IP Library › Granted Patent US 12,514,777
Granted Patent B2
US 12,514,777 · App. 16/574,177 · Granted Jan 6, 2026

Controller for an extremity hyperbaric device

Inventors: Phillip Loori (Farmingdale, NJ); George Hovorka (East Boston, MA)
Assignee: AOTI, Inc.
A61H9/0057A61G10/026A61M37/00A61G10/02A61G10/023A61H9/0078A61M2202/0208
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Quick Facts
Patent No.
US 12,514,777
App. No.
16/574,177
Granted
Jan 6, 2026
Kind
B2
Abstract

A controller is operable to selectively supply gas to, and evacuate gas from, regions of a hyperbaric wound treatment chamber. The controller operates to inflate a passage or rib of the device to provide that the device is made sufficiently rigid for inserting a limb therethrough, and inflate an inflatable cuff to create a seal against the limb. The controller also operates to evacuate ambient air trapped within the chamber, and optionally partially evacuate the passage or rib, after the seal is created by the inflatable cuff, and then introduce oxygen into the chamber, and optionally inflate the passage or rib. The cuff, when inflated and creating a seal against a limb, optionally is at least partially within the chamber, and the treatment gas is supplied to the chamber to maintain the seal of the cuff against the limb.

Claims (19)

1 . A method of operating a hyperbaric wound treatment device, wherein the device includes a chamber having an open end and an inflatable limb sleeve coupled to the chamber, the sleeve having a first end and a second end, the sleeve being positionable at least partially within the chamber at the open end with the first end within the chamber and at least partially outside the chamber with the second end outside the chamber, and including an outer wall, an inner wall defining an interior region therebetween and extending between the first end and the second end, and a side wall connecting the inner wall and the outer wall, the method comprising:

inserting a limb through the sleeve and into the chamber at the open end; and

inflating the sleeve to an inflated condition when the limb is positioned within the sleeve, thereby sealing the inner wall of the sleeve about the limb.

2 . The method of claim 1 , wherein the sleeve is positionable such that a portion of the limb is insertable through the sleeve and into the chamber without the portion of the limb contacting the sleeve.

3 . The method of claim 1 , wherein the inflating includes supplying a gas under pressure to the interior region.

4 . The method of claim 1 , wherein the inflating includes introducing a gas into the sleeve until at least a partial seal is formed between the limb and the sleeve.

5 . The method of claim 1 further comprising:

supplying a gas into the chamber at a pressure sufficient to cause a portion of the sleeve within the chamber to form at least a partial seal between the limb and the sleeve, wherein the sleeve is positioned at least partially within the chamber.

6 . The method of claim 1 , wherein the outer wall has a thickness greater than a thickness of the inner wall, the method further comprising:

inflating the sleeve to cause stretching of the inner wall while the outer wall remains substantially non-stretched.

7 . The method of claim 6 , wherein, when the sleeve is inflated to the inflated condition, the method further comprising:

supplying a gas into the chamber at a pressure sufficient to have the pressure in the chamber exceed the pressure within the sleeve, whereby the pressure in the chamber causes the inner wall to form at least a partial seal against the limb.

8 . The method of claim 7 , wherein the pressure within the sleeve is up to about 1 psi.

9 . The method of claim 6 , wherein the inner and outer walls define respective inside and outside diameters, and wherein the inside diameter is reduced based on the inflating of the sleeve while the outside diameter is substantially unchanged.

10 . The method of claim 1 , wherein the interior region extends along an entire length of the sleeve.

11 . The method of claim 1 , wherein the interior region extends at least partially outside the chamber.

12 . The method of claim 1 , wherein the inflating includes supplying a gas under pressure to the interior region via an air valve on the sleeve outside the chamber.

13 . The method of claim 1 , wherein the inflating the sleeve comprises inflating the sleeve at the second end of the sleeve.

14 . The method of claim 1 , further comprising a second side wall connecting the inner wall and the outer wall.

