U.S. patent number RE48,117 [Application Number 15/970,774] was granted by the patent office on 2020-07-28 for apparatuses and methods for negative pressure wound therapy.
This patent grant is currently assigned to Smith & Nephew, Inc.. The grantee listed for this patent is Smith & Nephew, Inc.. Invention is credited to Sean J. Albert, Ed Armstrong, Ken Beaudoin, Iain Michael Blackburn, Phil Bussone, Brendan Crawford, Robert Emmerson, Mike Ewaschuk, Stephen Gianelis, Andrew Goddard, Joseph Gordon, Mark Guarraia, Tim Johnson, Darwin Keith-Lucas, Andrew Linton, Dan Nelsen, Michael Salame, Tim Stern, Mark White.
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United States Patent |
RE48,117 |
Albert , et al. |
July 28, 2020 |
Apparatuses and methods for negative pressure wound therapy
Abstract
Disclosed herein are several embodiments of a negative pressure
appliance and methods of using the same in the treatment of wounds.
Some embodiments are directed to improved fluidic connectors or
suction adapters for connecting to a wound site, for example using
softer, kink-free conformable suction adapters.
Inventors: |
Albert; Sean J. (Barrington,
NH), Armstrong; Ed (Palm Harbor, FL), Beaudoin; Ken
(Wakefield, MA), Blackburn; Iain Michael (Cottingham,
GB), Bussone; Phil (S. Hamilton, MA), Crawford;
Brendan (Westborough, MA), Emmerson; Robert (Beverley,
GB), Ewaschuk; Mike (Vershire, VT), Gianelis;
Stephen (Abington, MA), Goddard; Andrew (Beverly,
MA), Gordon; Joseph (Mansfield, MA), Guarraia; Mark
(Cranston, RI), Johnson; Tim (Raymond, NH), Keith-Lucas;
Darwin (Arlington, MA), Linton; Andrew (Woodthorpe,
GB), Nelsen; Dan (Warwick, RI), Salame;
Michael (Norwich, CT), Stern; Tim (Belper,
GB), White; Mark (Norton, GB) |
Applicant: |
Name |
City |
State |
Country |
Type |
Smith & Nephew, Inc. |
Memphis |
TN |
US |
|
|
Assignee: |
Smith & Nephew, Inc.
(Memphis, TN)
|
Family
ID: |
71664716 |
Appl.
No.: |
15/970,774 |
Filed: |
May 3, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
13381885 |
Aug 12, 2014 |
8801685 |
|
|
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PCT/US2010/061938 |
Dec 22, 2010 |
|
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61289358 |
Dec 22, 2010 |
|
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|
61332440 |
May 7, 2010 |
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61369008 |
Jul 29, 2010 |
|
|
|
Reissue of: |
14267636 |
May 1, 2014 |
9327065 |
May 3, 2016 |
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M
1/742 (20210501); A61F 13/0216 (20130101); A61M
1/90 (20210501); A61M 1/86 (20210501); A61M
1/964 (20210501); A61F 13/0206 (20130101); A61F
13/00068 (20130101); A61F 13/022 (20130101); A61M
1/86 (20210501); A61F 13/0216 (20130101); A61M
1/90 (20210501); A61F 13/02 (20130101); A61F
13/00068 (20130101); A61F 2013/00536 (20130101); A61F
2013/0057 (20130101); A61F 2013/0074 (20130101); A61F
2013/00846 (20130101); A61F 2013/00238 (20130101); A61M
39/20 (20130101); A61M 2205/7518 (20130101); A61F
2013/00174 (20130101) |
Current International
Class: |
A61M
1/00 (20060101); A61F 13/00 (20060101); A61F
13/02 (20060101); A61M 39/20 (20060101) |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
674837 |
|
Jan 1997 |
|
AU |
|
3 907 007 |
|
Sep 1990 |
|
DE |
|
20 2010 009 148 |
|
Oct 2010 |
|
DE |
|
0 325 771 |
|
Sep 1993 |
|
EP |
|
0 392 640 |
|
Jun 1995 |
|
EP |
|
0 441 418 |
|
Jul 1995 |
|
EP |
|
0 692 987 |
|
Oct 1997 |
|
EP |
|
0 853 950 |
|
Jul 1998 |
|
EP |
|
0 651 983 |
|
Sep 1998 |
|
EP |
|
0 777 504 |
|
Oct 1998 |
|
EP |
|
0 782 421 |
|
Jul 1999 |
|
EP |
|
1 018 967 |
|
Jul 2000 |
|
EP |
|
0 690 706 |
|
Nov 2000 |
|
EP |
|
1 088 569 |
|
Apr 2001 |
|
EP |
|
1 129 734 |
|
Sep 2001 |
|
EP |
|
0 921 775 |
|
Dec 2001 |
|
EP |
|
1 169 071 |
|
Jan 2002 |
|
EP |
|
0 853 950 |
|
Oct 2002 |
|
EP |
|
1 283 702 |
|
Feb 2003 |
|
EP |
|
0 708 620 |
|
May 2003 |
|
EP |
|
1 014 905 |
|
May 2003 |
|
EP |
|
0 993 317 |
|
Sep 2003 |
|
EP |
|
0 880 953 |
|
Oct 2003 |
|
EP |
|
1 565 219 |
|
Dec 2003 |
|
EP |
|
1 219 311 |
|
Jul 2004 |
|
EP |
|
1 440 667 |
|
Jul 2004 |
|
EP |
|
1 578 477 |
|
Jul 2004 |
|
EP |
|
1 448 261 |
|
Aug 2004 |
|
EP |
|
1 476 217 |
|
Nov 2004 |
|
EP |
|
1 478 313 |
|
Nov 2004 |
|
EP |
|
1 487 389 |
|
Dec 2004 |
|
EP |
|
1 100 574 |
|
Feb 2005 |
|
EP |
|
1 513 478 |
|
Mar 2005 |
|
EP |
|
1 517 660 |
|
Mar 2005 |
|
EP |
|
1 556 120 |
|
Jul 2005 |
|
EP |
|
1 565 219 |
|
Aug 2005 |
|
EP |
|
1 637 088 |
|
Mar 2006 |
|
EP |
|
1 284 777 |
|
Apr 2006 |
|
EP |
|
1 660 000 |
|
May 2006 |
|
EP |
|
1 663 062 |
|
Jun 2006 |
|
EP |
|
0 982 015 |
|
Aug 2006 |
|
EP |
|
0 620 720 |
|
Nov 2006 |
|
EP |
|
1 620 720 |
|
Nov 2006 |
|
EP |
|
1 772 160 |
|
Apr 2007 |
|
EP |
|
1 809 350 |
|
Jul 2007 |
|
EP |
|
1 824 533 |
|
Aug 2007 |
|
EP |
|
1 227 853 |
|
Jan 2008 |
|
EP |
|
1 476 217 |
|
Mar 2008 |
|
EP |
|
1 904 137 |
|
Apr 2008 |
|
EP |
|
1 906 903 |
|
Apr 2008 |
|
EP |
|
2 079 507 |
|
Apr 2008 |
|
EP |
|
2 218 431 |
|
Apr 2008 |
|
EP |
|
1 919 533 |
|
May 2008 |
|
EP |
|
1 920 791 |
|
May 2008 |
|
EP |
|
1 940 485 |
|
Jul 2008 |
|
EP |
|
1 957 018 |
|
Aug 2008 |
|
EP |
|
1 976 477 |
|
Oct 2008 |
|
EP |
|
1 977 776 |
|
Oct 2008 |
|
EP |
|
1 986 584 |
|
Nov 2008 |
|
EP |
|
1 993 491 |
|
Nov 2008 |
|
EP |
|
1 827 561 |
|
Jan 2009 |
|
EP |
|
2 010 065 |
|
Jan 2009 |
|
EP |
|
2 037 852 |
|
Mar 2009 |
|
EP |
|
2 052 750 |
|
Apr 2009 |
|
EP |
|
2 063 952 |
|
Jun 2009 |
|
EP |
|
2 068 798 |
|
Jun 2009 |
|
EP |
|
2 081 629 |
|
Jul 2009 |
|
EP |
|
2 098 257 |
|
Sep 2009 |
|
EP |
|
2 103 290 |
|
Sep 2009 |
|
EP |
|
2 244 746 |
|
Sep 2009 |
|
EP |
|
2 109 473 |
|
Oct 2009 |
|
EP |
|
1 513 478 |
|
Dec 2009 |
|
EP |
|
2 127 690 |
|
Dec 2009 |
|
EP |
|
2 129 409 |
|
Dec 2009 |
|
EP |
|
2 138 139 |
|
Dec 2009 |
|
EP |
|
1 652 549 |
|
Jan 2010 |
|
EP |
|
1 905 465 |
|
Jan 2010 |
|
EP |
|
2 146 759 |
|
Jan 2010 |
|
EP |
|
l 905 465 |
|
Jan 2010 |
|
EP |
|
2 152 196 |
|
Feb 2010 |
|
EP |
|
2 127 690 |
|
Mar 2010 |
|
EP |
|
2 167 157 |
|
Mar 2010 |
|
EP |
|
2 172 164 |
|
Apr 2010 |
|
EP |
|
2 203 137 |
|
Jul 2010 |
|
EP |
|
2 218 431 |
|
Aug 2010 |
|
EP |
|
2 244 217 |
|
Oct 2010 |
|
EP |
|
2 244 746 |
|
Nov 2010 |
|
EP |
|
2 252 247 |
|
Nov 2010 |
|
EP |
|
2 254 537 |
|
Dec 2010 |
|
EP |
|
2 268 348 |
|
Jan 2011 |
|
EP |
|
2 279 017 |
|
Feb 2011 |
|
EP |
|
2 279 018 |
|
Feb 2011 |
|
EP |
|
2 285 430 |
|
Feb 2011 |
|
EP |
|
2 306 951 |
|
Apr 2011 |
|
EP |
|
1 703 922 |
|
May 2011 |
|
EP |
|
1 578 477 |
|
Sep 2011 |
|
EP |
|
1 763 378 |
|
Dec 2011 |
|
EP |
|
2 628 500 |
|
May 2014 |
|
EP |
|
2307180 |
|
May 1997 |
|
GB |
|
2356148 |
|
May 2001 |
|
GB |
|
2356148 |
|
Jun 2004 |
|
GB |
|
2431351 |
|
Apr 2007 |
|
GB |
|
2001-314479 |
|
Nov 2001 |
|
JP |
|
2013-514871 |
|
May 2013 |
|
JP |
|
WO 1994/03214 |
|
Feb 1994 |
|
WO |
|
WO 1994/21207 |
|
Sep 1994 |
|
WO |
|
WO 1994/23678 |
|
Oct 1994 |
|
WO |
|
WO 1999/01173 |
|
Jan 1999 |
|
WO |
|
WO 2000/007653 |
|
Feb 2000 |
|
WO |
|
WO 2000/61206 |
|
Oct 2000 |
|
WO |
|
WO 2001/85228 |
|
Nov 2001 |
|
WO |
|
WO 2001/085248 |
|
Nov 2001 |
|
WO |
|
WO 2002/043634 |
|
Jun 2002 |
|
WO |
|
WO 2002/070040 |
|
Sep 2002 |
|
WO |
|
WO 2002/092783 |
|
Nov 2002 |
|
WO |
|
WO 2003/086232 |
|
Oct 2003 |
|
WO |
|
WO 2003/092620 |
|
Nov 2003 |
|
WO |
|
WO 2003/101508 |
|
Dec 2003 |
|
WO |
|
WO 2004/018020 |
|
Mar 2004 |
|
WO |
|
WO 2004/037334 |
|
May 2004 |
|
WO |
|
WO 2004/041064 |
|
May 2004 |
|
WO |
|
WO 2004/060148 |
|
Jul 2004 |
|
WO |
|
WO 2005/009488 |
|
Feb 2005 |
|
WO |
|
WO 2005/016179 |
|
Feb 2005 |
|
WO |
|
WO 2005/025447 |
|
Mar 2005 |
|
WO |
|
WO 2005/046760 |
|
May 2005 |
|
WO |
|
WO 2005/046761 |
|
May 2005 |
|
WO |
|
WO 2005/046762 |
|
May 2005 |
|
WO |
|
WO 2005/051461 |
|
Jun 2005 |
|
WO |
|
WO 2005/061025 |
|
Jul 2005 |
|
WO |
|
WO 2005/072789 |
|
Aug 2005 |
|
WO |
|
WO 2005/079718 |
|
Sep 2005 |
|
WO |
|
WO 2005/102415 |
|
Nov 2005 |
|
WO |
|
WO 2005/105174 |
|
Nov 2005 |
|
WO |
|
WO 2005/105175 |
|
Nov 2005 |
|
WO |
|
WO 2005/105176 |
|
Nov 2005 |
|
WO |
|
WO 2005/105179 |
|
Nov 2005 |
|
WO |
|
WO 2005/105180 |
|
Nov 2005 |
|
WO |
|
WO 2005/115497 |
|
Dec 2005 |
|
WO |
|
WO 2005/115523 |
|
Dec 2005 |
|
WO |
|
WO 2005/123170 |
|
Dec 2005 |
|
WO |
|
WO 2006/046060 |
|
May 2006 |
|
WO |
|
WO 2006/052338 |
|
May 2006 |
|
WO |
|
WO 2006/052745 |
|
May 2006 |
|
WO |
|
WO 2006/056408 |
|
Jun 2006 |
|
WO |
|
WO 2006/114637 |
|
Nov 2006 |
|
WO |
|
WO 2006/114638 |
|
Nov 2006 |
|
WO |
|
WO 2006/114648 |
|
Nov 2006 |
|
WO |
|
WO 2007/006306 |
|
Jan 2007 |
|
WO |
|
WO 2007/013049 |
|
Feb 2007 |
|
WO |
|
WO 2007/015964 |
|
Feb 2007 |
|
WO |
|
WO 2007/019038 |
|
Feb 2007 |
|
WO |
|
WO 2007/030598 |
|
Mar 2007 |
|
WO |
|
WO 2007/030599 |
|
Mar 2007 |
|
WO |
|
WO 2007/030601 |
|
Mar 2007 |
|
WO |
|
WO 2007/030601 |
|
Mar 2007 |
|
WO |
|
WO 2007/031757 |
|
Mar 2007 |
|
WO |
|
WO 2007/031762 |
|
Mar 2007 |
|
WO |
|
WO 2007/031765 |
|
Mar 2007 |
|
WO |
|
WO 2007/041642 |
|
Apr 2007 |
|
WO |
|
WO 2007/062024 |
|
May 2007 |
|
WO |
|
WO 2007/067685 |
|
Jun 2007 |
|
WO |
|
WO 2007/084792 |
|
Jul 2007 |
|
WO |
|
WO 2007/085396 |
|
Aug 2007 |
|
WO |
|
WO 2007/087808 |
|
Aug 2007 |
|
WO |
|
WO 2007/087809 |
|
Aug 2007 |
|
WO |
|
WO 2007/087811 |
|
Aug 2007 |
|
WO |
|
WO 2007/092397 |
|
Aug 2007 |
|
WO |
|
WO 2007/095180 |
|
Aug 2007 |
|
WO |
|
WO 2007/106590 |
|
Sep 2007 |
|
WO |
|
WO 2007/106591 |
|
Sep 2007 |
|
WO |
|
WO 2007/133618 |
|
Nov 2007 |
|
WO |
|
WO 2007/143060 |
|
Dec 2007 |
|
WO |
|
WO 2008/008032 |
|
Jan 2008 |
|
WO |
|
WO 2008/010094 |
|
Jan 2008 |
|
WO |
|
WO 2008/011774 |
|
Jan 2008 |
|
WO |
|
WO 2008/012278 |
|
Jan 2008 |
|
WO |
|
WO 2008/013896 |
|
Jan 2008 |
|
WO |
|
WO 2008/014358 |
|
Jan 2008 |
|
WO |
|
WO 2008/016304 |
|
Feb 2008 |
|
WO |
|
WO 2008/027449 |
|
Mar 2008 |
|
WO |
|
WO 2008/036162 |
|
Mar 2008 |
|
WO |
|
WO 2008/040020 |
|
Apr 2008 |
|
WO |
|
WO 2008/041926 |
|
Apr 2008 |
|
WO |
|
WO 2008/043067 |
|
Apr 2008 |
|
WO |
|
WO 2008/048527 |
|
Apr 2008 |
|
WO |
|
WO 2008/064502 |
|
Jun 2008 |
|
WO |
|
WO 2008/086397 |
|
Jul 2008 |
|
WO |
|
WO 2008/100437 |
|
Aug 2008 |
|
WO |
|
WO 2008/100440 |
|
Aug 2008 |
|
WO |
|
WO 2008/100446 |
|
Aug 2008 |
|
WO |
|
WO 2008/112304 |
|
Sep 2008 |
|
WO |
|
WO 2008/131895 |
|
Nov 2008 |
|
WO |
|
WO 2008/132215 |
|
Nov 2008 |
|
WO |
|
WO 2008/135997 |
|
Nov 2008 |
|
WO |
|
WO 2008/141470 |
|
Nov 2008 |
|
WO |
|
WO 2008/154158 |
|
Dec 2008 |
|
WO |
|
WO 2009/002260 |
|
Dec 2008 |
|
WO |
|
WO 2009/004370 |
|
Jan 2009 |
|
WO |
|
WO 2009/016603 |
|
Feb 2009 |
|
WO |
|
WO 2009/016605 |
|
Feb 2009 |
|
WO |
|
WO 2009/019229 |
|
Feb 2009 |
|
WO |
|
WO 2009/021047 |
|
Feb 2009 |
|
WO |
|
WO 2009/021353 |
|
Feb 2009 |
|
WO |
|
WO 2009/034322 |
|
Mar 2009 |
|
WO |
|
WO 2009/062327 |
|
May 2009 |
|
WO |
|
WO 2009/066104 |
|
May 2009 |
|
WO |
|
WO 2009/066106 |
|
May 2009 |
|
WO |
|
WO 2009/067711 |
|
May 2009 |
|
WO |
|
WO 2009/068665 |
|
Jun 2009 |
|
WO |
|
WO 2009/071926 |
|
Jun 2009 |
|
WO |
|
WO 2009/071929 |
|
Jun 2009 |
|
WO |
|
WO 2009/071932 |
|
Jun 2009 |
|
WO |
|
WO 2009/071933 |
|
Jun 2009 |
|
WO |
|
WO 2009/071935 |
|
Jun 2009 |
|
WO |
|
WO 2009/071948 |
|
Jun 2009 |
|
WO |
|
WO 2009/078790 |
|
Jun 2009 |
|
WO |
|
WO 2009/086580 |
|
Jul 2009 |
|
WO |
|
WO 2009/088925 |
|
Jul 2009 |
|
WO |
|
WO 2009/111655 |
|
Sep 2009 |
|
WO |
|
WO 2009/114624 |
|
Sep 2009 |
|
WO |
|
WO 2009/114760 |
|
Sep 2009 |
|
WO |
|
WO 2009/114790 |
|
Sep 2009 |
|
WO |
|
WO 2009/124473 |
|
Oct 2009 |
|
WO |
|
WO 2009/124548 |
|
Oct 2009 |
|
WO |
|
WO 2009/126102 |
|
Oct 2009 |
|
WO |
|
WO 2009/126103 |
|
Oct 2009 |
|
WO |
|
WO 2009/137194 |
|
Nov 2009 |
|
WO |
|
WO 2009/145703 |
|
Dec 2009 |
|
WO |
|
WO 2009/145894 |
|
Dec 2009 |
|
WO |
|
WO 2009/146441 |
|
Dec 2009 |
|
WO |
|
WO 2009/158123 |
|
Dec 2009 |
|
WO |
|
WO 2009/158125 |
|
Dec 2009 |
|
WO |
|
WO 2009/158126 |
|
Dec 2009 |
|
WO |
|
WO 2009/158127 |
|
Dec 2009 |
|
WO |
|
WO 2009/158129 |
|
Dec 2009 |
|
WO |
|
WO 2009/158130 |
|
Dec 2009 |
|
WO |
|
WO 2010/033271 |
|
Mar 2010 |
|
WO |
|
WO 2010/033574 |
|
Mar 2010 |
|
WO |
|
WO 2010/033769 |
|
Mar 2010 |
|
WO |
|
WO 2010/035017 |
|
Apr 2010 |
|
WO |
|
WO 2010/042240 |
|
Apr 2010 |
|
WO |
|
WO 2010/051073 |
|
May 2010 |
|
WO |
|
WO 2010/056977 |
|
May 2010 |
|
WO |
|
WO 2010/059712 |
|
May 2010 |
|
WO |
|
WO 2010/059730 |
|
May 2010 |
|
WO |
|
WO 2010/072395 |
|
Jul 2010 |
|
WO |
|
WO 2010/085270 |
|
Jul 2010 |
|
WO |
|
WO 2010/094957 |
|
Aug 2010 |
|
WO |
|
WO 2010/147533 |
|
Dec 2010 |
|
WO |
|
WO 2010/147592 |
|
Dec 2010 |
|
WO |
|
WO 2011/091052 |
|
Jul 2011 |
|
WO |
|
WO 2011/091952 |
|
Aug 2011 |
|
WO |
|
WO 2011/100851 |
|
Aug 2011 |
|
WO |
|
WO 2011/115908 |
|
Sep 2011 |
|
WO |
|
WO 2012/028842 |
|
Mar 2012 |
|
WO |
|
Other References
US 7,186,244 B1, 03/2007, Hunt et al. (withdrawn) cited by
applicant .
Chinese Office Action, re CN Application No. 201080064562.2, dated
Aug. 27, 2014. cited by applicant .
Fleischmann, W. et al., "Vacuum Sealing: Indication, Technique, and
Results", Eur J Orthop Surg Traumatol, vol. 5, 1995, pp. 37-40, in
5 pages. cited by applicant .
Greer, S. et al., "Techniques for Applying Subatmospheric Pressure
Dressing to Wounds in Difficult Regions of Anatomy", JWOCN, vol.
26(5), 1999, pp. 250-253, in 4 pages. cited by applicant .
International Preliminary Report on Patentability, re PCT
Application No. PCT/US2010/061938, dated Jun. 26, 2012. cited by
applicant .
International Search Report and Written Opinion, re PCT Application
No. PCT/US2010/061938, dated Sep. 8, 2011. cited by applicant .
International Search Report and Written Opinion, re PCT Application
No. PCT/US2011/041521, dated Oct. 7, 2011. cited by applicant .
Jeter, K. et al., "Managing Draining Wounds and Fistulae: New and
Established Methods", Chronic Wound Care, 1990, pp. 240-246, in 7
pages. cited by applicant .
KCI V.A.C. Granufoam Bridge Dressing Product Brochure (2009), in 2
pages. cited by applicant .
Bevan, D. et al., "Diverse and potent activities of HGF/SF in skin
wound repair", Journal of Pathology, vol. 203, 2004, pp. 831-838,
in 8 pages. cited by applicant .
Info V.A.C. User Manual--KCI--Dec. 2006, in 76 pages. cited by
applicant .
Landis, E.M. et al., The Effects of Alternate Suction and Pressure
on Blood Flow to the Lower Extremities, Alternate Suction and
Pressure, J Clin Invest. Sep. 1933, vol. 12(5), pp. 925-961. cited
by applicant .
Mitchell, R. et al., "Role of Stem Cells in Tissue Homeostasis",
Pocket Companion to Robbins and Cotran Pathologic Basis of Disease,
7th Edition, 2006, in 3 pages. cited by applicant .
Morykwas, M. J. et al., "Nonsurgical Modalities to Enhance Healing
and Care of Soft Tissue Wounds", Journal of the Southern
Orthopaedic Association, vol. 6, No. 4, Winter 1997, in 12 pages.
cited by applicant .
Petition for Post-Grant Review of U.S. Pat. No. 9,642,750 dated
Feb. 9, 2018 in 2271 pages filed by Molnlycke Health Care AB,
including the following Exhibits: U.S. Pat. No. 9,642,750;
Prosecution history of U.S. Pat. No. 9,642,750; U.S. Pat. No.
9,327,065; U.S. Pat. No. 8,801,685; U.S. Appl. No. 61/369,008; U.S.
Appl. No. 61/332,440; U.S. Appl. No. 61/289,358; U.S. Pat. Pub. No.
2015/0359951; Prosecution history of U.S. Appl. No. 14/761,335;
Expert Declaration by Dr. Michael Helmus; Expert Declaration by
Carianne Nilsson; U.S. Pat. Pub. No. 2010/0137775; U.S. Pat. Pub.
No. 2009/0227968; U.S. Pat. Pub. No. 2010/0106108; U.S. Appl. No.
