Catheter Connections is the only company to hold patents for protecting and disinfecting “male luer” connectors, which are used to connect IV tubing lines to IV catheters, a proven vector of microbes that can cause bloodstream infections.  The patent covers the Company’s new DualCap IV Pole Strips™.  These new products are strips of disinfectant caps for IV connectors that hang from the IV pole, in the patient room and at the point of care, which provide quick and convenient access for the caregiver.  The Company is the sole provider of disinfectant caps individually packaged in pouches which keep the caps sterile and IV Pole Strips of caps for convenient bedside access.  “Today, success of a medical device is not only based on its proprietary technology but also its accessibility at the point of patient care and convenience of use.  With the launch of our IV Pole Strips, Catheter Connections is now the only company with patented technology to protect male luers and needleless luer access valves.  The Company now has the broadest product offering that allows each customer to select the product mix that best fits its individual needs. This is a significant advancement which positions the Company to lead the market with new, superior and patented products,” said Vicki Farrar, CEO.

About Catheter Connections
Headquartered in Salt Lake City, Utah, Catheter Connections^®, Inc., develops and commercializes innovative vascular access products designed to protect patients from acquiring infections during intravenous infusion therapy.  Its DualCap System™ is a family of user-friendly products that provides healthcare facilities with a cost-effective, integrated solution for IV disinfection and protection, helping in the fight against IV catheter-related blood stream infections.  Designed by nurses for nurses, flagship product DualCap^® safely disinfects both IV tubing end connectors and IV catheter access valves — a major breakthrough for infection control.  For more information, visit www.catheterconnections.com.

The Company has the only granted U.S. patents for protecting and disinfecting “male luer” connectors, which are the connectors used to connect IV tubing lines to IV catheters.  In its mission to save patient lives, Catheter Connections conceived, developed, manufactures and markets the DualCap System™, which includes DualCap^®─ the first 510(k) cleared medical device that disinfects male luer connectors, killing the microorganisms known to cause bloodstream infections and protecting the connectors from contamination.

The Company has pending lawsuits against Ivera Medical Corporation (“Ivera”) in the U.S. District Court of Utah, Central Division, where it accuses Ivera of infringing some of its patents, unfair competition, deceptive practices and false advertising related to the marketing of Ivera’s male luer disinfectant cap.

Ivera has a history of filing suits against its competitors ─ Excelsior Medical Corporation, Hospira, Inc., and Catheter Connections ─ and has patent infringement suits pending against each in the U.S. District Court for the Southern District of California.  While the California Court recently denied a request to stay these suits without prejudice to filing the request again, the stay has no impact upon the pending inter partes reexaminations in which the United States Patent and Trademark Office (“USPTO”) has rejected each of Ivera’s patent claims for which reexamination was requested.  The Court has not examined the merits of Ivera’s suits and by denying the stay it did not make any comment about whether the USPTO will invalidate the contested patent claims.

The USPTO sometimes makes mistakes and issues a patent that should not have been granted in the first place.  Because these mistakes happen an “inter partes reexamination” procedure was created, which allows a third party to challenge the validity of an issued patent.  Reexamination of Ivera’s patents was granted by the USPTO on the basis that there was a reasonable likelihood the challenger would prevail with respect to at least one claim challenged in the request for reexamination.  Subsequently, the USPTO has issued office actions rejecting all of the contested claims.

“We are confident that the USPTO will not reverse itself on the rejection of Ivera claims, as statistics published by the USPTO show that once it has granted an inter partes reexamination and rejected claims, 89% of the time the patent ends up with rejected or changed claims.  Moreover, in the response Ivera filed with the USPTO, it did not amend any of the rejected claims.  Thus we expect the rejections will be confirmed,” said Vicki Farrar, Esq., CEO of Catheter Connections.  “Hospitals are rapidly gaining an understanding of the importance of increasing patient safety by protecting the male luer from contamination.  Being the only company that has issued patents protecting devices which disinfect male luer connectors, we are in a strong position to provide hospitals with the complete solution they are seeking to help reduce IV catheter related bloodstream infections.  We are vigorously defending our intellectual property and will not stand by and let others exploit our efforts of bringing this life-saving technology to the public.”

