the dispensing calllkin~ gun. However, a se~aldl~ dispellsillg system is required and extra h~ntllin~
5 and exposure of the mixed cement to the sulloul~ding l)el~-,mlel is required. Further-more, care must be exercised during the transfer of the mixed cement to the dispenser, since air is frequently introduced into the cement during this transfer operation as well as the risk of dropping or spilling the material.
Therefore, it is a principal object of the present invention to provide a bone 10 cement mixing and dispensing system which conlplises a fully integrated, unitary structure which elimin~t~s the requirement for independent transfer of the mixedcement to a dispensing member.
Another object of the present invention is to provide a unitary, integrated, mixing and ~ P~.cing system for bone cement having the characteristic features 15 described above which is easy to use and is virtually fool-proof in its operation.
Another object of the present invention is to provide a unitary, integrated, mixing and dispensing system for bone cement having the characteristic features described above which provides i~lr~ ...i~ed bone cement virtually devoid of elllla~ped air pockets or air bubbles while elimin~ting the need for mixing under vacuum but enabling vacuum to be used, if desired.
Another object of the present invention is to provide a unitary, integrated, mixing and disl el~ g system for bone cement having the characteristic features described above which is easily employed by any individual, free from lmw~llLed odors and product h~n~ling difficulties.
Other and more specific objects will in part be obvious and will in part appear hereinafter.

CA 02266699 1999-03-2~

SUMMARY OF THE INVENTION
By employing the present invention, all of the drawbacks and difficulties encoullle-ed with prior art systems are elimin~ted and a unitary, fully i~ ldted~ bone cement mixing and dispensing system is ~tt~in~d. This unique achievement is realized by creating a single housing or lllc,lllbel which comprises a mixing chamber integrally combined with a delivery chamber or tube. The delivery chamber terminates with aportal through which the mixed bone cement is directly dispensed to any desired location.
In order to provide a mixing chamber which can be operated independently of the delivery chamber, the two chambers of the integrated system of the present invention are movable between two alternate positions. In the first position, each chamber is sealed from the other, while in the second position, the two chambers are in direct co-n",~ ir~tinn with each other.
By employing the present invention, the two components forming the bone cement are placed in the mixing chamber and int~rmixed, with complete assurance that no unmixed bone cement will enter the delivery chamber. Complete mixing of the bone cement is assured by providing, in the preferred construction, an integrated counter and display which informs the op.,ldtor the exact time at which the cement components have been thoroughly inLt~ ed.
Once the two components forming the bone cement are fully intermixed with each other, to provide the desired bone cement product, the integrated, dual chamber system of the present invention is moved from its first sealed position to its second open position, enabling the fully mixed bone cement to be transferred from the mixing chamber directly into the delivery chamber. When desired and under the complete control of the operator, the mixed bone cement is advanced through the delivery chamber to a delivery portal, formed at the termin~ting end thereof. Then, the fully intermixed bone cement is dispensed through the portal directly to the desired location where the product is to be used.
In the pl~efe..~d construction of the present invention, the bone cement is 30 Llal~rt:lled through the system to the delivery portal regardless of the position or orientation of the system. In this way, assurance is provided that fully mixed bone CA 02266699 1999-03-2~

W 098/20963 PCTrUS97/20536 cement is delivered to the desired site regardless of the patient's position or the orientation of the bone into which the cement is being dispensed.
One of the pfi-lci~al components of the fully integrated bone cement mixing and delivering system of the present invention is an elongated, multi-component shaft member extending through both the mixing chamber and the delivery chamber of thepresent invention. Although this elongated shaft member may be formed from a single component, the ple~ d construction employs at least two components interconnected with each other. In the preferred construction, the shaft member comprises a mixing portion which incorporates a plurality of mixing blades and a movement controlling portion which is preferably formed as a helical shaped auger or helical shaped, radially e~ten~ing screw thread member.
By employing an elongated, multi-conlponellL shaft member which axially extends through both the mixing chamber and the delivery ch~mher, the mixing portion thereof provides the desired components to cooperate with the walls of the mixing chamber to fully intermix the liquid and powder until the desired bone cement isformed. Once the bone cement has been fully prepared, which information is automati-cally provided to the user by the rotation counter means, the two cooperating chambers are moved from their first sealed position into their second co~ ic~ting position, allowing the bone cement to move from the mixing chamber to the delivery chamber.
By rotating the radially ext~on-lin~, substantially continuous, ramped, helical coil or screw thread member of the shaft member in coopeld~ g relationship with the inside wall of the delivery chamber, the fully intermixed bone cement is advanced through the delivery chamber. In addition, the helical, ramped auger or screw threads also extend into the base of the mixing chamber, thereby assuring complete transfer of the mixed bone cement from the mixing ch~mher to the delivery chamber or tube. Due to the pitch angles employed for these components, the cement is controllably advanced with the mixingtdelivery system in any typical orientation or position. The auger also compresses or sq~lee7es the bone cement during the movement through the deliverytube or chamber thereby elimin~ting subst~nti~lly all air pockets while also dispensing 30 the material under ples~ul~.

CA 02266699 1999-03-2~

W O 98t20963 PCTrUS97/20536 As a result, all of the fully intermixed bone cement is quickly and easily, controllably advanced from the mixing chamber through the delivery chamber to the outlet portal of the delivery chamber. In addition, the movement of the bone cement through the delivery chamber is fully controlled by the rotation of the spiral shaped 5 thread member. Furthermore, the mixing/delivery system of this invention delivers the mixed bone cement at an increased pres~ level, thereby assuring that the cement is forced into any cavities or interstices that may exist in the bone being repaired.
By employing the fully integrated, mixing/delivery system of the present invention, the two components forming the bone cement are quickly and easily 10 intermixed and, once the mixture has been formed, autom~ir~lly fed and delivered to a portal for being controllably advanced to the precisely desired site for its use. In addition, in the ~lere"~,d embodiment, the radially-ext~n~ling, ramped, helical-shaped auger/screw thread member is formed to cooperate with the inside wall of the delivery chamber to colllpl'ess the bone cement as the cement is advanced through the delivery 15 chamber. As a result, any air bubbles or air pockets contained in the mixed cement are broken or elimin~ted, thereby producing a cement product virtually free of any unwanted air and with adequate ~res~ure to assure complete bonding with the bonematerial.
By employing the present invention, all of the difficulties and drawbacks found 20 in prior art systems are completely elimin~t~cl along with the prior art requirement that the mixed bone cement be m~ml~lly transferred from a mixing chamber to a delivery component. By achieving a single, fully integrated, mixing/delivering system, user exposure to the mixed bone cement is elimin~tecl and all of the problems encountered with air being el"~ped in the mixed bone cement as the bone cement is transferred 25 from the mixing vessel into the delivery means are completely elimin~tecl The mixing/delivery system of the present invention is also constructed for being colllpdlil,le with all types of bone cement. As a result, pre-mixed bone cement or two-co~ ollell~ bone cement can be employed with this invention. Furthermore, the system of this invention is equally effective with all viscosity bone cements, thereby 30 enabling a single system to be employed for any bone cement, ranging from lowviscosity cements to high viscosity cellle.ll~. In addition, vacuum may be used, if ..... . ... . ...... .. ..

W O 98/20963 PCT~US97/20536 desired, thereby further e~l,a~ g the range of products with which the present invention can be employed.
The invention accordingly col~lplises the features of construction, combinationsof elements, and arrangement of parts which will be exemplified in the constructions S hereinafter set forth, and the scope of the invention will be inrlic~te~ in the claims.

CA 02266699 1999-03-2~

W O 98/20963 PCTrUS97120536 THE DRAWINGS
For a fuller underst~n-ling of the nature and objects of the present invention, reference should be had to t'ne following ~:let~ile~l description taken in connection with the acco~ )allying drawings, in which:
FIGURE 1 is a partially exploded perspective view of one embodiment of the integrated mixing and delivery system of the present invention depicted with the two components forming the bone cement being added thereto;
FIGURE 2 is an exploded perspective view, partially in cross-section, of the integrated mixing and delivery system of the present invention ~et~iling the mixing and delivery system of the present invention;
FIGURE 3 is a cross-sectional side elevation view depicting the integrated mixing and delivery system of the present invention fully assembled;
FIGURE 4 is a cross-sectional view of the integrated mixing and delivery system of the present invention taken along line 4-4 of FIGURE 3, showing the system in its first position;
FIGURE 5 is a cross-sectional view, similar to FIGURE 4, showing the integrated mixing and delivery system of the present invention in its second position;
FIGURE 6 is a side elevation view ~et~iling an alternate embodiment of the movement control means forming a component of the integrated mixing and deliverysystem of the present invention;
FIGURE 7 is an exploded pe~ eclive view, partially in cross-section, depicting an alternate embodiment of the integrated, mixing and delivery system of the present invention;
FIGURE 8 is a cross-sectional, side elevation view, of the fully assembled mixing and delivery system of FIGURE 7 shown in its first position;
FIGURE 9 is a cross-sectional, side elevation view of the embodiment of integrated mixing and delivery system of FIGURE 8 shown in its second position;
FIGURE 10 is a cross-sectional view of the mixing and delivery system of FIGURE 8 taken along line 10-10 of FIGURE 8;
FIGURE 11 is a cross-sectional view of the mixing and delivery system of FIGURE 9 taken along line 11-11 of FIGURE 9;

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W 098/20963 PCTrUS97/20536 FIG U RE 12 is an exploded pel~ective view, partially in cross section, depict-ing a still further alternate embodiment of the integrated, mixing and delivery system of the present invention;
FIG U RE 13 is a cross-sectional side elevation view of the embodiment of 5 mixing and delivery system of FIG U RE 12 depicted in its first position;
FIG U RE 14 is a cross-sectional side elevation view of the embodiment of the mixing and delivery system of FIG U RE 13 depicted in its second position;
FIG URUE 15 is a cross-sectional view taken along line 15-15 of FIG UPUE 13;
FIG URUE 16 is a cross-sectional view taken along line 16-16 of FIG URUE 14, 10 depicting the integrated mixing and delivery system of the present invention in its second position;
FIG U RE 17 is a side elevation view of the integrated mixing and delivery system of FIG U RES 12-16 shown in its second position;
FIG U RE 18 is a side elevation view of the mixing and delivery system of 15 FIG U RES 7-11 shown its second position;
FIG U RE 19 is a side elevation view det~iling a further alternate embodiment ofthe movement controlling means forming a component of the integrated mixing and delivery system of the present invention;
FIG U RE 20 is a side elevation view det~iling a still further alternate embodi-ment of the movement controlling means forming a component of the integrated mixing and delivery system of the present invention;
FIG U RE 21 is a side elevation view det~iling an alternate embodiment of the mixing portion forming a component of the integrated mixing and delivery system of the present invention;
FIG U RE 22 is a bottom pe~sl~ecLi~/e view of the mixing portion of FIG U RE 21;FIG U RE 23 is a top plan view, partially broken away, depicting the construc-tion of indicator means formed in the cover of the integrated mixing and delivery system of the present invention; and FIG U RE 24 is a side elevation view, partially in cross-section and partially broken away, providing further depiction of the in~ tor means of FIG U RE 23.

