MicroSeal Total Hip Acetabular System. Like Nothing Else

Transcription

1 MicroSeal Total Hip Acetabular System Like Nothing Else

2 Like Nothing Else Unique Patented Sealing and Locking Design The MicroSeal design features: Locking/Sealing mechanisms work together to minimize micromotion Sealing mechanism creates a water tight seal Screw holes ensure safe shell placement Simple Procedure The MicroSeal surgical instrumentation: Simple tools that aid with alignment and seating of the implant Minimal instrumentation for the operating room Outstanding Clinical Success First used in 1998, the MicroSeal acetabular component has remarkable clinical success

3 Unique Patented Sealing & Locking Design The sealing ridges of the implant press into a smooth tapered surface on the inner aspect of the metal shell and create a water tight seal Seal The sealing mechanism is the most important feature of the MicroSeal acetabular component 1 Seals out joint fluid and particulate debris 2 Prevents screw hole associated osteolysis Augments rigid fixation to the acetabular shell Minimizes micromotion Allows for the safe use of screws

4 Unique Patented Sealing & Locking Design Seal No leakage of water or sub-micron microspheres occurs under high hydrostatic pressure (higher than that recorded in human hip joints) and with greater than physiological axial and torsional loading, even after 10 million cycles. No Seal Vs. Seal This sealing characteristic enables the screw holes to be used safely, without the risk of screw-hole associated osteolysis. This is a real advantage over all other modular acetabular components, which allow particulate debris to enter this interface and then pump this debris through screw holes and around screws. With no seal, all of the microspheres passed easily between the metal shell and the polyethylene liner With the seal, no microspheres passed so none are present on the filter

5 Unique Patented Sealing & Locking Design Eccentric mating surface resists sliding at the interface The Elasto-Dynamic locking system effectively resists micromotion Press-fit central locking mechanism provides no-tilt inserting and locks the components Fixation All of these features integrate the unique locking and sealing capability of the MicroSeal system Rigid fixation of the polyethylene liner in the metal shell is vitally important to prevent backside wear of the polyethylene. This goal is accomplished with a combination of features in the MicroSeal cup that reduces micromotion and backside wear.

6 Unique Patented Sealing & Locking Design Central Locking Mechanism: Provides no-tilt insertion Dome 45 taper 45 Taper: Self-Locking Dome } 5 Taper: Seals interface & aids fixation Elasto-Dynamic Locking Tabs: Ensures seating and longterm rigid fixation

7 Unique Patented Sealing & Locking Design The screw holes prevent blood and marrow buildup behind the component while the shell is being driven into the acetabulum Safe in Three Ways The MicroSeal shell eliminates the risk of embolization with the use of 6 screw holes Screw holes are often necessary for fixation and are safe to use with the MicroSeal design The thin acetabular shell ensures the thickest possible polyethylene is used

8 Unique Patented Sealing & Locking Design The Elasto-Dynamic locking system is driven by the stored energy in the tabs Tabs are tapered for easy lead in Tabs are compressed within elastic limits of polyethylene Tabs find correct positioning All tabs snap simultaneously under overhanging ridges Shell has peripheral tapered notches for effective hold down Tabs are not plastically deformed

9 Unique Patented Sealing & Locking Design Elastic energy is stored in the tabs Arrangement of the rim drives poly into the dome Tabs do not deform plastically Tabs do not bottom out on the notch Tabs constantly press the polyethylene downwards to ensure tight seating in the dome Tabs effectively resist sliding and micromotion

10 Unique Patented Sealing & Locking Design Stored elastic energy in the tabs press the polyethylene into the shell The dome-shaped area of the polyethylene bottoms out on the corresponding domed area of the shell

11 Quality Extruded GUR 1050 Resin Fully-fused stearate-free Single stage 10M-rad Cross-linked Annealed to reduce free-radicals Ethylene Oxide (EtO) sterilized Wear Resistant Polyethylene quality is one of the most important factors in wear and longterm durability of the acetabular component. We use processes and materials that reduce oxidation and delamination as well as creep and wear 3,4,5 that occur with other methods.

12 Simple Instruments Acetabular Shell Driver Alignment of the acetabular shell is achieved by sighting 15 anteversion and 45 opening angle Alignment Both the metal shell and polyethylene liner are inserted with simple tools that lock securely to the components and aid the surgeon in orienting and seating the implants.

