Patients with respiratory insufficiency often require continuous mechanical ventilation with a positive-pressure ventilator. In such patients, an endotracheal breathing tube, or a tracheotomy tube, is positioned in the patient's main airway. An internal end of the endotracheal breathing tube is positioned for exchange of air within the lungs and an externally protruding end of the endotracheal breathing tube is connected with a ventilator circuit of a ventilator system. The ventilator system provides heated, humidified, filtered breathable air at a prescribed respirable rate, tidal volume or pressure, and FiO2 to a patient in repetitive respiration cycles.
It is frequently necessary to use a Metered Dose Inhaler (“MDI”) to deliver a prescribed amount of an aerosolized drug into an air stream that is forced through an inspiratory phrase of a ventilator system. In the present practice, to engage a MDI ventilator assembly with a ventilator circuit, an inspiratory hose is disconnected from a ventilator at a Wye connector, and the MDI ventilator assembly is used to reconnect the inspiratory hose to the Wye connector. The aerosolized drug is dispensed into an inspiratory stream, and upon completion of the therapy, the MDI ventilator assembly is removed from the inspiratory side of the ventilator circuit.
There are a number of problems with this practice. For example, due to the distance from an inspired limb of a ventilation circuit to an end of an endotracheal tube leading to a patient, loss of the aerosolized drug dispensed in the inspired limb often occurs before reaching the patient.
Another problem with present MDI ventilator assemblies is that they may not be attached directly to an endotracheal tube and left in connection to a main ventilator circuit because it presents a “dead space area” where gases exhaled from a patient remain between each breath such that the same gases are inhaled by the patient upon their next breath. For example, neonates often require aerosol medication, which can be difficult to administer due to the small airway size and because ventilation is required immediately after birth.
In addition, it is desirable to provide for aerosol medication delivery in conjunction with a resuscitation bag, which may be connected to an oxygen supply. Importantly, such systems must maintain a positive-end expiratory pressure (PEEP) for patients that have been intubated.
For at least these reasons, improved MDI ventilator assemblies are desirable.
The present disclosure is directed to ventilator circuit aerosol delivery systems. The disclosed ventilator circuit aerosol delivery systems include implementations to be used with intermittent flow ventilators and implementations to be used with continuous flow ventilators. As described in more detail below, by implementing systems to separate an inspired gas flow from an expired gas flow at the entrance to an endotracheal tube, or a tracheotomy tube, and integrating a Wye connector into an MDI ventilator assembly, the MDI ventilator assembly may be moved from the inspired limb and connected directly to the endotracheal tube, or a tracheotomy tube. By connecting the MDI ventilator assembly directly to the endotracheal tube, or tracheotomy tube, aerosolized drugs may be more effectively administered to a patient without “dead space area” where gases exhaled from a patient remain between each breath such that the same gases are inhaled by the patient upon their next breath
Preferably, the housing 102 is made of a clear plastic, although it can be non-transparent in certain embodiments. In one implementation, the housing 102 may be made from an antistatic material such that a surface resistivity of the housing 102 is less than about 10E12 ohm/sq., and preferably between about 10E10 and about 10E12 ohm/sq. Examples of antistatic housings are disclosed in U.S. patent application Ser. No. 10/821,260, filed Apr. 8, 2004, the entirety of which is hereby incorporated by reference. Further examples of housings used in MDI ventilator assemblies are disclosed in U.S. patent application Ser. No. 10/774,751, filed Feb. 9, 2004, and U.S. patent application Ser. No. 11/410,270, filed Apr. 24, 2006, the entirety of each of which is hereby incorporated by reference.
The housing 102 additionally defines an inhalation port 106, an exhalation port 108, a patient port 110, and a MDI receptacle 112. It should be understood that the term port is meant to include connectors that insert into a limb or tube of a ventilation system (a male connector) as well as connectors that receive a limb or tube of a ventilation system (a female connector).
The inhalation port 106 is typically located on a first distal end 114 of the housing 102, but the inhalation port 106 may be located at other positions on the housing 102. The inhalation port 106 defines an inhalation passageway into the interior space 104 of the housing 102. In one implementation, the inhalation port 106 may be annular in shape with a radius such as 22 mm so that the inhalation port 106 may be inserted into, and coupled with, an inhalation limb of a ventilator system to form an airtight seal. However, the inhalation port 106 may be other shapes and sizes such. For example, the inhalation port 106 may be shapes such as a triangular port or a square port.
