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Title:
SYSTEMS AND METHODS FOR ENDOGASTRIC TUBE PLACEMENT
Document Type and Number:
WIPO Patent Application WO/2016/160842
Kind Code:
A1
Abstract:
A retaining element improves accurate placement of an endogastric tube within a patient by limiting the displacement of a stylet relative to an endogastric tube. In some embodiments, the retaining element is magnetic and reversibly couples to the stylet. A distal displacement of a self-illuminating stylet is limited, allowing the clinician to assess tube placement without the use of radiography or sonography. A kit allows the stylet to be coupled to the endogastric tube, locking the stylet into place relative to the endogastric tube. A method of use comprises inserting the stylet coupled to the endogastric tube, confirming placement of the endogastric tube, removing the stylet, and administering a medical procedure through the endogastric tube.

Inventors:
EJIKE JANETH CHIAKA (US)
ABD-ALLAH SHAMEL (US)
Application Number:
PCT/US2016/024779
Publication Date:
October 06, 2016
Filing Date:
March 29, 2016
Export Citation:
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Assignee:
FACULTY PHYSCIANS AND SURGEONS OF LOMA LINDA UNIV SCHOOL OF MEDICINE (US)
International Classes:
A61M39/08; A61B90/00; A61J15/00; A61M5/00
Foreign References:
US20120184924A12012-07-19
US20060074374A12006-04-06
US20070287961A12007-12-13
US20040127814A12004-07-01
US20140018732A12014-01-16
Attorney, Agent or Firm:
ALTMAN, Daniel, E. (LLP2040 Main Street, 14th Floo, Irvine CA, US)
Download PDF:
Claims:
THE FOLLOWING IS CLAIMED:

1. A kit comprising:

a stylet comprising:

a cylindrical body formed without a lumen and having no openings, a distal section of the cylindrical body comprising a closed terminal end portion, at least the distal section comprising a light transmission section extending entirely around a circumference of the cylindrical body; and

a plurality of light transmitting elements extending through the cylindrical body and terminating in the light transmission section, each of the light transmitting elements comprising an optical fiber through which a light source can transmit light through the light transmission section; an endogastric tube comprising a lumen extending therethrough and an opening at or near a distal end of the endogastric tube, the stylet being placed within the lumen and having a length which registers the light transmission section of the stylet adjacent the opening of the endogastric tube, whereby light from the light source transmits out of the endogastric tube and in all directions; and

a retaining element comprising:

a first segment comprising a first top rail and a first bottom rail;

a groove disposed between the first top and bottom rails, the groove configured to engage at least a portion of the stylet; and

a distal surface of the retaining element being configured to prevent the stylet from moving distally relative to the endogastric tube when the distal surface interfaces with the endogastric tube.

2. The kit of Claim 1, wherein at least a portion of the first top rail has a magnetic polarity that is opposite to at least a portion of the first bottom rail.

3. The kit of Claim 1, wherein the retaining element further comprises:

a second segment comprising a second top rail and a second bottom rail,

4. The kit of Claim 3, wherein at least a portion of the second top rail has a magnetic polarity that is opposite to at least a portion of the second bottom rail, wherein the second top rail is configured to magnetically couple with the first top rail of the first segment.

5. The kit of Claim 3, wherein the retaining element further comprises an elastic band connected to the first and second segments.

6. The kit of Claim 1, wherein the stylet comprises a coupling interface configured to engage at least a portion of the retaining element.

7. The kit of Claim 6, wherein at least a portion of the coupling interface is made of metal.

8. A method of intubating a patient using the kit of any one of Claims 1-7, the method comprising:

inserting the stylet into the endogastric tube;

coupling the retaining element to the stylet to prevent the stylet from moving distally relative to the endogastric tube;

inserting both the stylet and the endogastric tube through a nasal passage or oral cavity of the patient and into a gastrointestinal tract of the patient;

illuminating the plurality of light transmitting elements; and

examining the abdominal wall and the chest wall of the patient to locate the light and determine proper placement of the endogastric tube within the gastrointestinal tract.

Description:
SYSTEMS AND METHODS FOR ENDOGASTRIC TUBE PLACEMENT

BACKGROUND

Field

[0001] This application is directed to systems and methods for intubating a patient with an endogastric tube. For example but without limitation, embodiments disclosed herein relate to achieving accurate placement of a nasogastric tube within a patient.

