Case Studies

Arterial Catheter Component

Objective

Develop a Polyurethane Spray Coating Solution to produce a component of an arterial catheter for coronary applications.

Result

The customer is a Fortune 500 company, and a major producer of coronary catheters. Their R&D group had developed a new catheter tip component that was formed via spray coating onto a mandrel. The critical issue for the customer was they were unsuccessful in developing a spray forming solution that was stable; the polymer would precipitate in a very short time yielding the process impractical.

Bay Materials developed a solvent system that maintains polyurethane in solution, and worked with the client to optimize the polymer properties for the application. We further completed a formal development including documentation that met the requirements of their stringent quality system.

Upon completion of the development, the customer needed a “small volume” source, so Bay Materials agreed to produce the spray-forming solution. This required a Quality System Audit that met the highest quality standards for invasive medical devices. “Bay Materials passed with pride.”


Nano-Tube Heat Transfer

Objective

Develop a compound with exceptional heat transfer properties that can wet and flow into a matrix of carbon nano-tubes that are grown off a substrate.

Result

The customer was a Silicon Valley Start Up addressing the issue of efficiently pulling thermal energy out of computer chips. Carbon nano-tubes have exceptional heat transfer properties, but to be effective in a heat transfer application, they must be wet by a heat transfer medium; and make good contact to the heat source and heat sink.

Bay Materials performed a materials screening to identify candidate materials that could be effective as a heat transfer medium that was also able wet and flow into a nano-tube matrix in a melt condition. Test methods were developed to screen candidate materials. Screening was completed and a few top candidates were selected for development. A matrix of formulations were produced and tried until a final candidate was selected.

The outcome of the project was a material formulation, a process for application, quality documentation, and related intellectual property were handed off to the customer.


Human Hydration Sensor

Objective

Develop a sensor that can measure a property of saliva (Saliva Osmolality) that is a bio-marker for the state of Human Hydration.

Result

The US Army recognized some leading physiology research that identified an association between saliva osmolality and human hydration. They initiated a Small Business Innovation Program to unlock practical approaches to measuring saliva osmolality in soldiers. Bay Materials conceptualized and proposed the use of a “sensing polymer” in combination with a MEMS Microcantilever, a base technology that was invented at Northern Arizona University by Tim Porter, PhD, and Michael Eastman, PhD. The development had two needs to prove the concept; we needed a polymer that would swell reversibly as a function of saliva osmolality, and a piezo-resistive microcantilever to measure volume changes of the polymer.

Hydrogel Polymers that are available commercially were screened and showed promise, but none could meet all the requirements. Dr. Stewart formulated a sensing polymer at the Bay Materials Facility that did meet all the requirements. In parallel, Jim Reed worked with Alisa Fitzgerald, Fitzgerald Associates, to develop a micro-cantilever MEMS die that met all the requirements of a sensor that would eventually reside in the oral cavity. After a few MEMS development cycles at Stanford Fab Lab, we eventually worked with a commercial MEMS Foundry to produce micro-cantilever MEMS die on 6” wafers (commercial scale). We did succeed at demonstrating “proof-of-concept” and went on to develop a hand held instrument.

Recognizing that a Medical Device Human Hydration Sensor did not fit the Bay Materials Business Model, Cantimer Incorporated was founded to commercialize the technology. (see “Cantimer.com”)


Orthodontic Aligner Material

Objective

Our client is a leading aligner therapy company with an idea for a revolutionary orthodontic aligner material that has superior stress retention, chemical resistance and optical clarity properties.

Result

Working closely with the client’s scientists and clinicians, we developed a comprehensive material needs and wants profile. After finalizing the material criteria, we identified multiple candidate polymeric materials and developed manufacturing processes to speed them into clinical tests. Along with the material selection, we designed an annealing process that further improved the performance of the materials without adding regulatory burden. Simultaneously, we developed rigorous laboratory test methods to predict product performance and lifetime.

