Medical apparatus with hypopharyngeal suctioning capability

A laryngeal mask apparatus includes a mask portion, a breathing tube and a suction tube. The suction tube is adapted for connection to a suction-producing device. The suction tube further includes suction ports that suck fluids and secretions from the patient's hypopharyngeal region when suction is created within the interior of the suction tube. The breathing tube is adapted for connection to a ventilating system. Air flows through the breathing tube and into the mask portion. A capillary tube is positioned within the interior of the suction tube. When the mask portion is positioned within a patient's throat and suction is created within interior of the suction tube, the suction ports suck the fluids and secretions in the patient's hypopharyngeal region. At the same time, the suction tube and capillary tube cooperate to provide a stream of air that decreases the direct suction forces on the mucosa of the patient's throat that are caused by the suction ports. The laryngeal mask apparatus includes a scope tube having an interior and an inner tube disposed within the interior of the scope tube. The inner tube is sized for receiving a gastric tube.

TECHNICAL FIELD

The present invention generally relates to nasogastric tubes and laryngeal masks.

BACKGROUND ART

Nasogastric tubes and related devices are described in U.S. Pat. Nos. 5,643,230, 5,417,664, 5,011,474, 5,000,175, 4,821,715, 4,787,894, 4,735,607, 4,699,138, 4,508,533, and 4,214,593. Nasogastric tubes and related devices are also described in the following patents and published patent applications: EP 0500778, JP 10179677, WO 9716154, WO 9631248, and WO 8000538.

Nasogastric tubes are used to aspirate food contents from the stomach or to feed patients who are unable to safely feed themselves. Nasogastric tubes are commonly used in the operating room, intensive care units, home care, and in hospice settings. Prior art nasogastric tubes are frequently used to aspirate stomach contents. However, in some cases, aspiration of the stomach contents results in micro-aspirations that can cause nosocomial infections.

Similar problems can occur with prior art laryngeal masks. Laryngeal masks are used to provide ventilation and are commonly used in the operating room and in situations where it is difficult to insert an endotracheal tube. Prior art laryngeal masks and related devices are described in U.S. Pat. Nos. 4,351,328, 4,509,514, 4,995,388, 5,241,956, 5,303,697, 5,355,879, 5,632,271, 5,878,745, 6,631,720 and 6,895,966 and in published international patent application No. WO 1994/02191. A disadvantage of prior art laryngeal masks is that there is no protection from aspiration into the lungs of gastric contents or saliva regurgitated into the hypopharynx and pharynx.

DISCLOSURE OF THE INVENTION

The present invention is directed to, in one aspect, a medical apparatus comprising a nasogastric tube with hypopharyngeal suctioning capability. An important feature of the medical apparatus of the present invention is that it includes a suction intake in the area of the hypopharynx which effects capturing microaspirations as well as larger regurgitated material that reaches the hypopharynx. A significant advantage of the present invention is that it reduces infection rates in intubated patients.

In one aspect, the present invention is directed to laryngeal mask apparatus (2000) comprising a mask (2001) comprising a front side (2002) and a rear side (2004) that faces the back of a patient's throat when the mask (2001) is positioned within a patient's throat. The mask (2001) include an inflatable tubular ring (2005) and an inner spatial region (2005A) that is surrounded by the inflatable tubular ring (2005). The mask (2001) has a front end (2007) and an opening in front end (2007) which extends to the inner spatial region. The laryngeal mask apparatus (2000) further includes an air tube (2012) that is connected to the inflatable tubular ring (2005) and adapted to be connected to an air source to enable inflation of the inflatable tubular ring (2005). A joint section (2006) is attached to the rear side (2004) of mask (2001) and has an exterior surface. A flexible breathing tube (2010) is connected to the joint section (2006). The flexible breathing tube (2010) has an interior (2011) for the flow of air therethrough, wherein air in flexible breathing tube (2010) can flow through the flexible breathing tube (2010) and through the joint section (2006) and into the mask (2001). The flexible breathing tube (2010) includes a portion configured for connection to a ventilating system. An additional flexible tube (2018) is attached to the exterior surface of the flexible breathing tube (2010) and has an interior (2019), a first portion (2018A) and a second portion (2018B) that is configured to be connected to a suction producing device that produces suction within interior (2019). A portion of first portion (2018A) is wrapped about and attached to the exterior surface of joint section (2006), wherein the additional flexible tube (2018) extends to a distal end (2018C). The distal end (2018C) is part of first portion (2018A). The first portion (2018A) has a plurality of suction ports (2009) in communication with the interior (2019) of additional flexible tube (2018). The suction ports (2009) are located in the first portion (2018A) such that the suction ports (2009) face the back of the patient's throat when the mask (2001) is positioned within a patient's throat so that the suction ports (2009) suck in fluids and secretions in a patient's hypopharyngeal region when suction is created within interior (2019). The additional flexible tube (2018) further comprises an air entry hole (2050) in the second portion (2018B) and an air exit hole (2060) in the first portion (2018A). The section of first portion (2018A) that has the distal end (2018C) and the air exit hole (2060) is not attached to the exterior surface of joint section (2006) or mask (2001) but is spaced apart from mask (2001) to ensure that the air exit hole (2060) is not blocked by any portion of the mask (2001). The additional flexible tube (2018) includes a flexible air capillary tube (2020) that is positioned within the interior (2019) of additional flexible tube (2018) and which extends for substantially the entire length of the additional flexible tube (2018). The air capillary tube (2020) has a first open end in communication with the air entry hole (2050) and an opposite second open end in communication with the air exit hole (2060). When suction is created within interior (2019), air is drawn into air entry hole (2050) and enters first open end of air capillary tube (2020) wherein the air then flows through air capillary tube (2020), exits the opposite second open end and then exits air exit hole (2060), such that when the mask (2001) is positioned within a patient's throat and suction is created within interior (2019), the air exiting air exit hole (2060) decreases the direct suction forces on the mucosa of the patient's throat that are caused by suction ports (2009). The laryngeal mask apparatus (2000) further includes a scope tube (2500) attached to the flexible breathing tube (2010) and having a first end that is attached to the joint section (2006) and an opposite second end. The scope tube (2500) includes an interior and an inner tube (2510) that is disposed within the interior of the scope tube (2500). The inner tube (2510) extends through the scope tube (2500) and inner spatial region (2005A) and is joined to the opening (2008) in the front end (2007) of the mask (2001). The inner tube (2510) is sized for the passage therethrough of a gastric tube.

