WO2002015968A2 - Flow control valve for manual resuscitator devices - Google Patents
Flow control valve for manual resuscitator devices Download PDFInfo
- Publication number
- WO2002015968A2 WO2002015968A2 PCT/CA2001/001204 CA0101204W WO0215968A2 WO 2002015968 A2 WO2002015968 A2 WO 2002015968A2 CA 0101204 W CA0101204 W CA 0101204W WO 0215968 A2 WO0215968 A2 WO 0215968A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- valve
- mask
- bag
- flow
- gas
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/0057—Pumps therefor
- A61M16/0078—Breathing bags
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/0001—Details of inhalators; Constructional features thereof
- A61M15/002—Details of inhalators; Constructional features thereof with air flow regulating means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/0057—Pumps therefor
- A61M16/0084—Pumps therefor self-reinflatable by elasticity, e.g. resuscitation squeeze bags
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
- A61M16/0866—Passive resistors therefor
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S137/00—Fluid handling
- Y10S137/908—Respirator control
Definitions
- the invention relates to a flow control valve for preventing gastric distention and aspiration of stomach contents due to excessive gas flow rates delivered to patients by controlling the flow rate of pressurized air from a manually operated resuscitation device, such as a Bag-Naive-Mask device, pocket mask, face shield, or endotracheal tube.
- a manually operated resuscitation device such as a Bag-Naive-Mask device, pocket mask, face shield, or endotracheal tube.
- the Bag-Naive-Mask resuscitator (commonly referred to as a "BMV") has been the primary method of ventilating the patient in respiratory arrest for some 40 years.
- the BVM device is well known to those in the relevant art and examples of BVM designs are shown in U.S. Patent Nos. 4,532,923 and 4,622,964 to Flynn.
- Cardio-pulmonary resuscitation (CPR) can be administered mouth-to-mouth without protection but recently to protect the patient and emergency medical personnel, use of various protective manually operated devices is common. For example, one way valves, patient exhalation valves and fabric shields are fitted to pocket masks and face shields in order to inhibit cross-contamination.
- the BVM consists of a self inflating balloon at one end having a one way intake valve that allows gas to be drawn into the balloon as the balloon recoils after it has been manually squeezed by the user.
- the intake valve self seals when the inflated bag is squeezed, and opens when the bag is permitted to recoil naturally.
- a one way output valve permits the gas to leave the bag when squeezed directing the flow of gas to the patient through a facemask, or other airway adjunct.
- the output valve opens when the inflated bag is squeezed, and self seals when the bag is permitted to recoil naturally.
- the output valve when sealed diverts the exhausted gas from the patient out through an expiratory port on the valve housing.
- the original BVM was a development from the "Black Anaesthesia Bag” whereby the black bag was supported internally by a foam, self inflating balloon causing the bag to recoil to its original shape when the squeezed bag was permitted to recoil when released.
- the quality of ventilation delivery when operator powered devices are used is particularly unpredictable and varies greatly according to experience, training and general coordination ability.
- the emergency medical technician should pay attention to consistently timed tidal volumes of approximately equal volume and pressure dependant on the body size and age of the patient.
- emergency care personnel are often under extreme stress and have many other duties to perform in urgent care situations that tend to reduce the attention and level of care directed to ventilation techniques.
- the positive pressure required to deliver a set volume (tidal volume) of gas to a patient is dependent on two factors: (1) the compliance, stiffness or elasticity of the lung, and (2) the resistance to gas flow within the conducting airways.
- a "stiff lung that is damaged by pulmonary fibrosis, disease or trauma requires a higher pressure to deliver a set tidal volume than a normal elastic lung.
- gas will encounter less resistance through a normal airway that is not narrowed by bronchospasm or asthma, kinked by a poor airway opening technique, or plugged with blood, mucous, vomit or other debris.
- a generally accepted rate is a tidal volume of one litre at 12 breath cycles per minute.
- the breathing rate of 12 breath cycles/minute equals 5 seconds/breath cycle
- the problem in the emergency medical service field is that users generally perceive that they are competent in using the manual devices and that the manual devices and methods themselves are efficacious. Many technicians claim that the manual "feel" of the BVM allows them to make clinical judgements on the patient's lung condition. In reality what they are feeling is the backpressure created by the high flow rates generated when squeezing the bag too hard or for too short an inspiratory time. The backpressure condition masks the actual compliance and resistance of the patient's airway.
