TUBE ASSEMBLY AND DISSOLVABLE TIP

Abstract

A tube assembly for placement within a patient includes a tube having a lumen, a proximal end portion, and a distal end portion attached to a dissolvable tip. The dissolvable tip may have an axial passageway and at least one non-axial vent. Once the assembly is positioned within the patient, the tip is dissolved by gastrointestinal fluids thereby providing an unobstructed distal tube end for material to flow through.

Claims

1-37. (canceled)

38. A tube assembly, comprising: a tube for placement within a patient, the tube having a distal end portion, a proximal end portion, and a lumen extending a length of the tube; and a tip having a proximal end portion engaging the distal end portion of the tube and a non-axial vent; wherein at least the proximal end portion of the tip comprises a soluble material.

39. The tube assembly of claim 38, wherein the proximal end portion of the tip engages an inner diameter of the distal end portion of the tube.

40. The tube assembly of claim 39, wherein the tube includes a corresponding vent.

41. The tube assembly of claim 40, wherein the tip includes a collar extending at least partially through the tube vent.

42. The tube assembly of claim 39, wherein the tube lumen increases in cross section from the proximal end portion toward the distal end portion along at least a portion of the tube.

43. The tube assembly of claim 42, wherein the tube includes a corresponding vent.

44. The tube assembly of claim 43, wherein the tip includes a collar extending at least partially through the tube vent.

45. The tube assembly of claim 42, wherein the tip includes a central aperture.

46. The tube assembly of claim 42, wherein the tip includes a conical distal end.

47. The tube assembly of claim 39, wherein the proximal end portion of the tip includes at least one of a ridge or ring engaging the inner diameter of the distal end portion of the tube.

48. The tube assembly of claim 47, wherein the tube includes a corresponding vent.

49. The tube assembly of claim 48, wherein the tip includes a collar extending at least partially through the tube vent.

50. The tube assembly of claim 47, wherein the tip includes a central aperture.

51. The tube assembly of claim 47, wherein the tip includes a conical distal end.

52. The tube assembly of claim 38, wherein the non-axial vent is a laterally-facing vent.

53. The tube assembly of claim 52, wherein the tube includes a corresponding vent.

54. The tube assembly of claim 53, wherein the tip includes a collar extending at least partially through the tube vent.

55. The tube assembly of claim 54, wherein the tube lumen increases in cross section from the proximal end portion toward the distal end portion along at least a portion of the tube.

56. The tube assembly of claim 52, wherein the tube lumen increases in cross section from the proximal end portion toward the distal end portion along at least a portion of the tube.

57. The tube assembly of claim 56, wherein the tube includes a corresponding vent.

58. The tube assembly of claim 57, wherein the tip includes a collar extending at least partially through the tube vent.

Description

BRIEF DESCRIPTION OF THE DRAWING FIGURES

[0022] The accompanying drawing figures incorporated herein and forming a part of the specification, illustrate several aspects of the invention and together with the description serve to explain certain principles thereof. In the drawing figures:

[0023] FIG. 1 is a perspective view of an enteral tube illustrating a distal end portion of a tube and a tip;

[0024] FIG. 2 is a perspective view of a tip;

[0025] FIG. 3 is a perspective view of yet another embodiment of an enteral tube illustrating a tip encasing a distal end portion of a tube;

[0026] FIG. 4 is another perspective view of the tip showing the proximal end thereof;

[0027] FIG. 5a is a partial plan view of a tube having a gradually increasing lumen cross section in a portion positioned within a patient;

[0028] FIG. 5b is a partial plan view of a tube having a gradually increasing lumen cross section and a uniform outer cross section;

[0029] FIG. 6 is a perspective view of an alternate enteral tube illustrating a distal end portion of a tube and a tip;

[0030] FIG. 7 is a side elevational view of another alternate tip showing an oblique connection between a tube and the tip; and

[0031] FIG. 8 is a side elevational view of still another alternate tip showing a curved connection between a tube and the tip.

[0032] Reference will now be made in detail to the present described embodiments of the invention, examples of which are illustrated in the accompanying drawing figures, wherein like numerals are used to represent like elements.

DETAILED DESCRIPTION

[0033] Reference is now made to FIG. 1 which partially illustrates a tube 12 for placement within a patient (P). In this embodiment, the tube is an enteral tube which includes, but is not limited to, nasogastric tubes, nasoduodenal tubes, oral gastric tubes, oral duodenal tube, and feeding tubes located distal to the duodenum. Other embodiments may utilize other types of tubes, for example, gastrostomy or G-tubes inserted through the patient's abdomen to deliver nutrition directly to the stomach. While some designs utilize a bolster system designed to prevent withdrawal of the gastrostomy tube, others utilize other anchor means (e.g., inflatable balloons) to prevent withdrawal. In all designs, a dissolvable tip (solid or otherwise) may be utilized to improve the insertion process by limiting patient discomfort while ultimately allowing for the free flow of nutrients through the tube. One family of such gastrostomy devices is marketed under the brand MiniONE including balloon and non-balloon devices. As shown, a tube assembly 10 includes the enteral tube, or tube 12, and a tip 14.