Background

[0002] Gastric intubation via the nasal passage (i.e., nasogastric route) is a procedure that provides access to the stomach for diagnostic and therapeutic purposes. Once a nasogastric (NG) tube is in place, healthcare providers can deliver food and medicine directly to the stomach or remove substances from it. NG aspiration can also be used in poisoning situations when a potentially toxic liquid has been ingested, for preparation before surgery under anesthesia, and to extract samples of gastric liquid for analysis.

SUMMARY

[0003] Certain aspects of the present disclosure are directed toward methods and instruments for use in placement of an endogastric tube. However, the concepts disclosed herein are not to be construed as limited to endogastric or nasogastric intubation of a patient. Aspects of the present disclosure may apply to endotracheal tubes, sheath placement, or any other tubular structure that may need placement.

[0004] Therapeutic indications for NG intubation include the following: feeding; gastric decompression, administration of medication; maintenance of a decompressed state after endotracheal intubation, often via the oropharynx; relief of symptoms and bowel rest in the setting of small-bowel obstruction; aspiration of gastric content from recent ingestion of toxic material; and bowel irrigation. [0005] Diagnostic indications for NG intubation include the following: evaluation of upper gastrointestinal (GI) bleeding (e.g., presence, volume); aspiration of gastric fluid content; identification of the esophagus and stomach on a chest radiograph; and administration of radiographic contrast to the GI tract.

[0006] If the NG tube is not properly inserted, the tube can injure the tissue inside the sinuses, throat, esophagus, or stomach. NG tubes can also be mistakenly placed into the lungs, possibly resulting in food or medicine passing into the lungs. Accordingly, great care must be taken to ensure that the tube has not passed through the larynx into the trachea and down into the bronchi.

[0007] To ensure proper placement of an endogastric tube, air is sometimes injected into the tube. If the air is heard in the stomach with a stethoscope, then the tube is in the correct position. Another method of confirming whether the tube is placed properly is to aspirate some fluid from the tube with a syringe. The pH of the aspirated fluid is then tested. If the pH is 5.5 or below then the tube is in the correct position. Another method of verifying tube position is to obtain an X-ray image of the chest/abdomen.

[0008] Although pH, enzyme, bilirubin, and carbon dioxide testing have been used to distinguish respiratory from gastrointestinal placement of NG tubes, none of these methods has enabled detection of tube placement in the esophagus or gastroesophageal junction. Therefore, x-ray verification of tube placement remains a common modern practice. Although radiographic methods are a reliable means of ensuring proper placement of an NG tube, such methods expose the patient to radiation. Additionally, some medical facilities may not have access to radiographic systems.

[0009] Constant exposure to radiation can be especially problematic for pediatric and neonatal patients. Thus, there is a need for simple, cost-effective methods for confirming that an endogastric tube has been properly seated within pediatric and neonatal patient. While the methods and devices herein disclosed are suitable for use in pediatric and neonatal patients, the present disclosure may also be applied to adult patients.

[0010] The present disclosure is directed toward an illuminated stylet and/or illuminated endogastric tube that transmits light that can be visible through the abdominal wall of the patient. The stylet can be positioned in the endogastric tube to facilitate trackability of the endogastric tube through tortuous anatomy. After advancing the stylet and the endogastric tube through a nasal passage or oral cavity of the patient, the abdominal wall and the chest wall of the patient can be examined to locate the light and determine proper placement of the endogastric tube within the gastrointestinal tract. Light appearing between the costal border and the umbilicus of the patient indicates proper placement of the distal end of the endogastric tube within the gastrointestinal tract of the patient, and light appearing superior to the costal border indicates incorrect placement of the distal end of the endogastric tube outside of the gastrointestinal tract of the patient. Additional information regarding the illuminated stylet, the illuminated endogastric tube, or methods of using the illuminated system can be found in U.S. Publication No. 2012/0184924, titled "SELF-ILLUMINATING ENDOGASTRIC TUBES AND METHOD OF PLACING ENDOGASTRIC TUBES," filed January 13, 2012, which is incorporated by reference in its entirety herein.