61/109,360; http://www.merriam-webster.com/dictionary/obstruct,
accessed Feb. 2, 2018;
https://www.merriam-webster.com/dictionary/duct, accessed Feb. 2,
2018; http://www.merriam-webster.com/dictionary/partition, accessed
Feb. 2, 2018;
https://www.merriam-webster.com/dictionary/side/%20by%20side,
accessed Feb. 2, 2018; KCI user's manual, Dec. 2006; Trademark
prosecution history for SENSAT.R.A.C.; Presentation from KCI;
Certified English translation of "Presentation from KCI";
Certification of translation of "Presentation from KCI"; "KCI
Launches Next Generation Wound Care Therapy Systems"
(https://www.itnonline.com/content/kci-launches-next-generation-wound-car-
etherapy-systems) Aug. 30, 2007; KCI product catalog, 2009; KCI
user's manual, Mar. 5, 2010; 510K filing K062227 by KCI with the
Food and Drug Administration on Sep. 27, 2006; 510K filing K022011
by KCI with the Food and Drug Administration on Jun. 19, 2002;
Images of SensaTRAC produced in 2016. cited by applicant .
Australian Office Action, re AU Application No. 2010341491, dated
Dec. 5, 2013. cited by applicant .
U.S. Appl. No. 14/261,296, filed Apr. 24, 2014, Heagle. cited by
applicant.
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Primary Examiner: Wehner; Cary E
Attorney, Agent or Firm: Knobbe, Martens, Olson & Bear
LLP
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
The present application is .Iadd.a reissue of U.S. Pat. No.
9,327,065, issued May 3, 2016 and entitled "APPARATUSES AND METHODS
FOR NEGATIVE PRESSURE WOUND THERAPY," which is .Iaddend.a
continuation of U.S. patent application Ser. No. 13/381,885, filed
on Dec. 30, 2011, entitled "APPARATUSES AND METHODS FOR NEGATIVE
PRESSURE WOUND THERAPY," which is a national phase application
under 35 U.S.C. .sctn.371 of International Application No.
PCT/US2010/061938, filed on Dec. 22, 2010, entitled "APPARATUSES
AND METHODS FOR NEGATIVE PRESSURE WOUND THERAPY," which claims the
benefit of U.S. Provisional Application No. 61/289,358, filed Dec.
22, 2009, U.S. Provisional Application No. 61/332,440, filed May 7,
2010, and U.S. Provisional Application No. 61/369,008, filed Jul.
29, 2010, the entirety of each of which is hereby incorporated by
reference.
Claims
What is claimed is:
.[.1. An apparatus to provide suction to a wound site through a
drape covering the wound site, the apparatus comprising: an
applicator configured to be positioned over an opening in the
drape, the applicator comprising: a flexible layer having an upper
surface and a lower surface; an adhesive provided on the lower
surface of the flexible layer configured to seal the applicator to
the drape; and a removable protective release layer provided over
the adhesive on the lower surface of the flexible layer; and a
bridge comprising: a proximal end provided with a connector
configured to provide fluid communication with a source of negative
pressure, an enlarged distal end having at least one aperture
therethrough, the enlarged distal end of the bridge coupled to the
applicator, an upper wall and a lower wall extending between the
proximal end and the enlarged distal end, and at least a first
channel and a second channel positioned between the upper wall and
the lower wall such that at least one of the first channel and
second channel is configured to provide fluid communication between
the at least one aperture and the connector; wherein the flexible
layer of the applicator is coupled using an adhesive to the
enlarged distal end of the bridge..].
.[.2. The apparatus of claim 1, wherein the flexible layer
comprises polyethylene or polyurethane..].
.[.3. The apparatus of claim 1, wherein the at least one aperture
of the enlarged distal end of the bridge portion is configured to
be positioned over the wound site to fluidically connect the wound
site to the source of negative pressure..].
.[.4. The apparatus of claim 1, wherein the applicator is enlarged
relative to the enlarged distal end of the bridge..].
.[.5. The apparatus of claim 1, wherein the applicator is
substantially square..].
.[.6. The apparatus of claim 1, wherein the flexible layer,
removable protective release layer, and removable backing layer are
shaped with substantially the same perimeter, each having two sets
of substantially parallel sides..].
.[.7. The apparatus of claim 1, further comprising an intermediate
wall, wherein the intermediate wall of the bridge defines one side
of the first channel and also defines one side of the second
channel..].
.[.8. The apparatus of claim 1, wherein the enlarged distal end of
the bridge comprises a first aperture and a second aperture, the
first aperture corresponding to at least the first channel and the
second aperture corresponding to at least the second
channel..].
.[.9. The apparatus of claim 1, wherein the first channel and
second channel are formed as side by side conduits..].
.[.10. The apparatus of claim 1, wherein the removable protective
release layer covers a perimeter of the flexible layer..].
.[.11. The apparatus of claim 1, the applicator further comprising
a removable backing layer provided on the upper surface of the
flexible layer to facilitate handling of the applicator due to
flexibility of the flexible layer, wherein the removable backing
layer is positioned beneath the bridge..].
.[.12. The apparatus of claim 11, wherein the removable backing
layer covers a perimeter of the flexible layer..].
.[.13. The apparatus of claim 11, wherein the removable protective
release layer covers a first area around a perimeter of the
flexible layer and the removable backing layer covers a second area
around the perimeter of the flexible layer, wherein the first area
is greater than the second area..].
.[.14. The apparatus of claim 1, wherein a width of the bridge is
greater than a height of the bridge..].
.[.15. The apparatus of claim 1, wherein the bridge is comprised of
flexible materials..].
.[.16. The apparatus of claim 1, further comprising an aperture in
the applicator configured to be positioned under the at least one
aperture in the enlarged distal end of the bridge..].
.[.17. The apparatus of claim 1, wherein the bridge is more rigid
than the applicator..].
.[.18. The apparatus of claim 1, wherein the first channel overlies
the second channel..].
.[.19. The apparatus of claim 1, wherein at least the second
channel comprises a 3D knitted or 3D fabric material..].
.[.20. The apparatus of claim 19, wherein the 3D knitted or 3D
fabric material at the enlarged distal end of the bridge has a
generally circular shape..].
.[.21. A negative pressure wound treatment system, comprising: a
suction adapter comprising the apparatus of claim 1; and a flexible
drape configured to be positioned over a wound and sealed to skin
surrounding the wound; wherein the suction adapter is configured to
attach to the drape and surround at least one aperture formed in
the drape..].
.[.22. The system of claim 21, further comprising a vacuum pump
connected by at least one conduit to the suction adapter..].
.[.23. A method of applying a suction adapter comprising the
apparatus of claim 1 to a wound site, the method comprising:
positioning a drape over the wound site; removing the removable
protective release layer from the applicator to expose the
adhesive; positioning the applicator over an aperture in the drape;
and sealing the applicator to the drape via the adhesive..].
.[.24. The method of claim 23, further comprising connecting a
fluidic conduit to the proximal end of the bridge..].
.[.25. The method of claim 23, further comprising applying negative
pressure to the wound site through the suction adapter..].
.[.26. An apparatus to provide suction to a wound site through
drape covering the wound site, the apparatus comprising: a bridge
comprising: a proximal end provided with a connector configured to
provide fluid communication with a source of negative pressure, an
enlarged distal end having at least one aperture therethrough, an
upper wall and a lower wall extending between the proximal end and
the enlarged distal end, and at least a first channel and a second
channel positioned between the upper wall and the lower wall such
that at least one of the first channel and second channel is
configured to provide fluid communication between the at least one
aperture and the connector; and an applicator configured to be
positioned over an opening in the drape comprising a flexible layer
having an area that is larger than an area of the enlarged distal
end of the bridge; wherein the flexible layer of the applicator is
coupled using an adhesive to the enlarged distal end of the
bridge..].
.[.27. The apparatus of claim 26, wherein the flexible layer has at
least one aperture therethrough..].
.[.28. The apparatus of claim 27, wherein the at least one aperture
in the enlarged distal end of the bridge is configured, in use, to
provide suction to the wound site through the at least one aperture
in the applicator..].
.[.29. The apparatus of claim 26, further comprising an adhesive
provided on a lower surface of the flexible layer configured to
seal the applicator to the drape..].
.[.30. The apparatus of claim 29, further comprising a removable
protective release layer provided over the adhesive on the lower
surface of the flexible layer..].
.[.31. The apparatus of claim 26, wherein at least one of the first
channel and the second channel is configured to provide suction to
the wound site..].
.[.32. The apparatus of claim 26, wherein the first channel is
configured to provide suction to the wound site and the second
channel is configured to provide vented air to the wound
site..].
.[.33. The apparatus of claim 26, wherein the first channel and the
second channel are formed as side by side conduits..].
.Iadd.34. An apparatus to provide suction to a wound site through a
drape covering the wound site, the apparatus comprising: a suction
adapter configured to be sealed to the drape covering a wound site,
the suction adapter comprising: an applicator configured to be
positioned over an opening in the drape, the applicator comprising
at least one aperture, the applicator further comprising: a
flexible layer having an upper surface and a lower surface; a first
adhesive provided on the lower surface of the flexible layer
configured to seal the applicator to the drape; and a bridge
portion comprising: a proximal end provided with a connector
configured to provide fluid communication with a source of negative
pressure; a distal end positioned over the at least one aperture in
the applicator; and a first channel and a second channel extending
parallel to an upper surface of the applicator, wherein at least
one of the first channel and second channel is configured to
provide suction to the wound site through the aperture in the
applicator from the source of negative pressure; a visualization
window provided in an upper surface of the bridge portion over the
at least one aperture in the applicator that provides visualization
from outside of the suction adapter, through the visualization
window and through the aperture in the applicator; and a straight
wall between at least a portion of the first channel and a portion
of the second channel, wherein the straight wall comprises a flat
surface and extends distally within the bridge portion past the
aperture; wherein the flexible layer of the applicator is coupled
using a second adhesive to the distal end of the bridge
portion..Iaddend.
.Iadd.35. The apparatus of claim 34, wherein the visualization
window comprises an at least partially transparent
material..Iaddend.
.Iadd.36. The apparatus of claim 34, wherein the visualization
window is configured to permit visualization of the wound site
prior to sealing the suction adapter to the wound
cover..Iaddend.
.Iadd.37. The apparatus of claim 34, wherein the visualization
window is configured to permit monitoring of the wound site while
the apparatus is providing suction to the wound site..Iaddend.
.Iadd.38. The apparatus of claim 34, wherein the visualization
window comprises polyurethane..Iaddend.
.Iadd.39. The apparatus of claim 34, wherein the visualization
window is positioned at a distal end of the bridge
portion..Iaddend.
.Iadd.40. The apparatus of claim 34, further comprising a straight
wall between at least a portion of the first channel and a portion
of the second channel, wherein the straight wall comprises a flat
surface..Iaddend.
.Iadd.41. The apparatus of claim 34, wherein the first channel is
configured to provide suction to the wound site and the second
channel is configured to provide vented air to the wound
site..Iaddend.
.Iadd.42. The apparatus of claim 41, wherein the bridge portion
further comprises an air leak configured to vent air to the second
channel..Iaddend.
.Iadd.43. The apparatus of claim 34, wherein the first channel and
the second channel are formed as side by side
conduits..Iaddend.
.Iadd.44. The apparatus of claim 34, wherein the applicator has an
area that is larger than an area of the distal end of the
bridge..Iaddend.
.Iadd.45. The apparatus of claim 34, wherein the applicator further
comprises an adhesive provided on a lower surface of the
applicator, and wherein the adhesive is configured to seal the
applicator to the drape..Iaddend.
.Iadd.46. The apparatus of claim 34, further comprising a wound
cover for covering the wound site..Iaddend.
.Iadd.47. The apparatus of claim 46, wherein the wound cover
comprises a drape..Iaddend.
.Iadd.48. The apparatus of claim 34, wherein the applicator
comprises a substantially planar surface..Iaddend.
.Iadd.49. The apparatus of claim 34, wherein the bridge portion
includes no more than two channels..Iaddend.
.Iadd.50. An apparatus to provide suction to a wound site through a
drape covering the wound site, the apparatus comprising: a suction
adapter configured to be sealed to the drape covering a wound site,
the suction adapter comprising: an applicator configured to be
positioned over an opening in the drape, the applicator comprising:
at least one aperture; a flexible layer having an upper surface and
a lower surface; and a first adhesive provided on the lower surface
of the flexible layer configured to seal the applicator to the
drape; a bridge portion comprising: a proximal end provided with a
connector configured to provide fluid communication with a source
of negative pressure; a distal end positioned over the at least one
aperture in the applicator; and a first channel and a second
channel extending parallel to an upper surface of the applicator,
wherein the first channel is configured to provide suction to the
wound site through the aperture in the applicator from the source
of negative pressure and the second channel is configured to
provide vented air to the wound site through the aperture in the
applicator from an air leak; a visualization window provided in an
upper surface of the bridge portion over the at least one aperture
in the applicator that provides visualization from outside of the
suction adapter, through the visualization window and through the
aperture in the applicator; and a straight wall having a flat
surface, the straight wall extending below the visualization
window, distally within the bridge portion past the aperture,
wherein the straight wall at least partially partitions the first
channel from the second channel; wherein the flexible layer of the
applicator is coupled using a second adhesive to the distal end of
the bridge portion..Iaddend.
.Iadd.51. A method of treating a wound, the method comprising:
providing a suction adapter comprising: an applicator configured to
be positioned over an opening in the drape comprising: at least one
aperture; a flexible layer having an upper surface and a lower
surface; a first adhesive provided on the lower surface of the
flexible layer configured to seal the applicator to the drape; and
a bridge portion comprising: a proximal end provided with a
connector configured to provide fluid communication with a source
of negative pressure; a distal end positioned over the at least one
aperture in the applicator; and a first channel and a second
channel extending parallel to an upper surface of the applicator,
wherein at least one of the first channel and second channel is
configured to provide suction to the wound site through the
aperture in the applicator from the source of negative pressure; a
visualization window provided in an upper surface of the bridge
portion over the at least one aperture in the applicator that
provides visualization from outside of the suction adapter, through
the visualization window and through the aperture in the
applicator; and a straight wall between at least a portion of the
first channel and a portion of the second channel, wherein the
straight wall comprises a flat surface and extends distally within
the bridge portion past the aperture; wherein the flexible layer of
the applicator is coupled using a second adhesive to the distal end
of the bridge portion; situating the at least one aperture of the
applicator of the suction adapter over an opening in a drape
covering the wound, using the viewing window as a positioning aid;
and sealing the suction adapter to the drape..Iaddend.
Description
FIELD OF THE INVENTION
Embodiments of the present invention relate generally to the
treatment of wounds using negative pressure wound therapy, and more
specifically to an improved apparatus and method thereof.
BACKGROUND OF THE INVENTION
The treatment of open or chronic wounds that are too large to
spontaneously close or otherwise fail to heal by means of applying
negative pressure to the site of the wound is well known in the
art. Negative pressure wound treatment systems currently known in
the art commonly involve placing a cover that is impermeable to
liquids over the wound, using various means to seal the cover to
the tissue of the patient surrounding the wound, and connecting a
source of negative pressure (such as a vacuum pump) to the cover in
a manner so that an area of negative pressure is created under the
cover in the area of the wound.
SUMMARY OF THE INVENTION
Embodiments of the invention disclosed herein are directed to a
negative pressure appliance and methods of treatment using a
negative pressure appliance, and may be useful in the treatment of
wounds using negative pressure.
Certain embodiments of the invention employ fluidic connectors
and/or suction adapters for connecting a source of negative
pressure to a dressing positioned over a wound site. These fluidic
connectors and/or suction adapters offer advantages over the prior
art. For example and for illustrative purposes only, some of the
embodiments may offer a softer, kink-free fluidic connector for
connecting a wound site to a source of negative pressure for
treatment. Such a fluidic connector and/or suction adapter is
faster to apply, requiring fewer steps compared to prior art
connectors, and offers greater patient comfort and safety by being
soft and conformable, thereby avoiding pressure ulcers and other
complications caused by harder connectors.
Certain embodiments provide for a negative pressure wound treatment
system comprising a wound packing material configured to be
positioned at a wound, a flexible drape configured to be positioned
over the wound and wound packing material and sealed to the skin
surrounding the wound, and which further comprises a conduit
configured to deliver negative pressure to the wound through an
aperture in the drape and through the wound packing material to the
wound. Such embodiments further comprise a flexible suction adapter
configured to surround the aperture and connect the conduit to the
flexible drape and for transmitting negative pressure from the
conduit through the aperture.
In one embodiment, a negative pressure wound treatment system is
provided comprising a flexible drape configured to be positioned
over a wound and sealed to skin surrounding the wound. A conduit is
configured to deliver negative pressure to the wound, wherein
negative pressure is delivered through an aperture in the drape. A
flexible suction adapter is configured to surround the aperture and
connect the conduit to the flexible drape, the flexible suction
adapter comprising upper and lower layers forming an elongate
interior channel having a proximal end and a distal end, the
proximal end configured for fluid communication with the conduit
and the lower layer including at least one aperture for
communicating with the aperture in the drape. An elongated foam
spacer is within the interior channel extending between the
proximal end and the distal end.
In another embodiment, a negative pressure wound treatment system
comprises a flexible drape configured to be positioned over a wound
and sealed to skin surrounding the wound. The flexible drape
defines an elongate channel extending between upper and lower
portions of the flexible drape, wherein the channel extends from an
edge of the flexible drape to an interior portion thereof. The
lower portion of the flexible drape includes at least one aperture
in communication with the elongate channel for transmitting
negative pressure through the channel and through the aperture. A
conduit is configured to deliver negative pressure to the wound,
wherein the conduit is connected to the channel to deliver negative
pressure through the channel and the at least one aperture in the
lower layer.
In yet another embodiment, a negative pressure wound treatment
system comprises a bridge with top, bottom, and intermediate layers
sandwiching top and bottom fluid channels, wherein the top channel
comprises an air leak, and the bottom channel is connected to a
source of negative pressure suitable for drawing exudates from a
wound site. The bridge is attached to an applicator portion
including at least one aperture and suitable for placement over a
wound site, and may also include a visualization window for
visualization of the wound site.
Methods of treating wounds with negative pressure are also
described. A method of treating a wound with negative pressure may
include applying a flexible drape over a wound site, applying a
flexible suction adapter over the wound site, where the flexible
adapter comprises an applicator and bridge portion provided with an
air leak. The suction adapter is then connected to a source of
negative pressure, and negative pressure is applied to the wound
until it has reached a desired level of healing.
Also disclosed herein are embodiments of an apparatus for providing
suction to a wound site comprising a top and bottom layer
constructed from a liquid-impermeable material with a 3D knitted or
3D fabric material located between these top and bottom layers. An
aperture in the bottom layer is in fluid communication with the 3D
knitted or 3D fabric material. An elongate channel extends between
the top and bottom layers containing the 3D knitted or 3D fabric
material. The top layer, bottom layer, and 3D knitted or 3D fabric
material include enlarged distal ends with the elongate channel
extending in a proximal direction away from the enlarged distal
ends.
In some embodiments, the elongate channel comprises a lower fluid
passage, and the apparatus comprises an upper fluid passage
disposed above and separate from the 3D knitted or 3D fabric
material that is connected to an air leak. In some cases, the upper
fluid passage may contain foam or another compliant spacer
material. In other embodiments, an air leak communicates with a
wound site through a conduit extending in a proximal direction away
form the enlarged distal ends and may in some cases include a
looped portion. The enlarged ends of the top and bottom layers may
be rectangular or square, or may form a teardrop shape, and the 3D
knitted or 3D fabric material may have a circular enlarged end. The
3D knitted or 3D fabric material may also be in fluid communication
with a source of negative pressure, such as a pump. The bottom
layer may be configured to be attached to a drape, or may be
attached to an applicator. The bottom layer may also comprise an
adhesive disposed on its wound-facing side, and can in some cases
be provided with multiple apertures. In some embodiments, the 3D
knitted or 3D fabric material may be in fluid communication with a
dual lumen tube that incorporates an air leak at a proximal portion
thereof. The air leak may in some cases comprise a plurality of
discrete air channels, and may be located on the enlarged distal
end of the top layer. The 3D knitted or 3D fabric material can be
provided with a flattened distal end.
Embodiments of systems for the treatment of wounds using negative
pressure using embodiments of the suction adapters disclosed above
are also disclosed. These systems can comprise a suction adapter as
described previously, a flexible drape configured to be positioned
over a wound and sealed to the skin surrounding the wound, and
where the suction adapter is configured to be attached to the drape
so as to surround an aperture formed in the drape. A vacuum pump
may be connected by at least one conduit to the suction
adapter.
In another embodiment of a suction adapter, this adapter has an
applicator with an upper and lower surface, with the upper surface
connected to the distal end of a bridge. The bridge has a proximal
end and a distal end, and has an upper fluid passage connected to
an air leak and a lower fluid passage in fluid communication with a
source of negative pressure, with the lower fluid passage
comprising a 3D knitted or 3D fabric material.
In some embodiments of the suction adapter, the upper fluid passage
may comprise foam. The bridge portion may further comprise a top
layer, a bottom layer and an intermediate layer, each of the layers
having proximal ends and distal ends and elongate portions
extending therebetween, where the upper fluid passage extends
between the top and intermediate layers, and the lower fluid
passage extends between the intermediate and bottom layers. The
distal end of the bridge may also have an enlarged shape. The air
leak may be disposed at the proximal end of the bridge. The 3D
knitted or 3D fabric material may include a top knitted layer, a
bottom knitted layer, and a middle area with vertically extending
fibers, and may be approximately 1.5 to 6 mm thick. The 3D knitted
or 3D fabric material may be constructed so as to resist
compression to less than half its original thickness when subjected
to a load of 15 psi.
The suction adapter embodiments above may be used in embodiments of
a negative pressure wound treatment system comprising a flexible
drape configured to be positioned over a wound and sealed to the
skin surrounding the wound, and where the suction adapter is
configured to be attached to the drape so as to surround at least
one aperture formed in the drape. A vacuum pump is preferably
connected by at least one conduit to the suction adapter.
Further embodiments of negative pressure wound treatment systems
described herein may comprise a flexible drape configured to be
positioned over a wound and sealed to skin surrounding the wound, a
conduit configured to deliver negative pressure to the wound,
wherein negative pressure is delivered through an aperture in the
drape, and a flexible suction adapter configured to surround the
aperture on the drape and connect the conduit to the flexible
drape. The flexible suction adapter can comprise upper and lower
layers forming an elongate interior channel with proximal and
distal ends, where the proximal end is configured to communicate
fluidically with the conduit and wherein the lower layer has at
least one aperture for communicating with the aperture in the
drape. An elongated spacer extending between the proximal and
distal ends may also be placed within the interior channel.
In some embodiments, the elongated spacer may become progressively
larger toward the distal end. The interior channel may incorporate
a looped portion that extends toward and away from the at least one
aperture in the lower layer, and the spacer may be configured
similarly. The channel in the suction adapter may also comprise an
air leak, which may be disposed between the proximal and distal end
of the channel, and may also incorporate a filter. The lower layer
of the suction adapter may comprise more than one aperture, for
example four apertures. The wound may also be packed with a wound
packing material placed under the flexible drape.
Another embodiment of a negative pressure wound treatment system
described herein includes a wound packing material configured to be
positioned at a wound, a flexible drape configured to be positioned
over the wound packing material and over the wound and sealed to
skin surrounding the wound, a conduit configured to deliver
negative pressure to the wound through an aperture in a drape and
through the wound packing material placed in the wound, and a
flexible suction adapter configured to surround the aperture and
connect the conduit to the flexible drape and for transmitting
negative pressure from the conduit through the aperture.
In some embodiments, the suction adapter may be a flexible shroud
having a distal end configured to seal with the flexible drape
around the aperture and a proximal end configured to seal about the
conduit, where the conduit is configured to extend through the
flexible shroud into the aperture. The suction adapter may also be
a sealing disc sandwiched between annular upper and lower support
discs, where the lower support disc is configured to be adhered to
the flexible drape around the aperture, and the conduit is
configured to extend through openings in the sealing disc and upper
and lower support discs into the aperture. In other cases, the
flexible suction adapter may be a sealing ring integrated with the
aperture in the drape, with the conduit being sized and configured
to make a sealing contact with the sealing ring. The flexible
suction adapter may also comprise upper and lower support layers
sandwiching a looped portion of the conduit, where the lower layer
includes at least one aperture and the conduit includes a plurality
of apertures so that negative pressure can be transmitted through
the plurality of apertures in the conduit through the at least one
aperture in the lower layer and through the aperture in the
flexible drape. The flexible suction adapter can also have upper
and lower support layers sandwiching an elongated foam spacer,
where the lower layer includes at least one aperture for
transmitting negative pressure from the foam spacer to the aperture
in the flexible drape, and the elongated foam spacer includes a
proximal end configured to connect to a distal end of the conduit.
