m36 [Lifting Biomagnet]

BACKORDERED UNTIL FURTHER NOTICE
We are redesigning the manufacturing process due to various quality issues with our previous process. We have no ETA at this time. If you would like to be notified when the m36 becomes available, please sign up for an email alert.

  • Ideal object lifting magnet
  • 3mm x 6mm neodymium disc
  • Proprietary titanium nitride coating process
  • N52+ strength with highest Gauss rating!

$89.00

Out of stock

SKU: 851294007134 Category:

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WARNING This device is definitely a dangerous thing. This device has not been tested or certified by any regulatory agency for implantation or use inside the human body. Use of this device is strictly at your own risk.

The m36 lifting biomagnet is the big brother to the m31 sensing biomagnet. Together they are the world’s only biomagnets that have been designed from the ground up for direct and permanent in vivo use. Using a special process, we prepare the surface of our magnets for titanium nitride (TiN) coating and employ a modified PVD procedure to bond the TiN directly to the neodymium disc.

Why is the m36 better?
Simply put, the m36 exhibits exceptional strength without unnecessary bulk. Other magnets being implanted these days are basic off the shelf magnets with thick silicone, PTFE, or parylene coatings applied. Parylene is very brittle and will eventually form micro-fractures that will allow small pieces of parylene to float around in the body, and ultimately cause catastrophic implant failure. Silicone does not bond to the magnet’s surface at all, meaning shear and tensile strength are serious problems which must be overcome by using a large amount of encapsulation material, producing extra thickness which does not benefit the recipient in any way and increases the difficulty and trauma caused by the implantation procedure.

Additionally, the surface quality of these other coatings is very low. Silicone and parylene are pitted and full of fractures and tears that could provide anchor points for bacteria to adhere to, starting the process of biofilm production and ultimately biofouling which leads to rejection. Our TiN coating process leaves a smooth uniform surface, even at the microscopic level. It is the premium coating used in medical implants for decades.

The m36 is not sold sterilized
The m36 is not sold sterile. Commercial sterilization services and autoclaves alike will permanently damage the m36’s performance. We supply the m36 with a 0.67mL ampoule of ChloraPrep which contains 2% chlorhexidine gluconate (CHG) and 70% isopropyl alcohol (IPA). We are not suggesting that the m36 can be made clinically sterile by soaking it in this solution, but it is one possible option if you understand and accept the risks. Ultimately, the best course of action is to consult a professional partner or medical practitioner for proper “cold sterilization” techniques and services just prior to installation.
What is TiN (titanium nitride)?
Titanium nitride (TiN) coating is a biocompatible ceramic layer used on load bearing surfaces of certain medical implants to form a hard surface for articulation. TiN is the only surface coating with over ten years of clinical history, providing the ultimate low wear coating solution(1,2,3). An innovative surface coating technology, well-established within the orthopedic industry, TiN allows articulation whilst maintaining the strength and flexibility of metal implants(1,2,3,4).

As a ceramic surface, TiN coating exhibits hardness four times greater than cobalt chrome alloys (2400HV for TiN compared to 650HV for CoCr) and low surface roughness (Ra<0.05┬Ám). It has enhanced wettability characteristics and a low coefficient of friction, minimizing wear and making it ideal as a surface coating.

What about metal allergies?
TiN surface coatings have been shown to provide a solution to metal allergy, protecting implant recipients from adverse allergic reactions. The ceramic layer reduces release of metal ions into the patient’s body and minimizes bacterial proliferation(4,5). Especially for nickel sensitive patients, TiN provides a simple, effective and proven implant solution.

TiN References:

1. Saxler G, Temmen D, Bontemps G. Medium-term results of AMC unicompartmental knee arthroplasty. The Knee 2004; 11:39-355.
2. Wisbey A, Gregson PJ, Tuke M. Application of PVD TiN coating to Co-Cr-Mo based surgical implants. Biomaterials 1987; 8:477-480.
3. Coll BF, Jacquot P. Surface modification of medial implants and surgical devices using TiN layers. 15th International Conference on Metallurgical Coatings, San Diego, Ca, USA, 1988.
4. Scarano A, Piattelli M, Vrespa G, Caputi S, Piattelli A. Bacterial adhesion on titanium nitride coated and uncoated implants; an in vivo human study. J Oral Implantol 2003;29(2):80-5.
5. Streicher RM, Schon R, Semlitsch MF. Tribology and possibilities of optimising the wear properties of metal-on-polyethylene combinations for artificial joints. Biomedizinische Technik 1990; 4.
6. Pappas MJ, Makris G, Buechel FF. Titanium nitride ceramic film against polyethylene. A 48 million cycle wear test. Clin Orthop Aug 1995; 317:64-70.
7. DOT GmbH internal test report. Data on file Corin Group.