WO1993017742A1

WO1993017742A1 - Improved apparatus for ventilating and aspirating

Info

Publication number: WO1993017742A1
Application number: PCT/US1992/003093
Authority: WO
Inventors: Valdon G. Reynolds; Gordon S. Reynolds; Joseph T. Sorenson; James L. Sorenson; Stephen Clyde Mackert; Joseph Hunter Jeffs; David W. Kaufman
Original assignee: Sorenson Laboratories, Inc.
Priority date: 1992-03-09
Filing date: 1992-04-15
Publication date: 1993-09-16
Also published as: US5368017A

Abstract

A ventilating and aspirating apparatus for delivering respiratory gases to the trachea and the congested lungs and breathing passageways of a patient includes a flexible catheter tube (14) extendable into and withdrawable from the patient's trachea. The catheter (14) is housed within a pliable sheath (40) extending from a manifold (49) that is attachable to an endotracheal tube (13). The sheath has a slit (41) defined by backing members (80, 81) formed along elongate opposed edges. A releasable, air tight ''ziplock'' seal (82, 83) is effected at the slit by a bead on one backing member and a groove to sealingly receive the bead on the other backing member. A ''ziplock'' actuator is structured as a slider membrane (87) which travels along the bead and groove, and includes converging ends (88, 89) to hold the bead in the groove and a conduit membrane extending centrally through the slider member to interconnect an end of the catheter tube inside the sheath.

Description

IMPROVED APPARATUS FOR VENTILATING AND ASPIRATING

BACKGROUND OF THE INVENTION

Field: This invention relates generally to an apparatus for ventilating and aspirating the lungs of a medical patient and is particularly directed to an improved apparatus for ventilating and aspirating congested lungs and obstructed breathing passageways.

State of the Art; Apparatus for the ventilating and aspirating of lungs of a medical patient have been proposed in the past. U.S. Patent Nos. 4,836,199; 4,569,344; and 3,991,762 each disclose a device in which a flexible catheter tube is sealed inside a collapsible plastic envelope. This arrangement is intended to assure sterility even when the catheter tube is removed from the trachea of a patient. The catheter of the device is attached at its proximal (user) end to a valve so that a vacuum source can be selectively communicated to the catheter lumen. The device also contains a manifold which attaches to an endotracheal tube and a ventilating fixture. Insertion of the catheter tube into the trachea of the patient is accomplished by grasping the catheter tube through the envelope and manually moving it into the trachea. Each of the patented devices also contains a port through which the exterior of the catheter tube can be rinsed with a suitable irrigating solution. The ^,762 patent further discloses a wheel attached to the catheter tube so that it can be rotated during its insertion or removal.

The ventilating/aspirating devices of the above-identified patents are not always entirely satisfactory. The catheter tubes are relatively pliant and lack any structural reinforcement. Consequently, such a device tends to fall where it may, interfering with both patient movement and patient care. Further, the device itself tends to interfere with other structures attached to the patient. Structures such as intravenous delivery tubing or electronic sensors may become tangled with the pliant catheter tube. Moreover, the catheter tube cannot conveniently be taped to the patient or secured out of the. ax because it must be positioned generally in line with the endotracheal tube to facilitate insertion of the catheter into the patient. These prior art devices also require a user to employ both hands when inserting the catheter into the trachea of a patient. One hand must grasp the catheter tube to insert it incrementally into the trachea, while the other hand must hold either the manifold body (to ease insertion) or the proximal end of the device (to keep it out of the way) . If aspiration is desired during the insertion step, a second person must operate the valve.

Indiscriminate movement of the pliant catheter tube, repeated insertion into the patient, or exposure to objects which can penetrate the flexible envelope result in inadequate assurance of sterility. Pinholes in the envelope can easily occur, exposing the catheter to outside air and thereby compromising sterility of the catheter. Similarly, pinholes can expose users to contaminants from the patient.

U.S. Patents Nos. 4,938,741 and 4,981,466 disclose a suctioning catheter tube with an elbow bend at the distal (patient) end. The purpose of the bend is to facilitate entry of the catheter into the left bronchus. The left bronchus is disposed at an angle from the trachea making it more difficult to enter than the right bronchus. The elbow bend, however, is temporary. A retaining device must be inserted into the distal end of the catheter tube to retain the bend during storage. The bend must be heated before use to destroy the memory of the linear catheter tube and set the bend. It is known to provide a radiopaque band at the distal end of a catheter to aid in placement of the catheter in either bronchus. The radiopaque band reveals the linear positioning of the distal end of the catheter but is incapable of relaying information concerning the direction in which the distal end beyond an elbow is pointing. Proper orientation of the distal end is helpful for proper placement of the catheter in a bronchus. To obtain positioning information via radiopaque bands requires expensive radiological equipment to locate the band during catheter insertion. Such equipment is not always available as, for example, to a paramedic at an accident scene. In instances in which locating the radio indicia on the catheter would be the only purpose for radiological services, such services cannot ordinarily be economically justified to the patient.

SUMMARY OF THE INVENTION

The present invention provides an improved apparatus and method for simultaneously ventilating and aspirating a medical patient. The invention enables a user to insert a flexible catheter tube into either lung of a patient in one smooth motion without risk of contamination or infection. Additionally, a user is able to activate, in one motion, a vacuum valve to evacuate undesired respiratory fluids and simultaneously ventilate and/or irrigate the lungs.

A flexible catheter tube is attached at the proximal (user) end to a valve. The valve is selectively actuated to communicate a vacuum suction to the lumen of the catheter. The distal (patient) end of the catheter tube is structured to permit fluid to be suctioned into the lumen of the catheter tube. The distal end may also include an elbow bend orienting the distal end of the catheter tube at any desired angle but ideally at approximately.20 degrees. The elbow bend is located near, typically approximately 2.54 centimeters (one inch) from, the distal tip of the catheter tube. The distal end of the catheter tube is thereby inclined from the central longitudinal axis of the catheter tube to facil¬ itate entry of the catheter tube into the patient's bronchi, especially the left bronchus.