About Catheter Connections

Headquartered in Salt Lake City, Utah, Catheter Connections^®, Inc., develops and commercializes innovative vascular access products designed to protect patients from acquiring infections during intravenous infusion therapy.  Its DualCap System™ is a family of user-friendly products that provides healthcare facilities with a cost-effective, integrated solution for IV disinfection and protection, helping in the fight against IV catheter-related bloodstream infections.  Designed by nurses for nurses, flagship product DualCap^® safely disinfects both IV tubing end connectors and IV catheter access valves — a major breakthrough for infection control.  For more information, visit www.catheterconnections.com.

The Company was the first to recognize and demonstrate that the IV tubing male luer connector is a vector of microbial contamination and is a significant risk factor for hospital-acquired infections.  In its mission to save patient lives, Catheter Connections conceived, developed, manufactures and markets the DualCap System™, which includes DualCap^® ─ the first 510(k) cleared medical device that disinfects male luer connectors, killing the microorganisms known to cause bloodstream infections and protecting the connectors from contamination.

 The Company has a pending lawsuit against Ivera Medical Corporation (“Ivera”), in the U.S. District Court of Utah, Central Division, Case No. 2:12-cv-00531-DN.  Catheter Connections accuses Ivera of patent infringement, unfair competition, deceptive practices and false advertising related to Ivera’s Curos Tips™ – a “me-too” copy of Catheter Connections’ DualCap component that disinfects and protects the male luer.

“The issuance of yet another patent for our IV disinfection technology is an important milestone for the Company as we continue expanding our IP portfolio that broadly covers the disinfection of male luer connectors” said Vicki Farrar, Esq., CEO of Catheter Connections.  “Hospitals using the DualCap System are reporting significant improvements in patient safety by reducing IV catheter-related bloodstream infections.”

The DualCap System also includes a component for disinfection of IV luer access valves, which are the female connectors into which an IV tubing male luer fits.  In addition to Catheter Connections, there are three other manufacturers of disinfecting caps for use only on luer access valves: Ivera, Hospira, Inc., and Excelsior Medical Corporation.  Ivera has a history of filing suits against its competitors ─ the same Ivera patents at issue in each suit pending against its competitors are currently in inter partes reexaminations in which the USPTO has rejected each of Ivera’s patent claims for which reexamination was requested.  In granting the reexaminations, the USPTO concluded that there is a reasonable likelihood the Ivera patent claims are invalid, and has issued office actions rejecting all the contested claims.

About Catheter Connections
Headquartered in Salt Lake City, Utah, Catheter Connections^®, Inc., develops and commercializes innovative vascular access products designed to protect patients from acquiring infections during intravenous infusion therapy.  Its DualCap System™ is a family of user-friendly products that provides healthcare facilities with a cost-effective, integrated solution for IV disinfection and protection, helping in the fight against IV catheter-related blood stream infections.  Designed by nurses for nurses, flagship product DualCap^® safely disinfects both IV tubing end connectors and IV catheter access valves — a major breakthrough for infection control.  For more information, visit www.catheterconnections.com.

Under the agreement, Catheter Connections can receive up to $1M in up-front payments and additional revenue from product sales for providing Merit with rights to exclusively distribute Catheter Connection’s proprietary disinfection technology in the fields of interventional radiology and interventional cardiology.  The products provided under the agreement include Catheter Connections’ DualCap® technology for IV connector disinfection and protection.  Merit has exercised its option under the agreement to secure the exclusive right to distribute Catheter Connections’ proprietary male luer disinfection technology.

The distribution agreement follows the most recent patent issued by the United States Patent and Trademark Office, entitled “Disinfecting Caps For Medical Male Luer Connectors,” which broadly covers Catheter Connections’ male luer disinfection technology.  Only Catheter Connections has patent protection as well as FDA clearance to market a device to disinfect and protect male luer connectors attached to the end of IV tubing lines.

Vicki Farrar, Chief Executive Officer of Catheter Connections, said, “We look forward to the association with Merit.  Merit’s impressive track record of innovation and growth in addition to its global marketing resources will expedite the commercialization of our DualCap® technology and increase patient safety.  This agreement validates our superior position in the IV disinfection market in terms of both our intellectual property and our ability to help hospitals reduce bloodstream infections.”