[0011] Certain aspects of the disclosure are directed toward a retaining element that couples a stylet to an endogastric tube to limit at least the distal displacement of the stylet within the endogastric tube. The retaining element can be a separate structure or a component of the stylet or endogastric tube. The retaining element can include a first segment including a first top rail and a first bottom rail. At least a portion of the first top rail can have a magnetic polarity that is opposite to at least a portion of the first bottom rail. A groove can be disposed between the first top and bottom rails. The groove can be configured to engage at least a portion of the stylet. A distal surface of the retaining element can be configured to prevent the stylet from moving distally relative to the endogastric tube when the distal surface interfaces with (e.g., abuts) the endogastric tube.

BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Various embodiments are depicted in the accompanying drawings for illustrative purposes, and should in no way be interpreted as limiting the scope of the embodiments. Furthermore, various features of different disclosed embodiments can be combined to form additional embodiments, which are part of this disclosure.

[0013] FIGURE 1 illustrates the intubation of a patient with an endogastric tube.

[0014] FIGURE 2 illustrates an embodiment of an endogastric tube. [0015] FIGURE 3 is a front view of an embodiment of a stylet having a coupling interface.

[0016] FIGURE 4 is a perspective view of an embodiment of a retaining element.

[0017] FIGURE 5 is a perspective view of an embodiment of a magnetic retaining element.

[0018] FIGURE 6 is a front cross-sectional view of an embodiment of a retaining element coupled to a stylet that has been inserted into an endogastric tube.

[0019] FIGURE 7 is a top view of an embodiment of a tool used to decouple the retaining element from the stylet.

DETAILED DESCRIPTION

[0020] Light emitting stylets may provide a method for confirming tube placement without the use of expensive medical imaging systems or potentially harmful radiation. Stylets disclosed herein may include a retaining element that restricts migration of the stylet relative to the endogastric tube. Restriction of stylet migration may facilitate accurate placement of the endogastric tube within the patient. The stylet or the endogastric tube may be designed to emit light that can be visualized through the patient's skin, allowing the clinician to determine placement of the endogastric tube. The stylet may be coupled to the endogastric tube, with a distal portion of the stylet designed to emit light that can be visualized outside the patient.

[0021] The retaining elements disclosed herein can be used with commercially available stylets and endogastric tubes. Alternatively and additionally, examples of stylets and endogastric tubes that are suitable for use with the embodiments herein can be found in U.S. Publication No. 2012/0184924, titled "SELF-ILLUMINATING ENDOGASTRIC TUBES AND METHOD OF PLACING ENDOGASTRIC TUBES," filed January 13, 2012, which is incorporated by reference in its entirety herein. The devices and methods herein described encompass, but are not limited to, nasogastric or orogastric intubation.

[0022] FIGURE 1 depicts a nasogastric intubation of a patient. In nasogastric intubation, an endogastric tube 100 is passed through the patient's nose 10, past the throat 12, and down into the stomach 14. Orogastric intubation is similar to nasogastric intubation except the insertion of a plastic tube (orogastric tube) is through the mouth 16, then past the throat 12, and down into the stomach 14. A distal portion 102 of the endogastric tube 100 provides access to the patient's stomach 14.

[0023] FIGURE 2 shows an endogastric tube 100. The distal portion 102 of the endogastric tube 100 can be placed inside the patient, as described above. The proximal portion 104 of the endogastric tube 100 remains outside of the patient and is accessible to the clinician. The endogastric tube 100 can be hollow, having an outer surface 105 and an inner surface 106. The inner surface 106 defines a central lumen 110. The outer surface 105 can be coated with a lubricious material that facilitates insertion of the tube. The inner surface 106 can be coated with a lubricious material that facilitates the passage of a substance or instrument through the central lumen 1 10. In some cases, the lubricious material is hydrophobic (e.g., polytetrafluoroethylene).

[0024] The distal portion 102 of the endogastric tube 100 may include at least one opening 112 at or near a distal end of the endogastric tube 100. In this way, the opening 112 may provide a pathway from the central lumen 110 of the endogastric tube 100 to a patient's stomach 14. The central lumen 1 10 can extend the full length of the endogastric tube 110, communicating with a proximal end 114 of the endogastric tube and fluidically connecting the opening 1 12 at the distal portion 102 with the proximal end 114 of the endogastric tube 100. The central lumen 110 can open onto, and be fluidically connected with, the proximal end 114 of the endogastric tube 100.