Assignments (2)
SECURITY INTEREST Recorded Apr 11, 2022
From: AOTI, INC.; AOTI LIMITED
To: SWK FUNDING LLC
Reel/Frame 059560/0845 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 24, 2020
From: LOORI, PHILLIP; HOVORKA, GEORGE
To: AOTI, INC.
Reel/Frame 053869/0117 →
Continuity (5)
Division 13968683 · Aug 16, 2013
Division 12156466 · May 30, 2008
Provisional Application 61002077 · Nov 6, 2007
Provisional Application 60932708 · May 31, 2007
Related Publication 20200009008A1 · Jan 9, 2020
References Cited (154)
US 871760A · Long et al. · 1907 [cited by applicant]
US 1117168A · Crowley · 1914 [cited by applicant]
US 2134646A · Sauzedde · 1938 [cited by applicant]
US 3368556A · Jensen et al. · 1968 [cited by applicant]
US 3478738A · Altman et al. · 1969 [cited by applicant]
US 3536063A · Werding · 1970 [cited by examiner]
US 3602221A · Bleicken · 1971 [cited by applicant]
US 3604421A · Pizzella · 1971 [cited by applicant]
US 3669096A · Hurwitz · 1972 [cited by applicant]
US 3701349A · Larson · 1972 [cited by applicant]
US 3712298A · Snowdon et al. · 1973 [cited by applicant]
US 3744491A · Fischer · 1973 [cited by applicant]
US 3785374A · Lipson · 1974 [cited by applicant]
US 3859989A · Spielberg · 1975 [cited by examiner]
US 3877427A · Alexeev et al. · 1975 [cited by applicant]
US 3920006A · Lapidus · 1975 [cited by applicant]
US 3955565A · Johnson, Jr. · 1976 [cited by applicant]
US 4003371A · Fischer · 1977 [cited by applicant]
US 4211223A · LoPiano · 1980 [cited by applicant]
US 4227524A · Galerne · 1980 [cited by applicant]
US 4236513A · LoPiano · 1980 [cited by applicant]
US 4280489A · Johnson, Jr. · 1981 [cited by applicant]
US 4328799A · LoPiano · 1982 [cited by applicant]
US 4331133A · Arkans · 1982 [cited by applicant]
US 4346699A · Little et al. · 1982 [cited by applicant]
US 4353359A · Milbauer · 1982 [cited by applicant]
US 4363317A · Broucek · 1982 [cited by applicant]
US 4378009A · Rowley et al. · 1983 [cited by applicant]
US 4460370A · Allison et al. · 1984 [cited by applicant]
US 4509513A · Lasley · 1985 [cited by applicant]
US 4628945A · Johnson, Jr. · 1986 [cited by applicant]
US 4633859A · Reneau · 1987 [cited by applicant]
US 4635635A · Robinette-Lehman · 1987 [cited by applicant]
US 4667672A · Romanowski · 1987 [cited by applicant]
US 4801291A · Loori · 1989 [cited by applicant]
US 4938208A · Dye · 1990 [cited by examiner]
US 5000164A · Cooper · 1991 [cited by applicant]
US 5007411A · Dye · 1991 [cited by applicant]
US 5029579A · Trammell · 1991 [cited by applicant]
US 5060644A · Loori · 1991 [cited by applicant]
US 5125400A · Johnson, Jr. · 1992 [cited by applicant]
US 5154697A · Loori · 1992 [cited by applicant]
US 5211642A · Clendenning · 1993 [cited by applicant]
US 5234459A · Lee · 1993 [cited by applicant]
US 5264218A · Rogozinski · 1993 [cited by applicant]
US 5312385A · Greco · 1994 [cited by applicant]
US 5376067A · Daneshvar · 1994 [cited by applicant]
US 5413582A · Eaton · 1995 [cited by applicant]
US 5425742A · Joy · 1995 [cited by applicant]
US 5437602A · Polyakov et al. · 1995 [cited by applicant]
US 5458562A · Cooper · 1995 [cited by applicant]
US 5478310A · Dyson-Cantwell et al. · 1995 [cited by applicant]
US 5578055A · McEwen · 1996 [cited by applicant]
US 5605534A · Hutchison · 1997 [cited by applicant]
US 5620001A · Byrd et al. · 1997 [cited by applicant]
US 5660182A · Kuroshaki et al. · 1997 [cited by applicant]
US 5669390A · McCormick et al. · 1997 [cited by applicant]
US 5678543A · Bower · 1997 [cited by applicant]
US 5688236A · Gragg · 1997 [cited by applicant]
US 5738093A · Santi · 1998 [cited by applicant]