The valve at the proximal end of the catheter tube is used to communicate a suctioning vacuum to the lumen of the catheter. A typical source of vacuum is the vacuum line commonly found in a hospital room. The valve may contain a biasing means to urge the valve to normally closed position. This structure may also be a component of a valve actuator. In some embodiments of the invention, the biasing means of the valve may be structured as a resilient cap carrying a depending valve stem. The stem is arranged for mounting in a valve body having an inlet and an outlet. A more preferred valve, however, while including some similar components, includes a valve structure with a side operated push button for opening the normally closed valve. No matter how the valve may be embodied, when a suctioning vacuum is desired, the user presses the valve operating means, or in some embodiments the biasing means, to bring the catheter into fluid flow communication with the vacuum source. The use of such a valve arrangement avoids the need for a user to involve more than one hand, either to actuate the valve or to lock it in a closed position. The user's other hand is thereby left free to aid in placement or movement of the catheter. The entire valve assembly serves as a convenient handle for inserting and withdrawing a catheter tube. The catheter tube is slidable lengthwise through a multi-function manifold positioned at the distal end of the apparatus. The manifold may include several segments, including a port at the distal end for communication with an endotracheal tube inserted into the patient.

This invention is typically embodied such that a distal port is positioned at the end of a generally cylindrical passageway which extends through the length of the manifold. A proximal port is located at the opposite end of the passageway. The catheter tube is slidable through this passageway so that it enters the endotracheal tube through the distal port. A ventilating structure extends radially from the passageway and is in fluid communication with the interior of the passageway. Ambient air, oxygenated air, and other therapeutic gasses can be selectively introduced into the respiratory system of the patient through the ventilating structure. The ventilating structure may be formed so that ventilation can be accomplished by inhalation and exhalation of ventilating air through the same conduit or, in an alternate configuration, through two or more conduits, allowing inhalation of ambient air through one port and exhalation through a second port. A third conduit may also be provided for the introduction of other suitable gases to the respiratory system.

The manifold may be disposed between front (distal) and rear (proximal) swivel segments which allow the manifold to rotate in a generally coaxial manner about the catheter tube. The apparatus and any connected devices may thus be moved about independent of the endotracheal tube inserted into the patient. As a consequence, the accessibility of conduits associated with the manifold is enhanced. The attachment of tubing, such as that associated with the ventilation source, is thereby facilitated. A user may rotate the catheter as convenient to perform the aspiration function. Moreover, orientation of the elbow bend for insertion into a bronchus is facilitated.

The rear swivel segment may be adapted to receive in its interior a silicone seal or "©"-ring which fits snugly over the catheter tube. A seal is thereby effected between the outside wall of the catheter tube and the inside wall of the "0"-ring. The distal portion of the catheter tube extending beyond the seal is thereby isolated. The seal is snug enough to be air tight but loose fitting enough to allow both linear movement of the catheter tube through the "0"-ring and rotational movement of the swivel coaxially about the catheter tube. The rear swivel segment may also contain an irrigation port terminating a conduit disposed at an angle to direct injected irrigating solution onto the catheter tube and toward the patient. Suitable irrigating solutions can be introduced through the irrigation port while the catheter tube is in the advanced position in the trachea or bronchi of the patient. The irrigating solutions flow down the external surface of the catheter tube and into the lungs of the patient providing antimicrobial activity and loosening and diluting phlegm and other undesired respiratory flu¬ ids. Fluids may then be aspirated out of the lungs through the catheter tube.

Irrigating solutions may also be introduced as the previously inserted catheter tube is withdrawn from the respiratory tract. Disinfecting and rinsing activity is thereby provided on the external surface of the catheter tube. The swivel connections allow the complete perimeter of the catheter to be rinsed with the irrigating solution. Excess fluid may be evacuated during withdrawal of the catheter.

A sheath entirely surrounds the catheter tube when the tube is inserted into or withdrawn from the patient. In some embodiments, the sheath may be semirigid. The term "semirigid," as used in this disclosure, refers to structures such as plastic conduits which are both pliable and resilient. Thick walled, medical grade plastic tubing constitutes a suitable construction material for a semirigid sheath of this invention. The sheath is closed at its distal end and is secured with the manifold so as to become an extension of the cylindrical passageway through the manifold. The prszimal end of the sheath is sealed by a cap, preferably a rigid finger tab structure. The sheath may perform several important functions. In those embodiments utilizing a semirigid sheath, the structural reinforcement provided by the sheath enables a user to insert the catheter into the patient in one smooth motion. This advantage is due to the catheter tube being properly positioned for insertion while the device is at¬ tached to the endotracheal tube. When the catheter tube is being inserted, the sheath acts as a guide to direct the tube through the manifold, thereby eliminating kinking and collapsing of the tube and correspondingly, the need for incremental insertion. The sheath also ensures that the device remains in a predictable and stable position when attached to the patient's endotracheal tube, thereby avoiding interference with other tubing and electrical wires which may also be attached to the patient. Finally, the sheath provides an added measure of assurance of sterility while the catheter is withdrawn from the patient.

In some embodiments, the sheath is provided with a "self sealing" slit along one edge. While various constructions are within contemplation, a construction commonly referred to as a "ziplock" in the packaging field is presently preferred. Such a construction typically includes a pair of opposed sidewalls defining the slit and interconnectable by mutually opposed structures carried by the respective sidewalls. Typically, a bead is formed along the edge of one sidewall and a groove is formed along the edge of the other sidewall such that the bead may be pressed into a sealing engagement within the groove to provide an airtight closure of the slit. The slit of the sheath is preferably positioned parallel to the central axis of the sheath, longitudinally substantially along its entire length, providing a pathway for structure connecting the catheter to the valve. A notable feature of one of the preferred embodiments of this invention is the relationship between the vacuum valve, the longitudinal split in the semirigid sheath, and the catheter tube. The valve actuating structure is positioned outside the sheath for convenient operation by the user. The longitudinal split in the sheath allows a slider portion of the valve to extend through the split into the interior of the sheath for attachment to the catheter tube. This relationship allows the slider portion of the valve to move longitudinally through the split to effect an insertion or withdrawal of the catheter tube. A resilient sheath provides a gripping effect by the opposed split surfaces of the sheath against the slider portion. This gripping, combined with the snug fit of the "0"-ring against the catheter tube, permits the catheter tube to be positively positioned anywhere along the patient's trachea or bronchi.

The precise position of the valve with respect to the elbow bend at the distal end of the catheter tube constitutes an important feature of certain embodiments of the invention. An indicia may be associated with the valve to indicate the direction that the distal end beyond the bend is pointed. When the catheter tube is being inserted, the user can determine the orientation of the distal end by reference to the valve.