The exhalation port 108 is typically located on a bottom 116 of the housing 102, but the exhalation port 108 may be located at other positions on the housing 102. The exhalation port 108 defines an exhalation passageway from the interior space 104 of the housing 102. In one implementation, the exhalation port 108 may be shaped in an annular manner with a radius such as 22 mm so that the exhalation port 108 may be inserted into, and coupled with, an exhalation limb of a ventilator system to form an aright seal. However, the exhalation port 108 may be other sizes and shapes. For example, the exhalation port 108 may be shapes such as a triangular port or a square port.
The patient port 110 is typically located on a second distal end 118 of the housing 102 that opposes the first distal end 114 of the housing 102 that includes the inhalation port 106, but the patient port 110 may be located at other positions on the housing 102. The patient port 110 may be shaped in an annular manner with a radius such as 15 mm so that the patient port 110 may be inserted into, and coupled with, an endotracheal breathing tube, or a tracheotomy tube, of a patient to form an airtight seal. However, the patient port 110 may be other sizes and shapes. For example, the patient port 110 may be shapes such as a triangular port or a square port.
The MDI receptacle 112 is typically located on a top 120 of the housing 102, but the MDI receptacle 112 may be located at other positions on the housing 102. The MDI receptacle 112 is positioned away from the patient port 110 such that, as explained in more detail below, when an aerosolized drug is dispensed into the interior space 104 via the MDI receptacle 112, the aerosolized drug may expand before being inhaled by a patient via the patient port 110.
The MDI receptacle 112 may define a socket or recess to receive an end of a MDI container 122 such that when the MDI container 122 is placed in the MDI receptacle 112, an actuator nozzle 124 in the recess of the MDI receptacle 112 engages a stem 126 extending from the MDI container 122 and causes the aerosolized drug within the MDI container 122 to be dispensed into the interior space 104 of the housing 102. It should be understood that the receptacle can be configured to connect to and support medication containers, aerosol dispersal devices, or systems other than the disclosed MDI containers 122.
During operation, gases for inhalation and exhalation flow through the MDI ventilator assembly 100. Referring to
Referring to
Because most of the gases, moisture, condensation, and/or mucus expelled by a patient flow out of the interior space 104 to the exhalation limb during exhalation, during subsequent inhalation, the amount of gases, moisture, condensation, and/or mucus that are rebreathed by the patient is reduced.
As seen in
Referring to
Referring to
The exhalation port 210 is typically also located on the first distal end 216 of the housing 202, but the exhalation port 210 may be located at other positions on the housing 202. The exhalation port 210 defines an exhalation passageway into the exhalation interior space 206. The exhalation port 210 may be shaped in an annular manner with a radius such as 22 mm so that the exhalation port 210 may be inserted into, and coupled with, an exhalation limb of the ventilator system to form an airtight seal. However, the exhalation port 210 may be other sizes and shapes. For example, the exhalation port 210 may be shapes such as a triangular port or a square port.
The patient port 212 is typically located on a second distal end 220 of the housing 202 that opposes the first distal end 216 including the inhalation port 208 and the exhalation port 210. However, the patient port 212 may be located at other positions on the housing 202. The patient port 212 defines a patient passageway that is in communication with both the inhalation interior space 204 and the exhalation interior space 206. In some implementations, the patient port 212 may be positioned on the second distal end 220 of the housing 202 so that the patient port 212 substantially aligns with the inhalation port 208 to assist in the inhalation of gases and aerosolized drugs from the inhalation interior space 204, as explained in more detail below.
A one-way exhalation valve 222 is positioned at an end 224 of the exhalation interior space 206, adjacent the patient port 212, to permit one-way flow from the patient port 212 to the exhalation interior space 206 while not affecting the flow of gases from the inhalation interior space 204 to the patient port 212. The one-way exhalation valve 222 may be a center post valve, a flap valve, a duckbill valve, an annular valve, or any other type of one-way valve known in the art.
The patient port 212 may be shaped in an annular manner with a radius such as 15 mm so that the patient port 110 may be inserted into, and coupled with, an endotracheal breathing tube, or a tracheotomy tube, of a patient to form an airtight seal. However, the patient port 212 may be other sizes and shapes. For example, the patient port 212 may be shapes such as a triangular port or a square port.
The MDI receptacle 214 is typically located on a top 222 of the housing 202, but the MDI receptacle 214 may be located at other positions on the housing 202. The MDI receptacle 214 is positioned away from the patient port 212 such that, as explained in more detail below, when an aerosolized drug is dispensed into the inhalation interior space 204 via the MDI receptacle 214, the aerosolized drug may expand before being inhaled by a patient via the patient port 212.