- the prior art has proposed solutions that do not control the gas flow, but provide high pressure relief exhaust ports or an indication of the gas pressure within a BVM circuit.
- the prior art does not appear to recognize that excessive pressure and flow rates can be delivered from pocket masks and face shields as well.
- U.S. Patent No. 5,557,049 to Ratner discloses a disposable manometer, which is used on a BVM device to indicate the pressure of gas being delivered to the patient.
- the Ratner solution presumes that the user has time and attention available to view the manometer and adjust their ventilation efforts accordingly.
- the bag-valve-mask requires almost continuous contact with one hand of the user and thereby imposes extreme limitations on their actions. In an effort to accomplish more than one task at a time, the operator can easily neglect the bag-valve- mask or deliver inconsistent ventilation to the patient.
- U.S. Patent No. 5,722,394 to Loescher shows an example of a BVM including a high pressure exhaust valve.
- U.S. Patent No. 5,537,998 to Bauman provides a spring loaded piston which serves to detect and exhaust excess air pressure in a simple manual resuscitator with vent ports open depending on the extent of internal pressure delivered to the patient with the manual resuscitator.
- None of the prior art devices specifically prevent stomach aspiration and distention by controlling the flow rate, pressure or volume of gas with any degree of accuracy.
- the invention relates to an improved bag- valve-mask (BVM) device with flow control valve to eliminate the danger of patient distension and aspiration of stomach contents during ventilation.
- BVM bag- valve-mask
- the BVM having the usual patient mask with a gas inlet and flexible patient face sealing edge, flexible manually squeezed bag with a one way intake and output valves in flow communication with a gas source and the mask inlet, and exhaust port for exhausting exhaled gas from the mask when the bag output valve is closed.
- the flow control valve is interposed between the mask and bag to automatically and variably limit the rate of gas flow from the bag to the mask between a predetermined minimum flow rate and a maximum flow rate.
- Figure 1 is a view of a Bag- Valve-Mask where a patient ventilated by the operator and the gas flow is controlled with a flow control valve located in a modified neck bushing disposed between the bag and the mask, the flow control valve having a frusto-conical valve plug slidably biased to the right and moved to the left to restrict the gas flow through the valve in response to gas flow impinging on the upstream surface of the valve plug.
- Figure 2 is a longitudinal section view through the flow control valve with sliding valve stem, spring loaded frusto-conical piston and frusto-conical inlet chamber serving as a valve seat.
- Figure 3 is a perspective view of a face shield with a flow control valve in accordance with a second embodiment of the invention disposed within the tube extending through the plastic sheet.
- Figure 4 is a perspective view of a face shield with a flow control valve in accordance with a third embodiment of the invention disposed within the tube extending through top of the patient mask.
- FIG 1 shows the general arrangement and use of a bag- valve-mask device 1 also known as a BVM.
- the invention centres on a simple but valuable modification to the conventional BVM by insertion of a flow control valve 7 between the patient mask 2 and the bag 3. Details of one embodiment of flow control valve 7 are shown in Figure 2.
- a similar flow control valve 7 can be included in any manual resuscitation device such as a pocket mask 23 as indicated in Figure 4 or face shield 24 as indicated in Figure 3 to equal advantage.
- the patient mask 2 has a gas inlet and a patient face sealing edge held by the operator's hand.
- the operator's other hand cyclically squeezes and releases the flexible bag 3 to pump gas through a one way intake valve 4 from a breathable gas source, through a one way output valve 6 in flow communication with the mask 2.
- Exhaust ports 5 exhaust exhaled gas from the mask 2 when the bag output valve 6 is closed.
- the flow control valve 7 is disposed in flow communication between the mask 2 and bag 3 for automatically variably limiting the rate of gas flow from the bag 3 to the mask 2 between a predetermined minimum flow rate and a maximum flow rate.
- the tidal volume delivered will remain relatively constant since the bag 3 contains a limited volume of gas and the operator should generally squeeze the bag 3 until the bag 3 is deflated to the same degree for each breath.
- the flow control valve 7 controls the rate or speed (for example in units of litres per minute) of delivering the tidal volume to reduce the variation in flow rate when used by different operators, with different size hands, varying strength, varying skill etc.
- the flow control valve 7 includes a housing 8 with control valve inlet 9, control valve outlet 10 and an orifice 12 therebetween.