A collapsible plastic envelope may surround the semirigid sheath and seal it from contamination and contact by the user. The collapsible envelope may be separated into two pieces, one connected between the manifold and the distal side of the valve, the other connected between the proximal side of the valve and the cap at the proximal end of the apparatus.

In one embodiment, the vacuum valve may be mounted on a slider member that includes spaced-apart legs positioned to straddle the bead and groove structures carried by the edges of the respective flexible sidewalls of the sheath. The slider member is structured to move longitudinally in either direction along the sheath, interacting in either case with the sealing components of the slit. Movement of the slider continuously opens the slit in a region which is localized with respect to the slider but travels with respect to the sheath, together with the slider. Concurrently, the slider functions to reseal the slit directly behind, in the direction of travel, the moving open region. In this fashion, a substantially air tight seal is maintained across the sheath barrier.

In a typical arrangement, the legs of the slider member are configured as panels interconnected at their respective distal ends by a web. The panels converge in opposite directions from a central region at which a port is provided through the web. The port accommodates a conduit which interconnects the catheter within the sheath and an external vacuum source through a valve carried by the slider. When a "ziplock" seam construction is utilized, the slider assembly may be regarded as an air tight "ziplock" actuator.

A user, grasping the valve and/or slider member can push the valve, slider member and catheter tube in the direction of a patient, at which time the catheter tube is passed through the manifold, into, and through, an endotracheal tube in the patient. Alternatively, the valve slider member and catheter tube may be moved away from the patient, with the catheter tube always remaining sterile and protected by the sheath and manifold. The interlocking sidewall structures couple and decouple as appropriate to maintain a sealed sheath extending in both directions from the slider/valve assembly. These structures form a stiffening member that holds the sheath in a projected condition. A finger tab may optionally be provided at either or both the distal and proximal ends of the sheath to be grasped as the valve, slider member and catheter tube are reciprocated, with respect to the sheath.

A leading edge of the slider member will typically be configured to hold cooperating structures, such as a bead and groove arrangement, in an interlocked configuration. The trailing edge of the slider member will typically be configured to again interlock the cooperating structures so that the sheath is sealed during all portions of travel of the slider member, except for the portion split by a divider device associated with the slider member between its leading and trailing edges.

To maintain the sterility of the catheter tube, an airtight relationship may be provided between the divider device and the cooperating structures.

In practice, various indicia may be associated with the devices of this invention to inform the user concerning the location and orientation of the distal end of the catheter tube. The longitudinal advance of the catheter may be monitored by means of indicator marks or colored segments on the catheter tube and/or barrier sheath, for example. According to certain embodiments, the slider assembly serves as a position indicator by reference to a scale imprinted on the sheath in the proximity of the self sealing slit. The radial orientation of the catheter tip is of interest for constructions utilizing a curved or bent tip. Indicia, such as index marks, associated with a swivel joint are useful for this purpose. More sophisticated embodiments carry field affecting devices, such as coils, magnets or capacitors, at the distal end of the catheter tube. The position and orientation of such devices can be precisely monitored by conventional means from outside the patient. Other embodiments monitor the catheter tip position by resort to radio opaque markers detectable by conventional radiologic techniques. BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a preferred embodiment of the assembled invention; FIG. 2 is an exploded view of the embodiment of

FIG. 1;

FIG. 3a is an enlarged view in side elevation of certain components shown in FIG. 2;

FIG. 3b is a view in end elevation of some of the components shown by FIG. 3a;

FIG. 4 is an enlarged view of a portion of the embodiment shown in FIG. 2;

FIG. 5 is a perspective, partially exploded and partially broken away view of an alternative preferred embodiment of the assembled invention;

FIG. 6 is an enlarged sectional view taken on the line 6-6 of FIG. 5;

FIG. 7 is a top plan view of a suction valve used in one embodiment of the invention; FIG. 8 is an enlarged sectional view taken through the valve of FIG. 7;

FIG. 9 is an enlarged transverse section view of the valve of FIG. 8;

FIG. 10 is a transverse section through the sheath of the invention, taken on the line 10-10 of FIG. 5;

FIG. 11 is a perspective view of another embodiment of suction valve suitable for use with the invention; FIG. 12 is an enlarged transverse section taken on the line 12-12 through the valve of FIG. 11;

FIG. 13 is a top plan view of the valve of FIG. 11, broken away to show the structure inside;

FIG. 14 is a top plan view of the valve plunger of the valve of FIG. 11;

FIG. 15 is a side plan view of the plunger shown in FIG. 13; FIG. 16 is a perspective view of one-half of the plunger of FIG. 13 and 14, the other half being identical thereto;

FIG. 17 is a side elevation view, partially broken away;

FIG. 18 is a perspective view of another embodiment of a manifold of the invention;

FIG. 19 is a fragmentary section view taken on the line 19-19 of FIG. 18; and FIG. 20 is a side elevation view, like that of

FIG. 15, but showing a modified plunger.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS The ventilating and aspirating device, designated generally 10 in FIG. 1, includes front swivel segment 11 which attaches to an endotracheal tube, a fragment which is indicated generally 13 (FIG. 4) , associated with the patient.

A suction catheter tube 14 includes a distal (patient) end 14A and a proximal end 14B (see FIG. 2) . The distal end 14A includes radially disposed perforations 15 and an open end 16. A curved end 17 may be disposed near the distal end 14A, as shown. The proximal end 14B of the catheter tube 14 is attached to a vacuum valve shown generally at 20 (see FIG. 2) . During operation, the valve 20 is attached to a vacuum source (not shown) by means of a connector fitting 22. The valve 20 is actuated to apply suction to the lumen of the catheter tube 14, when desired. When the catheter tube 14 is inserted into the endotracheal tube 13 of the patient, the distal end 14A moves into either the endotracheal tube or a bronchus of the patient, depending on the depth of insertion. The curved end 17 is intended to facilitate entry of the catheter tube 14 into the patient's bronchi. The elbow bend 17 is especially useful in entering the patient's left bronchus which is disposed from the trachea at a more severe angle than is the right bronchus. Undesired respiratory fluids can be suctioned out of the patient's breathing passageways by actuating the valve 20. With vacuum communicated to the catheter tube 14, fluids and secretions are suctioned into the catheter tube lumen through the perforations 15 and open end 16. The fluids and secretions are then transferred out through the conduit attached to connector 22 of the valve 20.