US 5810795A · Westwood · 1998 [cited by applicant]
US 5848998A · Marasco, Jr. · 1998 [cited by applicant]
US 5865722A · Heng · 1999 [cited by applicant]
US 6007559A · Arkans · 1999 [cited by applicant]
US 6120860A · Bowen et al. · 2000 [cited by applicant]
US 6235365B1 · Schaughency et al. · 2001 [cited by applicant]
US 6321746B1 · Schneider et al. · 2001 [cited by applicant]
US 6500192B1 · Werding · 2002 [cited by applicant]
US 6622326B2 · Richardson · 2003 [cited by applicant]
US 6639745B1 · Cheng · 2003 [cited by applicant]
US 6702794B2 · Blum et al. · 2004 [cited by applicant]
US 6793644B2 · Stenzler · 2004 [cited by applicant]
US 6814720B2 · Olsen et al. · 2004 [cited by applicant]
US 6881929B2 · Hovorka · 2005 [cited by applicant]
US 7540283B2 · Loori et al. · 2009 [cited by applicant]
US 7998125B2 · Weston · 2011 [cited by applicant]
US 20030036771A1 · McEwen et al. · 2003 [cited by applicant]
US 20050027218A1 · Filtvedt et al. · 2005 [cited by applicant]
US 20050043672A1 · Piuk et al. · 2005 [cited by applicant]
US 20050161039A1 · Gurnee et al. · 2005 [cited by applicant]
US 20050191372A1 · Stenzler et al. · 2005 [cited by applicant]
US 20050261615A1 · Weston · 2005 [cited by applicant]
US 20060069357A1 · Marasco · 2006 [cited by applicant]
US 20060185670A1 · Loori et al. · 2006 [cited by applicant]
US 20060293630A1 · Manna et al. · 2006 [cited by applicant]
US 20070037472A1 · Greenwald et al. · 2007 [cited by applicant]
US 20070118096A1 · Smith et al. · 2007 [cited by applicant]
US 20080140029A1 · Smith et al. · 2008 [cited by applicant]
US 20080249444A1 · Avitable · 2008 [cited by examiner]
US 20090120433A1 · Loori et al. · 2009 [cited by applicant]
US 20090126727A1 · Loori et al. · 2009 [cited by applicant]
US 20090270910A1 · Hargens et al. · 2009 [cited by applicant]
DE 19846922A1 · 2000 [cited by applicant]
EP 0392669A2 · 1990 [cited by applicant]
JP 45022313 · 1970 [cited by applicant]
JP 57195468 · 1982 [cited by applicant]
JP 11057007 · 1999 [cited by applicant]
JP 2008531113A · 2008 [cited by applicant]
WO 2006091243 · 2006 [cited by applicant]
WO 2008130689A1 · 2008 [cited by applicant]
Inflatable, Merriam-Webster On-Line Dictionary, https://www.merriam-webster.com/dictionary/inflatable, last visited Aug. 11, 2025. [cited by examiner]
Inflate, Merriam-Webster On-Line Dictionary, https://www.merriam-webster.com/dictionary/inflate, last visited Aug. 11, 2025. [cited by examiner]
U.S. Appl. No. 11/064,581, filed Feb. 24, 2005, entitled “Hyperbaric Oxygen Device and Delivery methods”. [cited by applicant]
U.S. Appl. No. 12/156,465, filed May 30, 2008, entitled “Controller for an Extremity Hyperbaric Chamber”. [cited by applicant]
U.S. Appl. No. 12/156,466, filed May 30, 2008, entitled “Controller for an Extremity Hyperbaric Chamber”. [cited by applicant]
U.S. Appl. No. 61/002,269, filed Nov. 7, 2007, entitled “Pressure Compensating Seal With Positive Feedback”. [cited by applicant]
American Diabetes Association, “Economic Costs of Diabetes in the U.S. in 2002” Diabetes Care, vol. 26, No. 3, Mar. 2003, pp. 917-932. [cited by applicant]
Branom, et al., “Constant Force Technology' versus Low-Air-Loss Therapy in the Treatment of Pressure Ulcers”, OstomyWound—Utilizing a Systems Approach to Implement Pressure Ulcer Prediction and Prevention, Sep. 2001, vo… [cited by applicant]
CDC Diabetes, Department of Health and Human Services, Centers for Disease Control and Prevention, “National Diabetes Fact Sheet”, United States, 2003, General Information, 3 pages. [cited by applicant]
