Respiratory access port assembly with passive lock and method of use

A respiratory access assembly includes a distal plate having a port, which is adapted to be positioned in operable communication with an artificial airway of a patient. The assembly includes a distal plate having a port and a proximal plate which has a first port and a second port. The distal plate is positioned against the proximal plate in a stacked configuration, and each plate is configured to move relative to the other. The assembly has an actuator which is positioned adjacent to at least one plate. The actuator cooperates with both plates to substantially prevent movement of the plates when the port of the distal plate is positioned in an alignment with at least one port of the proximal plate and an object, such as a suction catheter, is positioned through the aligned ports of the plates. The actuator cooperates with at least one plate to permit movement of at least one plate when (a) no object is positioned through aligned ports, and (b) when no ports are aligned. The assembly desirably has predetermined positions, which include a first open position, a second open position, and a third closed position.

BACKGROUND

The inventions disclosed herein relate generally to improved medical care for intubated patients, and more particularly to a novel multiple access respiratory port, assembly, manifold, fitting, adaptor, connector and/or access control assembly inventions, and related methods, for ventilating, aspirating, monitoring, sampling, and providing therapeutic delivery to the respiratory tracts of intubated patients, including infants, adolescents, and adults.

Respiratory patient care is a dynamically developing field in medicine, ranging in its needs from infants to the aged. The range of respiratory ailments, both temporary and permanent, to which such patients are subjected, are many and varied. For example, the range of procedures for intubated patients may include the following: ventilation, aspiration, oxygenation, sampling, visual inspection, in-line sensing, pressure monitoring, flushing, medicating and/or lavage. Most problems now center or focus on multiple needs of the patient and accommodation of multiple treatments, some to be performed at the same time. The lack of equipment to facilely, efficiently, and safely accomplish the multiple therapies in the best interest of the patient has been and continues to be a concern.

For example, in low lung capacity patients, such as premature babies and adults suffering from emphysema, one problem is the removal of accumulated lung secretions. It is undesirable to starve such patients of oxygen during the secretion removal process. Secretion removal is accomplished via a suction catheter which is temporarily positioned via a respiratory access assembly in an artificial airway, i.e., an endotracheal tube placed in a portion of the patient's respiratory tract to provide air (oxygen and other gases) to the lungs of such patients. While this procedure sounds simple, it is fraught with difficulties, particularly when a caregiver must change devices or perform other therapeutic treatments sequentially or simultaneously. In fact, these difficulties may result in the patient contracting ventilator acquired pneumonia. There is a need to address and overcome these difficulties.

SUMMARY OF THE INVENTION

In response to the difficulties and problems discussed herein, a respiratory access assembly is provided. The respiratory access assembly comprises a distal plate having a port. The port is adapted to be positioned in operable communication with an artificial airway of a patient. The assembly includes a proximal plate, which has a first port and a second port. The distal plate is positioned against the proximal plate in a stacked configuration, and each plate is configured to move. The assembly also has an actuator which is positioned adjacent to at least one plate. The actuator cooperates with both plates to substantially prevent movement of the plates when the port of the distal plate is positioned in an alignment with at least one port of the proximal plate and an object is positioned through the aligned ports of the plates. The actuator cooperates with at least one plate to permit movement of at least one plate when (a) no object is positioned through aligned ports, and (b) when no ports are aligned.

In another aspect of the invention, a method of using a respiratory access assembly is provided. The method includes providing a respiratory access assembly. The respiratory access assembly includes a distal plate having a port. The port is adapted to be positioned in operable communication with an artificial airway of a patient. The assembly also includes a proximal plate which has a first port and a second port. The distal plate is positioned against the proximal plate in a stacked configuration. The distal plate and the proximal plate are configured to move relative to each other. The assembly further includes an actuator positioned adjacent to at least one plate. The actuator cooperates with both plates to substantially prevent movement of the plates when the port of the distal plate is positioned in an alignment with at least one port of the proximal plate and an object is positioned through the aligned ports of the plates. The actuator cooperates with at least one plate to permit movement of at least one plate when (a) no object is positioned through aligned ports, and (b) when no ports are aligned. The method also includes moving one of more plate so that the port of the distal plate is aligned with a port of the proximal plate to provide an opened assembly. The method further includes moving an object through the opened assembly, such that contact of the object against a portion of the actuator activates at least the portion of the actuator such that the actuator locks the plates in a position which substantially prevents movement of the plates.

