Method of implanting a prosthesis device using bone cement in
Contents
1. 2010 the disclosure of which is hereby incorporated by ref erence herein in its entirety FIELD OF THE INVENTION 0002 The present invention generally relates to the use of bone cement in a liquid form in joint arthroplasty BACKGROUND OF THE INVENTION 0003 During the resurfacing techniques used in joint arthroplasty the boney surface is prepared using saw cuts mills or burs and a metal or plastic insert is bonded to the prepared surface ofthe bone using a bone cement such as poly methyl methacrylate PMMA in a paste or dough form The bone cement is applied to the surface ofthe resected bone the underside of the implant or both and the implant is put in place The bone cement is in the form ofa thick bonding agent that is easily handled since it can be kneaded into shape and pressed into place by hand At the stage it is used it also does not stick to the surgeons tools or gloves which makes it even easier to handle However there are significant limitations in using such bone cement for joint arthroplasty For example it is difficult to insert the bone cement into narrow or tight spaces in and around the implant area Further the bone cement is not easily conformable to complex geometries Less viscous forms of the bone cement also are problematic because they can leak or have unreasonable curing times leading to ineffective or poorly setting implants In addition this sort of thinner bone cement is difficult to contain and2. The cement working stages and setting set times are important to know because the surgeon is concerned with the length of time needed to hold the knee in place while the cement sets It is important to note that most practicing sur geons are trained to hold the limb in position for as long as it takes the cement to cure Under standard mixes and thumb pack technique this is typically 10 15 minutes The standard of care relies on these times and a bolus of cement from the original mix being monitored for curing outside the wound It has been found that this method may not be reliable since a bolus of cement cures at a different rate than a mantle of cement that is located between the implant and the host bone Ifthe cement does not set properly it could lead to malposi tioning or early cement failure It is important to know setting times in all conditions so that company representatives in the room may answer any questions should complications arise Icing 0066 Since the curing reaction is largely heat dependent cooling the cement slows the reaction Placing the filled syringe into an ice bath after filling would therefore be useful specifically in warmer Operating Room temperatures where the injectability phase ends just over 4 minutes after mix leaving little time for the procedure to be completed 0067 The addition of the ice bath removes ambient tem perature variability controls reaction time extends inject ability range
3. adheres to most surfaces it comes in contact with making it difficult for surgical teams to use in joint arthroplasty proce dures 0004 There is a need for a method for using bone cement in a liquid form in joint arthroplasty where the bone cement is less viscous e g in a liquid cement form than the tradi tional bone cement currently and regularly used in the art There is also a need for a bone cement that has the ability to fill the bone voids more readily and provide better adhesive properties as it is applied to joint arthroplasty 0005 The present invention is directed to overcoming these and other deficiencies in the art SUMMARY OF THE INVENTION 0006 In one aspect the present invention relates to a method of implanting a prosthesis device in a subject This method involves the following steps 1 providing a prosthe sis device to be attached to an exposed surface of a bone of a subject 11 applying bone cement in liquid form to a bone implant interface region where the bone implant interface region includes a region between the exposed surface of the bone and an outer surface of the prosthesis device and iii contacting the bone cement to both the exposed surface of the bone and the outer surface of the prosthesis device under conditions effective to allow the bone cement to cure thereby resulting in attachment ofthe prosthesis device to the bone of the subject Apr 5 2012 0007 In another aspect the pr
4. 2 and FIG 3 0078 4 Ensure surgeon is ready and has implants and injectors in place on back table prior to mixing 0079 5 Pour enough chilled saline into a container to completely cover cement filled 10 mL syringe Use needle cap to close end of syringe 0080 6 Have four 4 standard 10 mL syringes available for cementing technique III Cement Mixing 0081 Cementing mixing steps can include without limi tation the following steps 0082 1 Remove cement mixer and cement from any packaging Examples of various components needed for cement mixing are shown in FIG 4 0083 2 Connect vacuum system to Lid using vacuum tube see FIG 5 0084 3 Pour powder into cement base first Add mono mer when ready and begin mixing cement immediately Mix for 45 seconds Do not allow powder and monomer to sit for any length of time before mixing as time is critical in the LiquiFloTM cementing procedure Note Do not mix vigor ously 0085 4 Once mix is complete pull the vacuum tube from the mixer lid before proceeding to the next step IV Syringe Transfer 0086 Syringe transfer can be performed according to the following steps without limitation 0087 1 Connect a standard 10 mL syringe to the lure adapter on the side of the mix system see FIG 6 Once connected twist the bottom of the cement base so that the bottom ofthe cement mixing shelf lowers and allows cement to flow through the port US 2012 00837
5. and 32 degrees is easy to reproduce This is a value added simple step to incorporate into the procedure 0068 Icing was found to slow injectability for up to 15 minutes After 15 minutes the reaction has progressed enough to increase the rate of becoming more viscous to a point where it would cause significant changes to the inject ability of the cement 0069 Cement is a self curing polymer it should be noted that the reaction can be slowed by icing but not stopped Icing slows the reaction and maintains the injectability state of the cement when it entered the ice bath for up to 15 minutes When the cement is removed from the ice the curing times are delayed and care should be taken to ensure full cure With the addition of a warm water lavage after implantation these delays are negligible 0070 Different holding volumes before injection were considered as smaller boluses were previously shown to have longer set times This was tested to determine if the holding bolus effects changed injectability The results did not show any appreciable effect on injectability Set times outlined here are for setting boluses of 2 cc each which is similar to the amount seen between the implant and the host bone for a partial knee replacement Bolus effects had no noticeable effect on injectability as a holding volume of 10 cc seemed to have the same injectability as 5 cc 0071 The surgical procedure for any arthroplasty using injecting liquid c
