FEEDING TUBE

Abstract

A gastrostomy tube for enteral nutrition or medication of a subject, comprising a dual lumen first flexible tube with an internal retention device at an internal end and a substantially Y-shaped connector at an external end. A single lumen second flexible tube is connected at a first end to a main longitudinal channel of the dual lumen tube via the substantially Y-shaped connector. A second end of the second flexible tube is connectable to a nutrient or medicine source. The invention also relates to a kit of parts comprising a gastrostomy tube and a nutrient/medicine container attachable to the gastrostomy tube.

Claims

1. A gastrostomy tube for enteral nutrition or medication of a subject, comprising: a first flexible tube having an internal end positionable in vivo within the stomach of the subject and an external end positionable ex vivo, wherein the first flexible tube has a main longitudinal channel and a secondary longitudinal channel, and wherein the main and secondary longitudinal channels are not in fluid communication with each other; an internal retention device attached at or towards the internal end of the first flexible tube and in fluid communication with the secondary longitudinal channel; a substantially Y-shaped connector attached to the external end of the first flexible tube, wherein the substantially Y-shaped connector has a first port, a second port and a third port, wherein the external end of the first flexible tube is connected to the first port, the second port is in fluid communication with the main longitudinal channel and the third port is in fluid communication with the secondary longitudinal channel; and a second flexible tube having a first end and a second end and a conduit extending between the first end and the second end, wherein the first end is connected to the second port of the substantially Y-shaped connector to define a delivery channel extending between the internal end of the first flexible tube and the second end of the second flexible tube for delivering a nutrient or medicine to the subject, wherein the second end of the second flexible tube is attachable to a nutrient or medicine source.

2. The gastrostomy tube of claim 1, further comprising a feed connection port attached to the second end of the second flexible tube.

3. The gastrostomy tube of claim 1, further comprising an external retention device adjustably mounted on the first flexible tube.

4. The gastrostomy tube of claim 1, wherein the first flexible tube and the substantially Y-shaped connector are composed of a first material and the second flexible tube is composed of a second material which is different from the first material.

5. The gastrostomy tube of claim 4, wherein the first flexible tube and the substantially Y-shaped connector are formed as a single continuous part.

6. The gastrostomy tube of claim 1, wherein a cross-sectional area of the conduit is the same size or larger than a cross-sectional area of the main longitudinal channel.

7. The gastrostomy tube of claim 1, wherein the main longitudinal channel has a substantially circular, oval or substantially D-shaped cross-section.

8. The gastrostomy tube of claim 1, wherein the internal retention device comprises a balloon having an elastic body with an interior void in fluid communication with the secondary longitudinal channel.

9. The gastrostomy tube of claim 1, wherein the second flexible tube is at least 5 cm in length.

10. A kit of parts comprising: a gastrostomy tube according to claim 1; and a nutrient/medicine container attachable or attached to the gastrostomy tube via the second flexible tube or the feed connection port.

11. The kit of parts of claim 10, further comprising a first syringe attachable to the third port to supply fluid to or to remove fluid from the internal retention device.

12. The kit of parts of claim 11, wherein the first syringe is preloaded with a predetermined quantity of sterile fluid.

13. The kit of parts of claim 10, further comprising a second syringe attachable to the delivery channel via the second flexible tube or the feed connection port.

Description

[0052] A specific implementation of the present invention will now be described, by way of example only, and with reference to the accompanying drawings in which:

[0053] FIG. 1 is a perspective view of a gastrostomy tube according to a first embodiment of the present invention.

[0054] FIG. 2 is a longitudinal cross-sectional view of the gastrostomy tube of FIG. 1.

[0055] FIG. 3 is an expanded view of the Y-shaped connector of FIG. 2.

[0056] FIG. 4 is an expanded view of the Y-shaped connector, first flexible tube and internal retention device of FIG. 2.

[0057] FIG. 5 is an expanded view of the internal retention device of FIG. 4.

[0058] FIG. 6 is an expanded view of the Y-shaped connector, second flexible tube and feed connection port of FIG. 2.

[0059] FIG. 7 is a transverse cross-sectional view of the first flexible tube and internal retention device of FIG. 1, viewed looking towards the internal end.