DETAILED DESCRIPTION OF THE INVENTION

Reference will now be made in detail to one or more embodiments of the invention, examples of the invention, examples of which are illustrated in the drawings. Each example and embodiment is provided by way of explanation of the invention, and is not meant as a limitation of the invention. For example, features illustrated or described as part of one embodiment may be used with another embodiment to yield still a further embodiment. It is intended that the invention include these and other modifications and variations as coming within the scope and spirit of the invention.

The present respiratory access port assembly operates in a closed ventilating system and is designed to accommodate multiple access to the respiratory system of an intubated patient without compromising the closed circuit character of the closed system and without interruption of the flow of ventilating gases to the patient. Access to the closed respiratory system through one or more access sites is provided, for example, but not by way of limitation, to ventilate the lungs of the patient with gas or gases, to aspirate secretions from the lungs, to oxygenate the lungs to eliminate or reduce residual carbon dioxide therefrom, to visually inspect selected parts of the patient's respiratory system, to sample sputum and gases, to sense parameters such as flow rates, pressure, and/or temperature, to flush with solution(s), and to administer medication, gases, and/or lavage.

Many current designs for respiratory access port assemblies may have only one port. In these instances, the suction catheter must be removed when other tasks need to be performed, such as, for example, bronchoscopy, bronchial alveolar lavage, and so forth. Opening a closed ventilating system by removing the suction catheter on such a ventilated patient can lead to infection, as noted previously. Also, current designs of multiple access port manifolds and/or assemblies do not contain a safety lock. In certain instances, due to the lack of such a safety lock, the introduction of a suction catheter through a manifold port may result in a portion of the catheter being guillotined or cut off and aspirated into the patient's lungs. This can lead to significant complications, including airway blockage, infection, and even death. Further, failure to adequately seal a respiratory access assembly may cause a compromise of positive end-expiration pressure (PEEP), which in turn may cause suboptimal ventilation which can result in collapsing alveoli in the patient's lungs. The present respiratory access assembly includes features which permit multiple access without opening the closed ventilation system, and it contains a passive safety lock feature which prevents loss of any portion of the suction catheter and/or other object while it is positioned within the assembly.

Turning now to the drawings, as illustrated inFIGS. 1-15, a respiratory access assembly10is provided. The assembly10, as shown inFIGS. 1-9, includes a distal disk or plate12and a proximal disk or plate14which are positioned next to each other in a stacked and axially aligned configuration. The terms “align,” “alignment,” and variations thereof desirably, but not by way of limitation, refer to the spatial property possessed by an arrangement or position of things in a straight line. The terms “configure” or “configuration”, and derivatives thereof desirably, but not by way of limitation, refer to the design, arrangement, set up, or shape with a view to specific applications or uses. For example: a military vehicle that was configured for rough terrain; configured the computer by setting the system's parameters.

The distal disk or plate12includes at least one port16having an opening formed through the disk or plate12, as illustrated in FIGS.2and4-6. A cuff, such as cuff20, may, for example, but not by way of limitation, be provided on an outer distal surface22of the disk or plate12. Such a cuff20generally encircles the port16and the opening extends therethrough, such that the cuff20provides a portion of the port16. It will be understood that any cuff(s) shown and/or described herein, whether on an inner or outer surface of a disk or plate, desirably include the characteristics and features described herein for cuff20.

The term “port” as used herein desirably, but not by way of limitation, means an opening into or through a component for the passage of an object and/or a liquid and/or a gas. The term “cuff” as used herein also desirably, but not by way of limitation, means a generally cylindrical component having an opening therethrough which is positioned over a port and forms a portion of the port. Further, it will be understood that a port and its cuff may collectively be given the term herein of “port”, and two or more ports, each with its associated cuff, may collectively be given the term herein of “ports”.

The term “plate” as used herein desirably, but not by way of limitation, refers to any shape and configuration of a plate, including, but not limited to, round, square, rectangular, and so forth. It will be appreciated that the plate may be arced, arched, planar, convex, concave, and so forth.

The distal disk or plate12also has a proximal surface24which includes an outer perimeter26and a perimeter wall28which is desirably formed along the outer perimeter26. The perimeter wall28may extend proximally away from the outer perimeter26at about a 90 degree angle. The term “about” desirably, but not by way of limitation, when placed adjacent a number/numeral, refers to the stated number plus or minus ten (10) percent of the stated number. An inner surface30of the perimeter wall28desirably has a plurality of teeth32formed thereon. The plurality of teeth32may be positioned adjacent the port16. The perimeter wall28also desirably includes an outer surface34which has a groove36formed therein. An O-ring38may be positioned in the groove36. The O-ring38serves as at least a partial seal when it is positioned against a perimeter wall of the proximal disk14. The proximal surface24of the distal plate12includes a center aperture40configured to receive a fastener, such as a screw or pin42therethrough (shown inFIGS. 11 and 12). The pin42desirably holds the distal and proximal plates12,14adjacent each other in a stacked and axially aligned position, while permitting movement of each plate12,14relative to the other. A semi-circular indentation44surrounds the center aperture40. This semi-circular indentation44cooperates with other components and may limit the movement of the distal and proximal plates12,14relative to each other. In this embodiment, but not by way of limitation, the rotation is desirably limited to a range of about less than 200 degrees. More desirably, the rotation is limited to a range of between about 1 degree and about 200 degrees.

