The present disclosure provides a device that includes a tube having a first end and a second end. The device also includes a stopper coupled to a surface of the tube adjacent to the second end of the tube. The stopper is configured to extend radially from the surface of the tube. The device also includes a first rib coupled to the surface of the tube. The device also includes a second rib coupled to the surface of the tube. The first rib and the second rib are positioned opposite one another on the surface of the tube between the first end of the tube and the stopper.

BACKGROUND THE INVENTION

Gastrostomy tubes are used by medical professionals to facilitate delivery of enteral nutrition in critically ill patients who are unable to tolerate receiving nutrition by mouth. Gastrostomy tubes are placed through the abdominal wall into the stomach. Liquid feed is delivered directly through the tube into the stomach thus bypassing the upper digestive system. A conventional design of a gastrostomy tube includes a long tube with a cuffed end that sits within the stomach holding the stomach against the abdominal wall. The tubular portion passes through the abdominal wall and is of sufficient length to facilitate the delivery of liquid feed to the stomach. The external portion of the tube is approximated to the skin by a movable bolster. Gastrostomy tubes may be placed in a patient for several weeks or indefinitely, depending on the needs of each particular patient.

Historically, patients who have gastrostomy tubes would be characterized as having limited activity and mobilization, heavy and prolonged sedation, and those patients who require use of physical restraints by nurses with many years of intensive care unit (“ICU”) experience. Today, patients who have gastrostomy tubes may be characterized by frequent mobilization, light to minimal sedation, and no physical restraints provided by nurses with much less ICU experience. On account of this transition in ICU practice, a gastrostomy tube dislodgment event may be more likely.

Dislodgment occurs when forces pull on the long external portion of the tube, which may result in the migration of the cuffed intra-gastric portion of the tube out of the stomach and into the abdominal wall. This migration occurs because the gastrostomy tube cannot be definitively secured to the abdominal wall. The dislodgment may or may not be noticed until the patient becomes critically ill as a consequence of feeds or gastric contents leaking into the abdominal cavity. The consequences of dislodgment may be severe, including but not limited to, major emergency surgery, significant morbidity, prolonged ICU stays, significant increases in healthcare expenditures, and, not uncommonly, death. While recurrent education of caregivers and efforts to increase awareness of gastrostomy tube risks helps prevent such complications, the inherent design of the traditional gastrostomy tube promotes dislodgment on account of the long external segment that lacks an effective anchoring mechanism to the body that will resist dislodgment. Therefore, an improved percutaneously placed trans-abdominal gastric feeding tube may be desirable.

SUMMARY OF THE INVENTION

The present disclosure provides a percutaneously placed tube of variable lumen size with a stopper at the gastric end with a flanged body that integrates with an external locking mechanism to hold the tube at optimal depth and allow redundant external tubes to be excised so as to resist external forces and avoid causing dislodgment.

In particular, in a first aspect, a device is provided that includes: (a) a tube having a first end and a second end, (b) a stopper coupled to a surface of the tube adjacent to the second end of the tube, where the stopper is configured to extend radially from the surface of the tube, (c) a first rib coupled to the surface of the tube, and (d) a second rib coupled to the surface of the tube, where the first rib and the second rib are positioned opposite one another on the surface of the tube between the first end of the tube and the stopper.

In a second aspect, a locking mechanism is provided that includes: (a) a first component having a first end and a second end, the first component comprising: (i) a first depression on a mating face of the first component, (ii) a first protrusion coupled to the mating face of the first component and positioned between the first depression and the first end of the first component, and (iii) a second protrusion coupled to the mating face of the first component and positioned between the first depression and the second end of the first component, and (b) a second component having a first end and a second end, the second component comprising: (i) a second depression on a mating face of the second component, (ii) a first cavity arranged on the mating face of the second compartment and positioned between the second depression and the first end of the second component, where the first cavity is configured to receive the first protrusion, and (iii) a second cavity arranged on the mating face of the second component and positioned between the second depression and the second end of the second component, where the second cavity is configured to receive the second protrusion.

In a third aspect, a cap is provided that includes: (a) a tubular structure having a first end and a second end, where the tubular structure defines a lumen, (b) a flange coupled to the second end of the tubular structure, (c) a first input port coupled to the flange, and (d) a first channel defined in the flange and configured to provide fluid connection between the first input port and the tubular structure.

