TREA

Nasal ventilation as a treatment for stroke

Follow

Information

  • Patent Grant
  • 6336454
  • Patent Number
    6,336,454
  • Date Filed
    Friday, May 15, 1998
    27 years ago
  • Date Issued
    Tuesday, January 8, 2002
    23 years ago
Information
Abstract
A new treatment and apparatus for acute and chronic treatment is described here which incorporates nasal ventilation, with or without concomitant drug therapy, using continuous positive airway pressure (CPAP) or bi-level pressure treatment or variants thereof, including devices which automatically set their pressures based on physiologic data inputs.
Description




FIELD OF THE INVENTION




The present invention relates to a method of treatment and apparatus for stroke patients.




BACKGROUND OF THE INVENTION




Stroke, or brain attack as it is commonly called, can be caused by either vascular hemorrhage or vascular blockage with the latter accounting for about 80% of the events which lead to a stroke. Stroke is associated with considerable morbidity in terms of long-term neurological deficit and the risk of subsequent stroke as well as mortality post stroke is considerable in stroke patients. Treatment in the acute phase typically entails the invasive administration of clot dissolving drugs within the first three hours of the stroke as well as stabilization of cardiovascular function and vital signs. Post stroke therapy can include intensive and costly rehabilitation depending on the degree of neurological deficit.




Continuous positive airway pressure (hereinafter CPAP) has been identified as a method of treatment for sleep disorders, and in particular, sleep apnea. The application of CPAP for sleep disorders was first introduced in U.S. Pat. No. 4,944,310. This patent described the application of continuous positive airway pressure being applied to the patient, through the patient's nares, to treat sleep disorders, including obstructive sleep apnea. It has been found that the application of pressure which exceeds atmospheric pressure, typically 4 to 15 centimeters of H


2


O is useful in treating sleep disorders. However, prior to this invention, the application of CPAP as a method for treating stroke patients has never been known.




There exists a need for a method of treatment for stroke patients which is non-invasive, and does not include the use of drugs.




There also exists a need for the treatment of stroke patients which is inexpensive and does not require a medical facility or hospital.




SUMMARY OF THE INVENTION




A new treatment and apparatus for acute and chronic treatment of stroke patients is described here which incorporates nasal ventilation, with or without concomitant drug therapy, using continuous positive airway pressure (CPAP) or bi-level pressure treatment or variants thereof, including devices which automatically set their pressures based on physiologic data inputs.











DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT




Nasal CPAP treatment has been traditionally used for the management of patients with obstructive sleep apnea where CPAP acts as a pneumatic splint to maintain upper airway patency and therefore ensures free flow of air while the patient sleeps. The current invention describes the use of positive pressure ventilation, which may include CPAP, bi-level pressure, or variants thereof, for stroke patients. The use of CPAP treats stroke patients by improving arterial blood oxygen levels and reducing arterial carbon dioxide levels as well as improving auto-regulation of, for example, blood pressure, cardiac output and ventilation. Improvements in morbidity, such as rate and degree of recovery of vital signs and patient stabilization in the acute phase, is an expected benefit.




Also, an improvement in neurological deficits in the short and/or long term is an expected benefit.




An apparatus for the treatment of stroke patients is also disclosed herein. The apparatus comprises an airflow generator; an interface adapted to fit a patient; and a conduit for the flow of air from the generator to the interface. In one embodiment, the airflow being delivered to the interface is at a pressure which exceeds atmospheric pressure for at least a portion of a breathing cycle of the patient.




It is understood that while the invention has been described above in conjunction with the preferred method and preferred embodiment, the description and examples are intended to illustrate but not limit the scope of the invention, which is defined by the scope of the following claims.



Claims
  • 1. A method for the treatment of a patient who is suffering a stroke, said method comprising:identifying the stroke in an acute phase, said acute phase being defined as the first three hours from onset of the stroke; and applying continuous positive airway pressure to said patient at least during said acute phase of said stroke in order to improve the patient's blood oxygen level.
  • 2. The method of claim 1 wherein said pressure is applied in a bi-level fashion.
  • 3. The method of claim 1 wherein said patient's carbon dioxide blood level is reduced.
  • 4. The method of claim 1 wherein auto regulation of blood pressure, cardiac output and ventilation is improved.
Parent Case Info

This application claims priority under 35 U.S.C. §119(e) to prior U.S. Provisional Patent Application Serial No. 60/046,746 entitled “NASAL VENTILATION AS A TREATMENT FOR STROKE”, filed on May 16, 1997, the disclosure of which is hereby incorporated by reference in its entirety.

