United States Patent (19) 11 Patent Number: 5,029,579 Trammell (45) Date of Patent: Jul
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United States Patent (19) 11 Patent Number: 5,029,579 Trammell (45) Date of Patent: Jul. 9, 1991 54 HYPERBARIC OXYGENATION 4,452,242 6/1984 Bänziger ......................... 128/205.26 APPARATUS AND METHODS 4,467,798 8/1984 Saxon et al. ... ... 128/205.26 4,474,571 10/1984 Lasley ................................... 604/23 75 Inventor: Wallace E. Trammell, Provo, Utah 4,509,513 4/1985 Lasley ....... ... 128/202.12 4,624,656 1 1/1986 Clark et al. ........................... 604/23 73) Assignee: Ballard Medical Products, Midvale, 4,691,.695 9/1987 Birk et al. ............................. 128/38 Utah Appl. No.: 392,169 FOREIGN PATENT DOCUMENTS 21) 317900 12/1919 Fed. Rep. of Germany ... 128/256 22) Filed: Aug. 10, 1989 1 14443 12/1941 United Kingdom ................ 128/248 Related U.S. Application Data OTHER PUBLICATIONS 63 Continuation of Ser. No. 297,351, Jan. 13, 1989, aban TOPOX Literature. doned, which is a continuation of Ser. No. 61,924, Jun. Oxycure Literature. 15, 1987, abandoned, which is a continuation-in-part of B & F Medical Products, Inc. Literature. Ser. No. 865,762, May 22, 1986, abandoned. Primary Examiner-Richard J. Apley (51) Int. Cl. ............................................... A61H 9/00 Assistant Examiner-Linda C. M. Dvorak (52) U.S. Cl. ................................ 128/205.26; 128/30; Attorney, Agent, or Firm-Lynn G. Foster 128/202.12; 128/205.24; 604/23 (58) Field of Search ...................... 128/202. 12, 205.26, 57 ABSTRACT 128/28, 30, 30.2, 38, 40, 402; 600/21; 604/23, A novel hyperbaric oxygenation apparatus, and related 289, 290, 293,304, 305, 308 methods, the apparatus comprising a chamber in the form of a disposable inflatable bag of impervious inex 56 References Cited pensive synthetic resinous material which can be used at U.S. PATENT DOCUMENTS any desired location, such as a hospital, a home or other 2,168,611 8/1939 Thompson .......................... 128/299 site where oxygen can be appropriately made available. 2,385,683 8/1945 Burton ................................ 128/298 The pressure of the oxygen in the collapsible bag is 2,531,074 11/1950 Miller ....... ... 128/64 X pulsated between maximum and minimum positive val 2,896,612 7/1959 Bates et al. ............................ 128/60 ues. The patient cyclically experiences first a medicinal 3,269,388 8/1966 Glascock et al. ... ... 28/30 increase in the blood gas levels in the limb under treat 3,450,450 6/1969 Hopkins et al. ......................... 312/1 3,478,738 11/1969 Altman et al. .. ... 128/66 ment with a corresponding restricted bloow flow and, 3,602,221 8/1971 Bleicken .............. ... 28/204 thereafter, a progressive return to normal blood flow 3,712,298 1/1973 Snowdon et al. ..................... 128/40 rates in the limb of the patient as the pressure in the 3,744,491 7/1973 Fischer ................................ 128/84 chamber changes from maximum to minimum positive 3,749,091 7/1973 Basa ........ 28/260 pressure. A respirator, normally used for intubated res 3,768,467 10/1973 Jennings ... 28/145 R piratory patients, in conjunction with a single oxygen 3,786,809 1/1974 Kitrilakis ............................. 128/191 influent/effluent port in hyperbaric oxygenation appa 4,003,371 1/1977 Fischer ................................ 28/184 ratus is efficacious to provide the oxygen and generate 4,224,941 9/1980 Stivala ...... ... 28/2O7.26 4,236,513 12/1980 LoPiano .............................. 128/184 the desired pressure variations. Cuff inversion under 4,296,743 10/1981 Lasley ................................... 128/30 positive pressure is prevented by anti-blowout struc 4,328,799 5/1982 LoPiano ... ... 128/207.26 ture. 4,432,354 2/1984 Lasley ............................... 128/40 X 4,448, 189 5/1984 Lasley ............................... 128/25 R 5 Claims, 3 Drawing Sheets HOSPTAL O source U.S. Patent July 9, 1991 Sheet 1 of 3 5,029,579 MITTTTTNN U.S. Patent July 9, 1991 Sheet 2 of 3 5,029,579 U.S. Patent July 9, 1991 Sheet 3 of 3 5,029,579 5,029,579 2 1. the patient cyclically experiences first a medicinal in HYPERBARICOXYGENATION APPARATUS AND crease in the blood gas levels in the limb under treat METHODS ment with a corresponding restricted blood flow and, thereafter, a progressive return to normal blood flow This application is a continuation of U.S. patent appli- 5 rates in the limb of the patient as the pressure in the cation Ser. No. 297,351, filed Jan. 13, 1989, now aban chamber changes from maximum to minimum positive doned which is a continuation of U.S. patent application pressure. It has also been discovered that a respirator, Ser. No. 61,924, filed June 15, 1987, now abandoned normally used for intubated respiratory patients, can be which is a continuation in-part of U.S. patent applica efficaciously used preferably in conjunction with a sin