IP Library › Granted Patent US 12,746,321
Granted Patent B2
US 12,746,321 · App. 18/140,170 · Granted Sep 29, 2026

Sub-atmospheric wound-care system

Inventors: Brett A. Freedman (Landstuhl, DE); Robert L. Pauly (Athens, GA)
Assignee: J&M Shuler Medical, Inc.
A61M1/74A61M1/915A61M1/966A61M1/916A61M2205/3344A61M2205/3379A61M2205/502Y10S604/902
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,746,321
App. No.
18/140,170
Granted
Sep 29, 2026
Kind
B2
Abstract

Methods and systems are provided for a sub-atmospheric wound-care (SAWS) system for treating an open wound. The SAWS system includes a regulated vacuum source for developing a negative pressure, a flow rate meter configured to measure a flow rate of liquid removed from the wound, a primary pressure regulating sensor located proximate the wound for directly measuring the negative pressure at the wound, a backup pressure regulating sensor located vacuum tube, a porous dressing suitable to be sealed airtight which is positioned within a wound interface chamber, a collection canister configured to collect said liquid removed from the wound, and an adapter configured to use wall suction a primary regulated vacuum source.

Claims (36)

1 . A system comprising:

an electronic vacuum regulator (EVR) comprising a housing and an automated pressure valve within the housing, the EVR configured to regulate suction pressure applied by a vacuum source at a negative pressure wound dressing by actuating the automated pressure valve, an intake end of the automated pressure valve fluidically connected to the vacuum source;

a flow path extending between an outlet and an inlet, wherein the outlet is configured to fluidically connect to the vacuum source and wherein the inlet is configured to fluidically connect to the negative pressure wound dressing; and

a first sensor positioned in the flow path, the first sensor configured to:

detect a flow rate of liquid flowing through the flow path; and

transmit a signal representative of the detected flow rate to the EVR; and

a second sensor positioned at the negative pressure wound dressing, the second sensor configured to:

detect a negative pressure applied at the negative pressure wound dressing; and

transmit a signal representative of the detected negative pressure to the EVR;

a third sensor configured to detect negative pressure, wherein the EVR further comprises software configured to compare at least one of the detected negative pressures received from the second and third sensors to a programmed suction pressure and to open and close the automated pressure valve in response to both of the detected flow rate of liquid flowing through the flow path and the comparison of the detected negative pressure to the programmed suction pressure to automatically regulate the suction pressure.

2 . The system of claim 1 , wherein the EVR is configured to regulate suction intermittently by opening and closing the automated pressure valve to increase or decrease suction.

3 . The system of claim 1 , wherein the EVR comprises an interface for programming a suction pressure applied by a vacuum source at the negative pressure wound dressing.

4 . The system of claim 3 , wherein the EVR is configured to:

compare a programmed suction pressure to one or both of a negative pressure determined from the detected flow rate of liquid flowing through the flow path and the detected negative pressure applied at the negative pressure wound dressing.

5 . The system of claim 4 , wherein the EVR is further configured to:

determine, based on the comparison, presence of a leak in the system; and

temporarily increase suction in response to determining the presence of the leak in the system.

6 . The system of claim 4 , wherein the EVR is configured to:

determine, based on the comparison, presence of a leak in the system; and

output an alarm in response to determining the presence of the leak in the system.

7 . The system of claim 4 , wherein the EVR is configured to:

determine, based on the comparison, a high flow rate condition in the system; and

output an alarm in response to determining the high flow rate condition in the system.

8 . The system of claim 1 , wherein the EVR is configured to be operable when the vacuum source is a wall vacuum source and operable when the vacuum source is a vacuum motor of the EVR, the vacuum motor of the EVR configured for use as a back-up to the wall vacuum source.

9 . The system of claim 8 , wherein the EVR is configured to be releasably coupled to the wall vacuum source and to the flow path.

10 . The system of claim 9 , wherein the EVR comprises a connector for coupling to the wall vacuum source, and wherein the connector is configured to be retractable into a housing of the EVR when the vacuum motor of the EVR is in use.