[0060] FIG. 8 is a perspective view of the first flexible tube and internal retention device of FIG. 1.

[0061] FIG. 9 is a simplified cross-sectional view of the gatrostomy tube of FIG. 1 in position in the abdomen of a patient, with the external retention device in an open state.

[0062] FIG. 10 is a perspective view of the gastrostomy tube of FIG. 1 including an external retention device and a clamp.

[0063] FIG. 11 is a longitudinal side view of the gastrostomy tube of FIG. 10.

[0064] FIG. 12 is a longitudinal side view of the gastrostomy tube of FIG. 11 showing the balloon inflated.

[0065] FIG. 13 is a perspective view of the external retention device of FIG. 10 in an open position.

[0066] FIG. 14 is a different perspective view of the external retention device of FIG. 13 in an open position.

[0067] Referring initially to FIG. 1, a gastrostomy tube 1 of a first embodiment of the invention is shown. The gastrostomy tube 1 has a first flexible tube 2 connected at an internal end to an internal retention device 3 and at an external end to a Y-shaped connector 4. A second flexible tube 5 is also connected at a first end to the Y-shaped connector 4 and has a feed connection port 6 attached at a second end.

[0068] As best illustrated by FIGS. 2, 4, 7 and 8, the first flexible tube 2 is a dual lumen or dual channel tube having a main channel 23 and a secondary channel 24 running substantially parallel to the main channel 23. Both channels are surrounded by an external tubing wall 20. The two channels are separated by a separating wall 25. In this embodiment, the main channel 23 has a substantially D-shaped cross-section and the secondary channel 24 has a circular cross-section. The main channel 23 has a larger cross-sectional area than the secondary channel 24. The cross-sectional areas of the main and secondary channels 23, 24 remains essentially the same along the entire length of the first flexible tubing 2. An external surface of the first flexible tube 2 is marked with a gradated scale 26 to measure tract length to ensure correct placement of the gastrostomy tube 1 within the abdomen of a patient. The gradated scale 26 shown in FIGS. 1, 8 and 10-12 measures the tract length in centimetres. The external diameter of the first flexible tube 2 is also marked on the external surface to ensure the correct diameter tubing is used. In this embodiment the first flexible tube 2 has a French size of 14. The first flexible tube 2 is composed of medical grade silicone.

[0069] Referring now to FIG. 3, a longitudinal cross-section of the Y-shaped connector 4 is shown. The Y-shaped connector 4 has a first port 41, a second port 42 and a third port 43. In this embodiment, the first and second ports 41, 42 are disposed along a common longitudinal axis, whilst the third port 43 is offset with respect to the common longitudinal axis. The first and second ports 41, 42 are connected by an intermediate channel 44 which runs along the longitudinal axis between the second port 42 and the first port 41. The first and third ports 41, 43 are connected by an inflation channel 45.

[0070] Each of the first, second and third ports 41, 42, 43 are shaped and sized differently to ensure correct assembly. The third flexible port 43 may be fitted with a suitable adapter (not shown) to enable attachment of a syringe. The first port 41 has a protruding wedge 46 which corresponds to a cutting in the external end 22 of the first flexible tube 2. The inflation channel 45 opens into the first port 41 at the protruding wedge 46. This ensures correct alignment of the first flexible tube 2 in the first port 41 so that the secondary channel 24 is aligned and in fluid communication with the inflation channel 45 and the main channel 23 is aligned and in fluid communication with the intermediate channel 44. The separating wall 25 and body of the Y-shaped connector 4 ensure that the intermediate channel 44 and main channel 23 are completely separated from and are not in fluid communication with the secondary channel 24 and the inflation channel 45. The Y-shaped connector 4 is composed of medical grade silicone. The external end 22 of the first flexible tube 2 is bonded to the first port 41 with a silicone adhesive.

[0071] Referring again to FIG. 3 and to FIG. 6, a second flexible tube 5 is connected at a first end 52 to the second port 42. The second flexible tube 5 is composed of polyurethane. As the second flexible tube 5 is positioned entirely ex vivo in normal use there is no need for it to be composed of expensive medical grade silicone. The first end 52 is bonded to the second port 42 with a silicone adhesive. The second flexible tube 5 is a single lumen tube and consists of a single conduit 51 extending between the first end 52 and the second end 53 and surrounded by an outer wall 50. The conduit 51 has a circular cross-section. The conduit 51 is in fluid communication with the intermediate channel 44, the main channel 23 and an opening 31 of the internal retention device 3 to define a delivery channel extending along the full length of the gastrostomy tube.