The suction adapter can also comprise a membrane with elongate
parallel channels integrated onto it and configured to be
positioned over the flexible drape around the aperture so as to
channel wound exudate. In another embodiment, the flexible drape
can define a lower layer and further comprises an upper layer that
sandwiches the flexible suction adapter between the upper and lower
layers; the flexible suction adapter can comprise a foam
spacer.
Yet another embodiment of a negative pressure wound treatment
system comprises a flexible drape configured to be positioned over
a wound and sealed to skin surrounding the wound, with the flexible
drape defining an elongate channel extending between upper and
lower portions of the flexible drape, and where the channel extends
from an edge of the flexible drape to an interior portion of the
flexible drape, the lower portion of the flexible drape including
at least one aperture in communication with the elongate channel
for transmitting negative pressure through the channel and through
the aperture. A conduit is configured to deliver negative pressure
to the wound, where the conduit is connected to the channel to
deliver negative pressure through the channel and the at least one
aperture in the lower layer. In some embodiments, a foam spacer may
extend into the channel, and spacer comprising bosses may also be
present on in an interior portion of the channel.
Embodiments of a suction adapter described herein can include an
applicator with an upper surface and a lower surface, a bridge with
a proximal end and a distal end, where the distal end of the bridge
is connected to the upper surface of the applicator, and where the
bridge comprises a top layer, a bottom layer and an intermediate
layer, each of the layers having proximal ends and distal ends and
elongate portions extending therebetween. A first channel layer
then extends between the top and intermediate layers, where the
first channel layer has a proximal end and a distal end and an
elongate portion extending therebetween. A second channel layer
extends between the intermediate and bottom layers, where the
channel layer has a proximal end and a distal end and an elongate
portion extending therebetween. An air leak is disposed at the
proximal end of the top layer that is configured to provide an air
path into the first channel layer.
Another embodiment described herein includes a suction adapter
suitable to treat a wound site with negative pressure that includes
an applicator with an upper surface and a lower surface, a bridge
having a proximal end and a distal end, where the distal end of the
bridge is connected to the upper surface of the applicator. The
bridge comprises a top layer, a bottom layer and an intermediate
layer, with each layer having a proximal end and a distal end and
an elongate portion extending therebetween, a first channel layer
extending between the top and intermediate layers, the first
channel layer having a proximal end and a distal end and an
elongate portion extending therebetween and a second channel layer
extending between the intermediate and bottom layers, the second
channel layer having a proximal end and a distal end and an
elongate portion extending therebetween. An air leak is disposed at
the proximal end of the top layer, the air leak configured to
provide an air path into the first channel layer. One of the first
and second channel layers comprises foam and the other of the first
and second channel layers comprising a fabric.
Methods of treating a wound with negative pressure are also
disclosed herein. A method of treating a wound site with negative
pressure comprises applying a flexible drape over a wound site,
applying a flexible suction adapter over an opening in the flexible
drape, where the flexible suction adapter comprises top and bottom
layers constructed from a liquid-impermeable material, a 3D knitted
or 3D fabric material located between the top and bottom layers, an
aperture in the bottom layer in fluid communication with the wound
site through the opening and the 3D knitted or 3D fabric material,
and applying negative pressure to the wound, the negative pressure
being transmitted to the wound through at least one conduit
connected between the source of negative pressure and the flexible
suction adapter and passing through the 3D knitted or 3D fabric
material through the aperture in the bottom layer and into the
opening in the flexible drape.
In some embodiments, the application of negative pressure to the
wound may cause air to flow into the wound via an air leak disposed
on the flexible suction adapter. The flow rate of air, may, in some
embodiments be at least 0.08 liters/minute when negative pressure
is applied to the suction adapter, and this flow rate may be
maintained while a weight is placed on the suction adapter, for
example a 4.75 kg weight. Adhesive may be placed on the suction
adapter when adhering the adapter to the drape, or the adapter can
be supplied pre-attached to a drape. Otherwise, the method above
may comprise cutting an opening into the drape. Wound contact
material can also be placed into the wound site prior to applying
the drape. A similar method may transmit negative pressure to the
wound through at least one conduit connected between the source of
negative pressure and the flexible suction adapter and that passes
through the 3D knitted material into the opening in the flexible
drape.
Yet another method of treating a wound site with negative pressure
is disclosed herein. This method comprises applying a flexible
drape over a wound site, applying a flexible suction adapter over
an opening made in the flexible drape, the flexible suction adapter
comprising an applicator having an upper surface and a lower
surface and a bridge having a proximal end and a distal end, and
where the distal end of the bridge is connected to the upper
surface of the applicator, and the bridge comprises a top layer, a
bottom layer and an intermediate layer, each of the layers having
proximal ends and distal ends and elongate portions extending
therebetween, a first channel layer extending between the top and
intermediate layers, where the first channel layer has a proximal
end and a distal end and an elongate portion extending
therebetween, a second channel layer extending between the
intermediate and bottom layers, the channel layer having a proximal
end and a distal end and an elongate portion extending
therebetween, an air leak disposed at the proximal end of the top
layer configured to provide an air path into the first channel
layer. The flexible suction adapter is connected to a source of
negative pressure, and negative pressure is applied to the wound,
the negative pressure being transmitted through the second channel
layer and drawing in air from the air leak through the first
channel layer.
A further method for treating a wound with negative pressure is
described herein. This method comprises applying a flexible drape
over a wound site, applying a flexible suction adapter over an
opening made in the flexible drape, connecting the flexible suction
adapter to a source of negative pressure; and applying negative
pressure to the wound, the negative pressure being transmitted
through the second channel layer and drawing in air from the air
leak through the first channel layer. The flexible suction adapter
used comprises an applicator having an upper surface and a lower
surface and a bridge having a proximal end and a distal end, the
distal end of the bridge being connected to the upper surface of
the applicator. The bridge comprises a top layer, a bottom layer
and an intermediate layer, with each of the layers having proximal
ends and distal ends and elongate portions extending therebetween,
a first channel layer extending between the top and intermediate
layers, the first channel layer having a proximal end and a distal
end and an elongate portion extending therebetween, a second
channel layer extending between the intermediate and bottom layers,
the channel layer having a proximal end and a distal end and an
elongate portion extending therebetween, an air leak disposed at
the proximal end of the top layer configured to provide an air path
into the first channel layer, and wherein one of the first and
second channel layers comprises foam and the other of the first and
second channel layers comprising a fabric.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 illustrates a negative-pressure system that can be used in
the treatment of wounds.
FIG. 2A illustrates an embodiment of a negative pressure wound
treatment system with a flexible shroud being applied over a
flexible drape.
FIG. 2B illustrates the system of FIG. 2A with the shroud applied
to the flexible drape.
FIGS. 2C-2F illustrates a method of applying the negative pressure
wound treatment system of FIGS. 2A and 2B to a patient.
FIG. 3A illustrates an embodiment of a negative pressure wound
treatment system with a sealing disc being applied over a flexible
drape.
FIG. 3B is an exploded view of the sealing disc of FIG. 3A.
FIG. 3C illustrates the system of FIG. 3A with the sealing disc
applied to the flexible drape.
FIGS. 3D-3H illustrate a method of applying the negative pressure
wound treatment system of FIGS. 3A-3C to a patient.
FIG. 4A illustrates an embodiment of negative pressure wound
treatment system with a flexible drape having an integrated sealing
ring.
FIG. 4B illustrates the system of FIG. 4A with a conduit inserted
through the sealing ring.
FIG. 5A illustrates an embodiment of a negative pressure wound
treatment system using a suction adapter with an air leak.
FIG. 5B is an exploded view of the suction adapter of FIG. 5A.
FIGS. 5C-5F illustrate a method of applying the negative pressure
wound treatment system of FIGS. 5A-5B to a patient.
FIG. 6A illustrates an embodiment of a negative pressure wound
treatment system with a flexible suction adapter.
FIG. 6B is an exploded view of the flexible suction adapter of FIG.
6A.
FIGS. 6C and 6D are alternative embodiments of the flexible suction
adapter of FIGS. 6A-6B.
FIGS. 6E-6H illustrate a method of applying the negative pressure
wound treatment system of FIGS. 6A-6D to a patient.
FIGS. 7A-7B illustrate other embodiments of a flexible suction
adapter.
FIG. 7C illustrates a negative pressure wound treatment system
using a flexible suction adapter.
FIGS. 8A and 8B illustrate another embodiment of a negative
pressure wound treatment system with a flexible suction
adapter.
FIG. 9A illustrates an embodiment of a negative pressure wound
treatment system with a flexible drape integrating a suction
channel therein.
FIG. 9B is an exploded view of the flexible drape of FIG. 9A.
FIG. 9C-9D illustrate a method of applying the negative pressure
wound treatment system of FIGS. 9A and 9B to a patient.
FIGS. 10A and 10B illustrate another embodiment of a negative
pressure wound treatment system with a flexible drape integrating a
suction channel therein.
FIGS. 11A and 11B illustrate another embodiment of a negative
pressure wound treatment system with a flexible drape integrating a
suction channel and spacers comprising bosses therein.
FIGS. 12A and 12B illustrate an embodiment of a flexible one-piece
suction adapter.
FIGS. 13A and 13B illustrate an embodiment of a negative pressure
wound treatment system with a drape-piercing suction adapter.
FIGS. 14A and 14B illustrate another embodiment of a negative
pressure wound treatment system with an integrated drape and wound
packing material.
FIGS. 15A-D illustrate another embodiment of a negative pressure
wound treatment system with a flexible suction adapter.
FIGS. 16A-B illustrate another embodiment of a negative pressure
wound treatment system with a flexible drape integrating a suction
channel therein.
FIGS. 17A-B illustrate an embodiment of a negative pressure wound
treatment system with a low profile side drain.
FIGS. 18A-B illustrate an embodiment of a negative pressure wound
treatment system comprising a wicking layer.
FIGS. 19A-D illustrate embodiments of a negative pressure wound
treatment system incorporating a flat drain portion.
FIGS. 20A-B illustrate an embodiment of a negative pressure wound
treatment system incorporating a trimmable suction port.
FIGS. 21A-B illustrate another embodiment of a negative pressure
wound treatment system incorporating a sealing ring.
FIGS. 22A-B illustrate an embodiment of a negative pressure wound
treatment system incorporating a piercing attachment for use with a
port.
FIGS. 23A-B illustrate a different embodiment of a negative
pressure wound treatment system incorporating a piercing attachment
for use with a port.
FIGS. 24A-B illustrate embodiments of a negative pressure wound
treatment system incorporating a piercing connector and a
controlled air leak.
FIGS. 25A-B illustrate embodiments of a negative pressure wound
treatment system incorporating a manifold and a central controlled
air leak.
FIGS. 26A-B illustrate embodiments of a negative pressure wound
treatment system incorporating two manifolds.
FIGS. 27A-C illustrate embodiments of a negative pressure wound
treatment system comprising a flexible suction adapter with
separate controlled air leak paths.
FIGS. 28A-B illustrate an embodiment of a negative pressure wound
treatment system incorporating a controlled air leak in a suction
head.
FIGS. 29A-B illustrate an embodiment of a negative pressure wound
treatment system incorporating a starburst negative pressure
distribution manifold and a central controlled air leak.
FIGS. 30A-B illustrate an embodiment of a negative pressure wound
treatment system provided with a piercing nozzle.
FIGS. 31A-B illustrate an embodiment of a negative pressure wound
treatment system with a port, a piercing connector, and a
controlled air leak.
FIGS. 32A-K illustrate embodiments of a negative pressure wound
treatment system with a port and a piercing tool.
FIGS. 33A-H illustrate embodiments of a negative pressure wound
treatment system incorporating a cutting template.
FIGS. 34A-H illustrate embodiments of a negative pressure wound
treatment system comprising a soft port with a protruding
channel.
FIGS. 35A-H illustrate an embodiment of a negative pressure wound
treatment with drape strips provided with a port.
FIGS. 36A-I illustrate a negative pressure wound treatment system
comprising a drape with integrated drainage channels.
FIGS. 37A-G illustrate a negative pressure wound treatment system
incorporating a drape with miniature openings.
FIGS. 38A-I illustrate an embodiment of a negative pressure wound
treatment system comprising a bayonet connector between a ring and
a port.
FIGS. 39A-B illustrate a negative pressure wound treatment system
comprising a low-profile port configured to attach to a valve
attached to a drape.
FIG. 40 illustrates an embodiment of a negative pressure wound
treatment system provided with a low-profile fluidic connector.
FIGS. 41A-B illustrate an embodiment of a negative pressure wound
treatment system provided with a plurality of suction tubes.
FIGS. 42A-B illustrate an embodiment of a negative pressure wound
treatment system incorporating a pre-made aperture onto a
drape.
FIGS. 43A-B illustrate an embodiment of a negative pressure wound
treatment system incorporating a piercing connector.
FIGS. 44A-B illustrate an embodiment of a negative pressure wound
treatment system with a drape incorporating an integrated suction
port.
FIGS. 45A-C illustrate an embodiment of a negative pressure wound
treatment system incorporating a drape with cross-linked air
channels and port integrated thereupon.
FIGS. 46A-B illustrate an embodiment of a negative pressure wound
treatment system comprising suction channels integrated into a
wound cover.
FIGS. 47A-B illustrate an embodiment of a negative pressure wound
treatment system incorporating a low-profile suction unit.
FIGS. 48A-E illustrate an embodiment of a negative pressure wound
treatment system comprising a flexible suction adapter sheet.
FIGS. 49A-B illustrate an embodiment of a negative pressure wound
treatment system incorporating a wound packing pouch.
FIGS. 50A-C illustrate embodiments of a negative pressure wound
treatment system comprising a port provided with a sealing
ring.
FIGS. 51A-B illustrate another embodiment of a negative pressure
wound treatment system incorporating a low-profile suction
adapter.
FIGS. 52A-B illustrate an embodiment of a negative pressure wound
treatment system provided with a bladder.
FIGS. 53A-D illustrate a different embodiment of a negative
pressure wound treatment system provided with a bladder.
FIGS. 54A-B illustrate an embodiment of a negative pressure wound
treatment system using discrete wound packing material
portions.
FIG. 55A illustrates an embodiment of a negative pressure wound
treatment system comprising a pump, and illustrating a flexible
suction adapter being applied to a wound.
FIG. 55B illustrates the embodiment of FIG. 55A, with the flexible
suction adapter having been placed over a wound.
FIG. 55C illustrates an isometric view of a flexible suction
adapter that may be used in a negative pressure wound treatment
system.
FIG. 55D illustrates an exploded view of the flexible suction
adapter of FIG. 55C.
FIG. 55E illustrates a close-up view of the proximal end of the
flexible suction adapter of FIG. 55D.
FIG. 55F illustrates a close-up cutaway view of the proximal end of
the flexible suction adapter of FIG. 55C.
FIG. 55G illustrates a top view of the flexible suction adapter of
FIG. 55C.
FIG. 55H illustrates a side view of the flexible suction adapter of
FIG. 55C.
FIG. 55I illustrates a bottom view of the flexible suction adapter
of FIG. 55C.
FIG. 55J illustrates an exploded view of an alternative flexible
suction adapter.
FIG. 56A illustrates a top view of a 3D fabric that may be used in
a negative pressure wound treatment system.
FIG. 56B illustrates a bottom view of the 3D fabric of FIG.
56A.
FIG. 56C illustrates a side cutaway view of the 3D fabric of FIG.
56A.
FIGS. 57A-B illustrate an embodiment of a connector with two or
more projections and that may be connected to a suction adapter
illustrated in FIG. 55.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
Preferred embodiments disclosed herein relate to wound therapy for
a human or animal body. Therefore, any reference to a wound herein
can refer to a wound on a human or animal body, and any reference
to a body herein can refer to a human or animal body. The term
"wound" as used herein, in addition to having its broad ordinary
meaning, includes any body part of a patient that may be treated
using negative pressure. Wounds include, but are not limited to,
open wounds, pressure sores, ulcers and burns. Treatment of such
wounds can be performed using negative pressure wound therapy,
wherein a reduced or negative pressure can be applied to the wound
to facilitate and promote healing of the wound. It will also be
appreciated that the negative pressure systems and methods as
disclosed herein may be applied to other parts of the body, and are
not necessarily limited to treatment of wounds.
With reference initially to FIG. 1, treatment of a wound with
negative pressure in certain embodiments of the application uses a
system as illustrated schematically. In one embodiment, a wound 101
may be partly or completely filled with a wound packing material
102, such as foam, gauze, or any other suitable material.
Alternatively, no wound packing material may be utilized. A
flexible drape 103 that is at least partially fluid impermeable,
and preferably liquid impermeable, may then be laid over the wound
packing material 102 and preferably onto at least part of the
surrounding healthy skin surrounding a wound. The drape 103 may be
connected via a conduit 104 such as a flexible tube to a source of
negative pressure 106 such as a pump. This conduit 104 may, in some
embodiments, comprise one or more tubes. Suitable sources for
negative pressure include both powered negative pressure sources
such as vacuum pumps, and manually powered negative pressure
sources such as suction bulbs. Negative pressure is applied to the
wound through the conduit 104 and through the wound packing
material 102, and wound exudate and other secretions are drawn away
from the wound, through the wound packing material, and into a
canister or other collection unit 105. The collection unit 105 may
be located along the conduit before the negative pressure source,
or may be located elsewhere relative to the negative pressure
source. In some embodiments, one or more filters 107 may be
provided along the vacuum pathway, for example at the outlet of the
pump. This filter 107 may be useful for absorbing odors or may be a
bacterial filter. Suitable systems for treating wounds in the above
manner include the RENASYS-F, RENASYS-G, RENASYS EZ and RENASYS GO
systems available from Smith & Nephew.
The application of reduced or negative pressure to a wound in the
above manner may be used to promote faster healing, increase blood
flow, decrease bacterial burden, increase the rate of granulation
tissue formation, remove exudate and slough from the wound,
alleviate interstitial edema, stimulate the proliferation of
fibroblasts, stimulate the proliferation of endothelial cells,
close chronic open wounds, inhibit burn penetration, and enhance
flap and graft attachment, among other things. It has also been
reported that wounds that have exhibited positive response to
treatment by the application of negative pressure include infected
open wounds, decubitus ulcers, dehisced incisions, partial
thickness burns, and various lesions to which flaps or grafts have
been attached.
Suitable drapes such as those used in the embodiments described
herein are preferably liquid tight, such that at least partial
negative pressure may be maintained at the wound site. The drape
may be constructed from, for example, transparent flexible plastics
such as polyurethane. Other suitable materials include without
limitation synthetic polymeric materials that do not absorb aqueous
fluids, including polyolefins, such as polyethylene and
polypropylene, polysiloxanes, polyamides, polyesters, and other
copolymers and mixtures thereof. The materials used in the drape
may be hydrophobic or hydrophilic. Examples of suitable materials
include Transeal.RTM. available from DeRoyal and OpSite.RTM.
available from Smith & Nephew. In order to aid patient comfort
and avoid skin maceration, the drapes in certain embodiments are at
least partly breathable, such that water vapor is able to pass
through without remaining trapped under the dressing. Lastly,
although several embodiments illustrated herein illustrate an
operator cutting an aperture into a drape manually, drapes used in
the embodiments disclosed here may also be provided with one or
more pre-cut apertures.
The wound is optionally filled with a wound packing material.
Preferably, this wound packing material is conformable to the wound
bed. This material is preferably soft and resiliently flexible.
Examples of suitable forms of such wound fillers are foams formed
of a suitable material, e.g. a resilient thermoplastic. Preferred
materials for the present wound dressing include reticulated
polyurethane foams with small apertures or pores and open-celled
foams. Other suitable materials may include gauze. Preferably, such
wound packing material will be able to channel wound exudate and
other fluids through itself when negative pressure is applied to
the wound. Some wound packing materials may include preformed
channels or openings for such purposes.
Typically, the negative pressure wound treatment system is operated
until a wound has reached a level of healing acceptable to a
physician. The treatment system is preferably operated using a
negative or reduced pressure ranging from about 40 to 200 mm Hg,
though the amount may be lower or higher depending on physician
preference. The time period for use of the wound treatment
apparatus on a wound is selected by the physician. During the time
period that negative pressure is applied, dressing changes and
other temporary interruptions to the treatment may occur.
Preferably, the negative pressure wound treatment system is able to
handle at least 1 L of wound exudate or other fluid per day, or
0.694 ml/min. Some embodiments may handle over 10 L of wound
exudate per day.
In preparing a wound site for treatment with the embodiments
described herein, the wound is typically cleaned, debrided, and
dried in a medically-acceptable manner. Optionally, the wound site
may be filled partly or completely with a wound packing material
102 as shown in FIG. 1, including for example but without
limitation gauze or foam. This wound packing material may be
trimmed to fit into the wound space. Next, a drape 103 is placed to
cover the wound site while overlapping onto the healthy skin
surrounding the wound; in some cases, the drape may need to be
trimmed to size. Depending on the type of drape, a skin sealant may
need to be applied to the skin surrounding the wound prior to
placing the drape so that the drape may be adhered to the skin.
Preferably, the drape 103 has an adhesive layer on its wound-facing
side. Once adhered to the skin, the drape should form an air-tight
seal against the skin. In order to treat the wound using negative
pressure, some embodiments disclosed herein may require that the
drape be pierced (for example to insert a conduit or to communicate
with a suction adapter as described below) to create an aperture
leading to the wound site. Obviously, some drapes may have an
aperture or apertures already pre-cut or preformed into the drape,
and some embodiments disclosed herein may not require an aperture
to be made (as shown in FIG. 1). After application of negative
pressure to the wound site, wound exudate and other fluids may be
drawn away from the wound site and into a suitable receptacle 105,
preferably interposed between the wound site and the source of
negative pressure 106. Application of negative pressure is
continued (with intervening dressing changes, if necessary) until
the wound has reached a desired level of healing.
With reference to FIGS. 2A and 2B, one embodiment of a negative
pressure wound treatment system 201 uses a flexible shroud 202 at
the interface between a flexible drape 203 and a conduit 204. In
dressing a wound to be treated using negative pressure, a wound
packing material 205 as described above may be appropriately sized
and placed into the wound cavity. As shown in FIG. 2A, the wound
packing material 205 may be a foam having an elongate groove or
channel 207 for receiving conduit 204. The drape 203 may be placed
over the wound and over the wound packing material 205, with one or
more apertures 206 formed through the drape that permit wound
exudate to be evacuated from the wound through tube 204 leading to
a negative pressure source. In order to effectively evacuate wound
exudate from the wound, these drape apertures are preferably made
fluid-tight. In the illustrated embodiment of FIGS. 2A and 2B, the
flexible shroud 202 is placed over the aperture in the drape and
around the tube 204, permitting a fluid-tight connection to be made
without the use of cumbersome tape, paste, or other such sealing
materials typically used.
As shown in FIG. 2A, the flexible shroud 202 has a distal end 210
facing toward the wound, and a proximal end 211 facing away from
the wound. The distal end is enlarged relative to the proximal end
to surround the aperture 206, giving the shroud in one embodiment
the shape of a skirt. The distal end 210 preferably has a flat,
distally facing surface, with a layer of adhesive 212 and a release
layer 213 disposed on the distal end of the flexible shroud. The
adhesive may be chosen from any adhesive able to create a
fluid-tight seal, including pressure-sensitive adhesives such as
silicone adhesives. In some embodiments, an adhesive layer is not
necessary, and the flexible shroud 202 is self-sealing against the
drape, for example when suction is applied. In order to seal the
flexible shroud 202 against the conduit 204, a flexible grommet 214
may be provided at the proximal end 211, although some embodiments
may have the flexible shroud be sealed or molded to the conduit 204
without the use of a grommet. The flexible shroud 202 may be fixed
to a single location on the conduit 204, or it may slide freely
along it. If the flexible shroud 202 is fixed to a single location
on the conduit 204, it may be adhered to the conduit with any
suitable means, including adhesives such as cyanoacrylates,
light-activated adhesives, or welding.
In a preferred embodiment, the flexible shroud 202 is constructed
from a pliable plastic material such as polyurethane. Preferably,
the material chosen for the flexible shroud 202 is soft and at
least partially conformable to the skin of a patient to avoid
causing pressure ulcers or other complications due to prolonged
pressure onto patient skin or the wound site.