tion Ser. No. 865,762, filed May 22, 1986, now aban- 10 gle oxygen influent/effluent port in hyperbaric oxyge doned. nation apparatus embodying the principles of the pres ent invention. Thus, influent oxygen is delivered to the FIELD OF INVENTION bag encircling the limb of the patient until the bag is The present invention relates generally to oxygena entirely inflated and the internal pressure thereof is at tion of a limb of a medical patient and more particularly 15 said maximum positive value. Influent delivery of oxy to novel hyperbaric oxygenation apparatus, and related gen is then temporarily terminated and effluent oxygen methods, by which a selected limb of a medical patient is thereafter slowly bled from the bag through the port is effectively oxygenated. at a controlled rate until the minimum positive pressure desired within the bag is reached and the bag is partially PRIOR ART 20 deflated. The cycle is then repeated. While external hyperbaric oxygen chambers have The present hyperbaric oxygenation invention, there been used over the years to treat the wounds, sores, etc. fore, provides for: use of an inexpensive efficacious of medical patients, the following problems have per existing source of oxygen, an inexpensive and reliable sisted: (1) patient immobility, (2) lack of portability of hyperbaric oxygenation apparatus and related methods, the equipment, (3) failure to provide low cost hyper- 25 portability, disposability, improved patient mobility, baric equipment, (4) excessive cost for purchasing spe economy, procedures which optimize the healing pro cially designed oxygen delivery equipment used in con cess and use of the apparatus at any one of several ap junction with hyperbaric chambers. propriate sites. Patents known to the applicants are: With the foregoing in mind, it is a primary object of 30 the present invention to provide novel hyperbaric oxy U S. Pat. No. 2,68,611 U.S. Pat. No. 2,385,683 genation apparatus and related methods. U S. Pat. No. 3450,450 U.S. Pat. No. 3,478,738 A further important object of the present invention is S. Pat. No. 3,712.298 U.S. Pat. No. 3.744,491 to provide a novel hyperbaric oxygenation apparatus U S. Pat No. 3,749,091 U.S. Pat. No. 3,768,467 U S . Pat. No. 4.236,513 Ui.S. Pat No. 4328,799 3 and related methods which overcome or substantially U S . Pat. No. 4.467,798 U.S. Pat. No. 4,474,571 5 alleviate the aforementioned problems of the prior art, U.S.S Pat.Pat No. 4,509,513 West German 317,900 It is an additional significant object of the present Britisht 4.4.43 invention to provide a novel hyperbaric oxygenation apparatus comprising a chamber in the form of a dispos To the extent that the above-identified patents are rele able inflatable bag of impervious inexpensive synthetic vant, they are individually and collectively of general 0 resinous material. interest only. It is a further dominant object of the present inven In the past, it has been advocated that expensive and tion to provide a novel hyperbaric oxygenation appara complex equipment be fabricated for one specific pur tus wherein the pressure and delivery of oxygen into the pose, i.e. to control the amount of oxygen delivered to hyperbaric chamber thereof is pulsated between maxi and the pressure levels within a hyperbaric chamber. It is mum and minimum positive values causing the patient, has also been the common thinking within the medical at the limb under treatment to experience first a desir field that the interior of hyperbaric chambers should be able increase in the blood gas levels in the limb under either maintained at a constant relatively high pressure treatment notwithstanding a restrict on in blood flow or cycled between a maximum positive and a minimum and thereafter a return to normal blood flow in the limb. vacuum pressure. The medical profession has retained a 50 A further object of paramount importance is the pro clear preference for massive, single location, expensive, vision of the novel hyperbaric oxygenation apparatus iron lung-type hyperbaric chambers. In contrast the and related methods wherein a respirator, normally medical profession has been basically dissatisfied with used for intubated respiratory patients, is selectively previously proposed disposable hyperbaric chambers. used in conjunction with a hyperbaric oxygenation bag BRIEF SUMMARY AND OBJECTS OF THE 55 according the present invention by which oxygen is INVENTION delivered through port means to the bag until the bag is In brief summary, the present invention overcomes or entirely inflated and fully pressurized following which substantially alleviates the aforementioned prior art oxygen is slowly bled from the bag through the port problems and provides a novel hyperbaric oxygenation 60 means at a controlled rate until the minimum positive apparatus, and related methods, the apparatus compris pressure is reached at which time the bag is partially ing a chamber in the form of a disposable inflatable bag deflated.