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BLOG TEASERS

An FDA orthopedic devices advisory panel unanimously recommended approval of Johnson & Johnson’s ceramic-on-metal hip bearing implant. In a 5-0 vote, the panel suggested approval of the Pinnacle CoMplete Acetabular Hip System, with conditions that include a 10-year follow-up study.


The panel made its recommendation after reviewing a two-year study that compared the Pinnacle’s safety and effectiveness with a DePuy metal-on-metal implant. The study revealed no significant difference between adverse events, revision rates, or survivorship after two years.


If approved, the device would be intended for patients who experience severe pain and disability as a result of osteoarthritis or posttraumatic arthritis. It would also be the first implant to use ceramic-on-metal instead of metal-on-metal.


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Precision Machining Trends

 

There are 13 different sizes within this family of parts.
Substantial efficiencies can be achieved when families of parts are manufactured using an automated cell. Within a particular family machined from 17-4 PH stainless steel, there are 13 different components with a combined annual production run of 65,000 parts. The hex, shank, and length (which is 38 mm) for all 13 components are identical. The difference between each family part member is the outer angle of the flare, the step diameter dimensions at the end of the flare, and the inner angle of the flare.

 

All 13 parts within this family are machined from the same raw bar stock size (based on the largest diameter). Because these parts require a common bar size, changeover time is eliminated (cutting tools, guide bushings, collets, and bar feeder tooling remain constant). The best way to arrange the 13 different sizes is to run one size to another, and design 13 different programs to produce the parts. That way the machine continues to operate during changeover.

 

Return to Article:
Advances in Fully Automated Swiss Machining Cells
 
In addition, the automated cell has sufficient flexibility to run a different part in each of the four machines when required. The palletization process keeps parts separated during the run to ensure lot integrity and traceability. Each part can be inspected according to its own program and can be called up when the gantry robot delivers it for viewing at the inspection station.

 

 

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PRECISION NEWS

Kurt Manufacturing Co. (Minneapolis) has formed a national network of authorized vise and workholding repair centers. The seven centers, which are strategically located throughout the United States and Mexico, are staffed with company-trained workholding experts. The staffers are skilled in repairing Kurt original equipment, including precision manual vises, hydraulic vises, and vertical machining vises. The company plans to add more service centers soon, including in Chicago and Costa Rica. The network of centers is intended to minimize repair time, save transportation costs, and keep equipment operating. Kurt’s workholding products include multiple-station CNC vises, five-axis vises, rotary table workholding for vertical machining centers, and a full line of tombstones for achieving maximum high-density workholding.


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Joints are jumpin’ and muscles are movin’ thanks to technology advances in the patient-specific implants market.

Photo courtesy of BIOMET INC.
As life expectancies increase, many of the aging baby boomers who receive their first knee, shoulder, and other implants today are likely to require a second and third replacement implant in the future—a key trend behind the $22 billion orthopedic implant market and its projected 8.9% annual growth rate.1 Surgeons strive to preserve as much of the patient’s own bone structure as possible during the initial implant surgery so that if future replacements are needed, enough structures remain intact to support them.

 

The replacement-for-the-replacement trend is increasing the number of instances in which off-the-shelf implants cannot meet patient needs. Off-the-shelf implants are often too large, don’t fit well into the remaining bone structure, or have a strong likelihood to chafe already infected or inflamed tissue.

 

For years, replacement hips, knees, and sections of spinal columns have come in a small range of sizes, and more recently, in modular designs that surgeons can order for use together. Surgeons relied on them because they were easy to order, affordable, and covered by insurance. Patient-specific implants were reserved for the most complex of cases and sometimes required between six and eight weeks of lead time. Clinicians tried to limit these efforts, in part because manufacturing processes were too costly and labor-intensive to economically support custom projects, which often received little or no additional reimbursement beyond conventional procedures.

 

Thanks to a confluence of digital hardware and software advances, tech-savvy physicians, and new manufacturing techniques, patient-specific implants now are becoming more common and are readily designed. Patient-specific implants are also developing into a viable business for orthopedic firms, which can command a premium for custom implants. However, there is still a need for improvements in the overall reimbursement process.

 

The same sculptural computer-aided design (CAD) technology used for making product prototypes, toys, and collectibles is now helping to fuel a shift toward custom-designed implants, including hips, leg bones, and shoulders as well as restorative muscle implants. Such implants fit better and are significantly faster and less expensive to design and manufacture than just a few years ago.

