Connector for a Gastrostomy Device

20230000725 · 2023-01-05

    Inventors

    Cpc classification

    International classification

    Abstract

    A connector for coupling an enteral feeding solution supply tube to a port of a gastrostomy device, comprising a fluid conduit having an upstream end and a downstream end; and a nozzle housing a first portion of the fluid conduit at the downstream end configured to be connectable to an orifice defined in the port of the gastrostomy device. The nozzle has a proximal end, a distal end and a longitudinal axis extending therebetween. An external diameter of the nozzle at or adjacent the distal end is substantially equal to an external diameter of the nozzle at or adjacent the proximal end. An external surface of the nozzle includes one or more indentations. The invention also relates to a feeding extension set including a connector and an enteral feeding solution supply tube.

    Claims

    1. A connector for coupling an enteral feeding solution supply tube to a port of a gastrostomy device, wherein the connector comprises: a fluid conduit having an upstream end and a downstream end; a nozzle housing a first portion of the fluid conduit at the downstream end configured to be connectable to an orifice defined in the port of the gastrostomy device, wherein the nozzle has a proximal end, a distal end and a longitudinal axis extending therebetween, wherein an external diameter of the nozzle at or adjacent the distal end is substantially equal to an external diameter of the nozzle at or adjacent the proximal end, and wherein an external surface of the nozzle includes one or more indentations.

    2. The connector of claim 1, wherein the nozzle has a substantially circular cross section.

    3. The connector of claim 1, wherein the external surface of the nozzle includes multiple circumferentially spaced apart indentations.

    4. The connector of claim 3, wherein the circumferential extent of each indentation is defined by its arc on the external circumference of the nozzle, and wherein the sum of the circumferential extent (arc) of each indentation gives a total circumferential extent of between 50% and 90% of the external circumference of the nozzle.

    5. The connector of claim 3, wherein the circumferential extent of each indentation is defined by its arc on the external circumference of the nozzle, and wherein each indentation has a circumferential extent (arc) of between 15% and 20% of the external circumference of the nozzle.

    6. The connector of claim 1, wherein each indentation extends longitudinally between a first point at the distal end and a second point between the distal end and the proximal end.

    7. The connector of claim 6, wherein a first longitudinal distance between the distal end and the second point is greater than a second longitudinal distance between the second point and the proximal end.

    8. The connector of claim 7, wherein the first longitudinal distance is between 1.5 and 3 times longer than the second longitudinal distance.

    9. The connector of claim 1, further comprising a body housing a second portion of the fluid conduit at the upstream end, wherein the upstream end is configured to be connectable to the enteral feeding solution supply tube.

    10. The connector of claim 9, wherein the second portion of the fluid conduit is substantially perpendicular to the first portion of the fluid conduit.

    11. The connector of claim 9, wherein the second portion of the fluid conduit is substantially coaxial with the first portion of the fluid conduit.

    12. The connector of claim 1, further comprising an attachment mechanism provided at or adjacent the proximal end of the nozzle to releasably engage with a corresponding element on the gastrostomy device to secure the connector in place during feeding.

    13. The connector of claim 12 wherein the attachment mechanism comprises a pair of arms circumferentially arranged around the proximal end of the nozzle, wherein each arm includes a first free end and a second free end, wherein the second free end includes a catch configured to releasably engage with a circumferential rim on the port of the gastrostomy device, and wherein each arm is connected to the body by a flexible bridge about which the first and second free ends can be pivoted.

    14. A feeding extension set comprising: an enteral feeding solution supply tube; and a connector according to claim 1, wherein the connector is configured for coupling the enteral feeding solution supply tube to a port of a gastrostomy device.

    15. A method of delivering an enteral fluid to a patient comprising: (i) taking a connector according to claim 1; (ii) inserting the nozzle of the connector into a corresponding port on an indwelling gastrostomy device; (iii) coupling the upstream end of the fluid conduit to an enteral feeding solution supply tube; and (iv) providing an enteral feeding solution to the patient's stomach through the feeding solution supply tube to and through the connector and gastrostomy device.