The inner proximal surface24of the distal plate12also may include a plurality of ramped indentations46. These ramped indentations desirably cooperate with other components described herein to assist in holding the plates12,14in specific, predetermined positions relative to each other. Such components and predetermined positions will be discussed in detail below.

The terms “orientation” or “position” used interchangeably herein desirably, but not by way of limitation, refer to the spatial property of a place where or way in which something is situated; for example, “the position of the hands on the clock.”

The proximal disk or plate14includes, but not by way of limitation, a first port50and a second port52, each having an opening extending through the proximal plate14, as shown inFIGS. 7-9. The first port50may have a first cuff54which is provided on an outer proximal surface56of the proximal plate14. In this instance, as illustrated inFIG. 9, the first cuff54extends beyond an inner distal surface58as well, and may include a notch60therein. Similarly, the second port52may have a second cuff62which is provided on the outer proximal surface56of the proximal plate14. The second cuff62, like the first cuff54, also extends beyond the inner distal surface58, and may also include a notch60therein as well.

The proximal plate14has an outer perimeter64which desirably includes a perimeter wall66. The perimeter wall66may be formed along the outer perimeter64and it desirably extends distally away from the outer perimeter64at about a 90 degree angle. In the present embodiment, but not by way of limitation, the perimeter wall28of the distal plate12is sized to fit within the perimeter wall66of the proximal plate14, such that the O-ring38on the outer surface34of the perimeter wall28of the distal plate12at least assists in forming a movable seal against an inner surface68of the perimeter wall68of the proximal plate14.

A center opening69is provided in the proximal plate14. The center opening69desirably aligns with the center aperture40in the distal plate12, and both are held at least adjacent each other by the screw or pin42(FIGS. 11 and 12) positioned therethrough.

A plurality of protuberances, such as the plurality of raised circular ribs70, may be provided adjacent the center opening69and the cuffs54,62on the distal surface58of the proximal plate14. At least a portion of a passive lock assembly or a means for locking the distal and proximal plates together may be positioned adjacent to the distal surface58of the proximal plate14.

An actuator or passive lock assembly desirably includes, for example, but not by way of limitation, a pair of pawls74attached by a U-shaped connector76, as illustrated inFIGS. 2,3, and10A. The pawls74and connector76are desirably positioned on the distal surface58of the proximal plate14. At one end, the pawls74each have a circular portion78with an opening80therein. At an opposite end, each pawl74has a plurality of teeth82. Each pawl74also desirably includes a flange84positioned along an outer edge86thereof. The flange84on each of the pair of pawls74is configured to moveably extend into the notch60in the first cuff54and the notch60in the second cuff62, respectively. In this manner, the flange84of one of the pawls74extends into the first cuff54and slightly into the first port50. Similarly, the flange84of another of the pawls74extends into the second cuff62and slightly into the second port52. Each flange84is desirably moveable out of its respective notch60when an object, such as, for example, but not by way of limitation, a suction catheter, is positioned through the first or second port50,52.

A base88is provided as a portion of the actuator or passive lock assembly, as shown inFIGS. 2,3, and10B. The base88is desirably provided adjacent the pair of pawls74and the U-shaped connector76. A distal surface90of the pair of pawls74and the U-shaped connector76is desirably positioned against a proximal surface92of the base88. The proximal surface92of the base desirably includes a plurality of posts94.

Each circular portion78on each of the pair of pawls74is configured to be positioned over a post94on the proximal surface92of the base88, as illustrated inFIGS. 11 and 12. The U-shaped connector76may also be positioned between two of the posts94. In turn, each of the plurality of posts94is desirably positioned to fit within each of the plurality of circular ribs70on the distal surface58of the proximal plate14, in order to hold the pair of pawls74and U-shaped connector76in a position adjacent the proximal plate14and to limit the movement of the pair of pawls74. The base88includes an opening95therethrough, to permit passage of the fastener, i.e., such as a screw or pin42, therethrough. A distal surface96of the base88includes a tab or stop98near the opening95. One end of the base88includes a curved leg100which includes a tab102on the distal surface96of each end of the curved leg100(FIGS. 2 and 10B). The opposite end of the base88may include a circular groove104which is configured to hold an O-ring106. The distal surface96of the base88is desirably positioned against the proximal surface24of the distal plate12.