. , CA 02266699 1999-03-2~

W O98/20g63 PCTrUS97/20536 DETAILED DESCRIPTION

By ~efe~ g to FIGURES 1-24, along with the following detailed disclosure, the construction and operation of several alternate embodiment~ of the fully integrated bone cement mixing and delivering system of the present invention can best be understood.
5 Although several alternate embodiments are fully disclosed herein, it is understood that further alternate embo~lim~ntc can be made without departing from the scope of the present invention. Consequently, the embodiments detailed herein are presented for exemplary purposes only, and are not intended to limit the scope of the present invention.
1 0 In FIGURES 1-5, the overall construction of one embodiment of integrated mixing/delivery system 20 of the present invention is fully depicted. In this embodi-ment, integrated mixing/delivery system 20 comprises an integrated housing 21 which incorporates a mixing chamber 22 and a delivery tube 23 integrally interconnPcte~ with each other. In addition, integrated mixing/
1 5 delivery system 20 also comprises a cover 24 which is removably mountable to mixing chamber 22.
In the prer~lled construction, cover 24 incorporates a plurality of slots 25 formed about an outer peripheral surface thereof, with each slot 25 cooperating with a raised pin member 26 extending from the outer surface of chamber 22. In this way, 20 cover 24 is easily locked in position, peripherally ~ loullding and securely closing mixing vessel 22, whenever desired. By positioning slots 25 with coopeldtillg pin members 26 and rotating cover member 22 relative to chamber 22, pin 26 is advanced into locked engagement with slot 25. Whenever cover 22 is to be removed from chamber 22, the process is reversed, thereby enabling cover 22 to be easily removed 25 t~lClcr~
The overall construction of integrated, mixing/delivering system 20 of the present invention is completed by incorporating elongated, multi-component shaftmember 28 which comprises mixing portion 29 and movement controlling portion 30.Although shaft member 28 may be constructed as a single component, it has been 30 found that the plefelled construction is to form shaft member 28 from at least two ., ,, , ., . ~ .

CA 02266699 1999-03-2~

W O 98/20963 PCTrUS97t20536 separate and distinct sections, each of which are integrally interconnPcted to each other.
However, if desired, three or more sections can be employed, as well as a singleelongated component, without d~lJa~ g from the scope of this invention.
Furthermore, cover 24 incorporates a centrally disposed aperture 31 constructed 5 for enabling shaft member 28 to extend thefc~ ough and be rotationally driven from outside of mixing vessel 22. In order to prevent u~all~ed leakage, the dirnensions of aperture 31 and shaft member 28 are m~int~in~d in close relationship to each other.
As di.cc~csed above, mixing/delivery system 20 of the present invention may be employed when connected to a vacuum source, in order to further enhance the removal 10 of all air bubbles or air pockets. In addition, certain types of bone cement are more likely to develop air pockets during the mixing and delivery system and, as a result, are best employed with mixing/delivery system 20 connected to a vacuum source. In order to enable mixing/delivery system 20 of the present invention to be quickly and easily interconnPcted to a vacuum source, cover 24 incorporates a fitting 32 constructed for 15 enabling a vacuum source to be directly conn~cted to mixing chamber 22 to provide the desired removal of air from the bone cement being mixed therein. Of course, if avacuum source is not required, vacuum fitting 32 would be sealed, if desired, so as to enable the bone cement to be intermixed without being exposed to vacuum conditions.
Another feature incolpol~ted into the mixing/delivery system of the present 20 invention is the incorporation of indictor means 160 which provides the operator with a positive indication that the bone cement is completely mixed and ready for delivery.
The pler.,.led construction for in-iicator means 160iS fully det~iled below, with FIGURE 1 depicting a window mçmher 161 through which a positive, visual inrli~tor is easily observed which provides the operator with visual notice of the progress being 25 made during the mixing cycle. Once the bone cement has been fully and completely intermixed and is ready for delivery, an easily observable indication is displayed through window 161 of in-lie~tl~r means 160.
In the plcr~ llcd construction, mixing portion 29 of elongated, multi-component shaft member 2~ comprises an elongated, rod member 34 and at least two mixing 30 blades 35,35 integrally ~tt~ d to rod member 34 and radially extçn~ling lhele~
As is more fully det~iled below, mixing blades 35,35 are preferably formed with an ,, , . ... ~ , .

CA 02266699 l999-03-2~

W O 98/20963 PCT~US97/20536 arcuately curved shape, and with an outer edge constructed having a size and shape that provides a cooperative relationship with mixing chamber 21.
Although mixing blades 35~35 may be constructed without an arcuate curved shape, c~ n~lising subst~nti~lly flat, planar blade members, the plcfellcd construction of mixing blades 35,35 colll~.ise an arcuately curved shape which ranges betweenabout 45~ and 360~. As is more fully detailed below, the prcrclled arcuate curveformed in blades 35,35 ranges between about 90~ and 180~.
In the preferred embodiment, mixing portion 29 comprises post receiving socket 36 formed at the distal end of rod member 34, with socket 36 comprising a size and shape constructed for secure, locked, driving interengagement with post 37 of move-ment controlling portion 30. In the preferred embodiment, post receiving socket 36 comprises a generally square or rectangular shape, dimensioned for receiving, secure, locked hltelellgagement with square or rectangular shaped post 37 of movement controlling portion 30.
The construction of mixing portion 29 of shaft member 28 is preferably completed by forming terrnin~ting end 38 of rod member 34 for being received andlocked in hllclcllgagement with drive means 39 (FIGURE 3), employed for rotatingshaft member 28 when desired. As further di~cussed herein, when desired, shaft member 28iS continuously, controllably rotated in order to enable blade members 35,35 eo cooperate with the inside walls of mixing chamber 22 and fully mix the two components forming the desired bone cement.
In addition, in order to provide the desired controlled movement of the mixed cement through delivery tube 23, as well as its delivery under pr~s~uie, movement controlling portion 30 iS rotated in Coo~cldlillg relationship with the inside walls of delivery tube 23. This rotational movement is provided under the complete control of the user by employing drive means 39 securely engaged with termin~ting end 38 ofmixing portion 29 of shaft member 28.
In the plercllcd implementation of the present invention, drive means 39 for elongated, multi-component shaft member 28 comprises a rotatable drill member, as depicted in FIGURE 3. If desired, however, any alternate drive means can be CA 02266699 1999-03-2~

W O 98/20963 PCTrUS97120536 employed without depa,~ g from the scope of the invention, such as manual handledrive shown in FIGURE 3.
In the plefe.led embodiment, drive means 39 is capable of rotating shaft member 28 with sufficient speed to assure the mixing of the components forming the 5 bone cement and the controlled delivery of the mixed bone cement through delivery tube 23. In this way, assurance is provided that the two-part bone cement is complete-ly intermixed and, when completed, controllably advanced through delivery tube 23 to the outlet portal thereof, with the cement being delivered under pl~es~ulc;, to assure secure bonded engagement in the desired location.
In the embodiment depicted in FIGURES 1-5, mixing ch~mher 22 iS formed in a substantially U-shape, co~ illg outer wall 45 and inner wall 46. In addition,mixing chamber 22 comprises an enlarged, open entry zone 47 formed at the top of the substantially U-shaped chamber 22, and an upst~n~ling collar 48 formed at the base of U-shaped chamber 22.
In the plef.,l,ed construction, upst~nrling collar 48 c~ fises an upst~n-~ing, subst~nti~lly circular shape, incorporating a central apellule 49 for receiving elongated, multi-component shaft member 28, and two enlarged side portal zone 50 formed in the sides of upst~n-ling collar 48 subst~nti~lly diametrically opposed from each other. As is more fully detailed below, portal zones 50 provide the co~ iration between 20 mixing chamber 22 and delivery tube 23.
As briefly ~ cus~ed above, each of the two mixing blades, 35,35 are mounted to rod member 34 of elongated, multi-component shaft member 28 cooperating therewilll to form mixing portion 29. In this embodiment, each mixing blade 35 comprises an outer edge 54 which is dimensioned to conform with the axial or longitu-25 dinal, curved shape of inside wall 46 of U-shaped mixing chamber 22. In addition, outer edge 54 of each mixing blade 35 is dimensioned for being in juxtaposed, spaced, aligned, close relationship with inside wall 46 of mixing chamber 22 in order to assure that the components forming the bone cement are efficiently and easily contacted and completely intermix~d by the rotational movement of blade members 35,35 relative to 30 inside wall 46 of mixing ~h~mher 22.

. . .

CA 02266699 1999-03-2~

In addition, each blade member 35 also comprises an overall axial length subst~nfi~lly equivalent to the axial length of inside wall 46 of mixing chamber 22.
Preferably, top edge 55 of each mixing blade 35 radially extends outwardly from rod member 34 in juxtaposed, spaced cooperaling relationship with the inside surface of cover 24. As a result, complete intermixing of the components forming the bone cement is assured.
In this embodiment, delivery tube 23 comprises an elongated, generally cylindrical shape defined by outer surface 51 and inner surface 58. In addition, the end of delivery tube 23, which cooperates with mixing chamber 22, comprises an upstand-1 0 ing, subst~nti~lly cylindrically shaped wall 59 dirnensioned for retained inserted engagement within collar 48 of mixing chamber 22.
In addition, cutout zones 60 are formed in upst~n(ling wall 59 forming a commnniratin~ portal zone between the interior of mixing chamber 22 and the interior of delivery tube 23. In the plefel,cd construction, two cutout zones 60 are formed in 1 5 wall 59 positioned in juxtaposed, spaced diametrically opposed locations thereof.
Cutout zones 60 are constructed for cooperating relationship with portal zones 50 of collar 48 in order to provide at least two positions relative thereto. In one position, the interior of mixing chamber 22 is completely sealed from the interior of delivery tube 23, while in the second, alternate position, the two interior zones are in communication with each other.
In the preferred construction of this embodiment of the present invention, delivery tube 23 is constructed with a pluMlity of ribs 62 formed on outer surface 57 of delivery tube 23. Preferably, ribs 62 are formed as longit~ in~l1y extending ribs positioned in juxtaposed spaced relationship to each other on outer surface 57.
Although not required, ribs 62 are preferred in order to assist the user in arcuately rotating delivery tube 23 relative to mixing vessel 22 whenever mixing/delivery system 20 is moved from its first position into its second position.
Furthermore, in the preferred construction, delivery tube 23 incorporates a ledge 70 at the juncture between inside wall 58 and outlet portal 61. As best seen in FIGURE 3, ledge 70 is constructed for coope-alillg relationship with distal end 66 of movement controlling portion 30 for receiving and securely positioning distal end 66 in CA 02266699 1999-03-2~