US Referenced Citations (175)
Number Name Date Kind
1224180 Lake May 1917 A
2712927 Blum Jul 1955 A
2953355 Hungate Sep 1960 A
3099985 Wilson et al. Aug 1963 A
3502100 Jonson Mar 1970 A
3659604 Melville et al. May 1972 A
3726270 Griffis et al. Apr 1973 A
3741208 Jonsson et al. Jun 1973 A
3783893 Davison Jan 1974 A
3869529 Follette Mar 1975 A
3903875 Hughes Sep 1975 A
3903883 Pecina et al. Sep 1975 A
3914994 Banner Oct 1975 A
3932054 McKelvey Jan 1976 A
3985467 Lefferson Oct 1976 A
3987133 Andra Oct 1976 A
3992598 Welsh et al. Nov 1976 A
3995661 Van Fossen Dec 1976 A
4051205 Grant Sep 1977 A
4060576 Grant Nov 1977 A
4109749 Sweet Aug 1978 A
4110419 Miller Aug 1978 A
4119096 Drews Oct 1978 A
4201204 Rinne et al. May 1980 A
4203027 O'Hare et al. May 1980 A
4206754 Cox et al. Jun 1980 A
4249527 Ko et at. Feb 1981 A
4301833 Donald, III Nov 1981 A
4312235 Daigle Jan 1982 A
4346048 Gates Aug 1982 A
4387722 Kearns Jun 1983 A
4389353 Gates Jun 1983 A
4396034 Cherniak Aug 1983 A
4448035 Moriyama et al. May 1984 A
4448058 Jaffe et al. May 1984 A
4449525 White et al. May 1984 A
4481944 Bunnell Nov 1984 A
4499914 Schebler Feb 1985 A
4519399 Hori May 1985 A
4530334 Pagdin Jul 1985 A
4558710 Eichler Dec 1985 A
4579114 Gray et al. Apr 1986 A
4590772 Nose et al. May 1986 A
4592349 Bird Jun 1986 A
4592880 Murakami Jun 1986 A
4595139 Levine Jun 1986 A
4621632 Bartels et al. Nov 1986 A
4655213 Rapoport et al. Apr 1987 A
4677975 Edgar et al. Jul 1987 A
4686974 Sato et al. Aug 1987 A
4747403 Gluck et al. May 1988 A
4773411 Downs Sep 1988 A
4795314 Prybella et al. Jan 1989 A
4802485 Bowers et al. Feb 1989 A
4819629 Jonson Apr 1989 A
4827922 Champain et al. May 1989 A
4838258 Dryden et al. Jun 1989 A
4856506 Jinotti Aug 1989 A
4870960 Hradek Oct 1989 A
4870963 Carter Oct 1989 A
4913401 Handke Apr 1990 A
4928684 Breitenfelder et al. May 1990 A
4938210 Shene Jul 1990 A
4938212 Snook et al. Jul 1990 A
4944310 Sullivan Jul 1990 A
4957107 Sipin Sep 1990 A
4986269 Hakkinen Jan 1991 A
4989599 Carter Feb 1991 A
5007420 Bird Apr 1991 A
5009635 Scarberry Apr 1991 A
5024219 Dietz Jun 1991 A
5046491 Derrick Sep 1991 A
5048515 Sanso Sep 1991 A
5063922 Hakkinen Nov 1991 A
5063938 Beck et al. Nov 1991 A
5065756 Rapoport Nov 1991 A
5099837 Russel, Sr. et al. Mar 1992 A
5105354 Nishimura Apr 1992 A
5107830 Younes Apr 1992 A
5107831 Halpern et al. Apr 1992 A
5116088 Bird May 1992 A
5117819 Servidio et al. Jun 1992 A
5129390 Chopin et al. Jul 1992 A
5134995 Gruenke et al. Aug 1992 A
5148802 Sanders et al. Sep 1992 A
5161525 Kimm et al. Nov 1992 A
5163423 Suzuki Nov 1992 A
5165398 Bird Nov 1992 A
5178138 Walstrom et al. Jan 1993 A
5183983 Knop Feb 1993 A
5199424 Sullivan et al. Apr 1993 A
5203343 Axe et al. Apr 1993 A
5230330 Price Jul 1993 A
5231979 Rose et al. Aug 1993 A
5231983 Matson et al. Aug 1993 A
5239994 Atkins Aug 1993 A
5239995 Estes et al. Aug 1993 A
5240177 Muramatsu et al. Aug 1993 A
5245995 Sullivan et al. Sep 1993 A