In a fourth aspect, a kit is provided that includes the device of the first aspect and the locking mechanism of the second aspect.

In a fifth aspect, a kit is provided that includes the locking mechanism of the second aspect and the cap of the third aspect.

In a sixth aspect, a kit is provided that includes the device of the first aspect, the locking mechanism of the second aspect, and the cap of the third aspect.

In a seventh aspect, a system is provided that includes the device of the first aspect coupled to the locking mechanism of the second aspect, where the first protrusion is positioned at least partially within the first cavity, where the second protrusion is positioned at least partially within the second cavity, and where the first depression and the second depression are positioned around the surface of the tube such that the mating face of the first component contacts the mating face of the second component.

In an eighth aspect, a system is provided that includes the device of the first aspect coupled to the locking mechanism of the second aspect, where the first protrusion is positioned at least partially within the first cavity, where the second protrusion is positioned at least partially within the second cavity, where the third protrusion pierces the first rib and is positioned at least partially within the third cavity, where the fourth protrusion pierces the second rib and is positioned at least partially within the fourth cavity, and where the first depression and the second depression are positioned around the surface of the tube such that the mating face of the first component contacts the mating face of the second component.

DETAILED DESCRIPTION OF THE INVENTION

Exemplary devices, kits, systems and methods are described herein. It should be understood that the word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any embodiment or feature described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments or features. The exemplary embodiments described herein are not meant to be limiting. It will be readily understood that certain aspects of the disclosed devices, kits, systems and methods can be arranged and combined in a wide variety of different configurations, all of which are contemplated herein.

As used herein, with respect to measurements, “about” means +/−5%.

As used herein, “French” refers to a unit of measurement for a catheter. A round catheter of 1 French has an external diameter of ⅓ mm, and therefore the diameter of a round catheter in millimeters can be determined by dividing the French size by 3.

As used herein, “coupled” means associated directly, as well as indirectly. For example, a member A may be directly associated with a member B, or may be indirectly associated therewith, via another member C. It will be understood that not all relationships among the various disclosed elements are necessarily represented.

Reference herein to “one embodiment” or “one example” means that one or more feature, structure, or characteristic described in connection with the example is included in at least one implementation. The phrases “one embodiment” or “one example” in various places in the specification may or may not be referring to the same example.

With respect to the Figures,FIG. 1illustrates an example device100including a tube102having a first end104and a second end106. The device100may further include a stopper108coupled to a surface110of the tube adjacent to the second end106of the tube102. The stopper108may be configured to extend radially from the surface110of the tube102. The device100may further include a first rib112coupled to the surface110of the tube102. In addition, the device may include a second rib114coupled to the surface110of the tube102. The first rib112and the second rib114are positioned opposite one another on the surface110of the tube102between the first end104of the tube104and the stopper108.

The tube102may have a length ranging from about 15 cm to about 30 cm, and the tube102may have a diameter ranging from about 4 mm (12 French) to about 8 mm (24 French). The length of the tube102accommodates variable thickness abdominal walls to hold the tube102securely in place when in use. The length of the intra-gastric portion of the tube102may range from about 1 cm to about 3 cm. The first rib112and the second rib114may have a length (in a direction parallel to a longitudinal axis of the tube) ranging from about 10 cm to about 15 cm, a width (in a direction perpendicular to a longitudinal axis of the tube) ranging from about 4 mm to about 8 mm, and a thickness ranging from about 1 mm to about 3 mm. In one example, the tube102has an adjustable length. In particular, as shown inFIG. 1, a portion115of the tube102between the stopper110and the first and second ribs112,114may be adjustable. Other portions of the tube102may be adjustable as well. In such examples, the tube102may include a helical section, an accordion section, or a coiled section that are able to expand or contract in response to a force (e.g., push-pull force). Other example expandable configurations are possible as well. Such an adjustable length of the tube102enables a single tube to work for a variety of patients with a variety of sized abdominal walls. In yet another example, the tube102has a first lumen and a second lumen that is separate from the first lumen. In such an example, a gastronomy tube may be positioned in the first lumen and a jejunostomy tube may be positioned in the second lumen. Other example tubes positioned in the first and second lumens are possible as well.