6. thereby resulting in attach ment of the prosthesis device to the bone of the subject 0026 The method of the present invention is suitable for use with all types of prosthesis devices For example a suit able prosthesis device can include without limitation a joint prosthesis device for replacing or partially replacing a joint such as a knee a hip a shoulder an ankle an elbow a spinal disc a cervical disc and a small joint Other suitable examples of prosthesis devices for use in the method of the present invention can include without limitation devices having all or portions of a tibial component a femoral com ponent a patellar component an acetabular component a glenoid component a humeral component a talar compo nent an ulnar component or a fusion cage component In one embodiment the prosthesis device can include a body having at least one port through which the bone cement in liquid form is applied to the bone implant interface region 0027 Other suitable examples of joint prosthesis devices can be those used for a partial knee replacement a patello femoral replacement or a total knee replacement With regard Apr 5 2012 to joint prosthesis devices for small joints suitable devices can be those used for a PIP joint finger an MCP joint knuckle a DIP joint finger a CMC joint thumb and a metatarsophalangeal joint toe 0028 Various types of bone cement known in the art can be used in the metho
7. uid form in accordance with the methods ofthe present inven tion can be used For example in one embodiment the bone cement in liquid form is applied to the bone implant interface region using a delivery instrument Those of ordinary skill in the art in view of the present specification can determine various types of delivery instruments that are suitable for use US 2012 0083789 A1 in the methods ofthe present invention syringe is a suitable example of a delivery instrument for use in the method of the present invention Those of ordinary skill in the art can readily determine the various types and sizes of syringes that can be used in the methods of the present invention While not intending to be limiting in a particular example the syringe can be configured to contain a volume of liquid of up to about 50 cubic centimeters cc 0036 In one embodiment an injector adapter is used to facilitate application of the bone cement in liquid form from the delivery instrument to the bone implant interface region In a particular embodiment the prosthesis device includes a body having at least one port through which the bone cement in liquid form is applied to the bone implant interface region with the injector adapter being configured to couple the injec tion instrument to the at least one port ofthe prosthesis device 0037 In another embodiment ofthe method of the present invention prior to and or during the applying step the me
8. 89 A1 0088 2 Pull the plunger on the syringe to 10 mL see FIG 7 Cement will follow the plunger and fill the syringe Do not pull further than the 10 mL mark as this can disengage the plunger Complete for all four 4 syringes 0089 3 Once the four 4 syringes are full complete the Drip Test with one of the syringes then place one 1 syringe in chilled saline bath and give surgeon one 1 full 10 mL syringe see FIG 8 V Viscosity Drip Test 0090 A viscosity drip test can be performed according to the following steps without limitation 0091 1 This syringe gauges the cement viscosity through the drip test Hold the syringe vertically and allow cement to freely drip from the luer nozzle 0092 2 Monitor the drip rate or flow of the cement from the 10 mL syringe with no plunger installed as shown in FIG 9 0093 3 Flow of cement will turn to a perceptible dripping rate When drip rate approaches 1 drip per second the surgeon may begin injection ofthe third syringe into the tibial implant 0094 4 If the surgeon is not ready for the femoral syringe within the allocated time use the 1st syringe chilled in saline bath VI Cement Injection 0095 Cement injection for the tibia and femur can be performed as described below without limitation Cement curing can also be performed as described below without limitation 0096 Tibia Surgeon will use one syringe to inject cement into the tibial implant
9. Tibial implant requires a 45 degree injector and will require approximately 3 cc of cement injected 0097 Femur Once the tibial implant is cemented surgeon will inject the femoral implant with the 130 degree injector attached into the cement portals Note Do not impact implant prior to injection Inject 5 7 cc of cement into the femoral implant then impact femoral implant to seat implant into resected bone Remove any extruded cement from femoral and tibial areas 0098 Cement Curing Let cement cure for at least 15 minutes To expedite curing process warm sterile saline car diac can be introduced throughout the incision site Flex knee and visualize implants for any additional extruded cement and remove if present EXAMPLES 0099 The following examples are intended to illustrate particular embodiments of the present invention but are by no means intended to limit the scope of the present invention Example 1 The Effect of Chilling PMMA Bone Cement Poly merization to Prolong Injectability Summary 0100 When mixed polymethylmethacrylate PMMA bone cement undergoes an irreversible reaction eventually hardening into a solid state The rate of this reaction 15 largely dependent on the temperature of the components involved 0101 Different states of the cement are identified as the reaction progresses defined by the apparent viscosity of the Apr 5 2012 cement Since the speed of the reaction is dependent on te
10. US 20120083789 1 a2 Patent Application Publication Pub No US 2012 0083789 A1 as United States BLAKEMORE et al 43 Pub Date Apr 5 2012 54 METHOD OF IMPLANTING A PROSTHESIS DEVICE USING BONE CEMENT IN LIQUID FORM 75 Inventors David BLAKEMORE Warsaw IN US Keith PENNINGTON Warsaw IN US Shaun PITTS Warsaw IN US 73 Assignee VOT LLC Warsaw IN US 21 Appl No 13 249 044 22 Filed Sep 29 2011 Related U S Application Data 60 Provisional application No 61 389 193 filed on Oct 1 2010 Publication Classification 51 Int Cl 61 17 58 2006 01 521405 otros osi iin 606 93 606 92 57 ABSTRACT The present invention relates to a method of implanting a prosthesis device in a subject In one embodiment this method involves i providing a prosthesis device to be attached to an exposed surface of a bone 11 applying bone cement in liquid form to a bone implant interface region the bone implant interface region including a region between the exposed surface of the bone and an outer surface of the prosthesis device and iii contacting the bone cement to the exposed surface of the bone and the outer surface of the prosthesis device under conditions effective to allow the bone cement to cure thereby resulting in attachment of the pros thesis device to the bone of the subject The present invention also relates to a kit for implanting a prosthesis device in a s