11 . The system of claim 1 , wherein the EVR is configured to regulate suction intermittently in an intermittent suction program whereby the EVR maintains suction throughout the intermittent suction program such that suction is higher than zero during the intermittent suction program even when suction is reduced.

12 . The system of claim 1 , the EVR further comprising a recording system configured to record a rate of fluid removal from a wound over a time period exceeding multiple hours, the rate of fluid removal from the wound determined based on one or both of the detected flow rate of liquid flowing through the flow path and the detected negative pressure applied at the negative pressure wound dressing.

13 . The system of claim 1 , wherein the second sensor is configured to be in direct contact with the wound surface.

14 . The system of claim 1 , wherein the housing further comprises:

a memory configured to record the signal representative of the detected negative pressure transmitted by the at least two sensors;

a processor configured to use the recorded signals to determine the presence of a leak or a high flow rate in the system; and

a vacuum motor configured for use as a back-up to a wall vacuum source.

15 . The system of claim 1 , wherein the second sensor is configured to be located between a wound and the negative pressure wound dressing.

16 . The system of claim 1 , wherein detecting the flow rate comprises detecting a volume of liquid per unit of time.

17 . The system of claim 1 , wherein the first sensor is configured to detect flow rate of only liquid.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 21, 2023
From: FREEDMAN, BRETT A.; PAULY, ROBERT L.
To: KELLEY, MARY BETH
Reel/Frame 064986/0327 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 21, 2023
From: KELLEY, MARY BETH
To: J&M SHULER MEDICAL, INC.
Reel/Frame 064986/0582 →
Continuity (7)
Continuation 16384737 · Apr 15, 2019
Continuation 13915600 · Jun 11, 2013
Continuation 13843507 · Mar 15, 2013
Continuation 13118544 · May 30, 2011
Continuation 11875668 · Oct 19, 2007
Provisional Application 60853000 · Oct 20, 2006
Related Publication 20230256154A1 · Aug 17, 2023
References Cited (168)
US 4460354A · Weilbacher et al. · 1984 [cited by applicant]
US 4559035A · Benjamin et al. · 1985 [cited by applicant]
US 4650462A · DeSatnick · 1987 [cited by examiner]
US 4886502A · Poirier et al. · 1989 [cited by applicant]
US 4969880A · Zamierowski · 1990 [cited by applicant]
US 5071409A · Rosenberg · 1991 [cited by applicant]
US 5100396A · Zamierowski · 1992 [cited by applicant]
US 5176663A · Svedman et al. · 1993 [cited by applicant]
US 5261893A · Zamierowski · 1993 [cited by applicant]
US 5358494A · Svedman · 1994 [cited by applicant]
US 5527293A · Zamierowski · 1996 [cited by applicant]
US 5549584A · Gross · 1996 [cited by applicant]
US 5636643A · Argenta et al. · 1997 [cited by applicant]
US 5645081A · Argenta et al. · 1997 [cited by applicant]
US 5678564A · Lawrence et al. · 1997 [cited by applicant]
US 5755706A · Kronenthal et al. · 1998 [cited by applicant]
US 5911222A · Lawrence et al. · 1999 [cited by applicant]
US 6045541A · Matsumoto et al. · 2000 [cited by applicant]
US 6048337A · Svedman · 2000 [cited by applicant]
US 6071267A · Zamierowski · 2000 [cited by applicant]
US 6142982A · Hunt et al. · 2000 [cited by applicant]
US 6176868B1 · Detour · 2001 [cited by applicant]