 

Digital Advances

 

Four major factors are propelling greater ease in creating patient-specific implants. These factors include the digital transition, tech-savvy clinicians, sculptural CAD software, and the advent of rapid manufacturing.

 

The Digital Transition. The technology to create digital 3-D patient models has existed for some time, but it is really taking off now because the entire digital work flow—from data acquisition to modeling and custom manufacturing—is vastly easier. A patient’s x-ray or CT scans are more readily converted into the stereolithography (STL) file type for import into 3-D modeling software.

 

These digital modeling packages quickly handle computationally complex tasks such as creating mirror images of body parts or using a normal section of bone to digitally recreate its missing counterpart. Using actual patient data to design these models on a computer delivers far greater accuracy than hand drawings that approximate the patient’s bone geometry.

 

In addition, a cottage industry of medical modeling specialists has arisen so that physicians can more easily source patient-specific implants. They can get everything from data acquisition to 3-D modeling to implant creation and delivery from a single source.

 

Tech-Savvy Physicians and Technicians. Tech-savvy users are comfortable with digital technologies and, in fact, often see such technologies as superior ways to create better-fitting replacement body parts. For them, these tools can translate to reduced surgical time when the patient is open and exposed to infection.

 

Sculptural CAD Software. Traditional 3-D CAD modeling packages were created for designing cars and aircraft, for which geometric shapes could be readily extruded mathematically. However, with complex, organic shapes—like the bones of the human body—the time and effort required to create such models skyrockets. So-called sculptural CAD programs, such as the FreeForm modeling system from SensAble Technologies (Woburn, MA), have become more popular among the medical modeling sector because the underlying voxel technology of sculptural CAD more quickly and easily handles the intricate organic shapes of patient-specific implants.

 

The Rapid Manufacturing Revolution. Improvements in scanners, 3-D printers, rapid prototyping, and additive manufacturing techniques have led to more design and manufacturing options. Titanium remains the metal of choice for implants, and most custom implants are produced using traditional milling processes. However, newer biocompatible materials are appearing more frequently, and rapid manufacturing techniques such as electron-beam melting (EBM) show particular promise.

 

EBM uses a high-power electron beam to melt successive layers of pre-alloyed metal powder, forming solid, metallic parts in an additive fashion. EBM enables moving a file directly from a CAD environment into a fully dense titanium or cobalt-chromium part.

 

The process can reduce the need to use other near-net-shape fabrication processes such as machining, forging, and casting as well as their associated long lead times. Research has validated EBM-produced Ti6Al4V components for use compatible with the demanding specifications of the orthopedic industry. It is particularly well-suited for the following:

 

  • On-demand manufacturing in small to medium size quantities.
  • Customization of a design to a specific patient’s anatomy.
  • Complex, free-form shapes like net structures and complex porous geometries (for its ease of manufacturing).

 

Four examples show the range of design challenges and manufacturing options typically faced today.

 

Mid-Shaft Tibia Implant

 

Figure 1. Biomet’s designer used the FreeForm sculptural CAD system to determine the exact size and shape required for the replacement tibia implant and to position it precisely into the digital model of the patient’s remaining bone structure to ensure the perfect fit and length. (Photo courtesy of BIOMET INC.)
Biomet Inc., a manufacturer of products for joint replacement of the hip, knee, shoulder, elbow, and other small joints, has a Patient-Matched Implants (PMI) business unit with 30 professionals who develop more than 1000 customized highly durable joint replacement components annually.

 

In early 2009, Biomet’s PMI team designed a replacement for a mid-shaft tibia implant to replace a failed allograft component, a donor bone segment. The tibia is the larger of the two bones in the human leg beneath the knee. The previous allograft tibia implant had been attached to the patient’s intact bone by a trauma nail; however, an infection in that area caused the allograft construct to fail.

 

Due to the need to remove additional intact bone in support of another implant, the patient had only 3 cm of remaining intact tibia proximally (the end closer to the knee joint) and 5 cm distally (the end closest to the ankle)—a very small amount of intact bone into which to anchor an implant with screws.

