Patent ID: 12239610

DETAILED DESCRIPTION OF THE INVENTION

The present invention is directed to feeding tube apparatus comprising (a) a feeding tube comprising an inflatable balloon component in combination with (b) a carbon dioxide (CO2) sampling line and/or (c) a suction tube component that extends along a portion of an outer surface of the feeding tube. The present invention is further directed to methods of using a feeding tube apparatus comprising a feeding tube in combination with a carbon dioxide (CO2) sampling line and/or a suction tube component that extends along a portion of an outer surface of the feeding tube. The present invention is even further directed to kits that may be used in methods of providing nutrients to a patient.

The feeding tube apparatus of the present invention may comprise a number of components. A description of individual components and combinations of individual components is provided below.

I. Feeding Tube Apparatus Components

FIG.1Adepicts an exemplary feeding tube apparatus10of the present invention with an exemplary inflatable balloon component282in a non-inflated state, and an exemplary carbon dioxide (CO2) sampling line70in an unconnected state.FIG.1Bdepicts exemplary feeding tube apparatus10shown inFIG.1Awith exemplary inflatable balloon component282in an inflated state, and exemplary carbon dioxide (CO2) sampling line70in an unconnected state.

As shown inFIGS.1A-1B, feeding tube apparatus of the present invention may comprise one or more of the following components.

A. Catheter

Feeding tube apparatus of the present invention, such as exemplary feeding tube apparatus10shown inFIGS.1A-1B, comprise a catheter20. Catheter20comprises a tube with a proximal end22and a distal end24. Distal tip25of distal end24may be closed as shown inFIGS.1A-1B, or may form an open lumen266as shown inFIG.2B. Open lumen266allows for the delivery of food from distal tip25of catheter20. Alternatively, distal tip25of catheter20is closed (as shown inFIG.1A) and does not contain an open lumen266. In this alternative embodiment, catheter20may contain one or more side holes28for food/nutrient delivery to a patient480.

As shown inFIGS.2A-2B, even when distal tip25of distal end24forms an open lumen266, catheter20may comprise one or more side holes28for food/nutrient delivery to a patient480and/or aspiration of fluid from the stomach (e.g., sampling by aspiration using a syringe to test acidity or alkalinity using pH paper) through the one or more side holes28. As shown inFIGS.2A-2B, exemplary catheter20comprises an open lumen266at distal end24, and a single side hole28.

Distal tip25and the region21proximal to distal tip25may be formed of a softer material than the material that forms the rest of the catheter20. This allows distal tip25and region21proximal to distal tip25to be atraumatic and allows magnetic material(s)32to have a more pronounced effect on maneuverability and guidance than they would if a stiffer material were used. Proximal end22of catheter20also forms an opening23into which removable stylet30is placed when inserted into catheter20.

Catheter20may be formed of any suitable tubing material. Suitable tubing materials include, but are not limited to, the tubing materials disclosed in U.S. Pat. No. 9,713,578, the subject matter of which is incorporated herein in its entirety.

In one exemplary embodiment, catheter20is constructed in whole or in part of a medical grade radio-opaque material. Suitable medical grade radio-opaque materials include, but are not limited to, polyurethane, polyvinyl chloride (PVC) or silicon tubing. In some embodiments, the tubing comprises a polyurethane for strength. Examples of suitable polyurethanes include, but are not limited to, those available under the trade designations ESTANE® (Lubrizol Advanced Materials, Inc.), PEBAX® (Arkema France Corp.), PELLETHANE® (Dow Chemical Co.), and CARBOTHANE® (Lubrizol Advanced Materials, Inc.).

Typically, the medical grade radio-opaque material has a durometer ranging from about 60 A to about 100 D on the durometer shore hardness scale, but the medical grade radio-opaque material may have any durometer typically used in tubing materials such as feeding tubes. In some embodiments, the medical grade radio-opaque material has a durometer ranging from about 70 A to about 90 D on the durometer shore hardness scale.

In some embodiments, the walls of the catheter may contain a reinforcing material222e.g., as shown inFIGS.3-5. In these embodiments, the walls201of catheter20may contain, for example, an MRI compatible reinforcing material222, such as a fiber, monofilament, or non-ferrous metal. This allows the catheter20to have a thin wall, while maintaining the desired inner diameter. Reinforcing material222also provides kinking and/or crush-resistance to catheter20even when the catheter20is conforming to a tortuous path in the patient's body. Reinforcing material222also allows catheter20to be especially resilient to perforation, thereby facilitating the use of a plunger (not shown) to purge a clogged catheter20without the risk of perforating or damaging the feeding tube10.

When present, reinforcing material222may be present as a coil reinforcing material222(e.g., a metal coil222) as shown inFIGS.3-5. Coil reinforcing material222may extend a complete length Lcof catheter20, or less than the complete length Lc. For example, in some embodiments, coil reinforcing material222extends the complete length Lcof catheter20except for about one centimeter on either end of catheter20. See, for example,FIG.2A, wherein a metal coil reinforcing material (i.e., embedded within wall201or along an inner surface261of wall201) extends from point18ato point18balong catheter20. In other embodiments, coil reinforcing material222extends from about point5ato one or more side holes28of catheter20. In other embodiments, coil reinforcing material222extends from about point5ato distal tip25of catheter20.

In some embodiments, coil reinforcing material222is embedded within wall201of catheter20as shown inFIGS.3-5. However, in other embodiments (not shown), coil reinforcing material222extends along inner surface261of wall201of catheter20so as to form an inner surface (i.e., that comes into contact with removable stylet30). When coil reinforcing material222lines an inner surface of catheter20, the contact surface of coil reinforcing material222(i.e., the surface that comes into contact with removable stylet30) may further comprise a coating (not shown) that minimizes friction between catheter20and removable stylet30.

Any standard diameter and length of tubing material may be used to form the catheter20. Standard catheter sizes are referred to as “French” sizes, e.g. size F4 refers to a tube with a 0.053 inch outer diameter, F5 refers to a tube with a 0.066 inch outer diameter, F6 refers to a tube with a 0.079 inch outer diameter, F7 refers to a tube with a 0.092 inch outer diameter, F8 refers to a tube with a 0.104 inch outer diameter, F10 refers to a tube with a 0.131 inch outer diameter, F11 refers to a tube with a 0.143 inch outer diameter, and F12 refers to a tube with a 0.156 inch outer diameter. In one exemplary embodiment, the tubing is a single lumen 2603-80AE PELLETHANE® F11 or F12 tube. The F11 tube has an outer diameter of 0.143 inches and an inner diameter of 0.111 inches; and the F12 tube has an outer diameter of 0.156 inches and an inner diameter of 0.116 inches. However other size tubing is suitable as well. In place of single lumen tubing, double lumen tubing or alternative styles may be used as described below. The inner diameter of the tubing (i.e., the diameter of the lumen) should be sufficiently large to allow the fluids and nutrients to pass through catheter20without clogging catheter20. Typically, the inner diameter of the tubing (i.e., the diameter of the lumen) is sufficiently large to allow commercially available nutrition formulas to pass through the tubing.

The length of catheter20determines how deep into the gut the feeding tube10can be placed for the delivery of fluids and nutrients. Typical lengths for catheter20range from about 80 cm to about 150 cm. More typically, catheter20is at least 125 cm long. In one exemplary embodiment, catheter20is 127 cm long. This allows for nutrients to be delivered deep into the bowel and thereby prevent reflux.

