Traditional over-the-needle delivery systems, because of their design limitations, have documented low first attempt insertion success and high rates of complications. Most concerning is the emerging data surrounding the prevalence of peripheral intravenous catheter bloodstream infection (PIVBSI) attributed to the catheter’s early exposure to skin flora during insertion. The costs associated with these complications are high and ultimately very detrimental to a hospital’s bottom line and community profile.
The current design relies on the needle acting as a “rail” for the correct placement of the catheter. This often results in the damage or perforation of the intima, the innermost coat of a blood vessel. This damage can also lead to clot formation which may block the flow of fluid out of the catheter. When the catheter is advanced over the needle, it is led straight to, and sometimes through the vessel.
This needle advancement can cause an infiltration, or the infusion of fluids, into the surrounding tissue. If the fluid is chemically irritating it can cause tissue destruction, referred to as extravasation. Irritants can result in pain at the IV site and along the vein, may cause inflammation and can result in tissue sloughing, pain, loss of mobility in the extremity, and infection. The incidence rate for these complications has been reported to be between 22-27%, making it a very real problem clinically and financially for hospitals. A complication and loss of vascular access sites can also lead to the escalation of therapy to the midline or peripherally inserted central catheter (PICC) line. Midlines can cost $75 or more, while PICC lines can cost well over $100 which results in expensive and is non-reimbursed for the hospital.
The SkyDance goal is to reduce the risks associated with current PIVs and EDCs. To this point, the Company has identified the four most serious issues surrounding their use, and has established a feature set to address and reduce the complications from each.
While healthcare professionals disinfect the skin surface prior to each PIV or EDC insertion, the skin still remains a point of possible infection. Simply put, the skin surface cannot be fully sterilized in preparation for catheter insertion. Furthermore, 20% of the normal skin flora resides below the skin surface, in hair follicles and sweat glands. Therefore, all traditional PIV and EDCs are at inherent risk because they come in direct contact with residual skin flora during each insertion. Flora such as S. aureus adheres to the catheter surface, grows and aggregates into microcolonies, ultimately breaks off into the bloodstream and a catheter-related bloodborne infection is the result. In published studies, colonization of vascular access devices passing through the skin during insertion ranged from 17% - 57.6%.
These infections place the patient at significant risk including developing sepsis and at times, death. It is thought that mandatory CMS reporting will occur within 6-12 months and treatment of these hospital-acquired infections could be subject to non-reimbursement by the Centers for Medicare & Medicaid Services (CMS) at a non-reimbursed average of $30,000 per case. Recent studies indicate that over 36% of catheter blood infections are related to PIVs, with an estimated 200,000 PIV bloodborne infections per year in the U.S., amounting to nearly $6B annual cost.
SkyDance will address bloodstream infections with our Skin Avoidance Technology™.
Insertion Success Rate and Vessel Damage
Current catheter designs rely on the needle acting as a “rail” for the correct placement of the catheter, which often results in the damage or perforation of the innermost layer of the vessel known as phlebitis. This damage can also lead to clot formation which may block the flow of fluid out of the catheter. When the catheter is advanced over the needle, it is led straight to, and sometimes through the vessel.
This needle advancement can also cause an infiltration, or the infusion of fluids into the surrounding tissue. If the fluid is chemically irritating it can cause harm to surrounding tissue, referred to as an extravasation. Irritants often cause pain and inflammation at the IV site and along the vein path. This issue can ultimately result in tissue sloughing, loss of mobility in the extremity, and infection.
SkyDance will address these complications with our Bevel Only Technique™.
Inefficient Fluid Delivery
Because of the over-the-needle design, traditional PIVs are forced to deposit infusions directly from their distal tip and along the sensitive inner lining of the vessel. These infusions can damage this lining and chemically cause inflammation, loss of PIV function, and ultimately PIV failure. To mitigate these complications, infusions should be directed away from the inner lining of the vessel and into its center of the vessel where comparatively faster blood flow dilutes the infusions and protects the vessel. SkyDance will address these complications with our Contoured Directional Flow™.
Needlestick injuries are wounds caused by needles that accidentally puncture the clinician’s skin. These injuries are a hazard for people who work with catheters and can occur at any time when healthcare workers use, disassemble, or dispose of the catheter.
A needle stick can cause serious issues to a clinician emotionally and physically by transmitting infectious diseases, especially blood-borne viruses. Concern includes the Human Immunodeficiency Virus (HIV) which leads to AIDS (Acquired Immune Deficiency Syndrome), hepatitis B, and hepatitis C. Injuries have also transmitted many other diseases involving viruses, bacteria, fungi, and other microorganisms to health care workers. SkyDance will address these complications with our Passive Needle Retraction™.