In accordance with one embodiment of the invention, the medical apparatus comprises a flexible nasogastric tube for insertion through a patient's nose. The nasogastric tube has a first end and a distal, second end that defines an opening. The nasogastric tube has a length sufficient to allow the opening to be positioned in a patient's stomach. The medical apparatus further comprises a flexible oropharyngeal tube for insertion through a patient's mouth. The oropharyngeal tube has a first end and a distal, second end that defines a suction intake. The oropharyngeal tube has a length that is less than the length of the nasogastric tube and which allows the suction intake to be positioned in a patient's hypopharynx region. The medical apparatus further comprises a section of tube joined to and in communication with the flexible nasogastric and oropharyngeal tubes. The section of tube is configured to be joined to a suction apparatus that creates suction within the oropharyngeal tubes. This suction causes microaspirations and regurgitated material in the hypopharynx region to be sucked into the suction intake of the oropharyngeal tube.

In another aspect, the present invention is related to a medical apparatus comprising a laryngeal mask and a suction tube attached to the laryngeal mask. The suction tube includes a plurality of suction ports or intakes that suck oropharyngeal secretions from the patient's mouth and the back of the patient's throat. Thus, in one embodiment, this medical apparatus comprises a laryngeal mask having a front side and rear side wherein the rear side faces the back of a patient's throat when the laryngeal mask is used in a patient, and a flexible suction tube attached to and extending along the rear side of the laryngeal mask. The suction tube comprises a plurality of suction ports or intakes for suctioning oropharyngeal secretions from the patient's mouth and back of the patient's throat and has an opening that is configured to be connected to an apparatus for producing suction within the flexible suction tube.

In a further aspect, the present invention is directed to a laryngeal mask apparatus (1000) for facilitating ventilation of a patient, comprising a mask (1001) comprising a front side (1002) and a rear side (1004) that faces the back of a patient's throat when the mask (1001) is positioned within a patient's throat, and a flexible breathing tube (1010) that has an interior (1011) for the flow of air. The flexible breathing tube (1010) is in communication with the mask (1001). A joint section (1006) is attached to the rear side (1004) of the mask portion (1001). The flexible breathing tube (1010) is connected to the joint section (1006) so that air in flexible breathing tube (1010) can flow through the joint section (1006) and into the mask (1001). The flexible breathing tube (1010) is configured for use with a ventilating system. The laryngeal mask apparatus (1000) further comprises an additional flexible tube (1018) comprising an interior (1019), a first portion (1018A) and a second portion (1018B) that is configured to be connected to a device that facilitates creation of suction within interior (1019). A substantial portion of first portion (1018A) is joined or attached to the exterior surface of joint section (1006). The additional flexible tube (1018) extends to a distal end (1018C) which is part of the first portion (1018A). The first portion (1018A) has a plurality of suction ports (1009) in communication with the interior (1019). The suction ports (1009) are located on the first portion (1018A) such that the suction ports (1009) face the back of the patient's throat when the mask (1001) is positioned within a patient's throat so that the suction ports (1009) suck in fluids and secretions in a patient's hypopharyngeal region when suction is created within interior (1019). The additional flexible tube (1018) further comprises an air entry hole (1050) in the second portion (1018B) and an air exit hole (1060) in the first portion (1018A). The section of first portion (1018A) having distal end (1018C) and air exit hole (1060) is not joined or attached to joint section (1006) or rear side (1004) of mask (1001), but instead is spaced apart from mask (1001) such that air exit hole (1060) is not blocked by mask (1001). The additional flexible tube (1018) further comprises a flexible air capillary tube (1020) that is located within the interior (1019) of additional flexible tube (1018). The flexible air capillary tube (1020) includes a first open end (1020A) that is in communication with the air entry hole (1050) and a second open end (1020B) that is in communication with the air exit hole (1060). When suction is created within interior (1019), air is drawn into air entry hole (1050) and enters first open end (1020A) of air capillary tube (1020) wherein the air then flows through air capillary tube (1020), exits second open end (1020B) and then exits air exit hole (1060), whereby when the mask (1001) is positioned within a patient's throat and suction is created within interior (1019), the air exiting air exit hole (1060) decreases the direct suction forces on the mucosa of the patient's throat.

In one embodiment, the aforementioned substantial portion of first portion (1018A) is also joined or attached to the rear side (1004) of mask (1001).

The additional tube (1018) has a middle portion that is between first portion (1018A) and the second portion (1018B). The middle portion is joined or attached to the flexible breathing tube (1010).

The laryngeal mask apparatus (1000) further comprises a suction tube connector (1024) that is connected to the second portion (1018B) of additional flexible tube (1018). The suction tube connector (1024) further comprises a suction enablement device (1025) to enable creation of suction within interior (1019).

Mask (1001) further comprises an inflatable tubular ring (1005). The laryngeal mask apparatus (1000) further comprises an air tube (1012) that is connected to the inflatable tubular ring (1005) and, when connected to an air source, provides an air stream that inflates inflatable tubular ring (1005). The laryngeal mask apparatus (1000) further comprises a connector (1026) that has a first portion (1028) that is inserted into the flexible breathing tube (1010) and a second portion (1030) that is configured for connection to a ventilating system that provides air or oxygen or anesthesia.