As best shown by FIGS. 2 and 3a, the valve 20 includes a resilient cap 23 which suspends a depending valve stem 24 in a close-fit relation with a cylindrical valve body 25. When the valve 20 is assembled, a retaining ring 26 locks a skirt 27 of the cap 23 into an annular channel 28 to enclose the valve body 25. With vacuum applied to the conduit 22 the flexible stem 24 is drawn into a sealing relation with port 22A defined by the conduit 22. When the cap 23 is pressed in the direction indicated P, an internal channel 30 of the stem 24 is brought into alignment with the port 22A and the port 29A defined by an inlet conduit 29 depending from the valve body 25. Vacuum is then applied to the lumen of the catheter tube 14. When finger pressure P is released, the resilience of the cap 23 biases the stem 24 upward to the normally closed condition of the valve 20 with the stem 24 again sealing the port 22A.

The valve 20 is associated with a slider assembly 35, which includes, in addition to the valve components enumerated, a slider cylinder 36 and a protective housing 37. The protective housing 37 encloses the valve body 25 and the resilient cap 23 such that skirt 27 is enclosed by and seals against the internal surfaces of the protective housing 37. The protective housing 37 guards against inadvertent actuation of the valve 20. Referring to FIGS. 1 and 2, a semirigid sheath

40 receives and coaxially surrounds the catheter tube 14 when it is withdrawn from a patient. The sheath 40 has a longitudinal split 41 (FIG. 1) which extends substantially the entire length of the sheath 40. The cylinder 36 of the slider assembly 35 fits coaxially over the semirigid sheath 40. The inlet conduit 29 extends through the longitudinal split 41 into the interior of the sheath 40 where it attaches to the proximal end 14B of catheter tube 14. This arrangement of the valve slider assembly 35 and semirigid sheath 40 enables the valve 20 to be placed outside the sheath 40 where it is accessible to the user for use as a slider handle.

Longitudinal movement of the valve 20 along the semirigid sheath 40 moves the catheter 14 into and out of the sheath 40 as required. The catheter tube 14 can thus be inserted and withdrawn from the patient simply by moving valve 20 toward or away from the patient. The gripping action of the opposing edges of the sheath 40 defining the split 41 restrains the catheter 14 from accidental movement into a patient.

Referring to FIG. 4, a segmented manifold assembly denoted generally 49 is indirectly attached to the distal end 40A of the semirigid sheath 40. This as¬ sembly 49 includes port casing 50, ventilation conduit 51, and ventilation port 52 disposed between rear swivel segment 53 and front swivel segment 11. Port casing 50 includes a generally cylindrical passage 55 through which catheter tube 14 moves during insertion or withdrawal. Ventilation conduit 51 extends radially from port casing 50 and is in fluid communication with the interior of the passage 55. Ambient air, oxygenated air, and other therapeutic gases can be selectively introduced into the respiratory system of the patient through ventilation port 52.

The front swivel segment 11 attaches to the port casing 50 at the distal end of the passage 55. The attachment is such that the passage 55 communicates with the interior of the front swivel segment 11. The connection between the front swivel segment 11 and port casing 50 is sufficiently fluid tight to maintain a sterile, air-tight seal but loose fitting enough to allow independent rotation of each segment. The front swivel segment 11 is adapted to attach to the patient's endotracheal tube 13 such that the passage 55 is in fluid communication with the endotracheal tube 13.

The rear swivel segment 53 attaches to the port casing 50 at the proximal end of the passage 55 in a fashion generally similar to that explained in connection with the front swivel segment 11. The passage 55 communicates with the interior of the rear swivel segment 53. The connection effected between the casing 50 and segment 53 also allows independent rotation of the segments as previously described. FIG. 3a illustrates the arrangement of the semirigid sheath 40, valve 20, swivel mounted manifold means 49, and catheter tube 14. To aid in inserting the catheter tube 14 into the left bronchus, elbow bend 17 is disposed near the distal end 14A of the catheter tube 14. The elbow bend 17, however, is more helpful if the user knows the orientation of the distal end 14A. The valve 20, being attached to the proximal end 14B of the catheter tube 14, provides a positional index relative to the orientation of distal end 14A. The fixed relationship between the valve 20 and the distal end 14A, as shown in FIG. 3b, coupled with the swivel capability of the manifold 49, allows the user to orient the distal end 14A so that the catheter tube 14 can easily be inserted into the patient's left bronchus. The semirigid sheath 40 ensures that the device is structurally supported so that the positional relationship between the valve 20 and distal end 14A is readily evident to the user.

Referring again to FIG. 4, the rear swivel segment 53 carries an "0"-ring 57 which is held in place by a seal cover 58. The "0"-ring 57 thus fits snugly to form a seal between the inside wall of the segment 53 and the outside wall of the "0"-ring 57. The interior surface of the "0"-ring 57 fits snugly over the catheter tube 14, forming an air-tight sterility seal. The catheter tube 14 is slidable lengthwise through the "O"- ring 57 during insertion or withdrawal of the catheter tube 14 with respect to a patient. The extended portion of the catheter tube 14 is thereby isolated from the remainder of the device 10.

Molded into the exterior wall of the rear swivel segment 53 is an irrigation extension conduit 59 which is in fluid communication with the passage 55. When an irrigating solution is injected into the conduit 59, the solution is directed onto the exterior of the catheter tube 14 and flows down the catheter tube 14 toward its distal end 14A.

The assemblage of the casing segment 50, front swivel segment 11, and rear swivel segment 53 permits each of these segments to rotate coaxially around the catheter tube 14 independent of the other segments. Several significant advantages follow from this arrangement. The accessibility of ventilation conduit 51 during attachment of the ventilation source is enhanced. The casing segment 50 and any attached hoses or tubing can also be swiveled out of the way of the user or the patient during use. The catheter tube 14 may be rotated during use to facilitate aspiration. Moreover, the irrigation conduit 59 can be pivoted to allow rinsing of the complete perimeter of the catheter tube 14 during withdrawal. A collapsible envelope is provided in two portions, 60 and 61 (FIG. 1) . This envelope surrounds the semirigid sheath 40 and is intended to assure sterility of the device during use. The distal portion 60 of the collapsible sheath attaches between the distal end of the valve 20 and the proximal end of the rear swivel segment 53 by means of locking collars 62A and 62B (FIG. 2) . The proximal portion 61 of the collapsible envelope attaches between the proximal end of the valve 20 and the proximal end of the device by means of locking collars 63A and 63B. During insertion of the catheter tube 14 into the patient, the distal portion 60 of the collapsible envelope shortens in length as the valve 20 slides toward the manifold assembly 49 while the proximal portion 61 of the envelope extends as the valve 20 moves away from the proximal end of the device 10. This re¬ lationship is reversed during withdrawal of the catheter tube 14 by moving the valve 20 in the opposite direction towards the proximal end of the device 10.