[0072] The second flexible tube 5 has the same outer diameter as the first flexible tube 2. However, as the first flexible tube 2 has two internal channels and the second flexible tube 5 only has one internal channel, the cross-sectional area of the main channel 23 is smaller (and a different shape) to the cross-sectional area of the conduit 51. The intermediate channel 44 of the Y-shaped connector 4 is therefore tapered to gradually adjust the diameter and shape of the delivery channel. This gradual transition between the larger circular cross-section of the conduit 51 and the smaller substantially D-shaped cross-section of the main channel 23 aids the smooth movement of fluids along the delivery channel and prevents pressure build-ups or blockages.

[0073] As best illustrated by FIG. 6, a feed connection port 6 is connected to the second end 53 of the second flexible tube 5. The feed connection port 6 has a body 60 with a female port 61 and a male port 63. The female port 61 receives the second end 53 of the second flexible tube 5. The second flexible tube 5 is bonded to the female port 61 using an adhesive 62. The male port 63 has a protruding central tube 67 which is in fluid communication with the conduit 51. Arranged around the central tube 67 is a thread 64. The thread 64 allows a nutrient or medicine source to be connected via a threaded connector to the delivery channel via the central tube 67.

[0074] The feed connection port 6 also has a cap 65 which can be screwed into the male port 63 to seal the open end of the central tube 67 and delivery channel. This may be advantageous to prevent backflow and leakage of stomach acids through the delivery channel when, for example, no nutrient or medicine source is connected to the gastrostomy tube 1. The cap 65 is attached to the main body 60 of the feed connection port 6 via a flexible arm 66.

[0075] Referring now to FIGS. 10-14, the gastrostomy tube 1 is also equipped with an external retention device 7. The external retention device 7 has a main body 70 and an aperture 73 in the main body 70 through which the first flexible tube 2 is snugly fitted. The first flexible tube 2 passes through a duct 74 in the central part of the main body 70. The duct 74 extends substantially perpendicularly to the aperture 73. The duct 74 has an elongate slot in an outer wall and therefore only partially encloses the first flexible tube 2. The external retention device 7 is slidable longitudinally along the first flexible tube 2 to allow selective positioning.

[0076] A locking arm 72 is hingedly connected to the perimeter of the main body 70. The locking arm is pivotal in an arc between an open position (shown in FIGS. 13 and 14) and a locked position (not shown). In the open position, the first flexible tube 2 is removable from the duct 74 through the elongate slot to leave the external retention device 7 retained on the first flexible tube 2 only via the aperture 73. In the locked position, a locking rod 76 on the free end of the locking arm 72 is captured within a correspondingly-shaped groove 75 on the main body 70. A tooth 77 on an inner wall of the locking arm 72 passes through the slot of the duct 74 and grips the first flexible tube 2 to prevent longitudinal movement of the first flexible tube 2. The grip provided by the tooth 77 in the locked position is tight enough to hold the first flexible tube 2 but not so tight that the first flexible tube 2 is compressed as this could block the main and/or secondary channels 23, 24. An underside 71 of the main body 70 is configured to be substantially planar to sit against the skin of the patient in use. The external retention device 7 is composed of a thermoplastic polyurethane.

[0077] The gastrostomy tube 1 also has a clamp 8 positioned around the second flexible tube 5. The clamp 8 provides a convenient means to isolate the feed connection port 6 from the rest of the gastrostomy tube 1, for example when a nutrient or medicine source is attached or removed from the feed connection port 6. This prevents stomach acid backflowing up the main channel 23 and conduit 51 and leaking.

[0078] The clamp 8 has a first shoulder 81 and a second shoulder 82. The two shoulders are displaced longitudinally relative to each other at either end of a main body 84 and each have an aperture through which the second flexible tube 5 is passed. The second shoulder 82 has an arm 80 which is resiliently biased in an open position (shown) and can be moved into a locked position (not shown) to press the second flexible tube 5 against the main body 84 to close the conduit 51 and prevent fluid flow. The first shoulder 81 is also resiliently deformable and has a protrusion 83 which acts to retain the arm 80 in the locked position as required. The arm 80 can be released from the locked position by pulling the first shoulder 81 outwards (i.e. away from the second shoulder 82).