In a further aspect, the present invention is directed to a laryngeal mask apparatus (1000) for facilitating ventilation of a patient, comprising a mask (1001) that comprises a front side (1002) and a rear side (1004) that faces the back of a patient's throat when the mask (1001) is positioned within a patient's throat. The laryngeal mask apparatus (1000) further comprises a flexible breathing tube (1010) having an interior (1011) for the flow of air, and a joint section (1006) that is joined or attached to the rear side (1004) of the mask (1001). The flexible breathing tube (1010) is connected the joint section (1006) so that air in the flexible breathing tube (1010) flows through the joint section (1006) and into the mask (1001). The flexible breathing tube (1010) is configured for use with a ventilating system. The laryngeal mask apparatus (1000) further comprises an additional flexible tube (1018) that comprises an interior (1019), a first portion (1018A) and a second portion (1018B) that is configured to be connected to a device that facilitates creation of suction within interior (1019). A substantial portion of first portion (1018A) is joined or attached to the exterior surface of joint section (1006). The additional flexible tube (1018) extends to a distal end (1018C) which is part of the first portion (1018A). The first portion (1018A) has a plurality of suction ports (1009) in communication with the interior (1019). The suction ports (1009) are located on the first portion (1018A) at particular positions such that the suction ports (1009) face the back of the patient's throat when the mask (1001) is positioned within a patient's throat so that the suction ports (1009) suck in fluids and secretions in a patient's hypopharyngeal region when suction is created within interior (1019). The additional flexible tube (1018) further comprises an air entry hole (1050) in the second portion (1018B) and an air exit hole (1060) in the first portion (1018A). The additional flexible tube (1018) further comprises a flexible air capillary tube (1020) that is located within the interior (1019) of additional flexible tube (1018). The flexible air capillary tube (1020) includes a first open end (1020A) that is located so that it is near the air entry hole (1050) and a second open end (1020B) that is located so that it is near the air exit hole (1060). When suction is created within interior (1019), air is drawn into air entry hole (1050) and enters first open end (1020A) of air capillary tube (1020) wherein the air then flows through air capillary tube (1020), exits second open end (1020B) and then exits air exit hole (1060), whereby when the mask (1001) is positioned within a patient's throat and suction is created within interior (1019), the air exiting air exit hole (1060) decreases the direct suction forces on the mucosa of the patient's throat. In one embodiment, the aforementioned substantial portion of first portion (1018A) is also joined or attached to rear side (1004) of mask (1001). In one embodiment, the additional flexible tube (1018) has a middle portion that is between first portion (1018A) and the second portion (1018B). The middle portion is joined or attached to the flexible breathing tube (1010).

DETAILED BEST MODE FOR CARRYING OUT THE INVENTION

It is to be understood that throughout this description, terms such as “vertical”, “horizontal”, “top”, “bottom”, “upper”, “lower”, “middle”, “above”, “below”, and the like are used for convenience in identifying relative locations of various components and surfaces relative to one another in reference to the drawings and that the medical apparatus may be installed and used in substantially any orientation so that these terms are not intended to be limiting in any way. Approximating language, as used herein throughout the specification and claims, may be applied to modify any quantitative representation that could permissibly vary without resulting in a change in the basic function to which it is related. Accordingly, a value modified by a term or terms, such as “about”, are not limited to the precise value specified.

Referring toFIG. 1, there is shown a diagrammatic view of one embodiment of the medical apparatus of the present invention. This medical apparatus, generally indicated by reference numeral10, comprises tube structure12. Tube structure12comprises nasogastric tube section14and oropharyngeal tube section16. The interior of nasogastric tube section14is known as the lumen. Similarly, the interior of oropharyngeal tube section16is known as the lumen. Nasogastric tube section14and oropharyngeal tube section16are joined together at tube section18so as to form a generally “Y” shaped configuration. Tube section18is configured to be connected to tube section20. Tube section20is configured to be connected to an external apparatus21(shown in phantom). For example, such external apparatus21can be a suction apparatus for creating suction within tube structure12. In another example, the aforesaid external apparatus can be a food source for feeding a patient that is unable to feed himself or herself.

As shown inFIG. 1, nasogastric tube section14has a sufficient length that allows it to be inserted through the patient's nose30, through the hypopharnyx region40(which is just below epiglottis42) and into the patient's stomach50. Nasogastric tube section14has opening60that is located in the patient's stomach50. When tube section20is connected to suction apparatus21, the opening60functions as a suction intake that effects aspiration of food contents from the stomach. As a result of the suction, the aspirated food contents travel through nasogastric tube section14and into a container (not shown) in suction apparatus21. On the other hand, if tube section20is connected to a food source, then opening60functions as an output for this food.

As shown inFIG. 1, oropharyngeal tube section16is inserted through the patient's mouth52and has a length that is relatively shorter than the length of nasogastric tube section14. Oropharyngeal tube section16has suction intake70. The length of oropharyngeal tube section16is such that suction intake70is positioned in hypopharynx region40. When tube section20is connected to suction apparatus21, suction intake70of oropharyngeal tube section16sucks in microaspirations and regurgitated material located in hypopharynx region40thereby removing such microaspirations and regurgitated material from hypopharynx region40. Such microaspirations and regurgitated material travel through oropharyngeal tube section16and into the aforesaid container (not shown) in suction apparatus21. Thus, suction intake70substantially reduces the risk of infection due to aspirations from the stomach50moving into the mouth52.

In one embodiment, nasogastric tube section14and oropharyngeal tube section16are fabricated from commercially available flexible, soft plastic material, similar to the material used to fabricate conventional endotracheal tubes. In one embodiment, preferably, the internal diameter of such commercial plastic tubing is between about 5 mm and 10 mm.

Referring toFIG. 2, there is shown medical apparatus100in accordance with another embodiment of the present invention. Medical apparatus100comprises tube structure102. Tube structure102comprises nasogastric tube section104, nasopharyngeal tube section106, and tube section108. Nasogastric tube section104and nasopharyngeal tube section106are joined together at tube section108so as to form a generally “Y” shaped configuration. Both nasogastric tube section104and nasopharyngeal tube section106are inserted through the patient's nose30. Tube section108is configured to be connected to tube section110. Tube section110is configured to be connected to an external apparatus (not shown). For example, such an external apparatus can be a suction apparatus such as suction apparatus21described in the foregoing description. Such a suction apparatus produces suction within tube structure102. Thus, tube section108and tube section110have the same structure and perform the same functions as tube section18and tube section20, respectively, of medical apparatus10described in the foregoing description. Nasogastric tube section104has opening160. Nasogastric tube section104has a length that ensures that opening160is positioned in the patient's stomach50. Nasogastric tube section104performs the same function as nasogastric tube section14(seeFIG. 1). Nasopharyngeal tube section106has suction intake170. Nasopharyngeal tube section106has a predetermined length that is less than the length of nasogastric tube section104. This predetermined length of nasopharyngeal tube section106allows suction intake170to be positioned in the patient's hypopharynx region40. Suction intake170performs the same function as suction intake70of oropharyngeal tube section16shown inFIG. 1. When the aforementioned suction apparatus is connected to tube section110, suction intake170sucks in microaspirations and regurgitated material located in hypopharynx region40thereby removing such microaspirations and regurgitated material in hypopharynx region40. Thus, suction intake170substantially reduces the risk of infection due to aspirations from stomach50moving into mouth52.