One method for using the negative pressure treatment system of
FIGS. 2A and 2B is illustrated in FIGS. 2C-2F. An operator may
first debride and clean a wound in a typical manner known to a
medical professional of ordinary skill in the art. As shown in FIG.
2C, a wound packing material 205, as previously described, may then
be placed into the wound; in some cases, the wound packing material
may extend above the level of the skin in the wound. As also
illustrated in FIG. 2C, a drape 203 may be placed over the wound
and the wound packing material 205, preferably overlapping onto the
healthy skin adjacent the wound. Preferably, the drape is adhered
to the skin and/or wound packing material. An aperture 206 is then
made into the drape as shown in FIG. 2D, preferably in proximity to
the wound packing material 205 and along the groove 207 formed in
the wound packing material 205. Although FIG. 2D demonstrates an
aperture 206 being made into the drape 203 with a pair of scissors,
an aperture may be made by any suitable means, and in some
embodiments, the drape 203 may be provided with an aperture pre-cut
into the drape. As shown in FIG. 2E, a conduit 204 as described
above is inserted through the aperture 206 and into the groove 207.
In some cases, trimming or cutting of the tube may be
necessary.
To apply the flexible shroud 202, as illustrated in FIG. 2F,
release sheet 213 is removed to expose the adhesive layer 212 of
the flexible shroud, and the flexible shroud is then adhered over
and around the aperture 206 in order to create a fluid-tight seal.
In certain embodiments, the shroud 202 may slide freely over the
conduit 204; in such cases, the shroud 202 is slid down and adhered
around the aperture 206. In other embodiments where the shroud 202
is attached to and does not slide freely over the conduit 204, the
conduit 204 may need to be trimmed as needed to fit into the wound
space under the drape 203. Preferably, the conduit 204 is slid into
a groove 207 in the wound packing material 205. Subsequently, the
conduit 204 may be connected to a negative pressure source. When
activated, the negative pressure source will collapse the flexible
shroud 202 (as shown in FIG. 2B) and draw wound exudate and other
fluids from the wound area.
Turning to FIGS. 3A-3C, another embodiment of a negative pressure
wound treatment system 301 uses a sealing disc 302 to seal the
interface between the drape 303 and a conduit 304 in a fashion
similar to what is described above. In this embodiment, the sealing
disc 302 comprises an annular lower support disc 310 preferably
constructed from an at least partly-flexible material, such as a
polyurethane layer, with a hole through its center. On the bottom
side of the lower support disc 310, an adhesive layer 312 may be
disposed with an optional protective release layer 313 covering the
adhesive layer, where the protective release layer may be removed
prior to use. This adhesive layer 312 may be used to adhere the
sealing disc 302 to the drape 303.
Preferably, the sealing disc 302 further comprises a seal 311
placed above the lower support disc 310, where the seal is able to
create a fluid-tight seal between itself and a conduit 304. The
seal 311 is preferably constructed from a flexible, conformable
material such as silicone and comprises a central hole 316 that is
preferably smaller than the central hole in the support disc. The
exact size of the seal 311, and its relation in size to the support
disc is not important, as long as the seal is able to create a
fluid-tight seal between itself and the conduit 304. Some
embodiments may comprise a lower support disc 310 with a central
seal 311 integrated into the middle of sealing disc 310 (instead of
above it), to create a one-piece unit construction.
Preferably, the sealing disc 302 also comprises an upper support
disc 315 placed above the other components of the sealing disc,
such that the seal 311 is sandwiched between the upper support disc
315 and lower support disc 310. The top disc may be constructed
from the same material as the support disc, or it may be of a
different material. Preferably, the top disc, the seal, and the
support disc are secured together to form a single sealing disc
302, for example using means such as adhesives or welding.
To use the suction disc 302 described above, and with reference to
FIG. 3D-3H, an operator will typically prepare the wound as
described previously. Once the wound is prepared and a drape 303
placed over the wound (FIG. 3D), the drape 303 is pierced (FIG. 3E)
and the sealing disc's adhesive protective layer 313 is removed
(FIG. 3F) and placed over the resulting aperture 306 (FIG. 3G).
Preferably, the sealing disc 302 is placed with its central hole
316 aligned with an aperture 306 made through the drape 303.
Subsequently, as shown in FIG. 3H, the conduit 304, which may be
cut to size, is inserted through the sealing disc 302 and into the
drape 303, and connected to a source of negative pressure. In some
embodiments, a channel 307 may be formed in the wound packing
material 305, such that the conduit 304 may be slid into this
channel 307. If necessary, a strip of tape or other adhesive 318
may be used to secure the conduit 304 to the drape 303 to prevent
the conduit 304 from undesired movement. The wound is then treated
until it has reached a desired level of healing.
FIGS. 4A-4B illustrate another embodiment of a negative pressure
wound treatment system 401. As illustrated, a flexible drape 403
includes an integrated sealing ring 402 surrounding a pre-made
aperture 406 in the flexible drape. The integrated sealing ring 402
(which may be similar to the embodiment discussed in FIGS. 3A-C)
should be of a diameter large enough to permit passage of a conduit
404, but small enough so that a substantially fluid-tight seal is
maintained once the conduit 404 is inserted therein. The sealing
ring 402 is preferably constructed from a compliant material such a
silicone or urethane. Here, rather than using an adhesive layer to
attach the sealing disc to the drape as shown in FIGS. 3A-C, the
sealing ring 402 is pre-attached to the drape 403, for example by
molding the ring 402 onto the drape 403.
In use and after preparation of the wound as described previously,
and with reference to FIG. 4B, a drape 403 is trimmed, if
necessary, and sealed over a wound site optionally filled with a
wound packing material 405. A conduit 404 is inserted through the
aperture 406 of the integrated sealing ring 402. The tube 404,
which may be cut to size, is connected to a source of negative
pressure, and the wound is treated until it has reached a desired
level of healing.
In FIGS. 5A and 5B, another embodiment of a negative pressure wound
treatment system 501 is shown with a suction adapter 502 comprising
an integrated air leak. The suction adapter 502 comprises upper and
lower layers 511 and 510, which may be annular and/or disc shaped
as shown, and formed of a flexible plastic material. As illustrated
in FIG. 5B, the conduit 504 is preferably sandwiched between the
upper and lower layers 511, 510 and forms a loop within the upper
and lower layers 511, 510. The conduit 504 includes a plurality of
apertures 515 in the looped portion, and the lower layer 510 is
provided with an aperture or apertures 516 enabling it to serve as
a conduit for removing wound exudate from the wound through the
drape aperture or apertures 506 and into the apertures 515 of the
conduit 504 sandwiched in the suction adapter 502. Preferably, a
layer of adhesive 512 is placed on the lower portion 510 to provide
for securing of the suction adapter to the drape. A protective
release layer 513 removable by an operator may also be placed on
the adhesive layer to protect it during handling.
In some embodiments, the conduit 504 may be secured to the upper
and/or lower layers 511, 510 using, for example, a strip of
adhesive, clip, or other fixative 517. In some embodiments, the
fixative 517 may serve as a targeting or visual indicator to aid in
the placement of the suction adapter 502 over the aperture 506.
Preferably, the upper and lower layers 511, 510 of the suction
adapter are sealed together with the conduit 504 to form a
substantially fluid-tight suction adapter 502. The sealing may be
accomplished through any appropriate means, such as adhesives or
welding.
The conduit 504 has a proximal end 518 leading toward a source of
negative pressure and a distal portion inserted into the suction
adapter with its distal end 519 extending past the loop to form a
controlled air leak 520. This air leak 520 provides a constant
source of air entering into the suction adapter 502 and may aid in
the removal of wound exudate. Additionally, this air leak 520, due
to the constant rate at which air enters the negative pressure
system, may be used in a feedback mechanism to the pump control
circuitry and may be useful in detecting blockages occurring in the
system, for example in the conduit 504. Preferably, a filter 521 is
placed at the end of the air leak 520 to prevent outside
contaminants, such as microorganisms, dust, or other foreign matter
from entering the wound area. In some embodiments, the filter 521
may be designed so that a patient may use the system 501 in a
shower or other similar environment without occluding the air leak
520. The filter may be hydrophobic and/or oleophobic. Preferably,
the air leak 520 supports a flow rate of air of at least 0.08
L/min. Some embodiments may support an air leak of at least 0.16
L/min.
In use, and as illustrated in FIGS. 5C-5F, an operator would
prepare a wound site in an acceptable manner as previously
described. As shown in FIG. 5C, an optional wound packing material
505 may then be placed into the wound site, which would then be
covered by a drape 503, appropriately sized and sealed. After
piercing the drape 503 (FIG. 5D), the adhesive protective layer 513
is removed from the suction adapter 502 (FIG. 5E), placed over the
drape aperture 506 (FIG. 5F), and connected to a source of negative
pressure (not illustrated). The wound is then treated substantially
as described previously. Note that in this embodiment, because the
conduit 504 does not need to be inserted through the drape 503, no
groove or channel in the wound packing material 505 (which was
preferably included in certain other embodiments disclosed herein)
is needed in using this suction adapter 502.
FIGS. 6A-6D show another embodiment of a negative pressure wound
treatment system 601. The system comprises a wound packing material
605 and flexible drape 603 as described above. A flexible suction
adapter 602 is further provided for connecting an aperture 606 in
the drape to a conduit 604. Here, the suction adapter 602 is
preferably formed of a relatively compliant and pliable material to
avoid causing patient discomfort and injury, which may include
pressure sores or ulcerations. The suction adapter 602 is connected
via connectors 614, 615 to a source of negative pressure via the
conduit 604. The connectors 614, 615 may be constructed from a
semi-rigid material, including for example but without limitation
plastics such as acrylonitrile butadiene styrene (ABS). In some
embodiments, end caps (not illustrated) may be provided to seal off
one or more of the connectors 614, 615 when they are disconnected
from each other, so as to prevent wound exudate from leaking out of
the system.
The flexible suction adapter 602 comprises an upper layer or sheet
611, a lower layer or sheet 610, and an elongate channel 608
extending between the upper and lower sheets having a proximal end
616 and a distal end 617. As illustrated, the channel preferably
enlarges toward its distal end, and may form an elongated teardrop
shape so as to permit negative pressure to be applied to a larger
wound area at the distal end 617 while maintaining a smaller size
at the proximal end 616 for connecting with the conduit 604.
Additionally, the teardrop shape aids the suction adapter 602 in
conforming to different wound sizes and shapes. The channel 608 as
illustrated includes a spacer 609 extending between the proximal
and distal ends, and at least one aperture 618 is formed on the
lower sheet near the distal end 617 that permits fluid to be
evacuated from a wound area (in a manner similar to what has been
previously described). In some embodiments, there may be multiple
apertures 618 to permit efficient transfer of fluid from the wound.
For example, there may be four smaller apertures instead of one
larger aperture. The spacer 609 is preferably constructed from a
compliant material that is flexible and that also permits fluid to
pass through it if the spacer is kinked or folded over. Preferably,
the spacer 619 is sandwiched between the upper and lower layers 611
and 610, for example using adhesives or heat-sealing. In order to
secure the suction adapter 602 over an aperture 606 on a drape,
lower layer 610 may be provided with a layer of adhesive 612
disposed on its underside, and with an optional protective release
sheet 613.
Suitable materials for the spacer 609 include without limitation
foams, including open-cell foams such as polyethylene or
polyurethane foam, meshes, 3D knitted fabrics, non-woven materials,
and fluid channels. Advantageously, such materials used in the
spacer 609 not only permit greater patient comfort, but may also
provide greater kink resistance, such that the spacer 609 is still
able to transfer fluid from the wound toward the source of negative
pressure while being kinked or bent. In some embodiments, the fluid
channels may simply comprise folds created when the upper sheet is
wider than the lower sheet, or vice versa, such that application of
negative pressure causes the wider sheet to collapse and form folds
or wrinkles suitable to channel fluids from the wound to the source
of negative pressure. An example of such an embodiment is
illustrated in FIG. 8A described below, where a suction adapter may
be constructed from a flexible and non-rigid material such as a
film.
In other embodiments, and as illustrated in FIG. 6C, fluid channels
may comprise one or more solid channels 619, and may not require
the use of the spacer 609 described above. In some embodiments,
these solid channels are molded into either or both the upper and
lower sheets; alternatively, these may be constructed separately
and inserted in the space between the upper and lower sheets. If
possible, such channels are at least partly compliant and
non-rigid, thereby avoiding patient discomfort and other
complications. FIG. 6D illustrates another embodiment where the
spacer 609 comprises a thin mesh 620.
FIGS. 6E-6H illustrate a method of using and applying the suction
adapter 602 described above. The wound is prepared in an acceptable
manner as described above, and a drape 603 is fitted and sealed
over the wound site (which may contain an optional wound packing
material 605) (FIG. 6E). An aperture 606 is then cut into the drape
603 (although some drapes may be provided with an aperture 606
already pre-cut) (FIG. 6F). The release layer 613, if present, is
removed to expose the adhesive layer 612 on the underside of the
suction adapter 602 (FIG. 6G). The suction adapter 602 is then
placed such that the apertures 618 on its underside are
substantially aligned with the aperture 606 on the drape 603. The
suction adapter 602 is then connected to a source of negative
pressure, and the treatment is applied until the wound has reached
an acceptable level of healing.
FIGS. 7A-7B illustrate embodiments of the wound treatment system
701 with an air leak provided, where the conduit used in FIGS. 5A-H
is replaced with a compliant material, for example foam. The
compliant material aspect of these two embodiments will be
described in further detail below. FIG. 7A demonstrates a suction
adapter 702 similar in design to FIG. 5A, but which uses a
compliant material. Here, the compliant spacer channel 707,
preferably constructed from a compliant material such as foam able
to transmit fluid through itself, is connected at its proximal end
718 to a conduit 704, which is then connected directly or
indirectly to a source of negative pressure. At the distal end 719
an air leak 720 is provided, optionally with a filter 721. This air
leak provides a constant source of air entering the suction adapter
702, and (as described previously in FIGS. 5 A-B) may be useful in
detecting blockages in the system (for example the conduit 704) and
may aid in the removal of wound exudate. Preferably, the filter 721
is constructed from a thin membrane, which may be hydrophobic or
oleophobic. The filter 721 is preferably able to filter
microorganisms and foreign particles from entering the wound site.
In some embodiments, the filter 721 is able to be wetted, for
example when a patient enters a shower. The filter 721 may be
die-punched from a membrane stock and attached to the air leak 720
by any suitable means, such as welding or adhesives. This compliant
spacer channel 707 is sandwiched between an upper layer 711 and a
lower layer 710, with the lower layer 710 preferably being provided
with a layer of adhesive optionally covered with a release layer in
a similar fashion to the embodiments illustrated in FIGS. 5A-B. The
lower layer 710 has one or more apertures permitting it to be
fluidically connected to an aperture on a drape used to cover a
wound (not illustrated). The apertures on the lower layer 710 are
also fluidically connected to the compliant spacer channel 707,
such that upon the application of negative pressure, wound exudate
and other such fluids may be evacuated from the wound site through
the aperture in the drape, through the aperture in the lower layer
710, and into the compliant spacer channel 707. Preferably, the
section of the compliant spacer channel 707 situated over the
apertures in the lower layer 710 is larger to permit more effective
removal of wound exudate from the wound site, and may form an
elongated teardrop shape.
Focusing on the air leak aspect of these embodiments, FIG. 7B
illustrates an embodiment with a controlled air leak 720 on the
suction adapter 702 that is provided at the proximal end 718 of the
compliant spacer channel 707, instead of being provided at the
distal end as described above. A filter 721 is optionally provided
at the air leak site. The proximal end 718 is joined to a conduit
704. In a proximal air leak design, the air leak may be disposed at
a "T"-junction between the apertures near the distal end and the
proximal end of the spacer channel 707 connected to the negative
pressure source. Of course, although FIG. 7B illustrates a proximal
air leak using a foam fluid transfer material, such an embodiment
could also be realized using other materials, for instance the
conduit used in FIG. 5A.
FIG. 7C illustrates an embodiment joining a compliant suction
adapter 702 and short compliant spacer channel 707 connected to a
dual lumen tube 704 incorporating an air leak 720 at the proximal
portion 718. Here, one lumen in the tube 704 is fluidically
connected through connector 730 to a source of negative pressure
731 at its proximal end 718, and the other lumen is open at the
proximal end 718 to form an air leak 720. This open end may
optionally include an air filter 721. At the distal end of the dual
lumen tube, both lumens are fluidically connected to the compliant
spacer channel 707 to permit the application of negative pressure
to the wound site through the suction head 702, in a manner similar
to the other embodiments discussed above. In some embodiments, a
compliant spacer channel 707 may not be necessary, and the dual
lumen tube 704 may be directly connected to the suction head.
FIGS. 8A-B illustrate a suction adapter 802 of a similar design to
the embodiments described in FIGS. 6A-H. Here, however, the suction
adapter 802 is not filled with any material, and instead comprises
a flat portion comprising elongate parallel channels 810 integrated
onto the underside of suction adapter 802. These channels 810 may
be molded integrally or attached separately onto the suction
adapter 802. The suction adapter 802 preferably comprises one or
more apertures 816 that would permit a fluidic connection to be
made between an aperture 806 made in a drape 803, such that wound
exudate from a wound site can be drawn through optional wound
packing means 805, through the aperture 806, and into the suction
adapter 802 through its aperture 816. The wound exudate is then
drawn off through the conduit 804. An adhesive layer 812 is
preferably provided on the underside of the suction adapter 802 to
permit it to be secured to the drape 803, and preferably includes a
release layer 813 that is removed prior to adhesion of the suction
adapter 802.
FIGS. 9A and 9B illustrate an embodiment of the wound treatment
system 901 using a drape 903 with a suction channel 902 integrated
therein. In this embodiment, the drape 903 typically used to cover
the wound and the optional wound packing material 905 that may be
disposed in the wound also serves as a suction channel 902 to
transfer fluids such as wound exudate away from the wound using a
source of negative pressure, connected to the drape 903 through
conduit 904. The drape 903 includes at least one aperture 916
suitable for the passage of wound exudate. A spacer 907 is
preferably placed over the apertures 916, the spacer 907 being
preferably composed of the same types of materials as the spacer
609 used in FIG. 6A, such as foam. The drape 903 comprises a top
layer 911 and a bottom layer 910. In order to create a fluid-tight
seal, the top layer 911 is attached to the bottom layer 910,
sandwiching the spacer 907 between it. This top layer 911 should
cover at least the spacer 907, and may be dimensioned to be as
large or larger than the bottom layer 910 situated below it. The
bottom and the top layers 910, 911 may be attached together using
any suitable means, for example adhesives or welding.
An adhesive layer 912 with an optional release sheet 913 is
preferably disposed on the wound-facing side of the bottom layer
910, as well as on the wound-facing side of the top sheet 911, if
the top sheet is larger than the drape. The adhesive layer 912
preferably covers the entire wound-facing side of the drape 903,
and may in some embodiments incorporate a multi-part release sheet
913 rather than a single release sheet 913. In this case, the
release sheet 913 may be removable in several parts, for example to
permit only a portion of the adhesive to be exposed for initial
placement on the wound site, followed by removal of another portion
of the release sheet 913 once the drape placement is finalized. The
components of the assembled drape 903, including the drape itself,
the spacer, and the top layer, may also comprise markings or other
indicators, including visual or tactile indicators, to aid an
operator in aligning, positioning, and deploying the drape.
In order to use the wound treatment system 901 described above and
illustrated in FIGS. 9C-D, a medical professional would to prepare
a wound site and optionally place wound packing material 905 inside
the wound substantially in the manner described previously.
Advantageously, instead of having to then place a drape over the
wound site and create an aperture into the drape, a medical
professional using a drape 903 with an integrated suction channel
would only have to position the drape over the wound site, trim the
drape 903 (if necessary), remove any adhesive release layer 913
(FIG. 9C), and seal the wound by attaching the drape 903 over the
wound site (FIG. 9D). The drape 903 would then be connected to a
conduit 904. This drape 903 would thus save time and avoid
complications and difficulties in having to size and cut a hole in
a drape that the prior art and some of the other embodiments
presently employ.
In some embodiments, illustrated in FIGS. 10A and 10B (which is
similar to the embodiment illustrated in FIG. 9A), the wound
treatment system 1001 incorporates a drape without a separate
spacer. Instead, the suction channel 1002 may comprise one or more
ridges or folds 1010 present on the underside of the suction
channel 1002, the ridges 1010 serving to maintain patency of the
negative pressure connection from the wound to the source of
negative pressure. In some cases, the ridges 1010 may be molded
into either the top layer or the bottom layer of the drape 1003.
Preferably, such ridges 1010 are substantially compliant and
pliable to avoid causing patient discomfort and other
complications.
FIGS. 11A-B demonstrate a variation of the embodiment illustrated
in FIG. 9A, where wound treatment system 1101 uses a drape 1103
incorporating a spacer comprised of bosses 1107 serving to keep the
top layer 1111 and bottom layer 1110 of the drape 1103 separate in
order to form a suction channel 1102 for removal of wound exudate
from a wound site at the aperture 1116. These bosses 1107 may be
molded into the top or bottom layer of drape 1103, or else may be
constructed separately and attached thereto. In some embodiments,
the bosses 1107 are solid; in other embodiments they may be hollow.
Preferably, the bosses 1107 are at least partially compliant and
flexible, and may be formed from any suitable material, such as
flexible plastics including polyurethane. The bottom layer 1110
optionally includes an adhesive layer and release sheet.
FIGS. 12A-B illustrate a wound treatment system 1201 comprising a
flexible one-piece suction adapter. Here, the suction adapter 1202
may be manufactured from a compliant, flexible material such as
plastic, including for example silicone, and comprises a proximal
portion 1218 and a distal portion 1219, where the distal portion
1219 comprises a central aperture 1216 for placement around a wound
site. The edges of the suction adapter may be chamfered (for
example at chamfer 1206) to help seal the suction adapter against
the edges of the wound site, and also minimize the risk of the
suction adapter snagging or catching on other tubes, dressings, or
other materials that may be in proximity to the wound site. Suction
channels 1210 are also provided that serve to draw fluid away from
the wound site through a conduit 1204 and toward a source of
negative pressure connected thereto. In some embodiments,
illustrated in FIG. 12B, the suction channels 1210 are formed
through the proximal portion 1219 of the suction head, and are thus
connected to a source of negative pressure. In other embodiments,
illustrated in FIG. 12A, the suction channels 1210 may not be
enclosed on all or part of the skin-facing portion. Optionally, a
layer of adhesive 1212 is present on the wound-facing side of the
suction head, although some embodiments may instead be
self-sealing, for example if the suction head is constructed
entirely or in part from silicone.
In use, once a wound site is cleaned, prepared in accordance with
typical medical protocols, and optionally filled with a wound
packing material, a first drape is placed over the wound and an
aperture made thereon. Next, the suction adapter 1202 is placed
over the drape aperture, with the central aperture 1216 being
placed over the drape aperture. Subsequently, a second drape is
placed over the wound site and suction adapter 1202. After
connecting the suction adapter to a source of negative pressure
through the conduit 1204, wound exudate is removed from the wound
and the wound may then progress to a desired stage of healing.
FIGS. 13A and 13B illustrate another embodiment of a wound
treatment system 1301 using a piercing cap 1302. Here, the piercing
cap 1302 is provided with a bayonet or other piercing element 1310
suitable for perforating a drape 1303 placed over a wound site. On
the wound-facing side of the drape is a suction base 1307 adapted
to fit together with the piercing cap 1302, typically with a drape
1303 in between. The suction base 1307 is provided with a central
aperture 1311 to be placed over the wound site. In order to fit
together, the piercing cap 1302 and suction base 1307 are
preferably each provided with portions that lock and fit together,
for example locking tabs or screw-like engagement mechanisms 1308
and 1309. In certain preferred embodiments (illustrated in FIG.
13B), the piercing cap 1302 rotationally engages with the suction
base 1307, thereby minimizing the force applied to the wound. Some
embodiments may also include a sealing gasket to prevent air leaks
between the interface of the piercing cap 1302 and the suction base
1307, although the drape 1303 may in some cases provide a
sufficient seal.
In use, a wound site is prepared substantially in the manner that
has been described previously above, but with a suction base 1307
being provided under the drape 1303 at the site over which a
fluidic connection is to be made. After the drape 1303 has been
sealed over the wound site (which may optionally include a wound
packing material 1305), a piercing cap 1302 pierces the drape and
attaches to the suction base 1307, thereby creating a fluidic
connection enabling wound exudate to be conveyed from the wound
site to the source of negative pressure through a conduit 1304. The
wound site may then be maintained as such until it has reached a
desired stage of healing.
