Lid for an ostomy implant

Abstract

A lid for an ostomy implant is provided. A base includes an attachment means for attachment to the implant and a sliding part. The sliding part is arranged such that when the sliding part is slid along a first sliding route, the sliding part causes the lid to be attachable to or detachable from the implant, and when the sliding part is slid along a second sliding route, the sliding part causes the lid to open, for evacuating a stoma to which the ostomy implant is connected, and closed, for preventing leaks from the stoma, while the lid remains attached to the implant.

Claims

1. A lid for an ostomy implant, the lid comprising: a base comprising an attachment means for attachment to the implant; and a sliding part; wherein the sliding part is arranged such that when the sliding part is slid along a first sliding route, the sliding part causes the lid to be attachable to or detachable from the implant, and when the sliding part is slid along a second sliding route, the sliding part causes the lid to open, for evacuating a stoma to which the ostomy implant is connected, and closed, for preventing leaks from the stoma, while the lid remains attached to the implant.

2. The lid as claimed in claim 1, wherein the lid comprises an opening part comprising a hatch.

3. The lid as claimed in claim 2, wherein the sliding part is arranged such that when the sliding part is slid in the second sliding route, the sliding part opens and/or closes the opening part.

4. The lid as claimed in claim 1, further comprising connection means such that a further device may be attached to the lid.

5. The lid as claimed in claim 4, wherein the connection means comprises one or more raised or lowered parts, a ridge and/or a groove.

6. The lid as claimed in claim 1, wherein the attachment means comprises an engaging edge for engagement with the implant.

7. The lid as claimed in claim 1, wherein the lid is operable between a relaxed configuration in which the lid cannot fit over the implant, and a stressed configuration in which the lid can fit over the implant.

8. The lid as claimed in claim 2, wherein the lid comprises a sealing surface arranged to form a sealing engagement between the opening part and the implant, while the lid is attached to the implant and the opening part is in a closed position.

9. The lid as claimed in claim 2, wherein the lid comprises a sealing surface for sealing engagement with the opening part.

10. The lid as claimed in claim 2, wherein the opening part is movably connected to the base.

11. The lid as claimed in claim 10, wherein the base comprises at least one stretchable part.

12. The lid as claimed in claim 11, wherein the base can be stretched from a relaxed configuration in which the base cannot fit over the implant, to a stressed configuration in which the base can fit over the implant.

13. The lid as claimed in claim 1, wherein the sliding part is operable to apply a force on the lid so as to allow the lid to be attached and/or detached from the implant.

14. The lid as claimed in claim 2, wherein the opening part is movably connected to the base and wherein the base comprises at least one stretchable part, and wherein the base can be stretched from a relaxed configuration, to a stressed configuration.

15. The lid as claimed in claim 14, wherein the base comprises an opening which can be closed by the opening part, and wherein stretching the lid from the relaxed configuration to the stressed configuration comprise enlarging the opening such that the lid can fit over the implant.

16. The lid as claimed in claim 14, wherein the base is stretched in response to radially moving the sliding part with respect to the lid.

17. The lid as claimed in claim 2, wherein the sliding part is operable to apply a force on the opening part so as to open or close the opening part, and/or keep the opening part open or closed.

18. A system for evacuation of a stoma, the system comprising: a lid as claimed in claim 1; and one or more connectors comprising attachment means for attachment to the lid, and connecting means or a connection surface for connection to a further device; wherein the one or more connectors are connectable to the lid.