W O 98120963 PCTrUS97/20536 the precisely desired manner wherein movement controlling portion 30 is capable of continuously rotating, while enabling the intermixed bone cement to be lldl~.rci.led through delivery tube 23 to outlet portal 61 under the desired ples~ule level.
In order to best understand the coo~e.d~ g relationship of delivery tube 23 to 5 mixing c~mher 22 and the two alternate positions provided by mixing/ delivery system 20 of the present invention, ref.,le,lce should be made to FIGURES 2-5 along with the following detailed disclosure. As shown therein, when delivery tube 23 and mixing chamber 22 are fully assembled, upst~n~ling wall 59 is telescopically inserted and cooperatively received within collar 48 of mixing chamber 22.
1 0 In the first cooperative position, depicted in FIGURE 4, mixing chamber 22 is sealed from delivery tube 23. When in this position, upst~nAing wall 59 of delivery tube 23 is in juxtaposed, spaced, blocking relationship with portal zones 50,50 of collar 48. As a result, when mixing delivery system 20 of the present invention is m~int~inPd in this first position, the components forming the bone cement can be inserted into 1 5 mixing chamber 22 and completely int~rmixed without fear that any partially mixed cement will be transferred from mixing chamber 22 to delivery tube 23.
In the second position of mixing/delivery system 20, depicted in FIGURE 5, the interior of mixing chamber 22 is in direct co~ tion with the interior of delivery tube 23. In this position, delivery tube 23 is arcuately rotated relative to mixing chamber 22, causing cutout zones 60,60 of upst~ntling wall 59 to be aligned with portal zones 50,50 of collar 48. As a result, when mixing/delivery system 20 is in thisposition, the fully mixed bone cement is capable of passing through portal zones 50,50 and cutout zones 60,60 to be completely transferred from mixing chamber 22 into delivery tube 23.
The construction of this embodiment of mixing/delivery system 20 is completed by securely ~fflxinE plate 71 to the base of mixing chamber 22 by employing screw means 72. Preferably, mixing tube 23 incol~ulal~s a radially extending cam-ring 73 which is sandwiched between mixing chamber 22 and plate 71 when plate 71 is secured in position.
As best seen in FIGURES 2, 4 and 5, cam ring 73 incorporates a cam surface 74 constructed for defining the two altern~tç positions of delivery tube 23 relative to CA 02266699 l999-03-2~

W O 98/20963 PCT~US97/20536 mixing chamber 22, as well as the interm~ te travel positions therebelween. By employing a cam post 75, mounted either to mixing vessel 22 or plate 71, the twoalternate positions of delivery tube 23 relative to mixing vessel 22 are defined and easily ~tt~in-ocl, while assuring no further movement beyond these two alternate5 positions.
By employing this construction, the first position, as depicted in FIGURE 4, is ~tt~intq.~l when cam post 75 is in abutting contact with one end of cam surface 74 of cam ring 73. By arcuately rotating delivery tube 23 relative to mixing chamber 22, cam surface 74 is moved relative to cam post 75 a ~ t~nl~e of about 90~, until the 1 0 opposed end of cam surface 74 is brought into abutting contact with cam post 75.
Once in this position, the second position of mixing/delivery system 20 is ~tt~inP~
By employing this construction, the operator is capable of completely mixing thetwo components forming the bone cement with the as~,ula,-ce that the bone cement is completely h~lelllli~ed prior to any cement composition being Llall~,r~llcd to delivery 1 5 tube 23. Once the bone cement is fully prepared by complete intermixture, mix-ing/delivery system 20 is moved from its first position to its second position, enabling the completely intermixed bone cement to be llall~relled from mixing chamber 22 to delivery tube 23.
As is appa,~l,l from the preceding ~iet~iled ~isclosure, the movement of the fully 20 mixed bone cement from mixing cha"lbel 22 to delivery tube 23 is achieved in a completely sealed environment, with cover 24 rem~inir~ in place, sealing mixing chamber 22 from exposure to the ambient air. As a result, none of the ~lifflr,lllti~.s and drawbacks found with prior art systems are encountered, and automatic, safe, conve-nient, full-proof l,d,~,rel of the bone cement from the mixing chamber to the delivery 25 chamber is realized, without exposing the opel~or to the noxious, offensive odor associated with the bone Cern~nt In order to assure that the fully mixed bone cement is lld~r~,.led through delivery tube 23 to outlet portal 61, formed at the distal end of delivery tube 23, movement control portion 30 of elongated, multi-component shaft member 28 is 30 employed. In the embodiment depicted in FIGURES 1-5, movement controlling portion 30 comprises a contin~ons, radially e~ellding, ramped, helical or spiral shaped .. . . .

CA 02266699 1999-03-2~

W O 98120963 PCT~US97/20536 auger or screw thread member 63. As shown in FIGURES 2 and 3, continuous, ramped, helical or spiral shaped auger/screw thread member 63 radially extends ouLw~ldly from elongated, supporting rod m~mber 64. In this embodiment, rod member 64 co~ ises a sub~ lly uniform ~ m~ter "C" throughout its length.
As diccussed above, one end of rod member 64 of movement controlling portion 30 is formed with subst~nti~lly square shaped or rectangular shaped post 37, construct-ed for being inserted through apellu~c 49 of collar 48 of mixing chamber 22 and being securely1 lockingly and drivingly engaged with post receiving socket 36 of rod member 34 of mixing portion 29. In addition, opposed end 66 of rod member 64 is preferably 1 0 formed with a subst~nti~lly flat surface constructed for nested, rotational engagement with edge 70 of delivery tube 23. In this way, the rotational movement imparted to multi-component shaft member 28 by drive means 39 causes mixing blades 35 to rotate about the axes of rod member 29 while ~imnlt~n~ously causing helical or spiral thread member 63 to rotate about the central axis of rod member 64.
1 5 Continuous, ramped, radially extending, helical or spiral shaped auger/screw thread member 63 is mounted to rod member 64 with an angular pitch which assuresthat a plurality of convolutions are formed along the length of rod member 64. ~n this way, the desired controlled movement of the bone cement through delivery tube 23 is provided.
In order to assure complete, controlled movement of the mixed bone cement from mixing chamber 22 through delivery tube 23, helical or spiral shaped screw thread member 63 co~ lises a rii~m~ter slightly less but dim~n~ionally similar to the di~m~ter of inner wall 58 of delivery tube 23. In this way, assurance is provided that movement controlling member 30 is free to rotate within delivery tube 23 while being in close, juxtaposed, spaced, coopel~tillg relationship with the inside wall thereof. As a result, all of the mixed bone cement is controllably advanced through the interior of delivery tube 23, with maximum cclllpr~ssion of the bone cement being ~tt~in~d as well as pressure build-up for forcing the bone cement into the desired bone structure.
In order to enhance the coll~plession of the bone cement during its travel through tube 23, the prer~l,cd embodiment of movement controlling portion 30 is formed with the spacing between each adjacent thread or convolution of continuous screw thread CA 02266699 1999-03-2~

W098/20963 PCT~US97/20536 members 63 decreasing as the thread members 63 advance from post 37 to the op-posed, distal, te~ g end 66 of movement controlling portion 30. Although any desired spaced ~ t~nre can be employed between adjacent threads or convolutions to attain the benefit derived from this invention, it has been found that the spacing preferably ranges between about 1.25 and 0.10 inches. It has also been found that dirrere,lt bone cement viscosities are preferably advanced using different thread spac-ings. Generally, bone cement having a low viscosity preferably employs a controlling portion 30 wherein the spacing between adjacent threads or convolutions ranges between about 0.25 and 0.10 inches. In addition, bone cement having a high viscosity preferably employs a controlling portion 30 having a spacing between adjacent threads or convolutions ranging between about 1.25 and 0.185 inches.
In order to best understand this plcr~llcd construction, rcfelcnce should be made to FIGURE 2. As shown therein, the ~ t~nre defined by spacing "A", which isadjacent post 37, is greater than the tii~t~nce defined by spacing "B", located adjacent distal end 66 of controlling portion 30. Preferably, the ~li.ct~nres employed fall within the ranges detailed above. In addition, the ~ t~nre between the interrn~ te threads or convolutions continuously decreases, consistent with the dimensions of spacings "A"
and "B".
By constructing screw thread members 63 with the variable spacing detailed above, a variable pitch is imparted to screw thread members 63 throughout the length of movement controlling portion 30. By employing this variable pitch construction, it has been found that the mixed bone cement is not only controllably advanced through delivery tube 23, but is more effectively compressed and sql~eç7rd during the axial ~rel of the bone cement through delivery tube 23. Furthermore, this construction is able to force the mixed bone cement out of portal 61 under pres~ulc, which assures complete filling of all cavities in the bone.
As a result of this construction, controlled compression of the bone cement is achieved during its advance through tube 23, causing any air e~ pped in the mixed bone cement to be forced out autom~tir~lly by the delivery process. In this way, the bone cement delivered through portal 61 of delivery tube 23 is subst~nti~lly free of CA 02266699 1999-03-2~

W 098/20963 PCTrUS97/20536 ellLldpped air, ~tt~ining a bone cement having all of the q~l~litie~ and inherent character-istics desired by the surgeon.
In most applications wh.,lcin mixing/delivery system 20 is employed, outlet portal 61 of delivery tube 23 is positioned in direct association with the particular bone 5 cavity or joint into which the cement is to be dispensed. As a result, by activating drive means 29, after the bone cement has been fully mixed and mixing/delivery system 20 has been rotated into its second, chamber co~ ting position, the fully mixed bone cement is advanced through delivery tube 23 directly to the site desired under pressure for its use.
1 0 In some applications, outlet portal 61 is unable to reach the desired site. In order to accommodate these in.ct~n~es, an extension tube 65, shown in FIC~URE 3, is employed to deliver the mixed bone cement to more remote locations or locations where delivery tube 23 cannot be easily positioned.
In order to assure ease of mounting of extension tube 65 to the termin~ting, 1 5 distal end of delivery tube 23, in a peripherally surrounding and coopela~ g manner with outlet portal 61, the distal end of delivery tube 23 incorporates thread means 67 formed thereon. In addition, extension tube 65 incol~olates cooperating thread means formed at its proximal end, thereby enabling extension tube 65 to be quickly and easily threadedly engaged to thread means 67 of the distal end of delivery tube 23. Once 20 mounted in position, the activation of drive means 39 causes the mixed bone cement to be advanced through delivery tube 23, out of portal 61 and through the interior of extension tube 65, until the fully int~ cl bone cement is delivered to the precisely desired surgical site.
In addition, the system of this invention forces the mixed bone cement through 25 portal 61 and tube 65, if employed, under p~ ule to enable the surgeon to usestandard bone filling teçhniq ~es to fill all cavities and interstices in the bone with cement, thereby providing secure bonded engagement. Typically, after filing the bone canal with cement, mixing/delivery system 20 is sealed against the opening of the bone canal. Then, by rotating movement controlling portion 30, p~s~uleis created which 30 insures the cement creates a good interlock beLweel1 cement and bone. The pl'eSS~
tion increases the subsequent strength of the bone cement and improves the quality of CA 02266699 1999-03-2~