FIGS. 14A-B illustrate an embodiment of a wound treatment system
1401 comprising a drape 1403 provided with a wound-packing material
1405 integrated thereon. In this embodiment, a drape 1403
substantially of same material used in the other embodiments
described herein is provided with a wound packing material 1405,
for example foam, attached to the wound-facing side of the drape
1403. Preferably, the adhesive does not attach the entire portion
of the wound packing material to the wound-facing side of the
drape, thus permitting a medical professional using the drape to
easily trim the wound packing material to size. Optionally, precut
or preformed detachable sections 1406 of wound packing material may
be provided. The drape may be secured to the wound-facing material
by a patch of adhesive 1412 disposed in the center of the drape
1403. In some embodiments, a channel 1407 may be provided through
the wound packing material 1405, preferably through the center, so
as to facilitate the placement of a conduit 1404 into the wound
treatment system 1401. Optionally, the wound treatment system 1401
may be provided with such a conduit 1404 pre-attached or adhered
into the channel 1407. Such an arrangement may be advantageous in
providing optimal application of negative pressure to the wound
site through the conduit 1404. Optionally, a seal bridge 1408 may
be provided at the junction where the conduit 1404 exits the drape
1403, thereby sealing the wound site and preventing air leaks that
may affect the application of negative pressure to the wound site.
Preferably, the drape 1403 is provided with a further adhesive
layer (not illustrated here) surrounding the adhesive patch 1412
and extending to the edges of the drape 1403, which is preferably
covered with a release sheet (not illustrated here). Such a
configuration permits an operator to accurately place the wound
treatment system 1401 over a wound site and seal the drape 1403
against the skin surrounding the wound site by removing the release
sheet once the drape 1403 and wound packing material 1405 have been
positioned and sized appropriately. In some embodiments, additional
adhesives, for example sealing tape, may be provided to aid in
sealing the drape 1403 to the skin of a patient.
In order to use the wound treatment system 1401 described above, a
wound site is cleaned and prepared in any suitable manner. Next,
the wound packing material 1405 attached to the drape 1403 is
fitted into the wound site, by trimming the wound packing material
and/or by removing precut or preformed sections 1406 (if so
provided) as necessary as well as by trimming the drape 1403 if
necessary. A conduit 1404 is then inserted into a channel 1407, and
after trimming (if necessary) and sealing the drape 1403 against
the skin of the patient, the conduit 1404 is connected to a source
of negative pressure and the wound is treated until it reaches a
desired level of healing. In some embodiments, the conduit 1404 is
provided pre-inserted into the channel 1407.
FIGS. 15A-D illustrate an embodiment of a negative pressure wound
treatment system 1501 comprising a flexible suction adapter. This
system may be combined with other components as described elsewhere
in this application, for example the components illustrated in FIG.
7C, and particularly the source of negative pressure 731, tubing
and a connector 730. Here, the system 1501 may comprise a bridge
1502 having a proximal end 1503 and a distal end 1505 and an
applicator 1520 at the distal end 1505 of the bridge 1502. In some
embodiments, the bridge 1502 may comprise an upper channel layer
1512 sandwiched between an upper layer 1510 and an intermediate
layer 1514, with a lower channel layer 1516 sandwiched between the
intermediate layer 1514 and a bottom layer 1518. Preferably, the
layers 1510, 1514, and 1518 have elongate portions extending
between proximal and distal ends and may be comprised of a material
that is fluid-impermeable, for example polymers such as
polyurethane. It will of course be appreciated that the layers
1510, 1514, and 1516 may each be constructed from different
materials, including semi-permeable materials. Similarly to the
embodiment described in FIG. 6 with regards to the spacer 609, the
upper and lower channel layers 1512 and 1516 are preferably
elongate layers extending from the proximal end 1503 to the distal
end 1505 and may each preferably comprise a porous material,
including for example open-celled foams such as polyethylene or
polyurethane. In some embodiments, one or more of the upper and
lower channel layers 1512 and 1516 may be comprised of a wicking
fabric, for example a knitted or woven spacer fabric (such as a
knitted polyester 3D fabric, Baltex 7970.RTM., or Gehring 8790) or
a nonwoven fabric. These materials selected are preferably suited
to channeling wound exudate away from the wound and for
transmitting negative pressure and/or vented air to the wound site,
and may also confer a degree of kinking or occlusion resistance to
the channel layers 1512 and 1516. In some embodiments, the wicking
fabric may have a three-dimensional structure, which in some cases
may aid in wicking fluid or transmitting negative pressure. To
prevent the channels 1512 and/or 1516 from being displaced or
twisted while encased in the system 1501--which may impair
performance of the respective channels under negative pressure--it
may in some embodiments be preferable to adhere or otherwise secure
the channels 1512 and/or 1516 to one or more of the layers 1510,
1514, and 1518. In certain embodiments, including wicking fabrics,
these materials remain open and capable of communicating negative
pressure to a wound area under the typical pressures used in
negative pressure therapy, for example between 80 to 150 mmHg. In
some embodiments, the wicking fabric may comprise several layers of
material stacked or layered over each other, which may in some
cases be useful in preventing the channel 1516 from collapsing
under the application of negative pressure. In other embodiments,
the wicking fabric used in channel 1516 may be between 1.5 mm and 6
mm; more preferably, the wicking fabric may be between 3 mm and 6
mm thick, and may be comprised of either one or several individual
layers of wicking fabric. In other embodiments, the channel 1512
may be between 1.2-3 mm thick, and preferably thicker than 1.5 mm.
Additionally, and as described previously, the materials used in
the system 1501 are preferably conformable and soft, which may help
to avoid pressure ulcers and other complications which may result
from a wound treatment system being pressed against the skin of a
patient.
Preferably, the distal ends of the layers 1510, 1514, and 1518 and
the channels 1512 and 1516 are enlarged at the distal end (to be
placed over a wound site), and may form a "teardrop" or other
enlarged shape. Preferably, and with additional reference to FIG.
15C, a connector 1504 is provided at the proximal end 1503 which
may be used to connect the lower channel layer 1516 to a source of
negative pressure. The connector 1504 may for example be embedded
into the lower channel layer 1516, and preferably extends
sufficiently away from the assembled bridge 1502 so as to permit a
fluidic connector, for example a tube, to be connected to it so as
to permit wound exudate to be suctioned away from the wound and for
negative pressure to be applied to the wound site. The upper layer
1510 may comprise additional material extending downward,
preferably at least of the thickness of the bridge 1502. During
assembly, the upper layer 1510 is preferably attached, for example
by melting, welding, or with adhesives, to the lower layer 1518 so
as to form a fluid-tight seal (with the exception of the apertures
at the distal and proximal ends). Preferably, the middle layer 1514
is attached to the top layer 1510 and the bottom layer 1518. Note
that FIG. 15C is intended to illustrate the various materials and
components at the proximal end 1503, and that a system 1501
constructed accordingly will preferably not have the proximal end
1503 open and unsealed. In some embodiments, it will be preferable
to attach or bond the connector 1504 to at least one of the layers
1510, 1514, 1518 so as to create a fluid-tight connection.
In certain embodiments, a controlled air leak 1524 may be disposed
on the bridge portion 1502, for example at the proximal end
thereof. This air leak 1524 may comprise an opening or channel
extending through upper layer 1510, such that the air leak 1524 is
in fluidic communication with the upper channel 1512. Upon the
application of suction to the system 1501, air will enter through
the air leak 1524 and move from the proximal end 1503 to the distal
end 1505 along the upper channel 1512. The air will then be
suctioned into the lower channel 1516 by passing through the
apertures through the distal ends of the layers 1512, 1514, 1516
and 1518. The air leak 1524 preferably comprises a filter (not
illustrated), which may be similar in function to the filter 521
illustrated in FIG. 5A. Preferably, the air leak 1524 is located at
the proximal end of the bridge portion 1502 so as to minimize the
likelihood of wound exudate or other fluids coming into contact and
possibly occluding or interfering with the air leak 1524 or its
filter. In some embodiments, this filter is a microporous membrane
capable of excluding microorganisms and bacteria, and which may be
able to filter out particles larger than 45 .mu.m.
Advantageously, some embodiments may provide for a filter that is
at least partially chemically-resistant, for example to water,
common household liquids such as shampoos, and other surfactants.
In some embodiments, reapplication of vacuum to the system 1501
and/or wiping of the outside portion of the filter may be
sufficient to clear any foreign substance occluding the filter. The
filter may be composed of a suitably-resistant polymer such as
acrylic, polyethersulfone, or polytetrafluoroethylene, and may be
oleophobic and/or hydrophobic. In some embodiments, the filter may
also comprise a supporting backing layer, for example a non-woven
polyester support. Preferably, the air leak 1524 will supply a
relatively constant air flow that does not appreciably increase as
additional negative pressure is applied to the system 1501. In
embodiments of the system 1501 where the air flow through the air
leak 1524 increases as additional negative pressure is applied,
preferably this increased air flow will be minimized and not
increase in proportion to the negative pressure applied
thereto.
The system 1501 is preferably constructed so as to provide a
consistent fluid flow even if the system 1501 is kinked or weighted
down. For example, in use on a patient, the bridge portion 1502 may
become folded over itself, or else the patient may roll over, thus
placing his or her weight over at least a portion of the system
1501. Typically, prior art dressings and fluidic connectors become
blocked or ineffective in such situations. Here, however, certain
embodiments provide for improved blockage resistance if kinked or
weighed down. Preferably, the system 1501 is able to maintain a
flow rate through the air leak 1524 of at least 0.08 L/min, and
preferably 0.12 L/min while negative pressure is applied through a
source of negative pressure. Further embodiments also provide for
the system 1501 to be able to handle fluid exudate drainage from
the wound site through the lower channel 1516 of at least 10 L/day,
or 6.9 ml/min. Certain embodiments provide for the system 1501 to
maintain these flow rates with a weight, for example a 12 kg weight
pressing down on the bridge portion through a rod with a 1 in.
diameter. In some embodiments, these flow rates are also maintained
while the bridge portion 1502 is kinked over itself with the same
weight, or for example with a 4.75 kg weight placed directly on the
folded region. It is preferable that the system 1501 be able to
withstand being folded or kinked over even during an extended
period of time, for example over 40 hours. Preferably, embodiments
of the system 1501 are also able to transmit and maintain a
negative pressure at the wound that is close to the negative
pressure level at the source of negative pressure. For example, an
acceptable level of pressure maintained at the wound may be within
.+-.25 mmHg of the negative pressure set at the source of negative
pressure, with this pressure being preferably maintained at this
level within for example 95% of the time that the system 1501 has
negative pressure applied to it. Acceptable pressure levels may
include pressure ranges between 40-120 mmHg, although levels of 200
mmHg have successfully been used.
With additional reference to FIG. 15D, the system 1501 also
comprises an applicator 1520 designed for placement over a wound
site. Preferably, the applicator 1520 comprises a flexible layer
1530, for example polyethylene or polyurethane, with a layer of
adhesive on its lower (wound-facing) side. Optionally, a protective
release layer 1532 may be placed on the adhesive layer, which is
removable before use. In some embodiments, a more rigid removable
backing layer 1534 may be provided to facilitate handling of the
applicator 1520 due to its flexible adhesive-backed layer 1530. The
applicator 1520 preferably comprises an attachment point for the
bridge 1502 at the distal end 1505, for example using a section of
double-sided adhesive tape 1528. The double-sided adhesive tape
1528 may be protected by an additional protective release layer
1529, which is removed prior to adhering the bridge 1502 to the
applicator 1520. It will be understood that different attachment
methods are also contemplated, for example heat sealing, welding,
or suitable adhesives. Some embodiments may also permit the
manufacture of the bridge 1502 and the applicator 1520 as a single
unit that does not require separate attachment means. The
applicator 1520 preferably comprises at least one aperture 1526
through itself and designed to be placed over a wound site, and
which can serve to fluidically connect the wound site to the source
of negative pressure and to the air leak while also serving as a
conduit to draw out wound exudate from the wound site.
Additionally, certain embodiments may provide for the aperture 1526
to be used in a viewing window 1522 described below.
With continued reference to FIGS. 15A-B, certain embodiments may
also provide for a viewing window 1522 that permits targeting and
visualization of the wound site prior to placement of the system
1501 as well as ongoing monitoring of the wound site during the
course of treatment. Preferably, a set of apertures are created or
formed through the distal portions of layers 1510, 1512, 1514,
1516, and 1518 in alignment with aperture 1526 through the
applicator 1520. Although FIG. 15B illustrates a set of apertures
with a circular cross-section, other cross-sections are possible,
for example with a polygonal or rectangular cross-section.
Preferably, a viewing window 1522 which is at least partially
transparent is provided to cover the first aperture through the top
layer 1510 to shield the wound from contamination.
The filter provided in the controlled air leak 1524 in certain
embodiments may be useful in a system 1501 for use with more
ambulatory and active patients. For example, a chemically-resistant
filter may permit a patient to bathe or shower without damaging the
filter's functionality when reconnected to a source of negative
pressure. Any occlusion or fluid blocking the air leak 1524 could
then be cleared by, for example, wiping off the filter or
re-applying negative pressure to the system 1501. Such a system
would also have the advantage that the system 1501 and any assorted
wound dressing materials, if present, would not need to be removed
and then re-applied should a patient need to be disconnected from
the source of negative pressure, for example incidental to bathing.
This would entail significant advantages in improving the
cost-effectiveness and ease of use of the present treatment
system.
In use, the system 1501 may be used in a similar fashion to the
other embodiments previously disclosed herein. A wound site is
preferably cleaned and prepared in a suitable fashion, and a wound
packing material, if necessary, placed into the wound site,
followed by a drape. An opening through the drape to the wound site
is then created, although some embodiments may have a pre-made
aperture. Subsequently, an operator may situate the applicator
portion 1520 over the aperture, optionally using the viewing window
1522 as a positioning aid. After removing the backing layer (if
present) from the adhesive layer on the underside of the applicator
portion 1520, the applicator is sealed to the drape, and the
support layer (if present) is also removed from the applicator
portion 1520. A fluidic conduit such as a tube may then be
connected to the connector 1504. After the fluidic conduit is
connected to a source of negative pressure, preferably with a
container suitable for containing wound exudate interposed
therebetween, the application of negative pressure may then be
effectuated to the wound site until the wound site progresses to a
desired level of healing.
During use of the system 1501, wound exudate is drawn by the
negative pressure through the lower channel layer 1516. The air
leak 1524 allows air to pass through the upper channel layer 1512
into the apertures through the distal ends of the layers 1512,
1514, 1516 and 1518. The negative pressure draws air passing
through the upper channel layer into the lower channel layer 1516
back toward the source of negative pressure or pump. In some
embodiments, the controlled air leak 1524 provides a constant flow
of air through the system 1501, which then may be used to determine
whether blockage or leakage is present. Causes of blockage can
include, for example, situations where the lower channel 1516
becomes occluded with wound debris. Leakage causes can include, for
example, improper sealing of the drape over the wound site, or
physical damage to the system 1501 leading to excess air leaking
into the system. The blockage or leakage may be determined, in
certain embodiments, by measuring the speed of the pump while the
pump works to maintain a constant negative pressure. Pump speed may
also be measured indirectly by measuring the amount of voltage or
signal sent to the pump.
FIG. 16A illustrates a wound treatment system 1601 similar to the
embodiment described in FIG. 9. Here, a top layer 1603 (illustrated
with a square or rectangular shape) is preferably constructed from
a liquid-impermeable material, although it is preferably at least
partially gas and water vapor permeable. A bottom layer 1607
(illustrated with a square or rectangular shape) may then be
attached or bonded to the top layer 1603, for example using
adhesives or welding, while sandwiching a wicking layer 1605
between these two layers. The bottom layer preferably has a layer
of adhesive (not illustrated) disposed on at least part of the
wound-facing side, which may be protected by an optional protective
layer 1608 (illustrated in FIG. 16B). Preferably, at least the
layers 1603, 1607, and 1608 are constructed of a material that is
easily cut, for example with scissors, so that the system 1601 may
be sized as appropriate for placement over a wound site.
The bottom layer 1607 preferably has at least one aperture 1606
capable of creating a fluidic connection between a wound site
disposed under the aperture and the wicking layer 1605. This
wicking layer 1605 is preferably an elongate layer placed between
the layers 1603 and 1607, constructed from a material capable of
wicking or transporting fluid from a wound site, especially while
under suction. Suitable materials include but are not limited to
foams as described above, woven materials, 3D knitted materials,
materials constructed of from either or both hydrophilic materials
(such as cotton), hydrophobic materials (such as polyethylene), or
a mixtures of both. Either or both the top or bottom layers may
have a channel 1612 suitable for containing the wicking layer 1605,
and this channel and wicking layer are preferably enlarged at the
distal end closest to the aperture 1606. As illustrated, the
wicking layer 1605 has an enlarged end with a circular shape place
over the aperture 1606. Preferably, a fluidic connector 1610 is
attached to the top layer 1603 to permit a suction tube or other
conduit 1604 to create a fluidic connection between the wound
space, the wound treatment system 1601, and a source of negative
pressure.
FIG. 16B illustrates a method of using the system 1601, where the
system 1601 is cut to size and secured to the wound. In some
embodiments, a strip of tape or other fixative may be used to
secure the tube 1604 to the connector 1610.
FIG. 17A illustrates an embodiment of a negative pressure wound
treatment system 1701. The system 1701 preferably has a low-profile
port 1712 integrated into a drape 1703 (illustrated with a square
or rectangular shape), where the port 1712 preferably situated
along one side of the drape 1703. The port 1712 is preferably sized
to permit one side of a fluidic connector 1710 to be connected to
it. The other side of the connector 1710 is preferably sized to
permit a conduit or tube 1704 to be connected, although some
embodiments may permit the conduit 1704 to be connected directly to
the port 1712 without the use of a connector 1710. Preferably, the
port 1712 is attached over an aperture through the drape 1703,
permitting a fluidic connection to be made from the wound site
through the port 1712, through the fluidic connector 1710, and into
the conduit 1704, which is preferably connected to a source of
negative pressure. A layer of adhesive may also be provided on all
or some of the wound facing side of the drape 1703, and which may
be protected by a release layer 1708.
FIG. 17B illustrates a method of using the system 1701 described
above, where the drape 1703 is cut to size and applied to the
wound.
FIG. 18A illustrates an embodiment of a negative pressure treatment
system 1801 similar to FIG. 6A. In a preferred embodiment, a
flexible wicking layer 1805 is sandwiched between a top layer 1803
and a bottom layer 1808, where the bottom layer 1808 is preferably
provided with at least one aperture 1806 to expose the wicking
layer to a wound site. Similarly to other embodiments, an adhesive
layer and an optional protective layer may be disposed on the
wound-facing side of the bottom layer 1808. A fluidic connector
1810 may be disposed at the proximal end of the system 1801 so as
to create a fluidic connection between the wound site and a source
of negative pressure through a conduit 1804. Preferably, the system
1801, and in particular the layers 1803, 1805, and 1808, are
flexible and conformable to aid in the placement over a wound site
located on, for example, a non-flat or difficult to access area of
the body, such as a heel.
FIG. 18B illustrates a method of using the system 1801. As
illustrated the system 1801 is applied to a drape having an
incision or hole extending through the drape. In some embodiments,
a strip of tape or other fixative may be used to secure the tube
1804 to the connector 1810.
FIGS. 19A-B illustrate embodiments of a negative pressure treatment
system 1901. With reference to FIG. 19A, the system 1901 comprises
an exposed wicking layer 1905 extending from a flat drain portion
1903. The drain portion 1903 is preferably integrated with a tube
or conduit 1904, and tapers down to become wider and flatter at its
distal end. Preferably, the drain portion 1903 and the conduit 1904
are formed together as a single unit. The drain portion 1903 is
also preferably constructed from a soft elastomeric material,
including for example silicone, polyurethane, polyethylene, and/or
polyvinylchloride, and which is able to conform to a wound site and
spread out any pressure over a larger area. The wicking portion
1905 is preferably constructed from a soft material able to
transmit fluid along itself, for example a nonwoven, open textile
material (such as cotton gauze or XD spacer fabric (Baltex.RTM.)),
thereby permitting it to be placed over or into a wound site so as
to drain wound exudate and transmit negative pressure to the wound
site. Some embodiments of the system 1901 may also provide for a
controlled air leak 1916, similar to the air leak 1524 described in
FIG. 15A. In certain embodiments, this air leak 1916 may be in the
form of a one-way valve which opens and permits air to enter the
system when high negative pressure is applied.
FIG. 19B illustrates another embodiment of the negative pressure
treatment system 1901. Here, the drain portion 1903 may be partly
bifurcated to permit a lumen 1918 attached to a controlled air leak
1916 to reach the area close to the wound site. This air leak 1916
preferably includes a filter element 1917 to prevent particulates
and other contaminants from entering the wound site. The drain 1903
is preferably flat and tapered so as to present a low profile on
the wound, and is preferably constructed of a soft elastomeric
material of the type described above. To facilitate drainage of
exudate from the wound, an aperture or apertures 1906 may be
provided along the wound-facing portion of the drain. Turning back
to the air leak 1916, certain embodiments provide for the proximal
end of the air leak 1916 (closest to the air filter 1917) to be
accommodated on a suction adapter 1910, for example in a notch 1920
made in the adapter 1910. The suction adapter 1910 is preferably
designed to receive a tube or conduit 1904 and connect it to the
drain 1903.
FIGS. 19C-D illustrate methods of using embodiments of the system
1901 described above.
FIG. 20A illustrates an embodiment of a negative pressure wound
treatment 2001 comprising a trimmable suction port. A suction head
2006 is attached to a tail 2008 (although the head 2006 and tail
2008 may be formed as a single unit), where the tail 2008 comprises
a channel 2009 disposed longitudinally inside to create a channel
leading from the wound site, through at least one aperture 2012
disposed on the wound-facing side of the suction head 2006, and to
a source of negative pressure. Preferably, this channel 2009 is
sized to accommodate the insertion or attachment of a suction
adapter 2010 and/or a conduit or tube 2004. The head 2006, although
illustrated as being round, may be of any suitable shape, and
preferably comprises a layer of adhesive disposed on its
wound-facing side for attachment to a drape. Similar to
previously-described embodiments, this adhesive layer is preferably
protected by a removable backing layer.
The suction adapter 2010 may be sized to taper from a shorter,
wider cross-section at its distal end inserted into the channel
2009 to a rounder profile at its proximal end to permit insertion
or attachment of a tube 2004. Some embodiments may provide for a
controlled air leak 2016 similar in design to other examples
previously illustrated.
The tail 2008 is preferably constructed from a flexible,
conformable material capable of being trimmed or cut, for example
during sizing of the system 2001 for placement over a wound site.
Accordingly, an operator may trim the tail 2008 as appropriate for
the size and location of the wound site, followed by the insertion
of, preferably, the suction adapter 2010 into the channel 2009,
although some embodiments provide for the insertion of a tube 2004
directly into the channel 2009 without necessitating the use of a
suction adapter 2010.
FIG. 20B illustrates a method of using the system 2001 described
above.
FIG. 21A illustrates another embodiment of a negative pressure
wound treatment system 2101 comprising a sealing ring similar to
the system 301 illustrated in FIG. 3A. Here, a sealing disc 2103 is
preferably constructed from a flexible, resilient material able to
seal against a tube or conduit 2104 that is inserted through the
sealing disc 2103's central aperture 2106 so as to create a
fluid-tight seal. A preferred material may include silicone or
polyurethane, although hydrogels may be used as well. Preferably,
an adhesive layer 2108 is disposed on the wound-facing side of the
disc 2103, optionally protected by a removable backing layer.
In use, and with further reference to FIG. 21B, the sealing disc
2103 is positioned over a drape covering a wound site, and the
adhesive layer of the disc adhered to the drape. Flaps 2110 may
also be provided to form a template or cutting guide for cutting a
hole through the drape, in addition to serving as additional
sealing means against the tube 2104. In some embodiments, the flaps
2110 may be arranged, for example, to form a cross or "X" shape,
such that a cutting implement such as a scalpel can be used to form
a correspondingly-sized aperture in the underlying drape.
Subsequently, a conduit 2104 may be pushed through the aperture
created through the drape. After verifying that the conduit 2104
has formed a fluid-tight seal against the disc 2103 and/or the
flaps 2110, negative pressure therapy may be applied until the
wound has reached a desired stage of healing.