ABOUT CATHETER CONNECTIONS

Headquartered in Salt Lake City, Utah, Catheter Connections^®, Inc., develops and commercializes innovative vascular access products designed to protect patients from acquiring infections during intravenous infusion therapy.  Its DualCap System™ is a family of user-friendly products that provides healthcare facilities with a cost-effective, integrated solution for IV disinfection and protection, helping in the fight against IV catheter-related blood stream infections.  Designed by infusion nurses, flagship product DualCap^® safely disinfects both IV tubing end connectors and IV catheter access valves — a major breakthrough for infection control.  For more information, visit www.catheterconnections.com.

Catheter Connections is a start-up company in Salt Lake City, Utah, co-founded by nurses seeking to reduce deadly hospital-acquired bloodstream infections.  In its mission to save patient lives, Catheter Connections conceived and developed the DualCap System™, which includes DualCap® ─ the only 510(k) cleared medical device that disinfects and protects the male luer connector at the end of the IV tubing (“male luer”).  On April 8, 2010, Catheter Connections received 510(k) premarket clearance for DualCap.  On May 8, 2012, United States Patent No. 8,172,825 (‘825 Patent), entitled “Methods For Disinfecting Medical Connectors,” was issued by the United States Patent and Trademark Office.  This patent covers key aspects of the DualCap technology, including a method of disinfecting IV male luers.  Catheter Connections manufactures, markets, and sells the DualCap System.

Case No. 2:12-cv-00531-PMW accuses Ivera of patent infringement and unlawfully promoting and preparing to sell a “me-too” copy of Catheter Connections’ DualCap component that disinfects and protects the male luer.  The suit claims that Ivera’s promotional activities are part of a scheme to mislead customers as to the clearance status of Ivera’s male luer cap and the truth about when the product will be available, in order to convince customers not to purchase DualCap.  The Complaint alleges Ivera’s male luer cap is not 510(k) cleared, which is required before the product can be legally sold in the United States.  Catheter Connections alleges in its Complaint that no disclaimers regarding the regulatory status of Ivera’s male luer cap are displayed at tradeshows where its product is exhibited.  Catheter Connections charges Ivera with:

• Patent Infringement
• False or Misleading Advertising under the Lanham Act
• Unfair Competition under Utah common law
• Violation of the Utah Truth In Advertising Act
• Violation of the Utah Unfair Practices Act.
• Violation of the Utah Unfair Competition Act

Catheter Connections’ civil action seeks temporary, preliminary and permanent injunctive relief prohibiting Ivera from infringing the ‘825 patent and from engaging in false or misleading promotion of its non-510(k) cleared male luer cap.  Compensatory, treble, and punitive damages are sought to compensate Catheter Connections for Ivera’s unlawful activities.

Case No. 2:12-cv-00530-BCW seeks a declaratory judgment that Catheter Connections does not infringe Ivera’s issued U.S. patents and that such patents are invalid.  The suit accuses Ivera of filing Ivera v. Catheter Connections, Case. No.3:12-cv-0954-H (WVG) (S.D.Ca.) under the patent laws for improper purposes, including interfering with Catheter Connections’ market penetration, market traction, financings, and business focus.

“These actions signal to the market that Catheter Connections will vigorously defend its intellectual property,” according to Vicki Farrar, Esq., CEO of Catheter Connections.  “We will not stand by and let Ivera mislead the market or unlawfully exploit the tireless efforts of the founders and the investment made in Catheter Connections by investors who believed in the nurses’ dream of saving patients from deadly infections.  The company worked very hard over many years to bring this technology to the public, and we simply feel the actions of Ivera are wrong and unlawful.  We look forward to presenting our cases and are very confident that the truth will come out and that Catheter Connections will prevail.”

A copy of the Complaints and the ‘825 Patent are available at: www.catheterconnections.com/savethenursesidea.

About Catheter Connections

Headquartered in Salt Lake City, Utah, Catheter Connections^®, Inc., develops and commercializes innovative vascular access products designed to protect patients from acquiring infections during intravenous infusion therapy.  Its DualCap System™ is a family of user-friendly products that provides healthcare facilities with a cost-effective, integrated solution for IV disinfection and protection, helping in the fight against IV catheter-related blood stream infections.  Designed by nurses for nurses, flagship product DualCap^® safely disinfects both IV tubing end connectors and IV catheter access valves — a major breakthrough for infection control.  For more information, visit www.catheterconnections.com.