Cianci “Advances in the treatment of the diabetic foot: Is there a role for adjunctive hyperbaric oxygen therapy?” Wound Repair Regen, Jan.-Feb. 2004; 129(1):2-10, Department of Hyperbaric Medicine, Doctors Medical Cent… [cited by applicant]
Clinical Device Group and the Food and Drug and Law Institute are happy to present: “Getting CMS Reimbursement for Medical Technology Product” 2006, Clinical Device Group, Inc. Powerpoint presentation, 78 pages. [cited by applicant]
Diabetes Care, published by the American Diabetes Association “Study Finds Diabetes Will Double in World by 2030: Predicts Rapid U.S. increase That Greatly Exceeds Prior CDC Projections” lead author Dr. Sarah Wild, Publ… [cited by applicant]
Diamond, et al. “The Effect of Hyperbaric Oxygen on Lower Extremity Ulcerations” Journal of the American Podiatry Association, vol. 72, No. 4, Apr. 1982, pp. 180-185. [cited by applicant]
Dutton, et al. “Topical Hyperbaric Oxygen Therapy: A Case Study” Macassa Lodge, Hamilton, Ontario. [cited by applicant]
Edsberg, et al. “Reducing Epibole Using Topical Hyerpbaric Oxygen and Electrical Stimulation” OstomyWound Managemet Apr. 2002, vol. 48, Issue 4, pp. 26-29. [cited by applicant]
Edsberg, et al. “Use of Topical Hperbaric Oxygen for Treatment of Chronic Wounds in Long-Termn Health Care Facilities” Natural & Health Sciences Research Center, Daemen College, Amherst, NY, Copyright 2001. [cited by applicant]
Extended European Seach Report for Application No. EP08767897 dated Jun. 3, 2014. [cited by applicant]
Fischer “Topical Hyperbaric Oxygen Treatment of Pressure Sores and Skin Ulcers” reprinted from The Lancet, Aug. 23, 1969, pp. 405-409. [cited by applicant]
Fischer “Treatment of Ulcers on the Legs with Hyperbaric Oxygen” reprinted from The Journal of Dermatologic Surgery, Inc. vol. 1, No. 3, Oct. 1975, J of Derm Surg 1:3, Oct. 1975, pp. 55-58. [cited by applicant]
Fries, et al., “Dermal excisional wound healing in pigs following treatment with topically applied pure oxygen” Mutat. Res. Nov. 11, 2005; 579(1-2): 172-81 Epub Aug. 18, 2005, Laboratory of Molecular Medicine, Dorothy M… [cited by applicant]
Frykberg, et al. “Diabetic Foot Disorders: A Clinical Practice Guideline” 2006 revision, The Journal of Foot and Ankle Surgery, vol. 45, No. 5, Sep./Oct. 2006, S1-S66. [cited by applicant]
Gordillo, et al. “Revisiting the essential role of oxygen in wound healing” Department of Surgery, Laboratory of Molecular Medicine, 512 Davis Heart and Lung Research Institute, The Ohio State University, 473 West 12th … [cited by applicant]
Harkless, et al. “Seven keys to Treating Chronic Wounds” Diabetes Watch, Podiatry Today, Dec. 2000, pp. 17-19. [cited by applicant]
Heng “Topical Hyperbaric Therapy for Problem Skin Wounds” J Dermatol Surg Oncol. Aug. 1993; 19(8):784-93, Department of Medicine, UCLA San Fernando Valley Internal Medicine Program, Veterans Administration Medical Cente… [cited by applicant]
Heng, et al. “Angiogenesis in Necrotic Ulcers Treated with Hyperbaric Oxygen” OstomyWound Management, Sep. 2000, vol. 46, Issue 9, pp. 18-32. [cited by applicant]
Heng, et al. “Endothelial cell toxicity in leg ulcers treated with topical hyperbaric oxygen” Am. J. Dermatopathol Oct. 1986; 8(5):403-10; MID: 3777378 [PubMed—indexed for Medline]. [cited by applicant]
Heng, et al. “Enhanced Healing and Cost-Effectiveness of Low-Pressure Oxygen Therapy in Healing Necrotic Wounds: A feasibility study of technology transfer” Ostomy/Wound Management 2000; 46(3):52-62; From the Division o… [cited by applicant]
Hopf, et al. “Hyperoxia and angiogenesis” Blackwell Synergy: Wound Repair Regen, vol. 13, Issue 6, pp. 558-564: Hyperoxia and angiogenesis (Abstract); Wound Repair and Regeneration vol. 13 Issue 6 p. 558—Nov. 2005; http… [cited by applicant]