W O 98/20963 P~TrUS97/20536 the mech~ni~l interlock between cement and bone by forcing the cement into irregular-ities in the bone's surface.
In FIGURE 6, an ~ltorn~te embodiment for movement controlling portion 30 is depicted. In this embo~limPnt7 movement controlling portion 30 comprises an overall shape and construction similar to the construction detailed above. These similarities are evident from the construction depicted in FIGURE 6, as well as the referenceindices employed. In this regard, reference indicia cli.~c~sse~l above and shown in FIGURE 6 has equal applicability to the embodiment of FIGURE 6.
In this alternate construction, one l,li"ci~al variation incorporated in movement controlling portion 30 is the construction thereof with a rod member 69 having atapered di~mPter. As depicted in FIGURE 6, the fli~m~oter of rod member 69 increases as one advances from the proximal end of rod member 69, adjacent post 37, to opposed, tennin~ting distal end 66.
As shown in FIGURE 6, the diameter of tapered rod member 69 varies from a ~ m~oter "D", adjacent post 37, to a fli~m~ter "E", adjacent distal end 66. Although any desired di~mPt~Pr range can be employed to attain the benefit provided by this embo-~imPnt it has been found that the preferred di~meter for tapered rod member 69 ranges between about 0.18 inches and 0.50 inches. In the l)lcr~.lcd construction as depicted in FIGURE 6, ~ m~t~r "D" ranges between about 0.l8 inches and 0.30 inches, while cli~mPter "E" ranges between about 0.38 inches and 0.50 inches.
By employing this tapered, diameter construction for rod member 69, with continuous, ramped, radially extending, helical or spiral shaped auger or screw thread member 63 mounted thereto, a construction is ~tt~inPd wheleill the distal end ofdelivery tube 23 comprises an overall area which is smaller than the area provided by the embodiment depicted in FIGURE 3. As a result, further col"pression of the mixed bone cement is ~t~intod and added assurance is provided that all ellL~ped air isremoved and additional exit pressure is gtnel~lted. Furthermore, by employing this construction, added s~l~n~lll and rigidity is imparted to movement controlling portion 30, particularly in the area directly adjacent outlet portal 61 where added pressure is imparted to the screw thread member, due to the proximity of the thread members to each other.

CA 02266699 l999-03-2~

W O 98/20963 PCTrUS97/20536 By referring to FIGURES 19 and 20, two further alternate embo~ for movement controlling portion 30 of the present invention are depicted. In the embodi-ment depicted in FIGURE 19, movement controlling portion 30 comprises a rod member 155 which may comprise either a uniform tli~meter throughout its length or 5 may be tapered, as ~let~iled above. Mounted to rod m~mber 155 is contimlo~s~
ramped, radially extending, helically shaped auger or screw thread member 156 which is constructed in this embodiment with spaced (li~t~nre "F" between each aclj~cent thread member comprising a subst~nti~lly equivalent ~i~t~n~e throughout the entire length of rod member 155. Depending upon a particular type of bone cement being 1 0 employed, movement controlling portion 30 with a uniform pitch screw thread member 156 may be effectively employed.
In the embodiment depicted in FIGURE 20, movement controlling portion 30 co~ lises a rod member 157 which is tapered in the opposite direction of movement controlling portion 30 of FIGURE 6. In this embodiment, the largest ~ m~oter of rod 1 5 member 157 is formed near the jull~;lule with mixing chamber 22 while the ~m~ st ~i~m~tPr thereof is formed at the distal end of movement controlling portion 30.Mounted to rod member 157 is a continuous, ramped, radially extending, helical-shaped auger or screw thread member 158 which may be formed with either a variable spacing between adjacent thread members or a ul~irolm spacing, as det~ above.
20 However, in the pr~fe.led construction, screw thread member 63 would be constructed using the variable pitch configuration thoroughly det~ilçd above.
By employing the funnel shaped rod member 157 for movement controlling portion 30, the tube member with which this construction would be associated would be formed in a subst~nti~lly complim~nt~ry funnel shape. In this construction, it has been 25 found that m~ximmn pres~ule and bone cement squee7ing is ~tt~in~cl due to thesubst~nti~lly reduced area near the distal end of the delivery tube. Consequently, for certain viscosities of bone ce~nPnt this construction provides highly effective results.
In FIGURES 7-11, a second, alternate embodiment of a fully integrated, bone cement mixing and delivering system 20 of the present invention is fully det~ d. For 30 convenience and ease of undel~ g, these drawings, and the following ~let~ d disclosure, employ similar reference numerals for similar structural components. As a . .

CA 02266699 1999-03-2~

result, it is to be understood that in addition to the following detailed disclosure regarding the embodiment of FIGURES 7-11, the foregoing detailed disclosure relating to the particular similar structural components is equally applicable to this embodiment and the structure of the components employed therein.
In this embodiment, integrated, mixing/delivery system 20 colllplises an integrated housing 21 which incorporates a mixing chamber 22 and a delivery tube 23 integrally interconn~cte~ with mixing chamber 22. In addition, integrated mix-ing/delivery system 20 also incorporates a cover 24 which is removably mountable to mixing chamber 22 in the manner detailed above.
1 0 In this embo~limPnt, cover 24 preferably incorporates a circular notch 76 formed in the underside of cover 24 with notch 76 comprising a di~m~ter generally equivalent to the diameter of the cylindrical wall forming mixing chamber 22. In addition, O-ring 77 is also incorporated into this embo~limPnt, for being positioned within notch 76. In this way, when cover 24 is securely affixed to mixing chamber 22, a sealing zone is 1 5 established by O-ring 77 and notch 76 in order to prevent any ullw~ cd seepage of bone cement from mixing chamber 22 during the mixing process.
As with the embodiment detailed above, this embodiment of the integrated, mix-ing/delivery system 20 incorporates elongated, multi-component shaft member 28 which collll"ises mixing portion 29 and movement controlling portion 30. As detailed above, mixing portion 29 of elongated, multi-component shaft member 28 comprises an elongated rod member 34 and at least two mixing blades 35,35 integrally ~tt~ch~cl to rod member 34 and radially extending thclcrr~nl. In addition, in the ~rerellcd construction, mixing blades 35,35 are formed in an arcuately curved shape, with outer edge 54 having a size and shape constructed for cooperative relationship with inside wall 46 of mixing chamber 22.
In this emborlim~nt, the plcfe~led construction of mixing portion 29 and movement controlling portion 30 of mixing/delivery system 20 is substantially identical to the construction detailed above. As shown in FIGURES 7-11, movement controlling portion 30 colll~,ises contin~ouc, ramped, radially e~l~n~ g helical-shaped auger or screw thread member 63 extending from ~,ub~ lly unirollll dialllcl~r rod member ~ , ... . ..

CA 02266699 1999-03-2~

W O 98/20963 PCTrUS97120536 64. However, if desired, tapered fii~mloter rod member 69 can be employed with equal efficacy and effect as well as the further alternate structures detailed above.
The p.h~il,al dirl~rellces b~Lw~en the embodiment depicted in FIGURES 7-11 and the embodiment ~et~ d above and shown in FIGURES 1-5 is found in the 5 construction and cooperative hll~rengagement between mixing chamber 22 and delivery tube 23 to form unitary housing 21. As det~ d herein, a further unique construction is employed for providing sealable hllelellgagement between mixing chamber 22 and delivery tube 23, as well as for providing movement between a first sealed position, wherein the interior of mixing chamber 22 is completely sealed from the interior of 10 delivery tube 23, and a second position, wherein these interior zones are in collllllulli-cation with each other. The following disclosure details this additional unique con-struction, as well as the cooperation with some of the elements detailed above.
In this ~ltPrn~te embodiment, mixing chamber 22 comprises a subst~nti~lly U-shape, formed by outer wall 45 and inner wall 46. In addition, mixing chamber 22 15 cullll,.ises an enlarged open entry zone 47 formed at the top of subst~nti~lly U-shaped chamber 22 which is constructed for the cooperative sealing interengagement withcover 24 and sealing O-ring 77.
In this embo~lim~nt the base or lower portion of mixing chamber 22 comprises a substantially circular shaped ope~ lg or passageway 80 which extends from the 20 interior of mixing chamber 22 part way toward bottom 82. In addition, mixingchamber 22 incorporates an enlarged open zone 81 which extends from passageway 80 to bottom 82 of mixing chamber 22. Mixing chamber 22 also incorporates a plurality of screw-receiving holes 83 which are preferably positioned in relationship with open zone 81 of mixing chamber 22, with threaded screw-receiving holes 83 being open 25 from bottom 82.
In this embo~1im~nt, delivery tube 23 comprises an outer surface 57, an inside surface 58, which defines the interior zone in which movement controlling portion 30 iS
positioned for cooperative relationship with inside wall 58 in order to controllably move the mixed bone cement there~ ough from the interior of mixing chamber 22 30 through outlet portal 61 of delivery tube 23. Furthermore, outside surface 57 of delivery tube 23 co",~lises two circular shaped recesses or notches 85 and 86 both of which are formed in cool)e.~li,lg relationship with proximal end-forming flange 87 of delivery tube 23. In addition, O-ring 88 is positioned in notch 85, while O-ring 89 is positioned in notch 86. Finally, ~ubsl~ ly mid-way along the length of outer surface 57 of delivery tube 23, a pair of radially c~LIe,~ g arms 90 and 91 are positioned.
The fli~m~t~r of outer wall 57 of the upper portion of delivery tube 23 iS
constructed for being substantially equivalent to and slightly less than the ~ m~ter of aperture 80. In this regard, the ~ m~ter of aperture 80 and the (li~mPter of outer wall 57 of the upper portion of delivery tube 23 are (lim~n~ioned for cooperative, sliding interengagement, while preventing any u,lwdllled passage or seepage of the bone 1 0 cement therebelwcell. In order to assist in preventing any unw~llLed seepage or passage of bone cement between aL~ellulc 80 and outside wall 57 of delivery tube 23, O-ring 88 and 89 are mounted in recesses 85 and 86, effectively sealing the area between these two cooperating components, while still enabling the desired axial sliding movement therebetween.
1 5 The construction of this embodiment of mixing/delivery system 20 is completed by mounting collar plate 93 to bottom 82 of mixing vessel 22. Collar plate 93 isconstructed for direct mounted affixation to the bottom of mixing chamber 22 by employing screw means 94 which are inserted through receiving apelLulcs in collar plate 93 and securely mounted in screw receiving holes 83 of mixing chamber 22.
In the prefelled construction, collar plate 93 comprises two upst~ntling walls or posts 95,95 which are constructed for being positioned within open zone 81 in cooper-ating relationship therewith. Posts 95 extend subsL~nlially perpendicularly from plate 93 a sufficient (li.ct~nre to provide a space bclwcen the end of posts 95,95 and the juncture of aperture 80 and zone 81 with the space being at least equal to the thickness of arms 90 and 91. In this way, arms 90 and 91 are independently retained on onepost 95, preventing axial movement of delivery tube 23. However, whenever desired, arms 90 and 91 are rotated away from retained engagement with posts 95, thereby enabling axial movement of arms 90 and 91, along with tube 23.
When this embodiment of mixing/delivery system 20 is fully assembled and placed in the closed position, with the interior of mixing chamber 22 completelyindependent from the interior of delivery tube 23, radially exten~ing arms 90 and 91 CA 02266699 l999-03-2~