5259373 Gruenke et al. Nov 1993 A
5271391 Graves Dec 1993 A
5280784 Kohler Jan 1994 A
5293864 McFadden Mar 1994 A
5303698 Tobia et al. Apr 1994 A
5303700 Weismann et al. Apr 1994 A
5305787 Thygesen Apr 1994 A
5311875 Stasz May 1994 A
5313937 Zdrojkowski May 1994 A
5322057 Raabe et al. Jun 1994 A
5335654 Rapoport Aug 1994 A
5335656 Bowe et al. Aug 1994 A
5343878 Scarberry et al. Sep 1994 A
5353788 Miles Oct 1994 A
5367604 Murray Nov 1994 A
5373842 Olsson et al. Dec 1994 A
5388571 Roberts et al. Feb 1995 A
5398673 Lambert Mar 1995 A
5400777 Olsson et al. Mar 1995 A
5404871 Goodman et al. Apr 1995 A
5433193 Sanders et al. Jul 1995 A
5443061 Champain et al. Aug 1995 A
5458137 Axe et al. Oct 1995 A
5479920 Piper et al. Jan 1996 A
5490502 Rapoport et al. Feb 1996 A
5492113 Estes et al. Feb 1996 A
5503148 Froehlich et al. Apr 1996 A
5509404 Lloyd et al. Apr 1996 A
5509414 Hok Apr 1996 A
5517983 Deighan et al. May 1996 A
5522382 Sullivan et al. Jun 1996 A
5526805 Lutz et al. Jun 1996 A
RE35295 Estes et al. Jul 1996 E
5535739 Rapoport et al. Jul 1996 A
5537997 Mechlenburg et al. Jul 1996 A
5540219 Mechlenburg et al. Jul 1996 A
5540220 Gropper Jul 1996 A
5635738 Estes et al. Jul 1996 A
5546933 Rapoport et al. Aug 1996 A
5551418 Estes et al. Sep 1996 A
5551419 Froehlich et al. Sep 1996 A
5558084 Daniell et al. Sep 1996 A
RE35339 Rapoport Oct 1996 E
5564415 Dobson et al. Oct 1996 A
5567127 Wentz Oct 1996 A
5570682 Johnson Nov 1996 A
5590644 Rosenkoetter Jan 1997 A
5590648 Mitchell et al. Jan 1997 A
5598837 Sirianne, Jr. et al. Feb 1997 A
5598838 Servidio et al. Feb 1997 A
5608647 Rubsamen et al. Mar 1997 A
5617846 Graetz et al. Apr 1997 A
5632269 Zdrojkowski May 1997 A
5633552 Lee et al. May 1997 A
5642730 Baran Jul 1997 A
5645053 Remmers et al. Jul 1997 A
5645054 Cotner et al. Jul 1997 A
5655520 Howe et al. Aug 1997 A
5655522 Mechlenburg et al. Aug 1997 A
5666946 Langenback Sep 1997 A
5673687 Dobson et al. Oct 1997 A
5682878 Ogden Nov 1997 A
5685293 Watt Nov 1997 A
5685296 Zdrojkowski et al. Nov 1997 A
5701883 Hete et al. Dec 1997 A
5704345 Berthon-Jones Jan 1998 A
5715812 Deighan et al. Feb 1998 A
5730121 Hawkins et al. Mar 1998 A
5740795 Brydon Apr 1998 A
5794615 Estes Aug 1998 A
5823187 Estes et al. Oct 1998 A
5862802 Bird Jan 1999 A
5901704 Estes et al. May 1999 A
5904141 Estes et al. May 1999 A
6041780 Richard et al. Mar 2000 A
6015575 Estes et al. Aug 2000 A
Foreign Referenced Citations (105)
Number Date Country
A-6222190 Mar 1991 AU
A-3387793 Apr 1993 AU
B-5927090 May 1993 AU
A-3850893 Jul 1993 AU
A-4874893 Sep 1993 AU
A-5262893 Jul 1994 AU
B 7917494 Jun 1995 AU
9226120 Jul 1995 AU
A-3447195 Feb 1996 AU
A-4071195 Apr 1996 AU
B 3435495 May 1996 AU
A 3913095 Jun 1996 AU
459104 Apr 1928 DE
3015279 Oct 1981 DE
34 02 603 Aug 1985 DE
3537507 Apr 1987 DE
3539073 May 1987 DE
4432219 Apr 1996 DE
0 062 166 Oct 1982 EP
0 666 451 Dec 1982 EP
0 088 761 Sep 1983 EP
0 164 500 Mar 1985 EP
0 171 321 Feb 1986 EP
0 185 980 Jul 1986 EP