A collar108may be positioned over an outer surface110of the perimeter wall66of the proximal plate14, as shown inFIGS. 2 and 3. The collar108may include a plurality of ribs112or other protuberances (not shown) on its outer surface110which assists a health care provider in holding the assembly10in the provider's hand and operating the assembly10. The collar108desirably includes a pair of caps114, each of which may be coupled to the collar108by a tether116. Each cap114is configured to fit within a cuff, such as the first cuff54and/or the second cuff62, to block or close the first port50and/or the second port52. It will be understood that the caps114may be configured to fit within the cuffs54,62, over the cuffs54,62, screw or snap into or over the cuffs54,62, and so forth.

The term “couple” and variations thereof, desirably includes, but is not limited to, joining, connecting, fastening, linking, tying, adhering (via an adhesive), or associating two things integrally or interstitially together. It will be understood that two things may be coupled directly or indirectly together.

In operation, the cuff20of the port16may be coupled to a port in a manifold120, which in turn is coupled to an endotracheal tube or artificial airway122and a ventilator (not shown). At least a portion of the artificial airway122is positioned in a portion of a patient's respiratory tract (not shown).

A suction catheter assembly130, as partially illustrated inFIG. 1, includes at least a distal end connector132which desirably releaseably couples to the first cuff54of the first port50of the proximal plate14. Alternatively, the suction catheter assembly130may be coupled to an intermediate quick release connector (not shown) which may be releaseably coupled to the first cuff54. A sleeve134is desirably coupled to the distal end connector132and extends at least substantially over a suction catheter136and may include a proximal end connector (not shown) to substantially cover the suction catheter154. The suction catheter136includes a distal tip with at least one opening therein (not shown). The terms “substantial” or “substantially” desirably, but not by way of limitation, refer to something which is done to a great extent or degree; a significant or great amount; for example, as used herein “substantially” as applied to “substantially covered” means that a thing is at least 70% covered.

The suction catheter136also desirably includes an elongated body139having a lumen therethrough and an open proximal end (not shown). The proximal end of the suction catheter134or the suction catheter assembly130is adapted to couple to at least a portion of a suctioning apparatus (not shown) which provides a suctioning force to the suction catheter136. It will be appreciated that the suction catheter136has a length which is sufficient to extend through the assembly10and through any attached manifold120and artificial airway122so that it extends into a portion of a patient's respiratory tract in order to suction secretions therefrom. When the suction force is discontinued, it will be understood that the suction catheter136is then desirably withdrawn from the patient's respiratory tract, the artificial airway122, the manifold120, and the respiratory access assembly10. The suction catheter136is desirably returned to its position in its assembly130and sleeve134. In this manner, the substantial length of the suction catheter136is contained within the sleeve134and it is therefore positioned outside of the closed circuit ventilation system of the patient until needed again for suctioning secretions.

Suction catheters are well known and widely commercially available for many medical uses. Suctioning may be performed using an “open” or “closed” system. In the open system, the suction catheter is merely a flexible plastic tube that is inserted into the flexible lumen with a source of suction connected to the proximal end of the suction catheter. Anything that the suction catheter touches before entering the lumen must be maintained in a sterile condition so a “sterile field” must be created on or next to the patient. The suction catheter must be carefully handled after it is used since it will be coated with the patient's secretions. In contrast, in the “closed” system, for example that disclosed in U.S. Pat. No. 4,569,344, a device which may be used to suction secretions is enclosed within a generally cylindrical plastic bag to eliminate or minimize contamination of the suction catheter prior to use. This is generally referred to as a “closed suction catheter” and is available under the tradename TRACH CARE® from BALLARD® Medical Products (Kimberly-Clark Corporation). Closed suction systems are generally preferred by healthcare providers because they are less likely to spread infection to the patient and the healthcare provider. The present respiratory access port assembly10is desirably used with such a closed suction assembly130.

It will be understood that the suction catheter assembly130may be coupled to either the first or the second cuff54,63of the first or second ports50,52, respectively. Similarly, a bronchoscope, or other instrumentation, and so forth, may be releasably coupled to one of the first or second cuffs54,63of the first or second ports50,52, respectively, as well. It will be appreciated that the suction catheter136and suction catheter assembly130are maintained as a part of the closed circuit ventilation system at all times.

