CA1162807A

CA1162807A - Pressure injection of bone cement apparatus and method

Info

Publication number: CA1162807A
Application number: CA000367212A
Authority: CA
Inventors: Jo Miller
Original assignee: Individual
Current assignee: Individual
Priority date: 1979-12-20
Filing date: 1980-12-19
Publication date: 1984-02-28
Also published as: US4338925A

Abstract

PRESSURE INJECTION OF BONE CEMENT
APPARATUS AND METHOD

ABSTRACT OF THE DISCLOSURE
A penetrating bone cement, for example a cement having a viscosity at 68° to 70° F of less than 5000 poise and, preferably, less than 2000 poise up to the fifth or sixth minute after the cement is mixed, is injected under high pressure such that the bone cement penetrates the trabeculae of the bone to provide an improved fixation interface between the bone cement and bone.
The bone cement is placed within a reinforced, front loading car-tridge having a plunger at one end thereof and a nozzle at the other end thereof.
The end of the cartridge having the plunger engages a high pressure injection gun including a housing axially supporting a rod with respect to the cartridge. Carried on the rod is a for-ward engaging member cooperating with a lever pivoted to the .
housing. Manual rotation of the lever engages the forward en-gaging member and forces the rod forward to force the plunger into the cartridge. A single manual actuation of the lever re-sults in the extrusion of approximately two cubic cm of bone cement from the cartridge and through the nozzle. In the pre-ferred embodiment, one end of the cartridge is flanged and engages the housing by means of a bezel. The lever is in the form of a trigger pivotally connected to the handle and having a notch engaging the forward engaging member. A rearward engaging member is also provided to prevent rearward movement of the rod and a release pin releasably engages the rearward engaging member. The front of the cartridge includes a front closure cap which con-tains the cement in the front-loading cartridge and which is con-figured to receive a plurality of different shaped tips.

Description

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! BACKGROUND OF THE INVENTION

! 1. Field of the Invention t 1' The invention generally relates to improved fixation of a l,prosthetic component to bone and, in particular, relates to an apparatus for and method of pressure injection of low viscosity bone cement into bone surfaces to improve the bone/cement inter-face.
, i 2. Description of the Prior Art ' Total arthroplasty has become widely accepted as a useful measure in the treatment of severe arthritis. It facilitates the correction of deformity, the reestablishment of stability and, most important, the relief of pain. Unfortunately, the procedure is associated with a number of complications including loosening , of the arthroplasty components. A number of factors contribute il to loosening including failure to correct a deformity, an over-weight or overactive patient, an osteoarthritic joint in com-'parison to a rheumatoidal joint and the use of a constrained ~prosthesis. The consequences of loosening include return of pain and deformity, the need for further reconstructive surgery with attendant technical difficulties and increased risk of sepsis and the possible risk of subsequent re-loosening.
Failure of the fixation rnay originate at the interface between the prosthesis ancl cement, at the interface between the cement and bone, or both. -Loosening of the joint arthroplasty components occurs in a ~ number of ways. Resorption of the bone co~nonly occurs, par-; ticularly, around the stem of a constrained prosthesis and is the result of high loads placed on the cement/bone interface ~1

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~ leading to micromovement, resorption and gross loos;ening.
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~ 1 Separation of the cement from the bone is usually due to a weak I bone/cement interface and results in gross displacement of the ; implant. A radiolucent line is co~monly seen between the cement S and bone and has the following characteristics.
; Microscopic examination of the interface between the celnent and bone indicates that the radiolucent line corresponds to a fibrous membrane which has developed at the interface. Mechanically, the fibrous membrane presents a plane of weakness between the ,' cement and bone and a potential site for loosening. Micromove-ment occurs at those interfaces where a fibrous membrane is inter-posed. The radiolucent line, therefore, represents a site of ! impaired mechanical integrity.
~ Failure of the cement/bone interface may be due to a mech-anically incompetent interface from the moment of implantation.
The doughy cement presently employed and having a viscosity at - 68 to 70 F of greater than 4000 poise at the 5th or 6th minute after mixing is applied to cancellous surfaces by hand and pene-trates trabeculae in the bone only to a limited degree, i at ~0 all. More practically lt ~ay conform to surface irregularities, - but does not penetrate the bone. Poor fixation of this type leads to micromovement which in turn leads to bone resorption which results in the development of a flbrous membrane. Acrylic cements as currently used for the fixation of joint arthroplasty components to bone has inherent dificiencies in terms of estab-lishing secure and enduring interfaces between the prosthesis and the cement and between the ce~ent and the bone.
Guns which are presently available for injecting cement generate a low pressure and are prone to blockage by the thick-ening cement. Therefore, the low pressure guns of the prior art are ineffectual in inducing cement ~o penetrate bone.