W 098/20963 PCT~US97/20536 are c~luled and m~int~in~d in position by upst~n~ing posts 9S,9S of collar plate 93.
When in this position, the upper proximal portion of delivery tube 23 iS m~int~in~
within ape~lule 80 of mixing vessel 22, while also ext~n-ling into the bottom of mixing chamber 22 in peripheral surrounding and sealing relationship with rarnped, radially ext~n~ing helical shaped auger or screw thread member 63 of movement controllingportion 30. As a result, any contact of screw thread member 63 with the bone cement is prevented and all of the bone cement is safely m~int~in~ within the interior of mixing chamber 22.
In order to assure secure, seepage-free separation of the bone cement from movement controlling portion 30, O-ring 88 iS placed in cont~r,ting engagement with the base of rod member 34 of mixing portion 29,~,vhile end-forming flange 87 iS
inserted in groove 99 formed about socket 36. In this way, complete sealing of movement controlling portion 30 from exposure to the bone cement within the interior of mixing chamber 22 iS ~tt~in-~cl, when mixing/delivery chamber 20 iS in its first 1 5 position.
In order to move mixing/delivery system 20 from its first position into its second position, wlleleill the interior of mixing chamber 22 iS in c~ ic~tion with the interior of delivery tube 23, delivery tube 23 iS arcuately rotated about its central axis by moving radially extending arms 90 and 91 away from retained engagement on posts 9S until arms 90 and 91 are away from posts 95 and within open zone 81. Once arms 90 and 91 are positioned within open zone 81, delivery tube 23 iS capable of axial, telescopic movement, in its entirety, relative to mixing vessel 22.
Once free from posts 95, delivery tube 23 iS axially movable dowllw~idly, causing arms 90 and 91 to advance towards bottom 82 of mixing chamber 22. Duringthe axial movement, proximal end-forming flange 87 of delivery tube 23 iS moved away from sealing engagement with rod member 34 of mixing portion 29, effectively exposing the proximal end of movement controlling portion 30 to the interior of mixing chamber 22.
When axial movement is complete, as clearly depicted in FIGURE 9, continu-ous, ramped, radially ~x~ g helical shaped auger or screw thread m~mher 63 iS
fully exposed to the mixed bone cement contained within mixing chamber 22, enabling CA 02266699 1999-03-2~

W O 98/20963 PCTrUS97t20536 the rotation of elongated, multi-component shaft member 28 to effectively advance the mixed bone cement from chamber 22 through delivery tube 23 until the desired mixed bone cement has been ll~llsre~lcd through delivery tube 23 to outlet portal 61.
As is ~palclll from the foregoing clet~ l disclosure, this embodiment of the 5 present invention functions in subst~nti~lly the same manner as the first embodiment, providing effective and complete mixing of the bone cement in a completely sealed chamber until the entire bone cement has been completely formed. Once the cement is completely intermixed, the user is able to autom~tir~lly advance the mixed cement through the delivery tube directly to the desired site. In addition, all of the features 10 detailed above relating to the automatic delivery of the bone cement to outlet portal 61 is equally applicable, as well as the construction of movement controlling portion 30 so as to elimin~te any c~l~ped air from the cement and provide the desired deliverypressure level. Consequently, this embodiment, like the previous embodiment, attains substantially air-free mixed bone cement delivered to the precisely desired site under 15 pl'cS~urc. In addition, if the use of a vacuum source is desired, to further assure the removal of any enlldl)ped air, cover 24 may be constructed with a vacuum, as detailed above.
In the same manner det~ilPd above, the distal end of delivery tube 23 incorpo-rates thread means 67 so as to accommodate an extension tube, if needed. In this way, 20 the mixed cement bone cement can be delivered directly to any desired location or position with the required l.les~ulc to provide the desired bone cement bonding.In FIGURES 12-16, a further embodiment for constructing a fully integrated bone cement mixing and delivering system 20 in accordance with the present invention is fully ~let~ile~l. As with the embodiments detailed above, similar reference numerals 25 are employed throughout the following disclosure and associated drawings for ,efc~ g to similar structural elements. Con~eq~ently, all of the detailed disclosure provided above regarding these components is intended to have equal efficacy and effect on the structure shown in FIGURES 12-16. Furthermore, in order to avoid repetition of llnn~oces~,qry disclosure, many of the details of the similar structural arrangements are 30 not provided hereafter, due to the full disclosure in the foregoing discussion regarding these components and the constructions thereof.

CA 02266699 l999-03-2~

WO 98/20963 PCTrUS97/20536 In the embodiment det~iled in FIGURES 12-16, mixing/delivery system 20 comprises housing 21 which incorporates a mixing chamber 22 and delivery tube 23, integrally interconn~cted and cooperatively associated with mixing chamber 22. In addition, integrated mixing/delivery system 20 also comprises a removable cover 101 5 which is mountable to mixing ch~mher 22.
In this embo~lim~nt, cover 101 is constructed with thread means 102 formed in the interior surface thereof, while mixing chamber 22 comprises coopel~ling thread means 103 formed on outer wall 45 of mixing chamber 22. In addition, circular shaped recess 104 is formed in cover 101 preferably positioned above thread means 102 with O-ring 105 constructed for being mountingly retained in recess 104.
In this way, when cover 101 is threadedly mounted to mixing chamber 102, by employing threads means 102 and 103, the secure, sealed, mounted engagement of cover 101 with mixing chamber 22 is assured. Furthermore, all unwdl~led seepage of the bone cement mixture from the interior of mixing chamber 22 through cover 101 is 15 completely avoided, due to the threaded sealing interengagement between cover 101 and ch~mher 22 as well as by the sealing mounted engagement of O-ring 105 in peripheral ~ullounding, sealing contact with outside wall 45 of chamber 22 As detailed above in the di.ccllccion regarding the previous two embotlimentc, this embodiment of mixing/delivery system 20 also incorporates elongated, multi-20 component shaft member 28 comprising mixing portion 29 and movement controllingportion 30. In this emboflim-ont, a construction subst~nti~lly equivalent to the construc-tion ~let~iled above is employed. Consequently, the complete, extensive disclosure provided above .~,~,ardillg the prer~ d construction, as well as the ~ltçrn~te construc-tion for multi-component shaft member 28, as well as mixing portion 29 and movement 25 controlling portion 30, is equally applicable to this embodiment of the present inven-tion. Furthermore, a uniform ~ meter rod member may be employed as part of movement controlling portion 30 or, if desired, a tapered ~ m~t~r construction, as shown in FIGURE 6 and fully ~li.cc~lssed above. Regardless of which embodiment is employed, equal efficacy and pclr)llllance results are obtained using this third embodi-30 ment of the present invention.

, ..... . . . . .

CA 02266699 1999-03-2~

W O 98/20963 PCTrUS97/20536 In order to enable elongated, multi-component shaft member 28 to be rotational-ly driven, as provided in the previous embo-iim~ntc, cover 101 incorporates a centrally disposed aperture 106 constructed for co~l~Lillg relationchip with rod member 34 of mixing portion 29. By employing this construction, as previously clet~ l, termin~ting end 38 of rod member 34 is easily, controllably interengaged with suitable drive means for providing the operator controlled rotation of elongated, multi-co~ )onent shaft member 28.
In this embodiment, both mixing portion 29 and movement controlling portion 30 are preferably constructed in a manner subst~nti~lly identical to the construction 1 0 detailed above. In this regard, at least two mixing blades 35,35 radially extend from elongated rod member 34 and are formed in an arcuately curved shape, with the outer edge 56 of each mixing blade 35 having a size and shape constructed for cooperative interrelationship with inside wall 46 of mixing cha--lber 22. In addition, movement controlling portion 30 comprises continuous, ramped, radially extending helical-shaped 1 5 auger or screw thread member 63 e~tt~-n~ g from rod member 64. As depicted in FIGURES 12-14, rod member 64 comprises a subst~nti~lly uniform ~ m~t~r Howev-er, as briefly mentioned above, rod member 69, with a tapered diameter as depicted in FIGURE 6 and fully ~liccl~5sed above, can be employed with equal efficacy and effect as well as the other rod member embodiments tlicr~lscecl above.
The pli.~i~al distinguishing features of the embodiment depicted in FIG-URES 12-16 and the embo~iimentc detailed above and shown in FIGURES 1-11 is found in construction and cooperative interengagement between mixing chamber 22 and delivery tube 23. In this embodiment, a still further unique construction is employed for establishing coopelalillg interengagement belweel1 mixing chamber 22 and delivery tube 23, as well as establishing and effectively providing a first sealed position, wherein the interior of mixing chamber 22 is completely sealed from the interior of delivery chamber 23, and a second position, wherein the interior zones of mixingchamber 22 and delivery tube 23 are in cooperating c~ llllir~tion with each other.
In this embodiment, mixing chamber 22 comprises a subst~nti~lly U-shape, formed by outer wall 45 and inner wall 46. In addition, mixing chamber 22 colllplises an enlarged, open entry zone 47 formed at the top of subst~nti~lly U-shaped chamber CA 02266699 1999-03-2~