In a method of operation and use, a health care provider grasps the manifold120which is coupled to the cuff20of the port16of the distal plate12. The health care provider also grasps the collar108which is coupled to the outer surface110of the perimeter wall66of the proximal plate14and rotates the proximal plate14such that the cuff20and port16of the distal plate12aligns with the first cuff54and first port50of the proximal plate14. The tab or stop98on the distal surface96of the base88is positioned within the semi-circular indentation44on the proximal surface24of the distal plate12. The tab or stop98cooperates with the circular portion78to limit rotation of the distal and proximal plates12,14to no more than about 200 degrees relative to each other. Therefore, if the ports16,50and their respective cuffs20,54are not aligned, a health care provider grasps the collar108and rotates the proximal plate14in a counterclockwise direction to its maximum point or rotation in order to permit alignment of the port16and cuff20of the distal plate12with the first port50and first cuff54of the proximal plate14, as illustrated inFIG. 1. Alternatively, it will be understood that the proximal plate14may be held by a health care provider while the distal plate12may be moved to its maximum point of rotation in a clockwise direction. However, the distal plate12and its port16and cuff20are coupled to the manifold120, which is coupled to a patient's artificial airway122, all of which is desirably maintained in a relatively fixed position. Therefore, it will be understood that it is more desirable to hold the distal plate12stationary while rotating the proximal plate14.

The phrase “stationary”, “stationary plate” and/or “stationary disk” desirably, but not by way of limitation, refers to either the proximal plate or the distal plate when that plate, or component holding that plate, is grasped by a health care provider and held in a relatively fixed “stationary” position while the opposite disk is rotated to one of the three pre-determined positions by a health care provider. Both plates may be relatively “stationary plates” as well when the plates are positioned and locked together in a fixed, unmoving position.

The phrase “rotating plate” and/or “rotating disk” desirably, but not by way of limitation, refers to either the proximal plate or the distal plate when the plates are unlocked, so that each may rotate relative to the other. The distal and proximal plates are configured to be positioned in three pre-determined positions. When un-locked, however, both distal and proximal plates are free to rotate relative to each other, and each plate may move or rotate in a direction opposite (up to about 200 degrees or less) relative to each other. Both plates may move or “rotate” as well when the plates are positioned in the un-locked position so that each plate is free to be rotate in opposite directions by a health care provider.

When the ports16,50and cuffs20,52of the distal and proximal plates12,14, respectively, are in an alignment, they are releasably held in this specific, predetermined position by the cooperation of the pair of tabs102on the leg100of the distal surface96of the base88and two of the plurality of ramped indentations46on the proximal surface24of the distal plate14. That is, each of the pair of tabs102on the leg100move into one of the plurality of ramped indentations46. The tabs102on the distal surface96of the leg100are on the base88, which is coupled to the proximal plate14, while the plurality (four) of the indentations46are formed on the proximal surface24of the distal plate12. Therefore, these components cooperate to releasably hold the distal and proximal plates12,14in a specific, predetermined position, that is, a first open position (FIGS. 1 and 13). In the first open position the ports16,50and cuffs20,54, respectively, are in an axially aligned position.

The term and phrase “open” and “open position” and variations thereof, desirably, but not by way of limitation, refers to a position of the aligned ports described herein to permit an object, such as a suction catheter, a portion of a bronchoscope, and so forth, move through the aligned ports and into a portion of a patient's respiratory tract.

Since the suction catheter assembly130is desirably coupled to the first cuff54of the first port50, the suction catheter134may be advanced through the aligned ports16,50and cuffs20,54, respectively, through the manifold120and the artificial airway122into at least a portion of a patient's respiratory tract to suction secretions therefrom. If a health care provider attempts to move the distal and proximal plates12,14relative to each other into another position while the suction catheter (or other object) is positioned through the ports16,50of the distal and proximal plates12,14, respectively, one or more components act to prevent movement of the plates12,14, thereby, providing a passive lock.

First, if the health care provider attempts to move the distal and proximal plates12,14by grasping the manifold120and/or the distal plate12, and holding it/them in a stationary position while simultaneously grasping the collar108and moving or rotating the proximal plate14in a counter-clockwise direction, such movement is prevented by the stop98. The stop98on the base88(which is firmly coupled to the proximal plate14) is positioned in the semi-circular indentation44on the proximal surface24of the distal plate12. The semi-circular indentation44limits the rotation of the distal and proximal plates12,14relative to each other. These components cooperate to prevent further rotation in a counter-clockwise direction.