 

Biomet’s challenge was to digitally define the precise dimensions of the replacement tibia implant and to design a platform for the base and the side of the tibia onto which the implant would rest next to the intact bone (see Figure 1). This was not an easy task when viewing a 2-D image of the complex 3-D shape and form of a bone.

 

After importing digital imaging and communications in medicine (DICOM) files from the patient’s CT scans, and using software to convert them into STL files, Biomet’s designer used the sculptural CAD system to determine the exact size and shape required for the replacement implant. Since the patient’s bone was already cut, Biomet’s team was able to gain a cross-sectional view of its geometry.

 

The sculptural CAD software also allowed the user to establish a plane at the level at which the designer wanted to acquire a cross-section. The software allows use of various software commands to extract curves where the plane intersects the evolving implant, allowing the designer to see within and behind the implant to verify its shape and design.

 

By manipulating complex, organic 3-D shapes, Biomet’s team was able to create a perfect-fitting tibia implant construct from design to manufacture in just four weeks, reducing the typical six- to eight-week process of moving from design concept to use by at least 50%. Because the sculptural CAD system retained all images as STL files, the file was made into an Adobe Acrobat 3-D file and e-mailed to the physician.

 

Custom Glenoid Socket in Shoulder

 

Figure 2. Using a sculptural CAD system, Biomet modeled this patient-specific shoulder implant and determined precise size, trajectory, and positioning of attachment site screw holes, as shown by the rods in the image. (Photo courtesy of BIOMET INC.)
Biomet’s patient-matched implant team also recently created an implant for a patient’s glenoid, the dish-shaped portion of the shoulder blade (scapula) where the long bone of the upper arm (humerus) meets the shoulder. The patient’s glenoid was worn away, and there was insufficient bone left from previous operations to utilize a standard off-the-shelf component.

 

Using the sculptural CAD system, Biomet’s designer imported the patient’s CT scan, positioned the model of the glenoid, custom-shaped a portion of clay to fill the space between the glenoid component and the bone, then subtracted the difference in the computer to obtain an image of the patient-matched implant that is required for a perfect fit. Because sculptural CAD systems are based on voxels (think 3-D pixels) and not on geometric constructs, such subtraction can take place in seconds compared with hours that a computer needs to calculate unusual curves and angles.

 

Sculptural CAD software also enabled Biomet designers to determine attachment sites for screws, bones, and other fixative devices used for implants much faster than by using traditional methods. The implant must be able to be securely attached to healthy bone. Sculptural CAD allowed Biomet to define the size and trajectory of screws in minutes, indicating to surgeons exactly where a screw enters the intact bone, the depth and the angle of entry, and possible locations for other screws or fixatives (see Figure 2 on p. 27). Typical CAD environments often require spending hours trying to define the position of screws. But in sculptural CAD, the designer can rotate, translate, and position the screw in limitless positions. The designer simply e-mails an Acrobat 3-D file to the physician for review and approval.

 

Calf Muscle Implant

 

Figure 3. Before and after views of calf muscle implants. Left: off-the-shelf implant shown over the bone; right: patient-specific implant.
Custom body parts aren’t restricted to replacement bones; they can also include implants that achieve the same subtle shape of musculature. For example, a 30-something female dancer was born with an underdeveloped calf muscle, and an off-the-shelf silicone implant was causing her great pain and exacerbating the atrophy of the existing muscles.

 

MedCAD, a Dallas-based medical modeling service bureau, and AART, a full-service implant provider in Reno, NV, designed a custom reconstructive calf implant that was approximately 25% smaller than the failed off-the-shelf calf implant and curved to perfectly match the patient’s other leg (see Figure 3 on p. 28). The implant did not operate mechanically like a muscle, but added appropriate volume and conformed perfectly to the patient’s existing leg shape. It provided greater stability and visual symmetry. After surgery, for the first time in her life, the patient danced on matching legs, and without pain.

 

Pectoral Muscle and Matched Breast Implant

 

Figure 4. A custom pectoral muscle implant provides better support to an off-the-shelf breast implant for a woman with Poland’s syndrome. (Photo courtesy MEDCAD INC.)
Custom reconstructive muscle implants can also better replace off-the-shelf implants that are used to correct disfigurement that results from asymmetry. For example, Poland’s syndrome is a condition in which underdeveloped chest and chest muscles leave female patients with the appearance of having at best only one breast, and at worst, a sunken depression next to the normal breast. A physician recently treated a 50-something physically fit woman with Poland’s syndrome who had previously received off-the-shelf breast implants with unsatisfactory results.