[0025] The endogastric tube 100 can be thin-walled. The endogastric tube 100 may be made of low-durometer material to reduce patient discomfort during insertion of the endogastric tube 100. The endogastric tube 100 may be made of soft, medical grade vinyl or medical grade polyurethane. The outer diameter of the endogastric tube 100 may be between about 6 Fr and 24 Fr. In some cases, the outer diameter of the endogastric tube 100 may be between about 10 Fr and 18 Fr. The endogastric tube 100 has a length measured from the proximal end 114 to the distal face 116 of the endogastric tube 100. The length of the endogastric tube 100 may be between about 12 inches and about 72 inches. In some cases, the length of the endogastric tube 100 may be between about 36 inches and about 60 inches. The length of the endogastric tube 100 may be selected from the group of lengths consisting of 36 inches, 48 inches, 55 inches, and 60 inches.

[0026] In some instances, due to the softness and thin-walled construction of the endogastric tube 100, the endogastric tube 100 may tend to kink under compressive force, making insertion of the endogastric tube 100 problematic. A stylet 200 (shown in FIGURE 3) can be used to facilitate intubation of the endogastric tube 100. The stylet 200 can provide enhanced rigidity to the endogastric tube 100, reducing kinking of the endogastric tube 100 during the intubation procedure. The stylet 200 can be inserted into the central lumen 1 10 of the endogastric tube 100.

[0027] The endogastric tube 100 may be cylindrical in shape, having a transverse cross-section that is circular in shape. Although, endogastric tubes having a non-circular transverse cross-section are also within the scope of the present disclosure. For example, the transverse cross-section of the endogastric tube 100 may have a shape that is elliptical or polygonal (e.g., triangular, rectangular, etc.). Endogastric tubes having any of the aforementioned transverse cross-sectional shapes are encompassed by the present disclosure.

[0028] In some instances, the stylet 200 includes a means for indicating the position of the stylet 200. The stylet 200 may emit light to indicate the position of the stylet 200. The stylet 200 may emit light that is visible through the skin of the patient, allowing the clinician to determine the position of the stylet 200 inside the patient.

[0029] In some instances, the endogastric tube 100 may emit light that is visible through the skin of the patient, allowing the clinician to determine the position of the endogastric tube 100 within the patient.

[0030] Migration of the stylet 200 within the endogastric tube 100 may lead to improper placement of the endogastric tube 100. Accordingly, many devices herein disclosed include a means for restricting the migration of the stylet 200 within the endogastric tube 100.

Stylet

[0031] Referring to FIGURE 3, the stylet 200 may be solid. Alternatively, at least a portion of the stylet 200 can be hollow. The stylet 200 can be cylindrical in shape, having a transverse cross-section that is circular in shape. Stylets having a non-circular transverse cross-section are also within the scope of the present disclosure. The transverse cross-section of the stylet 200 may have a shape that is elliptical or polygonal (e.g., triangular, rectangular, etc.). Solid and hollow stylets having any of the aforementioned transverse cross-sectional shapes are encompassed by the present disclosure. The stylet 200 may have a cylindrical body having at least a portion of the stylet 200 being formed without a lumen and having no openings. At least the distal portion of the stylet 200 may include a light transmission section extending entirely around a circumference of the cylindrical body, while a remaining portion of the stylet 200 may be opaque. The stylet may include light transmitting elements (e.g., fiber optics).

[0032] FIGURE 3 shows a stylet 200 that includes a means for restricting the migration of the stylet 200 within the endogastric tube 100. The stylet 200 can include a coupling interface 204 at a proximal portion 202 of the stylet 200. The coupling interface 204 may be integral with the stylet 200. The coupling interface 204 may be cast with the proximal portion 202 of the stylet 200. The coupling interface 204 may be fused or attached to the stylet 200 during the manufacture of the stylet 200. Alternatively, the coupling interface 204 may be a separate piece that is coupled to the stylet 200. The coupling interface 204 may be reversibly coupled to the stylet 200, or the coupling interface 204 may be irreversibly crimped onto the stylet 200.. The coupling interface 204 may be customized to attach to commercially available stylets 200.