    Description

    BRIEF DESCRIPTION OF DRAWINGS

    [0034] 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:

    [0035] FIG. 1 is a side view of a connector according to a first embodiment.

    [0036] FIG. 2 is an enlarged view of part of FIG. 1 showing the nozzle of the connector.

    [0037] FIG. 3 is a perspective view of the connector of FIG. 1.

    [0038] FIG. 4 is an underside view of the connector of FIG. 1.

    [0039] FIG. 5 is a cross-section of part of the connector of FIG. 1 partially inserted into a port on a gastrostomy device.

    [0040] FIG. 6 is a side view of a connector according to a second embodiment.

    [0041] FIG. 7 is a perspective view of the connector of FIG. 6.

    [0042] FIG. 8 is a cross-section of part of the connector of FIG. 6 partially inserted into a port on a gastrostomy device.

    DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT OF THE INVENTION

    [0043] Referring initially to FIGS. 1 and 3 a connector 1 for coupling an enteral feeding solution supply tube to a port of a gastrostomy device is shown. The connector 1 includes a nozzle 2 which extends from an underside face 32 of a body 3 and is substantially cylindrical with a circular cross-section. A fluid conduit 10 extends through the nozzle 2 and body 3 from a distal end 20 of the nozzle 2 to an upstream end 33 of a shank portion 31 of the body 3. In this particular embodiment the shank portion 31 extends along an axis which is substantially perpendicular to a longitudinal axis X of the nozzle 2. The fluid conduit 10 therefore includes a substantially L-shaped junction 34 (shown in FIG. 5) within the body 3.

    [0044] With reference now to FIG. 2, the nozzle 2 extends along the longitudinal axis X between the distal end 20 and a proximal end 21 adjacent the body 3. The nozzle 2 has a diameter D which is constant along substantially the entire distance between the distal end 20 and the proximal end 21, with the exception of a rounded edge 28 at the distal end 20 which has a longitudinal extent of less than 5% of the distance between the distal end 20 and proximal end 21. A fillet 29 is also provided at the proximal end 21 which has a longitudinal extent less than 5% of the distance between the distal end 20 and the proximal end 21. The fillet 29 is provided to improve the structural rigidity of the connector 1. The nozzle 2 therefore has a diameter D which is constant along greater than 90% of its length.

    [0045] The nozzle 2 has an exterior surface 27. As best shown in FIG. 4, four indentations 24 are spaced circumferentially around the exterior surface 27. Each indentation 24 extends circumferentially by a distance A which is an arc on the circumference of the nozzle 2. As best shown in FIG. 2, each indentation 24 extends longitudinally for a distance L between a first point 22 and a second point 23. In this particular embodiment, the first point 22 is at the distal end 20 of the nozzle 2 (i.e. the indentations 24 extend to the distal end 20), and each of the four indentations 24 have the same longitudinal extent (L) and circumferential extent (A). The four indentations 24 are equally spaced circumferentially, with ridges 26 between the indentations 24. Around the circumference of the nozzle 2, between the first point 22 and the second point 23 the indentations 24 account for approximately 70% of the area of the exterior surface 27, with the ridges 26 accounting for the remainder of the area of the exterior surface 27.

    [0046] In this embodiment, the longitudinal extent (L) is equivalent to approximately two-thirds of the distance between the distal end 20 and the proximal end 21.

    [0047] Between the second point 23 and the proximal end 21, the exterior surface 27 is substantially free from indentations. This defines a contact region 25.

    [0048] With reference now to FIGS. 1 and 4, the connector 1 includes an attachment mechanism in the form of a pair of arms 4 provided on the body 3. Each arm 4 is attached to the body 3 by a flexible bridge 44 about which the arm 4 can pivot. Each arm 4 has a first free end 41 and a second free end 42. As best shown in FIG. 1, the second free end 42 of each arm 4 is spaced apart from and annularly extends partially around the contact region 25 of the nozzle 2. The second free end 42 includes a catch 43 on an inwards facing wall 45 of the arm. The catch 43 is a ledge that projects inwardly towards the nozzle 2.