Ignacio, et al. “Topical Oxygen Therapy Treatment of Extensive Leg and Foot Ulcers” Journal of the American Podiatric Medical Association, vol. 75, No. 4, Apr. 1985, pp. 196-199. [cited by applicant]
International Search Report, PCT/US08/12535, dated Dec. 25, 2008. [cited by applicant]
International Search Report, PCT/US2008/12625, dated Dec. 22, 2008. [cited by applicant]
International Search Report, PCT/US2008/12669, dated Dec. 27, 2008. [cited by applicant]
Kalliainen, et al. “Topical oxygen as an adjunct to wound healing: a clinical case series” ISP Pathophysiology 9 (2003) 81-87, 2002 Elsevier Science Ireland Ltd. [cited by applicant]
Kaufman, et al. “The Microclimate Chamber: The Effect of Continuous Topical Administration of 96% Oxygen and 75% Relative Humidity on the Healing Rate of Experimental Deep Burns” The Journal of Trauma, vol. 23, No. 9, p… [cited by applicant]
Kaufman, et al., “Topical oxygen and burn wound healing: a review” Shriners Burns Institute, Cincinnati Unit, Ohio, 2000. [cited by applicant]
Landau, et al. “Topical hyperbaric oxygen and low energy laser therapy for chronic diabetic foot ulcers resistant to conventional treatment” Yale J. Biol. Med. Mar.-Apr. 2001. 74(2):95-100, The Hebrew University, Hadass… [cited by applicant]
Lehman, et al. “Human Bite Infections of the Hand: Adjunct Treatment with Hyperbaric Oxygen” Orthopedic Complications, Infections In Surgery, Jun. 1985, pp. 460-465. [cited by applicant]
Medical Coverage Advisory Committee, Usual Care of Chronic Wounds, Powerpoint presentation, 144 pages, 2006. [cited by applicant]
Olejniczak, et al. “Topical Oxygen Promotes Healing of Leg Ulcers” Dec. 1976, Medical Times, vol. 104, No. 12, pp. 115-120. [cited by applicant]
Pompeo “The Role of “Wound Burden” in Determining the Costs associated with Wound Care” OstonomyWound Management, Mar. 2001, vol. 47, Issue 3, pp. 65-71. [cited by applicant]
Rossi, Hudson Podiatry Center, Letter, Nov. 1997. [cited by applicant]
Sen, et al. “Oxygen, oxidants, and antioxidants in would healing: an emerging paradigm” Laboratory of Molecular Medicine, Dorothy M. Davis Heart and Lung Research Institute, Department of Surgery (CMIS), The Ohio State … [cited by applicant]
Snyder, et al. OstomyWound—Osteomyelitis in the Diabetic Patient: Overview, Diagnosis, Microbiology, “Osteomyelitis in the Diabetic Patient: Diagnosis and Treatment Part 1: Overview, Diagnosis, and Microbiology” (Abstra… [cited by applicant]
Stryker—Taoti Advanced Oxygen Therapy, Inc. Wound Care Solution Excellence, Strategic Discussions Kalamazoo, Michigan, Mar. 21, 2007 powerpoint presentation, 96 pages. [cited by applicant]
The Disposable Sacral Topical Hyperbaric Oxygen System, Copyright 2000. [cited by applicant]
The Topical Hyperbaric Oxygen Extremity Chamber, Copyright 1998. [cited by applicant]
U.S. Appl. No. 12/291,317, filed Nov. 6, 2008. [cited by applicant]
U.S. Appl. No. 12/291,328, filed Nov. 6, 2008. [cited by applicant]
U.S. Appl. No. 12/291,338, filed Nov. 8, 2008. [cited by applicant]
U.S. Appl. No. 12/291,342, filed Nov. 8, 2008. [cited by applicant]
U.S. Appl. No. 12/291,347, filed Nov. 8, 2008. [cited by applicant]
U.S. Appl. No. 12/291,348, filed Nov. 7, 2008. [cited by applicant]
Upson “Topical Hyperbaric Oxygenation in the Treatment of Recalcitrant Open Wounds—A clinical report” Physical Therapy, vol. 66, No. 9, Sep. 1986, pp. 1408-1411. [cited by applicant]
Venous Ulcers Appendix I, Evidence Table per FDA Draft Guidance Document, 8 pages. [cited by applicant]