In one example, the tube102comprises a material capable of being compressed and returned to an original shape, including, but not limited to, a polymer material such as PLGA (poly-pactic-co-glycolic acid), PCL (poly-caprolactone) or PMMA (poly-methyl-methacrylate), rubber, silicone or combinations thereof. In one example, the first and second ribs112,114and/or the stopper108may comprise the same material as the tube102. In another example, the first and second ribs112,114and/or the stopper108may comprise a different material than the tube102. For example, the first and second ribs112,114may comprise a more flexible material than the other components of the device100. In yet another example, the stopper108may comprise a less flexible material than the other components of the device100. Other examples are possible as well.

The stopper108may be configured to sit within the stomach and hold the stomach against the abdominal wall. The stopper108is configured to resist external dislodgment forces, yet may be flexible enough to allow the tube102to be extracted when it is no longer needed. The stopper108may be composed of a radio-opaque material such that computed tomography imaging or fluoroscopy can delineate how much of the tube102is positioned within the stomach if concern about extraction exists or to confirm accurate placement.

In one particular example, the stopper108comprises a single helical blade. In another example, as shown inFIG. 1, the stopper108comprises two helical blades116A,116B. In such examples, the helical blade(s)116A,116B may be flexible. The helical blade(s)116A,116B may have a diameter of about 25 mm and a length of about 2.5 mm, for example. In another example, the stopper108comprises a flange having a rounded dome defining a cavity arranged such that the dome faces the first end104of the tube102and the cavity faces the second end106of the tube102. In yet another example, the stopper108comprises an inflatable balloon that may be inflated and expand radially once the second end106of the tube102is positioned in the stomach of the patient. Other example stoppers are possible as well.

In one example, the first rib112and the second rib114are configured to be pierceable, as discussed in additional detail below. In another example, the first rib112and the second rib114include a plurality of through-holes. In another example, the first rib112and the second rib114each include a single channel. Further, the first rib112and the second rib114may be tapered at one end arranged nearest the first end104of the tube102, as shown inFIG. 1. Having the end of the ribs112,114nearest the first end104of the tube102tapered may enable easier removal of the tube102from a patient after use. In another embodiment, the first rib112and the second rib114may be tapered at the end arranged nearest the second end106of the tube102.

The device100may further include a plurality of measurement markings118on the surface110of the tube102. These measurement markings118may provide an indication to a medical professional of a depth of the tube102within the patient. The device100may further include a conical tip120coupled to the first end104of the tube102, and a loop122coupled to a tapered end124of the conical tip120. This configuration may be used to assist in percutaneous placement and removal of the device100. In particular, during placement of the device100, the device100is positioned in the mouth of the patient and down the throat into the stomach. Once the device100is located in the stomach of the patient, the medical professional makes a small incision to provide an access cite to the stomach from outside of the patient. The medical professional then snags the loop122of the device100through the access site, and pulls the device100through the access site. The stopper108then abuts the abdominal wall from inside the stomach of the patient, thereby preventing the device100from being pulled completely out of the stomach of the patient.

The device100described above and shown inFIG. 1may be secured against the abdominal wall by a locking mechanism200as shown inFIGS. 2-6. In particular, as shown inFIG. 2, the locking mechanism200may include a first component202having a first end204and a second end206. The first component202may include a first depression208on a mating face210of the first component202. The first component202may also include a first protrusion212coupled to the mating face210of the first component202and positioned between the first depression208and the first end204of the first component202. The first component202may also include a second protrusion214coupled to the mating face210of the first component202and positioned between the first depression208and the second end204of the first component202. The locking mechanism200may further include a second component216having a first end218and a second end220, and may include a second depression222on a mating face224of the second component216. The second component216may also include a first cavity226arranged on the mating face224of the second component216and positioned between the second depression222and the first end218of the second component216. In use, the first cavity226is configured to receive the first protrusion212. The second component216may also include a second cavity228arranged on the mating face224of the second component216and positioned between the second depression222and the second end220of the second component216. In use, the second cavity228is configured to receive the second protrusion214.