[0034] The tube 12 includes a lumen extending a length of the tube from a proximal end portion (not shown) to a distal end portion 18 having an orifice therein. The described tip 14 defines a vent 20 and a distal aperture 22 for a guidewire (not shown) to pass through if desired. A square or butt connection between the tube 12 and tip 14 is shown with a proximal portion of the tip being hidden from view and positioned within the tube in this figure. As described below, other methods of attaching the tip 14 to the tube 12 may be utilized.

[0035] Since the tip 14 is only useful during tube insertion, the tip is made of a dissolvable material. In other words, the tip 14 is dissolvable. More specifically, the tip 14 is designed to remain intact to facilitate the insertion process and placement of the tube 12 and then dissolve away. This leaves an unobstructed distal opening in the tube 12 encompassing its full inner diameter and allowing fluid flow along the long axis of the tube (designated reference numeral 15 in FIG. 1) without any change in direction. In other words, the tip 14 comprises a material, or materials, which are soluble and suitable for human or animal consumption. One soluble material is a polymer marketed under the trademark Affinisol. Broadly speaking, any soluble material may be utilized. In addition to being soluble, the material or materials may include additional properties such as lubriciousness when exposed to a moist environment. More specifically, the tip material may be coated with a water activated lubricious coating to facilitate gliding during insertion.

[0036] As best shown in FIG. 2, the tip 14 includes a conical or bullet shaped distal contoured surface or face 24. In the described embodiment (best shown in FIG. 1), an outer diameter of the tip 14 substantially corresponds to an outer diameter of the tube 12 to which it is attached creating a smooth outer surface even at the butt joint. Limiting the outer diameter of the tip 14 in these embodiments enhances patient comfort and eases the insertion process particularly when moving through narrower portions of the gastrointestinal tract.

[0037] While maintaining the outer diameter of the tip to substantially correspond with the outer diameter of the tube provides certain advantages, other embodiments may include an outer tip diameter that is larger than the outer diameter of the tube. As shown in FIG. 3, for example, an alternate tip 26 may include a proximal end portion 28 sized to receive a distal end portion 30 of a tube 32 therein. In this embodiment, the tip 26 encases or is attached to an outside diameter of the distal end portion 30 of the tube. In other words, the dissolving material may provide a covering over a distal end of the tube. The tip 26 may be formed by dipping the tube 32 in the dissolving material for example, may be pre-formed or molded, or otherwise.

[0038] As shown in FIG. 4, the diameter of the described tip 14 is reduced to just less than an inner diameter of the tube 12 along a proximal portion 34 such that the tip 14 is held in place within the tube's distal end portion 18 (see FIG. 1) by friction. Alternate embodiments, ensure retention of the tip 14 by means of adhesives, the natural tackiness of the tip material, or other retention means known in the art. One or more ridges 36, rings, or other mechanical features may be positioned on the proximal portion 34 of the tip 14 to provide retentive forces. Even more alternate embodiments may utilize a partially dissolvable tip. For example, the proximal portion 34 of the described tip 14 may be dissolvable to ensure the tip is dislocated from the tube 12 leaving an unobstructed distal opening in the tube 12 allowing fluid flow along the long axis of the tube. The remaining portion of the tip 14 may not be dissolvable but would dislodge from the tube 12 and pass through the gastrointestinal tract of the patient (P). In the embodiment shown in FIG. 3, the portion of the tip 26 surrounding the distal end portion 30 of the tube 32 may be dissolvable to ensure the tip is dislocated from the tube while the remaining portion of the tip may not be dissolvable. In other embodiments, varying portions of the tip may be dissolvable so long as the dissolvable portions are sufficient to ensure the tip is disclosed from the tube.

[0039] In alternate embodiments shown in FIGS. 5a and 5b, a tube 38 may have a tapered configuration. In other words, a portion 40 of the tube 38 which will reside within a patient (P) may have a gradually increasing lumen cross section 42 from a proximal end 44 to a distal end 46. A portion 48 of the tube 38 which remains external to the patient (P) may have a uniform lumen cross section 50 or, in an alternate embodiment, a tapered lumen cross section 52 may extend along an entirety of a tube 54, as shown in FIG. 5b, or along a portion thereof. For example, the lumen cross section may gradually increase from a proximal end portion of tube 52 toward a distal end or a distal end portion of the tube 54. Even more, an outer cross section of the tube may be uniform, as shown in FIG. 5b, or may gradually increase in areas where the lumen cross section gradually increases as shown in FIG. 5a. If the tube is round, the lumen cross section will necessarily be an inner diameter of the tube.

[0040] The purpose of providing a gradually increasing lumen cross section is to provide a smaller cross section at the area which would be best for patient comfort, such as the portion of the tube 38 residing in the nose. Then, distal to this, having the gradual increase in cross section makes clogging less likely. When the tube 38 is in place, the patient (P) will not be able to detect the larger cross section of the tube distally.