0 236 850 Sep 1987 EP
0 872 643 Mar 1988 EP
298 367 Jan 1989 EP
0 388 525 Sep 1990 EP
0 425 092 May 1991 EP
481 459 Apr 1992 EP
0549299 Jun 1993 EP
0 535 952 Jul 1993 EP
606 687 Jul 1994 EP
0705615 Sep 1994 EP
0 714 670 Dec 1994 EP
0 656 216 Jun 1995 EP
0 661 071 Jul 1995 EP
178 925 Apr 1996 EP
0 709 107 May 1996 EP
0 788 805 Aug 1997 EP
0 839 545 May 1998 EP
0 845 277 Jun 1998 EP
2 574 657 Jun 1986 FR
2 630 917 Nov 1989 FR
2 672 221 Aug 1992 FR
2682042 Apr 1993 FR
1 294 808 Nov 1972 GB
1432572 Apr 1976 GB
1 444 053 Jul 1976 GB
2 077 444 Dec 1981 GB
2 147 506 May 1985 GB
2 164 569 Mar 1986 GB
2 205 167 Nov 1988 GB
2 254 700 Oct 1992 GB
2 271 811 Apr 1994 GB
2 284 400 May 1996 GB
54-104369 Aug 1979 JP
60-212607 Oct 1985 JP
62-103297 Apr 1987 JP
63-275352 Nov 1988 JP
2-173397 Dec 1988 JP
4-70516 Mar 1992 JP
4-70516 Mar 1992 JP
06249741 Sep 1994 JP
6-249742 Sep 1994 JP
07280609 Oct 1995 JP
8019610 Jan 1996 JP
1710064 Feb 1992 SE
467041 May 1992 SE
WO 8001044 May 1980 WO
WO 8203326 Oct 1982 WO
WO 8203548 Oct 1982 WO
WO 8605965 Oct 1986 WO
WO 8606969 Dec 1986 WO
WO 8810108 Dec 1988 WO
WO 9014121 Nov 1990 WO
WO 9211054 Jul 1992 WO
WO 9215353 Sep 1992 WO
WO 9222244 Dec 1992 WO
WO 9308857 May 1993 WO
WO 9309834 May 1993 WO
WO 9321982 Nov 1993 WO
WO 9324169 Dec 1993 WO
WO 9416759 Aug 1994 WO
WO 9420051 Sep 1994 WO
WO 9423780 Oct 1994 WO
WO 9532016 Nov 1995 WO
WO 9616688 Jun 1996 WO
WO 9635911 Nov 1996 WO
WO 9640337 Dec 1996 WO
WO 9702064 Jan 1997 WO
WO 9710019 Mar 1997 WO
WO 9710868 Mar 1997 WO
WO 9715343 May 1997 WO
WO 9728838 Aug 1997 WO
WO 9741812 Nov 1997 WO
WO 9804311 Feb 1998 WO
WO 9806449 Feb 1998 WO
WO 9825662 Jun 1998 WO
WO 9833433 Aug 1998 WO
WO 9835715 Aug 1998 WO
WO 9836245 Aug 1998 WO
WO 9836338 Aug 1998 WO
WO 9847554 Oct 1998 WO
WO 9857691 Dec 1998 WO
Non-Patent Literature Citations (50)
Entry
Nachtman et al., Cheyne-Stokes respiration in ischemic stroke, Neurology 45:820-821, Apr. 1995.*
Bassetti et al., Sleep apnea in patients with transient ischemic attack and stroke: Aprospective study of 59 patients, Neurology 47:1167-1173, Nov. 1996.*
Krachman et al., Comparison of oxygen therapy with nasal CPAP on Cheyne-Stokes respiration during sleep in congestive heart failure, Chest V. 116, I 6 pp. 1550-1565, Dec. 1999.*
Dyken et al., Investigating the relationshp between Stroke and Obstructive Sleep Apnea, Stroke vol. 27: No. 3, pp. 401-407, Mar. 1996.*
Good et al., Stroke and Sleep Apnea, Neurology Network Commentary, 1:269-275, Dec. 1997.*
Good et al., Sleep-Disordered breathing and Poor functional outcome after stroke, Stroke vol. 27, No. 2, pp. 252-259, Feb. 1996.*
Puritan/Bennett Companion 320 I/E Bi-level Respiratory System Clinical Manual (for part No. 799959 Rev. A), Jan. 26, 1996.*
New! Breas PV 100 CPAP First Class Quality and Function. At the right Price; Jul. 4, 1998, pp. 1-2.
PV 101 Bi Level CPAP and PV 102 Bi-Level Time; pp 1-3, Dec. 10, 1998.
Prodigy Medical Supplies Co. Ltd.; CPAP.