US 6345623B1 · Heaton et al. · 2002 [cited by applicant]
US 6458109B1 · Henley et al. · 2002 [cited by applicant]
US 6468237B1 · Lina · 2002 [cited by applicant]
US 6685681B2 · Anker et al. · 2004 [cited by applicant]
US 6695823B1 · Lina et al. · 2004 [cited by applicant]
US 6752794B2 · Lockwood et al. · 2004 [cited by applicant]
US 6764462B2 · Risk, Jr. et al. · 2004 [cited by applicant]
US 6767334B1 · Randolph · 2004 [cited by applicant]
US 7004915B2 · Boynton et al. · 2006 [cited by applicant]
US 7022113B2 · Lockwood et al. · 2006 [cited by applicant]
US 7108683B2 · Zamierowski · 2006 [cited by applicant]
US 7117869B2 · Heaton et al. · 2006 [cited by applicant]
US 7276051B1 · Henley et al. · 2007 [cited by applicant]
US 7338482B2 · Lockwood et al. · 2008 [cited by applicant]
US 7361184B2 · Joshi · 2008 [cited by applicant]
US 7413571B2 · Zamierowski · 2008 [cited by applicant]
US 7438705B2 · Karpowicz et al. · 2008 [cited by applicant]
US 7520872B2 · Biggie et al. · 2009 [cited by applicant]
US 7524286B2 · Johnson · 2009 [cited by applicant]
US 7524315B2 · Blott et al. · 2009 [cited by applicant]
US 7532953B2 · Vogel · 2009 [cited by applicant]
US 7534927B2 · Lockwood et al. · 2009 [cited by applicant]
US 7608066B2 · Vogel · 2009 [cited by applicant]
US 7651484B2 · Heaton et al. · 2010 [cited by applicant]
US 7723560B2 · Lockwood et al. · 2010 [cited by applicant]
US 7790945B1 · Watson · 2010 [cited by applicant]
US 7837673B2 · Vogel · 2010 [cited by applicant]
US 7867206B2 · Lockwood et al. · 2011 [cited by applicant]
US 7883494B2 · Martin · 2011 [cited by applicant]
US 7922703B2 · Riesinger · 2011 [cited by applicant]
US 7927318B2 · Risk, Jr. et al. · 2011 [cited by applicant]
US 7951100B2 · Hunt et al. · 2011 [cited by applicant]
US 7967810B2 · Freedman · 2011 [cited by applicant]
US 7988680B2 · Lockwood et al. · 2011 [cited by applicant]
US 8057446B2 · Kane et al. · 2011 [cited by applicant]
US 8066243B2 · Svedman et al. · 2011 [cited by applicant]
US 8142405B2 · Vogel · 2012 [cited by applicant]
US 8162909B2 · Blott et al. · 2012 [cited by applicant]
US 8187210B2 · Hunt et al. · 2012 [cited by applicant]
US 8350116B2 · Lockwood et al. · 2013 [cited by applicant]
US 8372049B2 · Jaeb et al. · 2013 [cited by applicant]
US 8376972B2 · Fleischmann · 2013 [cited by applicant]
US 8425478B2 · Olson · 2013 [cited by applicant]
US 8444613B2 · Svedman et al. · 2013 [cited by applicant]
US 8447375B2 · Freedman et al. · 2013 [cited by applicant]
US 8460258B2 · Jones et al. · 2013 [cited by applicant]
US 8460273B2 · Freedman et al. · 2013 [cited by applicant]
US 9393354B2 · Freedman et al. · 2016 [cited by applicant]
US 10058643B2 · Freedman et al. · 2018 [cited by applicant]
US 10149930B2 · Shuler · 2018 [cited by applicant]
US 11666695B2 · Freedman · 2023 [cited by examiner]
US 11813058B2 · Shuler · 2023 [cited by applicant]
US 11963850B2 · Freedman et al. · 2024 [cited by applicant]
US 20010031943A1 · Urie · 2001 [cited by applicant]
US 20020115967A1 · Svedman · 2002 [cited by applicant]
US 20020143286A1 · Tumey · 2002 [cited by applicant]
US 20020150720A1 · Howard et al. · 2002 [cited by applicant]
US 20020183702A1 · Henley · 2002 [cited by applicant]
US 20030050594A1 · Zamierowski · 2003 [cited by applicant]
US 20030139255A1 · Lina · 2003 [cited by applicant]
US 20030163160A1 · O'Malley et al. · 2003 [cited by applicant]
US 20030208149A1 · Coffey · 2003 [cited by applicant]