 

Using sculptural CAD to achieve the perfect fit, MedCAD created a replacement pectoral muscle plate and a matched breast reconstruction. The firm designed a custom pectus excavatum (breast muscle) implant to first address the chest wall deformity, mirroring the intact breast on the other side and added mass that filled in the missing muscle tissue areas. The surgeon attached the implant to her intact muscle wall and used it as a solid foundation for addressing the missing, undeveloped pectoral musculature (see Figure 4 on p. 28). Using sculptural CAD technology, MedCAD also estimated and specified the best-fitting, off-the-shelf breast implant to match the opposing side.

 

Conclusion

 

The world of medicine has advanced dramatically since New York City’s Public Health Officer Hermann M. Biggs, MD, famously uttered, “The human body is the only machine for which there are no spare parts.” Now, off-the-shelf replacement body parts are commonplace. Patient-specific implants offer surgeons a superior option, not just for treating special cases, but also for replacing the replacements. These advances have begun to change the landscape for custom implant manufacturing.

 

 
Reference
1. “Freedonia Focus on Orthopedic Implants,” Freedonia Group, July 2008, as cited by MX: Issues Update, July 2008; available from Internet: devicelink.com/mx/issuesupdate/08/07/Ortho.html.

 

David Chen, PhD, is chief technology officer of SensAble Technologies Inc. (Woburn, MA).

 

 

David Chen SensAble Technologies Inc.
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PRECISION NEWS


For manufacturers of orthopedics products, QinetiQ North America Operations LLC (QNA; McLean, VA) is offering an outsourcing strategy that aids companies from concept to final product launch. In the orthopedics field, QNA has helped develop conformable grinding machines for complex parts, robotic devices, bone distraction devices, and implantable electronic packaging. It has also developed advanced lower limb prosthesis and smart upper extremity prosthesis products. With core competencies in several areas, the company can assist manufacturers with electronics, materials and software development, electromechanical systems, thermal engineering, automation, optical systems, and finite element analysis. It also has technical knowledge in integrated flex circuits for fabric platforms and microsctructures for liquid crystal polymer substrates. QNA has more than 50 years of experience and has more than 800 engineers and scientists that work on creating and developing new products.


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BLOG TEASERS

Patients suffering from multiple fractures upon arrival to the ER should only undergo a few hours of surgery if they’re in unstable condition. Limiting time in the operating room for patients with life-threatening injuries would help reduce the amount of blood loss during surgery and could lead to fewer complications. According to an article published in the Journal of the American Academy of Orthopedic Surgeons, this method helps to improve patient survival rates.


The doctors involved in the study examined outcomes data from trauma patient registries in Germany. They advise surgeons to use an external fixator to stabilize orthopedic injuries. Once the patient has stabilized (two or three days following initial surgery), this could be a more appropriate time to proceed with more invasive surgery.


Conducting fracture-repair surgery over several days allows the patient to recover from each procedure before moving ahead. This is critical because a patient is more fragile after blood loss due to a potentially weakened immune system.


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PRECISION NEWS



The Cryogenic Institute of New England Inc. (Worcester, MA) has added removal of machine burrs from PEEK medical devices to its line of capabilities. The Cryogenic Institute is an organization dedicated to the commercial application of cryogenic technologies for industry, government, and scientists. Results of trials undergone by medical device manufacturers have revealed that the Nitrofreeze process is highly effective at removing complex residual machine burrs from complex and medical parts. The method works by freezing the part to maintain essential tolerances, including surface finish and critical dimensions. Once frozen, the parts are tumbled while cryogenic-grade polycarbonate media are blasted at them to remove machine burrs. The company is offering the deburring service to device manufacturers on a contract service basis. It is also providing equipment to manufacturers for in-house parts processing.


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Med-Tech Precision's contributing authors are well-respected authorities in their fields. And they are essential to the success of our publication. Meet this month's expert contributors.

 

Contributors

 

 

Plantenberg
Hedtke
Tom Plantenberg and Michael Hedtke wrote “Advances in Fully Automated Swiss Machining Cells.” Plantenberg is in charge of market development and sales at Marshall Manufacturing Co. (Minneapolis). He has been with Marshall for more than 16 years and has been instrumental in taking the company from general to medical machining and manufacturing. He can be reached at tomp@marshallmfg.com.