[0079] A patient being fitted with gastrostomy tube 1 will typically already have an established stoma tract owing to an earlier fitted gastrostomy tube or PEG procedure. As shown in FIG. 9, the stoma tract is a channel established through the layers of skin 90, fatty tissue 91, muscle tissue 92 and the stomach wall 93. The gastrostomy tube 1 is fitted by inserting the internal retention device 3 (with the balloon 33 deflated) and internal end 21 of the first flexible tube 2 into the stoma tract of the patient to an appropriate depth (established using the gradated scale 26). A syringe containing sterile fluid is then connected to the third port 43 and fluid is inserted by pressing on the syringe to force fluid through the inflation channel 45, the secondary channel 24 and through an inflation hole 32 into the internal retention device 3 to inflate a balloon 33 (see FIG. 5). The balloon 33 is attached to and positioned axially around a body 30 of the internal retention device 3. The attachment between the balloon 33 and the body 30 is airtight to prevent fluid escaping from the balloon 33 into the stomach. The first flexible tube 2 is then pulled until the inflated balloon 33 of the internal retention device 3 comes into contact with the stomach wall 93, as shown in FIG. 9. The inflated balloon 33 of the internal retention device 3 thus protects the gastrostomy tube 1 from being prematurely or inadvertently pulled out of the stoma tract.

[0080] Once the internal retention device 3 is positioned against the stomach wall 93 as shown in FIG. 9, the external retention device 7 is slid along the first flexible tube 2 until the underside 71 of the main body 70 contacts the surface of the skin 90. The first flexible tube 2 is then pushed through the elongate slot into the duct 74. The locking arm 72 is moved into the locked position so that the tooth 77 grips the first flexible tube 2 and prevents further longitudinal movement of the external retention device 7 relative to the first flexible tube 2. The external retention device 7 serves to prevent the gastrostomy tube 1 from being inadvertently pushed further inwards through the abdomen which could cause pain or discomfort to the patient or damage the stoma tract or the internal retention device 3. The internal retention device 3 and the external retention device 7 together prevent inadvertent longitudinal movement of the gastrostomy tube 1.

[0081] Once the gastrostomy tube 1 is in position, a nutrient or medicine source can be connected to the feed connection port 6. A nutrient or medicine can then be delivered into the stomach through the delivery channel along the entire length of the gastrostomy tube 1.

[0082] Where a nutrient or medicine source needs to be attached to the feed connection port 6, removed or changed, the clamp 8 around the second flexible tube 5 is first moved into the locked position to block the delivery channel. This prevents any backflow of stomach acids out through the feed connection port 6. By providing the clamp 8 on the single lumen second flexible tube 5 (rather than the dual lumen tube as in the prior art), the risk of damage to the separating wall 25 of the first flexible tube 2 is reduced. This reduces the overall failure rate of the gastrostomy tube 1 compared to existing tubes. During periods where no nutrient or medicine is required, the clamp 8 is typically retained in an open position to prevent permanent deformation or damage of the second flexible tube 5. In this situation the cap 65 can be screwed into the male part 63 of the feed connection port 6. This provides a seal to prevent backflow and leakage of stomach acids.

[0083] During use, it may be necessary to replace the feed connection port 6, for example to enable attachment of a nutrient or medicine source with a differently shaped connector, or because of damage to the feed connection port 6. In this case, the feed connection port can be replaced by simply cutting the second flexible tube 5 between the clamp 8 and the feed connection port 6 (when the clamp 8 is in the locked position). A new feed connection port 6 can then be fitted to the cut end of the second flexible tube 5.

[0084] It may also be necessary to use the gastrostomy tube 1 to drain the contents of a patient's stomach. This can be achieved by simply removing the nutrient or medicine source from the male port 63 of the feed connection port 6 (or opening the cap 65). With the clamp 8 open, the contents can then be drained through the gastrostomy tube 1. If rapid draining is required then the second flexible tube 5 can be cut to remove the feed connection port 6 entirely.