[0041] Further, should a clog develop in the tapered portion 40 of the tube 38 within the patient (P), gentle pressure with a suitable fluid flush will make clearing the clog more likely than with a uniform lumen cross section. To further diminish the risk of clogging, an interior surface of the tube 38 may be coated in a non-stick or lubricious material. Clogs located in the constant lumen cross section portion 48 of the tube 38 would be mostly external to the patient (P). In this portion 48, external pressure may also be applied by the clinician to the tube 38 to milk or break up the clog and enhance clearing along with fluid flush.

[0042] In such alternate embodiments wherein the tube has a tapered inner diameter, the tip can be shaped to conform with the tapering inner diameter of the tube. For example, the proximal portion of the tip could be conically or frusto conically shaped.

[0043] Returning to the embodiment shown in FIG. 1 and as suggested above, the tip 14 may define one or more apertures, holes, or vents 20. A central aperture or passageway 22 located axially along its length allows placement of the tube 12 by passing it over a guidewire (not shown) such is commonly utilized during fluoroscopic placement or endoscopic placement of feeding tubes. The central aperture 22 does not compromise placement with or without a stylet which remains completely within the lumen of the tube 12. The central aperture 22 offers two additional advantages. First, the central aperture 22 increases the surface area available for contact with fluids passing through the tube 12 and gastrointestinal fluids thereby expediting dissolution of the tip 14. Second, in the case of tube placement under fluoroscopic guidance, small amounts of contrast material may be passed through the tube 12 and central aperture 22 of the tip 14 facilitating confirmation of tube position. In alternate embodiments, the tip 14 may be solid or may have a central aperture with no additional holes or vents.

[0044] While a single vent 20 is shown throughout the figures, one or more vents may be integrated into a tip to allow a higher flow rate of water, radiographic contrast media, nutritional formula, or other fluids. Importantly, each vent creates a minimally restricted flow pathway for any fluids passing down the lumen of the tube 12. Hence, patients may receive nutritional formula as soon as the tube 12 has been placed into the gastrointestinal tract with no need to wait until the tip 14 has completely or partially dissolved.

[0045] While allowing a higher flow rate of fluids, the vent 20 is formed such that the fluids exit the tube 12 via the vent at a substantially ninety-degree angle relative to the long axis of the tip 14 and tube. This configuration minimizes the risk that a guidewire inadvertently exists through the vent 20 rather than the central guide wire aperture 22. Nonetheless, other embodiments may include vents within a tip that exit at angles greater than and/or less than 90 degrees.

[0046] In the embodiment shown in FIG. 1, the vent 20 obviates the need for a vent defined by the tube 12 with the benefit of lower costs. In alternate embodiments, however, the one or more tip vents may be positioned more proximally such that the vents open through a corresponding one or more vents defined by the tube. As shown in FIG. 6, for example, a vent 56 formed in a tip 58 is located to cooperate with a vent 60 defined by a tube 62. In this arrangement, a cuff 64 extends through the tube vent 56 to provide further resistance preventing the tip 58 from coming out of the tube 62. In all embodiments, the vent(s) may include a uniform inside diameter or a non-uniform diameter such as a taper.

[0047] Following placement of the tube, the tip will reside in the gastrointestinal tract, typically, in the stomach (whether an enteral or gastrostomy tube) or small bowel. Both anatomic areas provide an aqueous environment which will lead to dissolution of the tip thereby leaving the end, or orifice, of the tube open and completely unobstructed. In addition, fluids such as water or nutritional formulas moving through the tip vent(s) and/or central aperture/hole, if one or both are present, further expedite dissolution of the tip. In an alternate embodiment of a solid dissolvable tip without a central hole or vents, the user may force the tip out of the tube by means of air or water pressure generated with a syringe placed at the proximal end of the tube. The ejected tip would then dissolve in the gastrointestinal tract in due course while immediately allowing fluids to move through the distal end of the tube.

[0048] As previously suggested, the tip 14 may be attached to the tube 12 utilizing a square or butt connection as shown in FIG. 1. In addition, a tip 64 and tube 66 may be shaped to form an oblique connection therebetween as shown in FIG. 7. Even more, a tip 68 and a tube 70 may be shaped to form a curved connection therebetween as shown in FIG. 8.

[0049] The foregoing has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the embodiments to the precise form disclosed. Obvious modifications and variations are possible in light of the above teachings. For example, one or more vents may be formed along the distal end portion 18 of the tube 12 shown in FIG. 1. Such tube vents may be in place of vents formed in the tip 14 (e.g., vent 20) or may be in addition thereto. In addition, a radiopaque material such as barium, for example, may be incorporated in the tip to assist in location of the tip during fluoroscopic placement. Even more, the proximal aspect of the tip may be solid or have a lumen. The proximal internal edge may have a chamfered or rounded shape to facilitate passing of a guidewire from proximal to distal. Likewise, the proximal outside edge may also be chamfered or rounded to facilitate placement inside of a tube. Further, the outside diameter of the proximal portion may be tapered to facilitate placement inside of a tube. The distal shape of the lumen may be configured conically to further direct a guidewire through the central guidewire hole. All such modifications and variations are within the scope of the appended claims when interpreted in accordance with the breadth to which they are fairly, legally and equitably entitled.