Referring toFIGS. 3A-D, there is shown medical apparatus300in accordance with a further embodiment of the present invention. Medical apparatus300comprises tube structure302which is configured to be inserted through the patient's nose30. Tube structure302comprises an outer tube304and an inner conduit306. Thus, inner conduit306is positioned within outer tube304. In one embodiment, as shown inFIG. 3B, inner conduit306is a tube having an outer surface308. In such an embodiment, outer surface308is attached to inner surface310of outer tube304. In another embodiment, inner conduit306is integrally formed with outer tube304during the manufacture of tube structure302. Outer tube304includes openings320and322. The length of outer tube304is such that opening322is located in the patient's stomach50. Opening322serves the same purpose as opening60(seeFIG. 1) and opening160(seeFIG. 2). As shown inFIGS. 3A and 3C, the length of inner conduit306is less than the length of outer tube304. Tube structure302has a predetermined length that allows opening320to be located in the patient's hypopharynx region40. Inner conduit306includes opening330that is aligned and in communication with opening320in outer tube304. Opening330functions as a suction intake port or opening.

Referring toFIG. 3A, tube structure302has end332. Outer tube304has opening334that is adjacent to end332. Inner conduit306has opening336that is adjacent to end332. Medical apparatus300includes tube section340that is joined to end332of tube structure302. Tube section340serves the same purpose as tube section20(seeFIG. 1) and is configured to be connected to an external apparatus such as suction apparatus21described in the foregoing description. When a suction apparatus is connected to tube section340, suction is produced within tube structure302which results in microaspirations and regurgitated material located in hypopharynx region40to be sucked into opening330. Thus, microaspirations and regurgitated material in hypopharynx region40are removed thereby substantially reducing the risk of infection due to aspirations from stomach50moving into mouth52.

The medical apparatus shown inFIGS. 1-3Dprovides many important advantages. One such advantage is that the suction intake in hypopharynx region40captures microaspirations as well as relatively larger regurgitated material and particles that enter the hypopharynx. This feature reduces the risk of infection due to aspirations from the stomach moving into the mouth. This medical apparatus can be used during surgery for patients with any of the following conditions:

c) diabetes patients who have full stomachs;

d) pregnancy (enlarged abdomens and at risk for aspiration);

f) patients on medications that increase incidence of nausea and vomiting.

This medical apparatus also can be used in the ICU (Intensive Care Unit) for (i) intubated patients who have increased risk of microaspiration in the presence of a nasogastric tube and an endotracheal tube, such as patients with bowel obstruction, (ii) patients with total parental nutrition who are not intubated but require a nasogastric tube to prevent aspiration, and (iii) patients who have gastroparesis, cancer, diabetes, pregnancy and other conditions where patients have a full stomach and require a nasogastric tube.

In accordance with another embodiment of the invention, medical apparatus400, shown inFIGS. 4-7, is an improved laryngeal mask apparatus configured to effect suctioning the hypopharynx region. Medical apparatus400comprises laryngeal mask402and suction tube404. In an exemplary embodiment, laryngeal mask402is configured as the laryngeal mask described in U.S. Pat. No. 4,509,514, the disclosure of which patent is hereby incorporated by reference. Laryngeal mask402has a front side406and rear side408. Suction tube404is located at the rear side408of laryngeal mask402. In one embodiment, suction tube404is integrally formed with laryngeal mask402during the manufacture of medical apparatus400. In another embodiment, suction tube404is a separate component that is attached to the rear side408of laryngeal mask400. In such an embodiment, any suitable technique can be used to attach suction tube404to rear side408of laryngeal mask400. Laryngeal mask402comprises flexible breathing tube410and mask portion412with an inflatable tubular ring414. Inflatable tubular ring414has distal end415. Suction tube404is preferably fabricated from soft plastics material, similar to that conventionally used for endotrachael tubes. Suction tube404comprises a rear side that is attached to rear side408of laryngeal mask402. Suction tube404includes front side422. Suction tube404further includes tube sections430and440that are joined together at middle tube section450. Sections430and440are attached to the rear side of mask portion412. Suction tube404further includes tube section460that is connected to middle tube section450and extends along the rear side of flexible breathing tube410. Each tube section430and440has a plurality of suction ports470formed on front side422. Suction tube404has end portion480that defines opening482. End portion480is configured to be connected to a suction hose (not shown) that is connected to an external suction apparatus (not shown) such as suction apparatus21described in the foregoing description.

Referring toFIG. 7, when in use, medical apparatus400is inserted into the patient's mouth500and down through the patient's throat502past the epiglottis504until mask portion412comes to rest with distal end415of inflatable ring414in the base506of throat502, lying against the upper end of the normally closed esophagus508. Suction ports470face the back of throat502. Inflatable ring414is then inflated as shown to seal around inlet514to larynx516. The patient's airway is thus secure and unobstructed and flexible tube410is then connected directly to the conventional anesthetic circuit hosing for either positive pressure or spontaneous breathing. End portion480of suction tube404is then connected to a suction apparatus to allow suction ports470to suck oropharyngeal secretions from the mouth and the back of the throat502. Such secretions are made not only from the patient's stomach, but also from the salivary glands in the mouth.

Medical apparatus400provides a laryngeal mask with increased versatility which can be used in many situations including patients with gastroesophageal reflux disease, gastric obstruction, diabetes with full stomachs and cancer (e.g. poor digestion, enlarged abdomen, nausea and vomiting). The laryngeal mask of the present invention can be used by patients during pregnancy (e.g. enlarged abdomen and at risk of aspiration).

Referring toFIGS. 8, 9 and 10, there is shown medical apparatus600in accordance with another embodiment of the invention. Medical apparatus600is configured for the situation wherein continuous suction is necessary. As will be shown by the ensuing discussion, medical apparatus600prevents collapse of the hypopharynx and stomach walls while continuous suctioning is occurring and also prevents damage to stomach and hypopharynx tissues. Medical apparatus600generally comprises nasogastric tube structure610. Nasogastric tube structure610comprises suction tube612and air tube614. Suction tube612and air tube614are joined together at end portion616. End portion616defines opening617. Opening617is in communication with suction tube612and air tube614. In one embodiment, the portions of suction tube612and air tube614that extend from end portion616are attached together until they exit the patient's body. The length of nasogastric tube structure610is such that end portion616is positioned in stomach50. Suction tube612has suction intakes618. Suction tube612and air tube614separate outside of the patient's body in order to allow these two tubes to be connected to separate medical equipment. Suction tube612is joined to tube section620and air tube614is joined to air source622.