FIG. 22A illustrates an embodiment of a negative pressure wound
treatment system 2201 incorporating a suction port with a piercing
attachment. The system 2201 comprises a port 2203 adapted for
placement over a wound site, and more preferably over a drape
situated over a wound site prepared substantially in the same
manner as previously described. The port 2203 preferably comprises
an aperture 2218 for placement over a wound site, and this side of
the port 2203 preferably comprises an adhesive layer 2216,
optionally protected with a backing layer and adapted to adhere to
a drape or to patient skin. The port 2203 preferably also comprises
a side aperture 2206 sized to permit a fluidic connector 2210 to be
connected to it. Advantageously, some embodiments permit for the
port 2203 to be of a relatively small size, such that smaller
wounds may be effectively treated. In some embodiments, the
connector 2210 may comprise a piercing end 2212, where this
piercing tip 2212 is sharpened or otherwise adapted to perforate a
drape positioned over a wound site when pushed through the aperture
2206 so that the tip 2212 extends past the lower aperture 2218.
This tip 2212 may also be adapted to create a fluidic connection
between a tube or conduit 2204 connected to it. The other side of
the fluidic connector 2210 is preferably a blunter and shorter end
2214. This end 2214 is preferably able to create a fluid-tight seal
between the fluidic connector 2210 and the aperture 2206, and
preferably does not extend past the aperture 2218 when inserted
into the aperture 2206. Preferably, the port 2203 also comprises a
controlled air leak 2216 similar to the embodiments previously
described, and which may be provided with a filter 2217.
In use, and with further reference to FIG. 22B, a wound site may be
prepared substantially in a manner previously described and sealed
with a drape. The port 2203 may then be situated over an
appropriate position over the drape, and then adhered to the drape.
The piercing tip 2212 of the fluidic connector 2210 may then be
pushed through the side aperture 2206 and past the bottom aperture
2218 so as to create an aperture in the drape positioned over the
wound site. The connector 2210 may then be pulled out from the
wound site and reversed so that the blunt end 2214 may then create
a fluid-tight seal to the aperture 2206. The piercing tip 2212 may
then be connected to a tube 2204, for example by slipping the end
of the tube 2204 over the end 2212, although other connection means
are possible. A suction source may then be activated, and negative
pressure is applied to the wound and wound exudates and other
materials suctioned from the wound site until the wound has reached
a desired level of healing.
FIG. 23A illustrates a fluidic connector used in a negative
pressure wound treatment system 2301. This system 2301 preferably
comprises a port 2303, which may be shaped in a low-profile bridge
shape with a flat side against a wound site. The port 2303 is
preferably placed under a drape, with the drape sealed over it.
Preferably, the port 2303 comprises at least one aperture 2306 on
its wound-facing side, adapted to convey fluid away from a wound
site and negative pressure to a wound site. The port 2303 may also
be provided with a side aperture 2308 leading into a channel 2309,
where the channel 2309 connects to the aperture 2306. The aperture
2308 and channel 2309 are preferably sized to receive a piercing
fluidic connector 2310. This connector 2310 may be provided with a
piercing tip 2312 at its distal end, where the piercing tip 2312 is
sharpened or otherwise designed to create an aperture through a
drape placed over the port 2303 to permit a fluidic connection to
be made between the connector 2310 and the port 2303. Preferably,
the port 2303 is constructed from a softer, more conformable
material which may also serve to seal against the connector 2310 to
aid in creating a fluid-tight seal. Some embodiments may provide
for the connector 2310 to have a controlled air leak 2316, which
may also be provided with a filter or a one-way valve. The one-way
valve may be designed to open only under high negative pressure.
The connector 2310 preferably comprises an aperture on its
underside (not illustrated) so as to create a fluidic connection
between itself and the aperture 2306. The proximal side 2314 of the
fluidic connector is preferably constructed so as to be able to
attach or connect a tube or conduit 2304 to it, where the tube 2304
is connected to a source of negative pressure.
FIG. 23B illustrates a method of using the system 2301 described
above.
FIGS. 24A-B illustrate an embodiment of a negative pressure wound
treatment system 2401 which comprises a port 2405 situated under a
drape 2403 pierceable by a piercing fluidic connector 2410. The
port 2405 is preferably situated over a wound site in need of
treatment, and sealed under a drape 2403, although certain
embodiments may instead provide for this port 2405 to be provided
with adhesive means enabling it to be situated over an aperture
made in a drape 2403. The port 2405 preferably contains at least
one large aperture 2406 on its wound-facing side permitting the
application of negative pressure to the wound and the removal of
exudate from the wound site, in addition to two side ports 2420,
2422. The system 2401 preferably comprises a piercing fluidic
connector 2410 provided with piercing tips 2412, 2413 able to
pierce through the drape 2403 so as to fluidically connect to
apertures 2420, 2422. One tip, illustrated for example here as tip
2412, may be used to create a fluidic connection from a tube or
conduit 2404 through to the aperture 2420, where the tube 2404 is
connected to the fluidic connector 2410 through hose fitting 2418.
Another tip, illustrated for example as tip 2413, may serve as to
create a conduit suitable for a controlled air leak 2415 through
the aperture 2422 similar to those previously described. An air
filter 2416 may optionally be provided.
FIGS. 25A-B illustrate an embodiment of a wound treatment system
2501 comprising a drape 2503 with a manifold 2520 integrated
therein. In certain embodiments of the system 2501, a drape 2503 is
provided which is trimmable and may be sealed over a wound site. A
manifold 2520 may integrated or attached over a portion of the
drape 2503 preferably the section of the drape 2503 which is to be
placed over a wound site to be treated--and the manifold 2520 may
contain multiple apertures or perforations suitable for channeling
suction to the wound site and for suctioning away exudate and other
fluids from the wound site. Preferably, a controlled air leak 2514
is provided that is in fluid communication with the wound site, and
may for example be located in the middle of a loop that may be
formed with the manifold 2520 around a wound site. This air leak
preferably comprises a filter 2515. The manifold 2520 is preferably
connected to a fluidic connector 2510, which may be used to connect
to a tube or conduit 2504.
FIGS. 26A-B illustrate an embodiment of a negative pressure wound
treatment system 2601 of a similar construction to the embodiments
illustrated in FIGS. 25 A-B, but with an air leak 2614 provided on
a fluidic connector 2610 rather than being formed in a central
aperture. A manifold 2620 is preferably integrated or attached to
the drape 2603, preferably in a semi-circular or looped
configuration, with perforations or apertures suitable for
conveying negative pressure and/or exudate from the wound site.
This manifold 2620 is preferably connected to the fluidic connector
2610 so as to fluidically connect the wound site with a tube or
conduit 2604 connected to a source of negative pressure. A second
manifold 2621, connected to the air leak 2614, is preferably
arranged in a similar semi-circular or looped arrangement around
the manifold 2620, and permits air from the outside environment to
enter into the wound site. Preferably, the air leak 2614 is
protected with a filter 2615 to prevent outside contaminants from
entering the wound site. In a similar fashion to the embodiment
described in FIGS. 25 A-B, the drape 2603 may be trimmable for
sizing purposes and may be sealed over a wound site.
FIGS. 27A-C illustrate an embodiment of a negative pressure wound
treatment system 2701 comprising a conformable wound drainage
device with separate controlled air leak paths. In a preferred
embodiment, a drape 2703 is provided with a conformable suction
bridge 2712 preferably constructed from a fluid-impermeable
material 2722. The bridge 22712 is preferably filled with a
fluid-channeling material 2720, for example open-celled foam, that
is at least partly resistant to occlusion due to pressure or
kinking. The bridge 2712 may be bonded to or integrated with the
drape 2703, or may be attached using any suitable means. The bridge
2712 is preferably provided with one or more apertures on its
wound-facing side to permit wound exudate to be drawn away from the
wound site using a source of negative pressure. The source of
negative pressure is connected to the system 2701 through a conduit
2704 attached to a fluidic connector 2710 connected to the bridge
2712. A controlled air leak 2714 may also be provided at a location
separate from the bridge 2712, with one or more air channels 2716
connecting to one or more apertures 2718 located near the wound
site. Preferably, the air leak 2714 is provided with a filter
2715.
FIGS. 28A-B illustrate embodiments of a negative pressure wound
treatment system 2801 comprising a controlled air leak 2814
integrated into a portion of a suction head 2805. The air leak 2814
causes air to be drawn into the suction head 2805, aiding in
suctioning exudate from the wound site through the aperture or
apertures 2806 disposed on the wound-facing side of the suction
head 2805. Similarly to other embodiments, a fluidic connector 2810
provides a connection between a tube or conduit 2804 leading to a
source of negative pressure and the suction head 2805. Preferably,
the suction head 2805 has a layer of adhesive on its wound-facing
side to permit attachment over an aperture made on a drape 2803
situated over a wound site. Other embodiments may instead provide
for the drape 2803 to be integrated or attached to the suction head
2805 with a pre-formed aperture to be situated over the wound
site.
FIGS. 29A-B illustrate embodiments of a negative pressure wound
treatment system 2901 comprising a distributed negative pressure
manifold. The system 2901 comprises a suction tail 2905 connected
or attached to a suction head 2908, where the head 2908 comprises
one or more projections 2910 extending outwardly from the center of
the head 2908. As illustrated in this particular embodiment,
several projections 2910 may form a web or starburst configuration,
although other configurations are also possible, and may include
further interlinking of the projections 2910. Each projection 2910
preferably comprises a central channel 2912 extending along the
length of the projection 2910 and connected in the center of the
suction head 2908. The channel 2912 is preferably connected to one
or more apertures 2906 disposed along its length and suitable for
suctioning wound exudate from a wound site. Preferably, a
centrally-located controlled air leak 2914 communicating with the
wound site is present, with a filter 2915 to keep particulates and
other contaminants from entering the wound site. The filter 2915
may be constructed from any suitable material, for example
Gore-Tex.RTM.. In some embodiments, at least a portion of the tail
2905 may be provided with a layer of adhesive on its wound-facing
side, which can serve to better adhere to patient skin and seal the
wound site.
In use, and with continued reference to FIGS. 29A-B, a wound site
is prepared and cleaned in substantially the same way as described
previously. The suction head 2908 is then trimmed as necessary to
fit the wound site; the trimming may include cutting through the
projections 2910. If so provided, an adhesive protective layer may
be removed from the wound-facing side of the tail 2905 to adhere
against the patient skin. Subsequently, a drape 2903 may be placed
over the suction head 2908 and sealed to the skin surrounding the
wound. A conduit 2904 connected to a source of negative pressure is
then connected to the tail 2905, thus applying negative pressure to
the wound site. When used, the head 2908 may be designed so that
the drape 2903 seals against all or part of the open ends of the
channels 2912 in the projections 2910 when the head 2908 is
trimmed.
FIGS. 30A-B illustrate an embodiment of a wound treatment system
3001 provided with a piercing nozzle 3010. Here, certain
embodiments provide for the piercing nozzle 3010 to be mounted or
attached to a plate 3008, where the plate 3008 is preferably
perforated so as to effectively serve as a distribution manifold
for negative pressure to the wound site and as a conduit to channel
exudates away from the wound site. In certain embodiments, multiple
piercing nozzles 3010 may be provided, and which may be distributed
over the plate 3008. The piercing nozzle is preferably designed to
have a sharp edge suitable for piercing a drape, for example a
drape 3003 placed over a wound site and over the piercing nozzle
3010 and plate 3008, and the nozzle 3010 is also preferably
comprises a conduit or channel therein suitable for conveying fluid
and/or negative pressure. In a preferred embodiment, a suction head
3005 is provided with at least one aperture 3006 disposed on its
wound-facing side. In some embodiments, an adhesive layer may be
provided on the wound-facing side of the head 3005 suitable for
securing the head 3005 to the drape 3003. In additional
embodiments, the drape 3003 may be mechanically fastened to the
head 3005 by means of features incorporated on the wound-facing
side of the head 3005 suitable for mechanical fastening of the head
3005 to the drape 3003. The aperture 3006 may be designed so as to
receive at least part of the piercing nozzle 3010, so as to create
a fluidic connection between a wound site and a source of negative
pressure connected to the head 3005 through the piercing nozzle
3010 and the aperture 3006. Some embodiments may also provide a
controlled air leak 3014 optionally provided with a filter and
integrated into the drape 3003; preferably, this air leak 3014 is
located in a region in close proximity to the plate 3008.
With continued reference to FIGS. 30A-B, in use a wound site is
prepared substantially as described previously. The plate 3008 is
preferably placed over the wound site area, with the piercing
nozzles 3010 facing upward. The drape 3003 is then placed over the
wound site and over the plate 3008, and then sealed to the skin
surrounding the wound site. Subsequently, the suction head 3005 is
pressed over the nozzles 3010, causing the nozzles 3010 to pierce
the drape 3003 and be received into the aperture 3006. The wound
site is then connected to a source of negative pressure and treated
until the wound has attained a selected stage of healing.
FIGS. 31A-B illustrate an embodiment of a negative pressure
treatment system 3101 comprising a suction port which shares some
similarities with the embodiments described in FIG. 22. In a
preferred embodiment, the system 3101 comprises a suction port 3105
integrated with a drape 3103. The port 3105 is preferably
constructed from a section of foam or other porous material, with
its outside surface surrounded by a semi-rigid plastic. In some
embodiments, the drape 3103 may be provided pre-attached to the
port 3105, for example by adhering the port 3105 onto the top side
of the drape 3103, or by attaching the port 3105 to the around and
to bottom side of the drape 3103. The port 3105 preferably
comprises a controlled air leak 3114 which communicates to the
interior of the port 3105. The port 3105 may also comprise an
aperture 3106 able to receive a connector 3110 and/or a tube or
conduit 3104. Preferably, this aperture 3106 is sealed with, for
example, a thin layer of plastic that can be perforated with a
connector 3110. The connector 3110 is preferably designed with a
sharp tip able to pierce a layer of plastic disposed over the
aperture 3106, and is able to create a fluid-tight seal between
itself and the aperture 3106, for example by means of barbs 3111. A
removable flap 3116 may also be attached to the port 3105 and made
to overlay the aperture 3106 so as to protect the aperture 3106
from damage during handling. The flap 3116 may also be pulled
during insertion of the connector 3110 to as to place the drape
3103 under tension and facilitate its perforation. To prevent the
connector 3110 and/or tube 3104 from projecting past the port 3105
and possibly disturbing the wound site, a plate 3107 may be
attached or formed with the port 3105. The plate 3107 is preferably
constructed from a resilient, harder material such as a plastic and
capable of resisting piercing when pushed by the connector 3110. In
order to channel wound exudate from the wound site, the plate 3107
preferably comprises one or more apertures 3108.
FIGS. 32A-K illustrate embodiments of a negative pressure system
3201. Here, the system 3201 comprises a port 3203 with a layer of
adhesive 3205 disposed on its underside. This adhesive layer 3205
may be placed over an aperture 3207 on a drape 3202 placed over a
wound to secure the port 3203. Alternatively, the port 3203 may be
adhered or welded to a smaller drape, optionally provided with a
further adhesive layer. In some embodiments, this port 3203 may be
relatively small, for example 17 mm across, although other sizes
may also be appropriate. The port 3203 may be provided with a
through opening 3209, preferably located on a vertical axis; this
opening 3209 may also be provided with a removable cover 3210,
which can in turn also function as a controlled air leak 3212.
Preferably, the air leak 3212 comprises a filter 3213 to prevent
contaminants from entering the wound. The opening 3209, preferably
when in a vertical configuration, can be designed to accommodate a
cutting tool 3215 designed to pierce an underlying drape. The port
3203 is also provided with a connection port 3217 to which a tube
3204 may be connected. In some embodiments, the tube 3204 is
pre-assembled to the connection port 3217.
In use, after adhering the port 3203 over a drape placed over a
wound, the removable cover 3210 is removed, and the cutting tool
3215 is pushed through the opening 3209 so as to pierce the drape.
The cover 3210 is replaced and the tube 3204 is connected (if
necessary) to the port 3203 and then connected at its downstream
end to the source of negative pressure.
FIGS. 33A-H illustrate embodiments of a negative pressure treatment
system 3301 provided with a template 3305. This template 3305 is
preferably provided with a double-sided adhesive layer 3306 on its
bottom-facing side, and comprises one or more cutting guides 3307.
These guides 3307 may, for example, be in the shape of a cross as
illustrated, or may take other forms. The system 3301 also
comprises a port 3309 which is preferably of a similar size and
shape to the template 3305, and which may have a tube 3304
pre-attached to itself. Obviously, some embodiments may instead
provide for detachable tube 3304. In one non-limiting embodiment,
the port 3309 measures approximately 25 mm across.
In use, the template 3305 is used to guide and control the size of
the drape incision. It is placed over a drape 3311, preferably by
adhering the bottom-facing side of the double-sided adhesive layer
3306 to the drape 3311 (an optional release layer 3312 may also be
present). Subsequently, an incision is made through the cutting
guides 3307 into the drape 3311 to create an aperture sufficient
for a fluidic connection. Subsequently, the template 3305 is peeled
away from the double-sided adhesive layer 3306 (optionally with the
aid of a tab 3313) to reveal a top-facing layer of adhesive upon
which the port 3309 may then be attached. Optionally, the
double-sided adhesive layer 3306 may be pigmented to allow the user
to easily align the port 3309 on the adhesive layer 3306.
Alternatively, the port 3309 may be adhered or welded to a smaller
drape, optionally provided with a further adhesive layer, and which
may then be placed over the aperture formed under the adhesive
3306. Treatment of the wound then proceeds in a similar fashion as
to the other embodiments previously described. An advantage of this
cutting template 3303 is that the drape aperture size may be
controlled so as to permit the use of a smaller port 3309, and
which may be advantageous in treating smaller wounds.
FIGS. 34A-H illustrate embodiments of a negative pressure treatment
system 3401 comprising a port 3403 including a protruding channel
3405 disposed on its underside. The channel 3405, and optionally
part or the remainder of the port 3403 may be constructed from a
soft and pliable material, including gels, foams, and combinations
thereof such as silicone, polyurethane, polyethylene, polyvinyl
chloride, and other plastics. The protruding channel 3405 may be
useful in properly positioning the port 3403 over an aperture made
into a drape 3413, and the preferably soft and conformable material
used to construct it minimizes pressure damage caused by the port
and/or channel pressing onto the wound. In some embodiments, the
port 3403 measures approximately 17 mm across, although larger or
smaller sizes may be used. A layer of adhesive 3407 with an
optional release layer 3409 are preferably provided on the
underside of the port for attachment to a drape, and the port 3403
should also comprise an opening 3411 so as to permit connection of
a tube 3404. In an alternative embodiment, the port 3403 may be
adhered or welded to a smaller drape, optionally provided with a
further adhesive layer.
In FIGS. 35A-H, embodiments of a negative pressure system 3501
comprise a port 3503 attached to a drape strip 3505. The port 3503
is preferably constructed from a soft, conformable material, and
includes an attachment port 3507 for a tube 3504 to be connected
thereto. The underside of the drape strip 3505 has a layer of
adhesive 3509, optionally covered by a release layer 3510. In use,
the drape strip 3505 is adhered directly over a prepared wound,
without the use of an additional drape, but with the wound
preferably filled with a wound-packing material. If no wound
packing material is used, then the adhesive 3509 is preferably
chosen to be minimally adherent to wound tissue but sufficiently
adherent to the skin surrounding the wound, for example a
water-soluble acrylic adhesive, such that a fluid-tight seal may be
made. After placing the initial drape strip 3505 over the wound,
additional drape strips 3506 (typically not provided with a port)
are placed in an overlapping fashion over the wound so as to create
a fluid-tight seal over the entire wound. If necessary, the drape
strips 3505 and 3506 are trimmed to fit. Subsequently, the tube
3504 is connected to a source of negative pressure and treated in a
fashion as previously described, with wound exudate being carried
through an aperture 3508 situated on the underside of the drape
strip 3505 and communicating with the port 3503. In some
embodiments, the drape strip 3505 and/or the additional drape
strips 3506 measure approximately 20 mm across, although other
sizes may be used.
FIGS. 36A-I illustrate embodiments of a negative pressure treatment
3601. Here, a drape 3603 is provided with one or more premade
drainage channels 3605 leading to a drainage hole 3607 preferably
centrally-located on and going through the drape 3603. The drape
3603 is provided with a layer of adhesive on its underside,
optionally protected by a release layer 3610. In one non-limiting
embodiment, the drape measures approximately 100 mm on one side.
The drainage channels 3605 run from the edge of the drape 3603 to
the drainage hole 3607, and are dimensioned so as to permit a tube
3604 to be slid into them so as to create a fluidic connection with
the drainage hole 3607. Preferably, several drainage channels 3605
are provided, with these channels 3605 facing different directions
on the drape 3603 so as to permit a tube 3604 to be connected from
different directions. For example, four drainage channels 3605 may
be provided at right angles to each other as illustrated. Of
course, other arrangements are possible, such as a "starburst"
configuration with more drainage channels 3605. Preferably, the
drainage channels are constructed so as to remain sealed until a
tube 3604 is inserted into them.
In FIGS. 37A-G, embodiments of a negative pressure treatment system
3701 are shown, the system 3701 comprising a drape 3703 and a port
3705 connected to a tube 3704. Here, the drape 3703 is preferably
constructed from a material provided with miniature, self-sealing
openings 3707. These openings 3707 may be molded or cut into the
drape 3703, and are ordinarily fluid-tight. The underside of the
drape 3703 as well as the underside of the port 3705 may be
provided with a layer of adhesive covered by an optional release
layer 3709. In an alternative embodiment, the port 3705 may be
adhered or welded to a smaller drape, optionally provided with a
further adhesive layer. Under the application of negative pressure,
for example through the port 3705, these openings 3707 open so as
to permit the transmission of negative pressure from the port to
the wound space beneath the drape. In other embodiments, the
openings 3707 may act as one-way valves. This drape 3703 has
several advantages, such as not requiring a separate aperture to be
cut into the drape 3703, while also permitting the port 3705 to be
positioned at any appropriate location on the drape 3703. In some
embodiments, the port 3705 measures approximately 25 mm across.
FIGS. 38A-I illustrate embodiments of a negative pressure treatment
system 3801 which comprise a bayonet connection between a ring 3803
and a port 3805. The port 3805 has one or more tabs 3807 which mate
into a corresponding recess 3808 located on the ring 3803, which in
some embodiments may have a diameter of approximately 35 mm. The
ring 3803 also includes a groove (not illustrated) adjoining the
recess 3808 and configured to receive the tab(s) 3807 and thus
create a fluid-tight connection. The ring 3803 preferably comprises
an adhesive layer disposed on its underside (optionally protected
by a release layer 3811), which may be used to secure it to a
drape. In an alternative embodiment, the ring 3803 may be adhered
or welded to a smaller drape, optionally provided with a further
adhesive layer. The port 3805 has a connector 3809 configured to
connect to a tube 3804. In use, the ring 3803 is placed and
preferably adhered over an incision 3812 made on a drape 3813
placed over a wound. Subsequently, the port 3805 is positioned over
the ring 3803 so that the tab 3807 may fit into the recess 3808.
Once so positioned, the port is rotated, for example by from 30 to
90.degree., so that the tab 3807 slides into the groove adjoining
the recess 3808 so as to create a fluidic seal. The user may
therefore choose the orientation in which the tube connector 3809
points irrespective of the orientation of the ring 3803.
Turning now to FIGS. 39A-B, one embodiment of a negative pressure
treatment system 3901 uses a low-profile port 3903 configured to
attach to a one-way valve 3905 (which can for example be a reed or
flap valve) attached to a drape 3907. In some embodiments, the
one-way valve 3905 may be pre-attached to the drape 3907 prior to
placing it over a wound. In other embodiments, the valve 3905 is
attached onto the drape 3907 after the drape has been placed over
the wound and an incision or aperture made into it, or else the
valve 3905 in incorporated into a port that is provided
pre-attached or welded to a drape. The port 3903 preferably
comprises one or more air leaks 3909, which are of a similar design
to those illustrated in other embodiments herein. A tube 3904 may
be attached to the port 3903.
FIG. 40 illustrates an embodiment of a negative pressure treatment
system 4001 that is somewhat similar in operation to the embodiment
illustrated in FIGS. 24A-B. Here, a low-profile fluidic connector
4003 may be slid under a drape 4005 situated over a wound. The
connector 4003 comprises a suction head 4007 at its distal end, and
has an adaptor 4009 at its proximal end configured to connect to a
tube 4004. At the boundary of the drape an air leak filter 4011 may
be placed next to the connector 4003 to permit for controlled air
flow into the wound space. The filter 4011 may either be attached
to the connector 4003 to allow for air flow into the interior
channel of the connector 4003 or else may be configured to let air
into the wound space without going through the connector 4003. In
an alternative embodiment, the fluidic connector 4003 may be
adhered or welded to the drape 4005 prior to use.
