Hydrophilic biomaterial intravenous hydrogel catheter for complication reduction in PICC and midline catheters

Figures & data

Table 1. Comparison of common catheter material properties and their performance.

Catheter Material	Advantages	Disadvantages
Polyurethane [6]	Durable; suitable for prolonged dwell times Flexible, yet kink-resistant Provides stable, consistent flow of fluids and medications	Hydrophobic surfaces promote inflammatory responses within the blood vessel High susceptibility to protein adsorption Requires modifications (e.g. surface coating and/or composite material changes) to improve resistance to cellular adhesion and biofilm formation [8,9]
HBM	Highly biocompatible [10] Hydrophilic, highly lubricious surface [10–12,21] reduces friction on the catheter surface [13–15] Discourages cellular adherence and biofilm formation [4,11,15,24] Requires 9X less force when inserting the catheter, compared to polyurethane catheters [12] Long-lasting surface functionality (> 5 months) [11] Enhances patient comfort [50,51]	Limited data from large-scale clinical trials

Figure 1. Hydrophilic biomaterial evidence. Used with permission of Access Vascular, Inc.

Figure 2. Representative images from in vitro blood loop model studies demonstrating differences in bacterial adhesion on HBM vs. polyurethane catheters. Presented at vascular access conference in 2023. Used with permission from Access Vascular, Inc.

Figure 3. Hydrophilic hydrogel lubricious material surface. Used with permission of Access Vascular, Inc.

Figure 4. Hydrophilic biomaterial used in the HydroPICC and HydroMID. Used with permission of Access Vascular, Inc.

Table 2. Comparison of available HBM catheters.

Device Name	Description	Indication
HydroPICC™	Peripherally inserted central catheter (PICC) with 4 French and 5 French, single and dual lumen catheters comprised of a radiopaque hydrophilic catheter material with a suture wing, Luer lock hubs, and extension tubes	Intravenous access with short or long-term peripheral and central venous access for: the administration of solutions, medications, parenteral nutrition, laboratory blood sampling power injection of contrast media (maximum power injection flow rate is 3.5 mL/sec) central venous pressure monitoring
HydroMID™	Radiopaque, hydrophilic midline catheter available with a suture wing and Luer lock hub in a single 4F outer diameter lumen, 20 cm in length	Short-term (< 30 days) intravenous access in any peripheral vein (commonly the basilic, brachial, or cephalic veins of the upper arm): for the infusion of solutions and medications considered isotonic and not irritating (pH between 5 and 9; osmolarity less than 600mOsm/L) for power injection (maximum power injection flow rate is 6mL/sec) as an alternative to short peripheral IVs and central PICCs (when no indication for central catheterization is present)

Continuous vesicant infusions or parenteral nutrition hyperosmolar solutions are not appropriate for Midline catheters.

Di Fiore A. Clinical and engineering considerations for the design of indwelling vascular access devices: materials and product development overview. JAVA. 2005;10(1):24–27. doi: 10.2309/java.10-1-2

 Google Scholar

Schults JA, Kleidon T, Petsky HL, et al. Peripherally inserted central catheter design and material for reducing catheter failure and complications. Cochrane Database Syst Rev. 2019 Jul;2019(7). Art. No.: CD013366. doi: 10.1002/14651858.CD013366

 Google Scholar

Slaughter E, Kynoch K, Brodribb M, et al. Evaluating the impact of central venous catheter materials and design on thrombosis: a systematic review and meta‐analysis. Worldviews Evid Based Nurs. 2020 Oct;17(5):376–384. doi: 10.1111/wvn.12472

 PubMed Web of Science ®Google Scholar

Aswathy SH, Narendrakumar U, Manjubala I. Commercial hydrogels for biomedical applications. Heliyon. 2020 Apr 1;6(4):e03719.

 PubMed Web of Science ®Google Scholar

Correa S, Grosskopf AK, Lopez Hernandez H, et al. Translational applications of hydrogels. Chem Rev. 2021 May 3;121(18):11385–11457. doi: 10.1021/acs.chemrev.0c01177

 PubMed Web of Science ®Google Scholar

Liem TK, Yanit KE, Moseley SE, et al. Peripherally inserted central catheter usage patterns and associated symptomatic upper extremity venous thrombosis. J Vasc Surg. 2012 Mar 1;55(3):761–767.

 PubMed Web of Science ®Google Scholar

Mannarino MM, Bassett M, Donahue DT, et al. Novel high-strength thromboresistant poly (vinyl alcohol)-based hydrogel for vascular access applications. J Biomater Sci Polym Ed. 2020 Mar 23;31(5):601–621. doi: 10.1080/09205063.2019.1706148

 PubMed Web of Science ®Google Scholar

Greenhalgh R, Dempsey-Hibbert NC, Whitehead KA. Antimicrobial strategies to reduce polymer biomaterial infections and their economic implications and considerations. Int Biodeterior Biodegrad. 2019;136:1–14. doi: 10.1016/j.ibiod.2018.10.005

 Web of Science ®Google Scholar

Mitra D, Kang ET, Neoh KG. Polymer-based coatings with integrated antifouling and bactericidal properties for targeted biomedical applications. ACS Appl Polym Mater. 2021 Apr 20;3(5):2233–2263.

 Web of Science ®Google Scholar

LeRoy KJ, Donahue DT. Trackability of a high-strength thromboresistant hydrogel catheter: an in vitro analysis comparing venous catheter forces in a simulated use pathway. J Mech Behav Biomed Mater. 2023 Mar 1;139:105670. doi: 10.1016/j.jmbbm.2023.105670

 PubMed Web of Science ®Google Scholar

Niemczyk A, El Fray M, Franklin SE. Friction behaviour of hydrophilic lubricious coatings for medical device applications. Tribol Int. 2015;89:54–61. doi: 10.1016/j.triboint.2015.02.003

 Web of Science ®Google Scholar

Yang SH, Lee YSJ, Lin FH, et al. Chitosan/Poly (vinyl alcohol) blending hydrogel coating improves the surface characteristics of segmented polyurethane urethral catheters. J Biomed Mater Res B Appl Biomater. 2007;83(2):304–313. doi: 10.1002/jbm.b.30796

 PubMedGoogle Scholar