Medical apparatus600further comprises oropharyngeal tube structure630. Oropharyngeal tube structure630includes suction tube632and air tube634which are joined at end portion636. End portion636defines opening637. Oropharyngeal tube structure630includes suction intakes638. Oropharyngeal tube structure630has a predetermined length that is shorter than the length of tube structure610thereby allowing end portion636to be positioned in hypopharynx region40. The portions of suction tube632and air tube634that extend from end portion636are attached together until these tubes exit the patient's body. Suction tube632is joined to tube section620. Air tube634is connected to air source640. Tube section620is joined to intermediate tube section642. Intermediate tube section642is connected to a suction apparatus644. Air source622provides air to air tube614. This air exits air tube614at opening617. Air source640provides air to air tube634. Such air exits air tube634at opening637in tube structure630. Suction apparatus644produces suction within suction tubes612and632. As a result of such suction, stomach contents are sucked into suction intakes618and microaspirations and regurgitated material and particles in hypopharynx region40are sucked through section intakes638. The air in air tube614prevents collapse of the stomach50and prevents suction intakes618from contacting and sucking the stomach walls. Thus, damage to the tissues of the stomach wall and mucosa is prevented. Similarly, the air in air tube634enters hypopharynx region40and prevents a collapse of the hypopharynx. This air also prevents suction intakes638from contacting and damaging the walls and tissues of the hypopharynx.

If low-level, continuous suctioning is needed in stomach50and high-level, continuous suctioning is needed in the hypopharynx, then air source622can be inactivated while air source640continues to provide air to air tube634. Similarly, if low-level, continuous suctioning is needed in hypopharynx region40and high-level, continuous suctioning is needed in stomach50, then air source622is activated and air source640is inactivated.

In another embodiment, nasogastric tube structure610is configured so that suction tube612, air tube614and end portion616are integral with each other. Similarly, in another embodiment, oropharyngeal tube structure630is configured so that suction tube632, air tube634and end portion636are integral with each other. In a further embodiment, nasogastric tube structure610is configured so that the air tube (e.g. air tube614) is positioned inside the suction tube (e.g. suction tube612). Similarly, in a further embodiment, oropharyngeal tube structure630is configured so that its air tube (e.g. air tube634) is positioned within the suction tube (e.g. suction tube632).

Referring toFIGS. 11 and 12, there is shown medical apparatus700in accordance with another embodiment of the invention. Medical apparatus700is configured to be used in a situation wherein continuous high-level suctioning is necessary. As will be shown by the ensuing discussion, medical apparatus700prevents collapse of the hypopharynx and stomach walls while continuous suctioning is occurring and also prevents damage to stomach and hypopharynx tissues. Medical apparatus700comprises outer tube702which is configured to be inserted either through a patient's mouth or patient's nose. Tube702has a distal end703and a predetermined length that allows end703to be positioned in a patient's stomach. Tube702comprises four separate conduits704,706,708and710which are not in communication with each other. Conduits704and708are suction conduits. Conduits706and710are air conduits. Tube702includes suction intakes or openings712that are in communication with suction conduit704. Suction intakes712are located a predetermined location along the length of tube702that correlates to the hypopharynx region of a patient when tube702is inserted in a patient. When suction is applied to suction conduit704, microaspirations and regurgitated material in the hypopharynx region are sucked through suction intakes712and up through conduit704and into an external suction apparatus as will be explained in the ensuing description. Tube702includes an opening or vent714. Air conduit706is in communication with opening714. When pressurized air is provided to air conduit706, such air is vented through opening714. The purpose of this configuration is explained in the ensuing discussion. Tube702also includes suction intakes or openings718. Suction conduit708is in communication with suction intakes718. When suction is applied to suction conduit708, stomach contents are sucked through suction intakes718and up through suction conduit708and into an external suction apparatus as will be explained in the ensuing description. As shown inFIG. 11, air conduit710has opening or vent720. When pressurized air is supplied to air conduit710, the pressurized air vents through opening720and into the patient's stomach.

Referring toFIG. 11, medical apparatus700further comprises tube sections730,732,734and736. Tube section730is joined to and in communication with conduit704. Tube section732is joined to and in communication with conduit706. Tube section734is joined to and in communication with conduit708. Tube section736is joined to and in communication with conduit710. Tube section730is configured to be connected to suction apparatus744. Tube section732is configured to be connected to pressurized air source742. Tube section734is configured to be connected to suction apparatus740. Tube section736is configured to be connected to pressurized air source738. Suction apparatuses740and744are separate apparatuses. In one scenario, one suction apparatus can provide high-level suction while the other suction apparatus can provide low-level suction. In another scenario, both suction apparatuses provide low-level suction. In a further scenario, both suction apparatuses provide high-level suction. Pressurized air sources738and742are separate air sources and each has an activated state and an inactivated state. Therefore, both pressurized air sources can be activated or inactivated or one pressurized source activated and the other pressurized air source inactivated.

When tube702is inserted into a patient and high-level suction of the stomach and hypopharynx is necessary, suction apparatuses744and740produce suction within suction conduits704and708, respectively. Stomach contents are sucked into suction intakes718, and microaspirations and regurgitated material in the hypopharynx region are sucked into suction intakes712. All material sucked into suction intakes712and718are sucked through conduits704and708, respectively, and into baskets or other containers inside suction apparatuses744and740, respectively. In order to prevent suction intakes712and718from damaging tissues in the hypopharynx and stomach, respectively, pressurized air sources742and738provide air to air conduits706and710, respectively. The pressurized air supplied to air conduit706is vented through opening714and the pressurized air provided to air conduit710is vented through opening720. As a result, the pressurized air vented through opening714keeps suction intakes712away from hypopharynx tissue, and the pressurized air vented through opening720keeps suction intakes718away from stomach tissue. If high-level suctioning is needed in the hypopharynx but only low-level suctioning is needed in the stomach, then pressurized air source738can be inactivated while pressurized air source742remains activated. Similarly, if low-level suctioning is needed in the hypopharynx but high-level suctioning is needed in the stomach, then pressurized air source742can be inactivated while pressurized air source738remains activated. In one embodiment, each conduit704,706,708and710is configured as a tube. In another embodiment, conduits704,706,708and710are integrally formed with tube702during the manufacturing process.