US 20040006319A1 · Lina et al. · 2004 [cited by applicant]
US 20040054338A1 · Bybordi et al. · 2004 [cited by applicant]
US 20040064111A1 · Lockwood et al. · 2004 [cited by applicant]
US 20040064132A1 · Boehringer et al. · 2004 [cited by applicant]
US 20040265040A1 · Rosenberg · 2004 [cited by applicant]
US 20050070858A1 · Lockwood et al. · 2005 [cited by applicant]
US 20050085795A1 · Lockwood · 2005 [cited by applicant]
US 20060041238A1 · Bowen · 2006 [cited by applicant]
US 20060065494A1 · Kim · 2006 [cited by applicant]
US 20060129137A1 · Lockwood et al. · 2006 [cited by applicant]
US 20060155260A1 · Blott et al. · 2006 [cited by applicant]
US 20060282028A1 · Howard et al. · 2006 [cited by applicant]
US 20070038247A1 · Lebner et al. · 2007 [cited by applicant]
US 20070118096A1 · Smith · 2007 [cited by examiner]
US 20070167926A1 · Blott et al. · 2007 [cited by applicant]
US 20070219532A1 · Karpowicz · 2007 [cited by examiner]
US 20070225634A1 · Ferren et al. · 2007 [cited by applicant]
US 20070225663A1 · Watt et al. · 2007 [cited by applicant]
US 20080015406A1 · Dlugos · 2008 [cited by examiner]
US 20080167593A1 · Fleischmann · 2008 [cited by applicant]
US 20080208011A1 · Shuler · 2008 [cited by applicant]
US 20080255498A1 · Houle · 2008 [cited by applicant]
US 20090177051A1 · Arons et al. · 2009 [cited by applicant]
US 20090221977A1 · Blott et al. · 2009 [cited by applicant]
US 20090299340A1 · Kazala et al. · 2009 [cited by applicant]
US 20100049150A1 · Braga et al. · 2010 [cited by applicant]
US 20100049151A1 · Aicher · 2010 [cited by applicant]
US 20100191196A1 · Heagle · 2010 [cited by applicant]
US 20100191198A1 · Heagle · 2010 [cited by applicant]
US 20100262091A1 · Larsson · 2010 [cited by applicant]
US 20100280428A1 · Widgerow et al. · 2010 [cited by applicant]
US 20100292549A1 · Shuler · 2010 [cited by applicant]
US 20110034888A1 · Aali · 2011 [cited by applicant]
US 20110054283A1 · Shuler · 2011 [cited by applicant]
US 20110106026A1 · Wu et al. · 2011 [cited by applicant]
US 20110125110A1 · Cotton · 2011 [cited by applicant]
US 20110172617A1 · Riesinger · 2011 [cited by applicant]
US 20110213319A1 · Blott et al. · 2011 [cited by applicant]
US 20120041403A1 · Bennett et al. · 2012 [cited by applicant]
US 20120316518A1 · Croizt et al. · 2012 [cited by applicant]
US 20130096520A1 · Lockwood et al. · 2013 [cited by applicant]
US 20130138060A1 · Haggstrom et al. · 2013 [cited by applicant]
US 20130144230A1 · Wu et al. · 2013 [cited by applicant]
US 20130165821A1 · Freedman et al. · 2013 [cited by applicant]
US 20130165878A1 · Heagle · 2013 [cited by applicant]
US 20130172834A1 · Heagle · 2013 [cited by applicant]
US 20130274695A1 · Freedman et al. · 2013 [cited by applicant]
US 20190111192A1 · Shuler · 2019 [cited by applicant]
US 20200101208A1 · Freedman et al. · 2020 [cited by applicant]
US 20240108254A1 · Shuler · 2024 [cited by applicant]
US 20240350319A1 · Freedman et al. · 2024 [cited by applicant]
CA 2619925 · 2007 [cited by applicant]
CN 101296716A · 2008 [cited by examiner]
EP 1304966 · 2003 [cited by applicant]
WO WO1997005838 · 1997 [cited by applicant]
WO WO2007041642 · 2007 [cited by applicant]
WO WO2008100440 · 2008 [cited by applicant]
WO WO2009062327 · 2009 [cited by applicant]
WO WO2009093116 · 2009 [cited by applicant]
WO WO2011091045 · 2011 [cited by applicant]
U.S. Appl. No. 60/853,000, filed Oct. 20, 2006, Freedman. [cited by applicant]