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~ In addition, these guns are non-modlllar and are not suitable_4,~V ~~~ 1 for a variety of tasks other than introducing cement into the ' upper end of the femur without pressurization.
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S , SUMMARY OF T~E INVENTION
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It is an object of this invention to describe a cement in-jecting apparatus which employs high pressure and low volume output.
, It is another object of this invention to describe a systern for preparing a bone area for receiving a prosthetic component including a front-loading reinforced cartridge for receiving a penetrating bone cement.
It is another object of this invention to describe a cement delivery system employing a variety of tips allowing for a , variety of special applications.
It is yet another object of this invention to describe a , system for preparing a bone area for receiving a prosthetic com-i' ponent which is extremely powerful and effective in delivering ! high viscosity cement.
l, In order to overcome the above problems, a mechanically secure interface between the prosthesis, cement and bone can be accomplished by inducing the cement to form a microinterlock with the prosthesis surface and the bone. Pressure in;ection of ' acrylic cement into bone surfaces results in an ~mproved fixatio~
j by microinterlock, Such pressure injection a~ s the cement )~f~
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to actually penetrate between the trabeculae of the bone, dis- ¦
placing the marrow and producing firm fixation at a multitude of sites. In order to accomplish bone penetration and interlock, 1 the cement must be used in a workable state. A bone cement ' having a low viscosity during the working period has been found advantageous for achieving the bone-cement inte~lock according

- 4 to the invention. The pressure injection of a low viscosity acrylic cement by an apparatus and method according to the invention results in an improved fixation by microinterlock. The ~I cement actually penetrates between the trabeculae, displacing the marrow and producing firm fixation at a multitude of sites.
The system according to the invention is used for preparing bone surfaces for receiving a prosthetic component. A cartridge , containing a penetrating bone cement is placed within an injection gun for extruding the bone cement from the cartridge. A nozzle and front closure cap fitted at the end of a front loading car-tridge allow the pressure injection of the penetrating bone cement into the bone cavity or onto a cut bone surface. The purpose for a front loading cartridge is to allow for proper vent-ing of entrapped air in the cartridge. Present rear-loading cartridges entrap air at the rear of the cartridge between the cement and the plunger. Since the entrapped air has no means of escape, it can become entrapped in the cement which could lead to failure of the cement. Also, such trapped air is compressible, so that energy which is intended to be delivered against the contents of the cartridge is waisted in compression of the trap-ped air. Subsequent release of pressure and re-expansion of the trapped air tends to extrude cement from the gun at times and locations at which cement delivery is not desired. -Furthermore, the modular system allows a variety of diffe~ent tips of varying size to be attached to the cartridge for varying tasks or applications. For example, the nozzle may be sized to fit the circumference of bone cavity so that the cayity may be sealed and cement may be forcefully injected into the bone cayity.
Alternatively, the nozzle may be designed to inject cement into fixation holes or into boney surfaces. I
The injection gun according to the invention is o~ a hi~h I ;
; pressure type and includes a housing having an axial opening , therein. The cartridge is placed w~thin the axlal opening of _ 5 ~