In addition to openings23and266at proximal and distal ends22and24of catheter20, catheter20may further comprise one or more side holes28along and within wall201of catheter20. In some embodiments, side holes28are located as close to distal tip25as possible without compromising the strength of the tubing and interfering with magnetic material(s)32and optional reed switch assembly60. In one embodiment, side holes28are located in region18between the proximal end22and inflatable balloon component282. In another embodiment, side holes28are located within region21proximate to distal tip25of catheter20.

B. Inflatable Balloon Component

Feeding tube apparatus of the present invention, such as exemplary feeding tube apparatus10shown inFIGS.1A-1B, further comprise an inflatable balloon component, such as inflatable balloon component282. Inflatable balloon component282comprises an inflatable material that may be pliable or non-pliable. Suitable materials for forming inflatable balloon component282include, but are not limited to, polyvinyl chloride (PVC), silicon, latex, medical grade rubber, nitrile, and ChronoPrene™ material.

Inflatable balloon component282is positioned along an outer surface27of catheter20, typically proximate distal end tip25. Inflatable balloon component282may be attached to outer surface27of catheter20via any known method of attaching one material to another. A description of known methods may be found in U.S. Pat. No. 9,713,578, the subject matter of all of which is hereby incorporated by reference.

Inflatable balloon component282may be inflated via at least one inflation tube202and an inflating device (e.g., a syringe288as shown inFIG.9F) as shown inFIG.1A. Each inflation tube202may connect with an inflation channel29′ extending along a length Lcof catheter20and within a sidewall201of catheter20. Each inflating channel29′ comprising an inflating channel inlet opening292proximate catheter proximal end22and an inflating channel outlet opening291along an outer surface27of catheter20positioned underneath inflatable balloon component282.FIG.3depicts a cross-sectional view of exemplary feeding tube apparatus shown inFIG.1Aalong line3-3shown inFIG.1Aso as to illustrate an exemplary inflation channel29′.

FIG.4depicts a cross-sectional view of exemplary feeding tube apparatus10shown inFIG.1Balong line4-4shown inFIG.1B. As shown inFIG.4, inflating channel outlet opening291is positioned along outer surface27of catheter20underneath inflatable balloon component282.

FIG.5depicts a cross-sectional view of a portion of exemplary catheter20within exemplary feeding tube apparatus10shown inFIG.1Afrom point5ato point5bshown inFIG.1A. As shown inFIG.5, inflating channel29′ comprising an inflating channel inlet opening292proximate catheter proximal end22and an inflating channel outlet opening291along an outer surface27of catheter20positioned underneath inflatable balloon component282.

Each inflation tube202may be attached to catheter20via any known method of attaching one material to another. A description of known methods may be found in U.S. Pat. No. 9,713,578, the subject matter of all of which is hereby incorporated by reference.

C. Removable Stylet

Feeding tube apparatus of the present invention, such as exemplary feeding tube apparatus10shown inFIGS.1A-1B, may further comprise a removable stylet, such as removable stylet30. Removable stylet30comprises a proximal end31and a distal end34, with distal end34terminating in a distal tip35. As shown inFIGS.1A-1B, removable stylet30further comprises stylet hub90, a stylet hub port98for attachment of a carbon dioxide (CO2) sampling line70.

In one exemplary embodiment, removable stylet30is long enough to extend along the length of catheter20, but not beyond distal tip25of catheter20. In another exemplary embodiment, removable stylet30is long enough to extend along the length of catheter20and beyond open lumen266at distal tip25of catheter20, which allows catheter20to track over a removable stylet30already in place in the desired location. Thus, removable stylet30can guide catheter20to its desired location, by passing catheter20over removable stylet30until it reaches the desired placement location.

Typical lengths for removable stylet30range from about 127 cm, which generally corresponds with the length of catheter20, to a length greater than the length of catheter20, such as about 175 cm, which allows for removable stylet30to extend beyond distal tip25of catheter20. In one preferred embodiment, removable stylet30is about 127 cm long.

The outer diameter of removable stylet30is selected based on the inner diameter of catheter20. The outer diameter of removable stylet30is less than the inner diameter of catheter20so that removable stylet30can easily slide into and out of catheter20, as desired. By way of example, for catheters20formed using 11 FR or 12 FR tubing, removable stylet30may have an outer diameter from 0.030 to 0.107 inches.

The proximal end84of feeding tube hub80attaches to the distal end96of stylet hub90. Stylet hub90contains an opening at each end (i.e., proximal end94and distal end96) and is hollow throughout the length of stylet hub90. Removable stylet30exits stylet hub90at distal end96of stylet hub90and extends inside and along the length Lcof catheter20. Stylet hub90also contains a port98for connection to a carbon dioxide (CO2) sampling line70.

A description of other possible features (e.g., materials, components, etc.) of removable stylet30may be found in U.S. Pat. No. 9,713,578, the subject matter of all of which is hereby incorporated by reference; however, it should be understood that other known removable stylets may also be used in the present invention.

D. Carbon Dioxide Sampling Line

Feeding tube apparatus10of the present invention may further comprise a carbon dioxide (CO2) sampling line70, which provides early detection of misplacement of feeding tube apparatus10in the trachea481, typically, within 5 seconds (i.e., one breath only). Prior to the present invention, a drop of pulse oximeter reading (i.e., a drop in oxygen saturation in the blood) was used to detect a misplaced feeding tube balloon, which could take one or more minutes.

In the feeding tube apparatus10of the present invention, balloon282, when inflated in an esophagus area485of the patient480, nearly occludes the esophagus485or trachea481such that exhaled air from the lung must exit through feeding tube apparatus10not around it as in other prior feeding tubes. Also, when feeding tube apparatus10is in the correct location, and the esophagus485is occluded by balloon282, exhaled air cannot travel from the trachea481into the esophagus485around the inflated balloon282, so the exhaled air exits through the feeding tube lumen266. A carbon dioxide monitor110will show a flat line with respiration when feeding tube apparatus10is in the esophagus485. However, if the feeding tube apparatus10is misplaced within the trachea481, the carbon dioxide monitor110will detect carbon dioxide, and trigger a user to withdraw the feeding tube10and retry intubation.

E. Suction Tube Component

Feeding tube apparatus10of the present invention may further comprise a suction tube component extending concurrently over a portion of catheter20. An exemplary feeding tube apparatus10showing this optional feature is shown inFIGS.8A-8B.

As shown inFIG.8A, exemplary feeding tube apparatus10comprises catheter20with proximal end22, distal end24, distal tip25, open lumen266, and inflatable balloon component282along outer surface27of catheter20. Exemplary feeding tube apparatus10also comprises a suction tube component40extending along a portion271of outer surface27of catheter20. Exemplary suction tube component40comprises a suction tube proximate end41, a suction tube distal end42, and a lumen43external to feeding tube shaft20extending between suction tube proximate end41and suction tube distal end42. See, for example, the cross-sectional view of exemplary feeding tube apparatus10shown inFIG.8Bas viewed along line8B-8B shown inFIG.8A. Exemplary suction tube component40further comprises one or more openings (i.e., suction holes)44positioned proximate suction tube distal end42, and at least one port45at suction tube proximate end41.