Puritan Bennett; Companion 318 Nasal CPAP System; 5/93.
Nellcor Puritan Bennett; Announcing the Goodnight 314 and GoodKnight 318 Nasal CPAP Systems, 1996.
Puritan Bennett; Clean, Quiet, and Comfortable . . . The Companion's 515 Nasal CPAP System; 6/88.
DeVilbiss Night Guard Nasal CPAP for the Tretment of Obstructive Sleep Apnea.
Sunrise; DeVilbiss Horizon LT 8001 Nasal CPAP Therapy Small in Size, big on features; 8/97.
Devilbiss; Revitalizer Soft Start; The Facts Speak for Themselves, 1992.
Tranquility; Performance CPAP Advantage.
Healthdyne International; Tranquility Plus.
Respironics Inc.; Respironics' Solo CPAP System Provides Simplified OSA Therapy at an Outstanding value; Sep. 19, 1996.
Respironics Inc.; The First Family of OSA Therapy; 1991.
Fisher & Paykel Healthcare; HC200 Series Nasal CPAP Blower & Heated Humidifier.
Pierre Medical; Morphee Plus appareil de traitment des apnees due sommeil manuel d'utilisation.
Weinmann:Hamburg; Somnotron nCPAP-Gerat WM 23000, 11/91.
Puritan Bennent; 515a Part of Our Blueprint for the Future; 03/90.
Puritan Bennett; Companion 320 I/E Bi-Level Respiratory System; 4/93.
ResMed; Sullivan VPAP II & II ST.
Resmed; The Sullivan V Family of CPAP Systems; 1996.
Resmed; The AutoSet Portable II; 1997.
ResMed; Sullivan Nasal CPAP System.
ResMed; The Sullivan IIID; 1995.
ResMed; The Sullivan Comfort; 1996.
DeVilbiss a Division of Sunrise Medical; Expand your Horizons With The Horizons; 1995.
Healthdyne Technologies; Home Health Care Dealer; The Journal of Home Medical Equipment and Services/Supplier; Nov. and Dec. 1997.
Healthdyne International; Tranquility Quest, The Compact CPAP for Greater patient comfort.
AirStep; Medical Products . . . Stand the Test of Time.
MAP Medical Progress for Physician und Patient; The Gentle Therapy for Sleep-Related Breathing Disorders.
Taema; Ventilation CP 90, 5/95.
DPAP; Breath, by breath, by breath.
Lifecare; Smallest. Quietest. Smartest.
Lifecare; Quiet CPAP System for Maximum Compliance; 1991.
Lifecare; Software Nasal Mask, Custom Nasal Masks; 1991.
Nidek Medical; Silenzio.
Weinmann; Just to Feel Well, Sensitive Sleep Apnea Therapy with Somnotron 3 and Somno-Mask System.
Respironics Inc.; Aria CPAP System; 1993.
Respironics Inc.; SleepEasy III A New Dawn in Patient Compliance.
Respironics Inc.; Multiple Choice REMstar Choice Nasal CPAP System, 1993.
MaxII nCPAP and Moritz II Bi-Level Brochure.
Derwent: Flowmeter for fluids-has turbine transducer and volumetric sensor for simultaneous calibration, 1995.
Mark Kantrowitz, Erik Horskotte and Cliff Joslyn; “Answers to Frequently Asked Questions about Fuzzy Logic and Fuzzy Expert Systems” Version 1.24 last Modified Feb. 20, 1996.
Pressman et al., “Transient Ischemic Attacks and Minor Stroke During Sleep—Relationship to Obstruction Sleep Apnea Syndrome,” pp. 2361-2365, Dec., 1995, Stroke vol. 26 No. 12.
Provisional Applications (1)
Number Date Country
60/046746 May 1997 US