The MDI receptacle may define a socket or recess to receive an end of a MDI container 225 such that when the MDI container 225 is placed in the MDI receptacle 214, an actuator nozzle 226 in the recess of the MDI receptacle 214 engages a stem 228 extending from the MDI container 225 and causes the aerosolized drug within the MDI container 224 to be dispensed into the inhalation interior space 204 of the housing 202. It should be understood that the receptacle can be configured to connect to and support medication containers, aerosolized dispersion devices, or systems other than the disclosed MDI containers 225.
During operation, gases for inhalation and exhalation flow through the MDI ventilator assembly 200. Referring to
As described above, when an MDI container 225 is inserted into the MDI receptacle 214, the actuator nozzle 226 of the MDI receptacle 214 engages a stem 228 extending from the MDI container 225 and causes an aerosolized drug to be dispensed into the inhalation interior space 204. Therefore, it will be appreciated that during inhalation, when gases flow from the inhalation interior space 204 to the endotracheal breathing tube, or tracheotomy tube, the aerosolized drug expand and flows to the patient. Further, if any portion of the aerosolized drug is not inhaled during an initial breath, the remaining aerosolized drug is inhaled during subsequent breaths.
Referring to
As seen in
Typically, the moisture removal port 234 is positioned on the same side of the housing 202 as the patient port 212, the second distal end 220 of the housing 202. However, the moisture removal port 234 may be positioned at other locations on the housing 202. The moisture removal port 234 provides for the removal of moisture, condensation, and/or mucus that may be expelled from the patient.
While the implementations described above with respect to
In this implementation with respect to the embodiment of
During exhalation, and referring to the embodiment of
Referring to the embodiments of
Now referring to the embodiment of
The third housing component 410 is formed as a connector and defines the ventilator port 236. The connector has first and second passageways 412, 414 separated by a wall. Additional walls 416 form a valve seat for the inhalation valve 418. The first and third components 400, 410 are secured to respective ends of the second component 402 to form the housing. An integrally formed inhalation/exhalation valve 418, 420 is disposed between the connector 410 and the second component 402. The second component 402 has a valve seat 422 for the exhalation valve. The valve includes a base portion 424, and inhalation/exhalation flaps 418, 420 extending in opposite directions from the base portion 422. The inhalation valve 418 moves off of the first seat 416 of the connector during inhalation, while the exhalation valve 420 moves off of the second seat 422 during exhalation. In one embodiment, the surface area of the inhalation valve 418 is greater than the surface area of the exhalation valve 420, although it should be understood that the surface areas can be the same, or that the surface area of the inhalation valve is less than the area of the exhalation valve. It should be understood that the inhalation and exhalation valves 418, 420 can be formed separately, again with the same or differential surface areas.
In operation, as shown in
While the embodiments of
It is therefore intended that the foregoing detailed description be regarded as illustrative rather than limiting, and that it be understood that it is the following claims, including all equivalents, that are intended to define the spirit and scope of this invention.
This application is a continuation of U.S. application Ser. No. 13/414,909, filed Mar. 8, 2012, which application is a continuation of U.S. application Ser. No. 12/105,881, filed Apr. 18, 2008, now U.S. Pat. No. 8,151,794, which application claims the benefit of U.S. Provisional Application No. 60/926,108, filed Apr. 24, 2007, entitled “Ventilator Circuit Aerosol Delivery System,” the entire disclosures of which are hereby incorporated herein by reference.
