Patent
Device and method for vascular access
| العنوان: | Device and method for vascular access |
|---|---|
| Patent Number: | 7,762,977 |
| تاريخ النشر: | July 27, 2010 |
| Appl. No: | 11/216536 |
| Application Filed: | August 31, 2005 |
| مستخلص: | Vascular access systems for performing hemodialysis are disclosed. The vascular access system contemplates a catheter section adapted for insertion into a vein and a graft section adapted for attachment to an artery. The catheter section may have metal or polymer wall reinforcements that allow the use of thin-walled, small outer diameter conduits for the vascular access system. One or more of the adhered, embedded or bonded conduit reinforcement structures may be removable without significant damage to the conduit sections to facilitate attachment of the sections, or to a connector between the sections. Various self-sealing materials are provided for use in the vascular access system, as well as temporary access sites and flow control/sensor systems. |
| Inventors: | Porter, Christopher H. (Woodenville, WA, US); Ziebol, Robert J. (Blaine, MN, US); Herrig, Judson A. (Elko, MN, US); Lynch, Laurie E. (Eden Prairie, MN, US); Doan, Tuan (Burnsville, MN, US) |
| Assignees: | Hemosphere, Inc. (Eden Prairie, MN, US) |
| Claim: | 1. A method for treating a patient, comprising: providing a first and second conduit of a vascular access system; accessing a vein at a first access site; inserting the first conduit of the vascular access system into the vein; forming a subcutaneous pathway between the first access site and an intermediate access site; accessing an artery at a second access site; attaching the second conduit to an artery through the second access site; and positioning the first conduit and second conduit of the vascular access system in the subcutaneous pathway; accessing an end of the first conduit and an end of the second conduit through the intermediate access site; connecting the end of the first conduit and the end of the second conduit and reinserting the connected ends of the first conduit and the second conduit through the intermediate access site. |
| Claim: | 2. The method for treating a patient as in claim 1 , further comprising providing a connector and connecting the first conduit and second conduit of the vascular access system via the connector. |
| Claim: | 3. The method for treating a patient as in claim 1 , wherein positioning the first conduit and second conduit in the subcutaneous pathway comprises passing an end of the first conduit from the first access site to the intermediate access site and passing an end of the second conduit from the second access site to the intermediate access site. |
| Claim: | 4. The method for treating a patient as in claim 1 , wherein positioning the first conduit and second conduit in the subcutaneous pathway comprises passing an end of the first conduit from the intermediate access site to the first access site and passing an end of the second conduit from the intermediate access site to the second access site. |
| Claim: | 5. The method for treating a patient as in claim 1 , wherein positioning the first conduit and second conduit in the subcutaneous pathway comprises passing an end of the first conduit from the first access site to the intermediate access site and passing an end of the second conduit from the intermediate access site to the second access site. |
| Claim: | 6. The method for treating a patient as in claim 1 , wherein positioning the first conduit and second conduit in the subcutaneous pathway comprises passing an end of the first conduit from the intermediate access site to the first access site and passing an end of the second conduit from the second access site to the intermediate access site. |
| Claim: | 7. A method for treating a patient, comprising: providing a blood pathway having a first section and a second section, the blood pathway for conveying blood between a vein and an artery; accessing a vein at a first access site; inserting an end portion of the first section of the blood pathway into the vein; forming a subcutaneous pathway between the first access site and a second access site; attaching an end portion of the second section of the blood pathway at the second access site; and coupling the first section with the second section through an incision formed at a third access site disposed between the first and second access sites. |