~6~C3'7 the housing and an internally-engaging bezel is located within the axial opening to engage the flange of the cartridge and hold the cartridge in position. The end of the rod projecting from the housing includes a knob and the other end of the rod within the housing has a cap for engaging a plunger within the cartridge. The rod carries a forward engaging member which co-operates with a hinged trigger. The forward engaging member engages a notch on the trigger and rotational movement of the trigger forces the forward engaging member and, therefore, the rod forward. A coil spring is provided between the forward engaging member and a support in the housing so that the forward engaging member is returned to its initial position after forward movement of the rod. A rearward engaging member also engages the rod and prevents rearward movement of the rod.
A release pin is associated with the rearward engaging member so that the rearward engaging member may be selectively released to withdraw the rod to a starting position.
BRIEF DESCRIPTION OF THE DRAWINGS
These features and objects of the invention will become apparent to those skilled in the art by referring to the accompanying drawings and following specification in which:-Fig. 1 is a sectional view of the injection gun andcartridge system according to the invention;
Fig. 2 is a sectional view of a tip according to the invention applying bone-cement to a bone cavity in a bone;
Fig. 3 is a view partially in section of a tip accor-ding to the invention depositing bone-cement into the femoral canal;
Fig. 4 is a sectional view of a tip according to the invention used to pressurize the bone-cement in the femoral canal;
Fig. 5 is a sectional view taken along lines 5-5 ~ 6 -z~
of Fig. 4~; and Fig. 6 is a perspective view of the cartridge of the system of Fig. 1 according to a particular embodiment of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
The cartridge means according to the invention con-tains a penetrating bone cement 23 held within a cylinder 10 having a flange 11 at one end thereof. The cartridge means includes a plunger 9 at one end thereof and a front closure cap at the opposite end allowing for frant loading of the cement into the cartridge and which also allows for the interchange-ability of tips. The cylinder wall 10 may be reinforced with ribs 25 for added strength.
As used herein, the term "penetrating bone cement"
connotes a bone cement which is capable of penetrating the trabeculae of bones when applied thereagainst under sub-stantial pressure during its period of workability. The best such penetrating cement presently known to me is an acrylic cement having a low viscosity of less than 5000 poiser 2Q preferably of less than 2000 poise, at 68 to 70F during a working period of up to 5 or 6 minutes after mixing.
The means for extruding the preferred low viscosity bone cement from the cartridge means includes a housing 5 with supports l9a and l9b and a handle 2 forming integral parts of the housing 5. The flange 11 of the cartridge means is located within an axial opening in the housing 5 and abutts the support l9a. A bezel 12 internally engages the axial opening and bosses 18 project from the housing into the axial opening. Therefore, the flange 11 of the cartridge means is locked within the housing 5 between the support l9a and the bezel 12.
Supports l9a and l9b have axial openings therein 1~L6Z~
which are in registry and along the axis of the cylinder 10.
These openings support rod 7 which is attached at one end thereof to a cap 8 for engaying the plunger 9 of the cart-ridge means. The other end of the rod 7 carries a knob 6.
In order to move the rod, ¢ap and plunger forward to extrude the bone cement 23 from the cartridge means, a forward engaging member 14 is provided on the 1~