    [0049] The connector 1 is moulded as a unitary component from polyurethane.

    [0050] With reference now to FIG. 5, the connector 1 can be connected to a port 51 on a gastrostomy device 50. The gastrostomy device 50 has a low-profile “button” connector and is a balloon gastrostomy device which includes a balloon inflation port 57 which connects to a secondary channel 62 of a feeding tube 60 via a conduit 56. The feeding tube 60 includes a main channel 61 for the supply of feed. The main channel 61 is in fluid communication with a void 55 downstream of a non-return valve 52 in the port 51.

    [0051] The non-return valve 52 in this embodiment is a duckbill valve. A sealing ring 53 extends annularly around the entrance to the port 51. The sealing ring 53 and duckbill valve are composed of an elastomeric material. An outwardly facing rim 54 composed of a rigid plastic material extends circumferentially around the port 51.

    [0052] The connector 1 is connected to the gastrostomy device 50 by inserting the nozzle 2 into the port 51. As the nozzle 2 is inserted, the distal end 20 contacts and pushes against the duckbill valve 52. The catches 43 on the arms 4 also contact the circumferential rim 54. As shown in FIG. 5, both the catches 43 and the rim 54 have rounded edges. As these components are pushed together, the second free end 42 of each arm 4 is forced outwards by the rounded edges contacting and sliding against each other. The arms 4 pivot about the flexible bridge 44, with the first free end 41 moving inwardly towards the body 3.

    [0053] As the connector 1 is pushed further downwards from the position shown in FIG. 5, the outward movement of the second free end 42 allows the catch 43 to slide past and underneath the rim 54. The rim 54 then prevents upwards movement of the connector 54, thereby locking the connector 1 onto the port 51 in a locked position to prevent premature disconnection. To release the connector 1, a user squeezes the first free end 41 of each arm 4 to release the catch 43, and then pulls the connector 1 away from the gastrostomy device 50.

    [0054] During insertion of the nozzle 2 into the port 51, the distal end 20 pushes against and opens the duckbill valve 52. The duckbill valve 52 is positioned within the port 51 to prevent accidental opening or damage. The nozzle 2 is long enough to penetrate and fully open the duckbill valve 52.

    [0055] Once the connector 1 is locked in position on the gastrostomy device 50 and the duckbill valve 52 is open, feed can be supplied via an enteral feeding solution supply tube attached to the upstream end 33 at the shank portion 31 through the fluid conduit 10, the duckbill valve 52, void 55 and into the main channel 61 of the feeding tube 60.

    [0056] When in the locked position, the sealing ring 53 is in a tight friction fit with the contact region 25, creating a fluid seal to prevent fluid leaking from the port 51. During insertion and removal, the sealing ring 53 is dragged along the exterior surface 27 of the nozzle 2. The indentations 25 (not visible in FIG. 5) reduce the surface area in contact with the sealing ring 53 during insertion and removal. This reduces the amount of force required to insert and remove the connector 1 and also reduces wear on the sealing ring 53, thus prolonging the life of the gastrostomy device 50.

    [0057] Referring now to FIGS. 6 and 7, an alternative connector 101 is shown. The connector 101 has the same nozzle 102, body 103 and arm 104 features as the connector 1. However in the connector 101, the fluid conduit 110 extends through the nozzle 102 and body 103 from a distal end 120 of the nozzle 102 to an upstream end 133 of a shank portion 131 of the body 3, and the shank portion 31 extends substantially coaxially with a longitudinal axis X of the nozzle 2. The fluid conduit 110 is therefore substantially straight between the upstream end 133 and the distal end of the nozzle 102. This configuration may be preferable for certain patients depending on their circumstances.

    [0058] As shown in FIG. 8, the connector 101 is attachable to the gastrostomy device 50 in the same manner as the connector 1. The fluid conduit 110 is aligned with the main channel 161 of the feeding tube 160. In this particular embodiment the inner diameter of the fluid conduit at the upstream end 133 is larger than the internal diameter at the downstream end.