[0033] The coupling interface 204 may include a recess 206a or a plurality of recesses 206a,b. The coupling interface 204 may have a flange 210 disposed between two recesses 206a,b. The coupling interface 204 may have a plurality of flanges 210, with each flange 210 of the plurality being disposed along the stylet 200 at different distances from the proximal face 212. The coupling interface 204 may have a plurality of spaced flanges 210 that enables adjustment of the position of the stylet 200 relative the endogastric tube 100. The coupling interface 204 may have an external thread.

Retaining Element

[0034] FIGURE 4 depicts a non-limiting example of a retaining element 300. The retaining element 300 may engage the coupling interface 204 of the stylet 200. Alternatively or additionally, the retaining element 300 may engage at least a portion of the stylet 200 directly. The retaining element 300 may engage a portion of the endogastric tube 100 and/or a portion of the stylet 200.

[0035] The retaining element may include one or more segments 302. At least a portion of the segment 302 may be made of plastic or metal. The retaining element 300 may comprise a plurality of identical segments 302 or a plurality of non-identical segments 302. The segment 302 may be designed to interlock with another segment 302. The segment 302 may be designed to interlock with the coupling interface 204 of the stylet 200 and/or at least a portion of the endogastric tube 100.

[0036] The segment 302 may have a groove 304 designed to engage at least a portion of the coupling interface 204. The groove 304 may engage at least a portion of a flange 210 of the coupling interface 204. The groove 304 may include an internal thread (not shown) designed to engage at least a portion of the stylet 200, or the endogastric tube 100, or both the stylet 200 and the endogastric tube 100.

[0037] The segment 302 may include a cavity 306 designed to accommodate at least a portion of the stylet 200 (e.g., at least a portion of the proximal portion 202 of the stylet 200 or at least a portion of the coupling interface 204). The cavity 306 can be interposed between arms 310a,b of the segment 302. The arms 310a,b can be designed with an inward bias, allowing the segment 302 to couple to the stylet 200 by a snap fit.

[0038] A plurality of segments 302 may couple to the stylet 200. A plurality of segments 302 may form a collar around the stylet 200. The segment 302 may include a tab 312 that engages a slot (not shown) on another segment 302, allowing the segments 302 to couple with one another. The tab 312 can engage at least a portion of the stylet 200 or the endogastric tube 100. The cavity 306 may include an internal thread (not shown) that engages at least a portion of the stylet 200, or the endogastric tube 100, or both the stylet 200 and the endogastric tube 100.

[0039] The segment 302 may have a distal surface 320 that interfaces (e.g., abuts) with at least a portion of the endogastric tube 100. The distal surface 320 may limit the stylet 200 from moving distally within the endogastric tube 100. The distal surface 320 may have a diameter that is larger than the central lumen 110 at the proximal end 1 14 of the endogastric tube 100. The distal surface 320 can prevent the distal surface 320 from moving distally past the proximal end 114 of the endogastric tube 100. The distal surface 320 may restrict the proximal portion 202 of the stylet 200 from moving distally into the endogastric tube 100.

[0040] The segment 302 can have a proximal surface 322 that engages at least a portion of the stylet 200. The proximal surface 322 can limit the stylet 200 from moving distally within the endogastric tube 100. The proximal face 322 of the segment 302 can prevent a distal face 214 of the stylet 200 from moving distally past the proximal face 322. The segment 302 may couple to the endogastric tube 100 but not to the stylet 200, and the proximal face 322 of the segment 302 may engage the distal face 214 of the coupling interface 204, preventing the distal face 214 from moving distally past the proximal face 322.

[0041] Referring to FIGURE 5, the retaining element 300 may include a magnetic member 314a. At least a portion of the magnetic member 314a may be non-magnetic. The magnetic member 314a can couple magnetically with at least a portion of the coupling interface 204. The magnetic member 314a can have a groove 304 disposed between two rails 316a,b. The two rails 316a,b of the magnetic member 314a can have opposite magnetic polarity.

[0042] The retaining element 300 can include a plurality of magnetic members 314a. For example, the retaining element 300 may include a pair of magnetic members 314a,b. The pair of magnetic members 314 a,b can be joined to one another by a band 324. The band 320 can help to orient the magnetic members 314a,b such that the rails 306a,b of the first magnetic member 314a align with rails on the second magnetic member 314b that have an opposite magnetic polarity. The magnetic member 314a may take any of the configurations discussed above for the segment 302. For example, the magnetic member 314a may include a cavity 306 (as shown in FIGURE 4) that is designed to accommodate at least a portion of the stylet 200.