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, rod between the support,s l9a and l9b. The forward engaging member 14 is spaced away from the support l9a by coil spring 13. Trigger 1 is hinged to housing 5 by pivot pin 4 and , carries a notch la which engages the forward engaging member. ' l, ' A rearward engaging member lS is also provi,ded to hold the rod 7 in position and prevent unwanted rearward movement of the ,, rod 7. The rearward engaging member 15 is hooked through an -,-l, aperture 15a in the support l9b and has an axial opening through ' I which the rod 7 is located. The rearward engaging member 15 ' '' is spaced away from the support l9b by coil spring 13. The end of the rearward engaging member 15 which is not hooked ' through aperture l5a is engaged by a release pin 17 slideably ~, located within the housing 5.
,' The trigger 1 is shaped to allow grasping of the trigger 1 , and handle 2 and the trigger 1 is biased in a counterclockwise ', position to be held open by a spring 3. It is contemplated that !i any convenient biasing means, such as resilient me~bers, coll ,- li .Cprings~ etc. may be used ~o bias the trigger 1 a~ay fro~ the j, handle 2.
" The front closure cap 20 and selected tip 21 form the ~eans ' for applying the extruded low viscosity bone cement to the bone cavity and the means, for pressurizing the low vlscoslty bone cement applied to the bone cavity.
In order to achieve ef~ective pressurization of penetrating cement into the trabeculae of the bone~ it is essential to haye a cavity which can be closed off by the in~ector tip to create a closed space. 'A varie~y of tips are available for the various types of bone surfaces. There are basically two types of bone surfaces which need to be considered: (1) a plateau surface such 30 ' the tibial surface of the knee or the acetabular surface for the '' hip ~oint, and (2) a long tubular canal such as that in the lor~g v i i - 8 - 1 i, .4,Ji ., ' 1, ~ ,bone of the femur for a hip replacement.
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IJhen a prosthesis is to be cemented to a plateau-type sur-face, holes may be drilled into the bone surface to create a cavity into which bone cement is to be injected, as sho~ in Figure 2. An appropriate tip is selected which is configured to interfit with the opening of the bone cavity. The end of the , tip is tapered inwardly to terminate in a portion having a dia-' meter less than the diameter of the bone cavity. This allowsthe tapered portion of the tip to be inserted into the bone i cavity and form a seal about the diameter of the bone cavity.
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. Thus, the cement is injected into a closed space so that pres-sure can build up to force the cement to penetrate the ~rabeculae , of the bone. Cement is also deposited over the remaining bone surface to which the prost~esis is to be attached.
A tip 21a with a 90~ bend as shown in Fig. 2 is used for a surface such as the tibia. A long straight tip is used for the - acetabular surface. Both of these tips contain the tapered end.
In the case of a long tubular bone canal, some type of Plug ', as shown in Figure 3 must be lodged in the canal to create a :~o closed space to prevent the extension of bone cement beyond the ' point where it is useful, and to facilitate more complete fllling and pressurization of the canal, Various means of plugging the .
canal have been advocated, including plugs made of natural bone, polyethylene or a bolus of doughy bone ce~ent, InItially, a long straight tip 21b, which has ~ diamete~ less than the diameter of the canal to allow the tip to pro~ect into -the bone canal, is used to deposit bone cement into the lon~ bone , canal, This tip 21b does not have a tapered end since t~e c~n~l is Initially just being fllled up, Then a tip such as the ~em~ral ' canal ~ressurizer 40 and adapter 41, as shown ~n Pigure 4, ~s ~ used to complete the f~lling of the canal and pressurize the ~j g :.,, ., iZ8~7' ~ =y~ the contents of the cavity. The tapered pressurizer seals off the ~--Y I canal to enable the pressure created upon injection of the cement j to force the cement to penetrate the bone.
1 Note in the above embodiments, the importance of sealing ,, off a cavity to help pressurize the cement.

,, MODE OF OPERATION OF THE INVENTION
. ,, The system of fixation according to the invention begins with 1, the mixing of penetrating bone cement and is followed by the lo-jl cation of the penetrating bone cement with the front loading ~ cartridge 10. The front closure cap 20 is connected onto the cartridge 10. A tip 21 is selected for the particular type of operation and is engaged with the front closure cap 20.
The engagement between the front closure cap 20 and the cartridge 10 may be by means of snap fit, an internal threading or an external threading. The flanged end 11 of the cylinder 10 is then ~_ ; closed off by locating plunger 9 within the cylinder 10.
The flanged end is then placed within the axial opening of the -~?~
housing 5 and bezel 12 is slideably located over the cylinder 10 engaging the bosses 18 and affixing the flange 11 between the support l9a and the bezel 12. ~;
At the same time the cartridge is engaged by the injection gun the rod 11 is placed in its rearmost position by pre~sing the release pin 17 and pulling rearwardly on the knob 6 until the cap 8 is against the support l9a, After the cartridge is engaged between the bezel 12 and the support l9a, the knob 6 is pushed forward until the cap 8 engages the plunger 9. The injector gun with engaged cartridge is then positioned for ~he pressurized extrusion of the bone cement 23. ' ? The surgeon performing the fixation grasps the handle 2 and -~
? 30 ; trigger 1 and squeezes them together. This causes a counterclock-, wise rotation of the trigger 1 and about the plvot pin 4. Such .? , l -- 10 ~1~i28~