 

Michael Hedtke started as an intern at Marshall Manufacturing Co. more than 15 years ago while pursuing a bachelor’s degree from the University of Minnesota in mechanical engineering. He currently serves as a project coordinator for the company. Hedtke was previously cochairman of M-Powered, a consortium of community members, industry leaders, and training partners that collaborate to build a competitive workforce in the Minnesota manufacturing industry. He can be reached at mikeh@marshallmfg.com.

Joe DeAngelo is author of “Using Green Technology to Machine Materials.” He is director of technical development for Oberg Industries (Freeport, PA). He is responsible for R&D for applied manufacturing processes using the Molecular Decomposition Process and electrochemical grinding. He studied mechanical engineering at the University of Pittsburgh. Reach him at joe.deangelo@oberg.com.

David Chen is the author of the article “Orthopedics Design: Replacing the Replacements.” He is chief technology officer of SensAble Technologies Inc. (Woburn, MA). He has led the development of software for transforming medical data into formats for visualization, surgical simulation, and biometric qualification. Contact him via e-mail at info@sensable.com.

 

 

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The molecular decomposition process helps manufacturers machine materials more efficiently.

A close-up view of a fixture holding nitinol tubing illustrates the accurate features generated by an MDP patent-pending, threading process. This unique grinding technology often eliminates the need for subsequent operations. (Photos courtesy of TESCAN USA/OBERG INDUSTRIES)
Generating a feature in standard alloys can be challenging. Design criteria mandate smaller products, more-defined features, and thinner material sections. In some cases, feature size is smaller than the residual burrs created when attempting to complete them using most conventional manufacturing methods. Add to the equation a demand for a fine feature required in a superalloy or memory material, and the challenges grow exponentially.

Properties such as improved strength-to-weight ratios enable materials to have increased wear resistance but remain light for biomedical implantation. However, such alloys are difficult to conventionally machine or grind. Through friction, the manufacturing process produces unacceptable heat or mechanical stress. Exotic shape-memory alloys hold much promise for a growing number of medical applications but also present significant manufacturing challenges for many of the same reasons.

 Molecular Decomposition Process 

Magnified 6000 times, smears, tears, and folds are visible in titanium carbide when conventionally ground.
An MDP sample shows no smears, tears, or folds.
Finishing with a wire EDM machine reveals bumps and a sintered appearance.
The molecular decomposition process (MDP) negates these obstacles and enables the production of relatively simple geometric configurations for both medical implants and instruments. More importantly, MDP produces no thermals or mechanical stresses to the material being manufactured. The results are superior surface finishes and repeatable dimensional results that yield a burr-free component without influencing the elemental profile of the materials. The benefits of MDP enable a manufacturer to make a product with fewer steps.

 Research and development to applied MDP projects has been proven to eliminate the need for a secondary deburring or polishing operation. This preserves the integrity of the feature by not violating the specified geometry. For material removal with the applied MDP technology, finer grit sizes for the abrasive can be used to roughen and finish a product. A finer grit enables crisp geometry as related to the abrasive size of a proprietary-formulated grinding wheel.

 MDP was developed for removing or cutting material using an electrochemical action with an abrasive assist. The process uses an abrasive wheel combined with a steady supply of electrolyte solution and electric current. As current flows through the electrolyte between the positively charged workpiece and the negatively charged abrasive wheel, the material oxidizes at the point of contact, causing a decomposing action known as anodic dissolution. As the process repeats, the oxidized surface is then wiped away by the grinding wheel.

 Throughout its history, anodic dissolution machining has been used extensively to machine electrically conductive materials such as titanium, stainless steel, and other high-performance alloys, but repeatability was heavily dependent on operator expertise. Typically, the operator set all key parameters, including electrical current and feed rate, adjusting them as the cut progressed. Adjustments were usually based on visual inspection of the interface area, because the color and amount of sparking would indicate the reaction of the material to the removal rate and depth of cut.