As shown inFIGS.8B and8C, exemplary suction tube component40further comprises vent channel47extending from vent opening49within lumen43, thru and along a wall portion401of exemplary suction tube component40to vent tube47′ and ending at vent tube inlet48.

Vent channel47and vent tube inlet48ensure that, even if suction tube component40is lodged against a wall in a patient's body, aspirating catheter40will not create a suction situation and potentially damage internal tissues or stomach walls. See, for example,FIGS.8B-8C. Vent channel47connects the inside cavity/lumen43of the suction tube component40to air outside of exemplary suction tube component40.

In one exemplary embodiment, feeding tube apparatus10has an overall length of about 132 cm, catheter20of feeding tube apparatus10has an overall length of about 130 cm, removable stylet30of feeding tube apparatus10has an overall length of less than or about 130 cm, and suction tube component40of feeding tube apparatus10(i) has an overall length of about 75 cm and (ii) is positioned about 45 cm from distal tip25of catheter20and about 10 cm from proximate end22of catheter20.

Suction tube component40may be formed from materials such as those described above for catheter20.

Suction tube component40typically has an outer diameter of from about 5.0 millimeters (mm) to about 10.0 mm, for example, 7.5 mm.

F. Optional Components

Feeding tube apparatus10of the present invention may further comprise a spring guide wire that is not attached to the stylet (not shown in figures). The spring wire guide may be a J-wire or a straight spring guide wire. In this embodiment, after removable stylet30is removed from catheter20, the spring guide wire can be placed in catheter20until it protrudes from opening266at distal end25of catheter20. Then, the spring guide wire can be used to facilitate guidance of catheter20as it advances through the intestinal tract. In other embodiments, stylet30has a stylet length Lsof about 175 cm to achieve same function as the J wire.

Optionally, distal end34of removable stylet30or catheter distal end24of catheter20may further comprise a pH sensor probe36connected to a digital pH meter (not shown) at stylet proximal end31or catheter proximal end22. This allows one to measure the pH of the surrounding environment around distal end34of removable stylet30or catheter distal end24as feeding tube apparatus10is maneuvered through the patient480to help determine when feeding tube apparatus10reaches the desired location for placement. In one exemplary embodiment, a pH sensor36is mounted on the outer wall (i.e., sidewall201) of catheter20for continuous or intermittent monitoring of pH. See, for example,FIG.5. In one exemplary embodiment, a pH sensor36is mounted on the outer wall38of removable stylet30for continuous or intermittent monitoring of pH. See, for example,FIG.6.

Distal end34of removable stylet30may further comprise an electromagnetic sensor37at the distal end34of removable stylet30to detect the travel course of the removable stylet30(and the catheter20. An electromagnetic detector (not shown) positioned outside of the patient480can detect the position of electromagnetic sensor37as distal end34of removable stylet30is maneuvered through the patient480to help determine when removable stylet30reaches the desired location for placement. In one exemplary embodiment, an electromagnetic sensor37is mounted on or within outer wall38of removable stylet30. Typically, when present, electromagnetic sensor37is positioned at a position/location along distal end34of removable stylet30, more typically, positioned proximate a tip39of removable stylet30. See, for example,FIG.6.

II. Kits Comprising a Feeding Tube Apparatus

The present invention is also directed to kits that may be used in methods of providing nutrients to a patient480while detecting misplacement of the catheter20within a patient's trachea481. The kits of the present invention comprise one or more of the feeding tube apparatus10described above. Other additional kit components suitable for use with the feeding tube apparatus10described above are disclosed in U.S. Pat. No. 9,713,578, the subject matter of all of which is hereby incorporated by reference.

Kits of the present invention may further include one or more additional components that assist the medical practitioner in use of feeding tube apparatus10. Suitable additional components include, but are not limited to, a syringe288, preferably a 60 CC syringe; one or more towels; one or more cups; disposable gloves; numbing gel (e.g., 2% Xylocaine gel); tape; gauze; spring guide wire; and/or pH paper. Kits may also comprise a spring guide wire that can be inserted into catheter20after removable stylet30is removed.

III. Methods of Using Feeding Tube Apparatus

The present invention is further directed to methods of using the disclosed feeding tube apparatus10comprising (1) a feeding tube10with an inflatable balloon component282, and (2) at least one of: (a) a carbon dioxide (CO2) sampling line70, (b) a suction tube component40that extends along a portion of an outer surface of the feeding tube catheter20, (c) a pH sensor36, and (d) an electromagnetic sensor37.

In one exemplary embodiment, the method of using the disclosed feeding tube apparatus10comprises a method for intubating a patient480(see,FIGS.9A-9D) so as to introduce one or more nutrients or medication into the duodenum of the patient, wherein the method comprises: inserting the distal tip25of the catheter20of the feeding tube apparatus10into a patient's nostril; and in response to the carbon dioxide (CO2) sampling line70of the feeding tube apparatus10detecting misplacement of the catheter20within a patient's trachea481, at least partially removing the catheter20from the patient's nostril.

Methods of using the disclosed feeding tube apparatus10of the present invention may also comprise a method for intubating a patient480so as to introduce one or more nutrients into the duodenum of the patient480, wherein the method comprises: inserting a distal tip25of a catheter20of the feeding tube apparatus10into a patient's nostril350until the distal tip25is positioned in a mid-esophagus region486of a patient480; inflating an inflatable balloon component282of the catheter20; monitoring carbon dioxide exiting the catheter20thru a carbon dioxide (CO2) sampling line70of the feeding tube apparatus10; and in response to detected carbon dioxide, indicating misplacement of the catheter20within a patient's trachea481, deflating the inflatable balloon component282of the catheter20, and at least partially removing the catheter20from the patient's nostril350.

The distal tip25of catheter20is introduced into the naris350of the patient's nose and advanced by the continued application of a compressive force to catheter20forcing distal tip25to the back portion of the patient's head (nasopharynx483) and into the esophagus485. As is common, the passageway of the esophagus485affords ample guidance to distal tip25whereupon it enters the body portion of the stomach380. A description of the advancement of a feeding tube, such as exemplary feeding tube10disclosed herein, may be found in U.S. Pat. No. 9,713,578, the subject matter of all of which is hereby incorporated by reference.

After catheter20is placed in the desired location within the patient's stomach (not shown), removable stylet30is removed. Catheter20can remain in place when the patient480undergoes diagnostic tests, such as MRI imaging when removable stylet10is removed.

When suction tube component40is present, the methods of using the disclosed feeding tube apparatus10comprising an inflatable balloon component282may further comprise one or more of the following steps: to remove fluids, gastric juice, air, food debris/items from the patient's stomach, to decompress the stomach, to remove gastric contents to prevent gastroesophageal reflux into the lung especially in unconscious, sedated, critically ill and burn patients. A suction line (not shown) may be connected to port45at suction tube proximate end41to remove fluid from the patient's stomach, into and through one or more openings44, through lumen43, and out of port45.