FIG. 41A illustrates an embodiment of a negative pressure treatment
system 4101 comprising a suction adapter 4103 placed underneath a
drape 4105. The suction adapter 4103 comprises a plurality of tubes
4106 so as to create a suction manifold that may be useful in
distributing negative pressure while reducing the overall height of
the adapter 4103, a useful aspect for low-profile conformable
suction adapters. At the proximal end of the adapter 4103, a
converging point 4107 connects to all of the tubes 4106 and
connects to a single tube 4104 connected to a source of negative
pressure. In some embodiments, an air leak 4109 may be provided on
the adapter 4103, for example over the converging point 4107.
Preferably, a seal 4111 can be provided at the junction where the
tubes 4106 meet the drape 4105. Such a seal 4111 may be either
integrated onto the tubes 4106, either in a fixed or slideable
configuration, or else placed separately. The material used for the
seal 4111 may be a closed-cell foam wedge, but any material capable
of creating a fluid tight seal can be used. FIG. 41B illustrates a
section taken along the line A-A illustrating how in some
embodiments, the tubes 4106 can be of a very low height, which may
be advantageous for example in minimizing patient discomfort. In
some embodiments, the seal 4111 and the tubes 4106 are attached or
welded to the drape 4105 to form a single unit.
In FIGS. 42A-B, an embodiment of a negative pressure treatment
system 4201 comprises a drape 4203 with an aperture 4205 integrated
into it. The aperture 4205 has an area 4206 coated with a layer of
adhesive and may optionally be protected by a release layer 4207.
The aperture 4205 may also comprise a controlled air leak 4209,
preferably provided with a filter to prevent entry of pathogens and
contaminants. A port 4211 is also part of the system 4201, and may
comprise a connector 4212 to connect to a tube 4204. On the
underside of port 4211, an adhesive layer optionally protected by a
release layer 4213 may also be present. In use, the drape 4203 is
placed over a wound with the aperture 4205 preferably located in a
central position. Subsequently, the release layer 4207 is removed
to expose an adhesive layer. Next, the port 4211, optionally
following the removal of a release layer 4213, is adhered to the
area 4206 so as to create a fluidic connection between the port
4211 and the aperture 4205.
FIGS. 43A-B illustrate an embodiment with a piercing point sharing
some similarities to the embodiment described in FIGS. 13A-B. Here,
an embodiment of a negative pressure treatment system 4301
comprises a port 4303 provided with one or more piercing tips 4305.
Preferably, this piercing tip 4305 is located on the top inner
surface of the port 4303 over an aperture 4307. In use, the
application of vacuum through a tube 4304 to the port 4303 draws a
portion 4309 of a drape 4308 placed over a wound into the aperture
4307. The piercing tip 4305 then pierces the drape portion 4309 so
as to create a fluidic connection between the wound space and the
source of negative pressure so as to permit wound exudate to be
removed from the wound. Other aspects of the port 4303 are similar
to embodiments described elsewhere herein, and the port may
comprise a controlled air leak 4311 and a layer of adhesive 4312
disposed on the underside of the port 4303.
FIGS. 44A-B illustrate an embodiment of a negative pressure
treatment system 4401 comprising a drape 4403 with an integrated
suction port 4405. Here, the suction port 4405 is preferably
constructed of a soft, conformable material which may in some
embodiments be the same as the material used in the drape 4403.
There is preferably a layer of adhesive disposed on the underside
of the drape 4403 so as to permit adherence to the skin surrounding
the wound. The port 4405 may be constructed separately and adhered
or welded to the drape 4403, or in other embodiments the port 4405
may comprise a channel integrated onto the drape 4403 so as to form
a single unit. At the proximal end of the port 4405, a connector
4406 is preferably provided so as to permit the connection of a
tube 4404 to the system 4401. The drape 4403 may also comprise an
air channel 4407 to permit air to enter the dressing, preferably at
a controlled rate. This air channel 4407 can also comprise a filter
to prevent contaminants from entering the wound.
In FIGS. 45A-C, an embodiment of a negative pressure treatment
system 4501 comprises a drape 4503 with a port 4505 integrated
thereto. The drape 4503 may also comprise cross-linked air channels
4507; such channels 4507 communicate with the wound space below the
drape 4503 (for example via through holes 4508) so as to permit a
controlled air flow rate to the wound. The edges of the drape 4503
provide openings for the cross-linked air channels 4507, and the
drape 4503 may be cut to size without significantly interfering
with the function of the air channels 4507. In some embodiments,
however, it may be advantageous to use a filter or filtering
element in conjunction with the air channels 4507 to prevent
contaminants from entering the wound space. Preferably, an adhesive
layer is disposed underneath the drape 4503. In one embodiment, the
port 4505 comprises a domed portion 4509 approximately centered on
the drape 4503. This domed portion 4509 forms a channel for the
evacuation of wound exudate together with an elongated portion
4512, which communicates to a fluidic adapter portion 4513
connecting to a tube 4504. As with other embodiments described
herein, the port 4505 is preferably constructed from a soft,
conformable material (while being able to maintain patency
sufficient to draw out fluid under negative pressure), and may be
either integrated to the drape 4503 as a single unit (e.g., by
molding) or constructed from multiple pieces later attached or
joined together.
FIGS. 46A-B illustrate an embodiment of a negative pressure wound
treatment system 4601 that comprises one or more suction channels
4603 integrated into an impermeable cover 4605. The one or more
suction channels 4603 may enter into the cover 4605 to form a
network of conduits surrounding a central air leak 4609, preferably
provided with a filter. Of course, alternative configurations are
possible, such as a fan- or net-shaped system of channels 4603, and
the air leak 4609 may in some embodiments be omitted or placed in a
different location. The channels 4603 converge onto a central
collector 4607, which connects to a tube 4604 that may be connected
to a source of negative pressure. The cover 4605 is preferably
constructed of a fluid-impermeable material, and is preferably
sufficiently thick so as to be able to integrate the channels 4603
within itself. Preferably, a layer of adhesive is disposed on its
underside. An example of a suitable material for the cover 4605 may
include a closed-cell foam. In some embodiments, spaces may be made
into the cover 4605 into which the channels 4603 connect to. In
other embodiments, the channels 4603 continue into the cover 4605
and the cover 4605 is, for example, molded around the channels
4603. In use, the system 4601's cover 4605 may be trimmed to size
if necessary (while avoiding cutting through the channels 4603) and
placed over a wound site, optionally filled with a wound packing
material, and adhered to the skin surrounding the site.
Subsequently, a source of suction may be applied to the wound and
exudates removed through the channels 4603.
Turning now to FIGS. 47A-B, an embodiment of a negative pressure
treatment system 4701 comprises a low-profile suction unit 4703
covered with a membrane 4707. In some embodiments, the suction unit
4703 may be constructed from open-cell foam. Embedded within the
suction unit 4703 is a tube 4704. This tube 4704 may be fenestrated
or perforated so as to help prevent clogging and apply suction over
a larger area. The tube 4704 passes through an impermeable section
4705. This impermeable section 4705 may be constructed, for
example, from a closed-cell foam, and is attached to the suction
unit 4703. In some embodiments, the impermeable section 4705 may be
molded around the tube 4704. Although the tube 4704 may be
connected directly to a source of negative pressure, it may in some
embodiments be advantageous to provide a connector situated
proximally to the tube 4704 to permit connection of another tube in
communication with a source of negative pressure. The membrane 4707
may be constructed in several parts, or may be one large sheet.
Preferably, it is provided with a layer of adhesive on its
underside, optionally protected by a release layer 4709 which
covers the portions of adhesive not secured to the suction unit
4703 and/or the impermeable section 4705. In use, the system 4701
may be positioned over a wound, optionally filled with packing
material. Then, the release layer 4709 is removed so as to permit
the membrane 4707 to be adhered to the skin surrounding the wound.
Negative pressure is then applied to the wound through the tube
4704.
FIGS. 48A-E illustrate an embodiment of a negative pressure
treatment system 4801 comprising a flexible suction adapter sheet
4803 capable of being packed into a wound space. The sheet 4803
preferably comprises a larger, planar section 4805 at its distal
end, connected to a tail portion 4806 at its proximal end. At the
proximal end of the tail portion 4806, a connector 4807 may be
provided to permit a tube 4804 to be connected thereto. The planar
section 4805 may be comprised of two layers: a bottom layer 4810
and a top layer 4811. The bottom layer 4810 comprises one or more
perforations 4812 that face toward the wound so as to collect wound
exudate and distribute negative pressure to the wound. The top
layer 4811 comprises a network of channels 4813 communicating with
the perforations 4812, and fluidically link to the source of
negative pressure so as to channel wound exudate to the source of
negative pressure. In some embodiments, the channels 4813 form an
interconnected network (such as in a grid configuration), which may
be advantageous in preventing clogging and permitting negative
pressure to be distributed to the entire bottom layer 4810 in spite
of folding that may occur when the portion 4805 is placed within a
wound. In some embodiments, the tail portion 4806 can comprise a
layer of adhesive on its wound-facing side, which may be useful in
forming a seal with the underlying skin. The sheet 4803 may also be
covered with a flexible drape 4815 to provide an additional,
substantially air-tight seal over the wound.
In use, a wound is cleaned, and the planar section 4805 is inserted
into the wound so as to function as a wound packing material.
Preferably, the bottom layer 4810 is placed facing into the wound.
Subsequently, the tail portion 4806 may be adhered to the skin
surrounding the wound. A drape 4815 is then placed and sealed over
the entire wound, followed by connecting the tube 4804 to a source
of negative pressure.
In FIGS. 49A-B, a negative pressure treatment system 4901 may
comprise a wound packing pouch 4903 used with a port 4905 and a
drape 4907. The pouch 4903 is a flexible pouch that may be filled
with a conformable filler 4909, for example granular beads, and may
be placed into the wound space as a filler. The pouch 4903 also
comprises a semi-permeable or perforated membrane 4910 containing
the filler 4909. In use, different size pouches 4903 may be
supplied, or multiple pouches 4903 may be used to fill the wound
space as desired. The port 4905 is similar to other ports described
herein, and comprises a distal head portion 4913 designed to be
placed in contact with the pouch 4903 so as to evacuate wound
exudate and communicate negative pressure to the pouch 4903. In an
alternative embodiment, this port 4905 may be adhered or welded to
a smaller drape, optionally provided with a further adhesive layer.
At the proximal end of the port 4905 is a connector 4915 configured
to connect to a tube 4904. In some embodiments, this connector 4915
may comprise a piercing or chisel tip configured to pierce through
the drape 4907, which may be advantageous in making an easier
connection to the tube 4904. The drape 4907 may be provided with an
adhesive layer on its wound-facing side, and provides an
essentially fluid-tight seal over the wound space and over the
pouch 4903. In some embodiments, the drape 4907 may be provided
with a controlled air leak 4917, optionally protected with a
filter, designed to permit a controlled amount of air into the
wound.
FIGS. 50A-C illustrate embodiments of a negative pressure treatment
system 5001 comprising a sealing port 5003. Here, the port 5003
comprises a distal head portion 5005 and a proximal tail portion
5006. The tail portion 5006 includes a connector 5007 configured to
connect to a tube 5004. The head portion 5005 comprises an outer
vacuum ring 5009; this ring 5009 may in some embodiments be used to
seal the port 5003 against the skin surrounding a wound, and may be
useful in smaller-sized wounds that the ring 5009 is able to
circumscribe. In other embodiments and for larger wounds, a drape
may be used in a manner similar to other embodiments described
herein. In use, a slot 5011, or a series of apertures on the
underside of the ring 5009 permits negative pressure transmitted
into the ring 5009 to seal the ring 5009--and thus the entire port
5003--against the skin of a patient. The head portion 5005 also
comprises a central region 5011 that applies a portion of the
vacuum from the vacuum source to the wound and evacuates wound
exudate (the remainder of the vacuum is applied to the skin
surrounding the wound by the ring 5009). Here, the region 5011 may
also comprise an air leak 5013, for example disposed centrally and
with an optional air filter 5014. In some embodiments, a separate
channel 5015 may be present to channel the air drawn into the wound
and port 5003 downward and into the wound space. Preferably, such a
channel 5015 is configured to make contact with any wound packing
material placed into the wound.
FIGS. 51A-B illustrates an embodiment of a negative pressure wound
treatment system 5101 comprising a low-profile suction adapter 5103
configured to be placed over a wound. The suction adapter 5103
preferably comprises a vacuum portion 5105 and a controlled air
leak portion 5106, wherein both of these portions 5105, 5106 are
preferably constructed of a flexible, soft material capable of
transmitting air and fluid flow through themselves. Examples of
such materials may include open-cell foams. The entire suction
adapter 5103, including the portions 5105, 5106, is preferably
covered on its upper portions with a liquid-impermeable membrane
5108. The vacuum portion comprises at its proximal end a connector
5107 for connecting to a tube 5104. The controlled air leak portion
5106 preferably comprises an open end 5109 not covered by membrane
5108 so as to permit a flow of air into the adapter 5103.
Preferably, a filter is disposed over this end 5109 to prevent the
entry of contaminants into the wound space. In this embodiment,
strips of tape 5111 are used to seal the edges of the membrane 5108
against the skin of a patient. In other embodiments, some or all of
the underside of the 5108 may be covered in a layer of adhesive.
Preferably, the system 5101 is used on a wound that has been filled
with a wound packing material such as foam or gauze.
In FIGS. 52A-B, a negative pressure treatment system 5201 comprises
a bladder 5203 in combination with a suction adapter sheet 5205 and
a drape 5207. The bladder 5203 may be filled with a fluid such as
air or water, and may be secured to the wound for example by straps
5209, although other means sufficient to apply positive pressure on
the wound may be used. Under the bladder 5203 is the drape 5207,
which is preferably liquid-impermeable and coated with a layer of
adhesive on its wound-facing side. The suction adapter sheet 5205
is below the drape, and may be of a type similar to the embodiment
described in FIG. 48A. Preferably, this sheet 5205 comprises one or
more conduits configured to channel wound exudate toward a source
of negative pressure while distributing negative pressure over the
entire wound area. The proximal portion 5206 of the sheet 5205 may
comprise a connector 5210 suitable for connecting to a tube 5204.
Optionally, the space below the suction adapter sheet 5205 is
filled with a wound packing material such as an open-cell foam.
Such a wound treatment system 5201 may be beneficial for use on
wounds that require additional positive pressure upon the wound
bed. Additionally, use of an embodiment with the straps 5209 may be
beneficial for use in particular on the legs and arms of a
patient.
FIGS. 53A-D show variations of the bladder system described in FIG.
52A. Here, the negative pressure wound treatment system 5301
comprises a bladder 5303 placed underneath a drape 5305. The
bladder 5303 may be filled with a fluid such as saline solution,
although other fluids such as air may be used. In some embodiments,
a layer of wound contacting material 5307 may be placed in contact
with the wound. This wound contacting material 5307 may be foam,
gauze, or other suitable materials. Preferably, this material 5307
forms a thin layer and is pushed into contact with the wound.
Subsequently, the bladder 5303 is placed into the wound so as to
fill the remainder of the wound space. The drape 5305 is then
placed over the bladder 5303 and wound contacting material 5307 and
sealed to the skin surrounding the wound. An aperture 5309 may then
be made into the drape 5305 (although the drape may be provided
with an aperture already made into it) over a portion of the wound
where the wound contacting material 5307 is in contact with the
drape 5305, and a suction adapter 5311 placed over the aperture
5309. Alternatively, the suction adapter 5311 may be adhered or
welded to the drape 5305 or a smaller drape, optionally provided
with a further adhesive layer. The adapter 5311 may be connected to
a source of negative pressure via a tube 5304 connected to its
proximal end. In some embodiments, the drape 5305 may also be
provided with a controlled air leak 5313, which is in some cases
covered with a filtration element to prevent contaminants from
entering the wound.
In FIG. 54A, an embodiment of a negative pressure wound treatment
system 5401 is illustrated that uses a wound packing material 5403
provided in discrete portions. The wound packing material 5403 may
be supplied in the form of a roll 5405, for example as illustrated
in FIG. 54B, and dispensed as necessary to fill a wound space;
individual sections may be detached, or long sections may be packed
into the wound. The wound packing material 5403 may be comprised of
a porous material such as open-cell foam, or any other material
capable of transmitting negative pressure to the wound site. The
form of the wound packing material 5403 may be achieved by molding
or heat-forming the material. Alternatively, it may be fabricated
using nets or films to join the individual sections. In a further
embodiment, the wound packing material 5403 may be molded from
solid polymers, and channels may be formed onto the surface to
allow removal of fluids from the wound tissue. After a wound is
filled with the wound packing material 5403, a drape 5407
(optionally provided with an integrated air leak 5408 similar to
those previously described herein) is placed over the wound and
sealed to the skin surrounding the wound. An aperture is then made
into the drape 5407 sufficient to permit a port 5409 to be placed
over it so that wound exudate may be removed from the wound site
through a tube 5404 connected to the port 5409. Alternatively, the
port 5409 may be adhered or welded to a smaller drape, optionally
provided with a further adhesive layer or else the drape 5407.
FIGS. 55A-J illustrate embodiments of a negative pressure wound
treatment system 5501 similar to the embodiments illustrated in
FIG. 15A. Here, the system 5501 may comprise a bridge 5502 having a
proximal end 5503 and a distal end 5505 and an applicator 5520 at
the distal end 5505 of the bridge 5502 forming a flexible suction
adapter. Preferably, the system 5501 is constructed in a similar
fashion to the system 1501, and may comprise a bridge 5502
constructed from a similar dual layer arrangement as previously
described. A connector 5504 is preferably disposed at the proximal
end 5503 of the bridge 5502, so as to connect to at least one of
the channels 5512 and/or 5516, as shown in FIG. 55D. A cap 5536 may
be provided with the system 5501 (and can in some cases, as
illustrated, be attached to the connector 5504). The cap 5536 can
be useful in preventing fluids from leaking out of the proximal end
5503. The system 5501 may include a source of negative pressure
such as a pump or negative pressure unit 5534 capable of supplying
negative pressure. The pump also preferably comprises a canister or
other container for the storage of wound exudates and other fluids
that may be removed from the wound. In some embodiments, this pump
5534 can be a RENASYS GO pump, as sold by Smith & Nephew. The
pump 5534 may be connected to the connector 5504 via a tube 5540.
In use, the applicator 5520 is placed over an aperture 5535 formed
in a drape 5531 that is placed over a suitably-prepared wound 5530,
which may in some cases be filled with a wound packing material
such as foam or gauze. Subsequently, with the pump 5534 connected
via the tube 5540 to the connector 5504, the pump is activated,
thereby supplying negative pressure to the wound. Application of
negative pressure may be applied until a desired level of healing
of the wound 5530 is achieved.
Here, and with particular reference to FIGS. 55C-D, the system 5501
may comprise a bridge 5502 having a proximal end 5503 and a distal
end 5505 and an applicator 5520 at the distal end 5505 of the
bridge 5502. In some embodiments, the bridge 5502 may comprise an
upper channel layer 5512 positioned between an upper layer 5510 and
an intermediate layer 5514, with a lower channel layer 5516
positioned between the intermediate layer 5514 and a bottom layer
5518. Preferably, the layers 5510, 5514, and 5518 have elongate
portions extending between proximal and distal ends and may be
comprised of a material that is fluid-impermeable, for example
polymers such as polyurethane. It will of course be appreciated
that the layers 5510, 5514, and 5518 may each be constructed from
different materials, including semi-permeable materials. As
illustrated in FIG. 55D, the upper and lower layers 5510 and 5518
may be curved, rounded or outwardly convex over a majority of their
lengths. During assembly, for example, the layers 5510, 5514, and
5518 may be pinched together to weld or adhere the layers together.
In doing so, the proximal ends of the channels 5512 and 5516 may be
sandwiched between these layers, thus partially compressing the
proximal ends of the channels 5512, 5516 and stretching the layers
5510, 5514, 5518 over these aforementioned proximal ends. Of
course, the proximal ends of the materials used in the bridge
section 5502 may not necessarily be rounded or curved; as shown in
FIG. 55J, they can remain substantially squared off and
straight.
Similarly to the embodiment described in FIG. 6 with regards to the
spacer 609, the upper and lower channel layers 5512 and 5516 are
preferably elongate layers extending from the proximal end 5503 to
the distal end 5505 and may each preferably comprise a porous
material, including for example open-celled foams such as
polyethylene or polyurethane. In some embodiments, one or more of
the upper and lower channel layers 5512 and 5516 may be comprised
of a fabric, for example a knitted or woven spacer fabric (such as
a knitted polyester 3D fabric, Baltex 7970.RTM., or Gehring
879.RTM.) or a nonwoven material. Suitable materials may also
include terry-woven or loop-pile materials. The fibers may not
necessarily be woven, and can include felted and flocked (including
materials such as Flotex.RTM.) fibrous materials. The materials
selected are preferably suited to channeling wound exudate away
from the wound and for transmitting negative pressure and/or vented
air to the wound site, and may also confer a degree of kinking or
occlusion resistance to the channel layers 5512 and 5516 as
described below. In one embodiment, the upper channel layer 5512
may comprise an open-celled foam such as polyurethane, and the
lower channel layer may comprise a fabric as described herein. In
another embodiment, the upper channel layer is optional, and the
system may instead be provided with an open upper channel. In the
embodiment illustrated in FIG. 55D, the upper channel layer 5512
may have a curved, rounded or upwardly convex upper surface and a
substantially flat lower surface, and the lower channel layer 5516
may have a curved, rounded or downwardly convex lower surface and a
substantially flat upper surface.
In some embodiments, the fabric may have a three-dimensional (3D)
structure, where one or more types of fibers form a structure where
the fibers extend in all three dimensions. Such a fabric may in
some cases aid in wicking, transporting fluid, and/or transmitting
negative pressure. To prevent the channels 5512 and/or 5516 from
being displaced or twisted while encased in the system 5501--which
may impair performance of the respective channels under negative
pressure--it may in some embodiments be preferable to adhere or
otherwise secure the channels 5512 and/or 5516 to one or more of
the layers 5510, 5514, and 5518. In certain embodiments, these
materials remain open and capable of communicating negative
pressure to a wound area under the typical pressures used in
negative pressure therapy, for example between 40 to 150 mmHg,
although higher and lower values are possible. In some embodiments,
the fabric may comprise several layers of material stacked or
layered over each other, which may in some cases be useful in
preventing the channel 5516 from collapsing under the application
of negative pressure. In other embodiments, the fabric used in
channel 5516 may be between 1.5 mm and 6 mm; more preferably, the
fabric may be between 3 mm and 6 mm thick, and may be comprised of
either one or several individual layers of fabric. In other
embodiments, the channel 5512 may be between 1.2-3 mm thick, and
preferably thicker than 1.5 mm. Additionally, and as described
previously, the materials used in the system 5501 are preferably
conformable and soft, which may help to avoid pressure ulcers and
other complications which may result from a wound treatment system
being pressed against the skin of a patient. Further examples of 3D
fabrics are discussed below in FIGS. 56A-C.
Preferably, the distal ends of the layers 5510, 5514, and 5518 and
the channel layers 5512 and 5516 are enlarged at their distal ends
(to be placed over a wound site), and may form a "teardrop" or
other enlarged shape. The distal ends of at least the layers 5512,
5514, 5516, and 5518 may also be provided with at least one through
aperture. This aperture may be useful not only for the drainage of
wound exudate and for applying negative pressure to the wound, but
also during manufacturing of the device, as these apertures may be
used to align these respective layers appropriately.
With additional reference to FIGS. 55D-E and J, a channel connector
5506 is provided at the proximal end 5503 of the bridge 5502, the
channel connector 5506 preferably being configured so as to be
embedded into the lower channel layer 5516 so as to create a secure
fluidic connection. The channel connector 5506 may in some
embodiments be inserted into a pre-made cavity formed into the
channel 5516; as illustrated in FIG. 55J, this cavity can be cut
out or can be in the form of a rabbet joint. In some embodiments,
the channel connector 5506 may be one of the connectors described
in FIGS. 57A-B below. With one end of the channel connector 5506
being embedded into the lower channel layer 5516, the other end of
the channel connector 5506 may be connected or in communication
with, in one embodiment, a connector tube 5507, although in some
embodiments the channel connector 5506 may be connected directly to
the connector 5504, or else connected directly to a tube 5540
connected to a source of negative pressure. When using a connector
tube 5507, the resulting assembly can permit a connector 5504 to be
attached thereto. A cap 5536, which may be secured to the suction
adapter for example via a cap leash 5527 secured with a ring
disposed on the outer surface of the connector tube 5507. The cap
5536 may be used to cover the end of the suction adapter, for
example at the connector 5504, so as to prevent exudate and other
wound fluids from leaking out. The connector 5504 is preferably
configured to connect with a tube 5540 connected to a source of
negative pressure. The connector 5504 may for example comprise a
lip or other such structure to aid in securing the connector 5504
to a tube 5540 and/or cap 5536, although it will be understood that
other connector types are possible, including quick-disconnect
couplings, luer locks, Christmas-tree, and other such
connectors.