In one embodiment, tube702and conduits704,706,708and710are fabricated from the same materials used to fabricate the tubes of the medical apparatuses described in the foregoing description.

Referring toFIGS. 13, 14A, 15 and 16-24, there is shown laryngeal mask apparatus1000in accordance with a further embodiment of the invention. Laryngeal mask apparatus1000also suctions secretions and fluids in a patient's hypopharynx region. Laryngeal mask apparatus1000comprises mask or cuff portion1001. Mask or cuff portion1001comprises front side1002, rear side1004and inflatable tubular ring portion1005. Joint section1006is joined or attached to rear side1004of mask1001. In one embodiment, joint section1006has a generally tubular shape. Laryngeal mask apparatus1000comprises flexible breathing tube1010which is connected to joint section1006. Flexible breathing tube1010has interior region1011for the flow of air and is discussed in detail in the ensuing description. The air in flexible breathing tube1010flows through the flexible breathing tube1010and through joint section1006and into mask1001. Mask portion1001has end1007.

Laryngeal mask apparatus1000further comprises flexible tube1018that is joined or attached to the exterior surface of flexible breathing tube1010and extends to mask1001. Flexible tube1018comprises portion1018A. A substantial portion of portion1018A is wrapped about and joined or attached to the exterior surface of joint section1006. In another embodiment, the aforementioned substantial portion of portion1018A is joined or attached to both the exterior surface of joint section1006and the rear side1004of mask portion1001. In a further embodiment, the aforementioned substantial portion of portion1018A is joined or attached to rear side1004and positioned or wrapped about joint section1006. Portion1018A of tube1018has a plurality of suction ports or openings1009. Suction ports1009suck in the fluids and secretions in the patient's hypopharyngeal region as will be discussed in the ensuing description. Suction ports or openings1009are also shown inFIG. 19.FIG. 19is an enlarged view of the portion of the view ofFIG. 18that is encompassed by the dashed circle and indicated by the number19. As shown inFIG. 14A, tube1018has interior1019which is used for suction. Suction ports or openings1009are in communication with interior1019. Tube1018includes air hole1060that is in portion1018A of tube1018and in proximity to distal end1018C of tube1018. Tube1018further includes air hole1050that is in portion1018B of tube1018. Air hole1050functions as an air entry hole and air hole1060functions as an air exit hole. As shown inFIG. 15, the section of portion1018A that has distal end1018C and air hole1060is not joined or attached to joint section1006or mask1001, but instead, is spaced part from mask1001. This configuration ensures that air hole1060is not blocked by any portion of mask1001.

Additional flexible tube1018further comprises flexible air capillary tube1020that is located within interior1019and extends for substantially the entire length of tube1018. As shown inFIG. 14C, air capillary tube1020has first open end1020A and opposite second open end1020B.FIG. 14Cshows air capillary tube1020in a straight configuration for purposes of facilitating understanding of the invention. However, it is to be understood that air capillary tube1020is flexible and will conform to the shape of additional flexible tube1018. First open end1020A of air capillary tube1020is in communication with air hole1050. Opposite second open end1020B of air capillary tube1020is in communication with the air hole1060. When suction is created within interior1019, the suction pressure draws air into air hole1050. The air drawn into air hole1050enters first open end1020A of air capillary tube1020, flows through air capillary tube1020, exits opposite second open end1020B of air capillary tube1020and then exits air hole1060. The air exiting air hole1060enters the patient's hypopharyngeal region so as to decrease the direct suction forces on the mucosa in the hypopharyngeal region. Thus, a sump function is created by: (a) the suction within interior1019of tube1018that draws air into air hole1050and into the first open end1020A of air capillary tube1020, (b) the flow of the air through the air capillary tube1020, and (c) the flow of the air out of the second open end1020B of air capillary tube1020and out of the air hole1060.

In one embodiment, portion1018A is configured so that air hole1060faces the front of the patient's throat. In another embodiment, portion1018A is configured so that air hole1060faces the back of the patient's throat.

Suction tube connector1024is connected to portion1018B of tube1018. Thus, the interior of portion1018B is in communication with the interior of suction tube connector1024. Suction tube connector1024includes a suction enablement device1025. Suction enablement device1025includes stop member1025A and opening1025B. Stop member1025A is sized to be frictionally inserted into opening1025B. Stop member1025A must be inserted into opening1025B in order for suction to take place through interior1019of tube1018. Thus, if a suction producing device is connected to suction tube connector1024, suction through interior1019will not occur unless stop member1025A is plugged into opening1025B. Such a configuration ensures that the patient's throat or mouth is not over-suctioned. The stop member1025A is inserted into or removed from opening1025B by medical personnel. When stop member1025A is inserted into opening1025B and a suction producing apparatus is connected to suction tube connector1024, suction will be created throughout interior1019of tube1018which causes secretions and fluids to be sucked in through suction ports1009. Suction within interior1019of tube1018causes air to be drawn into air hole1050. As described in the foregoing description, the air that is drawn into the air hole1050then flows through air capillary tube1020, exits air hole1060and then enters the area being suctioned so as to provide gentle but efficient suction without damaging the mucosa. Thus, the flow of air exiting air hole1060prevents suction ports1009from sticking to and sucking the mucosa. Such a configuration prevents trauma to and bleeding of the mucosa.

Referring toFIG. 14A, in one embodiment, flexible breathing tube1010is formed with a longitudinally extending protruding portion1040which has curved surface1042. Tube1018is joined or attached to curved surface1042by any suitable technique, e.g. adhesive, heat treatment, etc. In another embodiment, tube1018is integrally formed with flexible breathing tube1010. Referring toFIG. 14B, there is shown an alternate embodiment wherein flexible breathing tube1010and tube1018are replaced by flexible breathing tube1200and flexible tube1220, respectively. Flexible breathing tube1200performs the same function as flexible breathing tube1010but has a different structure. Flexible breathing tube1200has interior1202and a substantially circular cross-section. Flexible tube1220performs the same function as tube1018. Tube1220is joined or attached to the exterior surface of flexible breathing tube1200by any suitable technique, e.g. adhesive, heat treatment, etc. In one embodiment, tube1220is integrally formed with flexible breathing tube1200. Tube1220has an interior1230which provides the same function as interior1019of tube1018. Tube1220has air entry and air exit holes that perform the same functions as air holes1050and1060, respectively. A flexible air capillary tube1240is positioned within tube1220. Air capillary tube1240has the same structure and performs the same function as air capillary tube1020. Air capillary tube1240has interior1250.