Other Embodiments

Feeding Tube Apparatus:

1. A feeding tube apparatus10comprising a catheter20suitable for use with a removable stylet30, said catheter20comprising a catheter proximal end22, a catheter distal end24opposite said catheter proximal end22, a catheter channel26extending along a length Lcof said catheter20from said catheter proximal end22towards said catheter distal end24, and an inflatable balloon component282positioned along said catheter20proximate said catheter distal end24, said feeding tube apparatus10further comprising at least one of:(1) a carbon dioxide (CO2) sampling line70that is connectable to the catheter20, said carbon dioxide (CO2) sampling line70(a) comprising a sampling line distal end72, a sampling line proximal end74opposite said sampling line distal end72, a sampling line channel76extending along a length LSLof said carbon dioxide (CO2) sampling line70from said sampling line distal end72towards said sampling line proximal end74, and (b) enabling detection of misplacement of the catheter20within a patient's trachea481;(2) a suction tube component40extending along a portion271of an outer surface27of catheter20, said suction tube component40comprising a suction tube proximate end41, a suction tube distal end42, and a suction tube lumen43extending (i) between said suction tube proximate end41and said suction tube distal end42, and (ii) along and external to said outer surface27of catheter20;(3) a pH sensor36positioned along at least one of: (i) the catheter20, and (ii) a removable stylet30suitable for use with the catheter20; and(4) an electromagnetic sensor37positioned along at least one of: (i) the catheter20, and (ii) a removable stylet30suitable for use with the catheter20.2. The feeding tube apparatus10of embodiment 1, wherein said catheter distal end24comprises a catheter distal end tip25, and said catheter distal end tip25is open (e.g., as shown inFIGS.2A-2B). Note, in other embodiments, the catheter distal end tip25may be closed (e.g., as shown inFIGS.1A-1B).3. The feeding tube apparatus10of embodiment 1 or 2, wherein said inflatable balloon component282is positioned a distance dbfrom a catheter distal end tip25of said catheter20.4. The feeding tube apparatus10of any one of embodiments 1 to 3, wherein said inflatable balloon component282is positioned a distance dbof from about 0.0 centimeters (cm) to about 10.0 cm from a catheter distal end tip25of said catheter20(or any other distance dbfrom the catheter distal end tip25of said catheter20to about 10 cm, in increments of 0.1 cm, or any range of distances dbbetween 0.0 cm and about 10 cm, in increments of 0.1 cm, e.g., from about 0.1 to about 2.0 cm, with 1.5 cm being a preferred distance dbin some embodiments).5. The feeding tube apparatus10of any one of embodiments 1 to 4, wherein said inflatable balloon component282extends along an outer surface27of said catheter20. Inflatable balloon component282may be attached to outer surface27of catheter20via any known attaching member (not shown). Suitable attaching members include, but are not limited to, an adhesive, and a mechanical bond (e.g., an ultrasonic welding bond).6. The feeding tube apparatus10of any one of embodiments 1 to 5, wherein said inflatable balloon component282is sized so as to contain up to 10.0 milliliters (ml) of inflating fluid91(see,FIG.4) (or any amount up to 10 ml, or any range between greater than 0 ml to about 10 ml, in increments of 0.1 ml, with about 3.0 ml being preferred for adult patients, and about 1.0 ml being preferred for smaller, pediatric patient).7. The feeding tube apparatus10of any one of embodiments 1 to 6, wherein said inflatable balloon component282is sized so as to contain from about 1.0 ml to about 5.0 ml of inflating fluid91.8. The feeding tube apparatus10of any one of embodiments 1 to 7, wherein said inflatable balloon component282contains from about 1.0 ml to about 5.0 ml of inflating fluid91.9. The feeding tube apparatus10of embodiment 8, wherein said inflating fluid91comprises water. It should be noted that, in other embodiments, the inflating fluid91may comprise another type of fluid, such as air.10. The feeding tube apparatus10of any one of embodiments 1 to 9, wherein said catheter20further comprises one or more inflating holes29with each inflating hole29having an inflating hole outlet291along an outer surface27of said catheter20positioned underneath said inflatable balloon component282. Typically, the catheters20of the present invention comprise a single inflating hole29.11. The feeding tube apparatus10of any one of embodiments 1 to 9, wherein said catheter20further comprises one inflating channel29′ extending along a length Lcof said catheter20and within a sidewall201of said catheter20, said one inflating channel29′ comprising an inflating channel inlet opening292proximate said catheter proximal end22and an inflating channel outlet opening291along an outer surface27of said catheter20positioned underneath said inflatable balloon component282. Typically, the catheters20of the present invention comprise a single inflating channel29′.12. The feeding tube apparatus10of any one of embodiments 1 to 11, wherein said catheter20further comprises one or more inflation tubes202attached to said catheter20along an outer surface27of said catheter20proximate said catheter proximal end22. Typically, the one or more inflation tubes202are attached to the catheter20along an outer surface27of said catheter20as shown inFIG.5. Each inflation tube202may be attached to catheter20along outer surface27via any known attaching member (not shown). Suitable attaching members include, but are not limited to, an adhesive, and a mechanical bond (e.g., an ultrasonic welding bond). Typically, the catheters20of the present invention comprise a single inflation tube202, even though the catheters20of the present invention may comprise more than one inflation tube202.13. The feeding tube apparatus10of embodiment 12, further comprising a pilot balloon203positioned along and in fluid communication with said single inflation tube202, pilot balloon203being positioned so as to indicate whether said inflatable balloon component282is inflated or deflated.14. The feeding tube apparatus10of embodiment 12 or 13, further comprising one or more inflating devices288operatively adapted to provide inflating fluid91through said one or more inflation tubes202and into said inflatable balloon component282. Typically, the catheters20of the present invention comprise a single inflating device288, even though the catheters20of the present invention may comprise more than one inflating device288.15. The feeding tube apparatus10of embodiment 14, wherein said one or more inflating devices288comprise a syringe288(see,FIG.9F). (The syringe288may be connected to inflation tube202at port/valve205as shown inFIG.5so as to input water or another fluid into inflation tube202.)16. The feeding tube apparatus10of any one of embodiments 1 to 15, wherein said catheter20further comprises one or more magnetically inert, MRI compatible valves205that temporarily prevent inflating fluid91from exiting said inflatable balloon component282once inflated. Typically, the catheters20of the present invention comprise a single valve205for the catheter20or a single valve205for each inflation tube202. Each valve205may comprise a spring loaded, auto shut off valve that allows fluid flow into and out of inflatable balloon component282only when depressed by an inflating device288such as syringe288).17. The feeding tube apparatus10of any one of embodiments 1 to 16, wherein said catheter20further comprises one or more visual markers208extending along an outer surface27of said catheter20, each of said one or more visual markers208providing a visual indication of a catheter length extending from a catheter distal end tip25to a given visual marker208. In other words, the visual markers provide a visual reference that indicates a position (i.e., depth) of the catheter distal end tip25of the feeding tube10within a patient.18. The feeding tube apparatus10of any one of embodiments 1 to 17, wherein said catheter20further comprises two or more sets of one or more visual markers208(e.g., sets208a,208band208cshown inFIG.1A) extending along an outer surface27of said catheter20, each of said one or more visual markers208providing a visual indication of a catheter length extending from a catheter distal end tip25to a given visual marker.19. The feeding tube apparatus10of embodiment 18, wherein said two or more sets of one or more visual markers208comprise (i) a single visual marker208aat a distance of about 50 cm from a catheter distal end tip25, (ii) two adjacent visual markers208bat a distance of about 80 cm from said catheter distal end tip25, and (iii) three adjacent visual markers208cat a distance of about 110 cm