| Claim: | 8. The method for treating a patient as in claim 7 , further comprising closing each of the access sites such that the blood pathway is entirely subcutaneous. |
| Claim: | 9. The method for treating a patient as in claim 7 , wherein coupling comprises positioning a connector between the first and second sections, wherein smooth transitions are provided at least at the junction between the first section and the connector and between the second section and the connector. |
| Claim: | 10. The method for treating a patient as in claim 9 , wherein a smooth transition is provided along a change in circumference within the connector between the first and second sections. |
| Claim: | 11. The method for treating a patient as in claim 7 , wherein coupling comprises positioning a connector between the first and second sections, wherein an internal lumen within the connector comprises a change in circumference within no more than one inflection point as seen in a longitudinal cross-section of the connector. |
| Claim: | 12. The method for treating a patient as in claim 7 , further comprising providing a connector and inserting at least one of the first and second ends of the connector into lumens extending from ends of the first and second sections. |
| Claim: | 13. The method for treating a patient as in claim 12 , further comprising causing a circumferential force to be applied through at least a portion of at least one of the first and second sections toward at least one of the first and second ends of the connector. |
| Claim: | 14. The method for treating a patient as in claim 12 , further comprising advancing ends of at least one of the first and second sections over circumferential protrusions disposed on an outside surface of at least one of the first and second ends of the connector. |
| Claim: | 15. The method for treating a patient as in claim 14 , wherein the protrusion comprises one or more barbs. |
| Claim: | 16. The method for treating a patient as in claim 15 , wherein the circumferential compressive force is applied by applying a crimp ring to the outside of at least one of the first and second sections. |
| Claim: | 17. The method for treating a patient as in claim 12 , further comprising causing a circumferential force to be applied through at least a portion of each of the first and second sections toward a corresponding one of the first and second ends of the connector. |
| Claim: | 18. The method for treating a patient as in claim 12 , wherein the connector is pre-attached to the second section of the blood pathway. |
| Claim: | 19. The method for treating a patient as in claim 7 , wherein the artery is a brachial artery. |
| Claim: | 20. The method for treating a patient as in claim 7 , wherein the vein is a jugular vein. |
| Claim: | 21. The method for treating a patient as in claim 20 , wherein the artery is a brachial artery. |
| Claim: | 22. The method for treating a patient as in claim 21 , wherein the third access site is adjacent to the delto-pectoral groove. |
| Claim: | 23. The method for treating a patient as in claim 7 , wherein the subcutaneous pathway is formed to minimize kinking of the blood pathway. |
| Claim: | 24. The method for treating a patient as in claim 23 , wherein the subcutaneous pathway is formed to exceed a minimum bend radius to minimize kinking. |
| Claim: | 25. The method for treating a patient as in claim 7 , wherein the blood pathway comprises a self-sealing area. |
| Claim: | 26. The method for treating a patient as in claim 25 , wherein the self-sealing area comprises a self-sealing material. |
| Claim: | 27. The method for treating a patient as in claim 25 , wherein the self-sealing area comprises a self-sealing layer. |
| Claim: | 28. The method for treating a patient as in claim 25 , wherein the self-sealing area comprises an area of residual compressive stress. |
| Claim: | 29. The method for treating a patient as in claim 25 , wherein the self-sealing area is elongate and flexible along its length to facilitate implantation. |
| Claim: | 30. The method for treating a patient as in claim 7 , wherein the blood pathway comprises a needle access site comprising a self-sealing material or structure and further comprising positioning the needle access site subcutaneously. |
| Current U.S. Class: | 604/616 |