In another example, the first component202may include a first protrusion212coupled to the mating face210of the first component202and positioned between the first depression208and the first end204of the first component202. The first component202may also include a first cavity226arranged on the mating face210of the first component202and positioned between the first depression208and the second end204of the first component202. In such an example, the second component216may also include a second protrusion214arranged on the mating face224of the second component216and positioned between the second depression222and the first end218of the second component216. The second component216may also include a second cavity228arranged on the mating face224of the second component216and positioned between the second depression222and the second end220of the second component216. In use, the first cavity226is configured to receive the first protrusion212and the second cavity228is configured to receive the second protrusion214.

In one example, a system is provided that includes the device100, as described above, coupled to the locking member200, as described above. Specifically, the first protrusion212is configured to pierce the first rib112and is positioned at least partially within the first cavity226and the second protrusion214is configured to pierce the second rib114and is positioned at least partially within the second cavity228. In addition, the first depression208and the second depression222are positioned around the surface110of the tube102such that the mating face210of the first component202contacts the mating face224of the second component216.

In another example, the first rib112and the second rib114include a plurality of through-holes. In such an example, the first protrusion212is configured to be positioned through one of the plurality of through-holes of the first rib112and is positioned at least partially within the first cavity226. The second protrusion214is likewise configured to be positioned through one of the plurality of through-holes of the second rib114and is positioned at least partially within the second cavity228. And the first depression208and the second depression222are positioned around the surface110of the tube102such that the mating face210of the first component202contacts the mating face224of the second component216.

In another example, the first rib112and the second rib114each include a single channel. In such an example, the first protrusion212is configured to be positioned through the single channel of the first rib112and is positioned at least partially within the first cavity226, the second protrusion214is configured to be positioned through the single channel of the second rib114and is positioned at least partially within the second cavity228, and the first depression208and the second depression222are positioned around the surface110of the tube102such that the mating face210of the first component202contacts the mating face224of the second component216.

In yet another example, the first rib112and the second rib114are configured to be pinched between the mating face210of the first component202and the mating face224of the second component216. In such an example, the first depression208and the second depression222are positioned around the surface110of the tube102. Further, a first portion of the mating face210of the first component202contacts a first side of the first rib112, and a first portion of the mating face224of the second component216contacts a second side of the first rib112to thereby pinch the first rib112between the mating face210of the first component202and the mating face224of the second component216. Further, a second portion of the mating face210of the first component202contacts a first side of the second rib114, and a second portion of the mating face224of the second component216contacts a second side of the second rib114to thereby pinch the second rib114between the mating face210of the first component202and the mating face224of the second component216.

In one example, the first component202and the second component216each have a length ranging from about 25 mm to about 40 mm. Further, the first component202and the second component216independently range in width from about 10 mm to about 40 mm. In one example, the width of the first component202is equal to the width of the second component216. In another example, the width of the first component202is different than the width of the second component216. For example, the first component202may have a width ranging from about 25 mm to about 40 mm, and the width of the second component216may have a width ranging from about 10 mm to about 25 mm. Further, the first component202and the second component216each have a width ranging from about 10 mm to about 15 mm. In addition, the first depression208and the second depression222each have a diameter ranging in size from about 4 mm to about 10 mm to accept tubes ranging from, but not limited to, 12 French to 24 French size. In one example, the bottom surface230of the first component202and the bottom surface232of the second component216include an adhesive, which may be used to further secure the locking mechanism200to the stomach of the patient when the system is in use. In another example, the first component202may include through holes221A,221B and the second component may include through holes221C,221D, through which a suture223can be placed to further secure the location of the locking device200to the skin of the patient. Such an arrangement further secures the locking mechanism200to the skin of the patient and helps to prevent extraction when changing caps300.

As described above, when in use, the first protrusion212is configured to be positioned at least partially within the first cavity226, and the second protrusion214is positioned at least partially within the second cavity228such that the first component202and the second component216are coupled to one another to form a collar203around a tube102that has been placed at least partially in vivo. The coupling of the first component202to the second component216may be a permanent coupling, such that once the first protrusion212is positioned within the first cavity226and the second protrusion214is positioned within the second cavity228, the protrusions212,214cannot be removed from the cavities226,228. In such an example, the entire device100and locking mechanism200system may be pulled in a direction away from the body of the patient to remove the tube102when the tube102is no longer needed, and the entire system is discarded. In another example, the coupling of the first component202to the second component216may be a temporary coupling such that the first component202can be separated from the second component216after use. In such an example, only the tube102is discarded, and the locking mechanism200can be reused.