WO 98/20963 PCTrUS97/20536 22 which is constructed for cooperative, sealed interengagement with cover 101 and O-ring 105 as detailed herein.
Furthermore, in the construction of mixing chamber 22 of this embodiment, the base or lower portion of mixing ch~mh~r 22 comprises a subst~nti~lly circular shaped 5 opening or passageway 80 which extends from the interior of mixing chamber 22 outwardly theler~ . At the te..~ g end of passageway 80, two juxtaposed, spaced, cooperating wall members 110 and 111 are positioned exten-ling from surface 117, adjacent the outlet of passageway 80 to bottom 82 of mixing chamber 22. Since wall members 110 and 111 are independent from each other, and are formed in juxtaposed, spaced, cooperating relationship, an elongated open zone 112 iS formed therebetween, directly comml-ni~ting with passageway 80.
The construction of mixing ch~mher 22 is completed by incorporating a plurality of screw receiving holes in bottom surface 82 thereof. As detailed below, screw receiving holes are positioned for cooperating relationship with a portion of delivery tube 23 and screw means associated th~,lcwi~l.
In this embodiment, delivery tube 23 is formed as separate and independent coope,dlillg components. As depicted in FIGURES 12-14, delivery tube 23 CO~ )liSeS
axially movable, cylindrical tube portion 120 and fixedly mounted base portion 121. In the plc;felled construction of this embodiment, tube portion 120 comprises an elongat-ed, subst~nti~lly cy1indrical shape formed by outer wall 123 and inner wall 124.12Pcesses or grooves 125, 126, and 127 are formed in outer wall 123 at various spaced locations along outer wall 123. Preferably, recess 125 iS formed near the proximal end of tube portion 120, while recess 127is formed near the distal end thereof. Further-more, a pair of arm m~mbers 128 and 129 are formed on tube portion 120, radiallyext~n-lin~ ~~ulwal'dly from outer wall 123, positiQn~ adjacent the distal end of tube portion 120.
As shown in ~IGURES 12-14, the ~ meter of outer wall 123 of tube portion 120 is constructed for COOp~;ldl~llg, sliding h~lelc~ngagement with passageway 80 of mixing chamber 22. As a result, the ~ m~oter of outer wall 123 of tube portion 120 iS
subst~nti~lly equivalent to or slightly less than the ~ m~ter of passageway 80. In this way, tube portion 120 iS axially movable relative to passageway 80 of mixing chamber , CA 02266699 1999-03-2F, 22 when desired, with arm memhers 128 and 129 being positioned between walls 110and 111.
In addition to providing coc~c-dLing dimensions between tube portion 120 and mixing çh~mher 22 which subst~nti~lly elimin~t~s any ullv~nl~d seepage of the bone cement during the mixing operation bel~eell passageway 80 and outer wall 123 of tube portion 120, O-rings 130 are mounted in recesses 125, 126, and 127. By incorForating a sepaldte O-ring 130 in each of the recesses formed in outer wall 123 of tube portion 120, the area between outer wall 123 and passageway 80 of mixing vessel 22 is effectively sealed, while still assuring that the desired axial sliding movement of tube 10 portion 120 relative to mixing vessel 22 iS easily ~ttAinPd.
Completing the construction of delivery tube 23 for this embodiment of the present invention, base portion 121 comprises a support plate 134 on which two juxtaposed, spaced, upst~n~ling posts 135 and 136 extend in one direction while a substantially cylindrically shaped conduit 137 extends in the opposed direction.Plate 134 incorporates a plurality of through holes formed therein peripherally surrounding conduit 137 and positioned for cooperative ~lignm-ont with screw receiving holes of mixing vessel 22. By employing screw means 138, base portion 121 is securely affixed to bottom 82 of mixing vessel 22.
Base portion 121 of delivery tube 23 incorporates outlet portal 61 at the distal20 end of conduit 137. In addition, conduit 137 also incorporates ledge 70 for receiving and m~int~ining distal end 66 of movement controlling portion 30 in the desired position, aligned with outlet portal 61 for assuring the secure, continuous rotation of movement controlling portion 30 and the delivery of the mixed bone cement through outlet portal 61 to the desired location under pres~,ul~.
In this embo~lim~nt~ post 135 and 136 of base portion 121 are constructed for being positioned between wall members 110 and 111 in coop~laling relationship IlRr~ . Furthermore, post 135 and 136 extend subst~nti~lly perpen~ rly from plate 134 a sufficient rli~t~nre to provide a space between the ends of posts 135 and 136 and surface 117 from which walls 110 and 111 extend. Preferably, this spacing is 30 at least equal to the thi-lrn~.c of radially e~t~n~1ing arms 128 and 129 of tube portion 120, in order to enable arms 128 and 129 to be retained within the space, while also CA 02266699 1999-03-2~

WO 98/20963 PCTrUS97/20536 being removable thcler~ ll, whenever desired. By employing this construction, radially extending arms 128 and 129 are independently retained on either post 135 or 136, preventing axial movement of tube portion 120 relative to mixing vessel 22.However, whenever desired by the user, arms 128 and 129 are pivotable to be with-S drawn from retained engAgeln~tt with posts 135 and 136, thereby releasing tubeportion 120 from its axially immovable position into a position which enables the axial movement of tube portion 120 relative to mixing vessel 22.
In the plcrell~d construction of this embodiment of the present invention, an autom~tir~lly engaged lock system is provided to retain mixing/delivery system 20 in 1 0 the second position, once the second position has been attained by the user. As best seen in ~IGURES 15-17, this automatic lock system is ~t~inPcl by providing wall members 110 and 111 with an elongated rib 140 extending from the surface thereof, positioned in juxtaposed, spaced relationship with post 135 or 136. In the preferred construction, rib 140 extends substAnti~lly the entire length of the edge surface of wall 1 5 members 110 and 111 on which it is mounted, while tennin~ting at a spaced distance from plate 134 of base portion 121. The spaced fli.ctAnre remAining between the surface of plate 134 and the termin~-ng edge of rib 140 is substAntiAlly equivalent or slightly greater than the thirl~nPc~ of arm members 128 and 129.
In addition, posts 135 and 136 each comprise a side surface 141, which is 20 constructed with a continuous slope, providing a greater spaced di.~tAnre from rib 140 near the te..,-i"~ing end of posts 135 and 136, while being substantially closer to rib 140 as surface 141 contacts plate 134. In the preferred construction, the spacedli~t~nre of sloping surface 141 from the side edge of wall 110 and 111 at the juncture with plate 134 ,t:~lcsenl~ a ~ t~nre substAnti~lly equivalent to the width of arm members 128 and 129.
The lock construction is completed by incc,lpo~ g in each arm member 128 and 129 a flexible finger portion 141 formed along the side edge of arm members 128 and 129 facing rib 140. By employing this construction, whenever axially movable, cylindrical tube portion 120 of tube member 123 is to be moved from its first position into its second, cement delivering position, arm members 128 and 129 are arcuately pivoted about the central axis of tube portion 120 in order to cause arm members 128 . ...

CA 02266699 1999-03-2~

W O 98t20963 PCTrUS97/20536 and 129 to be removed from ca~l~l~d engagement between the top surface of posts 135 and 136 and support surface 117 of mixing chamber 22. Once arm members 128 and 129 are removed from the ~;aylul~:d position and arcuately pivoted into open zone 112, arm members 128 and 129 are free to be axially moved towards plate 134, simulta-5 neously causing cylindrical tube portion 120 to be controllably moved thercwi~l.
As arm members 128 and 129 are advanced towards plate 134, side edge 143 ofarm members 128 and 129 contact sloping surface 141 of posts 135 and 136, causing arm members 128 and 129 to advance towards wall members 110 and 111 and rib 140 extending thcrcrlolll. As arm members 128 and 129 are continuously advance towards plate 134, causing cylindrical tube portion 120 to be axially moved therewith, flexible finger 142 of arm members 128 and 129 are brought into contact with rib 140, causing flexible finger 142 of each arm member 128 and 129 to be flexed inwardly towardsarm member 128 and 129. This flexing or deflection of finger 142 continues until arm members 128 and 129 have been advanced into contact with plate 134 of base portion 15 121.
Once in this position, flexible fingers 142 of arm members 128 and 129 are disengaged from c~mt~rtin~ relationship with rib 140, due to its spaced ~ t~nre away from plate 134, thereby enabling flexible fingers 142 to return to their original position. Once in this position, flexible fingers 142 of arm members 128 and 129 are 20 in locked interengagement with ribs 140, thereby preventing cylindrical tube portion 120 to be returned from the second position to the first position. In this way, the secure, automatic, locked eng~g~ ont of cylindrical tube portion 120 in the second position is provided.
As best seen in FIGURES 13 and 14, when this embodiment of mixing/delivery 25 system 20 is fully assembled and placed in its first, closed position, with the interior of mixing chamber 22 completely independent from the interior of delivery tube 23, radially extending arms 128 and 129 are captured and m~int~in~d in position locked between the tt~ -g ends of posts 135 and 136 and support surface 117 of mixing vessel 22. When mixing/delivery system 20 is in this position, the upper proximal end 30 of cylindrical tube portion 120 of delivery tube 23 is m~int~in~l within a~clLur~ 80 of mixing vessel 22, while also extending into the bottom of mixing chamber 22 in CA 02266699 1999-03-2~

wo 98nos63 PCT/USg7/20536 peripheral, ~,ull~unding and sealing relationship with ramped, radially ext~n-ling, helical shaped auger or screw thread member 63 of movement controlling portion 30.
As a result, any contact of screw thread member 63 with the bone cement is prevented and all the bone cement is safely m~int~in.od within the interior of mixing chamber 22.
In order to assure secure, seepage-free separation of the bone cement from movement controlling portion 30, the proximal end of cylindrical tube portion 120 with O-ring 130 within recess 125 is inserted within grooves 118 formed at the distal end of rod member 34 of mixing portion 29. In this way, complete sealing of movement controlling portion 30 from exposure to the bone cement within the interior of mixing 1 0 chamber is ~tt~in~d, when mixing delivery chamber 20 is in its first position.
In order to move mixing/delivery system 20 from its first position into its second position, wh~leill the interior of mixing chamber 22 is in commlmiration with the interior of cylindrical tube portion 120 of delivery tube 23, cylindrical tube portion 120 is arcuately rotated about its central axis by controllably moving radially ext~n~ling 1 5 arms 128 and 129 out of retained engagement with posts 135 and 136, as ~ cl~ssed above. Once arms 128 and 129 are positioned within open zone 112, cylin-lri~l tube portion 120 of delivery tube 23 is capable of axial, telescopic movement, in its entirety, relative to mixing vessel 22.
When cylindrical tube portion 120 of delivery tube 23 is axially moved towards base portion 121, by advancing arm members 128 and 129 toward base portion 121, the proximal end of cylindrical tube portion 120 is moved away from sealing engage-ment with groove 118 of rod member 34 of mixing portion 29. In this way, the proximal end of movement controlling portion 30 is exposed to the interior of mixing chamber 22.
When the axial movement of tube portion 120 is completed, as depicted in FIGURE 14, continuous, ramped, radially extending helical-shaped auger/screw thread member 63 is fully exposed to the bone cement contained within mixing chamber 22.
As a result, when elongated, multi-component shaft mtomher 28 is rotated, the mixed cement is effectively advanced from chamber 22 through cylindrical tube portion 120 of delivery tube 23 until the desired mixed bone cement has been transferred through tube portion 120, conduit 137 of base portion 121 and through outlet portal 61.