Second, if the healthcare provider attempts to move or rotate the proximal plate14in a clockwise direction relative to the distal plate12, the suction catheter134is pressed against the flange84of the pawl74which is adjacent the first port and first cuff50,54, respectively. This pressure moves the flange84and therefore the pawl74, and causes at least some of the plurality of teeth82of the pawl74to engage at least some of the plurality of teeth32on the inner surface30of the perimeter wall28of the distal plate12, as illustrated inFIG. 12. The teeth82of the pawl74, which is coupled to the base88and to the proximal plate14via the base88, engage and interlock with the teeth32of the distal plate12. This engagement thereby substantially prevents clockwise movement of the proximal plate14relative to the distal plate12. That is, while some very limited movement of the distal and/or proximal plate12,14may occur, such movement does not substantially affect the alignment of the port16and first port50or the ability to move the suction catheter134through the ports16,50, because no substantial movement is allowed. Therefore a passive lock is provided by the cooperation of these components, which substantially prevents movement of the distal and proximal plates12,14. A health care provider is thereby prevented from inadvertently moving the distal and proximal plates12,14when the suction catheter136is positioned through the aligned ports15,50. Such a move, absent such a passive safety lock, would be likely to guillotine a distal portion of the suction catheter136, which could be catastrophic to the patient. This passive lock is disengaged when the suction catheter136is completely withdrawn from the aligned ports16,50of the assembly10, as illustrated inFIG. 11. This withdrawal permits the plurality of teeth82on the pawl74to move away from and disengage from the plurality of teeth32on the inner surface30of the perimeter wall28of the distal plate12. Therefore, the proximal plate14is now permitted to rotate in a clockwise direction relative to the distal plate12. Alternatively, it will be understood that the distal plate12may now also be rotated in a counter-clockwise direction relative to the proximal plate14.

The assembly10may be moved into a second open position, illustrated inFIG. 14, when the proximal plate14is moved or rotated relative to the distal plate12(which is again desirably grasped in a relatively stationary position by the health care provider for reasons stated previously herein) in a clockwise direction to its maximum point or rotation in order to permit alignment of the port16and cuff20of the distal plate12with the second port52and second cuff62of the proximal plate14. This position is a second selected, predetermined position, which provides an axial alignment of the ports16,52and respective cuffs20,62of the distal and proximal plates12,14. The tab or stop98on the distal surface96of the base88(which is coupled to the proximal plate14) is positioned within the semi-circular indentation44on the proximal surface24of the distal plate12. The stop98cooperates with the semi-circular indentation44to limit rotation of the distal and proximal plates12,14to no more than about 200 degrees relative to each other. Therefore, the second position is as far as the healthcare provider can rotate the proximal plate14in the clockwise direction relative to the distal plate12, since the stop98and the semi-circular indentation44cooperate to limit further rotation. When the ports16,52and cuffs20,62of the distal and proximal plates12,14, respectively, are in an axial alignment, they are releasably held in this specific, predetermined position by the cooperation of the pair of tabs102on the leg100of the distal surface96of the base88and two of the plurality of ramped indentations46on the proximal surface24of the distal plate14. That is, each tab102on the leg100moves into one of the plurality of ramped indentations46. The tabs102are on the base88, which is coupled to the proximal plate14. The two indentations46are formed on the proximal surface24of the distal plate12. Therefore, these components cooperate to releasably secure the distal and proximal plates12,14in another specific, predetermined position. That is, these components cooperate to secure the assembly10in the second open position. In this position, a bronchoscope, or other instrument or object, may be introduced through the aligned port16and second port52of the distal and proximal plates12,14or the assembly10, through the manifold120, into the artificial airway122and into a portion of a patient's respiratory tract (not shown). It will be appreciated that, as described in detail above for the first open position, if a heath care provider attempts to move the distal and proximal plates12,14while an object, such as, for example only, a portion of a bronchoscope is positioned through the aligned ports16,52and cuffs20,62, respectively, the assembly10is positioned in a passive locked position which substantially prevents movement of the distal and proximal plates12,14.

The phrase “substantially prevent movement,” and variations thereof, desirably, but not by way of limitation, refers to movement of the plates when a port of the distal plate is aligned with a port of the proximal plate, and an object is positioned through the aligned ports. The plates may have some slight movement which permits some slight misalignment, but the ports remain substantially aligned so that an object which is passed through the ports is not pinched off or closed by the slight misalignment, and the object may still be moved through the ports.