11. aline 27 The method according to claim 26 wherein said main taining comprises incubating the bone cement in liquid form in an ice bath or chilling the bone cement in liquid form using chilled saline 28 The method according to claim 27 wherein said incu bating is fora period of not more than about 25 minutes and or not more than between about 10 and about 25 minutes prior to applying the bone cement in liquid form to the bone implant interface region 29 A kit for implanting a prosthesis device in a subject said kit comprising a prosthesis device comprising a body having at least one port through which bone cement in liquid form can be applied to a bone implant interface region wherein said bone implant interface region comprises a region between an exposed surface of a bone of the subject and an outer surface of the prosthesis device and a user manual comprising instructions for applying bone cement in liquid form to said bone implant interface region US 2012 0083789 A1 30 The kit according to claim 29 further comprising an injection instrument for applying the bone cement in liquid form through the at least one port ofthe prosthesis device 31 The kit according to claim 30 further comprising an injector adapter configured to couple the injection instrument to the at least one port of the prosthesis device 32 A method of performing a joint arthroplasty surgical procedure said method comprising providing a p
12. ast one portal and 11 directing bone cement in liquid form through the at least one portal to a bone implant interface region where the bone implant interface region includes a region between the exposed surface of the bone and an outer surface of the prosthesis device thereby resulting in attachment ofthe pros thesis device to the bone of the subject 0042 The present invention also provides a method of reattaching loose implants arthroscopically using bone cement in liquid form as described herein Those of ordinary skill in the art in view ofthe present specification can readily determine the steps involved in perform this method 0043 The present invention further provides a method of performing a bone to bone fusion using bone cement in liq uid form as described herein Those of ordinary skill in the art in view ofthe present specification can readily determine the steps involved in perform this method 0044 Traditional bone cement e g PMMA used in joint arthroplasty is normally used in a doughy state Manufactur ers of traditional bone cement provide descriptions of the normal working phase a doughy state that no longer sticks to a gloved hand This state is accurately defined and predicted by existing ambient temperature charts However the manu facturers do not characterize injectability as it is done with respect to the present invention Therefore the information that bone cement manufacturers provide do
13. could provide for greater adhesive prop erties as seen in its properties at this stage seen in the inability to handle this liquid cement easily as it sticks to any surface it comes into contact with It is further provided that liquid cement can be injected through small openings as opposed to a doughy cement which 15 applied to the surface to be bonded first and then the surfaces joined In the present invention the implants can be set in place and the cement injected in the space between the component and the host bone Unlike the US 2012 0083789 A1 present invention the prior art does not provide current guide lines for injecting cement through a syringe relevant for use in orthopedic arthroplasty 0047 The present invention in one embodiment provides two parts The first part is the implant devices with which this liquid injection technique can be used with and the second part is the application and methodology used to control the injectability of the cement Some distinguishing characteris tic of the implant devices to be used with this process is that they have portals that allow for an interface ofa pressurization system and channels to direct the flow ofthe injected cement A distinguishing characteristic of the injectable cement sys tem is that it is used early in the mixing and curing process of the cement so that it is at a low viscosity upon application and the application of the cement takes place when the implant is a
14. device 8 The method according to claim 1 wherein the bone cement in liquid form comprises poly methyl methacrylate PMMA at a viscosity selected from the group consisting of about 10 000 centipoise cP or less about 9 000 cP or less about 8 000 cP or less about 7 000 cP or less about 5 000 or less about 4 000 cP or less about 3 000 cP or less about 2 500 cP or less about 2000 cP or less about 1500 cP or less about 1000 cP or less about 500 cP or less and about 250 cP or less 9 The method according to claim 1 further comprising prior to said applying step conducting a viscosity test on the bone cement to determine a viscosity range at which thebone cementis in liquid form suitable for applying to the bone implant interface region 10 The method according to claim 9 wherein said viscos ity test comprises a drip test effective to measure the rate of flow wherein the viscosity test is suitable to provide a begin ning and ending point for applying the bone cement in liquid form 11 The method according to claim 10 wherein the begin ning point comprises a rate of flow selected from the group consisting of 2 drips second 1 drip second and 1 drip 5 seconds and the like 12 The method according to claim 10 wherein the ending point comprises a rate of flow of selected from the group consisting ofless than about 1 drip 5 seconds less than about 1 drip 10 seconds and no apparent drips 5 10 seconds 13 The meth
15. ds of the present invention as long as such bone cement is configured to be in liquid form in accor dance with the present invention In one embodiment the bone cement in liquid form can be without limitation poly methyl methacrylate PMMA at a viscosity of about 10 000 centipoise cP or less about 9 000 cP or less about 8 000 cP or less about 7 000 cP or less about 5 000 cP or less about 4 000 cP or less about 3 000 cP or less about 2 500 cP or less about 2000 cP or less about 1500 cP or less about 1000 cP or less about 500 cP or less about 250 cP or less and the like 0029 In one embodiment of the method of the present invention the applying step includes introducing the bone cement in liquid form to the bone implant interface region through at least one port of the prosthesis device 0030 Inanother embodiment of the method of the present invention prior to the applying step the method further includes conducting a viscosity test on the bone cement to determine a viscosity range at which the bone cement is in liquid form suitable for applying to the bone implant inter face region 0031 A suitable viscosity test for use in the present inven tion can include without limitation a drip test effective to measure the rate of flow where the viscosity test is suitable to provide a beginning and ending point for applying the bone cement in liquid form In one embodiment for example the beginning point can be a rate o
16. dure called the drip test is a method to determine the ideal time for injection It corresponds to a viscosity of around 500 to 1000 centipoise and is easy to reproduce in an operating room environment The cement is considered injectable when 1 drip of curing cement per sec ond comes from tip of a plunger less 10 cc syringe when held upright Injectability 0061 equation Viscosity was determined by the Hagen Poiseuille which shows relationship between pipe size L r flow rate pressure difference AP and viscosity for non tur bulent flow through a pipe 0062 When modeled at the end of the luer syringe this equation gives viscosity as a function of weight applied to create pressure difference AP and velocity of plunger to calculate flow rate Q The final equation is reached when modeled at the end of a luer syringe and a force of 10 pounds US 2012 0083789 A1 is applied to the plunger of a 10 cc syringe to create the pressure differential This is factored in to the 0 0684 equation 0063 Bone cement is considered injectable when the viscosity is below a level where the cement can be comfort ably pushed from a syringe and fill the volume underneath the implant while not pushing the implant out of place 0064 Times are defined where injectability ends for different ambient temperatures with standard mix conditions These are outlined on the graph below for Palacos LV 0065
17. ed off the results of this test we recommend placing a syringe in a pre prepared ice bath as described when Apr 5 2012 or before the drip test reaches 1 Hz This syringe can be expected to remain injectable for up to 15 minutes well past any syringes of cement left out of the ice bath This syringe may or may not need to be used in the surgery but that it can remain as a backup will doubtless be helpful in case the cementing step takes longer than normal or if the ambient temperature causes the other extra syringes to be too viscous too quickly for use This will prevent another mix from being needed which would increase the overall time of the proce dure 0119 Since the period of time between needing the first syringe and any other syringe of cement in a given procedure is usually well under 10 minutes but possibly at times up to 10 minutes this is a good procedural recommendation that is both easy to execute and easy to remember REFERENCES 0120 Citation of a reference herein shall not be construed as an admission that such reference is prior art to the present invention All references cited herein are hereby incorporated by reference in their entirety Below is a listing of various references cited herein 0121 1 ParksM L Walsh H A Salvati E A Li S Effect of increasing temperature on the properties of four bone cements C in Orthop 1998 355 238 248 0122 2 Chavali R Resijek R et Al Extending Polymer izatio
18. embodi ments of the invention However the invention is not limited to the precise arrangements and instrumentalities of the embodiments depicted in the drawings Further if provided like reference numerals contained in the drawings are meant to identify similar or identical elements 0015 FIG 1 is a graph chart showing bone cement prop erties for Palacos LV cement including set times and inject ability ranges 0016 FIG 21sa photograph of a femoral implant and 130 degree injector used in one embodiment of a method of the present invention US 2012 0083789 A1 0017 FIG 3 is a photograph of a tibial implant and 45 degree injector used in one embodiment of a method of the present invention 0018 FIG 4 is a photograph of various components used for cement mixing in one embodiment of a method of the present invention 0019 FIG 5 is a photograph of a lid being connected to a vacuum system using a vacuum tube in accordance with one embodiment of a method of the present invention 0020 FIG 6 is a photograph of one view of a standard 10 mL syringe connected to a lure adapter on the side of a mix system suitable for use in one embodiment ofa method of the present invention 0021 FIG 7 is a photograph of one view of a standard 10 mL syringe connected to a lure adapter on the side of a mix system suitable for use in one embodiment ofa method of the present invention This view demonstrates that pulling the plunger on the
19. ement should include this information depicting the optimal time to inject the PMMA cement in Apr 5 2012 order to ensure full cement fill underneath the implant and to minimize the amount of uncontrolled extrusion The proce dure should also outline the time required for the cement to cure sufficiently to avoid displacement of the implant while the final steps are performed 0072 embodiment of a method of the present inven tion can include for example the below steps as contem plated during a surgical procedure and in a surgical setting for a partial knee procedure as follows I Pre Surgery 0073 If chilled saline is unavailable prepare an ice bath before the procedure starts and place a 1 liter sterile saline container within the ice bath Chilled saline will be used later in the procedure to chill mixed cement Ensure that 2 boxes of cements such as Palacos LV or Osteobond are available for surgery II Pre Cementing Steps 0074 Pre cementing steps can include without limita tion the following steps 0075 1 After drilling three 3 3 2 mm holes into the tibial plateau lavage and dry area to remove bone and other debris that could prohibit free flow of cement and adhesion to the prepared bony surface 0076 2 Dry area with gauze or hydrosorb 4x4 and remove just before inserting implants into proper position 0077 3 Place injector s in implants on back table to expedite cementing process see FIG