CA 02266699 1999-03-2~

W O g8/20963 PCTrUS97/20536 As is apparent from the foregoing detailed disclosure, this embodiment of the present invention opelates in subst~nti~lly the same manner as the first two embodi-ments, providing effective and complete mixing of the bone cement in a completely sealed chamber until the entire bone cement has been completely formed. Once the5 cement is completely il~lr.lllixed, the user is able to autom~tir~lly advance the mixed bone cement through the delivery tube directly to the desired site. In addition, all of the features detailed above relating to the automatic delivery of the bone cement to outlet portal 61 is equally applicable, as well as the contruction of movement control-ling portion 30, so as to elimin~te any e~ ~ped air from the cement and provide the 10 desired pressure at the bone being treated. Consequently, this embodiment, like the previous embodiments, attains subst~nti~lly air-free mixed bone cement delivered to the precisely desired site under pres~ e in a fully integrated system, without requiring exposure of the noxious odor or the bone cement to the user. Furthermore, if desired, the system may be conn~octecl to a vacuum source for further removal of ellll~ped air.
In the same manner detailed above, the end of conduit 137 of base portion 121 of delivery tube 23 incorporates thread means 67, so as to accommodate an extension tube if nloeded In this way, the mixed bone cement is able to be delivered directly to any location or position desired by the user.
If desired, the embodiment depicted in FIGURES 7-11 may also be constructed 20 to provide secure locked engagement of radially extending arms 90 and 91 when the arms are moved from the first position to the second position. In order to establish this interlocked position, a construction similar to the construction det~iled above in reference to FIGURES 12-17 may be employed. In this regard, by l~r~llhlg to FIGURES 10, 11, and 18, the impiern~nt~tion of a lock system with this embodiment 25 can best be understood.
Preferably, the ~l~tr~m~ti~ lock system is att~in~d by providing an elongated ramp 100 formed on the inside walls of zone 81 positioned for cooperation with radially extending arms 90 and 91. Preferably, each elongated rib 100 extends from a wall of mixing vessel 22 in juxtaposed, spaced relationship with upst~n~ing posts 95 30 ~e~ in~ g at a spaced ~ t~nre from plate 93. The spaced ~i~t~nre rem~ining between CA 02266699 1999-03-2~

W O 98/20963 PCTAUS97t20536 the surface of plate 93 and the terminAting edge of rib 100 is substantially equivalent or slightly greater than the thickness of arm members 90 and 91.
In addition, u~ g posts 95 each comprise a side surface 108 which is constructed with a continuous slope, providing a greater spaced fli~t~nre from rib 100 near the tP~ninAting end of posts 9S, while being s~lbst~nti~lly closer to rib 100 as surface 108 contacts plate 93. In the plerelled construction, the spaced ~li.ctAn~e of sloping surface 108 from the wall defining open zone 81 at the jull~;lule with plate 93 eplcselll~ a ~ t~n~e substAntiAIly equivalent to the overall width of arm members 90 and 91.
The lock construction is completed by forming each arm member 90 and 91 with a flexible finger 109 formed along the side edge of amm members 90 and 91 facing rib 100. By employing this construction, whenever axially movable, cylindrical delivery tube 23 is moved from its first position into its second position, arm members 90 and 91 are arcuately pivoted about the central axis of delivery tube 23 causing the arm members 90 and 91 to be removed from engagement on posts 95 into open zone 81. Once arm members 90 and 91 are moved into open zone 81, arm members 90 and 91 are free to be axially moved towards plate 93, simlllt~n~ously causing delivery tube 23 to be controllably moved lhele..i~
As arm members 90 and 91 are advanced towards plate 93, the side edge of each arm member contacts sloping edge 108 of posts 9S, causing arm members 90 and 91 to advance towards rib 100. As amm members 90 and 91 are continuously advanced towards plate 93, causing delivery tube 23 to be axially moved therewith, flexible fingers 109 of arm members 90 and 91 are brought into contact with rib 100, causing fingers 109 of each amm member 90 and 91 to be flexed inwardly towards the arm member. This flexing or deflection of finger 109 continues until arm members 90 and 91 have been advanced into contact with plate 93. Once in this position, flexible fingers 109 of arm members 90 and 91 are disengaged from confActing relationshipwith rib 100, due to its spaced (ii~t~nre away from plate 93, thereby enabling flexible fingers 109 to retum to their original position. Once in this position, flexible fingers 109 of arm m~mhers 90 and 91 are in locked h~lelellgagement with rib 100, thereby preventing delivery tube 23 from being returned from its second position to its first CA 02266699 1999-03-2~

wo 98/20963 PCT/USg7/20536 position. In this way, the secure, automatic, locked engagement of delivery tube 23 in its second position is provided.
As /1i~c--~sed above, as well as depicted throughout the drawings, mixing blades35,35 are mounted to rod member 34 with an outer edge 54 which is arcuately curved relative to the central axis of rod m~n ker 34. In the embodiment discussed and depicted above, each outer edge 54 of each mixing blade 35 comprises an arcuate radius of about 90~. In general, it has been found that a construction of this nature provides superior results while also assuring that the bone cement colllpol1elll~ are conkollably advanced towards the rotating movement controlling portion 30 regardless 1 0 of the particular orientation of mixing/delivery system 20.
Although an arcuate radius of 90~ for outer edge 54 of mixing blade 35 has been found to be particularly efficacious, alternate arcuate radii may also be employed without departing from the scope of this invention. In fact, as rli.ccllcse~ above, the arcuate radius may range between 45~ and 360~ in achieving mixing blades capable of l 5 functioning in the present invention.
In FIGURES 21 and 22, an alternate embodiment to the mixing blade contruction depicted in the foregoing figures is provided. In this embo~lim~nt, mixing portion 29 comprises an elongated rod member 34 having two mixing blades 150,150extending thelc~rl~ with the lc;.l"i~ iug edge 154 of each mixing blade 150,150 comprising an arcuate radius subst~nti~lly equal to 165~ degrees.
By employing this embodiment, it has been found that the Co~npOllelllS forming the bone cement are thoroughly intermixed and controllably advanced towards move-ment controlling portion 30, when desired, virtually independently of the position in which mixing/delivery system 20 is placed. As a result, by employing mixing blades 150,150 with an outer edge 154 having an arcuate radius of about 165~, a mix-ing/delivery system 20 is ~tt~in~od which is capable of thoroughly intermixing the components forming the bone cement as well as advancing the bone cement from themixing zone to the delivery zone regardless of the position or orientation in which mixing/delivery system 20 is placed. As a result, subst~nsi~lly enh~n~ed flexibility, CA 02266699 l999-03-2~

adaptability and control is ~tt~inrcl by mixing/delivery system 20 of the present invention.
As briefly mentioned above, mixing/delivery system 20 of the present invention may incorporate i--~lir~lor means 160 in order to provide the user with a positive indication when the components of the bone cement are thoroughly intermixed.
Although various alternate embo~ for in~jc~tor means can be employed, the plef.,.led construction of the present invention is depicted in FIGURES 23 and 24.
As shown in this embo-liment in~ir~tQr means 160 comprises a plurality of cooperating gear members 162 which are constructed to measure the number of times rod member 34 of mixing portion 29 has been rotated. In tests conducted on the l O mixing of bone cement, it has been found that neither the rotational speed nor time are the controlling factors in detrrmining when the components of the bone cement have been thoroughly intrrrnix~-l. Tn~t.o~(l, the number of actual revolutions the mixing blades make through the components has been found to provide the best measure ofdetermining when the bone cement has been fully intermixed. As a result, inllic~tor means 160 is constructed to provide this desired mea~urf l"tl".
In the plcfel~ed embodiment depicted in FIGURES 23 and 24, in-lic~tQr means 160 comprises a plurality of gear members 162 which are driven by the rotation of rod member 34 of mixing portion 29. In addition, inflir~tQr means 160 comprises a highly visible status in-lir~tQr plate 163 which is mounted in Cou~Jcld~ g association with window 161 formed in cover 24 in order to enable inAir~tor plate 163 to be easily viewed throughout the mixing operation.
In the plcfelled construction, in-lic~tor plate 163 provides a plurality of status m~rking~ printed thereon which represents the various stages experienced by this bone cement during the mixing operation. By employing appropliate indicia, such as color, the precise status of the bone cement is rcpl~csenled through window 161.
In order to provide a positive, accurate indication of the progress of the mixing operation of the bone c~m~nt in-lir~tor plate 163 iS constructed for movement relative to window 161. In addition, gear members 162 of in(li~tor means 160 are constructed to provide the positive movement for i"~1ir~tol plate 163 relative to window 161 in direct association with the "~n~lbel of rotations rod member 34 of mixing portion 29 has experienced. Consequently, by constructing inf1ic~tor means 160 with the proper gear CA 02266699 l999-03-2~

W O 98/20963 PCTrUS97/20536 ratio for driving in-lir~tor plate 163 in the proper ma,lller, in~ tQr plate 163 provides the user with a precise visual measurement of the mixing process as well as a positive indication when rod member 64 has been rotated a sufficient number of revolutions to assure the bone cement is completely intermixed. As a result, by employing this 5 construction, ease of operation is further enh~nred with the user being provided a virtually a full-proof construction wherein mere visual observation of an in-licator imm~ tely informs the user when the bone cement is ready for use.
It will thus be seen that the objects set forth above, among those made a~arenl from the preceding description, are efficiently ~tt~in~d and, since certain changes may 10 be made in the above construction, without departing from the scope of the invention, it is inten-le~l that all matter contained in the above description or shown in the accompanying drawings shall be il~ lclcd as illustrative and note in a limiting sense.
It is also to be understood that the following claims are intended to cover all of the generic and specific features of the invention herein described, and all statements of 15 the scope of the invention, which as a matter of language, might be said to fall therebetween.
Having described our invention, what we claim as new and desire to secure by Letters Patent is:

,

Claims

THE CLAIMS
1. An integrated mixing and delivering system for fully intermixing bone cement components and delivering the mixed bone cement to a desired location, said system comprising:
A. a mixing vessel having a. an enlarged entry portal for receiving the bone cement components, and b. an exit portal positioned for enabling the mixed bone cement to pass therethrough;
B. cover means removably mountable to the mixing vessel in covering engagement with the entry portal;
C. an elongated delivery tube comprising a. a proximal end cooperatively associated with the exit portal of the mixing vessel, b. a distal end incorporating a cement delivering outlet portal, and c. an elongated interior delivery zone extending between the proximal end and the outlet portal;
D. at least one mixing blade constructed for cooperative association within the mixing vessel and being rotationally driven therein for fully inter-mixing the components forming the bone cement;
E. movement control means constructed for cooperative association within the delivery tube for receiving the mixed bone cement at the proximal end of the delivery tube and controllably advancing the mixed cement through the delivery tube to the outlet portal; and F. position control means cooperatively associated with the delivery tube and the mixing vessel to enable the delivery tube to be movable from a. a first position wherein the interior of the mixing vessel and the interior delivery zone of the delivery tube are sealed from each other, and b. a second position wherein the interior of the mixing vessel and the interior zone of the delivery tube are in communication with each other;
whereby the bone cement components are fully intermixed in a separate zone completely sealed from the delivery tube and, once the cement is mixed, the mixing vessel and delivery tube are moved into communication with each other, enabling the mixed cement to be controllably advance from the mixing vessel to the outlet portal for direct use.
2. The integrated mixing and delivery system defined in Claim 1, wherein said mixing vessel comprises a substantially U-shaped interior mixing zone with the exit portal formed at the base thereof.
3. The integrated mixing and delivery system defined in Claim 2, wherein said delivery tube is further defined as comprising an elongated, hollow, substantially cylindrical shape with the proximal end thereof constructed for cooperative inserted interengagement with the exit portal of said mixing vessel.
4. The integrated mixing and delivery system defined in Claim 3, wherein said mixing blades are further defined as being affixed to a first elongated rod member and said movement control means is further defined as comprising substantially continuous, ramped, radially extending, helical or spiral shaped threads formed on a second elongated rod member.
5. The integrated mixing and delivery system defined in Claim 4, wherein said first rod member and said second rod member are constructed for cooperativeinterengagement and simultaneous rotation about the central axis thereof.
6. The integrated mixing and delivery system defined in Claim 5, wherein said first rod member and second rod member are further defined as being removably interconnectable to each other for enabling said first rod member and second rodmember to cooperatively function as a substantially single, integrated, elongated component.