- Gas flow sensor surface 14 senses the impingement of gas flowing from with the valve inlet 9 and the resultant sliding of the valve plug 11 against the bias of spring 18 serves to automatically restrict gas flow through the orifice 12 in response to the flow of gas impinging on the impingement surface 14 of the plug 11.
- Other means to sense the gas flow besides a spring loaded valve plug 11 can be provided but at higher cost than the simple device illustrated such as: a flexible diaphragm; pneumatic pressure sensing valves; rotating flow meter propellers; and electrical gas flow sensors.
- a simple reliable and inexpensive means to automatically variably restrict the orifice 12 can be constructed using a conical valve seat 12 and movable conical valve plug 11 with a gas flow impingement surface 14 and a valve seat mating surface 22.
- the plug 11 is normally biased away from the valve seat 12 by the spring 18 and is urged toward the valve seat 12 by gas flow against the flow impingement surface 14.
- a bulkhead 14 is included downstream of the valve seat 12.
- the bulkhead 14 includes perforations 16 that can be sized to ensure that at all times a minimum gas flow is permitted to pass through the valve 7 when the plug 11 is moved to it's furthest point.
- the spring and motion limiter 21 serve to prevent complete closure of the gas flow control valve and always permit a minimum gas flow to pass through.
- the plug 11 is mounted to an upstream end of a valve stem 13 and the valve stem 13 is slidably mounted within a through bore 17 in the bulkhead 14 with the spring 18 disposed about the valve stem 13 between the plug 14 and bulkhead 14.
- the valve stem 13 preferably includes a retainer 19 downstream of the bulkhead 14 for preventing removal of the stem 13 from the bore 17.
- the retainer 19 has a bulkhead abutting surface 20, as does the motion limiter 21. Both surfaces 20 are disposed on the valve stem 13 a selected distance from the bulkhead 14 for limiting the range that the stem 13 can slide within the bore 17.
- the valve stem 13 and bulkhead bore 17 preferably have a clearance space disposed therebetween sufficient to allow lateral motion of the valve plug 11 relative to the valve seat 12. Such clearance not only ensures that the stem 13 will not unintentionally bind but also allows the plug 11 to be self-centring and prevent binding of the valve seat 12 and plug surface 22.
- the same flow control valve 7 is adapted to use with a face shield 24.
- the face shield 24 has a flexible plastic sheet 25 with a tube 26 therethrough.
- the tube 26 has an upper end with an operator mouthpiece 27 about the gas inlet where the operator breathes exhaled air to the patient.
- the lower end has a patient mouthpiece 28 which is inserted into the patient's mouth and the sheet 25 serves to protect against contamination.
- conventional face shields include a tube 26 usually with a one-way intake valve (not shown) and patient exhalation valve (not shown), the invention may be easily adopted for use with a face shield 24 by including the flow control valve 7 housed within the tube 26.
- the same flow control valve 7 is adapted to use with a pocket mask 23.
- the pocket mask 24 has a flexible patient mask 29, with a patient sealing edge 30, and a tube 31 that has an upper end with an operator mouthpiece 32 about the gas inlet where the operator breathes exhaled air to the patient.
- the lower end of the tube 31 is sealed to the mask 29 which serves to protect against contamination and gas pressure loss.
- conventional pocket masks include a tube 31 usually with a one-way intake valve (not shown) and patient exhalation valve 33, the invention may be easily adopted for use with a pocket mask 23 by including the flow control valve 7 housed within the tube 31.
- FIG. 7 Further embodiments not illustrated include positioning the flow control valve 7 within a manually ventilated endotracheal tube that is inserted directly into the patient's trachea and includes an operator mouthpiece on the protruding end into which the operator breathes or attaches a bag-valve-mask device to ventilate the patient.
- the use of any manually operated ventilation device can be improved by controlling the gas flow rate with a flow control valve as described herein.
