CVC from special urethane material

In the U.S., more than 5 mil­lion cen­tral venous catheters (CVCs) are insert­ed every year, which cor­re­sponds to 15 mil­lion days of treat­ment with CVCs. In Ger­many, this fig­ure is 4.8 mil­lion in inten­sive care units alone. The use of these catheters is asso­ci­at­ed with some risks for the patient: the pos­si­ble com­pli­ca­tions range from injured ves­sels and nerves to infec­tions to pneu­moth­o­rax­es, air embolisms and catheter sep­sis, which can be fatal. In addi­tion, these sec­ondary dis­eases dras­ti­cal­ly increase health care costs. For this rea­son, efforts have long been made in med­ical tech­nol­o­gy to use new man­u­fac­tur­ing meth­ods to real­ize catheter designs that allow min­i­miz­ing these dan­gers. For exam­ple, an inter­na­tion­al med­ical device com­pa­ny com­mis­sioned the expe­ri­enced med­ical tech­nol­o­gy man­u­fac­tur­er Flex­an to design catheters that facil­i­tate inser­tion and posi­tion­ing. To achieve this goal, the com­pa­ny chose a spe­cial ure­thane mate­r­i­al that enters the body rigid but then becomes soft­er. This poly­mer was sub­se­quent­ly used to over­mold thin-walled 5FR triple-lumen, 4FR dou­ble-lumen, and 3FR sin­gle-lumen small diam­e­ter PICCs. Flex­an also designed and man­u­fac­tured a 4FR catheter that has the same lumen as con­ven­tion­al 5FR catheters but a 14 per­cent small­er diam­e­ter. An overview of Flexan’s man­u­fac­tur­ing ser­vices and process­es avail­able for the man­u­fac­ture of catheters will be pre­sent­ed at this year’s Medica/Compamed.

Cen­tral venous catheters are catheters that are insert­ed into the upper or low­er vena cava – just before the right atri­um of the heart – via a large vein near the heart. The appli­ca­tion of a CVC is actu­al­ly a min­i­mal­ly inva­sive pro­ce­dure, but it is still pos­si­ble, among oth­er things, to per­form a malpunc­tion, per­fo­rate a vein or dam­age nerves in the vicin­i­ty. This can cause com­pli­ca­tions that endan­ger the patien­t’s health and con­se­quent­ly cause an increase in treat­ment costs. With new man­u­fac­tur­ing tech­nolo­gies for cen­tral venous catheters, stan­dard­iza­tion of inser­tion tech­niques, and the use of ultra­sound guid­ance, how­ev­er, com­pli­ca­tion rates in the U.S. have already been reduced from 11.8 to 4 – 7 per­cent in recent years.

Special material and newly designed catheter tip reduce risk of complications

In order to fur­ther min­i­mize these risks with its own prod­ucts, an inter­na­tion­al med­ical device com­pa­ny has com­mis­sioned Flexan’s experts to devel­op the crit­i­cal man­u­fac­tur­ing process­es for a CVC with an opti­mized design that will sig­nif­i­cant­ly facil­i­tate the inser­tion and cor­rect posi­tion­ing of its prod­ucts. In sup­port of the project, the U.S. con­tract man­u­fac­tur­er lever­aged over two decades of spe­cif­ic PICC catheter design and man­u­fac­tur­ing expe­ri­ence. For exam­ple, Flex­an used a polyurethane mate­r­i­al tech­nol­o­gy to ful­fill the customer’s require­ments: “We were able to mold with a ure­thane mate­r­i­al that is insert­ed into the body in a rigid state, but imme­di­ate­ly becomes soft­er there due to the body tem­per­a­ture,” says Eric King, V.P. and Gen­er­al Man­ag­er at Flex­an. “This plays an impor­tant role in reduc­ing com­pli­ca­tions in catheter positioning.”

 For this project, Flex­an was able to draw on a broad port­fo­lio of process­es, with which bio­med­ical com­po­nents made of poly­mer can be adapt­ed to the desired appli­ca­tion. For exam­ple, Flex­an is able to design and man­u­fac­ture thin-walled 4FR catheters that are 14 per­cent small­er in diam­e­ter than con­ven­tion­al 5FR catheters but still have the same lumen. The com­pa­ny has also been able to man­u­fac­ture a 4FR thin-walled catheter that has a kink resis­tance com­pa­ra­ble to that of a stan­dard 5FR catheter with the same lumen size. More­over, the com­pa­ny has exten­sive expe­ri­ence in shap­ing catheter tips. It employs the lat­est high fre­quen­cy tech­nol­o­gy to design the tips in a way that reduces com­pli­ca­tions dur­ing insertion.

 Market growth opens up high future potential for new design

“Thanks to our pre­vi­ous expe­ri­ence and a very good coop­er­a­tion with the client, we were able to achieve the spec­i­fied project goal togeth­er,” says King. “With­in a project time of six to nine months, we suc­ceed­ed in devel­op­ing an opti­mized micro-catheter design, which sig­nif­i­cant­ly improves the func­tion­al per­for­mance of periph­er­al­ly insert­ed cen­tral venous catheters.” In addi­tion, the Flex­an team designed an effi­cient process con­trol plan and inspec­tion meth­ods to ensure reli­able bind­ing between all vital catheter com­po­nents. “This suc­cess­ful project for the devel­op­ment of a thin-walled catheter has paved the way for using the changed design for future orders. The poten­tial is high as the glob­al mar­ket for vas­cu­lar access devices is expect­ed to grow at an aver­age annu­al rate of near­ly 6.5 per­cent by 2023,” con­cludes King.

Flex­an at the Medica/Compamed 2019: Hall 8b, Stand F20‑1