In one example, as shown inFIG. 2, a free end233of the first protrusion212has a first radially extending rim234and a free end235of the second protrusion214has a second radially extending rim236. In such an example, the first protrusion212is configured to pierce the first rib112of the device100, and the first cavity226is configured to receive the first protrusion212and engage the first radially extending rim234. Similarly, the second protrusion214is configured to pierce the second rib114of the device100, and the second cavity228is configured to receive the second protrusion214and engage the second radially extending rim236to thereby lock the first component202to the second component216to form a collar203around the tube102.

In another example, as shown inFIG. 3, the first component202may further include a third protrusion238coupled to the mating face210of the first component202and positioned between the first depression208and the first protrusion212, and a fourth protrusion240coupled to the mating face210of the first component202and positioned between the first depression208and the second protrusion214. In such an example, the second component216further includes a third cavity242within the mating face224of the second component216and positioned between the second depression222and the first cavity226. In this arrangement, the third cavity242is configured to receive the third protrusion238. The second component216further includes a fourth cavity244within the mating face224of the second component216and positioned between the second depression222and the second cavity228. In this arrangement, the fourth cavity244is configured to receive the fourth protrusion240.

In operation, the first component202may be snap-fit to the second component216via the first protrusion212interacting with the first cavity226and the second protrusion214interacting with the second cavity228. As such, the first and second depressions208,222of the locking mechanism200are configured to be positioned around the surface110of the tube102such that the mating face210of the first component202contacts the mating face224of the second component216after the tube102has been placed at least partially in vivo. The third protrusion238is configured to pierce the first rib112of the device100, and the third cavity242is configured to receive the third protrusion238. Similarly, the fourth protrusion240is configured to piece the second rib114of the device100, and the fourth cavity244is configured to receive the fourth protrusion240.

In such an example, the present disclosure provides a system comprising the device100as described above coupled to the locking member200as just described in relation toFIG. 3, where the first protrusion212is positioned at least partially within the first cavity226, where the second protrusion214is positioned at least partially within the second cavity228, where the third protrusion238pierces the first rib112and is positioned at least partially within the third cavity242, where the fourth protrusion240pierces the second rib114and is positioned at least partially within the fourth cavity244, and where the first depression108and the second depression222are positioned around the surface110of the tube102such that the mating face210of the first component202contacts the mating face224of the second component216. Such an arrangement is illustrated inFIG. 4. The tube102can be cut flush with the top of the locking mechanism200to help prevent dislodgement of the tube102for the patient, as shown inFIG. 4.

FIG. 5Aillustrates a side view of the locking mechanism200, particularly illustrating the free end233of the first protrusion212with a first radially extending rim234, and the first cavity226is shown configured to receive the first protrusion212and engage the first radially extending rim234.FIG. 5Billustrates a top view of the locking mechanism200when the first and second components202,216are joined together to form a collar203around the tube102.

In one example, an outer portion246of the first component202and an outer portion248of the second component216are rotatable with respect to the first protrusion212and the second protrusion214when the first protrusion212is positioned in the first cavity226and the second protrusion214is positioned in the second cavity228. Such an arrangement may help relieve tension and/or tugging on the tube102as the patient moves. In one particular example, as shown inFIG. 5B, the first and second components202,216include a ball bearing system250that enables the outer portion246of the first component202and the outer portion248of the second component216to rotate with respect to the first protrusion212and the second protrusion214when the first protrusion212is positioned in the first cavity226and the second protrusion214is positioned in the second cavity228. Other mechanisms to enable rotation are possible as well.

FIG. 6illustrates another embodiment of the locking mechanism200. As shown inFIG. 6, the first component202may further comprise a third depression252on the mating face208of the first component202, and the second component216may further comprise a fourth depression254on the mating face224of the second component216. In such an example, a gastronomy tube may be positioned between the first depression208and the second depression220when the first component202and the second component216are locked together, and a jejunostomy tube may be positioned between the third depression252and the fourth depression254. Other example tubes are possible as well. In one example, the radius of each of the first depression208, the second depression222, the third depression252, and the fourth depression254are the same. In another example, a radius of the first depression208and the second depression222are the same, and the radius of the third depression252and the fourth depression254are the same, but the radius of the first depression208and second depression222is different than the radius of the third depression252and the fourth depression254.