. .. . . .
.~,, - .,rotation results in the notch la engaging the forward engaging -~'~~'~' member 14 at the lower portion ~hereof. This engagernent locks the forward engaging member 15 onto the rod 7 and compresses the coil spring 13 thereby moving the rod 7, cap 8, plunger 9 and bone cement 23 located within the cylinder 10 in a forward direction and through the tip 21. The trigger 1 is then released , and is returned to its original position by bias spring 3. Simul-taneously, the coil spring 13 returns the forward engaging member ;, 14 to its original position in engagement with notch 1. A stop/
' release member 16 is provided so that the forward engaging member , 14 returns to a position perpendicular to the rod 7. The forward '' engaging member 14 is held in perpendicu].ar position so that the - rod 7 may be moved forward merely by pushing on the knob 6 or i maybe moved backward by releasing the rearward engaging member 16 via release pin 17, In order to reset the rod 7, pin 17 is pushed into the housing until the rearward engaging member 15 is perpendicular to the rod 7 and disengaged therefrom. The rod " 7 can now be moved in either direction.
One critical feature of the invention is the ability of the in~ection gun to develop high pressure while applying a small amount of bone cement to the bone canal. In particular, the ' notch la, pivot pin 4 and trigger 1 are configured such that ,'. a single actuation of the trigger 1 results in sufficient for-, ward ~ovement of the forward engaging member 14 and rod 7 so that l', two or three cubic cm of bone ce~ent 23 are ejected through the tip 21, In :Eact, the trigger 1 is configured according to the diameter of cyllnder 10 so that the plunger 9 moves the equi~-' alent to two or three mm linearly when the trigger 1 xs squeezed i and ~eets handle 2, which results in the extrusion of 2 to 3 cubic : 30 ,' cm of cement. This feature of the invention is in contrast to guns of the prior art which were generally configured to eJect '', 10 to 15 cub~c c~ at low pressure.

Various changes may be made in the details of the invention, as disclosed, without sacrificing the advantages thereof or departing from the scope of the appended claims. Furthermore, although the present invention has been disclosed and discussed with particular regard to its exceptional advantages in terms of a system for preparing a bone for receiving a prosthetic com- !
ponent, it may be understood that the invention may be employed in several surgical and industrial applications wherein a high pressure, low volume, low viscosity injection system is desired.

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Claims

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:

Claim 1. A system for preparing a bone cavity for receiving a prosthetic component, said system comprising:
a) cartridge means for containing penetrating bone cement;
b) extruding means for extruding the penetrating bone cement from the cartridge means;
c) applying means for applying the penetrating bone cement extruded from the cartridge means by the extruding means to the bone cavity; and d) pressurizing means for pressurizing the penetrating bone cement applied to the bone cavity by the applying means.
Claim 2. The system of claim 1 wherein the cartridge means includes a plunger at one end thereof and an aperture at the other end thereof and said extruding means comprises a housing for engaging the end of the cartridge having the plunger, a compressing means for forcing the plunger into the cartridge means and manually actuating means for actuating the compressing means.
Claim 3, The system of claim 2 wherein the compressing means includes a rod axially supported by said housing with respect to said cartridge means, one end of said rod engaging the plunger means and a means for slideably engaging the rod and cooperating with the manual actuating means.
Claim 4. The system of claim 3 wherein the manual actuating means comprises a lever pivotally connected to the housing and having one end manually movable with respect to the housing and haying another end engaging the means for slideably engaging the rod.
Claim 5. The system of claim 4 further including first and second supports for supporting the rod, a forward engaging member connected to the rod and cooperating with the lever and a biasing means pivotally biasing the lever in the housing.
Claim 6. The system of claim 5 further including a rear-ward engaging member supported by the housing and engaging the rod to prevent rearward motion of the rod and release pin for selectively engaging the rearward engaging member and disengaging the rearward engaging member from the rod.
Claim 7. The system of claim 6 wherein the end of the cartridge means having the plunger is flanged and a bezel is selectively connected to the housing and engages the flange.
Claim 8. The system of claim 7 wherein said cartridge means comprises a front-loading cartridge having reinforcing ribs.
Claim 9. The system of claims 1 wherein the penetrating bone cement comprises a cement having a viscosity range, at 68° to 70° F, of less than 5000 poise up to the 5th or 6th minute after the cement is mixed.
Claim 10. The system of claim 8 wherein the penetrating bone cement has a viscosity, at 68° to 70° F, of less than 2000 poise up to the fifth or sixth minute from the time of initial mixing of the cement,
Claim 11; The system of claim 1 wherein said pressurizing means includes a nozzle having a portion shaped to close against an entrance to a bone cavity to close the cavity for pressuri zation.
12. The system of claim 1, wherein the penetrating bone cement comprises a high viscosity cement (doughy cement).
13. A system for injecting a low viscosity pre-mixed penetrating bone cement into a bone cavity, prior to placement of a prosthetic device into the bone cavity, under sufficient pressure to cause the cement to penetrate between the trabeculae of the bone, said system comprising: (a) cartridge means having an opening at one end thereof and a piston at the opposite end thereof, and a low viscosity bone penetrating cement having a viscosity, at 68° to 70°F, of less than 2,000 poises, up to about the sixth mniute after the time of initial mixing of the cement, said opening functioning as both an inlet for loading said cement into said cartridge means and as an outlet from which said cement can be forced out of said cartridge means; (b) extruding means for forcing a low volume of about 2 to 3 cubic centimeters of the penetrating bone cement in said cartridge means to move towards said outlet opening, said extruding means comprising a housing for engaging the end of the cartridge having the piston; pressure means for forcing the piston into the cartridge means and comprising a rod supported in said housing in axial alignment with respect to said cartridge means, one end of said rod engaging the piston and a means for slidably engaging said rod; and manual activating means for actuating the pressure means and comprising a lever pivotally connected to the housing by a pivot pin, said lever having one end manually movable with respect to the housing and having the opposed end thereof engaging the means for slideably engaging the rod;
wherein said opposed end of the lever which engages the means for slideably engaging the rod, said pivot pin, and said lever are configured such that a single manual actuation of said lever causes said slideable engaging means to move said rod which moves said piston into the cartridge means a distance sufficient to forcibly eject said low volume of low viscosity penetrating bone cement through said outlet opening under substantial pressure sufficient to cause said cement to pene-trate between the trabeculae of the bone; and (c) removable nozzle and pressure sealing means at the outlet opening of said cartridge means for applying the low volume of low vis-cosity penetrating bone cement forced from the cartridge means by the extruding means to the bone cavity and for providing a pressure seal between said bone cavity and said outlet opening whereby said low volume of low viscosity penetrating bone cement will be injected into the bone cavity under said sub-stantial pressure and will penetrate between the trabeculae of the bone to thereby provide a bone/cement interface to se-curely hold said prosthetic device in place, wherein said re-movable nozzle and pressure sealing means comprises a removable closure cap fitting over the outlet opening of said cartridge means and having an outlet orifice and at least one nozzle removably connectable to said outlet orifice, at least one of said nozzles having an outlet portion shaped to close against an entrance to a bone cavity to thereby provide said pressure seal between said bone cavity and said outlet opening.
14. The system of claim 13, wherein one of said at least one nozzle comprises an elongated tubular portion having an outlet tip which is tapered inwardly to terminate in a portion having a diameter less than the diameter of the bone cavity to be filled, said tapered portion of the tip forming the pressure seal between the bone cavity and the outlet opening.
15. The system of claim 13 or 14, wherein one of said at least one nozzle comprises a generally cylindrical tubular portion removably connectable to said outlet orifice of said closure cap and a generally inwardly tapered rubber portion fitting over the cylindrical tubular portion, said rubber portion being configured to fit within a femoral canal and provide a pressure seal between the femoral canal and the outlet opening.
16. The system of claim 13, further including first and second supports within said housing; each of said supports having an opening supporting the rod in axial alignment with respect to said cartridge means; said means for slidably engaging the rod comprising a first member located between said first and second supports, said first member having an opening therein, said rod passing through said opening; and biasing means pivotally biasing the lever in the housing in a direction in which the opposed end of said lever is biased in a direction away from said first member.
17. The system of claim 16, further including a second member supported by the housing and engaging the rod to prevent motion of the rod in the opposite direction from said outlet opening; and a release pin for selectively engaging the second member and disengaging the second member from the rod thereby allowing the rod to move in the direction away from the outlet opening.
18. The system of claim 17, wherein the end of the cartridge means having the piston is flanged and a collar is selectively connected to the housing and engages the flange.
19. The system of claim 18, wherein said cartridge means comprises a cartridge having reinforcing ribs.