Again, one or more components, and desirably, but not by way of limitation, two components cooperate to prevent movement of the distal and proximal plates12,14, thereby again providing a passive lock for the assembly10, when an object is positioned through the aligned port16and second port52of the distal and proximal plates12,14. First, if the health care provider attempts to move the distal and proximal plates12,14by grasping the manifold120and/or the distal plate12, and holding it/them in a stationary position while simultaneously grasping the collar108and moving or rotating the proximal plate14in a clockwise direction, such movement is prevented by the stop98. The stop98on the base88(which is firmly coupled to the proximal plate14) is positioned in the semi-circular indentation44on the proximal surface24of the distal plate12. The semi-circular indentation44limits over-rotation of the distal and proximal plates12,14relative to each other. These components cooperate to prevent further rotation of the proximal plate14in the clockwise direction.

Second, if the healthcare provider attempts to move or rotate the proximal plate14in a counter-clockwise direction relative to the distal plate12when the ports16,52of the distal and proximal plates12,14, respectively are aligned, the portion of the bronchoscope or object (not shown) is pressed against the flange84of the pawl74which is adjacent the second port52and second cuff62. This pressure moves the flange84and its pawl74, and causes at least some of the plurality of teeth82of the pawl74to engage at least some of the plurality of teeth32on the inner surface30of the perimeter wall28of the distal plate12, as illustrated inFIG. 12. The teeth82of the pawl74, which is coupled to the proximal plate14, engage and interlock with the teeth32of the distal plate12, thereby substantially preventing counter-clockwise movement of the proximal plate14relative to the distal plate12. That is, while some very limited movement of the distal and/or proximal plate12,14may occur, such movement does not substantially affect the alignment of the ports16,52or the ability to move the suction catheter134through the ports16,52, because no substantial movement is allowed. Therefore a passive lock is provided by the cooperation of these components, which substantially prevents movement of the distal and proximal plates12,14.

A health care provider is thereby prevented from inadvertently moving the distal and proximal plates12,14when an object, such as a bronchoscope, a suction catheter, and so forth, is positioned through the aligned port16and second port52. Such a move, absent such a passive safety lock, would be likely to affect an object, for example, guillotine a distal portion of such an object, which again could be catastrophic to the patient. This passive lock is removed when the object (illustrated inFIG. 12as a suction catheter136) is completely withdrawn from the aligned ports16,52of the distal and proximal plates12,14of the assembly10. This withdrawal permits the teeth82on the pawl74to move away from and disengage from the teeth32on the inner surface30of the perimeter wall28of the distal plate12, as shown inFIG. 11. Therefore, the proximal plate14is now permitted to rotate in a counter-clockwise direction relative to the distal plate12. Alternatively, it will be understood that the distal plate12may also be rotated in a clockwise direction relative to the proximal plate14.

The first position with alignment of port16and cuff20with the first port50and first cuff54are desirably positioned, for example, but not by way of limitation, about 180 degrees apart from the second position, with alignment of port16and cuff20with second port52and second cuff62(FIG. 13). When the assembly10is positioned in the first position, the second port52and second cuff62are desirably blocked by a portion of the distal plate12. Similarly, when the assembly10is position in the second position, the first port50and first cuff54are also desirably blocked by a portion of the distal plate12(FIG. 14). Such blocking cooperates with other components, such as caps114, and so forth, to maintain PEEP pressure and to prevent confusion over which port is open by preventing introduction of an object, such as a suction catheter, bronchoscope, and so forth, into the blocked port.

The respiratory access assembly10may also include an additional predetermined position, such as a third selected position, as shown inFIG. 15. That is, the assembly10may include a third position which is a closed position for all ports16,50and52of the distal and proximal plates12,14. In this instance, but not by way of limitation, the closed position is provided between the first open position and the second open position. Therefore, the closed position is a position, for example, at about a 90 degree angle relative to the first position and the second position. When a health care provider moves or rotates the proximal plate14relative to the distal plate12between first and second open positions, the distal and proximal plates12,14are moved through the intermediate closed position. This third closed position is an optional position, since there is no danger of guillotining any portion of an object positioned in a port, since no ports are aligned to permit an object to be passed therethrough. This position may be utilized when no objects are positioned through any of the ports16,50,52. In the third position, the manifold120and/or a portion of the distal plate12is desirably held in a relatively stationary position, while the health care provider moves or rotates the proximal port either counter-clockwise (if the distal and proximal plates12,14were in the first position) or counter-clockwise (if the distal and proximal plates12,14were in the second position), until the port16of the distal plate12is positioned between the first port50and the second port52. The port16is then desirably position on the O-ring contained in the groove104on the distal surface96of the base88, which blocks and acts to seal the port16. In this position, a portion of the distal plate12blocks both the first port50and the second port52. The ports16,50and52are not locked in this position. However, the ports16,50, and52are releasably held in the selected, predetermined third closed position by the cooperation of the pair of tabs102on the leg100of the distal surface96of the base88and two of the plurality of ramped indentations46on the proximal surface24of the distal plate14. Again, each of the pair of tabs102on the leg100move into one of the plurality of ramped indentations46. The tabs102are on the base88, which is coupled to the proximal plate14. The two ramped indentations46are formed on the proximal surface24of the distal plate12. Therefore, these components cooperate to releasably secure the distal and proximal plates12,14into the third closed position. It will be understood that the ramped indentations hold the distal and proximal plates12,14in a position until sufficient pressure is applied by a health care provider to move or rotate one or both plates12,14, at which time the ramps on the indentations46permit the tabs102to move out of the indentations46. The health care provider may choose to move the plates12,14into the third closed position to assist in maintaining PEEP when the ports16,50, and52will not be used for a period of time.

