Spinning New Possibilities from Bioabsorbable Polymers

The polymers behind bioabsorbable medical devices have been around since the late 1960s, with innovation arguably stifled by fear of numerous FDA hurdles should new materials be employed. 

That doesn't mean that there isn't innovation with what is out there.

Electrospinning has been explored to produce fabrics of even finer diameter, and there's the possibility of combining the absorbable materials with drugs, says Dennis Jamiolkowski, distinguished research fellow at Johnson & Johnson's Ethicon business.

Jamiolkowski's recent achievements include work on the Ethicon Securestrap 5mm Absorbable Strap Fixation Device, used for mesh fixation in endoscopic procedures.

He recently answered some MPMN questions via email about how the absorbable polymers field is changing:

MPMN: What are the latest advances with absorbable polymers?

Jamiolkowski: Implantable medical devices based on synthetic absorbable polyesters have been around since the late 1960s. The first products were multifilament sutures based on glycolide and then on copolymers of glycolide and lactide. Material innovations resulted in absorbable polyesters possessing low glass transition, further allowing the production of soft monofilament sutures and injection molded deformable devices such as ligating clips. Material innovations still occur, but there is great economic and regulatory advantage in attempting to use existing materials in new ways.

MPMN: What might be possible now because of them?

Jamiolkowski: Fiber extrusion was the primary processing technology employed in fabrication, this was followed by injection molding. More recently melt blowing to produce nonwoven fabric of very fine fiber diameter is gaining some attention. Electrospinning has been explored to produce fabrics of even finer diameter. 

MPMN: Is there anything cropping up in the bioresorbable area that is worrying to you? Anything that keeps you up at night as a researcher?

Jamiolkowski: The world of synthetic absorbable polymers is very complex. They degrade by reaction with water, even the water present in air! Their mechanical properties depend on polymer morphology-- the shape of the chains--which is established by the processing techniques employed. The loss of these mechanical properties with time post-implantation--after the device is placed in the body--depends not only on the basic chemistry of the material towards reaction with water, hydrolysis, by on polymer morphology as well. Residual monomer will affect biological performance as well.

To release new market successful products based on synthetic absorbable polymers requires not only a great knowledge of the marketplace and a great device design. It requires a knowledge of chemistry, processing, and biology and how these areas all interact with one another. It also requires as well a deep knowledge of regulatory requirements, sterilization, packaging, and a sound quality program. Having a great design for a product is only a start. What I expect to do in my presentation is show some of these interconnections giving the audience a better appreciation of this complex world. 

MPMN: Is there anything else that is especially interesting?

Jamiolkowski: The possibility of combination devices-- combining the mechanical properties of synthetic absorbable polymers with drugs and other entities that provide functionality that would not be possible alone.

Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker.