Neonatal valved manifold

Details Neonatal valved manifold Neonatal valved manifold

2000-11-27

2004-05-04

Lewis, Aaron J. (Department: 3761)

Surgery

Respiratory method or device

Means for mixing treating agent with respiratory gas

C128S207160

Reexamination Certificate

active

06729326

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field
This invention relates generally to valved manifold devices, and is specifically directed to such devices in medical conduit systems. It provides a valved manifold particularly useful at the patient intubation interface of endotracheal ventilation/aspiration systems.
2. State of the Art
Many gas delivery systems, particularly in a hospital or laboratory environment, utilize manifold devices for directing fluid flow. There is a variety of circumstances in which it is necessary or desirable to provide multiple, yet isolated, other path ways through the interior of such a manifold. The manifold is often associated with other components as a system. When the individual components of such a system are subjected to mechanical forces tending to rotate one component with respect to another, it is often essential to provide that travel path through a joint structure which permits rotating or swiveling movement.
As an example, closed systems for endotracheal suctioning and ventilating typically include a manifold enabling introduction of ventilating gases and intermittent exhalation of patient breath simultaneously with insertion and operation of a tracheal suctioning catheter. The manifold structure typically includes multiple ports, usually the open ends of respective conduits extending from a common chamber. One such port is interfaced to a patient through a patient connection device. The suction catheter is often included within an assembly which is connectable to a second port of the manifold. The catheter assembly conventionally includes a collapsible plastic envelope positioned to entirely surround the catheter. A practitioner manually externally collapses the envelope onto the external surface of the catheter, and advances the catheter through the manifold into an access tube connected to a patient, retracting the catheter in a similar fashion following the aspiration procedure.
The manifold thus provides a first pathway for ventilation gases, and a second pathway for the catheter. The catheter provides isolation from the ventilating gases for fluids withdrawn from the patient through the manifold. When the catheter is withdrawn, it is often desired to continue regulated ventilation through the manifold. In some cases, it is desirable for the catheter assembly to be disconnected from the manifold, without disturbing the ventilation of the patient. It is thus necessary to provide for a gas tight sealing of the pathway formerly occupied by the catheter upon its removal. Previous efforts in this connection have involved the provision of auxiliary sealing structures for use in association with the manifold. These arrangements have had several disadvantages. Because they have not been integral with the manifold, their use has been inconvenient in practice. With ventilation ports substantially transverse patient interface ports, air turbulence has been disruptive to potentially delicate and fragile ventilation flow. Certain resilient seals have been unacceptable because they lack the positive sealing characteristics of a mechanical valve. Available valves are not suitable for incorporation into a manifold because they lack the essential capability of providing a travel path for a catheter when catheter suction is needed. Any sealing arrangement employed should be as inexpensive as possible, thereby eliminating complex mechanical valve assemblies from practical consideration.
Material prior art structures and methods are described, among other places, in U.S. Pat. No. 5,333,607 to Kee, et. al.; U.S. Pat. No. 5,354,267 to Niermann, et. al.; U.S. Pat. Nos. 5,357,946 and 5,445,141 to Kee, et. al.; U.S. Pat. Nos. 5,140,983 and 5,487,381 to Jinotti; U.S. Pat. No. 5,882,348 to Winterton et al.; U.S. Pat. Nos. 5,735,271 and 5,730,123 to Lorenzen et al. and U.S. Pat. No. 5,642,726 to Owens et al. These patents each disclose ventilator manifold devices and systems in which those devices are utilized. The '
267
patent, for example, discloses a manifold and a multi-position stop cock valve. The valve is provided with a “Tee” shaped internal stem channel pattern so that the stem may be positioned selectively to wash the internal lumen of a catheter, to irrigate the patient or to accommodate travel of the catheter through the stem to suction the patient. The valve may be plugged directly into an access port of the manifold. Patient ventilation is conducted without respect to the valve through other ports of the manifold. The valve itself constitutes an integral component of a catheter assembly, and must be removed from the manifold with the remainder of that assembly. The '
348
patent discloses a valved manifold embodying a multi-position stop cock valve. The ventilation port is transverse the patient interface port, and is thus characterized by more dead air space than is generally regarded as acceptable for neonatal applications.
A neonatal closed system suction catheter assembly of Alcove Medical, Inc. of Salt Lake City, Utah, Bird Products Corporation of Palm Springs, Calif., and Corpak, Inc. of Wheeling, Ill. includes a depth-finding feature comprising a ring snugly but slidingly surrounding a suction catheter within a collapsible plastic envelope that carries the catheter. After the catheter is advanced to the desired depth, the ring is moved to a point immediately adjacent the manifold. This feature enables a respiratory care practitioner to establish a limit upon the depth to which a suction catheter is insertable into a patient. Accordingly, optimal placement of the catheter tip, once established, need not be reestablished when the catheter is withdrawn and subsequently reinserted. In practice, however, manipulation of the ring from outside the envelope is insufficiently facile.
There remains a need for an inexpensive, yet reliable, manifold assembly incorporating a valve positioned to minimize dead air space within the manifold and capable of passing a catheter. The valve must provide a sealed gas flow path through the manifold in both its open and closed conditions with respect to catheter travel. The manifold should further be removable from any associated catheter assembly. Ideally, the manifold should also include a ventilation port that is substantially axially aligned with the patient interface port. Particularly in neonatal applications, there remains a need for a manifold constructed to minimize fluid flow turbulence of ventilating gases and to minimize the likelihood of respiratory therapy fluids introduced through an aspiration portion of a device from back-washing into a ventilation portion of the device.
A further need remains for a patient ventilation/aspiration system wherein the desired depth of successive insertions of the suction catheter can be established by a single initial procedure by means that are external to the collapsible plastic envelope.
SUMMARY OF THE INVENTION
The invention may be embodied as a multi-function manifold positioned at the distal end of a catheter assembly. A catheter tube is slidable lengthwise through a passageway, which includes a first (distal) port at the distal side of the manifold and a second (proximal) port near the proximal side of the manifold. The distal and proximal ports are generally not in alignment. Accordingly, the catheter should be sufficiently flexible to accommodate a bend as it travels through the passageway. A special valve is positioned along the passageway in axial alignment with the distal side, thereby to minimize dead air space and ventilation turbulence. This valve may be operated to open a travel path for the catheter through the manifold. The manifold preferably includes a patient connection conduit at its distal side for attachment to (and communication with) an indwelling intubation device, such as a tracheal tube, endotracheal tube or nasopharyngeal tube. The manifold also includes a ventilating structure extending transversely from (and in fluid communication with) the distal end and the passageway. The ventilating structure constitutes means for selectively in

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