13 Outstanding Clinical Success In a recent follow up study, the MicroSeal liner design 1 minimized backside damage: 53% no compression 47% compression of machining marks 0% wear through machining marks * The locking mechanism design was effective under a variety of clinical conditions. A liner with no backside damage Demographics and Backside Damage Screw Hole Younger Males (Below 55 years of age) 2.8% Older Females (Above 55 years of age) 2.6% Mean backside damage of the worse cases found in the 13-yr. follow up study A liner with compression of machining marks * Majority of liners (59/62) were non-crosslinked and EtO sterilized

14 Like Nothing Else Unique, Simple, Outstanding Fail-safe mechanisms, over-engineering, and simple surgical technique characterize every aspect of the MicroSeal acetabular component.

15 Ordering Information Acetabular Shells & Screws MicroSeal Shell WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA WA Size 38 mm 40 mm 42 mm 44 mm 46 mm 48 mm 50 mm 52 mm 54 mm 56 mm 58 mm 60 mm 62 mm 64 mm 66 mm 68 mm 70 mm MicroSeal Reconstruction Shell WA WA WA WA WA WA WA WA WA WA WA WA WA WA Size 54 mm 56mm 58 mm 60 mm 62 mm 64 mm 66 mm 68 mm 70 mm 72 mm 74 mm 76 mm 78 mm 80 mm Cancellous Bone Screws WF WF WF WF WF WF WF WF Size 6.5 mm x 15 mm 6.5 mm x 20 mm 6.5 mm x 25 mm 6.5 mm x 30 mm 6.5 mm x 35 mm 6.5 mm x 40 mm 6.5 mm x 45 mm 6.5 mm x 50 mm

16 Ordering Information Acetabular Liners MicroSeal Anatomic (10 ) Liners Size 26mm ID Size 28mm ID Size 32mm ID WB WB WB WB WB WB WB mm 50 mm 52 mm 54 mm 56 mm 58 mm 60 mm WB WB WB WB WB WB WB WB WB WB WB WB WB WB WB WB mm 52 mm 54 mm 56 mm 58 mm 60 mm 62 mm 64 mm 66 mm 68 mm 70 mm 72 mm 74 mm 76 mm 78 mm 80 mm WB WB WB WB WB WB WB WB WB WB WB WB WB WB mm 56 mm 58 mm 60 mm 62 mm 64 mm 66 mm 68 mm 70 mm 72 mm 74 mm 76 mm 78 mm 80 mm

17 Ordering Information Acetabular Liners MicroSeal Augmented (20 ) Liners MicroSeal Stable Liners Size 26mm ID Size 28mm ID Size 32mm ID Size 22mm ID WB WB WB WB WB WB WB mm 50 mm 52 mm 54 mm 56 mm 58 mm 60 mm WB WB WB WB WB WB WB WB WB WB WB WB WB WB WB WB mm 52 mm 54 mm 56 mm 58 mm 60 mm 62 mm 64 mm 66 mm 68 mm 70 mm 72 mm 74 mm 76 mm 78 mm 80 mm WB WB WB WB WB WB WB WB WB WB WB WB WB WB mm 56 mm 58 mm 60 mm 62 mm 64 mm 66 mm 68 mm 70 mm 72 mm 74 mm 76 mm 78 mm 80 mm WB WB WB WB WB WB mm 40 mm 42 mm 44 mm 46 mm 48 mm

18 References 1 Khalily et al. Effect of Locking Mechanism on Fluid and Particle Flow Through Modular Acetabular Components. The Journal of Arthroplasty Vol.13 # pg Akbari A, Roy ME, Whiteside LA, Katerberg BJ, Schnettgoecke DJ. Minimal Backside Surface Changes in Retrieved Acetabular Lines. Presented at Society For Biomaterials Greer et al., Trans 48th ORS 2002 #0052. Wear of Crosslinked UHMWPE as a Function of Irradiation Dose and Crosslink Density. 4 Morrison et al., Trans 54th ORS 2008 #1771. Analysis of a Retrieved, Sequentially Crosslinked Acetabular Cup. 5 Goldman et al., Journal of Materials Science: Materials in Medicine 9 (1998) pg The Influence of Sterilization Technique and Aging on the Structure and Morphology of Medical-Grade Ultrahigh Molecular Weight Polyethylene. 6 Hagio et al., The Journal of Arthroplasty Vol pg Embolic Events During Total Hip Arthroplasty. MicroSeal is a registered US patent. REG. U.S. PAT. 00RE40090E 2010 Signal Medical Corporation Signal Medical Corporation 1000 Des Peres Rd. Suite 140 St. Louis, MO USA Visit us at Tel Fax Info