from said catheter distal end tip25. For example, the 50 cm mark208amay correspond to a lower end of the patient's esophagus, the 80 cm mark208bmay correspond to the first part of the patient's duodenum, and the 110 cm mark208cmay correspond to the catheter distal tip25being within the 4thpart of the patient's duodenum in an adult size patient.20. The feeding tube apparatus10of any one of embodiments 1 to 19, wherein said catheter20further comprises one or more side holes28, wherein each side hole28(1) extends from an inner surface261of said catheter20along said catheter channel26to an outer surface27of said catheter20, and (2) is positioned (i) between said inflatable balloon component282and a catheter distal end tip25, (ii) between said inflatable balloon component282and said catheter proximal end22, or (iii) both (i) and (ii). Typically, the catheters20of the present invention comprise two or more side holes28, more typically, from about 1 to about 4 side holes28. See, for example, side holes28shown inFIGS.1A-2B.21. The feeding tube apparatus10of embodiment 20, wherein at least one of said side holes28is positioned between said inflatable balloon component282and a catheter distal end tip25.22. The feeding tube apparatus20of any one of embodiments 1 to 21, wherein said catheter20further comprises a feeding tube hub80positioned at said catheter proximal end22, said feeding tube hub80comprising one or more hub ports82to allow for aspiration or delivery of medications via said catheter20.23. The feeding tube apparatus10of any one of embodiments 1 to 22, wherein said catheter20further comprises a feeding tube hub80positioned at said catheter proximal end22, said feeding tube hub80comprising two or more hub ports82to allow for aspiration or delivery of medications via said catheter20. Typically, the catheters20of the present invention comprise two to three hub ports82.24. The feeding tube apparatus10of any one of embodiments 1 to 23, wherein a wall201of said catheter20(see,FIG.5) extending along a length Lcof said catheter20comprises an MRI compatible reinforcing material222. In some embodiments, the MM compatible reinforcing material222comprising a coil reinforcing material222extending along a length Lcof said catheter20and within or along an inner portion of said wall201with individual coils of said coil reinforcing material222extending substantially perpendicular to length Lcof catheter20(see,FIGS.3-5).25. The feeding tube apparatus10of any one of embodiments 1 to 24, wherein a wall201of said catheter20extending along a length Lcof said catheter20comprises medical grade radio-opaque material. Suitable medical grade radio-opaque materials include, but are not limited to, polyvinyl chloride (PVC), and polyurethane loaded with from about 20% weight to about 40% weight barium sulfate or bismuth subsalicylate.26. The feeding tube apparatus10of any one of embodiments 1 to 25, wherein said catheter20further comprises said pH sensor36positioned along the catheter distal end24. See, for example,FIG.5. pH sensor36may be positioned along any portion of catheter20, but is typically positioned along an outer surface27of catheter20proximate the catheter distal end24.27. The feeding tube apparatus10of any one of embodiments 1 to 26, wherein said pH sensor36is positioned along an outer surface27of said catheter20.28. The feeding tube apparatus10of any one of embodiments 1 to 27, wherein said pH sensor36is positioned (i) between said inflatable balloon component282and said catheter distal end tip25, (ii) between said inflatable balloon component282and said catheter proximal end22, or (iii) both (i) and (ii).29. The feeding tube apparatus10of any one of embodiments 1 to 28, further comprising a removable stylet30, said removable stylet30comprising a stylet proximal end31and a stylet distal end34opposite said stylet proximal end31, said stylet distal end34being sized so as to be insertable within (i) a catheter opening23at said catheter proximal end22, and (ii) said catheter channel26.30. The feeding tube apparatus10of embodiment 29, wherein said removable stylet30comprises a stylet hub90at said stylet proximal end31, said stylet hub90comprising a stylet hub proximal end94, a stylet hub distal end96, and a stylet channel that allows air flow through said stylet hub90and between open lumen266of catheter20and lumen76of a CO2sampling line70, said stylet hub distal end96being connectable to the proximal end84of feeding tube hub80. See, stylet proximal end31inFIGS.1A-1B, and a stylet distal end35inFIG.6.31. The feeding tube apparatus10of embodiment 30, wherein said stylet hub90comprises a port98for connection to a carbon dioxide (CO2) sampling line70.32. The feeding tube apparatus10of embodiment 31, wherein said port98comprises one or more port connectors99that enable connection of said stylet hub90to a carbon dioxide (CO2) sampling line70.33. The feeding tube apparatus10of any one of embodiments 29 to 32, wherein said removable stylet30further comprises one or more magnetic materials (not shown) proximate said stylet distal end34. Suitable magnet configurations are disclosed, for example, in U.S. Pat. No. 6,126,647, the subject matter of which is hereby incorporated herein in its entirety.34. The feeding tube apparatus10of any one of embodiments 29 to 33, wherein said removable stylet30further comprises a reed switch assembly60. A suitable reed switch assembly60is shown inFIG.6. Other suitable reed switch assemblies60are disclosed in U.S. Pat. No. 6,126,647, the subject matter of which is hereby incorporated herein in its entirety.35. The feeding tube apparatus10of any one of embodiments 29 to 34, wherein said removable stylet30is formed from a dual durometer material. Suitable dual durometer materials include, but are not limited to, nylon, polyether ether ketone (PEEK), and ESTANE® polymers (The Lubrizol Corporation).36. The feeding tube apparatus10of any one of embodiments 29 to 35, wherein said removable stylet30further comprises said pH sensor36positioned along the stylet distal end34. See, for example,FIG.6. pH sensor36may be positioned along any portion of removable stylet30, but is typically positioned along an outer surface351of removable stylet30proximate tip39of the stylet30.37. The feeding tube apparatus10of any one of embodiments 29 to 36, wherein said pH sensor36is positioned along an outer surface351of said removable stylet30.38. The feeding tube apparatus10of any one of embodiments 29 to 37, wherein said pH sensor36is positioned proximate tip39of removable stylet30. See again,FIG.6.39. The feeding tube apparatus10of any one of embodiments 29 to 38, wherein said removable stylet30further comprises said electromagnetic sensor37positioned along the stylet distal end34. See, for example,FIG.6.40. The feeding tube apparatus10of embodiment 39, wherein said electromagnetic sensor37is mounted on or within outer wall38of removable stylet30. In some embodiments, electromagnetic sensor37comprises one or more loops of electromagnetic material371that can be electrically-driven to create a low-frequency magnetic field therein. An external electromagnetic meter (not shown) may be used to detect the low-frequency magnetic field of the electromagnetic sensor37and determine the exact location of the electromagnetic sensor37within the removable stylet30.41. The feeding tube apparatus10of embodiment 39 or 40, wherein said electromagnetic sensor37is positioned proximate tip39of removable stylet30. See again,FIG.6.42. The feeding tube apparatus10of any one of embodiments 29 to 41, wherein said removable stylet30has an overall length Lsequal to or greater than an overall length Lcof said catheter20.43. The feeding tube apparatus10of any one of embodiments 29 to 42, wherein said removable stylet30has an overall length Lsgreater than an overall length Lcof said catheter20.44. The feeding tube apparatus10of any one of embodiments 29 to 43, wherein said removable stylet30has an overall length Lsthat is greater than an overall length Lcof said catheter20by about 40 cm. Typically, the catheter20has an overall length Lcranging from about 80 to about 150 cm, while the removable stylet30has an overall length Lsranging from about 78 to about 200 cm.45. The feeding tube apparatus10of any one of embodiments 1 to 44, wherein said carbon dioxide (CO2) sampling line70is present. As shown inFIG.1A-1B, carbon dioxide (CO2) sampling line70may further comprise a filter paper type valve75positioned along (e.g., at a middle position) of the CO2sampling line70that prevents liquid fluid from passing from the patient to a carbon dioxide (CO2) monitor110. The filter paper expands when exposed to fluid occluding the CO2sampling line70but will not expand and block the CO2sampling line70in response to air passing through the CO2sampling line70.46. The