Method of Use

[0043] FIGURE 6 depicts some methods of use of the retaining element 300 disclosed herein (e.g., as shown in Figure 4 or 5). The endogastric tube 100 may include a side port 120 (as shown in FIGURE 6). The stylet 200 may include a means for emitting light. By way of a non-limiting example, the stylet 200 may include fiber optics enabling light emitted from the stylet 200 to be visualized from outside the patient. The retaining element 300 may hold the stylet 200 in place relative to the endogastric tube 100 so that the light emitted by the stylet 200 passes through the window 118 of the endogastric tube 100. Alternatively or additionally, the retaining element 300 can be configured to hold the stylet 200 in position relative to the endogastric tube 100 so that a distal portion of the stylet 200 that emits light protrudes from the distal face 116 of the endogastric tube 100, allowing the light emitted from the distal portion of the stylet 200 to be visualized outside of the patient.

[0044] The retaining element 300 may be attached to either the stylet 200, the endogastric tube 100, or both the stylet 200 and the endogastric tube 100. The retaining element 300 may be attached before the stylet 200 or the endogastric tube 100 is inserted into the patient (the method of insertion being by any of the methods described below). The retaining element 300 may be attached to either the stylet 200, the endogastric tube 100, or both the stylet 200 and the endogastric tube 100 only after the stylet 200 or the endogastric tube 100 is inserted into the patient.

[0045] The stylet 200 may be positioned within the central lumen 1 10 of the endogastric tube 100 before the resulting stylet-endogastric tube assembly is inserted into the patient. The stylet 200 may be removed from the endogastric tube 100 after intubation of the endogastric tube 100 to enable access to the patient's stomach. The stylet 200 may be reinserted into the endogastric tube 100 to confirm placement of the endogastric tube 100 before administering a medical procedure to the patient through the endogastric tube 100. A medical procedure that may be administered to the patient through the endogastric tube 100 includes, but is not limited to, feeding, administering medicine, or removing stomach contents.

[0046] The stylet 200 may be inserted into the endogastric tube 100 and advanced until the light emitting section of the stylet 200 is adjacent an opening at or near a distal end of the endogastric tube 100. The stylet 200 and endogastric tube 100 may then be inserted into the patient. The retaining element 300 may be attached to the stylet 200 or the endogastric tube 100 before insertion of the stylet 200 and endogastric tube 100 into the patient to hold the light emitting section of the stylet 200 adjacent the opening at or near the distal end of the endogastric tube 100 during intubation of the patient. The light transmitting elements of the stylet 200 can be illuminated during intubation, enabling the clinician to visualize the light through the patient's abdominal wall and chest wall to locate the light and determine the proper placement of the endogastric tube 100 within the patient's gastrointestinal tract. Light appearing between the costal border and the umbilicus of the patient indicates proper placement of the distal portion 102 of the endogastric tube, while light appearing superior to the costal border indicates incorrect placement of the distal portion 102 of the endogastric tube 100. Once the endogastric tube 100 has been properly placed within the patient, the stylet 200 can be removed from the endogastric tube 100.

[0047] The scope of the present disclosure encompasses all disclosed coupling methods combined with all possible methods of insertion. By way of a non-limiting example, a retaining element 300 coupled to a portion of the stylet 200 and a portion of the endogastric tube 100 after the stylet 200 has been inserted into the endogastric tube 100 but before the stylet-endogastric tube assembly has been inserted into the patient is one possible method of intubation that is within the scope of the present disclosure. By way of a second non-limiting example, the scope of the present disclosure also includes the method of coupling the retaining element 300 to the stylet 200 and then inserting the retaining element-stylet assembly into an endogastric tube 100 that has already been inserted into a patient. This second example of one of the disclosed methods of use may be useful, for example, to confirm correct placement of the endogastric tube 100 before administering a medical procedure through the endogastric tube 100.

[0048] The retaining element 300 may be reversibly coupled to the stylet 200 or the endogastric tube 100. The retaining element 300 may be removed from the stylet 200 or from the endogastric tube 100 by use of a tool 400 (see FIGURE 7).