A hose clip 65 (FIG. 1) facilitates fastening the device 10 out of the way during periods of non-use. A slider locking cap 67 (FIG. 2) is shown at the proximal end of the device 10 being held in place by the lock wedge 68. The wedge 68 seals the open end of the split tubing 40 and holds the proximal components 63B, 65, and 67 in place. The locking cap 67 fits over the shield 37 of the sliding valve assembly 20 when properly positioned to hold the catheter tube 14 in its fully retracted position prior to use. It also isolates the valve cap 23 from inadvertent actuation and preserves the cleanliness of the components of the valve assembly 20. Conventional PVC tubing 69 and an end fixture 70 are illustrated in association with the irrigation extension conduit 59.

An alternative embodiment of the invention is illustrated in FIGS. 5-10. It should be recognized that structural elements which are common to the previously described embodiment and the alternative embodiment are identified by identical reference number designations. As shown to advantage in FIG. 5, the alternative embodiment includes a front swivel 11 and a catheter 14 having perforations 15 and an open end 16 and a curved end 17 as previously described. The alternative embodiment also includes a segmented manifold 49, a port casing 50, passage 55, ventilation conduit 51 and a rear swivel segment 53 as previously described.

In contrast to the previously described embodiment, the alternative embodiment does not include a semirigid sheath 40. Instead, a flexible sheath 71 is sealingly coupled at its distal end to a sleeve 73 of the seal cover 58 by a locking collar 75.

The sheath 71 is elongate and, as best seen in FIG. 10, includes a pair of sidewalls 77 and 78 interconnected at a bottom edge 79. Semi-rigid, but flexible backing members 80 and 81 extend respectively along upper edges of the sidewalls 77 and 78, for substantially the entire length of the sheath. A groove

82 is formed on an inside face of the backing member 80 and extends for the length of the backing member. A bead

83 is similarly formed in the backing member 81 and extends the full length of the backing member 81. The bead 83 fits tightly into the groove 82 and when the bead 83 is pressed within groove 83 for the length of the backing members 80 and 81, the sheath 71 is fully sealed.

As has been noted, the distal end of the catheter tube 14 extends through the rear swivel segment 53, the manifold assembly 49, and into and through an endotracheal tube, not shown. As shown by FIGS. 5 and 8, the proximal end of the catheter tube 14 is coupled to an elbow connector 85 at the lower end of a nipple 86 forming part of a slider assembly, shown generally at 87 (FIG. 5) .

The slider assembly 87 includes a pair of legs 88 and 89, interconnected by a web 90, that straddle the backing members 80, 81 and the bead 83 and groove 82 of the sheath 71. The legs 88 and 89 and the web 90 are elongate and the legs diverge through a central portion of their length and converge at opposite ends so that as the slider assembly 87 travels along the sheath 71, the ends of the assembly force the bead 83 fully into the groove 82. The nipple 86 extends through a hole 91 formed in the web 90 and the elbow 85, at one end of the nipple 86, is connected inside the sheath 71 to the catheter tube 14. The nipple 86 and elbow connector 85 form part of an insert member 95 (FIG. 5) that also includes a series of stepped walls 96, 97 and 98. The walls 96, 97 and 98 each diverge around the nipple 86 and converge at opposite ends. A stepped surface 99 (FIGS. 5 and 9) interconnects the top of wall 96 with the bottom of the smaller wall 97 and another step surface 100 interconnects the top of wall 97 with the bottom of wall 98.

The insert member 95 extends from inside the sheath 71 into locking engagement with the slider member 87. The nipple 86 then extends through the hole 91 of the web 90 and the wall 98 serves as a divider to be positioned between corresponding portions of the bead 83 and groove 82, respectively. Thus, divider wall 98 is arranged to travel between the bead 83 and groove 82 as the slider member 87 is moved in either of its permissible directions of travel. The step surface 100 passes beneath the groove 82 during sliding movement of the slider member 87 and the wall 97 separates portions of the backing members 80 and 81 for the bead 83 and groove 82, respectively. The step 99 moves beneath the backing members 80 and 81 as the slider member is moved.

As best seen in FIG. 9, the bead 83 and groove 82, their backing members 81 and 80, and the portions of the sidewalls 77 and 78 of sheath 71 on which the backing members, bead and groove are formed, are wedged tightly between the wall 98 and the insides of walls 88 and 89 of the slider member 87 so that air cannot pass between the bead and groove, even during movement of the slider element. Similarly, the backing members 80 and 81 and sidewalls 77 and 78 are wedged between the wall 97 of the insert member and the insides of walls 88 and 89 of the slider member 87 to provide another airtight seal. Portions of the flexible sidewalls 77 and 78 of sheath 71 are also wedged between the wall 96 of the insert member 95 and the insides of legs 88 and 89 of the slider member 87. The tight, wedging relationship between the slider member 87, the insert member 95, and the components of the sheath 71 result in the insert member's being securely held within and between the legs 88 and 89 of the slider member. The tight wedging action also results in airtight seals between the bead 83 and groove 82 and wall 98 of the insert member; between the backing members 80 and 81 and wall 97 of the insert member and between a portion of the flexible sheath adjacent to the backing members and wall 96 of the insert member. Thus, an airtight seal is provided even as the slider member is moved along the sheath and the bead 83 and groove 82 are separated to allow such passage. The converging ends of the slider member provide a leading edge clamp for the bead and groove and a trailing edge clamp to close the bead and groove after the divider 98 has passed between them. A pair of stud projections 101 and 102, spaced at opposite sides of the nipple 86 project upwardly from the top surface 103 formed on the divider wall 98. The projections 101 and 102 fit into hollow well projections 104 and 105, respectively, formed on and opening through the web 90 of the slider member 87 and insure that the components of the slider member 87 and the insert member 95 move in unison.