feeding tube apparatus10of any one of embodiments 1 to 45, wherein said carbon dioxide (CO2) sampling line70is directly connectable to the catheter20.47. The feeding tube apparatus10of any one of embodiments 1 to 46, wherein said carbon dioxide (CO2) sampling line70is indirectly connectable to the catheter20.48. The feeding tube apparatus10of any one of embodiments 1 to 45 and 47, wherein said carbon dioxide (CO2) sampling line70is connectable to the removable stylet30.49. The feeding tube apparatus10of any one of embodiments 30 to 45 and 47 to 48, wherein said carbon dioxide (CO2) sampling line70is connectable to said stylet hub90of the removable stylet30.50. The feeding tube apparatus10of any one of embodiments 30 to 45 and 47 to 49 wherein said carbon dioxide (CO2) sampling line70is connectable to a port98positioned along said stylet hub90of the removable stylet30.51. The feeding tube apparatus10of any one of embodiments 1 to 50, wherein said carbon dioxide (CO2) sampling line70further comprises a first carbon dioxide (CO2) sampling line connector71that enables connection of said carbon dioxide (CO2) sampling line70to the catheter20or the removable stylet30(e.g., a port98of stylet hub90).52. The feeding tube apparatus10of embodiment 51, wherein said first carbon dioxide (CO2) sampling line connector71comprises a male Luer lock fitting or a female EnFit fitting.53. The feeding tube apparatus10of embodiment 51 or 52, wherein said first carbon dioxide (CO2) sampling line connector71is positioned at said sampling line distal end72.54. The feeding tube apparatus10of any one of embodiments 1 to 53, wherein said carbon dioxide (CO2) sampling line70further comprises a second carbon dioxide (CO2) sampling line connector73that enables connection of said carbon dioxide (CO2) sampling line70to a carbon dioxide (CO2) monitor110.55. The feeding tube apparatus10of embodiment 54, wherein said second carbon dioxide (CO2) sampling line connector73comprises a fitting compatible with (i.e., connectable to) the CO2 monitor.56. The feeding tube apparatus10of embodiment 54 or 55, wherein said second carbon dioxide (CO2) sampling line connector73is positioned at said sampling line proximal end74.57. The feeding tube apparatus10of any one of embodiments 1 to 56, further comprising a carbon dioxide (CO2) monitor110, said sampling line70being connectable to said carbon dioxide (CO2) monitor110so as to provide fluid flow between the catheter20and the carbon dioxide (CO2) monitor110. Suitable carbon dioxide (CO2) monitors for use in the present invention include, but are not limited to, carbon dioxide (CO2) monitors such as monitors made by Philips, Medtronic or Microstream (™).58. The feeding tube apparatus10of any one of embodiments 1 to 57, wherein the carbon dioxide (CO2) sampling line70enables detection of misplacement of the catheter20within a patient's trachea481in less than 45 seconds (sec.).59. The feeding tube apparatus10of any one of embodiments 1 to 58, wherein the carbon dioxide (CO2) sampling line70enables detection of misplacement of the catheter20within a patient's trachea481in less than 30 sec.60. The feeding tube apparatus10of any one of embodiments 1 to 59, wherein the carbon dioxide (CO2) sampling line70enables detection of misplacement of the catheter20within a patient's trachea481in less than 15 sec.61. The feeding tube apparatus10of any one of embodiments 1 to 60, wherein the carbon dioxide (CO2) sampling line70enables detection of misplacement of the catheter20within a patient's trachea481in less than 5 sec.62. The feeding tube apparatus10of any one of embodiments 1 to 61, wherein the carbon dioxide (CO2) sampling line70enables detection of misplacement of the catheter20within a patient's trachea481via a single breath of the patient480.63. The feeding tube apparatus10of any one of embodiments 1 to 62, wherein said suction tube component40is present.64. The feeding tube apparatus10of any one of embodiments 1 to 63, wherein said suction tube component40further comprises (i) one or more openings44(also referred to herein as suction holes44) positioned proximate said suction tube distal end42, and a port45at said suction tube proximate end41.65. The feeding tube apparatus10of any one of embodiments 1 to 64, wherein said suction tube component40further comprises a vent channel47extending from a vent opening49within lumen43, thru and along a wall portion401of said suction tube component40to a vent tube47′ and ending at a vent tube inlet48. See, for example, exemplary vent channel47. As discussed above, exemplary vent channel47(i) prevents suction against the stomach wall of a patient during use, and (ii) connects inside cavity/lumen43of the suction tube component40to air outside of exemplary suction tube component40(and feeding tube apparatus10).66. The feeding tube apparatus10of any one of embodiments 1 to 65, wherein said suction tube component40(i) has an overall length of about 75 cm, and (ii) is positioned about 45 cm from said distal tip25of said catheter20and about 10 cm from said proximate end22of said catheter20.67. The feeding tube apparatus10of any one of embodiments 1 to 66, wherein said suction tube component40is formed from materials such as those described above for catheter20. Typically, suction tube component40is formed from a medical grade plastic material such as a polyvinyl chloride (PVC) or a polyurethane.68. The feeding tube apparatus10of any one of embodiments 1 to 67, wherein said suction tube component40is formed from a medical grade plastic material comprising a PVC or a polyurethane.69. The feeding tube apparatus10of any one of embodiments 1 to 68, wherein said suction tube component40has an outer diameter of from about 5.0 millimeters (mm) to about 10.0 mm, for example, 7.5 mm.
Kits Comprising a Feeding Tube Apparatus:70. A kit100comprising the feeding tube apparatus10of any one of embodiments 1 to 69 in combination with one or more additional kit components.71. The kit100of embodiment 70, wherein the kit100comprises the feeding tube apparatus10, and the carbon dioxide (CO2) sampling line70.72. The kit100of embodiment 70 or 71, wherein the kit100further comprises the suction tube component40.73. The kit100of any one of embodiments 70 to 72, wherein the kit100further comprises a length of thread120(e.g., silk thread) that can (i) be inserted through the one or more openings28within the catheter20, and (ii) redirect the distal end24of catheter20by pulling on the length of thread120.74. The kit100of any one of embodiments 70 to 73, wherein the kit100further comprises a spring guide wire (not shown; see, for example, exemplary spring wire guides in FIGS. 10A-10C of U.S. Pat. No. 9,713,578, the subject matter of which is incorporated herein in its entirety), a syringe288, pH paper (not shown), numbing gel (i.e., that can be applied to a patient's nostril)(not shown), one or more cotton-tipped swabs (not shown), lubricating gel (i.e., for providing a reduced coefficient of friction when inserting the feeding tube distal tip25into the nostril)(not shown), a pulse oximeter (not shown), an electromagnetic meter (not shown), or any combination thereof.
Methods of Using Feeding Devices:75. A method for intubating a patient480(see,FIGS.9A-9C) so as to introduce one or more nutrients into the duodenum460of the patient480, said method comprising: inserting the distal tip25of the catheter20of the feeding tube apparatus10of any one of embodiments 1 to 69 into a patient's nostril; and in response to the carbon dioxide (CO2) sampling line70of the feeding tube apparatus10detecting misplacement of the catheter20within a patient's trachea481, at least partially retracting the catheter20from the patient's nostril to a level above the patient's vocal cords.76. A method for detecting misplacement of a catheter20within a patient's trachea481(see,FIGS.9A-9C), said method comprising: inserting the distal tip25of the catheter20of the feeding tube apparatus10of any one of embodiments 1 to 69 into a patient's nostril; and in response to the carbon dioxide (CO2) sampling line70of the feeding tube apparatus10detecting misplacement of the catheter20within a patient's trachea481, at least partially retracting the catheter20from the patient's nostril to a level above the patient's vocal cords.77. A method for monitoring carbon dioxide (CO2) output of a patient480(see,FIGS.9A-9C), said method comprising: inserting the distal tip25of the catheter20of the feeding tube apparatus10of any one of embodiments 1 to 69 into a patient's nostril; and monitoring carbon dioxide (CO2) exiting the carbon dioxide (CO2) sampling line70of the feeding tube apparatus10.78. The method of any one of embodiments 75 to 77, further comprising directly connecting the carbon dioxide (CO2) sampling line70to the flow-through stylet