Referring toFIGS. 15 and 16, laryngeal mask apparatus1000includes mouthpiece connector1026that is configured to be connected to a ventilating system which provides air, oxygen and anesthesia gases. Mouthpiece1026comprises portion1028that is configured and sized to be frictionally inserted into the opening of flexible breathing tube1010. Mouthpiece1026further comprises portion1030that is configured to be connected to the ventilating system. Mouthpiece1026further comprises flange portion1032that separates portions1028and1030and abuts the end of flexible breathing tube1010when portion1028is completely inserted into the opening of the flexible breathing tube1010.

Referring toFIGS. 15, 17, 18 and 24, laryngeal mask apparatus1000further comprises air tube1012that is connected to mask1001. Laryngeal mask apparatus1000further comprises pilot valve1014which is connected to air tube1012, and connector1016that is connected to pilot valve1014. Connector1016is configured to be connected to an air source which provides an air stream that inflates tubular ring1005of mask portion1001. The pilot valve1014controls the amount of air that passes through air tube1012and into tubular ring1005.

When in use, laryngeal mask apparatus1000is inserted into the patient's mouth and down through the patient's throat past the epiglottis until mask portion1001comes to rest with end1007of mask portion1001positioned in the base of the patient's throat, lying against the upper end of the normally closed esophagus. Suction ports1009face the back of the throat. Inflatable ring1005is then inflated via air tube1012and valve1014to seal the area around the inlet to the larynx. The patient's airway is thus secure and unobstructed and flexible breathing tube1010is then connected directly to the conventional anesthetic circuit hosing for either positive pressure or spontaneous breathing. Suction connector1024is then connected to a suction producing apparatus and stop member1025A is inserted into opening1025B to allow suction ports1009to suck oropharyngeal secretions from the mouth and the back of the patient's throat. Such secretions are made not only from the patient's stomach, but also from the salivary glands in the mouth. Air holes1050and1060of tube1018cooperate with air capillary tube1020to ensure that the suction at suction ports1009does not damage the mucosa.

Referring toFIGS. 25-34, there is shown laryngeal mask apparatus2000in accordance with a further embodiment of the invention. Laryngeal mask apparatus2000has generally the same structure as laryngeal mask1000except laryngeal mask apparatus2000includes scope tube2500. Scope tube2500includes scope funnel2550. A gastric tube may be inserted through scope funnel2550and scope tube2500in order to suck out stomach regurgitation and microaspirations thereby decreasing the risk of such regurgitation and microaspirations from entering the lungs or mouth. Scope tube2500and scope funnel2550are discussed in detail in the ensuing description. Laryngeal mask apparatus2000further comprises mask or cuff portion2001. Mask or cuff portion2001comprises front side2002, rear side2004and inflatable tubular ring portion2005. Mask2001includes inner spatial region2005A that is surrounded by inflatable tubular ring portion2005. Mask2001includes end portion2007. End portion2007is part of inflatable tubular ring portion2005. Mask2001includes opening or port2008that is in end2007. Opening or port2008extends through inflatable tubular ring portion2005and is in communication with spatial region2005A. The purpose of opening or port2008is described in detail in the ensuing description.

Joint section2006is joined or attached to rear side2004of mask2001. In an exemplary embodiment, joint section2006has a generally tubular shape. Laryngeal mask apparatus2000further includes flexible breathing tube2010which is connected to joint section2006. As shown inFIG. 35, flexible breathing tube2010has interior region2011for the flow of air and is discussed in detail in the ensuing description. The air in flexible breathing tube2010flows through the flexible breathing tube2010and through joint section2006and into mask2001. Laryngeal mask apparatus2000further comprises flexible tube2018that is joined or attached to the exterior surface of flexible breathing tube2010and extends to mask2001. Flexible tube2018has the same structure, configuration and function as flexible tube1018of laryngeal mask apparatus1000. Flexible tube2018comprises portion2018A. A substantial portion of portion2018A is wrapped about and joined or attached to the exterior surface of joint section2006. In another embodiment, the aforementioned substantial portion of portion2018A is joined or attached to both the exterior surface of joint section2006and the rear side2004of mask portion2001. In a further embodiment, the aforementioned substantial portion of portion2018A is joined or attached to rear side2004and positioned or wrapped about joint section2006. Portion2018A of tube2018has a plurality of suction ports or openings2009. Suction ports2009suck in the fluids and secretions in the patient's hypopharyngeal region as will be discussed in the ensuing description. Tube2018has interior2019which is used for suction (seeFIG. 35). Suction ports or openings2009are in communication with interior2019. Tube2018includes air hole2060that is in portion2018A of tube2018and in proximity to distal end2018C of tube2018(seeFIG. 30). Tube2018further includes air hole2050that is in portion2018B of tube2018. Air hole2050functions as an air entry hole and air hole2060functions as an air exit hole. As shown inFIGS. 29 and 30, the section of portion2018A that has distal end2018C and air hole2060is not joined or attached to joint section2006or mask2001, but instead, is spaced part from mask2001. This configuration ensures that air hole2060is not blocked by any portion of mask2001.