MDP adds new levels of control that allow for greater dimensional accuracy, surface finish, and repeatability. Stringent sphericity and surface finish specifications with tolerances in the submicron level have been consistently achieved. The power supply is closely controlled with proprietary algorithms that maintain consistent power to the system, eliminating power spikes or brownouts. The lower levels of power required to operate the system make it more energy efficient. New developments in electrolytic solution further optimize current flow. Research in grinding wheel composition has helped to develop formulations that maximize conductivity for the material being shaped. Such formulations enable the removal of stock with only 10% of the abrasiveness created in conventional grinding, resulting in extended wheel life. Because the process produces no thermals, mechanical stresses, or burrs, MDP increases material choices for medical product designers while satisfying demands for precision and efficiency.

Medical Applications

MDP is an appropriate method for making profiles as sharp as possible without burrs. Traditionally, sharps—needles, trocars, and biopsy products—have required a series of manufacturing steps such as grinding, deburring, and polishing. MDP can produce well-defined edges in a single pass with no need for subsequent processing.

 Nitinol. Shape-memory alloys, such as nitinol (nickel titanium), are highly biocompatible and have numerous promising applications in implants and other medical products. Nitinol is used for devices that demand extraordinary flexibility and torque ability. This material can absorb large amounts of strain energy and release it as the applied strain is removed. The elasticity of nitinol is approximately 10 times that of steel. Add to this the material’s torque ability and kink resistance and these distinctive characteristics make nitinol an appropriate choice for medical guidewires.

 Other examples of superelastic devices include vascular, esophageal, and biliary stents; medical guide pins; surgical localization hooks; flexible, steerable, and hingeless laparoscopic surgical instruments; remote suturing and stapling devices; and bone suture anchors.

 

Sidebar:
The History of MDP
 
Because heat is a factor in causing the alloy to exhibit its memory characteristics and return to its original shape, conventional friction-based manufacturing processes such as milling, turning, grinding, and honing can cause adverse effects, effectively giving nitinol amnesia. Fine feature generation into an alloy that has extraordinary flexibility and torque ability would be equally difficult since the material would deflect (plastic deformation) during the attempted cutting or grinding process. Plastic deformation of memory alloys during conventional machining can assist in breaking tool inserts or causing work material to bulge at the deformed zone. These negative effects are a direct result of the desirable characteristics of shape-memory alloys such as nitinol. Should the material yield to being cut or ground, burr removal from these operations becomes a larger task than generating the required features.

MDP is suitable for grinding memory alloys because the process introduces no heat or mechanical stress to the work piece. One patent-pending process has yielded threaded nitinol wire (0.04 in. diam.) with a thread pitch of 101 threads per inch. MDP enables the threads to be produced in a single cut at full depth, producing burr-free threads without any tearing or smearing of the nitinol material. The gentle process allows for the production of these fine features measuring 0.0035 × 0.003 in. deep. Examining the elemental profile of the material surface illustrated no changes to the chemistry of the product.

 

A 0.04-in. nitinol wire is ground using MDP. A grinding wheel with applied MDP technology helps maintain geometry and a burr-free condition.
Titanium Carbide. Titanium carbide is another specially formulated alloy that presents unique manufacturing challenges. Titanium is light, strong, and easily machined, making it ideal for the medical industry. Carbide, introduced to extend implant life, requires grinding methods to control size and surface finish.

Conventional grinding, however, can introduce a smearing action at the work surface. This not only makes achieving the best possible surface finish difficult, but it also transfers titanium particulate to the diamond wheel face.

In conventional grinding tests on a titanium carbide component using a 600-grit diamond wheel, grooving and smearing of material occurred at the work surface due to the abrasives within the conventional grinding wheel. In comparison, MDP produced a uniform surface with a similar 600-grit wheel due to the MDP deplating and wiping process without any material deformation.

The ease of equipment operation, tied to the mathematical algorithms, adds to the repeatability and dependability of MDP technology. From the early stages of development to current details regarding inputs and outcomes, separate lab experiments are fully recorded in which process parameters are developed inclusive of the necessary perishables required for the production of such fine details.

Keeping It Green

An MDP threading process enables fine feature development into exotic and
conventional materials. A grinding wheel with proprietary MDP formulation is used to process fine features smaller than the burrs generated by conventional machining or grinding.
A major contributor to the stability of the entire closed-loop system is the electrolyte management system. It keeps the electrolyte consistent during production for months at a time. Readily available systems typically do not provide the benefits of months after production. In fact, the industry standard for electrolyte management enables a 40-hour production level and yields undesirable by-products such as heavy metals (hexavalent chrome). This drawback was a driving factor for the design review and collaborative efforts to generate a unique system that, unlike others in the marketplace, does not have heavy metals as a by-product. Through the design and implementation phase of this system, some of the main focal points included protecting the operator and environment by managing waste in an easily controlled system where the resultant waste material, produced during the stock removal process, could easily be removed and recycled.