As previously noted, the slider member 87 supports and carries a vacuum valve 20A.

As best shown by FIGS. 5 and 8, the valve 20A includes a resilient cap 105 which acts as a pushbutton valve actuator and which suspends a depending valve stem 106 in a close-fit relation with a cylindrical valve body 107. When the valve 20A is assembled, a retaining ring 108 locks a skirt 109 of the cap 105 into an annular channel 110 of the valve body 107. Vacuum from a source, not shown, is applied to a connector 112 that opens into the valve body 107. The flexible stem 106 is normally biased by the resiliency of the cap 105 into an expelled position, sealing a port 113 through the connector 112. When the cap 105 is pressed in the direction indicated R, and into a flared chamber 107A formed in body 107, an internal channel 114 of the stem 106 is brought into alignment with the port 113 and the nipple 86. Vacuum is then applied to the lumen of the catheter tube 14. When pressure on the cap 105 is released, the resilience of the cap biases the stem 106 upward to the normally closed condition of the valve 20A, with the stem 106 again sealing the port 113.

The valve 20A, FIGS. 5 and 8, is coupled to the slider member 87 by bonding of a downwardly extending boss 115 to the nipple 86 and the inner surface of hole 91. The bottom 116 of the valve body 107 is also bonded to the top surface of the web 90 of the slider assembly 87. The valve 20A is moved with the slider member 87 along the length of sheath 71 having the bead 83 and groove 82 thereon. A user may manipulate the valve with one hand and may use the same hand to move the valve and slider along the sheath.

A protective fence 118 may be affixed to the valve body and arranged to partially surround the resilient cap 105, so as to prevent inadvertent actuation of the valve 20A. A cap 119 that will just fit over the protective fence 118 is connected by a flexible tether 119A to the valve body. The cap 119, when installed over the fence 118, provides positive protection against actuation of the valve 20A. Another embodiment of vacuum valve suitable for use with the slider member 87, is shown at 120 in FIGS. 11-17. As shown, the valve 120 includes a housing 121 with a peripheral wall 122 including sidewalls 122A and 122B interconnected by end walls 122C and 122D, and having an inside configuration corresponding to the exterior configuration of the walls 88 and 89 of the slider member 87. The housing 122 includes a top cover 124 and is open at its opposite, bottom end 125 so that the lower end of the housing will telescope tightly over the walls 88 and 89 of the slider member 87. So installed, the valve 120 is locked to the slider element 87 and is movable therewith. If desired, the housing 122 of the valve may be bonded to or be formed integrally with the slider element 87.

As best shown in FIGS. 12, 13 and 17, a flexible tube 126 has one end tightly telescoped over the upwardly extending nipple 86 and has a retainer sleeve 127, FIG. 17, inserted into its other end. An elbow connector 128 has one leg 128A fixed to the top cover 124 over a hole provided through the top cover and the other leg 128B extending for connection to a source of suction, through a flexible connecting hose, (not shown) . A reinforcement plate 128C (FIG. 17) may be provided between the legs 128A and 128B of the connector 128 and the top cover 124 to strengthen the connector 128 against being broken away from the valve body. The retainer sleeve 127, FIGS. 12 and 17, includes an outwardly projecting flexible ring 129 that is inserted into the connector 128 and snaps into a groove 130. The flexible tube 126 thus extends from the nipple 86 to the bore 128D through connector 128, to which the suction source is connected.

A plunger 135 (FIGS. 13-16) extends through a hole 136 provided in the sidewall 122A of the housing 121 and serves as a pushbutton valve actuator. The plunger 135 is guided within the housing 121 by walls 137 and 138. A spring pocket 139 is fixed to a face 135C of the plunger 135 and forms a pocket for a spring 141 that acts against the interior of the wall 122B and tends to bias the plunger out of the housing 121. The plunger 135 is preferably formed from identical halves 135A and 135B, each including one-half of the spring pocket and a pair of partial slots 140 formed in the side wall thereof at opposite sides of a generally half-barrel shaped plunger part. Alternatively, the plunger 135 can be formed in a generally cylindrical shape with the face 135C and spring pocket 139 being formed as one part and fixed to the plunger 135. When the plunger part is assembled, the plunger is of generally barrel configuration and the spring pocket is generally cylindrical. The assembled plunger then has aligned slots 140 through its top and bottom surfaces. The flexible tube 126 extends through the top and bottom slots 140 and holds the plunger in place, within the housing 121. Spring 141, in acting to bias the plunger 135 from the housing 121, causes the inside wall of the plunger to compress the flexible tubing 126 and to thereby prevent flow through the tubing. When the plunger 135 is pushed inwardly by a user, the pressure on the tube 126 is relieved and the natural resilience of the tube 126 opens the tube to permit flow therethrough.

"L"-shaped locking grooves 142 and 142A (FIGS. 15-16) may be provided in opposite sides of the wall of plunger 135 and between the slots 140. Corresponding lug members 143 and 143A, FIG. 13, may be provided in the housing 121 such that the lug members will extend into grooves 142 and 142A. Axial rotation of the inwardly pushed plunger 135 and slots 142 and 142A will position the lugs 143 and 143A in the corresponding angled legs of the locking grooves so that spring 141 is no longer able to bias the plunger and to close the valve. In this position, the valve 120 is locked open, and pressure on the flexible tube 126 is relieved. To again close the valve, it is only necessary for the user to axially rotate the plunger 135 in the opposite direction until the locking lugs are moved away from the angled legs of the grooves 142 and 142A. The spring 141 is then free again to bias the plunger outwardly and to compress the tube 126. Similarly, when plunger 135 is fully biased by spring 141 and the tube 126 is compressed, axial rotation of the plunger will position lugs 145 and 145A in corresponding "L"-shaped grooves 144 and 144A in the plunger 135 such that the plunger cannot be pushed inwardly without first axially rotating the plunger in the opposite direction until the lugs 145 and 145A are moved out of registration with the angled legs of the grooves. Tubing life is extended if the plunger is locked in the valve open position during periods of non- valve use, for example, during sterilization, storage and shipping. As with the previously disclosed valve 20A, the valve 120 can be operated with one hand of a user and will slide with the slider element 127 along the length of sheath 71. The bead and groove configuration, together with the backing members provided by the sheath 71 provide sufficient rigidity to maintain the sheath in a substantially extended position. However, some flexibility is retained to allow a user to reposition the sheath as necessary, relative to other equipment being used during an operation. Finger tabs (or pads) 146 and 146A at the proximal and distal ends of the sheath allow the user to anchor the sheath while running the slider member and valve along the sheath. Either or both tabs 146, 146A may be color coded or otherwise marked to indicate to an operator the intended function of the respective tabs. The proximal tab 146 functions as an anchor for the pliant sheath 71 during extension of the catheter 14 into the trachea of a patient. The distal tab 146A anchors the sheath 71 when the catheter 14 is withdrawn from the patient. Another embodiment of manifold assembly, shown generally in FIG. 18 corresponds to and may be used in place of the manifold assembly 49, previously described. As with the previously described structure, a front swivel segment 151 that attaches to an endotracheal tube, not shown, but inserted into a patient, has the manifold assembly secured thereto. In the embodiment shown in FIG. 18, a suction catheter tube 152 has a straight distal end 153 and a proximal end (not shown in FIG. 18) . The end 153 projects from the swivel segment 151 and has side perforations 154 and an end opening 155.

