This post will be a review of a 2017 paper in Bone Research , Calcium phosphate cements for bone engineering and their biological properties by Xu et al.

Calcium phosphate compounds are abundant in nature and in living systems and come in many forms.They are all bioactive, osteoconductive, and biodegradable and these properties are what make it a desirable material to be used in bone repair and regeneration applications.

Bioactivity refers to the ability of bone scaffolds to bind directly to the surrounding bone without the formation of fibrous tissue. Since bioactivity is such an important property of calcium phosphate cements (CPCs) , the paper discusses how they have been modified with the addition of bioactive glass.

Osteoconductivity is the property of a material to facilitate the growth of new bone on its surface. The paper discusses the importance of composition in osteconduction and uses an example of where a silicon CPC (Si-CPC) was developed and showed up to threefold osteoblast cell proliferation as compared to the no silicon. Not only does composition effect properties like osteoconduction, but it also plays a role in the solubility of the material which can be important for delivery and mixing.

Additionally, composition changes other properties such as degradation. Because of this, material properties are tunable, and a CPC scaffold should ideally degrade at the same rate that new bone forms. Varying physical factors such as crystal size is another way to tailor degradation.

An example how this material can be applied to sports medicine is in anterior cruciate ligament (ACL) reconstruction. This procedure is done to repair torn ACLs which occur in sports such as football,basketball and soccer due to rapid changes in directions and sudden stops. The surgery involves replacing the injured ligament with a soft tissue tendon graft. The long healing time of these grafts within the the bone tunnels from the procedure is a concern of surgeons. It has been shown however, that due to their resorbability and osteconductivity, CPCs can enhance graft healing within the bone tunnels. Figure 1 illustrates  a schematic for the graft and CPC coating. The image describes an experiment that the group designed in order to investigate how enhancing CPC osteoconductivity with the incorporation of strontium effected graft healing.

Figure 1. “Surgical design. The graft on the left limb was coated with strontium-enriched calcium phosphate cement (Sr-CPC). The graft on the right limb was coated with conventional calcium phosphate cement (CPC). The area of the cement coating on the tendon allograft surface is marked as gray, while the uncoated area of the allograft is marked as white.” (Kuang G.M. et al. The American Journal of Sports Medicine. 2014)

This post will review the development of a football helmet equipped to diagnose concussions in real time. The work is being done by Drs. Barclay Morrison and James Noble at Columbia University. Specific focus will be placed on the marketability of this project.

Diagnosis of a concussion first requires that symptoms are either noticed and reported by players themselves or others on sidelines. Because players are competitive and feel pressure to perform, they might chose to ignore or dismiss symptoms. As a result,  concussions can be difficult to diagnose when they occur and go unnoticed. Continuing to play after experiencing a concussion puts players at further risk of injury. The researchers at Columbia noticed this problem and posed a solution, a way of diagnosing concussions objectively and in real time by utilizing ECG technology imbedded into helmets.

The basic concept is that ECG electrodes and leads are outfitted into a helmet. The helmet sends a signal to a monitoring device that uses an algorithm that accounts for movement and is able to detect the unique signal produced by a concussion. This allows for clear and informed decision making.  Below, in figure 1 is a flow diagram depicting how the device would be used.

Figure 1. Diagram depicting how ECG technology and data would be used, collected, and analyzed. (NoMo Diagnostics)

Besides meeting the need of better diagnosing concussions, this product has potential to be profitable.  Therefore, it is interesting to examine its development and conception under the lens of patentability.

Helmet development is being funded by the Columbia-Coulter Translational Research Partnership which “provides funding and business support for translational projects that will improve patient care and address unmet healthcare needs”. This program is contributed to by Columbia Technology Ventures which  is analogous to the Office of Cooperative Research at Yale. Morrison and Noble cofounded a company called NoMo Diagnostics and its website reads, the “goal is to develop the first FDA approved, real-time, physiologically relevant concussion diagnostic to initiate early treatment thus avoiding life threatening and long term consequences associated with unrecognized brain trauma.” The source of funding for the project as well as the founding of this company indicate that  this product is marketable.

In order to be patentable an invention must be novel, useful, and non-obvious. The usefulness of a helmet that can diagnose concussions is already addressed above, which leaves the novelty and obviousness to discuss.

If the websites claim is true and this ends up being the first device of its kind, then it is unquestionably novel. The publications about this technology and product do not give many details and the reason for this could be that the company is trying to keep their idea novel in order to be able to patent it. If they were to give out more details, they might provide prior art which would make their patent claim void. An article published by Columbia however, explicitly states that the idea is not completely new  and that “researchers experimented with taping EEG electrodes to the scalps of college athletes” in the 1960’s.

In the case of this product I believe the novelty still remains because the team is taking an existing technology but using it in a new way. Additionally they are finding ways to improve that technology by miniaturizing it and developing new algorithms to analyze the data.

From a biomaterials perspective I’d be interested in knowing what the electrodes and leads are made out of because they would be in contact with human skin in order to pick up a signal. Therefore, their function would have to remain unaffected  by sweat.