20. es not apply for application in a liquid state What descriptions there are for using cement in aliquid state only apply to vertebroplasty and other vertebra augmentation procedures where the cement is injected with high pressure directly into the trabecular struc ture of the bone itself not between implants and bone as would be relevant to joint replacement surgery For example the Caspari group describes a method of injecting liquid cement underneath the implant but not through the implant 0045 The present invention provides inter alia a method that involves the application of cement in a liquid state that 15 superior to thumb packing a standard doughy state cement because it greatly increases the interdigitation of the cement into the trabecular structure of the bone beneath the implant This results in greater structural stability which should in turn lead to fewer implant failures due to loosening a leading cause of revision reoperations By enabling the surgeon to confidently inject cement at a lower viscosity the present invention helps to alleviate this and other problems relating to joint arthroplasty 0046 It is provided that a low viscosity cement would allow for a better mechanical bond to the trabecular structure of bone and the implant surface by providing greater inter digitation and penetration than the standard method of apply ing cement in a doughy state It is also provided that this liquid form of the cement
21. esent invention relates to a kit for implanting a prosthesis device in a subject The kit includes 1 a prosthesis device comprising a body having at least one port through which bone cement in liquid form can be applied to a bone implant interface region where the bone implant interface region includes a region between an exposed surface of a bone of the subject and an outer surface of the prosthesis device and ii a user manual comprising instructions for applying bone cement in liquid form to said bone implant interface region 0008 In another aspect the present invention relates to a method of performing a joint arthroplasty surgical procedure This method involves the following steps 1 providing a prosthesis device for use in a joint arthroplasty surgical pro cedure and to be attached to an exposed surface of a bone of a subject where the prosthesis device includes at least one portal and 11 directing bone cement in liquid form through the at least one portal to a bone implant interface region where the bone implant interface region includes a region between the exposed surface of the bone and an outer surface ofthe prosthesis device thereby resulting in attachment ofthe prosthesis device to the bone of the subject 0009 Ina further aspect the present invention relates to a method of reattaching loose implants arthroscopically using bone cement in liquid form as described herein 0010 In another aspect the present inve
22. establishes injectability ranges for use within a surgical arthroplasty procedure utilizing PMMA cement in its liquid state Step 1 Mixing the Cement 0051 The PMMA cement is vacuum mixed in a container according to the manufactures recommendations 30 60 sec onds Step 2 Transfer of Mixed Cement to Injection Syringe 0052 The mixed cement is transferred to an appropriate sized syringe through a transfer port or by pouring the liquid cement directly into the large open end of the syringe Step 3 Determination of Injectability of the Cement and Suspension of Cement Curing 0053 A drip test is performed in which a separate cement filled syringe is held vertically and the rate at which the cement drips from the syringe tip is monitored The remain Apr 5 2012 der ofthe mixed cement can be optional set into an ice bath of sterile water at 32 35 degrees to suspend its state of viscosity for subsequent use Step 4 Cement Delivery or Injection 0054 The syringe is attached to the implant via a propri etary adapter and the plunger is pressed until the prescribed amount of cement is delivered to the underside of the implants 0055 The injectability range of the cement is very impor tantto identify a new phaseis defined in which cement can be consistently pushed through injectors while completely fill ing the necessary boney voids and the geometries of the implant used to attain ridged fixation 0056 Examples of
23. f flow such as 2 drips second 1 drip second and 1 drip 5 seconds and the like In another embodiment for example the ending point can be a rate of flow such as less than about 1 drip 5 seconds less than about 1 drip 10 seconds and no apparent drips 5 10 seconds 0032 Another suitable viscosity test for use in the present invention can include without limitation a test that involves measuring migration of the bone cement on a test surface under conditions effective to determine when the bone cementis in a liquid form having a suitable viscosity range for said applying step 0033 Yet another suitable viscosity test for use in the present invention can include without limitation a test that involves measuring the change in temperature of the bone cement under conditions effective to determine when the bone cement is in a liquid form having a suitable viscosity range for said applying step 0034 In another embodiment ofthe method ofthe present invention after the applying step and or after the contacting step the method further includes subjecting the bone cement to curing conditions effective to decrease the setting time of the implanted prosthesis device In a particular embodiment the subjecting can include without limitation adding heat to the bone cement As a suitable example the heat can be added using saline at a temperature of between about 80 and 100 degrees F 0035 Various means for applying the bone cement in liq
24. hment of the prosthesis device to the bone of the subject 2 The method according to claim 1 wherein the prosthesis device is a joint prosthesis device for replacing or partially replacing a joint selected from the group consisting of a knee a hip a shoulder an ankle an elbow a spinal disc a cervical disc and a small joint US 2012 0083789 A1 3 The method according to claim 2 wherein the joint prosthesis device is for a partial knee replacement a patello femoral replacement or a total knee replacement 4 The method according to claim 2 wherein the small joint is selected from the group consisting ofa PIP joint finger an MCP joint knuckle a DIP joint finger a CMC joint thumb and a metatarsophalangeal joint toe 5 The method according to claim 1 wherein the prosthesis device is selected from the group consisting of a tibial com ponent a femoral component a patellar component an acetabular component a glenoid component a humeral com ponent a talar component an ulnar component and a fusion cage component 6 The method according to claim 1 wherein the prosthesis device comprises a body having at least one port through which the bone cement in liquid form is applied to the bone implant interface region 7 The method according to claim 6 wherein said applying step comprises introducing the bone cement in liquid form to the bone implant interface region through the at least one port of the prosthesis