Number | Name | Date | Kind |
---|---|---|---|
3028873 | Kindred | Apr 1962 | A |
3726274 | Bird et al. | Apr 1973 | A |
4333451 | Paluch | Jun 1982 | A |
4534343 | Nowacki et al. | Aug 1985 | A |
4803977 | Kremer et al. | Feb 1989 | A |
4938210 | Shene | Jul 1990 | A |
4984158 | Hillsman | Jan 1991 | A |
5002048 | Makiej, Jr. | Mar 1991 | A |
5005572 | Raemer et al. | Apr 1991 | A |
5012804 | Foley et al. | May 1991 | A |
5020530 | Miller | Jun 1991 | A |
5178138 | Walstrom | Jan 1993 | A |
5357946 | Kee et al. | Oct 1994 | A |
5617844 | King | Apr 1997 | A |
5647345 | Saul | Jul 1997 | A |
5666946 | Langenback | Sep 1997 | A |
5693944 | Rich | Dec 1997 | A |
5738087 | King | Apr 1998 | A |
5816240 | Komesaroff | Oct 1998 | A |
5848587 | King | Dec 1998 | A |
6014972 | Sladek | Jan 2000 | A |
6039042 | Sladek | Mar 2000 | A |
6269810 | Brooker et al. | Aug 2001 | B1 |
6279574 | Richardson et al. | Aug 2001 | B1 |
6390091 | Banner et al. | May 2002 | B1 |
6435177 | Schmidt et al. | Aug 2002 | B1 |
6527011 | Mantz | Mar 2003 | B1 |
6581600 | Bird | Jun 2003 | B2 |
6805118 | Brooker et al. | Oct 2004 | B2 |
6886561 | Bayron et al. | May 2005 | B2 |
7201164 | Grychowski et al. | Apr 2007 | B2 |
7201167 | Fink et al. | Apr 2007 | B2 |
7445006 | Dhuper et al. | Nov 2008 | B2 |
20020069870 | Farmer | Jun 2002 | A1 |
20020104531 | Malone | Aug 2002 | A1 |
20030131844 | Kumar et al. | Jul 2003 | A1 |
20040003808 | Fuhrman et al. | Jan 2004 | A1 |
20050005929 | Snyder et al. | Jan 2005 | A1 |
20050039746 | Grychowski et al. | Feb 2005 | A1 |
20050217666 | Fink et al. | Oct 2005 | A1 |
20050217667 | Dhuper et al. | Oct 2005 | A1 |
20050247312 | Davies | Nov 2005 | A1 |
20050274378 | Bonney et al. | Dec 2005 | A1 |
20060078506 | Niven et al. | Apr 2006 | A1 |
20060254579 | Grychowski et al. | Nov 2006 | A1 |
20080015475 | Lau et al. | Jan 2008 | A1 |
Number | Date | Country |
---|---|---|
2 210 721 | Jul 1996 | CA |
2 329 126 | Oct 1999 | CA |
2 354 561 | Jun 2000 | CA |
2 493 078 | Feb 2004 | CA |
2 515 593 | Aug 2004 | CA |
2 424 731 | Oct 2004 | CA |
0 281 650 | Sep 1988 | EP |
0 972 534 | Jan 2000 | EP |
0 972 534 | Jan 2000 | EP |
750 152 | Jun 1953 | GB |
WO 2004011071 | Feb 2004 | WO |
WO 2004071549 | Aug 2004 | WO |
WO 2006026237 | Mar 2006 | WO |
WO 2006114699 | Nov 2006 | WO |
WO 2007030162 | Mar 2007 | WO |
Entry |
---|
Cole, Cynthia, H., MD, “The Use of Aerosolized Medicines in Neonates,” Neonatal Respiratory Diseases, vol. 10, No. 4; Associates in Medical Marketing Co., Inc., Newtown, PA.; 2000, 6 pages. |
Shah, Dr. Vibhuti, “A Dose-ranging study to assess the effect of inhaled corticosteroids in ventilated preterm neonates,” Sunnybrook and Women's College Health Sciences Center, date unknown, 27 pages. |
International Search Report for International Application No. PCT/IB2004/000333, dated Aug. 30, 2004, 8 pages. |
Written Opinion of the International Searching Authority for International Application No. PCT/IB2004/000333, dated Aug. 30, 2004, 9 pages. |
International Search Report for International Application No. PCT/IB2006/001027, dated Sep. 21, 2006, 6 pages. |
Written Opinion of the International Searching Authority for International Application No. PCT/IB2006/001027, dated Sep. 21, 2006, 8 pages. |
Communication Relating to Results of Partial International Search in International Application No. PCT/US2008/061203, dated Aug. 12, 2008, 2 pages. |
International Search Report for International Application No. PCT/US2008/061203, dated Nov. 11, 2008, 8 pages. |
Written Opinion of the International Searching Authority for International Application No. PCT/US2008/061203, dated Nov. 11, 2008, 9 pages. |
International Preliminary Report on Patentability for International Application No. PCT/US2008/061203, dated Nov. 5, 2009, 14 pages. |
Reply to Oct. 6, 2008 Office Action in U.S. Appl. No. 10/774,751, dated Jan. 5, 2009, 14 pages. |
Office Action from U.S. Appl. No. 10/744,751, dated Jun. 24, 2009, 8 pages. |
Office Action from U.S. Appl. No. 11/410,270, dated Jan. 20, 2010, 14 pages. |
Number | Date | Country | |
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20160136379 A1 | May 2016 | US |
Number | Date | Country | |
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60926108 | Apr 2007 | US |
Number | Date | Country | |
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Parent | 13414909 | Mar 2012 | US |
Child | 14513494 | US | |
Parent | 12105881 | Apr 2008 | US |
Child | 13414909 | US |