Landmark clinical evidence shows that the IV tubing end connector (a “male luer” connector) is susceptible to microbial contamination and routinely causes cross-contamination between IV connectors. Studies also confirm that biofilm, which is responsible for the majority of blood stream infections, forms on these connectors and that a contaminated connector will transfer microbes into a patient’s IV catheter. The Company is now selling the DualCap System, a product family that includes DualCap^®, the only FDA-cleared device for disinfection and protection of both the IV catheter needleless luer access valve and the male luer connector.

In addition to DualCap, the system includes two devices: DualCap Duo™ and DualCap Solo™. DualCap Duo is a sterile, single-use device containing two disinfecting caps — both for use on frequently accessed luer access valves. It is the only device with two disinfectant caps for luer access valves conveniently located in one sterile package. DualCap Solo™ is a sterile, single disinfecting cap for use on luer access valves. The DualCap System combines efficacy and simplicity, arming clinicians with a complete set of easy-to-use and safe devices.

IV Catheter-Related Blood Stream Infections

Each year more than 500,000 patients in U.S. hospitals suffer from IV catheter-related blood stream infections and up to one in four patients die. Due to the preventability of these infections, insurers no longer reimburse hospitals for treating them, costing hospitals up to $11 billion annually; hospitals lose an average of $47,000 per infection.

This means that the traditional method of disinfecting IV access valves using an alcohol swab to scrub the valve surface, currently in place at the majority of U.S. hospitals, is insufficient. This method does not disinfect the male luer connector, and even if access valves are scrubbed the variability in scrubbing technique among clinicians leads to inconsistent valve disinfection. The DualCap System is the only integrated solution that addresses these deficiencies.

“We understand the profound sense of personal accountability that clinicians feel about delivering safe care to patients. Because current partial solutions fail, Catheter Connections designed the DualCap System to help healthcare professionals address safety gaps in IV delivery methods and prevent potentially deadly infections. We want to save lives,” said Vicki Farrar, Esq., CEO of Catheter Connections. “Many healthcare professionals are unaware that simply disinfecting the access valve of the patient’s IV catheter is not enough to protect the patient from contamination. The new DualCap System delivers the right devices at the right time for clinicians to make the right choice when managing patients’ IV lines.”

About Catheter Connections

Headquartered in Salt Lake City, Utah, Catheter Connections^®, Inc., develops and commercializes innovative vascular access products designed to protect patients from acquiring infections during intravenous infusion therapy. Its DualCap System™ is a family of user-friendly products that provides healthcare facilities with a cost-effective, integrated solution for IV disinfection and protection, helping in the fight against IV catheter-related blood stream infections. Designed by infusion nurses, flagship product DualCap^® safely disinfects both IV tubing end connectors and IV catheter access valves — a major breakthrough for infection control.  For more information, visit www.catheterconnections.com

Ivera provided no prior notice of its belief of infringement to the Company. It never requested a sample product from the Company, never sent a cease and desist letter nor any other communication regarding the alleged infringement to the Company.

Ivera has a history of filing suits against its competitors; at the present time, including this one against the Company, there are three pending while others have been dismissed or settled. These lawsuits can be viewed at www.pacer.gov (requires registration for a free account). The same patents at issue in its suit against the Company are at issue in suits against Hospira Inc. and Excelsior Medical Corporation. Both Hospira and Excelsior assert the patents are invalid and unenforceable and that Ivera has “unclean hands”. In connection with a US Patent and Trademark Office re-examination of Ivera patents, Ivera changed a claim in each patent at issue.

Ivera’s claims against the Company concern DualCap Solo™, one of three products in the DualCap System. It does not concern DualCap, the only FDA-cleared device for disinfection and protection of both the IV catheter needleless luer access valve and the male luer. “We absolutely deny Ivera’s claims and will prove that they are completely baseless,” said Vicki Farrar, Esq., CEO of the Company.

The Company was the first to recognize and prove that the IV tubing end connector (a male luer connector) is a vector of microbial contamination and is a significant risk factor for hospital-acquired infections. The traditional method of disinfecting IV access valves using an alcohol swab to scrub the valve surface, currently in place at the majority of U.S. hospitals, is insufficient. This method does not disinfect the male luer connector. Even if valves are scrubbed, the variability in scrubbing technique among clinicians leads to inconsistent valve disinfection. The Company is now selling the FDA-cleared and patent-pending DualCap System, which is the only integrated solution that addresses these deficiencies — a major breakthrough for infection control. For more information, visit www.catheterconnections.com.