25. implant interface region 0039 The present invention also provides a kit for implanting a prosthesis device in a subject The kit includes 1 a prosthesis device comprising a body having at least one port through which bone cement in liquid form can be applied to a bone implant interface region where the bone implant interface region includes a region between an exposed surface of a bone of the subject and an outer surface of the prosthesis device and ii a user manual comprising instructions for applying bone cement in liquid form to said bone implant interface region 0040 The kit of the present invention can further include aninjection instrument for applying the bone cement in liquid form through the at least one port of the prosthesis device Suitable examples of injection instruments are as disclosed herein and as readily understood by those of ordinary skill in the art in view of the present specification The kit of the present invention can further include an injector adapter con figured to couple the injection instrument to the at least one port of the prosthesis device Apr 5 2012 0041 The present invention further provides a method of performing a joint arthroplasty surgical procedure This method involves the following steps 1 providing a prosthe sis device for use in a joint arthroplasty surgical procedure and to be attached to an exposed surface of a bone ofa subject where the prosthesis device includes at le
26. lready in place Specialized implant design and injecting instrumentation can be used along with cement in this state which may otherwise be too thin to handle and utilize effectively 0048 Implants are developed with dams that limit extru sion and which also guide the flow Special interlocking geometries on the under surfaces of implants are also devel oped to work with liquid cement these geometries allow cement to flow into and up around corners of the implant in order to get a stronger mechanical lock Injectors which attach to portals on the implant on one end and syringes on the other are developed for a simple cement injection protocol These features and instruments are new to joint replacement implant techniques 0049 The present invention does not formulate a new kind of cement but instead in one embodiment takes advantage of regularly available PMMA bone cement that is used at an earlier stage of the curing process Cement applied with Liq uiFlo technology of the present invention is chemically and structurally the same as the original commercial bone cement used as there is no addition or removal of any ingredients and there is no change of the chemical makeup of the cement in any way 0050 In one embodiment this technique description of the present invention outlines the parameters needed to allow for an injectable cement to be used in the operating room For example it includes preparation mixing setting times and
27. m perature the time that the cement remains in a desirable state can be prolonged by artificially decreasing the temperature In order to more closely study the effect of chilling the cement to prolong the previously defined injectability state this series of tests was carried out to appropriately define a pro tocol and limitations regarding chilling cement in a clinical situation 0102 The objectives of this study are to define a limit if any to the effectiveness of using an ice bath to limit the progression of the reaction of curing PMMA cement and extend the amount of time it is considered to be injectable Introduction 0103 This cement chilling study was conducted at the VOT Solutions laboratory in Warsaw Ind 0104 Different states of the PMMA cement are identified as the reaction progresses defined by the apparent viscosity of the cement Since the speed of the reaction is dependent on temperature of the components involved the time that the cement remains in a desirable state can be prolonged by artificially decreasing the temperature of those components In order to more closely study the effect of chilling the cement to prolong the previously defined injectability state this series of tests was determined necessary to appropriately define a protocol and limitations regarding chilling cement in a clinical situation 0105 The objectives of this study are to define a limit if any to the effectiveness of u
28. n Time of Polymethylmethacrylate Cement in Percu taneous Vertebroplasty with Ice Bath Cooling AJNR Am J Neuroradiol 2003 24 545 546 0123 3 Lidgren L Bodelind B Moller J Bone cement improved by vacuum mixing and chilling Acta Orthop Scand 1987 57 27 32 0124 4 Pearson GP Jones D F Wright V Letter Effect of Operating theatre temperatures on the setting times of acrylic cements for use in orthopaedic surgery Lancet 1975 2 184 0125 Although preferred embodiments have been depicted and described in detail herein it will be apparent to those skilled in the relevant art that various modifications additions substitutions and the like can be made without departing from the spirit of the invention and these are there fore considered to be within the scope of the invention as defined in the claims which follow What is claimed is 1 A method of implanting a prosthesis device in a subject said method comprising providing a prosthesis device to be attached to an exposed surface of a bone of a subject applying bone cement in liquid form to a bone implant interface region wherein said bone implant interface region comprises a region between the exposed surface ofthe bone and an outer surface ofthe prosthesis device and contacting the bone cement to both the exposed surface of the bone and the outer surface of the prosthesis device under conditions effective to allow the bone cement to cure thereby resulting in attac
29. nce from the predictive line Since the fit of the trend line is not ideal to prevent leaving the syringe in too long taking into consideration different OR temperatures and situation would all create different results we want a factor of safety and estimate lower 15 minutes is a good upper limit to the time any post drip test syringe should remain in the ice bath and expect to be used 0116 These results do not include allowances for ambient temperature as most effects of ambient temperature are removed shortly after the syringe is placed into the ice bath and since all syringes are placed in the bath at the same state post drip test there should be little carry over effects Residual higher temperatures within the cement and syringe could lead to shorter times in theory however and this is all the more reason to decrease the recommended icing time for expected use from about 20 minutes to 15 minutes 0117 It is important to remember that these syringes had reached the 1 Hz drip test state immediately before being placed within the ice bath There remains the option to place the syringe in the ice bath before this injectability milestone is reached and this should increase the injectability even fur ther Since thetested reactions had at least a couple of minutes to progress in ambient temperature the injectability window certainly increases even further when placed in the bath before the drip test mark CONCLUSIONS 0118 Bas
