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(12) United States Patent (10) Patent No.: US 9.295,773 B2 Pr0s Et Al

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(12) United States Patent (10) Patent No.: US 9.295,773 B2 Pr0s Et Al US009295773B2 (12) United States Patent (10) Patent No.: US 9.295,773 B2 Pr0s et al. (45) Date of Patent: Mar. 29, 2016 (54) HEMODALYSIS ACCESS SYSTEM (56) References Cited (76) Inventors: Frank Prosl, Duxbury, MA (US); U.S. PATENT DOCUMENTS Hans-Dietrich Polaschegg, Koestenberg 3,731,681 A 5, 1973 BlackShear et al. (AT); Heidrun Polaschegg, legal 4,014,328 A 3, 1977 Cluff et al. representative, Koestenberg (AU) 4,190,040 A 2f1980 Schulte 4,258,711 A 3, 1981 Tucker et al. (*) Notice: Subject to any disclaimer, the term of this 4,337,251 A 6, 1982 Pfirrmann patent is extended or adjusted under 35 (Continued) U.S.C. 154(b) by 83 days. FOREIGN PATENT DOCUMENTS (21) Appl. No.: 13/884,115 EP 1442 753 A1 4/2004 (22) PCT Fled: Nov. 9, 2011 WO WOO1/32141 5, 2001 OTHER PUBLICATIONS (86) PCT NO.: PCT/US2O11AO60045 Masumoto et al., Usefulness of Exchanging a Tunneled Central S371 (c)(1), Venous Catheter Using a Subcutaneous Fibrous Sheath, Nutrition, (2), (4) Date: Sep. 26, 2013 2010, pp. 1-4. (87) PCT Pub. No.: WO2O12/064881 (Continued) PCT Pub. Date: May 18, 2012 Primary Examiner — Leslie Deak (65) Prior Publication Data (74) Attorney, Agent, or Firm — Pandiscio & Pandiscio US 2014/OO24998 A1 Jan. 23, 2014 (57) ABSTRACT A medical blood access system used for hemodialysis treat Related U.S. Application Data ment to enable blood withdrawal for processing of blood by an external apparatus and return the same blood to a patient, (60) Provisional application No. 61/411,537, filed on Nov. comprising an interfacial fluid conduit between the machine 9, 2010. and patient’s blood supply which is repeatedly connectable along a guided pathway passing through epidermis and Sub (51) Int. C. cutaneous tissue via a naturally formed tissue tract to enter A6M5/00 (2006.01) blood space, providing improved patient safely, convenience, A6M I/36 (2006.01) effective prophylaxis, without bleeding or tissue trauma or (52) U.S. C. pain, and is executable by the patient to precisely connect and CPC ........... A61M I/3653 (2013.01); A61M I/3655 disconnect with minimal disfigurement or life restrictions, (2013.01); A61M 1/3661 (2014.02) and is useable on virtually all patients soon after placement (58) Field of Classification Search and is robust and safe to high blood flow. CPC A61M 1/3653; A61M 1/3655; A61M 1/3661 See application file for complete search history. 21 Claims, 12 Drawing Sheets US 9,295,773 B2 Page 2 (56) References Cited Agarwal, Systemic Effects of Hemodialysis Access, Advances in Chronic Kidney Disease, 2015, vol. 22, No. 6, pp. 459-465. U.S. PATENT DOCUMENTS Asch et al., Effect of Financial Incentives to Physicians, Patients, or Both on Lipid Levels a Randomized Clinical Trial. The Journal of the 4400,169 A 8/1983 Stephen 4,417,888 A 11, 1983 Cosentino et al. 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Fontsere et al., Lock Tunneled Catheters with Taurolidine-Citrate 4,710,167 A 12/1987 LaZorthes Heparin Lock Solution Significantly Improves Inflammatory Profile 4,710, 174 A 12/1987 Moden et al. in Hemodialysis Patients, Antimicrobial Agents and Chemotherapy, 4,777,698 A 10, 1988 Lord 2014, vol. 58, No. 7, pp. 4180-4184, 4,781,680 A 11, 1988 Redmond et al. Hawley et al., Complications of Home Hemodialysis, Hemodialysis 4,781,695 A 11, 1988 Dalton 4,790,826 A 12/1988 Elftman International, 2008, vol. 12, pp. S21-S25. 4,832,054 A 5, 1989 Bark Iwashima et al., Effects of the Creation of Arteriovenous Fistula for 4,857,053 A 8, 1989 Dalton Hemodialysis on Cardiac Function and Natriuretic Peptide Levels in 4,978.338 A 12/1990 Melsky et al. CFR, American Journal of Kidney Diseases, 2002, vol. 40, No. 5, pp. 5,041,098 A 8, 1991 Loiterman et al. 974-982. 5,057,084 A 10/1991 Ensminger et al. Al-Jaishi et al., Patency Rates of the Arteriovenous Fistula for 5,092,849 A 3/1992 Sampson Hemodialysis: A Systematic Review and Meta-analysis, American 5, 180,365 A 1/1993 Ensminger et al. Journal of Kidney Disease, 2014, vol. 63, No. 3, pp. 464–478. 