Frequently Asked Questions

How are catheter related infections contracted?

The Centers for Disease Control and Prevention has confirmed that the primary site of entry for microorganisms into the bloodstream related to the use of long term indwelling catheters is the site of the cutaneous incision into which the catheter is inserted. The bacteria that enter the body causing infection are usually present on the surface of the skin and are 'dragged' in on the outer surface of the catheter either upon insertion of the device or upon repeated movement of the device over time. MedicInvent's design seeks to reduce the entry of bacteria as a result of repeated disturbance of the device during use.

Is it possible for bacteria to migrate through the internal lumen (channel) of the device?

Although it is possible that bacteria might enter on the internal surface of the device it is highly unlikely as long sterile procedures are followed. Devices are sterile upon unpackaging and are inserted directly into the body cavity which is also considered to be a sterile environment. Therefore, unless caused by accidental contamination due to improper aseptic technique, under normal circumstances it is not likely that bacteria would migrate down the internal lumen. It is common belief that bacteria migrating through the wound site do so on the exterior surface of the device which is typically unsterile.

How long must a device be in place for texturing to be effective?

Although it can be argued that MedicInvent's design can be effective in short term use applications due to increases in adhesion related to stiction from texturing, the design is primarily targeted for use in long term indwelling devices. In these applications the benefits of texturing are more readily observed. Further, it is in cases requiring long term indwelling devices where the vast majority of catheter related infections occur.

How long does it take for tissue ingrowth to occur?

Approximately 18 hours for microplast (pyogranulamataous) tissue to grow. This is the tissue which adheres to the catheter device. MedicInvent believes that its design stimulates and increases the amount of tissue ingrowth and allows for greater stiction of that ingrowth by creating a larger and more topographically complex surface area.

Does a smooth catheter have any advantages over a textured catheter?

Historically it has been assumed that a smooth catheter surface at the point of insertion reduces the area in which bacteria may hide. However, there is no compelling evidence that a smooth surface mitigates bacteria presence or that it reduces the amount of bacteria which are 'dragged in'. MedicInvent believes that the benefits of a textured surface at the point of insertion, particularly over extended indwelling time, far outweigh any benefits perceived to be associated with a smooth surface.

How hard is it to remove a textured long term indwelling device?

MedicInvent believes that the more successful the implementation of its design the more difficult the removal of the device. However, this is a 'good problem'. Catheters smooth at the point of insertion make for easier removal but with a trade off for increased catheter related infections. Over indwelling time texturing increases the callous made up of endothelial tissue and this helps to prevent bacteria migration. The textured catheter can be removed without a surgical procedure when clinical use is complete. On removal there are approximately 5 - 7 layers of redundant endothelial tissue. This endothelial tissue is non-vascular and its removal has no negative, immediate or long term, effect.

What range of devices does the MedicInvent design apply to?

PICC lines, central lines, introducers, trocar, heart pumps, intracranial shunts, and dialysis, nepherostomy, and pancreatic applications, specialized pediatric applications, and veterinary applications including interosseous are just some of the range of devices which could benefit from the MedicInvent design. There are likely many more, including new devices as they are introduced into the market.

What FDA clearances are required to market devices incorporating the MedicInvent design?

Generally the texturing process would be applied as a modification to already approved FDA class II devices. Therefore, MedicInvent believes that FDA approval of devices modified to incorporate the design should be fast tracked depending upon the claims being made by a given manufacturer as to efficacy.

How is the design implemented in manufacturing?

Although MedicInvent believes that individual manufacturers will implement their own solutions utilizing the design, the primarily method would be a secondary process applied after extrusion of the device. Secondary processes, such as microblasting of PVC tubing, are already in use in the medical device market including of catheters and related devices. MedicInvent believes that introducing a secondary process into the production line for relevant devices will be both inexpensive and non-disruptive to current manufacturing processes.

How does the process of implementing the design affect the integrity of the device?

MedicInvent has tested sodium bicarbonate microblasting of catheters resulting in 20 - 120 microns of surface material loss. The result has demonstrated to be significant enough to generate results for its intended purpose (texturing to increase static friction) without materially weakening the integrity of the device. In order into increase the depth of texturing without increasing the diameter of the device manufactures could implement the use of sturdier materials.