About Nexus
Medical

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.

  1. Mechanical or externally induced Blood Reflux from container run dry, syringe plunger rebound, connection and disconnection of male luer syringe and IV administration sets.
  2. 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.


TIMELINE

Nexus Medical history since 2001

2000

THE BEGINNING

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.

2001

RESEARCH

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.

2002

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.

2003

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”)

2004

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.

2005

NEXUS TKO®‐5

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.

2009

POWER INJECTION FDA 510K CLEARANCE

FDA 510K cleared the first Anti-Reflux Pressure-Rated Microbore and Standard Bore extension sets.

2009

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)

2012

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.

2012

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

2014

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.

2016

NEXUS TKO-6PHV

Nexus introduces the TKO-6PHV (High Visibility) Needleless Connector and Extension Sets for Home Infusion Therapy Patients.

2018

REFLUX STUDY RELEASED

Study demonstrates that TKO has the least amount of reflux compared to 14 commercially available needleless connectors (published in the Journal of Vascular Access)

2018

OCCLUSION REDUCTION STUDY RELEASED

Study demonstrates a 69% reduction in occlusions using TKO compared to a neutral connector (published in the Journal of Association of Vascular Access)

2020

REFLUX AND BI-DIRECTIONAL FLOW STUDY RELEASED

Study demonstrates that TKO has the least of amount of reflux and bi-directional flow control compared to 13 commercially available needleless connectors (published in the Journal of the Association of Vascular Access)

2021

INFUSION THERAPY STANDARDS OF PRACTICE

Anti-Reflux needleless connectors designed with a bidirectional, pressure-sensitive diaphragm require no specific clamping sequence to prevent reflux.
2021 Infusion Therapy Standards of Practice (8th edition)

Get 24/7 IV Protection

Reduce the occurrences of occlusions and infiltrates and the high cost of tPA, Heparin and IV catheter replacements.

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