| Patent References Cited: | 3363926 January 1968 Wilson 3490438 January 1970 Stupka et al. 3683926 August 1972 Suzuki 3814137 June 1974 Martinez 3818511 June 1974 Goldberg et al. 3826257 July 1974 Buselmeier 3882862 May 1975 Berend 3998222 December 1976 Shihata 4076023 February 1978 Martinez 4133312 January 1979 Burd 4184489 January 1980 Burd 4214586 July 1980 Mericle 4318401 March 1982 Zimmerman 4447237 May 1984 Frisch et al. 4496349 January 1985 Cosentino 4496350 January 1985 Cosentino 4503568 March 1985 Madras 4550447 November 1985 Seiler, Jr. 4619641 October 1986 Schanzer 4655771 April 1987 Wallsten 4734094 March 1988 Jacob et al. 4753236 June 1988 Healey 4771777 September 1988 Horzewski et al. 4772268 September 1988 Bates 4786345 November 1988 Wood 4790826 December 1988 Elftman 4822341 April 1989 Colone 4848343 July 1989 Wallsten et al. 4850999 July 1989 Planck 4856938 August 1989 Kuehn 4877661 October 1989 House et al. 4898669 February 1990 Tesio 4917067 April 1990 Yoshida 4917087 April 1990 Walsh et al. 4929236 May 1990 Sampson 4955899 September 1990 Della Corna et al. 5026513 June 1991 House et al. 5041098 August 1991 Loiterman et al. 5053023 October 1991 Martin 5061275 October 1991 Wallsten et al. 5064435 November 1991 Porter 5104402 April 1992 Melbin 5171227 December 1992 Twardowski et al. 5171305 December 1992 Schickling et al. 5192289 March 1993 Jessen 5192310 March 1993 Herweck et al. 5197976 March 1993 Herweck et al. 5330500 July 1994 Song 5399168 March 1995 Wadsworth, Jr. et al. 5454790 October 1995 Dubrul 5476451 December 1995 Ensminger et al. 5496294 March 1996 Hergenrother et al. 5509897 April 1996 Twardowski et al. 5558641 September 1996 Glantz et al. 5562617 October 1996 Finch, Jr. et al. 5562618 October 1996 Cai et al. 5591226 January 1997 Trerotola et al. 5607463 March 1997 Schwartz et al. 5637088 June 1997 Wenner et al. 5637102 June 1997 Tolkoff et al. 5647855 July 1997 Trooskin 5669881 September 1997 Dunshee 5674272 October 1997 Bush et al. 5676346 October 1997 Leinsing 5743894 April 1998 Swisher 5755773 May 1998 Evans et al. 5755775 May 1998 Trerotola et al. 5792104 August 1998 Speckman et al. 5797879 August 1998 DeCampli 5800512 September 1998 Lentz et al. 5800522 September 1998 Campbel et al. 5810870 September 1998 Myers et al. 5829487 November 1998 Thomas et al. 5830224 November 1998 Cohn et al. 5840240 November 1998 Stenoien et al. 5866217 February 1999 Stenoien et al. 5904967 May 1999 Ezaki et al. 5931829 August 1999 Burbank et al. 5931865 August 1999 Silverman et al. 5957974 September 1999 Thompson et al. 5997562 December 1999 Zadno-Azizi 6001125 December 1999 Golds et al. 6019788 February 2000 Butters et al. 6036724 March 2000 Lentz et al. 6102884 August 2000 Squitieri 6156016 December 2000 Maginot 6231085 May 2001 Olson 6255396 July 2001 Ding et al. 6261255 July 2001 Mullis et al. 6261257 July 2001 Uflacker et al. 6319279 November 2001 Shannon et al. 6338724 January 2002 Dossa 6398764 June 2002 Finch et al. 6402767 June 2002 Nash et al. 6428571 August 2002 Lentz et al. 6436132 August 2002 Patel et al. 6582409 June 2003 Squitieri 6585762 July 2003 Stanish 6689096 February 2004 Loubens et al. 6689157 February 2004 Madrid et al. 6692461 February 2004 Wantink 6699233 March 2004 Slanda et al. 6702748 March 2004 Nita et al. 6702781 March 2004 Reifart et al. 6719781 April 2004 Kim 6719783 April 2004 Lentz et al. 6730096 May 2004 Basta 6733459 May 2004 Atsumi 6740273 May 2004 Lee 6749574 June 2004 O'Keefe 6752826 June 2004 Holloway et al. 6758836 July 2004 Zawacki 6926735 August 2005 Henderson 6976952 December 2005 Maini et al. 7011645 March 2006 McGuckin, Jr. et al. 7025741 April 2006 Cull 7101356 September 2006 Miller 7211074 May 2007 Sansoucy 7244272 July 2007 Dubson et al. 7252649 August 2007 Sherry 7297158 November 2007 Jensen 7452374 November 2008 Hain et al. 2002/0049403 April 2002 Alanis 2002/0151761 October 2002 Viole et al. 2003/0139806 July 2003 Haverkost et al. 2004/0024442 February 2004 Sowinski et al. 2004/0073282 April 2004 Stanish 2004/0099395 May 2004 Wang et al. 2004/0147866 July 2004 Blatter et al. 2004/0193242 September 2004 Lentz et al. 2004/0215337 October 2004 Hain et al. 2005/0137614 June 2005 Porter et al. 2005/0203457 September 2005 Smego 2005/0215938 September 2005 Khan et al. 2006/0058867 March 2006 Thistle et al. 2006/0081260 April 2006 Eells et al. 2006/0118236 June 2006 House et al. 2007/0078412 April 2007 McGuckin, Jr. et al. 2007/0078416 April 2007 Eliasen 2007/0078438 April 2007 