The manifold assembly 150 includes a body 156 with a passage 157 therethrough, through which the tube 152 is passed. The body 156 attaches to the front swivel segment 151 such that the passage 157 communicates with the interior of the swivel segment 151 and the connection allows independent rotation between the swivel segment 151 and the body 156.

The body 156 has a pair of angled connector members 158 and 159, each opening into the passage 157, a pressure sensor connector 161, and a sheath connector

162, each extending from the body and each opening into the passage 157. The sheath connector 162 includes a collar 163, FIG. 19, and a plurality of partially encircling edges 164. An irrigation conduit connector 165 projects from the sheath connector 162 and opens into the sheath connector 162 to be in communication with passage 157. A flexible irrigation conduit 166 has one end connected into the irrigation conduit connector 165 and has one end of a tubular connector member 167 on the free end thereof. A cap 168 is formed to fit over the other end of tubular connector member 167 and flexible tether 169 interconnects the connector member 167 and the cap 168 which removably fits into and tightly closes the connector member. The sheath 170 is constructed in the same manner as the sheath 71 previously described and has a sleeve 171 secured to the open end thereof. The sleeve 171, with the attached end of sheath 170, is telescoped onto a step-down shoulder 172 of a plug 173 having a central hole therethrough, through which the suction catheter tube 152 is passed. A seal 175, FIG. 19, fits within a bore 176 of the plug 173 and snugly around the catheter tube 152 as the tube is passed therethrough. The bore 176 telescopes over the sheath connector 162 and a small ridge 177 on the outer surface of the conector. The bore snaps over the partially encircling ridges 164 to hold the plug 173, sleeve 171 and sheath 170 securely to the manifold assembly 150, with the airtight seal between the plug 173 and end of the sheath connector 162. The manifold assembly 150, when attached to the sheath 170, functions with respect to the catheter tube 152 and sheath 170 in generally the same manner as the manifold assembly 49 functions with respect to the sheath 71 and its attached structures. One or both connector members 158 and 159 can be used for the selective introduction of ambient air, oxygenated air and other therapeutic gases to the patient. The pressure sensor connector 161 provides a means for attachment of a sensing device, not shown, for use in determining the pressure in a patient's chest. The irrigation conduit connector 165 permits the introduction of fluids to cleanse the catheter tube as it is withdrawn from a patient, in the manner previously described.

As illustrated by FIG. 18, a separate connector member plug, designated generally 178, may be provided to fill the interior space of either or both of the members 158, 159. The plug 178, as shown, is configured to eliminate dead air space in a member, 158, 159, not in use and is configured at its distal end 179 to merge with the interior side wall defining passage 157.

Another embodiment of plunger is shown at 180 in FIG. 20. The plunger 180 differs from the plunger 135, as shown in FIG. 15, only in that it includes a single slot 181 having a first '^"-shaped end 182 and a second "L"-shaped end 183, rather than the plural slots 142 and 144 shown in FIG. 15. Only a single lug member, i.e. member 143, is required to extend into slot 181.

Thus, when the plunger is fully expelled, the plunger 180 may be turned to position lug 143 in the "L"-shaped end 182 and to thereby prevent inadvertent pushing of the plunger and opening of flow through the tube 126. Similarly, when the plunger is pushed to allow flow through tube 126, the plunger may be turned to position lug member 143 in the "L"-shaped end 183. The plunger is thereby held in its pushed-in position, insuring continuous access of sterilization gases through the tube 126.

While a locked open position is generally inappropriate for therapeutic applications, it is useful for sterilization, storage and shipping. The open condition relieves mechanical pressure and crimping stress on the tube 86 prior to its actual use.

While this disclosure has placed principal emphasis on tracheal aspirating devices, the invention is broadly applicable to other circumstances in which it is desired to manipulate an instrument across a barrier, particularly a sanitary barrier. Various medical applications involving catheter placement or other intubation procedures are within contemplation. Other, more elaborate embodiments may utilize the air tight ziplock slider construction of this invention to facilitate movement of probes or other devices to various locations about a surface defining an enclosed space. A typical such embodiment involves the positioning of one or more flexible gloves with respect to another such glove or device to facilitate the examination or manipulation of objects within an enclosed space from outside that space. The invention may be viewed broadly as a protective shield apparatus which permits the manipulation or positioning of an implement on one side of a barrier, typically within a confined or protected space, by manual or mechanical motion induced from the opposite side of the barrier by means of an actuator assembly. The actuator assembly is dynamically locatable at substantially any point along a travel path defined by a releasably closed parting line or slit opening through the barrier. The barrier is typically pliant to accommodate sealable parting constructions of the ziplock type or their mechanical equivalents. The barrier may be configured as a sheath, as illustrated, but it may alternatively be structured as a rigid or semirigid dome or other housing characterized by a surface capable of maintaining parting line adaptable to actuator travel. References herein to the details of the illustrated embodiments are by way of example only and are not intended to limit the scope of the appended claims which themselves recite those features regarded as important to the invention.