hub90of the removable stylet30.79. The method of any one of embodiments 75 to 78, further comprising directly connecting the carbon dioxide (CO2) sampling line70to a port98positioned along the stylet hub90of the removable stylet30.80. The method of embodiment 79, further comprising capping any open port in fluid communication with the feeding tube lumen266(e.g., any open hub port82of catheter20and/or any open port98of stylet hub90).81. The method of any one of embodiments 75 to 80, further comprising connecting the carbon dioxide (CO2) sampling line70to the carbon dioxide (CO2) monitor110.82. The method of any one of embodiments 75 to 81, further comprising connecting the patient to a pulse oximeter (not shown). Sedated patients480who are unresponsive to trachea misplacement should be connected to a pulse oximeter and a CO2monitor110compatible with the provided CO2sampling line70.83. The method of any one of embodiments 75 to 82, wherein said inserting step comprises inserting the catheter20through a naris350of the patient480; and when a distal end24of the catheter20is proximate a rear surface482of the nasopharynx483, pulling on and/or holding in place a thread-like member120attached to a tube portion28of the distal end24of the catheter20so as to alter an initial direction A of the distal end24of the catheter20and point the distal end24of the catheter20towards a throat area484of the patient480. This procedure for altering an initial direction A of the distal end of a feeding tube so as to point the distal end of the feeding tube towards the throat of the patient is disclosed in U.S. Pat. No. 10,881,588, which is assigned to the same assignee as the present case, namely, Syncro Medical Innovation, Inc., the subject matter of all of which is hereby incorporated by reference.84. The method of embodiment 83, further comprising advancing the distal end24of the catheter20toward the throat area484of the patient480while pulling on or holding in place the thread-like member120.85. The method of embodiment 84, further comprising advancing the distal end24of the catheter20toward the throat area484of the patient480while holding in place the thread-like member120.86. The method of embodiment 85, further comprising disengaging the thread-like member120from the catheter20; and further advancing the distal end24of the catheter20toward the throat area484of the patient480without the thread-like member120.87. The method of any one of embodiments 75 to 86, further comprising inflating inflatable balloon component282of the catheter20once the distal end24of the catheter20is about 30 centimeters (cm) within the patient480as measured via a 30 cm mark208/244on catheter20. See, for example,FIG.9C.88. The method of embodiment 87, wherein said inflating step comprises using a syringe288(e.g., a provided Luer Lock syringe288) to inflate the inflatable balloon component282.89. The method of embodiment 87 or 88, wherein said inflating step comprises inflating a pilot balloon203in fluid communication with the inflatable balloon component282.90. The method of any one of embodiments 87 to 89, wherein said inflating step comprises injecting about 6.0 cubic centimeters (cc) of air into the inflatable balloon component282and pilot balloon component203.91. The method of any one of embodiments 87 to 90, further comprising observing any end-tidal CO2wave and/or drop in pulse oximeter reading; and in response to detecting an end-tidal CO2 wave or a drop in pulse oximeter reading by about 5 or more points, indicating misplacement in the trachea, deflating the inflatable balloon component282; and withdrawing the catheter20to an 18 cm mark208/245on catheter20. See, for example, exemplary 18 cm mark208/245shown inFIG.9B.92. The method of embodiment 91, after said withdrawing step, re-inserting the distal tip25of the catheter20of the feeding tube apparatus10into the patient's nostril; and proceeding as discussed in any one of embodiments 67 to 81.93. The method of any one of embodiments 75 to 92, wherein the carbon dioxide (CO2) sampling line70enables detection of misplacement of the catheter20within a patient's trachea481in less than 45 seconds (sec.).94. The method of any one of embodiments 75 to 93, wherein the carbon dioxide (CO2) sampling line70enables detection of misplacement of the catheter20within a patient's trachea481in less than 30 sec.95. The method of any one of embodiments 75 to 94, wherein the carbon dioxide (CO2) sampling line70enables detection of misplacement of the catheter20within a patient's trachea481in less than 15 sec.96. The method of any one of embodiments 75 to 95, wherein the carbon dioxide (CO2) sampling line70enables detection of misplacement of the catheter20within a patient's trachea481in less than 5 sec.97. The method of any one of embodiments 75 to 96, wherein the carbon dioxide (CO2) sampling line70enables detection of misplacement of the catheter20within a patient's trachea481via a single breath of the patient480.98. The method of any one of embodiments 75 to 97, further comprising guiding the catheter20of the feeding tube apparatus10through the patient's stomach380until the inflatable balloon component282of the catheter20passes through the pyloric sphincter450; and inflating the inflatable balloon component282of the catheter20so as to allow natural peristalsis of the patient480to further advance the feeding tube apparatus10comprising an inflated balloon component into the patient's duodenum460/470. See, for example,FIG.9D.99. The method of embodiment 98, wherein said inflating step comprises inflating the inflatable balloon component282with water91.100. The method of embodiment 99, wherein said inflating step further comprises closing a valve205to prevent the water91from exiting the inflatable balloon component282.101. The method of embodiment 99 or 100, further comprising turning the patient on the patient's right side, allowing the feeding tube balloon282filled with water91to fall into/towards the pyloric sphincter450by gravity.102. The method of any one of embodiments 98 to 101, wherein said guiding step comprises: introducing a distal tip25of the catheter20into the patient's nose350; and pushing the catheter20through the patient's esophagus and into the patient's stomach380.103. The method of embodiment 102, wherein said guiding step further comprises: advancing the removable stylet30beyond the distal tip25of the catheter20into the patient's duodenum470; and pushing the catheter20over the removable stylet30so as to advance the catheter20.104. The method of any one of embodiments 75 to 103, further comprising removing stomach fluid via suction through the suction tube component40of the feeding tube10.105. The method of any one of embodiments 75 to 104, further comprising checking a pH of an environment around the feeding tube10.106. The method of embodiment 105, wherein said checking step comprises checking the pH of the environment around the feeding tube10via a pH sensor36positioned along the distal end24of the catheter20.107. The method of embodiment 105, wherein said checking step comprises checking the pH of the environment around the feeding tube10via a pH sensor36positioned along the stylet distal end34of the removable stylet30.108. The method of any one of embodiments 75 to 107, further comprising determining a position of the stylet distal end34of the removable stylet30via an electromagnetic sensor37positioned at the stylet distal end34of the removable stylet30.109. The method of embodiment 108, wherein said determining step comprises using an external electromagnetic meter (not shown) to detect the position of the electromagnetic sensor37within the patient480.110. The method of any one of embodiments 75 to 109, wherein said method further comprises: removing the removable stylet30from the catheter20.111. The method of any one of embodiments 75 to 110, wherein said method further comprises: conducting an x-ray procedure so as to verify a position of the catheter20within the patient480.112. The method of any one of embodiments 75 to 111, wherein said method further comprises: delivering one or more nutrients to the patient480through one or more openings28within the catheter20.113. The method of any one of embodiments 75 to 112, further comprising removing the catheter20from the patient480.114. The method of any one of embodiments 75 to 113, further comprising removing the catheter20from the patient480after deflating the inflatable balloon component282.115. The method of any one of embodiments 75 to 114, further comprising advancing the catheter20from a mid-esophagus region to the stomach while the inflatable balloon component282is inflated. This prevents accidental advancing of the catheter20deeper into the patient's lung, puncturing the small distal bronchioles and causing pneumothorax.