The term and/or phrase “closed” or “closed position” and variations thereof, desirably, but not by way of limitation, refers to a position of one or more ports in which the port(s) are not aligned, so that no large object, such as a suction catheter, a portion of a bronchoscope, and so forth, may move through the referenced “closed” port(s). A port may be “closed” or “blocked” such that an object, such as those referenced previously, are blocked or prevented from moving through the port(s). The port may not be totally blocked or closed, however, and gases and/or liquid may, in at least some instances, continued to move through a blocked or closed port.

Certain components herein have been described and shown at certain angles. However, it will be understood that any component may be positioned at any angle or any combination of angles, so long as the assembly operates as shown and/or described herein.

It will also be understood that curved or arched plates, convex or concave disks or plates, or flat or planar disks or plates may be used herein. Further, the disks or plates may comprise any configuration, so long as they operate as shown and/or described herein. Similarly, the disks or plates may move in varying ways, that is, the disks or plates may rotate, pivot, slide, and move in any manner, and so forth, relative to each other, so long as they operate to achieve the result(s) as shown and/or described herein.

If the distal and proximal plates are flat, square or rectangular plates (not shown), it will be appreciated that the distal and proximal plates may be positioned to slide relative to each other. In such an embodiment, but not by way of limitation, the base and pawls may be configured differently to accommodate sliding, and more than one base may be provided with one or more pawls. More than one stop may be provided to limit the movement of the plates relative to each other. The distal plate may have more than one line of teeth. The distal and/or proximal plate may have one or more, fingers, teeth, grooves, rails, ribs, and so forth. That is, the distal and/or proximal plate may have structural features which permit an interlock with each other. One skilled in the art will understand the modifications which will be required to implement this and other alternative embodiments.

Further, it will be appreciated that a rod, block, or any device known in the art, and so forth, may take the place of the pawl. Such a device would be movable so that it may be frictionally positioned against a portion of a plate wall to prevent movement of at least one plate relative to the other. Such a plate wall may itself contain a roughened area or frictional elements, such as teeth, bars, and so forth. Alternatively, the plate wall may include a frictional component, such as at least a portion of an O-ring, ribs, teeth, and so forth, in which the device would be frictionally positioned against to prevent movement of at least one plate.

The assembly10may include more than one port and cuff on the distal disk or plate, and more than two ports and cuffs on the proximal disk or plate (not shown). In addition, the assembly10may include the manifold120, or any other manifold known in the art. Further, the assembly10may include a suction catheter assembly130, or any other suction catheter assembly known in the art. In a further alternative, the assembly10may include both a manifold as well as a suction catheter assembly.

The phrase “operable communication” desirably, but not by way of limitation, refers to a transmission or passage between two points and/or two structures for a specific purpose. In this example, operable communication would be a passage which permits gasses and/or liquid(s) to pass, and may also be configured to permit objects to pass.

The terms “comprise,” “comprises,” “comprising” and other derivatives from the root term “comprise” desirably, but not by way of limitation, are intended to be open-ended terms that specify the presence of any stated features, elements, integers, steps, or components, but do not preclude the presence or addition of one or more other features, elements, integers, steps, components, or groups thereof. Similarly, the terms “include”, “includes”, “including,” as well as the terms “has”, “have”, “having”, “is” and derivatives thereof, are intended to be interpreted as the word “comprise”, and are intended to be open-ended terms that specify the presence of any stated features, elements, integers, steps, or components, but do not preclude the presence or addition of one or more other features, elements, integers, steps, components, or groups thereof.