30. ntion relates to a method of performing a bone to bone fusion using bone cement in liquid form as described herein 0011 The present invention provides a method of joint arthroplasty that involves using a less viscous or liquid cement than is the traditional bone cement currently used in the art The present invention provides a bone cement having the ability to fill the bone voids more readily and therefore provide a stronger attachment to the bone Further the present invention provides a technique to apply low viscosity cement to the needed area 0012 The present invention provides a technique to apply alow viscosity cement to the needed area The use ofthe bone cement e g PMMA in this form is typically discouraged since it is difficult to handle in the surgical setting However the present invention solves the issues of handling the low viscosity bone cement by providing a system that includes the choice of cement mixing transfer effects of environmental factors stages and application ofa liquid cement in a way that benefits the patient and the surgeon 0013 These and other objects features and advantages of this invention will become apparent from the following detailed description of the various aspects of the invention taken in conjunction with the accompanying drawings BRIEF DESCRIPTION OF THE DRAWINGS 0014 For the purpose of illustrating aspects ofthe present invention there are depicted in the drawings certain
31. od according to claim 10 wherein said vis cosity test comprises measuring migration ofthe bone cement onatest surface under conditions effectiveto determine when the bone cement is in a liquid form having a suitable viscosity range for said applying step 14 The method according to claim 10 wherein said vis cosity test comprises measuring the change in temperature of the bone cement under conditions effective to determine when the bone cement is in a liquid form having a suitable viscosity range for said applying step 15 The method according to claim 1 further comprising after said applying step and or after said contacting step subjecting the bone cement to curing conditions effec tive to decrease the setting time of the implanted pros thesis device Apr 5 2012 16 The method according to claim 15 wherein said sub jecting comprises adding heat to the bone cement 17 The method according to claim 16 wherein the heat is added using saline at a temperature of between about 80 and 100 degrees F 18 The method according to claim 1 wherein the bone cement in liquid form is applied to the bone implant interface region using a delivery instrument 19 The method according to claim 18 wherein an injector adapter is used to facilitate application of the bone cement in liquid form from the delivery instrument to the bone implant interface region 20 The method according to claim 19 wherein the pros thesis device compri
32. rosthesis device for use in a joint arthroplasty surgical procedure and to be attached to an exposed Apr 5 2012 surface of a bone of a subject wherein said prosthesis device comprises at least one portal and directing bone cement in liquid form through the at least one portal to a bone implant interface region wherein said bone implant interface region comprises a region between the exposed surface of the bone and an outer surface of the prosthesis device thereby resulting in attachment of the prosthesis device to the bone of the subject x
33. s the syringe was submerged completely into the ice bath after a 1 Hz drip test US 2012 0083789 A1 Supplies Product Manufacturer Components Used 0 cc Syringes Becton Dickinson and Co 16 Cement mixer Summit 3 MLP 1K CO Load Cell Omegadyne 1 Displacement Detector 1 DP25 E Process Filter Omega Inc 1 PMD 1208FS DAQ board Measurement Computing 1 LabTech Software system LabTech Software LLC 1 Palacos LV Cement Heraeus 3 Results 0111 Looking at the data in FIG 10 one can see that the reaction certainly still progresses after placement in an ice bath just at a slower pace 0112 Using viscosity measurements at time points at 2 min 5 min which had to be excluded 10 min 20 min 25 min 30 min and 45 min which also had to be excluded we were able to create this approximation ofthe rate progression in the ice bath 0113 The 5 min point had to be excluded because there was no point in time where the load was even at 10 lbs so the resulting plunger velocity was meaningless 0114 The 45 min point was excluded as the reaction had progressed beyond the point where 10 lbs was enough force to get any movement at all from the plunger on the syringe At this point the cement was clearly in setting phase with more plastic solid properties than viscous liquid properties Discussion 0115 The data showed that the cement reaches the inject ability limit of 2500 cP around 20 minutes though there is significant devia
34. ses a body having at least one port through which the bone cement in liquid form is appliedto the bone implant interface region and wherein the injector adapter is configured to couple the injection instrument to the at least one port of the prosthesis device 21 The method according to claim 18 wherein the injec tion instrument is a syringe 22 The method according to claim 21 wherein the syringe is configured to contain a volume of liquid of up to about 50 cubic centimeters cc 23 The method according to claim 1 further comprising prior to and or during said applying step delaying curing ofthe bone cement from its liquid form to its cured form 24 The method according to claim 23 wherein said delay ing comprises maintaining the bone cement in liquid form at a temperature range selected from the group consisting of between about 0 F and about 40 F between about 10 F and about 40 F between about 15 F and about 40 F between about 20 F and about 40 F between about 25 F and about 40 F between about 30 F and about 38 F and between about 32 F and about 35 F 25 The method according to claim 23 wherein said delay ing comprises maintaining the bone cement at a temperature of not more than about 0 F 26 The method according to claim 23 wherein said delay ing comprises maintaining the bone cement in crushed ice a mixture of ice and water refrigerator chilled saline and or freezer chilled s