[0049] Referring to FIGURE 7, the tool 400 may be scissors-like, having a hand grip 402 and a tip 404. The tip 404 may be designed to engage a portion of the groove 304 and the retaining element 300. The tip 404 may be designed to pry the retaining element 300 off of the stylet 200. A first tip 404 of the tool 400 may be designed to engage at least a portion of the groove 304 on a first segment 302 of the retaining element 300 while a second tip 404 of the tool 400 engages a portion of the groove 304 on a second segment 302 of the retaining element 300, and activation of the hand grip 402 of the tool 400 may drive apart the first tip 404 from the second tip 404, resulting in prying apart the first segment 302 from the second segment 302, thereby decoupling the retaining element 300 from the stylet 200.

[0050] The tool 400 can include a friction member 406. The friction member 406 can be designed to engage at least a portion of the retaining element 300. The friction element 406 can hold the retaining element 300 fixed relative to the tool 400 as the tool 400 is twisted around the stylet 200. Twisting the retaining element 300 around the stylet 200 with the tool 400 can result in decoupling the retaining element 300 from the stylet 200.

[0051] The tool 400 can include a spring 410. The spring 410 can push apart a pair of handles 412. The spring 410 can pull the handles 412 toward one another. The tool 400 can include a pair of blades 414 joined together by a pin 416. Each blade 414 may include an intermediate shaft 420 that is inwardly biased toward the other intermediate shaft 420 so that the tips 404 of the blades 414 approach one another as the handles 402 of the tool 400 are moved apart from one another. The intermediate shaft 420 may be designed so that the tips 404 move apart from one another as the handles 402 move apart from one another. Terminology

[0052] "Stylet" is a broad term that is to be given its ordinary and customary meaning to a person of ordinary skill in the art (i.e., it is not to be limited to a special or customized meaning and includes, without limitation, an implement used to enhance the rigidity of another member).

[0053] "Endogastric tube" is a broad term that is to be given its ordinary and customary meaning to a person of ordinary skill in the art (i.e., it is not to be limited to a special or customized meaning and includes, without limitation, a tubular structure inserted into a passageway of a patient).

[0054] "Illuminate" is a broad term that is to be given its ordinary and customary meaning to a person of ordinary skill in the art (i.e., it is not to be limited to a special or customized meaning and includes, without limitation, to emit or provide with light).

[0055] Although certain embodiments have been described herein with respect to nasogastric or orogastric intubation of pediatric or neonatal patients, the devices and methods described herein can include tube of adult patients. For example, in some embodiments, the methods and devices disclosed herein may be used to place a sheath inside an adult patient. [0056] Although certain embodiments have been described herein with respect to a coupling interface on or secured to the stylet, the coupling interface can alternatively or additionally be on or secured to the endogastric tube.

[0057] As used herein, the relative terms "proximal" and "distal" shall be defined from the perspective of the treating clinician. Thus, proximal refers to a portion of a device that is closer to the treating clinician and distal refers to a portion of the device that is farther from the treating clinician. For example, when a clinician intubates a patient with an endogastric tube, the portion of the tube that remains outside of the patient is "proximal" relative to the portion of the tube that has been inserted into the patient.

[0058] Conditional language, such as "can," "could," "might," or "may," unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements, and/or steps. Thus, such conditional language is not generally intended to imply that features, elements, and/or steps are in any way required for one or more embodiments.

[0059] The terms "comprising," "including," "having," and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term "or" is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term "or" means one, some, or all of the elements in the list.

[0060] The terms "approximately," "about," and "substantially" as used herein represent an amount close to the stated amount that still performs a desired function or achieves a desired result. For example, the terms "approximately", "about", and "substantially" may refer to an amount that is within than 10% of the stated amount, as the context may dictate.

[0061] The ranges disclosed herein also encompass any and all overlap, subranges, and combinations thereof. Language such as "up to," "at least," "greater than," "less than," "between" and the like includes the number recited. Numbers preceded by a term such as "about" or "approximately" include the recited numbers. For example, "about 12 inches mm" includes "12 inches mm." [0062] Although certain embodiments and examples have been described herein, it will be understood by those skilled in the art that many aspects of the illuminated stylet or illuminated endogastric tube shown and described in the present disclosure may be differently combined and/or modified to form still further embodiments or acceptable examples. All such modifications and variations are intended to be included herein within the scope of this disclosure. A wide variety of designs and approaches are possible. No feature, structure, or step disclosed herein is essential or indispensable.