The present invention is described above and further illustrated below by way of examples, which are not to be construed in any way as imposing limitations upon the scope of the invention. On the contrary, it is to be clearly understood that resort may be had to various other embodiments, modifications, and equivalents thereof which, after reading the description herein, may suggest themselves to those skilled in the art without departing from the spirit of the present invention and/or the scope of the appended claims.

Example 1

Preparation of Feeding Tube Apparatus

Exemplary feeding tube apparatus as shown inFIGS.1A-8Cwere prepared using conventional steps (e.g., one or more thermoforming steps, and one or more connection/assembly steps).

Example 2

Method of Using Feeding Tube Apparatus

The exemplary feeding tube apparatus formed in Example 1 were used to intubate patients using the following procedure, which is shown inFIGS.9A-9D. The following method steps were used:CO2sampling line70was connected to stylet end hub90of removable stylet30and the side port98(if any) was capped;numbing gel (not shown) was applied to the patient's nostril350using a provided cotton-tipped swab (not shown);silk thread120was inserted into the distal end hole28of the catheter20(see,FIG.9A);lubricating gel (not shown) was applied to the catheter distal tip25and patient's nostril350;both ends121/122of silk thread120were held at a six o'clock position and the feeding tube10was inserted into the patient's nostril350and pushed toward the back of the head to the nasopharynx483;both ends121/122of the thread120were pulled to flex the distal tip25and guide the feeding tube10downward to the oropharynx;the thread120was removed completely (see,FIG.9B);when the 18 cm mark208/245of the feeding tube10was at the patient's nostril350, the patient480was asked to swallow in order to advance the feeding tube10into the esophagus485(see,FIG.9B);when the 30 cm mark208/244of the feeding tube10was at the patient's nostril350, the tube tip25was positioned in the mid-esophagus region486of the patient (Note, coughing was intentionally absent in conscious patients.)(see,FIG.9C);sedated patients who were unresponsive to trachea misplacement were also connected to a pulse oximeter (not shown) and a CO2monitor110compatible with the provided CO2sampling line70;using a Luer Lock syringe288, the tube distal end balloon282and the pilot balloon203were inflated with 6 cc of air and end-tidal CO2wave and pulse oximetry was observed;detection of end tidal CO2wave or drop in pulse oximeter by 5 or more points indicated misplacement of feeding tube10in the trachea481;if misplacement in the trachea481was determined, the balloon282was deflated and the feeding tube10withdrawn from the patient480so that the 18 cm mark208/245was positioned at the patient's nostril350(i.e., to position the feeding tube10in a pre-esophagus region), and the above procedure was repeated; andif there was no detection of end tidal CO2wave or drop in pulse oximeter by 5 or more points (i.e., proper placement of the feeding tube10into the esophagus485), the feeding tube10was advanced into the patient's stomach (FIG.9D) while the inflatable balloon component282is inflated.

It should be understood that although the above-described feeding tube apparatus, kits and methods are described as “comprising” one or more components or steps, the above-described feeding tube apparatus, kits, and methods may “comprise,” “consists of,” or “consist essentially of” any of the above-described components, features or steps of the feeding tube apparatus, kits, and methods. Consequently, where the present invention, or a portion thereof, has been described with an open-ended term such as “comprising,” it should be readily understood that (unless otherwise stated) the description of the present invention, or the portion thereof, should also be interpreted to describe the present invention, or a portion thereof, using the terms “consisting essentially of” or “consisting of or variations thereof” as discussed below.

As used herein, the terms “comprises,” “comprising,” “includes,” “including,” “has,” “having,” “contains”, “containing,” “characterized by” or any other variation thereof, are intended to encompass a non-exclusive inclusion, subject to any limitation explicitly indicated otherwise, of the recited components. For example, a feeding tube apparatus, kit and/or method that “comprises” a list of elements (e.g., components, features, or steps) is not necessarily limited to only those elements (or components or steps), but may include other elements (or components or steps) not expressly listed or inherent to the feeding tube apparatus, kit and/or method.

As used herein, the transitional phrases “consists of” and “consisting of” exclude any element, step, or component not specified. For example, “consists of” or “consisting of” used in a claim would limit the claim to the components, materials or steps specifically recited in the claim except for impurities ordinarily associated therewith (i.e., impurities within a given component). When the phrase “consists of” or “consisting of” appears in a clause of the body of a claim, rather than immediately following the preamble, the phrase “consists of” or “consisting of” limits only the elements (or components or steps) set forth in that clause; other elements (or components) are not excluded from the claim as a whole.

As used herein, the transitional phrases “consists essentially of” and “consisting essentially of” are used to define a feeding tube apparatus, kit and/or method that includes materials, steps, features, components, or elements, in addition to those literally disclosed, provided that these additional materials, steps, features, components, or elements do not materially affect the basic and novel characteristic(s) of the claimed invention. The term “consisting essentially of” occupies a middle ground between “comprising” and “consisting of”.

Further, it should be understood that the herein-described feeding tube apparatus, kits and/or methods may comprise, consist essentially of, or consist of any of the herein-described components and features, as shown in the figures with or without any feature(s) not shown in the figures. In other words, in some embodiments, the feeding tube apparatus, kits and/or methods of the present invention do not have any additional features other than those shown in the figures, and such additional features, not shown in the figures, are specifically excluded from the feeding tube apparatus, kits and/or methods. In other embodiments, the feeding tube apparatus, kits and/or methods of the present invention do have one or more additional features that are not shown in the figures.

While the specification has been described in detail with respect to specific embodiments thereof, it will be appreciated that those skilled in the art, upon attaining an understanding of the foregoing, may readily conceive of alterations to, variations of, and equivalents to these embodiments. Accordingly, the scope of the present invention should be assessed as that of the appended claims and any equivalents thereto.