35. set times and injectability ranges are shown for Palacos LV cement in the graph of FIG 1 0057 Important factors that affect injectability and set time include 1 times of injection after initial mix 11 ambi ent temperature iii addition of or subtraction of heat on the loaded syringe for different lengths of time and iv bolus different setting volume waiting volume effects 0058 Mixes generally take around the same time to com plete and syringes are filled immediately after mixes were usually complete at 1 15 min after initial monomer cement contact and transferred to syringes at 2 15 0059 Viscosity is used as a metric for determining another term injectability which is defined as the cement s vis cosity as being below a certain value that is both easy to inject out of a standard syringe and spread down the length of a femoral partial knee implant more viscous and it would not fill the implant but instead form a ball near the site ofinjection that pushes the implant out of place The viscosities for dif ferent temperatures and bolus sizes are given as a function of time from mix for incorporation into a surgical procedure Higher temperatures lead to faster set times but also lead to increased viscosity early on which limits injectability Ranges are given for stages of injectability for both tibial and femoral components as well as final set times for different setting environment temperatures 0060 proce
36. sing an ice bath to limit the progression of the reaction of curing PMMA cement and extend the amount of time it is considered to be injectable Materials and Methods 0106 The same test setup from 0310 002 Injectabil ity as measured viscosity was used and the protocol devel oped to determine viscosity was also used from that docu ment as well as the definition of injectability as being less than 2500 cP 0107 An ice bath for the purposes of this study is defined as a large container first filled with ice then cold water The temperature of all ice baths used was measured to be around 32 degrees F which is expected in a mixture ofa large combination of ice and cold water Both ice and water were still present in the container when in use for all test cases 0108 An ice bath was chosen as the method to lower the temperature in this study primarily because it is an easy system to recreate in any operating room Also placing nearly anything in near freezing water combined with ice is a fast efficient way to conduct heat away and lower its temperature because of the combined effects of the heat buffer of the ice and the increased contact area given by the liquid nature ofthe water 0109 volumes used were contained in 10 cc syringes to both control bolus effect variables and to be more clinically relevant The temperature of the room was controlled to be 60 degrees F for all test cases 0110 In all case
37. syringe will allow the syringe to become filled with the cement 0022 FIG 8 is a photograph of one view of a standard 10 mL syringe in a chilled saline bath in accordance with one embodiment of a method of the present invention 0023 FIG 9 is a photograph of one view of a standard 10 mL syringe being held for monitoring of drip rate or flow of cement from the syringe during one embodiment of a viscos ity drip test in accordance with one embodiment of a method of the present invention 0024 FIG 10 is a graph showing the results of an experi ment to test the effect of chilling PMMA bone cement poly merization to prolong injectability The graph shows recorded viscosity cP over a period of time in an ice bath minutes for a PMMA bone cement polymerization reaction DETAILED DESCRIPTION OF THE INVENTION 0025 The present invention provides a method of implant ing a prosthesis device in a subject This method involves the following steps i providing a prosthesis device to be attached to an exposed surface of a bone of a subject 11 applying bone cement in liquid form to a bone implant inter face region where the bone implant interface region includes aregion between the exposed surface of the bone and an outer surface of the prosthesis device and 111 contacting the bone cement to both the exposed surface of the bone and the outer surface of the prosthesis device under conditions effective to allow the bone cement to cure
38. thod further includes delaying curing of the bone cement from its liquid form to its cured form In a particular embodi ment this delaying step can include maintaining the bone cement in liquid form at a temperature range such as but not limited to a temperature range of between about 0 F and about 40 F between about 10 F and about 40 F between about 15 F and about 40 F between about 20 F and about 40 F between about 25 F and about 40 F between about 30 F and about 38 F between about 32 F and about 35 F and the like In another particular embodiment this delaying step includes maintaining the bone cement at a temperature of not more than about 0 F Those of ordinary skill in the art in view of the specification would readily understand how to achieve the delaying step While not intending to be limiting in a particular example the delaying step can include main taining the bone cement in crushed ice a mixture of ice and water refrigerator chilled saline and or freezer chilled saline 0038 Suitable means for carrying out the maintaining step can include for example incubating the bone cement in liquid form in an ice bath or chilling the bone cement in liquid form using chilled saline In a particular embodiment the incubating is for a period of not more than about 25 minutes and or not more than between about 10 and about 25 minutes prior to applying the bone cement in liquid form to the bone
39. ubject a method of performing a joint arthroplasty surgical procedure and other methods of using bone cement in liquid form Patent Application Publication Apr 5 2012 Sheet 1 of 10 US 2012 0083789 A1 un Solo Bona Cement Properties Timefrom start of apo eins BO Patent Application Publication Apr 5 2012 Sheet 2 of 10 US 2012 0083789 A1 FIG 2 Patent Application Publication Apr 5 2012 Sheet 3 of 10 US 2012 0083789 A1 FIG 3 Patent Application Publication Apr 5 2012 Sheet 4 0f 10 US 2012 0083789 A1 FIG 4 Patent Application Publication Apr 5 2012 Sheet 5 of 10 US 2012 0083789 A1 FIG 5 Patent Application Publication Apr 5 2012 Sheet 6 of 10 US 2012 0083789 A1 FIG 6 Patent Application Publication Apr 5 2012 Sheet 7 of 10 US 2012 0083789 A1 FIG 7 Patent Application Publication Apr 5 2012 Sheet 8 of 10 US 2012 0083789 1 FIG 8 US 2012 0083789 1 Apr 5 2012 Sheet 9 of 10 Patent Application Publication FIG 9 Patent Application Publication Apr 5 2012 Sheet 10 of 10 US 2012 0083789 A1 2000 4300 4000 Recorded viscosity Time in ice bath min FIG 10 US 2012 0083789 A1 METHOD OF IMPLANTING A PROSTHESIS DEVICE USING BONE CEMENT IN LIQUID FORM CROSS REFERENCE TO RELATED APPLICATIONS 0001 This application claims priority benefit of U S Pro visional Patent Application Ser No 61 389 193 filed Oct 1
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