7. The integrated mixing and delivery system defined in Claim 5, wherein said cover means is further defined as comprising a substantially centrally disposed aperture formed therein for enabling the first rod member to extend therethrough for cooperative association with rotation inducing drive means.
8. The integrated mixing and delivery system defined in Claim 4, wherein said second rod member is further defined as comprising a substantially uniformdiameter throughout its length.
9. The integrated, mixing and delivery system defined in Claim 4, wherein said second rod member is further defined as comprising an overall tapered configuration, having a smaller diameter at the end thereof cooperatively associated with the first rod member and a larger diameter at the opposed end thereof.
10. The integrated mixing and delivery system defined in Claim 9, wherein said tapered rod member is further defined as comprising a diameter ranging between about 0.18 inches and 0.50 inches throughout the length thereof.
11. The integrated mixing and delivery system defined in Claim 4, wherein said second rod member is further defined as comprising a uniform diameter throughout its length.
12. The integrated mixing and delivery system defined in Claim 4, wherein said second rod member is further defined as comprising a funnel shape having a larger diameter adjacent the mixing vessel and a smaller diameter at the distal end thereof.
13. The integrated mixing and delivery system defined in Claim 4, wherein said radially extending, ramped, helical or spiral shaped thread members are further defined as comprising a pitch throughout the length of said second rod member selected from the group consisting of variable pitches and uniform pitches.
14. The unitary mixing and delivery system defined in Claim 13, wherein said radially extending, continuous, ramped, helical or spiral thread member is further defined as comprising a variable pitch with said pitch being formed by the spacing between adjacent thread members, said spacing ranging between about 1.25 and 0.10 inches.

15. The integrated mixing and delivery system defined in Claim 14, wherein said spacing is further defined as being larger at the proximal end of said second rod member and comprising a smaller distance at the distal end of said second rod member.
16. The integrated mixing and delivery system defined in Claim 2, comprising at least two mixing blades, each of which are arcuately curved relative to the first rod member with the outer edge thereof conforming to the inside wall of said U-shaped mixing zone.
17. The integrated mixing and delivery system defined in Claim 16, wherein each of said arcuately curved mixing blades is further defined as comprising an outer edge defining an arc ranging between about 45° and 360°.
18. The integrated mixing and delivery system defined in Claim 17, wherein said curved outer edge of each mixing blade is further defined as comprising an arc ranging between about 90° and 180°.
19. The integrated mixing and delivery system defined in Claim 1, wherein said cover means is further defined as being sealable about the entry portal of the mixing vessel, thereby preventing any unwanted seepage of bone cement during themixing process.
20. The integrated mixing and delivery system defined in Claim 1, wherein said position control means is further defined as comprising a support plate radially extending from the delivery tube and holding means cooperatively associated with the support plate of the delivery tube to enable the arcuate movement of the delivery tube relative to the mixing vessel with portal zones formed in the proximal end of said delivery tube, cooperating with the exit portal of the mixing vessel, said position control means providing a first position wherein said portals are sealed from each other and a second position wherein said portals are aligned, enabling communication therebetween.

21. The integrated mixing and delivery system defined in Claim 20, wherein said position control means further comprises a cam surface formed on the support plate radially extending from the delivery tube and a cam follower formed on themixing vessel cooperatively associated with the cam surface to define the arcuate movement of the delivery tube relative to the mixing vessel, thereby establishing the two alternate positions thereof.
22. The integrated mixing and delivery system defined in Claim 1, wherein said position control means is further defined as comprising c. a support plate mountable to the mixing vessel and incorporating a pair of upstanding post members extending therefrom and d. a pair of radially extending arm means formed on the delivery tube and positioned for cooperative association with the post members enabling the delivery tube to be movable from a first position, peripherally surrounding and sealing the movement control means from the interior of the mixing vessel to a second position, wherein the proximal end of the delivery tube is axially moved away from said exit portal of the mixing vessel, thereby enabling the mixed bone cement to easily contact and be controllably moved by the movement control means.
23. The integrated mixing and delivery system defined in Claim 22, wherein each of said upstanding post members is further defined as comprising a ramped surface positioned in juxtaposed spaced relationship with an elongated locking rib and said radially extending arm members are further defined as comprising a flexible finger portion constructed for cooperative association with the locking rib for flexing in a first direction as the radially extending arm means is advanced from the first position to the second position and returning to its original position in locked interengagement with the rib when said arm means is in its second position.

24. The integrated mixing and delivery system defined in Claim 1, wherein said delivery tube is further defined as comprising a fixedly mounted base portion incorporating the outlet portal and a cooperatively associated axially movable, cylindrically shaped tube portion controllably movable from a first position wherein the proximal end thereof is within the mixing vessel peripherally surrounding and sealing the movement control means therefrom and a second position, wherein said proximal end is axially moved away from engagement with the exit portal of the mixing vessel, thereby enabling the mixed bone cement to be in contact with the movement control means.
25. The integrated mixing and delivery system defined in Claim 1, wherein said mixing blade is further defined as being cooperatively associated with an elongated shaft for rotationally driving the mixing blades within the mixing vessel and said cover means is further defined as comprising a centrally disposed aperture cooperatively associated with the drive means of the mixing blades for enabling the mixing blades and drive means to be easily rotated.
26. The integrated mixing and delivery system defined in Claim 25, wherein said drive means is rotationally driven by employing one selected from the groupconsisting of electronically driven rotational drivers and hand cranks.
27. The integrated mixing and delivery system defined in Claim 25, wherein said cover is further defined as comprising seal means for assuring secure sealing interengagement of said cover with said mixing vessel.
28. The integrated mixing and delivery system defined in Claim 1, wherein said system further comprises:
G. indicator means cooperatively associated with the mixing vessel for measuring the progress of the mixing of the bone cement and providing a positive indication to the user when the bone cement has been fully intermixed.

29. The integrated mixing and delivery system defined in Claim 28, wherein said indicator means is further defined as comprising gear means cooperatively associated with the rotation of the mixing blades for measuring the revolutions thereof and providing a positive indication to the user once sufficient rotation of the mixing blades has been achieved to assure a fully intermixed bone cement product.
30. The integrated mixing and delivery system defined in Claim 1, wherein said system is further defined as comprising a vacuum port cooperatively associated with the mixing vessel to enable the mixing vessel to be exposed to a vacuum source during the mixing and delivery process.
31. The integrated mixing and delivery system defined in Claim 30, wherein said vacuum port is affixed to the cover means in order to provide a readily accessible interconnection for said vacuum source.

32. An integrated mixing and delivering system for fully intermixing bone cement components and delivering the mixed bone cement to a desired location, said system comprising:
A. a mixing vessel having a. an enlarged entry portal for receiving the bone cement components, and b. an exit portal positioned for enabling the mixed bone cement to pass therethrough;
B. cover means removably mountable to the mixing vessel in covering engagement with the entry portal;
C. an elongated delivery tube comprising a. a proximal end constructed for telescopic sliding engagement with the exit portal of the mixing vessel, b. a distal end incorporating a cement delivering outlet portal, and c. an elongated interior delivery zone extending between the proximal end and the outlet portal;
D. at least one mixing blade constructed for cooperative association within the mixing vessel and being rotationally driven therein for fully inter-mixing the components forming the bone cement;
E. movement control means constructed for cooperative association within the delivery tube for receiving the mixed bone cement at the proximal end of the delivery tube and controllably advancing the mixed cement through the delivery tube to the outlet portal; and F. position control means cooperatively associated with the delivery tube and the mixing vessel to enable the delivery tube to be movable from a. a first position wherein the interior of the mixing vessel and the interior delivery zone of the delivery tube are sealed from each other, and b. a second position wherein the interior of the mixing vessel and the interior zone of the delivery tube are in communication with each other;

whereby the bone cement components are fully intermixed in a separate zone completely sealed from the delivery tube and, once the cement is mixed, the mixing vessel and delivery tube are moved into communication with each other, enabling the mixed cement to be controllably advance from the mixing vessel to the outlet portal for direct use.
33. The integrated mixing and delivery system defined in Claim 32, wherein said elongated delivery tube is further defined as peripherally surrounding and blocking the movement control means when said delivery tube is in its first position, while revealing a portion of the movement control means when said delivery tube is moved to its second position, thereby assuring exposure of the movement control means to the mixed bone cement in the mixing vessel when desired.
34. The integrated mixing and delivery system defined in Claim 33, wherein said position control means are further defined as comprising a pair of radiallyextending arm members formed on the outer wall of the delivery tube for enabling the controlled movement of the delivery tube between its first and second positions.35. A process for preparing and delivering mixed bone cement to any desired site comprising the steps of:
A. adding the bone cement components to a mixing vessel;
B. closing the mixing vessel with a removable cover;
C. thoroughly mixing the bone cement components until fully intermixed;
D. exposing the mixed bone cement to movement control means while maintaining said cover on the mixing vessel;
E. activating the movement control means to remove the bone cement from the mixing vessel while drawing the mixed cement through a delivery tube; and F. forcing the bone cement through an outlet portal under pressure by continuously activating the movement control means;
whereby cement is mixed and delivered in a single integrated assembly without the exposure of cement to the user during the process.

36. The process defined in Claim 35, wherein said mixing step is performed by rotating blade means formed on an elongated shaft by attaching said shaft to one selected from the group consisting of electrically powered drivers and hand cranks 37. The process defined in Claim 36, comprising the additional step of:
G. measuring the number of rotations of said support shaft to determine when sufficient rotation of the blades has occurred to provide fully intermixed bone cement; and H. providing an indication to the operator that the bone cement is prepared.