5,226,879 A 7, 1993 Ensminger et al. Allon, Prophylaxis Against Dialysis Catheter-Related Bacteremia 5,281,199 A 1/1994 Ensminger et al. with a Novel Antimicrobial Lock Solution, Clinical Infectious Dis 5,318,545 A 6, 1994 Tucker 5,336,194 A 8/1994 Polaschegg et al. eases, 2003, vol. 36, pp. 1539-1544. 5,350,360 A 9/1994 Ensminger et al. Amerling, Con: On Cardiovascular Outcomes and the Arteriovenous 5,356.381 A 10/1994 Ensminger et al. Fistula: Lesser of Evils, Nephrol. Dial. Transplant, 2012, vol. 27, pp. 5,417,656 A 5/1995 Ensminger et al. 3756-3757. 5,476,451 A 12/1995 Ensminger et al. Blake et al., The Risks of Vascular Access, Kidney International, 5,503,630 A 4, 1996 Ensminger et al. 2012, vol. 82, pp. 623-625. 5,520,643 A 5/1996 Ensminger et al. Classen et al., Specialty Society Clinical Practice Guidelines Time 5,527,277 A 6/1996 Ensminger et al. for Evolution or Revolution?, The Journal of the American Medical 5,527,278 A 6/1996 Ensminger et al. Association, 2015. 5,531,684 A 7, 1996 Ensminger et al. Foley et al., Early Mortality in Patients Starting Dialysis Appears to 5,704.915 A 1/1998 Melsky et al. Go Unregistered, Kidney International, 2014, vol. 86, pp. 392-398. 5,755,780 A 5/1998 Finch, Jr. et al. 5,911,706 A 6, 1999 Estabrook et al. Gomes et al., Re-envisioning Fistula First in a Patient-Centered Cul 5,954,691 A 9, 1999 ProSl ture, Clinical Journal of the American Society of Nephrology, 2013, 5,989,206 A 11/1999 Proslet al. vol. 8(10), pp. 1791-1797. 5,989,239 A 11/1999 Finch et al. Karkar et al., Benefits and Implementation of Home Hemodialysis: A 6,007,516 A 12/1999 Burbank et al. Narrative Review, Saudi Journal of Kidney Diseases and Transplan 6,013,058 A 1/2000 Proslet al. tation, 2015, vol. 26(6), pp. 1095-1 107. 6,120,492 A 9, 2000 Finch et al. Kraus et al. A comparison of center-based vs. homebased daily 6,166,007 A 12/2000 Sodemann hemodialysis for patients with end-stage renal disease, Hemodialysis 6,206,851 B1 3, 2001 ProSl International, 2007, vol. 11, pp. 468-477. 6,350,251 B1 2/2002 Prosl et al. Lehman, Richard, Richard Lehman's Journal Review, The BMJ, 6,352,521 B1 3, 2002 ProSl 2015, vol. 373. 6,436,084 B1 8, 2002 Finch et al. 6,436,089 B1 8/2002 Danielson et al. Ridao-Cano et al., Vascular Access for Dialysis in the Elderly, Blood 6,451,003 B1 9, 2002 Prosl et al. Purification, 2002, vol. 20, pp. 563-568. 7,131,962 B1 1 1/2006 Estabrook et al. Polaschegg, Hans-Dietrich, Catheter Locking Solution 2003. O144362 A1 7/2003 Utterberg et al. Spillage:Theory and Experimental Verification, Blood Purification, 2003/0175323 A1 9/2003 Utterberg et al. 2008, vol. 26, pp. 255-260. 2004/O156908 A1 8/2004 Polaschegg Polaschegg, Hans-Dietrich, Venous Needle Dislodgement: The Pit 2004/0199.126 A1 10/2004 Harding et al. falls of Venous Pressure Measurement and Possible Alternatives, A 2005/004224.0 A1 2/2005 Utterberg et al. Review, Journal of Renal Care, 2010, vol. 36(1), pp. 41-48. 2005/0209573 A1 9/2005 Brugger et al. Polaschegg, Hans-Dietrich, Dialysis Times, 2000, vol. 7, No. 2. 2006, OO24372 A1 2/2006 Utterberg et al. Ori et al., The Contribution of an Arteriovenous Access for 2008, OO27043 A1 1/2008 Herdeis et al. Hemodialysis to Left Ventricular Hypertrophy, American Journal of 2008/O177217 A1 7/2008 Polaschegg Kidney Diseases, 2002, vol. 40, No. 4, pp. 745-752. 2009.0036872 A1 2/2009 Fitzgerald et al. Movilliet al., Long-term Effects of Arteriovenous Fistula Closure on 2009/02099.18 A1 8/2009 Berglund Echocardiographic Functional and Structural Findings in 2010/0106102 A1 4/2010 Ziebol et al. Hemodialysis Patients: A Prospective Study, American Journal of Kidney Diseases, 2010, vol. 55, No. 4, pp. 682-689. OTHER PUBLICATIONS Moore et al., Comparative Effectiveness of Two Catheter Locking Solutions to Reduce Catheter-Related Bloodstream Infection in Yee, There's No Place Like Home, Advances in Chronic Kidney Hemodialysis Patients, Clinical Journal of The American Society of Disease, 2009, vol. 16, No. 3, pp. 156-157. Nephrology, 2014, vol. 9, pp. 1-8. Abdelwhabet al., Pulmonary Hypertension in Chronic Renal Failure Mermel, Leonard A., What is the evidence for intraluminal coloni Patients, American Journal of Nephrology, 2008, vol. 28, pp. 990 zation of hemodialysis catheters?. International Society of Nephrol 997.
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