U.S. Appl. No. 61/233,797, filed Aug. 13, 2009, Shuler. [cited by applicant]
U.S. Appl. No. 61/234,857, filed Aug. 18, 2009, Shuler. [cited by applicant]
U.S. Appl. No. 61/245,789, filed Sep. 25, 2009, Shuler. [cited by applicant]
U.S. Appl. No. 61/554,080, filed Nov. 1, 2011, Freedman. [cited by applicant]
U.S. Appl. No. 61/643,840, filed May 7, 2012, Freedman. [cited by applicant]
Argenta et al., “Vacuum-Assisted Closure: A New Method For Wound Control And Treatment: Basic Foundation,” Annals Of Plastic Surgery, 1997, 38(6): 553-562. [cited by applicant]
Argenta et al., “Vacuum-Assisted Closure: A New Method For Wound Control And Treatment: Clinical Experience,” Annals of Plastic Surgery, 1997, 38(6): 563-577. [cited by applicant]
Brock et al., “Temporary Closure of Open Abdominal Wounds: The Vacuum Pack,” Am Surg., 1995, 61(1): 30-35. [cited by applicant]
Buckman, “Vacuum Assisted Wound Closure System,” Drexel University white paper, Jul. 15, 2006. [cited by applicant]
Davydov et al., “Concepts for Clinical Biological Management of the Wound Process in the Treatment of Purulent Wounds Using Vacuum Therapy,” The Kremlin Papers; Perspectives in Wound Care from the Russian Medical Journa… [cited by applicant]
Davydov et al., “The Bacteriological and Cytological Assessment of Vacuum Therapy of Purulent Wounds,” The Kremlin papers, Perspectives in Wound Care from the Russian Medical Journal, 1988, 48-52. [cited by applicant]
Davydov et al., “Vacuum Therapy in the Treatment of Purulent lactation Mastitis,” The Kremlin papers, perspectives in Wound Care from the Russian Medical Journal, 1986, 66-70. [cited by applicant]
International Search Report and Written Opinion for PCT/US2010/045262, mailed Jun. 17, 2011, 7 pages. [cited by applicant]
Kostiuchenok et al., “The Vacuum Effect in the Surgical Treatment of Purulent Wounds,” The Kremlin Papers, Perspectives in Wound Care from the Russian Medical Journal, 1986, 18-21. [cited by applicant]
Scherer et al., “The vacuum assisted closure device: A method for securing skin grafts and improving graft survival,” Arch Surg., 2002, 137(8): 930-933. [cited by applicant]
Singh et al., “Dynamic Wound Closure for Decompressive Leg Fasciotomy Wounds,” Am Surg, 2008, 74(3): 217-220. [cited by applicant]
Usupov et al., “Active Wound Drainage,” The Kremlin Papers, Perspectives in Wound Care from the Russian Medical Journal, 1987, 42-45. [cited by applicant]
Valenta, “Using the Vacuum Dressing Alternative for Difficult Wounds,” American J. of Nursing, 1994, 44-45. [cited by applicant]
Van der Velde et al., “VADER (vacuum-assisted dermal recruitment: a new method of wound closure,” Annals of Plastic Surgery, 2005, 55(6): 660-664. [cited by applicant]
Wackenfors et al., “Effects of vacuum-assisted closure therapy on inguinal wound edge microvascular blood flow,” Wound Repaire and Regeneration, 2004, 12(6): 600-606. [cited by applicant]
Webb, “New Techniques in Wound Management: Vacuum-assisted Wound Closure,” J. Am Acad Orthop Surg, 2002, 10(5): 303-311. [cited by applicant]
Zannis et al, “Comparison of Fasciotomy Wound Closures Using Traditional Dressing Changes and the Vacuum-assisted Closure Device,” Annals of Plastic Surgery, 2009, 62(4): 407-409. [cited by applicant]
Zorilla, et al, “Shoelace Technique for Gradual Closure of Fasciotomy Wounds,” The Journal of Trama, 2005, 59(6): 1515-1517. [cited by applicant]