There are several advantages to the design of the system of the device100and locking mechanism200as described above, including (i) the accommodation of variable abdominal wall thicknesses, (ii) the tube102may be cut flush with the locking mechanism200to prevent external forces from inadvertently pulling it out, and (iii) the locking mechanism200has a low profile to further protect the integrity of the placement of the tube102.

The present disclosure also provides a cap300, as shown inFIGS. 7A-10B. In particular, as shown inFIGS. 7A-7B, the cap300may include a tubular structure302having a first end304and a second end306. The tubular structure302defines a lumen308. The cap300may also include a flange310coupled to the second end306of the tubular structure302. In one embodiment, the flange310is circular. In another embodiment, the flange310is square. The flange310may be shaped to match a shape of the locking mechanism200described above. Other arrangements are possible as well. The cap300may also include a first input port312coupled to the flange310. The cap300may also include a first channel314defined in the flange310and configured to provide fluid connection between the first input port312and the tubular structure302.

The tubular structure302may have a diameter ranging from about 2 mm to about 5 mm. The flange310may have a thickness ranging from about 15 mm to about 30 mm, and a width ranging from about 30 mm to about 40 mm. The cap300may comprise a material having shape memory, including, but not limited to, a polymer material such as PLGA (poly-pactic-co-glycolic acid), PCL (poly-caprolactone) or PMMA (poly-methyl-methacrylate), rubber, silicone or combinations thereof.

As shown inFIGS. 7A-7B, the cap may further include a second input port318coupled to the flange310, and a second channel320defined in the flange310and configured to provide fluid connection between the second input port318and the tubular structure302. Such an arrangement may enable a practitioner to provide two substances to the stomach of the patient at the same time (e.g., both medication and food). In one example, the longitudinal axis of the lumen308is perpendicular to the longitudinal axis of the first channel314, and the longitudinal axis of the first channel is parallel to the longitudinal axis of the second channel320. Such an arrangement may provide a low-profile system when tubes322are positioned in the first input port312and the second input port318, as shown inFIG. 7B.

In another embodiment, the cap300may also include a first plug316removably positioned in the first input port312to thereby close access to the first channel314, as shown inFIG. 7B. Further, the cap300may include a second plug317removably positioned in the second input port318to thereby close access to the second channel320. In one example, the first plug316and/or the second plug317are permanently coupled to the flange310and/or are created integrally as a single piece with the flange310.

In one embodiment, the flange310is closed to an environment surrounding the cap300other than via the first input port312and the tubular structure302. Further, the first input port312may be configured to be reversibly opened and closed. In one such embodiment, the first input port312may comprise an upper portion324and a lower portion326, as shown inFIG. 8A. The upper portion324and the lower portion326may contact one another to thereby close access to the first channel314in a first position, and the upper portion324and the lower portion326may be configured to separate from each other in a second position when a tube322is inserted into the first input port312. Further, as shown inFIG. 8A, the cap300may include a second input port318similarly configured to the first input port312, including a second channel320defined in the flange310. The second input port318may include an upper portion328and a lower portion330, as shown inFIG. 8A. The upper portion328and the lower portion330may contact one another to thereby close access to the second channel320in a first position, and the upper portion328and the lower portion330may be configured to separate from each other in a second position when a tube322is inserted into the second input port318.

In another embodiment, as shown inFIGS. 9A-9C, the cap300may further include a third input port332positioned on a top surface334of the flange310, and a third channel336defined in the flange310and configured to provide fluid connection between the third input port332and the tubular structure302. In one example, the longitudinal axis of the third channel336is parallel to the longitudinal axis of the lumen308. In such an example, the cap300may include a third plug338removably positioned in the third input port332to thereby close access to the third channel336. In one example, the third plug338is permanently coupled to the flange310and/or is created integrally as a single piece with the flange310.