 Additional focus includes the control of conductivity within the electrolyte, fluid levels, and delivery to the interface area of product and equipment. The electrolyte formulations that are used mainly consist of simple salts and deionized water. A complete MDP system uses this electrolyte management system interfaced with the system controller to maintain electrolyte levels, conductivity, and cleanliness. The design allows for ease of operation, as well as extended electrolyte life to six months of manufacturing (compared with the industry standard of 40 hours) without the generation of heavy metals. These advances make the process safer for the environment while enabling small, very accurate feature production during the anodic dissolution process.

Achieving Finer Features

Generating and maintaining fine features during stock removal is a common challenge for manufacturers in general. Unique formulations are required to enable the material to be removed while attempting to gain as much tool life as possible. These problems grow exponentially when applied to shape-memory alloys. The advantages that these alloys present become the negatives in material removal, especially in the areas of fine features, as illustrated in the thread grinding of nitinol. Applying MDP technology to this part production enables the product to be manufactured with many benefits associated to the mechanical and elemental conditions of the subjected material (in this case nitinol). Extending or maintaining fine features during stock removal is still a focus point, because as with any manufacturing system, the longer the tool life, the more products are produced with less review of the system in general. This extends capability by requiring fewer tool changes, or dresses of the tool, during the required production.

MDP production of threaded 0.04-in.
nitinol wire is produced with a single-pass grind and no secondary operations.
The ability to address tooling life by an applied system such as MDP has yielded some exciting results. For example, to be able to remove 0.005 in. of stock from full hard stainless steel in a single pass, with a 600-grit grinding wheel, is something that would never be considered due to the increased thermals and slow cutting rates to the applied workpiece. However, with the ability to choose abrasive types and formulate a wheel to work in tandem with the MDP technology, manufacturers are able achieve this type of unheard of capability, while maintaining size, surface finish, and burr condition.
 
To achieve these benefits, a company can employ direct interaction to best define customer needs and, using their exclusive, proprietary formulations and manufacturing process, develop the necessary perishables. This interaction is a vital element to using MDP technology to its greatest capacity. Being able to refine the perishables according to a customer’s exact requirements adds a new level of specificity and precision to manufacturing.
 
The custom wheel formulations generated by grinding wheels assist in the production of fine features and are the last ingredient to ensure the applied MDP process yields a consistent product. In addition, the detail of crisp geometry and burr-free condition, as produced by MDP technology with a new technology abrasive formulation, adds to the consistency of being able to produce a product without thermal or mechanical stresses while maintaining geometry and size.
 
Conclusion

New technologies such as MDP can help medical device manufacturers machine materials more effiiciently. They eliminate the impediments of many promising new alloys for medical applications, both in implants and instruments. As a result, the future of promising new alloys achieving new standards of strength and endurance is very possible because of the innovative manufacturing techniques that shape and form them into products that improve the quality of life.

Joe DeAngelo is director of technical development at Oberg Industries (Freeport, PA). 

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PRECISION NEWS


Tecvac Ltd. (Cambridge, England) and Portal Medical Ltd. (Denbighshire, England) have developed gas plasma technology that has applications in cardiology and orthopedics. The low-temperature technology can be used with ceramics, metals, polymers, and polymer fabrics. Portal Medical is using a unit developed with Tecvac to meet increased capacity demands for plasma processing services. Portal Medical is currently developing technologies for surface modification of medical materials. One such project reduces drug adherence to the surfaces of delivery devices. The technologies are intended to enhance the surface adhesion and biocompatibility of polymer surfaces and contribute to surface cleanliness. The plasma technology modifies polymer surfaces that are ready for assembly. It can also control cross links in the polymerization process to create specified permeability, wetting, and adhesion characteristics. The Tecvac unit uses pulsed radio-frequency gas excitation, which produces energetic plasma at low processing temperatures. Polymer surfaces can be cleaned and sterilized to meet surgical standards without the need for aggressive cleaning treatments.


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