Vicki Farrar started a company called Catheter Connections, based in Salt Lake City. She’s almost evangelical about building a better catheter – one that kills the microbes that cause infection – and it’s not hard to understand why. The infections are totally preventable and Medicare won’t pay for them.

“It’s directly impacting the hospital’s bottom line, so they don’t want this out-of-pocket cost. It’s about $50,000 per infection rate,” she says.

Read more here.

Landmark clinical evidence shows that the IV tubing end connector (a male “luer lock” connector) is susceptible to microbial contamination and routinely causes cross-contamination between IV connectors. Studies also confirm that biofilm, which is responsible for the majority of blood stream infections, forms on these connectors and that a contaminated connector will transfer microbes into a patient’s IV catheter. The Company is now selling DualCap^®, the only FDA-cleared device for disinfection and protection of both the IV catheter needleless luer access valve and the IV tubing end connector.

Catheter Connections was the first to recognize and demonstrate that the IV tubing end connector is a vector of microbial contamination and I s a significant risk factor for hospital-acquired infections. “This patent issuance is particularly valuable because it confirms that we were the first to innovate a medical device solution unlike any other. It further protects the platform technology underlying the Company’s DualCap System™ and is an indicator of the dominant position we expect to achieve worldwide,” said Vicki Farrar, Esq., CEO of Catheter Connections.

IV Catheter-Related Blood Stream Infections

Each year more than 500,000 patients in U.S. hospitals suffer from IV catheter-related blood stream infections and up to one in four patients die as a result. Due to the preventability of these infections, insurers no longer reimburse hospitals for treating them, costing hospitals up to $11 billion annually; hospitals lose an average of $47,000 per infection.

The traditional method of disinfecting IV access valves using an alcohol swab to scrub the valve surface, currently in place at the majority of U.S. hospitals, is insufficient. This method does not disinfect the IV tubing end connector. Even if valves are scrubbed, the variability in scrubbing technique among clinicians leads to inconsistent valve disinfection. The DualCap System is the only integrated solution that addresses these deficiencies.

About Catheter Connections

Headquartered in Salt Lake City, Utah, Catheter Connections^®, Inc., develops and commercializes innovative vascular access products designed to help protect patients from acquiring infections during intravenous infusion therapy. Its DualCap System™ is a family of user-friendly products that provides healthcare facilities with a cost-effective, integrated solution for IV disinfection and protection, helping in the fight against IV catheter-related blood stream infections. Designed by infusion nurses, flagship product DualCap^® safely disinfects both IV tubing end connectors and IV catheter access valves — a major breakthrough for infection control. For more information, visit www.catheterconnections.com.

Figure 1. The luer access valve is also commonly referred to as a needleless injection site, connector or port. During an infusion, the male luer at the end of the administration set is connected to the luer access valve.

A study conducted at Loyola University Medical Center in Chicago found that IV tubing male luer connectors showed higher levels of microbial colonization than the luer access valve. The study concludes that colonization of the male luer may have greater significance than the IV catheter luer access valve due to its potential to introduce microorganisms directly into the fluid pathway — despite access valve disinfection — and that scrubbing the surface of the access valve cannot disinfect the fluid pathway once contaminated by a male luer.

Current nursing practices to prevent migration of infection into the intraluminal pathway have focused on only one side of the catheter. Nursing practice has simply assumed that the administration set male luer is protected, thus overlooking the danger of contamination and disconnection.

Capping a male luer, even with a sterile cap that protects the tip, provides no disinfection action. Further, replacing the administration set tubing with a new set each time the tubing is disconnected is not clinically possible and could potentially lead to increased fluid pathway contamination opportunities.

While sterile dry “dead ender” caps are used, these do not address the required disinfection of the administration set male luer. Because the administration set male luer is open ended, it cannot be cleaned with an alcohol swab as that could introduce alcohol into the fluid pathway. A new approach that addresses ease of use issues of the complex clinical setting and offers protection and disinfection is necessary.

For a copy of the complete paper, contact Catheter Connections at 1.888.706.8883 or email info@cathconn.com.

About the Author
Denise Macklin, BSN, is a healthcare education consultant and author in the vascular access field. She is present Chairman of the Board of the Wise Foundation.