Our journey began in October of 2000 when the Company was awarded a Federal Grant from the US Army Medical Material Command to solve the problem of Blood Reflux into I.V. Catheters of the “Warfighters” on the battlefield.
Nexus Medical first began studying the root causes of unintentional Blood Reflux with the Clinical Team from Wilford Hall Medical Center (now called Wilford Hall Ambulatory Surgical Center) and Brooks Army Hospital. These Clinicians were on the front lines of Operation Desert Storm and witnessed firsthand the effects of unintentional Blood Reflux.
From our very first work with the US Army and US Air Force, we discovered the unmet needs and dissatisfaction which existed with their current I.V. system. From the information we gathered from Wilford Hall Medical Center and Brooks Army Hospital we quickly learned this was not only a problem with the Warfighters on the Battlefield but every I.V. patient at all military hospitals.
The Evolution of Nexus TKO® Technology
Nexus Medical’s Engineering Team began work in our testing laboratory to simulate what we learned from the Clinical Team at Wilford Hall. Root cause analysis and human factors engineering principles were used to categorize the various ways in which blood can reflux into I.V. Catheters. The Nexus Engineering Team quickly learned Blood Reflux could be broken into two clearly distinct and definable root cause categories.
- Mechanical or externally induced Blood Reflux from container run dry, syringe plunger rebound, connection and disconnection of male luer syringe and IV administration sets.
- Physiological or internally induced Blood Reflux, from patient movement, muscle flexing, respiration, coughing, crying, vomiting, high thoracic pressure pressures changes.
The Need for Blood Reflux Protection 24/7™
From the very beginning the Nexus Medical Engineering Team was guided by a single vision and mission which was…
“IV Catheter Patency 24/7™”
Nexus Engineers learned very early unintentional and uncontrolled blood reflux not only occurred with connection or disconnection of IV Syringes and IV Administration Sets. The Engineers also discovered unintentional blood reflux occurred much more predominantly during the ever changing physiological and mechanical pressure variations in a closed IV systems. During lab testing, they discovered these pressure fluctuations can occur physiologically with the beat of the heart or mechanically with the fill cycles of electronic infusion pumps or inspiration and expiration forces of respirator ventilators.
With this discovery, Nexus Engineers designed a 3-Position Bi-Directional Flow Control Diaphragm which provided Blood Reflux Protection 24/7 to all patients which ultimately delivered upon our goal of IV Catheter Patency 24/7™ .
Nexus Medical Today
Nexus Medical today has over 25-published scientific and clinical studies, poster board presentation, white papers and laboratory testing to validate the efficacy of our proprietary TKO Pressure Activated Anti-Reflux technology. Nexus Medical designs, develops and manufactures a complete line of best-in-class Adult to Neonatal Infusion Sets here in Lenexa, Kansas USA.
The Nexus TKO® 3-Position Silicone Diaphragm automatically provides Bi-Directional Flow Control which prevents all known causes of unintentional blood reflux into your patient’s catheter.
Nexus Medical history since 2001
Nexus Medical LLC began in 2000 when the Company was awarded a grant from the US Army Medical Material Command in Fort Detrick Maryland to solve the problems associated with unintentional “Blood Reflux” into I.V. catheters and the many unintended consequences it caused the Warfighters.
Nexus Medical’s engineers learned “Blood Reflux” was caused by a multiplicity of physiological (enteral) and mechanical (external) pressure fluctuations in the patients closed IV system.
STUDY AND DEVELOPMENT
Nexus Medical’s Engineers lab tested and studied the human factors associated with the internal and external pressures cause “Blood Reflux” into Peripheral IV Catheters, Midlines, PICC and CV Catheters.
FDA 510K CLEARANCE
Nexus Medical submitted the first FDA 510K for both a pre-slit septum needleless connector and a luer activated needleless connector with pressure activated anti-reflux diaphragm. We called the new Anti-Reflux Needleless Connector TKO (“To Keep Open”)
STUDY AND DEVELOPMENT
The first Clinical Trials for the Nexus TKO-1 was conducted at Wilford Hall Medical Center, San Antonio, Texas in their Bone Marrow Transplant Unit.
While using the Nexus TKO®-5 on PICC and CVC lines, Wesley Medical Center reduced occlusion and tPA/Alteplase consumption by 71% while at the same time eliminated Heparin maintenance flushing.
POWER INJECTION FDA 510K CLEARANCE
FDA 510K cleared the first Anti-Reflux Pressure-Rated Microbore and Standard Bore extension sets.
OCCLUSION AND COST STUDY RELEASED
Study that results in fewer occlusions and cost utilizing TKO compared to a neutral connector (published in the Journal of Infusion Nursing)
FDA 510K CLEARANCE NEXUS TKO®‐6
Nexus Medical and our TKO®-6 received FDA 510K clearance and launched the first luer activated TKO Anti-Reflux technology.
NICU PEDIATRICS SETS LAUNCH
Nexus Medical and our TKO received FDA 510K clearance and launched a complete line of Neonatal and Pediatrics Infusion Extension Sets, Blood Gas Sampling Sets and Bi, Tri, and Quad-furcated Extension Sets and Manifold Sets
NEXUS FDA 510K CLEARANCE FOR NEXUS TKO®‐6P
Nexus TKO®-6P received FDA 510K clearance and launched the pressure rated version of the luer activated TKO Anti-Reflux technology.
Nexus introduces the TKO-6PHV (High Visibility) Needleless Connector and Extension Sets for Home Infusion Therapy Patients.