Claims

CLAIMS What is claimed is:

1. A ventilating and aspirating apparatus for delivering respiratory gases to the trachea of a patient and aspirating congested lungs and breathing passageways comprising: a flexible catheter tube having a catheter lumen and a longitudinal catheter axis, said catheter tube being extendable into and withdrawable from a patient's trachea and having a distal end structured to permit secretions to enter said catheter lumen; a vacuum valve with an inlet connected to the lumen of said catheter tube, an outlet constituting means for connection to a vacuum source, and an actuator for selectively communicating the lumen of said catheter tube with the vacuum source; a resilient, pliable sheath having a longitudinal sheath axis, said sheath receiving and coaxially surrounding said catheter tube and having an open distal end through which said catheter tube is slidable; and a manifold connected to the distal end of said sheath and having a center passage in open communication with the interior of said sheath, said manifold including means for establishing a fluid connection between said center passage and a patient ventilation and exhalation apparatus and being structured to permit slidable passage of said catheter tube through said center passage.

2. The ventilating and aspirating apparatus of Claim 1 further including: sealing means including a collapsible envelope, said sealing means being mounted to surround said sheath and the portion of said catheter tube residing between said sheath and said manifold.

3. The ventilating and aspirating apparatus of Claim 1 wherein the distal end of said catheter tube is oriented at an angle from said catheter axis.

4. The ventilating and aspirating apparatus of Claim 1 wherein said sheath is formed of a substantially continuous sidewall, a releasably closed slit formed in a portion of said sidewall, said slit being defined by opposed edges of a discontinuous portion of said sidewall.

5. The ventilating and aspirating apparatus of Claim 4 further including: connector means for connecting said catheter tube inside the sheath to the vacuum valve outside the sheath, said connector means including structure disposed through said slit and being otherwise structured and arranged for movement parallel said sheath axis, whereby to open a portion of said slit adjacent said connector means progressively in a direction of travel of said connector means while concurrently closing said slit following said connector means in said direction of travel.

6. The ventilating and aspirating apparatus of Claims 4 or 5 further including closing means for releasably closing said slit along its entire length, said closing means comprising a bead disposed along a first edge of said slit and a groove disposed along a second edge of said slit to tightly receive said bead, thereby to prevent air flow through said slit.

7. An improved ventilating and aspirating apparatus as in Claim 6 wherein the connector means includes a slider member having legs straddling a portion

75 of said closing means and a web interconnecting said legs, said legs converging at their respective opposite ends, whereby said ends function to hold the bead in the groove, and said legs diverging at a central portion of said slider member; a divider member between said legs at

80 said central portion and shaped to separate the bead from the groove at said central portion; and a conduit means extending through said divider member and having a first end connected to the catheter tube inside the sheath and a second end projecting through the web of the slider

85 member.

8. The ventilating and aspirating apparatus of Claims 1, 2, 3, -4, 5, 6 or 7 further including: swivel means connected to said manifold including a first

90 swivel structure rotatably mounted to the distal end of said manifold and a second swivel structure rotatably mounted to the proximal end of said manifold, said first and second swivel structures having respective interiors in open

95 communication with said center passage.

9. A ventilating and aspirating apparatus as in Claims 7 or 8 for delivering respiratory gases to the trachea of a patient and aspirating congested lungs and

100 breathing passageways wherein the vacuum valve is carried by the slider member and includes a valve body secured to the slider member and a passageway in said valve body connected to the catheter tube; and further including: a conduit connector opening into said passageway;

105 a valve actuator to open the valve; means biasing the valve actuator to a valve-closed position; means preventing flow from the catheter tube to the conduit connector when the valve is in a valve- 110 closed position; and means connecting the catheter tube to the conduit connector for flow therebetween upon movement of said valve actuator to a valve-open position. 115

10. An improved ventilating and aspirating apparatus as in Claim 9 for delivering respiratory gases to the trachea of a patient and aspirating congested lungs and breathing passageways, wherein:

120 the valve actuator includes a valve stem extending therefrom into the valve body, said valve stem having a passage therethrough for flow from the catheter tube to the conduit connector; and the means biasing the valve actuator comprises a

125 resilient pushbutton portion of the valve actuator.

11. A valve for use on a tracheal aspirator and the like comprising:

130 a valve body having a flexible tube extending therethrough, and a pair of spaced-apart sidewalls; a plunger extending slidably through a first one of said sidewalls, said plunger having a hole 135 therethrough inside the valve body, and said flexible tubing extending through said hole; and spring means positioned between said plunger and the other of said sidewalls to bias said plunger 140 out of said first sidewall to compress said flexible tubing to thereby prevent flow therethroug .

12. A protective shield apparatus for allowing 145 communication between a user located on a first side of a barrier and an implement located on a second side of said barrier across at least one channel dynamically locatable anywhere along a defined course of potential channel location through said barrier, comprising: 150 a pliant barrier means defining a substantially discrete space; at least one releasably closed slit formed through said barrier means, said slit defining a course of travel along said barrier means; and 155 connector means for allowing communication across said at least one channel between said user and said implement, said connector means including structure disposed through said at least one slit and being otherwise structured and 160 arranged for slidable movement along said course, whereby to open a portion of said slit adjacent said connector means progressively in the direction of movement of said connector means while concurrently closing said slit 165 following said connector means in the direction of movement.

13. The protective shield apparatus of Claim 12 including a vacuum pressure source positioned for

170 access by said user; wherein said implement comprises a flexible catheter tube having a catheter lumen and a longitudinal catheter axis, said catheter tube being extendable into and withdrawable from the trachea of a patient and having a distal end structured to permit

175 secretions to enter said catheter lumen; said pliant barrier means comprises a pliant sheath formed of a substantially continuous sidewall and having a longitudinal sheath axis, said sheath receiving and coaxially surrounding said catheter tube, having a closed

180 proximal end and an open distal end through which said catheter tube is slidable; said connector means comprises a vacuum valve with an inlet connected to the lumen of said.catheter tube, an outlet constituting means for connection to a vacuum source, and a valve actuator for

185 selectively communicating the lumen of said catheter tube with the vacuum source; and said anchoring means comprises a manifold connected to the distal end of said sheath having a center passage in open communication with the interior of said sheath, said manifold including

190 opening means for establishing a fluid connection between said center passage and a patient ventilation and exhalation apparatus and being structured to permit slidable passage of said catheter tube through said center passage.

195