Okada 2007/0088336 April 2007 Dalton 2007/0123811 May 2007 Squitieri 2007/0135775 June 2007 Edoga et al. 2007/0161958 July 2007 Glenn 2007/0167901 July 2007 Herrig et al. 2007/0173868 July 2007 Bachinski et al. 2007/0191779 August 2007 Shubayev et al. 2007/0197856 August 2007 Gellman et al. 2007/0219510 September 2007 Zinn et al. 2007/0233018 October 2007 Bizup et al. 2007/0249986 October 2007 Smego 2007/0249987 October 2007 Gertner 2007/0265584 November 2007 Hickman et al. 2007/0293823 December 2007 Sherry 2007/0293829 December 2007 Conlon et al. 2008/0009781 January 2008 Anwar et al. 2008/0027534 January 2008 Edwin et al. 2008/0167595 July 2008 Porter et al. 2008/0306580 December 2008 Jenson et al. 2009/0227932 September 2009 Herrig et al. 44 18 910 December 1995 295 15 546 March 1997 57-14358 January 1982 62 -112567 May 1987 05-212107 August 1993 06-105798 April 1994 09-84871 March 1997 WO 84/03036 August 1984 WO 96/24399 August 1996 WO 00/76577 December 2000 WO 01/05463 January 2001 WO 2004/112880 December 2004 |
| Other References: | U.S. Appl. No. 10/219,998, filed Aug. 15, 2002, Squitieri, Prosecution Events: Office Actions: May 9, 2003; Apr. 27, 2004; Oct. 19, 2004; Apr. 9, 2007; Oct. 7, 2008 Amendments: Nov. 10, 2003; Aug. 30, 2004; Jan. 31, 2005; May 23, 2005; Sep. 10, 2007; Nov. 3, 2008; Jun. 16, 2009. cited by other International Search Report and Written Opinion for PCT Application No. PCT/US05/310124 dated Mar. 12, 2007. cited by other International Search Report for PCT Application No. PCT/US98/01939 dated May 5, 1998. cited by other International Search Report and Written Opinion for PCT Application No. PCT/US2006/044564 dated Jun. 20, 2007. cited by other Search Report for EP Application No. 05006233.0 dated Jun. 8, 2005. cited by other International Search Report and Written Opinion for PCT Application No. PCT/US2009/035923 dated Jun. 3, 2009. cited by other Office Action in Japanese Patent Application No. 2007-530325 mailed Dec. 8, 2009. cited by other Interview Summary dated Mar. 11, 2009 for Co-Pending U.S. Appl. No. 11/417,658 in 4 pages. cited by other Co-Pending U.S. Appl. No. 10/219,998 and its prosecution history, Apr. 2009. cited by other PCT Notification of Transmittal of the International Search Report and the Written Opinion of the International Searching Authority. cited by other Coulson, Alan S., M.D., et al., Modification of Venous End of Dialysis Grafts: An Attempt to Reduce Neointimal Hyperplasia, Dialysis & Transplantation, vol. 29, No. 1, Jan. 2000, pp. 10-18. cited by other Coulson, A.S., M.D., et al., A Combination of the Elephant Trunk Anastomosis Technique and Vascular Clips for Dialysis Grafts, Surgical Rounds, Nov. 1999, pp. 596-608. cited by other L.C. Koo Seen Lin et al., “Contemporary Vascular Access Surgery for Chronic Haemodialysis”, The Royal College of Surgeons of Edinburgh, J.R. Coll. Surg. Edinb., 41, Jun. 1996, 164-169. cited by other Seshadri Raju, M.D., PTFE Grafts for Hemodialysis Access, “Techniques for Insertion and Management of Complications”, Ann. Surg. vol. 206, No. 5, Nov. 1987, pp. 666-673. cited by other Anatole Besarab et al., “Measuring the Adequacy of Hemodialysis Access”, Current Opinion in Nephrology and Hypertension, Rapid Science Publishers ISSN 1062-4821, 1996, 5:527-531. cited by other Methem J.A. Sharafuddin, MD et al., Dialysis Access Intervention, “Percutaneous Balloon-assisted Aspiration Thrombectomy of Clotted Hemodialysis Access Grafts”, Journal of Vascular and Interventional Radiology, vol. 7, No. 2, Mar.-Apr. 1996, pp. 177-183. cited by other David A. Kumpe et al., “Angioplasty/Thrombolytic Treatment of Failing and Failed Hemodialysis Access Sites: Comparison with Surgical Treatment”, Progress in Cardiovascular Diseases, vol. XXXIV, No. 4 (Jan./Feb.), 1992: pp. 263-278. cited by other Robert Y. Kanterman, MD et al., Intervention Radiology, “Dialysis Access Grafts: Anatomic Location of Venous Stenosis and Results of Angioplasty”, Radiology Apr. 1995, vol. 195, No. 1, 195:135-139. cited by other Clinical Review of MTI, Onyx® Liquid Embolization System, available at http://www.fda.gov/ohrms/dockets/ac/03/ briefing/3975b1-02-clinical-review.pdf , accessed Aug. 29, 2005. cited by other |
| Primary Examiner: | Deak, Leslie R |
| Attorney, Agent or Firm: | Knobbe Martens Olson & Bear LLP |
| رقم الانضمام: | edspgr.07762977 |
| قاعدة البيانات: | USPTO Patent Grants |
| الوصف غير متاح. |