[0063] Some embodiments have been described in connection with the accompanying drawings. However, it should be understood that the figures are not drawn to scale. Distances, angles, etc. are merely illustrative and do not necessarily bear an exact relationship to actual dimensions and layout of the devices illustrated. Components can be added, removed, and/or rearranged. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in connection with various embodiments can be used in all other embodiments set forth herein. Additionally, it will be recognized that any methods described herein may be practiced using any device suitable for performing the recited steps.

[0064] For purposes of this disclosure, certain aspects, advantages, and novel features are described herein. It is to be understood that not necessarily all such advantages may be achieved in accordance with any particular embodiment. Thus, for example, those skilled in the art will recognize that the disclosure may be embodied or carried out in a manner that achieves one advantage or a group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.

[0065] Moreover, while illustrative embodiments have been described herein, the scope of any and all embodiments having equivalent elements, modifications, omissions, combinations (e.g., of aspects across various embodiments), adaptations and/or alterations as would be appreciated by those in the art based on the present disclosure. The limitations in the claims are to be interpreted broadly based on the language employed in the claims and not limited to the examples described in the present specification or during the prosecution of the application, which examples are to be construed as non-exclusive. Further, the actions of the disclosed processes and methods may be modified in any manner, including by reordering actions and/or inserting additional actions and/or deleting actions. It is intended, therefore, that the specification and examples be considered as illustrative only, with a true scope and spirit being indicated by the claims and their full scope of equivalents.

[0066] Any methods disclosed herein need not be performed in the order recited. The methods disclosed herein include certain actions taken by a practitioner; however, they can also include any third-party instruction of those actions, either expressly or by implication. For example, actions such as "inserting the stylet and endogastric tube through a nasal passageway" include "instructing another to insert the stylet and endogastric tube through a nasal passageway."

EXAMPLE EMBODIMENTS

[0067] The following example embodiments identify some possible permutations of combinations of features disclosed herein, although other permutations of combinations of features are also possible.

1. A kit comprising:

a stylet comprising:

a cylindrical body formed without a lumen and having no openings, a distal section of the cylindrical body comprising a closed terminal end portion, at least the distal section comprising a light transmission section extending entirely around a circumference of the cylindrical body; and

a plurality of light transmitting elements extending through the cylindrical body and terminating in the light transmission section, each of the light transmitting elements comprising an optical fiber through which a light source can transmit light through the light transmission section; an endogastric tube comprising a lumen extending therethrough and an opening at or near a distal end of the endogastric tube, the stylet being placed within the lumen and having a length which registers the light transmission section of the stylet adjacent the opening of the endogastric tube, whereby light from the light source transmits out of the endogastric tube and in all directions; and

a retaining element comprising: a first segment comprising a first top rail and a first bottom rail, at least a portion of the first top rail having a magnetic polarity that is opposite to at least a portion of the first bottom rail;

a groove disposed between the first top and bottom rails, the groove configured to engage at least a portion of the stylet; and

a distal surface of the retaining element can be configured to prevent the stylet from moving distally relative to the endogastric tube when the distal surface interfaces with the endogastric tube.

2. The kit of embodiment 1, wherein the retaining element further comprises: a second segment comprising a second top rail and a second bottom rail, at least a portion of the second top rail having a magnetic polarity that is opposite to at least a portion of the second bottom rail, wherein the second top rail is configured to magnetically couple with the first top rail of the first segment.

3. The kit of any one of the embodiments above, wherein the retaining element further comprises an elastic band connected to the first and second segments.

4. The kit of any one of the embodiments above, wherein the stylet comprises a coupling interface configured to engage at least a portion of the retaining element.

5. The kit of embodiment 4, wherein at least a portion of the coupling interface is made of metal.

6. A method of intubating a patient using the kit of any one of the embodiments above, the method comprising:

inserting the stylet into the endogastric tube;

coupling the retaining element to the stylet to prevent the stylet from moving distally relative to the endogastric tube;

inserting both the stylet and the endogastric tube through a nasal passage or oral cavity of the patient and into a gastrointestinal tract of the patient;

illuminating the plurality of light transmitting elements; and

examining the abdominal wall and the chest wall of the patient to locate the light and determine proper placement of the endogastric tube within the gastrointestinal tract.