The upper layer 5510 may comprise additional material extending
downward, preferably at least of the thickness of the bridge 5502;
this material may then be used to bond or weld to the other layers
so to form a fluid-tight seal. More specifically, during assembly,
the upper layer 5510 may be attached, for example by melting,
welding, or with adhesives, to the lower layer 5518 so as to form a
fluid-tight seal (with the exception of the apertures at the distal
and proximal ends). Preferably, the middle layer 5514 is attached
to the top layer 5510 and the bottom layer 5518. In some
embodiments, it may be preferable to attach or bond the connectors
5504 and/or 5506, as well as the tube 5507 to at least one of the
layers 5510, 5514, 5518 so as to create a fluid-tight connection.
To provide for a more secure connection, some embodiments may also
be provided with a weld 5532 made onto the lower layer 5518. The
lower channel 5516 may have a hole or aperture made through it,
which may be used to weld it, via the weld 5532, to the lower layer
5518. This welding of the lower channel 5516 to the lower layer
5518 via the weld 5532 made through the hole 5533 may thus aid in
preventing the various layers and channels from shifting or being
displaced. Obviously, it will be understood that other securement
means may be used, for example adhesives and the like, and that
such arrangements may be also be used in the upper channel
5512.
In certain embodiments, for example as illustrated in FIGS. 55C-J,
a controlled air leak 5524 may be disposed on the bridge portion
5502, for example at the proximal end thereof. This air leak 5524
may comprise an opening or channel extending through upper layer
5510, such that the air leak 5524 is in fluidic communication with
the upper channel 5512. Upon the application of suction to the
system 5501, air will enter through the air leak 5524 and move from
the proximal end 5503 to the distal end 5505 along the upper
channel 5512. The air will then be suctioned into the lower channel
5516 by passing through the apertures through the distal ends of
the layers 5512, 5514, 5516 and 5518. The air leak 5524 preferably
comprises a filter 5525, which may be similar in function to the
filter 521 illustrated in FIG. 5A. Preferably, the air leak 5524 is
located at the proximal end of the bridge portion 5502 so as to
minimize the likelihood of wound exudate or other fluids coming
into contact and possibly occluding or interfering with the air
leak 5524 or its filter 5525. In some embodiments, this filter 5525
is a microporous membrane capable of excluding microorganisms and
bacteria, and which may be able to filter out particles larger than
45 .mu.m. Preferably, the filter 5525 can exclude particles larger
than 1.0 .mu.m, and more preferably, particles larger than 0.2
.mu.m. Advantageously, some embodiments may provide for a filter
5525 that is at least partially chemically-resistant, for example
to water, common household liquids such as shampoos, and other
surfactants. In some embodiments, reapplication of vacuum to the
system 5501 and/or wiping of the exposed outer portion of the
filter 5525 may be sufficient to clear any foreign substance
occluding the filter 5525. The filter 5525 may be composed of a
suitably-resistant polymer such as acrylic, polyethersulfone, or
polytetrafluoroethylene, and may be oleophobic and/or hydrophobic.
In some embodiments, the filter 5525 may also comprise a supporting
backing layer, for example a nonwoven polyester support.
Preferably, the air leak 5524 will supply a relatively constant air
flow that does not appreciably increase as additional negative
pressure is applied to the system 5501. In embodiments of the
system 5501 where the air flow through the air leak 5524 increases
as additional negative pressure is applied, preferably this
increased air flow will be minimized and not increase in proportion
to the negative pressure applied thereto.
The filter 5525 provided in the controlled air leak 5524 in certain
embodiments may be useful in a system 5501 for use with more
ambulatory and active patients. For example, a chemically-resistant
filter may permit a patient to bathe or shower without damaging the
filter's functionality when reconnected to a source of negative
pressure. Any occlusion or fluid blocking the air leak 5524 could
then be cleared by, for example, wiping off the filter 5525 or
re-applying negative pressure to the system 5501. Such a system
would also have the advantage that the system 5501 and any assorted
wound dressing materials, if present, would not need to be removed
and then re-applied should a patient need to be disconnected from
the source of negative pressure, for example incidental to bathing.
This would entail significant advantages in improving the
cost-effectiveness and ease of use of the present treatment
system.
The system 5501 is preferably constructed so as to provide a
consistent fluid flow even if the system 5501 is kinked or weighted
down. For example, in use on a patient, the bridge portion 5502 may
become folded over itself, or else the patient may roll over, thus
placing his or her weight over at least a portion of the system
5501. Typically, prior art dressings and fluidic connectors become
blocked or ineffective in such situations and in some cases may
contribute to complications such as pressure ulcers. Here, however,
certain embodiments provide for improved blockage resistance if
kinked or weighed down. Preferably, by employing channel layers
5512 and 5516 as described above, and more preferably by employing
a foam channel layer 5512 and a fabric channel layer 5516, the
system 5501 is able to maintain a flow rate through the air leak
5524 of at least 0.08 L/min, and preferably 0.12 L/min while
negative pressure is applied through a source of negative pressure.
Further embodiments also provide for the system 5501 to be able to
handle fluid exudate drainage from the wound site through the lower
channel 5516 of at least 10 L/day, or 6.9 ml/min. Certain
embodiments provide for the system 5501 to maintain these flow
rates with a weight, for example a 12 kg weight, pressing down on
the bridge portion through a rod with a 1 in. diameter. In some
embodiments, these flow rates are also maintained while the bridge
portion 5502 is kinked over itself with the same weight, or for
example with a 4.75 kg weight placed directly on the folded region.
It is preferable that the system 5501 be able to withstand being
folded or kinked over even during an extended period of time, for
example over 40 hours, and not show any degradation in performance
(e.g., flow rates) compared to its performance prior to being
folded or kinked over. Preferably, embodiments of the system 5501
are also able to transmit and maintain a negative pressure at the
wound that is close to the negative pressure level at the source of
negative pressure. For example, an acceptable level of pressure
maintained at the wound may be within .+-.25 mmHg of the negative
pressure set at the source of negative pressure, with this pressure
being preferably maintained at this level within 95% of the time
that the system 5501 has negative pressure applied to it.
Acceptable pressure levels may include pressure ranges between
40-120 mmHg, although levels of 200 mmHg have successfully been
used.
With additional reference to FIGS. 55A-D, G-J, the system 5501 also
comprises an applicator 5520 designed for placement over a wound
site. Preferably, the applicator 5520 comprises a flexible layer
5550, for example polyethylene or polyurethane, with a layer of
adhesive on its lower (wound-facing) side. Optionally, a protective
release layer 5529 may be placed on the adhesive layer, which is
removable before use. In some embodiments, a more rigid removable
backing layer 5552 may be provided on the upper side of the
applicator 5520 to facilitate handling of the applicator 5520 due
to the flexibility of the layer 5550. The applicator 5520
preferably comprises an attachment point for the bridge 5502 at the
distal end 5505, for example using a section of double-sided
adhesive tape 5528. The double-sided adhesive tape 5528 may be
protected by an additional protective release layer, which is
removed prior to adhering the bridge 5502 to the applicator 5520.
It will be understood that different attachment methods are also
contemplated, for example heat sealing, welding, or suitable
adhesives. Some embodiments may also permit the manufacture of the
bridge 5502 and the applicator 5520 as a single unit that does not
require separate attachment means. The applicator 5520 preferably
comprises at least one aperture 5526 through itself and designed to
be placed over a wound site, and which can serve to fluidically
connect the wound site to the source of negative pressure and to
the air leak while also serving as a conduit to draw out wound
exudate from the wound site.
In use, and with reference to FIGS. 55A-B, the system 5501 may be
used in a similar fashion to the other embodiments previously
disclosed herein. A wound site 5530 is preferably cleaned and
prepared in a suitable fashion, and a wound packing material, if
necessary, placed into the wound site, followed by a drape 5531. An
aperture 5535 through the drape to the wound site is then created,
although some embodiments may have a pre-made aperture 5535.
Subsequently, an operator may situate the applicator portion 5520
over the aperture 5535. After removing the backing layer 5529 (if
present) from the adhesive layer on the underside of the applicator
portion 5520, the applicator is sealed to the drape 5531, and the
backing layer 5552 (if present) is also removed from the applicator
portion 5520. A fluidic conduit such as a tube 5540 may then be
connected to the connector 5504. The tube 5540 may also be
connected to connector 5504 prior to applying the applicator to the
wound site. The fluidic conduit is connected to a source of
negative pressure 5534, preferably with a container suitable for
containing wound exudate interposed therebetween. The application
of negative pressure may then be effectuated to the wound site 5530
until the wound site progresses to a desired level of healing.
During use of the system 5501, wound exudate from the wound site
5530 is drawn by the negative pressure through the lower channel
layer 5516. The air leak 5524 allows air to pass through the upper
channel layer 5512 into the apertures through the distal ends of
the layers 5512, 5514, 5516 and 5518. The negative pressure draws
air passing through the upper channel layer into the lower channel
layer 5516 back toward the source of negative pressure or pump. In
some embodiments, the controlled air leak 5524 provides a constant
flow of air through the system 5501, which then may be used to
determine whether blockage or leakage is present. Causes of
blockage can include, for example, situations where the lower
channel 5516 becomes occluded with wound debris. Leakage causes can
include, for example, improper sealing of the drape over the wound
site, or physical damage to the system 5501 leading to excess air
leaking into the system. The blockage or leakage may be determined,
in certain embodiments, by measuring the speed of the pump while
the pump works to maintain a constant negative pressure. Pump speed
may also be measured indirectly by measuring the amount of voltage
or signal sent to the pump.
FIGS. 56A-C illustrate views of a 3D fabric that may be used in
various embodiments described herein, for example the bridge 5502
of the suction adapter illustrated in FIGS. 55A-J. Although other
porous materials such as foam may be used in the embodiments
described herein, for example in the upper and lower channels 5512
and/or 5516 illustrated in FIGS. 55A-C, the use of 3D fabrics may
be advantageous in some circumstances. Certain 3D fabrics have been
found to perform well in conveying negative pressure to and wound
exudate from a fluidic suction adapter, even while under
compression--for example when a patient's weight is placed directly
upon the suction adapter, or when negative pressure is applied
and/or when the fluidic suction adapter is kinked or folded. Some
3D fabrics that have been found to perform acceptably include
knitted polyester 3D fabric, Baltex 7970.RTM., Gehring 879.RTM., or
Coolmax.RTM.. Of course, other fibers and fabric types may be used
in part or in whole to make 3D fabrics, and include without
limitation polyamides such as nylon, viscose, cotton, as well as
other synthetic microfibers. 3D fabrics may also be constructed at
least in part from fibers such as Nomex.RTM. and Kevlar.RTM.. Other
types of fabrics and materials disclosed elsewhere herein may also
be used.
In one embodiment, as illustrated in FIGS. 56A-C, the 3D fabric may
comprise a bottom side 5603, a top side 5605, and an open middle
area 5607. FIG. 56A illustrates the bottom (wound-facing) side 5603
of a 3D fabric, which may be woven so as to create oblong or ovoid
openings 5611 extending lengthwise across the fabric. In one
embodiment, the oblong or ovoid openings 5611 represent or provide
an open area of between 10 and 45% (or about 10% to about 45%) of
the surface area of the bottom layer, more preferably 10% to 30%
(or about 10% to about 30%). Here, fibers are knitted (for example
by warp knitting) so as to also include these larger openings or
pores that permit bulk transport of wound fluids in addition to
wound fluids carried along the fibers by capillary action of the
fibers. Apertures that are optionally formed in the distal end of
the 3D fabric (as illustrated in FIGS. 55D and J) may also aid in
the bulk evacuation of wound debris and fluids.
FIG. 56B illustrates the top side 5605 of a 3D fabric that may be
used as described herein. This top side 5605 in one embodiment does
not have the larger ovoid apertures 5611 of the bottom side 5603,
but may have openings 5613 defined by fibers extending lengthwise
and generally transversely or at an angle across the width of the
fabric. As illustrated, these openings are generally
rhombus-shaped. In one embodiment, these openings 5613 may
represent or provide an open area greater than that of the bottom
layer, for example between 30% and 50% (or about 30% and about
50%). Of course, it will be understood that the fabric presented
here is a non-limiting example, and different fabric configurations
and orientations are possible, for example with the top side 5605
being placed downward so as to face the wound and with the bottom
side 5603 facing upward.
FIG. 56C illustrates a cross-section of a 3D fabric (the bulb-like
projections on the vertical fibers in the fabric are an artifact of
the cutting process). The vertically extending fibers 5609 may be
woven so as to extend through the middle open area 5607 while also
being connected to the bottom and top layers 5603 and 5605.
Preferably, the fibers 5609 present in the open middle layer 5607
will have sufficient stiffness so as to help prevent compression of
the fabric. As illustrated in this figure, and without wishing to
be bound by theory, 3D fabrics that have been found to perform well
will often include a larger open area 5607 in the middle portion
that may permit exudates and other fluids to be effectively
transported away from a wound site while under the application of
negative pressure, while more densely-woven outer layers 5603, 5605
may aid in providing additional tensile strength and capillary
wicking action. For example, the middle layer may include an open
volume of greater than 50% (or greater than about 50%). Obviously,
the resulting fabric cannot be too thick or composed of fibers that
are too stiff, as the resulting suction adapter and system may not
remain sufficiently flexible for comfortable usage with a
patient.
It will often be advantageous to tailor the performance
characteristics of the 3D fabric while in use to account for
various requirements of the suction adapter. In particular, the
flow rate of exudate through the fabric, for example when under
compression, may be simplified by considering the porosity of the
fabric. In such situations, and again without wishing to be bound
by theory, the porosity of the fabric, and thus the space that will
be available for fluids to travel through, may be determined in
part by the knit pattern of the fibers used in creating the 3D
fabric, the thickness of the fibers used therein, and their
respective stiffness and hardness (especially when under
compression). Fibers may also be modified by surface properties
(the fibers can be flat or textured) and the number of fibers or
filaments used in the resulting fabric. Compression resistance may
be affected by the choice of fiber or monofilament used in the
vertical axis of the fabric, and generally, a stiffer material will
improve compression resistance on this axis. Other materials
properties, such as hydrophobicity, may play a role. In some cases,
it may be beneficial to treat the fabric to be hydrophilic, for
example with a hydrophilic polymer, so as to improve wicking of
fluids. Preferred embodiments of the 3D fabric used with certain
suction adapters have been found to work well when Baltex.RTM.
fabric is treated in such a fashion. Other possible treatments may
include lipophilic coatings to prevent proteins from adhering and
building up during use, which may cause clogging and loss of
pressure to the wound site.
The flow rate through the 3D fabric while under the application of
negative pressure may be approximated by considering each opening
as a separate orifice plate subject to Bernoulli's principle while
under laminar flow. To simplify calculations, the area of openings
for a given area of 3D fabric may be used. Thus, the 3D fabric may
be optimized to achieve a good balance between factors such as the
compression resistance required and the resulting flow rate under
the application of negative pressure. Further optimization will
also take place with the stiffness and flow rate of the 3D fabric
being tailored to application in the embodiments described herein.
Optimization of the properties and dimensions of the 3D fabric will
also preferably take into account a balancing between the flow rate
and stiffness required and the conformability of the fabric, as a
fabric that is too stiff may not bend appropriately and may also be
uncomfortable on the patient. The 3D fabric should preferably be
designed so as to yield when compressed against tissue, thereby
preventing tissue compression (for example against bony prominences
in the patient) and the discomfort and damage, such as pressure
ulcers, that may follow. For example, the dimensions of the fabric
may be tailored for the ultimate use of the suction
adapter--smaller in the case of distal extremities such as fingers,
and larger for abdominal and burn wounds. A fabric that is too
stiff may also cause pressure ulcers and other such complications,
although it may function acceptably in larger dimensions.
In practice, and as also described previously herein, flow rates
through embodiments of the suction adapter using 3D fabrics are at
least 0.08 L/min, preferably up to 10 L/min during the application
of negative pressure, and should be able to handle fluid exudate
drainage of at least 10 L/day. Some embodiments of the suction
adapter may be configured to handle much larger wounds, including
abdominal wounds, and which in some cases may exude at least 0.5
L/hr, or 12 L/day. In more extreme cases, the pump used (for
example, the RENASYS EZ) may be able to evacuate up to 16 L/min,
thereby evacuating a large wound to a negative pressure level of
120 mmHg in less than a minute. The pressure drop calculated due to
the 3D fabric should be minimal, and the level of negative pressure
measured at a wound site is preferably within 25 mmHg of the
pressure level measured at the source of negative pressure.
Although the pressure drop increases as the negative pressure
applied increases (thus rendering the 25 mmHg target more difficult
to reach), embodiments of the wound treatment system are preferably
able to maintain this target pressure to at least a negative
pressure of 200 mmHg. The suction adapter and system are preferably
able to function within pressure ranges required for negative
pressure, which are estimated to be from around 40 mmHg to 200
mmHg. Pressure ranges greater than 200 mmHg are possible, but these
may in some circumstances cause patient discomfort. The apparatus
may also function at lower pressure ranges, such as 20 mmHg,
although at such low pressure levels the therapeutic effects
resulting from negative pressure may be diminished, with the device
acting more as a drainage device. Preferably, embodiments of a
negative pressure treatment system are able to maintain these
target pressures at the wound site within 95% of the time that
negative pressure is being applied to the wound. In some
embodiments, the fabric may comprise several layers of material
stacked or layered over each other, which may in some cases be
useful in preventing the channel 5516 from collapsing under the
application of negative pressure. In other embodiments, the fabric
used in channel 5516 may be between 1.5 mm and 6 mm; more
preferably, the fabric may be between 3 mm and 6 mm thick, and may
be comprised of either one or several individual layers of fabric.
In other embodiments, the channel 5512 may be between 1.2-3 mm
thick, and preferably thicker than 1.5 mm. Preferably, the 3D
fabric is able to withstand a load of at least 5.3 psi with a
compression of not more than 10% of the fabric's original
thickness. Further, the 3D fabric may also be able to resist
compression to less than half of its original thickness when
subjected to a load of 15 psi.
In a preferred embodiment, a 3D fabric may be woven from 100%
polyester using yarns of 150 and 225 Denier, to yield a fabric
weighing approximately 23 to 25 oz per square yard. In these cases,
the fabric may be approximately 5.8-6.8 mm thick. The bottom
portion of the fabric may also have several openings or pores 5611
similar to those illustrated in FIG. 56A, which may be elongated,
rectangular or ovoid in shape and oriented with their long axis
lengthwise along the fabric. The openings 5611 may be arranged in a
plurality of rows extending lengthwise across the fabric, for
example 2 to 5 rows, or more preferably 3 rows as illustrated in
FIG. 56A. The openings 5611 may be spaced equidistantly from each
other in each of the rows, and may form a staggered pattern from
one row to another. In one embodiment, each row may have
approximately 6-10 openings, more preferably 8 openings, per 2
inches (or about 50 mm). Along a given width or transverse
dimension of the fabric, the transverse rows formed by the openings
may have a spacing of approximately 6-10 openings, more preferably
8 openings, per 21/8 inches (or about 54 mm). In one embodiment,
the openings may have a length of between about 1/16'' to about 1''
lengthwise, and a width of between about 1/32'' and 1/2''
widthwise. In one example, the openings measure approximately 1/8''
(or about 3.2 mm) lengthwise and 1/32'' (or about 0.79 mm) across.
The 3D fabric in one embodiment may have an overall length of
between about 50 and 100 mm, more preferably about 60 mm, a width
between about 5 and 15 mm, more preferably about 9 mm, and a
thickness of about 6 mm.
Embodiments of the systems described herein have been tested and
found to perform satisfactorily. Such testing was performed by
constructing suction adapters from embodiments described herein.
The distal ends of the suction adapters were then placed over an
aperture made onto a drape placed over a simulated wound cavity
provided with a source of simulated wound fluid, which was
controllable and which can vary the flow rate of the wound fluid.
The simulated wound cavity was also in some cases packed with foam
or some other wound packing material. In some tests, the simulated
wound fluid was a 5:1 water to glycerol mix, and in others filtered
horse serum (available from Oxoid, United Kingdom) was used. The
proximal end of the suction adapter was then connected to a source
of negative pressure, in this case a pump. Flow rate tests and
other measurements were then conducted at various negative pressure
ranges and simulated exudate flow rates and air leak rates.
FIGS. 57A-B illustrate embodiments of a connector 5704, similar to
the connectors 1504 and 5506 described previously, and which may be
used to securely connect a source of negative pressure to a channel
5716 of a suction adapter such as the ones described herein. For
example, this channel 5716 may be the upper channel 1512 or, more
preferably, the lower channel 1516 illustrated in FIGS. 15A-D, as
well as the channels 5512 and 5516 in FIGS. 55-56. Generally, such
connectors 5704 may be useful in providing a more secure connection
from the source of negative pressure to a negative pressure
treatment system. The use of these connectors 5704 is optional, and
may not be necessary in all embodiments described herein. In use, a
tube 5740 connected to the connector 5704 may pull, or other
external forces may somehow disengage the connector 5704 away from
the channel 5716 to which it is attached. In such situations,
application of negative pressure to the wound may be reduced or
stopped. Further means to secure the connector 5704 to the
remainder of the system may, as described above, include bonding or
attaching other layers of the treatment system, if present, to the
connector 5704. For example, in the case of the embodiments
described in FIGS. 15A-D, this may include bonding at least one of
the layers 1510, 1514, 1518 to the connector 5704. The connectors
5704 may be designed so as to create a secure connection with a
fabric or material used in a channel; when 3D fabrics or 3D knitted
materials are used, some embodiments of the connector 5704 are
configured to engage with or attach to a portion of the material or
fibers of the material to create a more secure connection.
Preferably, embodiments of the connector 5704 are able to withstand
a pulling force of up to 20 kg before disconnection and/or failure
of the connector occurs, preferably such that the connector
disengages from the channel it is connected to. It will be
understood that other embodiments may be configured to withstand a
lower pulling force, and may be tailored to release so to prevent
injury to a patient (for example, constriction of the suction
adapter and/or drainage tubes around a limb).
FIGS. 57A-B illustrate an embodiment of the connector 5704a
comprising two or more projections 5752 extending distally
lengthwise from the preferably cylindrical main body of the
connector 5704a. The main body also comprises a central channel
5755 extending lengthwise through the main body of the connector
5704a. The projections 5752 may additionally comprise one or more
barbs 5754 attached thereto. Preferably, these barbs 5754 are
angled proximally so as to act as anchors when pushed or inserted
into the channel 5716. When the channel 5716 is a 3D fabric or
knitted material, the barbs 5754 are configured to engage to the
fibers therein, creating a more secure connection. At the proximal
end of the connector 5704a, a lip 5756, which may be provided in a
frustoconical form, may also be provided for connection to a tube
5740. The tube 5740 may be connected to the connector 5704a (as
well as the other connectors described herein) for example by
press-fitting, although other connections means are possible. The
tube 5740 may be the same as tube 5507 in FIG. 55J, or it may be
any other tube used to provide fluid communication with a source of
negative pressure. It will also be appreciated that the features of
these connectors, particularly at the distal ends, can be
incorporated onto the ends of tubes used to communicate negative
pressure, such that those tubes can be directly connected to the
suction adapter system.
While the above detailed description has shown, described, and
pointed out novel features as applied to various embodiments, it
will be understood that various omissions, substitutions, and
changes in the form and details of the device or process
illustrated may be made without departing from the spirit of the
disclosure. Additionally, the various features and processes
described above may be used independently of one another, or may be
combined in various ways. All possible combinations and
subcombinations are intended to fall within the scope of this
disclosure. Many of the embodiments described above include similar
components, and as such, these similar components can be
interchanged in different embodiments.
Although the invention has been disclosed in the context of certain
embodiments and examples, it will be understood by those skilled in
the art that the invention extends beyond the specifically
disclosed embodiments to other alternative embodiments and/or uses
and obvious modifications and equivalents thereof. Accordingly, the
invention is not intended to be limited by the specific disclosures
of preferred embodiments herein.
* * * * *
References