Our polymer material was used as a custom fitted aligner to sequentially move teeth over a period of time. Today, the client is the worldwide leader in aligner therapy treatment with over 2 million patients treated.

Our documentation and quality system enables us to meet industrial needs, and allows us to deliver extruded and die cut product on a monthly basis with 100% on-time and 0% reject over the last two years.


Heat Sealable High-Barrier Foil

Objective

Develop a metal foil that could be heat sealed to cyclic olefin co-polymer (COC) polymers.

Result

Commercial materials were screened and found to be unsuitable for the client’s needs. A custom heat seal layer r was developed and coated onto a thin commercial metal foil. This modified foil was suitable for application in the automatic sealing equipment used by the client. Client was delivered production information for the film along with prototype quantities of working material.


Pop-Up Cooking Timers

Objective

Who doesn’t love a perfectly roasted turkey? Our client was an established company with a desire to improve on a reliable temperature indicating device. An organic material was desired to replace the existing metal based trigger component for pop-up roasting timers. A significant number of variables must be taken into account to deliver an indicator for a perfectly roasted product and a safe, convenient material that will rapidly melt at the target temperature is the solution to that need.

Result

Bay Materials has developed a range of Precision Melting Organic Compounds (PMOC) with exact melting temperatures from 70-90 C for this industry. Materials are compounded at Bay Materials and their precise temperature properties are verified with each batch through our in house analytical systems. The material is shipped to the U.S. manufacturer for incorporation in the final device.

Today the pop-up timer market has expanded from consumer turkeys and industrial cooking to a much broader range of roasted products such as pork shoulder and tri-tip. If you go to the market on any given day you’ll see some of these timers with our enabling material just waiting to pop in your oven.


Intellectual Property

Bay Materials, LLC Patents

8,263,017 Temperature-switching materials having improved strength and thermal properties
8,083,969 Thermally-responsive materials and devices comprising such materials
7,875,207 Thermally-responsive materials and devices comprising such materials
20090306327 Method of reducing stress relaxation in polymer articles and articles formed thereby
20090217864 Device with visual temperature indicator (APPLICATION SOLD)
20090108230 Thermally-responsive materials and devices comprising such materials
NA Unpublished Application Dental products
NA Unpublished Application Electrochemical devices

Client Patents

Bay Materials is an inventor of a multiple patents owned by client companies whom Bay Materials provides consulting services to. Bay retains some patent right in specific fields.

Other Patents of Principal

Bay Materials currently only files patents in selected areas. The principal of Bay Materials holds a number of additional patents that are assigned to other companies including the following:

5382909 Method for detecting and obtaining information about changes in variables
5101657 Sensors for detecting and locating fluid
5074988 Apparatus for monitoring an electrolyte
5049247 Method for detecting and locating an electrolyte
5045163 Electrochemical method for measuring chemical species employing ion exchange material
5019235 Method and articles employing ion exchange Material
5015958 Elongate sensors comprising conductive polymers, and methods and apparatus using such sensors
5007989 Method and articles employing ion exchange materials
4990231 Corrosion protection system
4957612 Electrodes for use in electrochemical processes
4926165 Devices for detecting and obtaining information about an event
4830855 Temperature-controlled active agent dispenser
4826685 Molluscicidal device
5665822 Thermoplastic elastomers
5387450 Temperature-activated adhesive assemblies
5254354 Food package comprised of polymer with thermally responsive permeability
5156911 Skin-activated temperature-sensitive adhesive assemblies
5129180 Temperature sensitive seed germination control
5120349 Microcapsule having temperature-dependent permeability profile
6225367 Polymeric modifying agents
6199318 Aqueous emulsions of crystalline polymers for coating seeds
5783302 Thermoplastic elastomers
5752926 Orthopedic casts
6540984 Aqueous Dispersions of Crystalline Polymers and Uses
6492462 Side Chain Crystalline Polymer as Rehology modifier
6376032 Gas-Permeable membrane
718295 Selection and treatment of seeds