In one particular example, as shown inFIG. 10A, the locking mechanism200may include a vertically extending portion256configured to fit within a cutout portion340of the flange310. Such an arrangement may provide an improved low profile design to accept the cap300. In one embodiment, the longitudinal axis of the lumen308of the tubular structure102is perpendicular to the longitudinal axis of the first channel314, as shown inFIG. 7B. In another embodiment, the longitudinal axis of the lumen308of the tubular structure102is positioned at an acute angle with respect to the longitudinal axis of the first channel314, as shown inFIGS. 10A and 10B. Further, as shown inFIGS. 10A and 10B, the longitudinal axis of the second channel320may be positioned parallel to the longitudinal axis of the lumen308(as shown inFIG. 10A) or the longitudinal axis of the second channel320may be positioned at an acute angle with respect to the longitudinal axis of the lumen308(as shown inFIG. 10B).

In yet another example, the tubular structure302of the cap has a first lumen and a second lumen that is separate from the first lumen. In such an example, the first channel314may be in fluid communication with the first lumen, and the second channel320may be in fluid communication with the second lumen. As such, a gastronomy tube may be positioned in the first lumen and a jejunostomy tube may be positioned in the second lumen. Other example tubes positioned in the first and second lumens are possible as well.

In use, the tube102may be cut flush with the locking mechanism200to prevent external forces from inadvertently pulling the tube102out of the body of the patient. Once the tube102has been cut flush with the locking mechanism200, the tubular structure302of the cap300may be press fit into the tube102. The cap300may then provide one or more access ports into which a practitioner can provide food, medication, or other fluids to the stomach of the patient. The cap300is designed such that the tubes positioned in the cap300remain with a low profile, thereby protecting the integrity of the placement of the tube102.

In another embodiment, the a kit is provided that includes (i) the device100as described above in relation toFIG. 1and (ii) the locking mechanism200as described above in relation toFIGS. 2-6. In another embodiment, a kit is provided that includes (i) the locking mechanism200as described above in relation toFIGS. 2-6and (ii) the cap300as described above in relation toFIGS. 7A-10B. In yet another embodiment, a kit is provided that includes (i) the device100as described above in relation toFIG. 1, (ii) the locking mechanism200as described above in relation toFIGS. 2-6and (iii) the cap300as described above in relation toFIGS. 7A-10B.

In another embodiment, a system is provided that includes the device100as described above in relation toFIG. 1coupled to the locking mechanism200as described above in relation toFIGS. 2-6. In this arrangement, the first protrusion212is positioned at least partially within the first cavity226, the second protrusion214is positioned at least partially within the second cavity228, and the first depression208and the second depression222are positioned around the surface110of the tube102such that the mating face210of the first component202contacts the mating face224of the second component216. In one example, the first rib112and the second rib114are configured to be pinched between the mating face210of the first component202and the mating face224of the second component216. In such an example, a first portion of the mating face210of the first component202contacts a first side of the first rib112, and a first portion of the mating face224of the second component216contacts a second side of the first rib112to thereby pinch the first rib112between the mating face210of the first component202and the mating face224of the second component216. Further, a second portion of the mating face210of the first component202contacts a first side of the second rib114, and a second portion of the mating face224of the second component216contacts a second side of the second rib114to thereby pinch the second rib114between the mating face210of the first component202and the mating face224of the second component216. In another example, such a system may further include the cap300as described above in relation toFIGS. 7A-10Bcoupled to the device100as described above in relation toFIG. 1, where the tubular structure302is positioned at least partially in the tube102.

In yet another embodiment, a system is provided that includes the device100as described above in relation toFIG. 1coupled to the locking mechanism200as described above in relation toFIG. 3. In this arrangement, the first protrusion212is positioned at least partially within the first cavity226, the second protrusion214is positioned at least partially within the second cavity228, the third protrusion238pierces the first rib112and is positioned at least partially within the third cavity242, and the fourth protrusion240pierces the second rib114and is positioned at least partially within the fourth cavity244. In addition, the first depression208and the second depression222are positioned around the surface110of the tube102such that the mating face210of the first component202contacts the mating face224of the second component216. In one example, such a system may farther include the cap300as described above in relation toFIGS. 7A-10Bcoupled to the device100as described above in relation toFIG. 1, where the tubular structure302is positioned in at least partially the tube102.

While various aspects and embodiments have been disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. All embodiments within and between different aspects of the invention can be combined unless the context clearly dictates otherwise. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope and spirit being indicated by the claims.