Flexible tube2018further comprises flexible air capillary tube2020that is located within interior2019and extends for substantially the entire length of tube2018(seeFIG. 35). Air capillary tube2020has the same structure, configuration, purpose and function as air capillary tube1020of laryngeal mask apparatus1000. Air capillary tube2020has a first open end in communication with air-hole2050and an opposite second open end in communication with air hole2060. When suction is created within interior2019, the suction pressure draws air into air hole2050. The air drawn into air hole2050enters the first open end of air capillary tube2020, flows through air capillary tube2020, exits the opposite second open end of air capillary tube2020and flows out of air hole2060. The air exiting air hole2060enters the patient's hypopharyngeal region so as to decrease the direct suction forces on the mucosa in the hypopharyngeal region. Thus, a sump function is created by: (a) the suction within interior2019of tube2018that draws air into air hole2050and into air capillary tube2020, (b) the flow of the air through the air capillary tube2020, and (c) the flow of the air out of air capillary tube2020via air hole2060. In one embodiment, portion2018A is configured so that air hole2060faces the front of the patient's throat. In another embodiment, portion2018A is configured so that air hole2060faces the back of the patient's throat. Suction tube connector2024is connected to portion2018B of tube2018. Thus, the interior of portion2018B is in communication with the interior of suction tube connector2024. Suction tube connector2024includes a suction enablement device2025. Suction enablement device2025includes stop member2025A and opening2025B. Stop member2025A is sized to be frictionally inserted into opening2025B (seeFIG. 29). Stop member2025A must be inserted into opening2025B in order for suction to take place through interior2019of tube2018. Thus, if a suction producing device is connected to suction tube connector2024, suction through interior2019will not occur unless stop member2025A is plugged into opening2025B. Such a configuration ensures that the patient's throat or mouth is not over-suctioned. The stop member2025A is inserted into or removed from opening2025B by medical personnel. When stop member2025A is inserted into opening2025B and a suction producing apparatus is connected to suction tube connector2024, suction will be created throughout interior2019of tube2018which causes secretions and fluids to be sucked in through suction ports2009. Suction within interior2019of tube2018causes air to be drawn into air hole2050. As described in the foregoing description, the air that is drawn into the air hole2050then flows through air capillary tube2020, exits air hole2060and then enters the area being suctioned so as to provide gentle but efficient suction without damaging the mucosa. Thus, the flow of air exiting air hole2060prevents suction ports2009from sticking to and sucking the mucosa. Such a configuration prevents trauma to and bleeding of the mucosa.

Scope tube2500is joined or attached to the exterior of flexible breathing tube2010. In an exemplary embodiment, scope tube2500is joined or attached to the dorsal part or portion of flexible breathing tube2010. Scope tube2500includes end portion2502that is joined or attached to joint section2006and an opposite end to which is attached scope funnel2550. Scope tube2500has an interior region and an inner tube2510that is disposed within and extends throughout the interior region of scope tube2500. The configuration of scope tube2500and the manner in which end portion2502is joined to joint section2006allows inner tube2510to extend throughout the interior region of scope tube2500and through spatial region2005A of mask2001and into opening or port2008. The portion of inner tube2510that extends through spatial region2005A and into opening or port2008is indicated by reference number2510A. Inner tube2510includes interior2512for the flow of air, liquids, regurgitated material or particulate. The interior2512is not in communication with the interiors of flexible breathing tube2010or joint section2006. This means that fluid, microaspirations or regurgitated material flowing through interior2512of inner tube2510never enters the interiors of joint section2006or flexible breathing tube2010.

Referring toFIG. 35, in an exemplary embodiment, flexible breathing tube2010is formed with a first longitudinally extending protruding portion2040which has concave surface2042and a second longitudinally extending protruding portion2044which has a concave surface2046. Tube2018is joined or attached to concave surface2042by any suitable technique, e.g. adhesive, heat treatment, etc. Similarly, scope tube2500is joined or attached to concave surface2046by any suitable technique, e.g. adhesive, heat treatment, etc. In an exemplary embodiment, the adhesive used is a silicone adhesive. In another embodiment, tube2018and scope tube2500are integrally formed with flexible breathing tube2010.

Laryngeal mask apparatus2000further includes mouthpiece connector2026that is attached to the opening of flexible breathing tube2010. Mouthpiece connector2026is configured to be connected to a ventilating system which provides air, oxygen and anesthesia gases. Mouthpiece2026has the same purpose, function, structure and configuration as mouthpiece1026of laryngeal mask apparatus1000and is therefore not described in detail.

Laryngeal mask apparatus2000further comprises air tube2012that is connected to mask2001. Laryngeal mask apparatus2000further comprises pilot valve2014that is connected to air tube2012, and connector2016that is connected to pilot valve2014. Connector2016is configured to be connected to an air source which provides an air stream that inflates tubular ring2005of mask portion2001. The pilot valve2014controls the amount of air that passes through air tube2012and into inflatable tubular ring2005. Air tube2012, pilot valve2014and connector2016have the same purpose, function, structure and configuration as air tube1012, pilot valve1014and connector1016, respectively, of laryngeal mask apparatus1000.

When in use, laryngeal mask apparatus2000is inserted into the patient's mouth and down through the patient's throat past the epiglottis until mask portion2001comes to rest with end2007of mask portion2001positioned in the base of the patient's throat, lying against the upper end of the normally closed esophagus. Suction ports2009face the back of the throat. Inflatable ring2005is then inflated via air tube2012and valve2014to seal the area around the inlet to the larynx. The patient's airway is thus secure and unobstructed and flexible breathing tube2010is then connected directly to the conventional anesthetic circuit hosing for either positive pressure or spontaneous breathing. Suction connector2024is then connected to a suction producing apparatus and stop member2025A is inserted into opening2025B to allow suction ports2009to suck oropharyngeal secretions from the mouth and the back of the patient's throat. Such secretions are made not only from the patient's stomach, but also from the salivary glands in the mouth. Air holes2050and2060of tube2018cooperate with air capillary tube2020to ensure that the suction at suction ports2009does not damage the mucosa. In order to aspirate contents or particulate from the patient's stomach, a gastric tube2600is inserted into scope funnel2550and into scope tube2500. The gastric tube2600extends through inner tube2510and through portion2510A of inner tube2510and then through opening2008and into the patient's stomach. The gastric tube2600is then connected to a suction producing device in order to suction the stomach. Suctioning the stomach in this manner decreases the risk of any stomach regurgitation and microaspirations from entering the lungs or mouth. The gastric tube2600may be connected to the same suction producing device to which suction connector2024is connected. Alternatively, the gastric tube2600may be connected to a separate suction producing device. Thus, laryngeal mask apparatus2000sucks regurgitation and microaspirations from the stomach, mouth, pharynx and hypopharynx simultaneously so as to reduce the risk of infection caused by stomach aspirations and regurgitations from passing into the patient's stomach and lungs.

Laryngeal mask apparatuses1000and2000may be configured in different sizes for use with patients of various sizes, e.g. infants, children, adults, etc.

The foregoing description, for purpose of explanation, has been described with reference to specific embodiments. However, the illustrative discussions above are not intended to be exhaustive or to limit the invention to the precise forms disclosed. Furthermore, many modifications and variations in materials, dimensions, shapes and cross-sectional geometries are possible in view of the above teachings. The embodiments were chosen and described in order to best explain the principles of the invention and its practical applications so as to thereby enable others skilled in the art to best utilize the invention and various embodiments with various modifications as are suited to the particular use contemplated.