Abstract
Description
Claims
Priority Applications (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AT01966875T ATE296139T1 (en) | 2000-08-25 | 2001-08-23 | FLOW REGULATION VALVE FOR A HAND-OPERATED REVISITATION DEVICE |
EP01966875A EP1315534B1 (en) | 2000-08-25 | 2001-08-23 | Flow control valve for manual resuscitator devices |
AU2001287419A AU2001287419A1 (en) | 2000-08-25 | 2001-08-23 | Flow control valve for manual resuscitator devices |
DE60111061T DE60111061T2 (en) | 2000-08-25 | 2001-08-23 | FLOW CONTROL VALVE FOR A HAND-HELD RECOVERY DEVICE |
CA002420471A CA2420471C (en) | 2000-08-25 | 2001-08-23 | Flow control valve for manual resuscitator devices |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/648,143 | 2000-08-25 | ||
US09/648,143 US6792947B1 (en) | 2000-08-25 | 2000-08-25 | Flow control valve for manual resuscitator devices |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2002015968A2 true WO2002015968A2 (en) | 2002-02-28 |
WO2002015968A3 WO2002015968A3 (en) | 2002-06-06 |
Family
ID=24599606
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/CA2001/001204 WO2002015968A2 (en) | 2000-08-25 | 2001-08-23 | Flow control valve for manual resuscitator devices |
Country Status (7)
Country | Link |
---|---|
US (1) | US6792947B1 (en) |
EP (1) | EP1315534B1 (en) |
AT (1) | ATE296139T1 (en) |
AU (1) | AU2001287419A1 (en) |
CA (1) | CA2420471C (en) |
DE (1) | DE60111061T2 (en) |
WO (1) | WO2002015968A2 (en) |
Cited By (7)
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WO2005025654A1 (en) * | 2003-09-16 | 2005-03-24 | Injet Digital Aerosols Limited | Inhaler with air flow regulation |
US7073499B1 (en) | 2001-02-06 | 2006-07-11 | Injet Digital Aerosols Limited | Inhaler with airflow regulation |
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JP2010246946A (en) * | 2010-06-09 | 2010-11-04 | Injet Digital Aerosols Ltd | Inhaler with airflow regulation |
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- 2001-08-23 WO PCT/CA2001/001204 patent/WO2002015968A2/en active IP Right Grant
- 2001-08-23 AT AT01966875T patent/ATE296139T1/en not_active IP Right Cessation
- 2001-08-23 AU AU2001287419A patent/AU2001287419A1/en not_active Abandoned
- 2001-08-23 EP EP01966875A patent/EP1315534B1/en not_active Expired - Lifetime
- 2001-08-23 DE DE60111061T patent/DE60111061T2/en not_active Expired - Lifetime
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Cited By (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7073499B1 (en) | 2001-02-06 | 2006-07-11 | Injet Digital Aerosols Limited | Inhaler with airflow regulation |
WO2005025654A1 (en) * | 2003-09-16 | 2005-03-24 | Injet Digital Aerosols Limited | Inhaler with air flow regulation |
EP1670531A1 (en) * | 2003-09-16 | 2006-06-21 | InJet Digital Aerosols Limited | Inhaler with air flow regulation |
JP2007505644A (en) * | 2003-09-16 | 2007-03-15 | インジェット デジタル エアロソルズ リミテッド | Inhaler with air flow regulation |
EP1670531A4 (en) * | 2003-09-16 | 2009-02-18 | Injet Digital Aerosols Ltd | Inhaler with air flow regulation |
GB2450369A (en) * | 2007-06-21 | 2008-12-24 | Laerdal Medical As | Resuscitation bag with variable flow valve |
JP2010246946A (en) * | 2010-06-09 | 2010-11-04 | Injet Digital Aerosols Ltd | Inhaler with airflow regulation |
FR2988004A1 (en) * | 2012-03-19 | 2013-09-20 | Schrader | DEVICE FOR MANUAL INSUFFLATOR AND INSUFFLATOR HAVING THIS DEVICE |
WO2013140087A1 (en) | 2012-03-19 | 2013-09-26 | Polycaptil | Device for manual insufflator, and insufflator comprising said device |
US11129950B2 (en) | 2012-11-19 | 2021-09-28 | The General Hospital Corporation | System and method for monitoring resuscitation or respiratory mechanics of a patient |
WO2019232491A1 (en) | 2018-06-01 | 2019-12-05 | Safebvm Corp. | Pressure safety device for bag valve mask |
Also Published As
Publication number | Publication date |
---|---|
DE60111061T2 (en) | 2006-05-04 |
US6792947B1 (en) | 2004-09-21 |
EP1315534A2 (en) | 2003-06-04 |
ATE296139T1 (en) | 2005-06-15 |
WO2002015968A3 (en) | 2002-06-06 |
CA2420471A1 (en) | 2002-02-28 |
AU2001287419A1 (en) | 2002-03-04 |
DE60111061D1 (en) | 2005-06-30 |
EP1315534B1 (en) | 2005-05-25 |
CA2420471C (en) | 2009-04-07 |
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