19. A method of connecting a connector to a lid for an ostomy implant, comprising: providing the lid as claimed in claim 1; providing the connector comprising attachment means for attachment to the lid, and connecting means or a connection surface for connection to a further device; and connecting the connector to the lid.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) Preferred embodiments of the invention will now be described with reference to the accompanying drawings, in which:

(2) FIG. 1 is a perspective view of a known implant on which the present invention may be used;

(3) FIG. 2 is a side view of the implant of FIG. 1;

(4) FIG. 3 is a cross-sectional view of an implant implanted in a body with a lid according to an embodiment of the invention attached thereto;

(5) FIGS. 4 (a)-(d) show an implant with a lid according to an embodiment of the invention attached there to, where FIGS. 4 (a) and (b) show perspective and side views, respectively, with the lid closed, and FIGS. 4 (c) and (d) show perspective and side views, respectively, with the lid open;

(6) FIG. 5 is a perspective view of a closed lid;

(7) FIG. 6 is a perspective view of an open lid;

(8) FIG. 7 is a cross-sectional side view of an open lid;

(9) FIG. 8 is a cross-sectional top view of a closed lid;

(10) FIG. 9 is a perspective view of a lid in a stressed configuration ready for placing on an implant;

(11) FIG. 10 is a cross-sectional side view of a lid in a stressed configuration ready for placing on an implant;

(12) FIGS. 11(a) and (b) are perspective views of a closed lid from beneath in (a) a relaxed configuration and (b) a stressed configuration;

(13) FIG. 12 is a cross-sectional side view of a closed lid;

(14) FIG. 13 is a perspective view of a base;

(15) FIG. 14 is an exploded perspective view of components forming a base;

(16) FIG. 15 is an exploded side view of components forming a base;

(17) FIG. 16 is a perspective view of the top side of a slider;

(18) FIG. 17 is a side view of a slider;

(19) FIG. 18 is a perspective view of the bottom side of a slider;

(20) FIG. 19 is a perspective view of a hatch;

(21) FIG. 20 is a side view of a hatch;

(22) FIG. 21 is a top view of an embodiment of a connector;

(23) FIG. 22 is a bottom view of the connector of FIG. 21;

(24) FIG. 23 is a side view of the connector of FIG. 21;

(25) FIG. 24 is a perspective view of a lid with the connector of FIG. 21 attached thereto;

(26) FIG. 25 is a cross-sectional side view of a closed lid with the connector of FIG. 21 attached thereto;

(27) FIG. 26 is a cross-sectional side view of an open lid with the connector of FIG. 21 attached thereto;

(28) FIG. 27 shows (a) bottom and (b) top views of an embodiment of a connector in a closed configuration;

(29) FIG. 28 shows (a) bottom and (b) top views of the connector of FIG. 27 in an open configuration;

(30) FIG. 29 shows (a) bottom and (b) top views of an embodiment of a connector in a closed configuration;

(31) FIG. 30 shows (a) bottom and (b) top views of the connector of FIG. 29 in an open configuration;

(32) FIG. 31 shows (a) bottom and (b) top views of an embodiment of a connector in a closed configuration;

(33) FIG. 32 shows (a) bottom and (b) top views of the connector of FIG. 31 in an open configuration;

(34) FIG. 33 is an exploded perspective view of components forming an alternative embodiment of the base; and

(35) FIG. 34 is an exploded perspective view of components forming a further alternative embodiment of the base.

DETAILED DESCRIPTION OF THE INVENTION

(36) FIGS. 1 and 2 illustrate a known percutaneous ostomy implant 1 from the applicant's earlier application WO 2014/140344 A1. As described above, the implant 1 comprises a tubular interior section 2, which formed mainly of mesh, and a circular, radially-extending anchoring flange or dermal anchor 3. The tubular interior section 2 is attached to an exterior section 4, which, when the implant 1 is implanted in a patient, protrudes from the patient's body. A groove 6 around the exterior circumference of the exterior section 4 allows a lid, bag, catheter, irrigation sleeve or other device to be attached to the implant 1.

(37) The implant 1 is designed to be implanted in the subcutaneous tissue of the abdominal wall of a patient and to receive a bowel section drawn through it.

(38) FIG. 3 is a cross-sectional view of the implant 1 implanted in a body of a patient, through the peritoneum 101 and skin 102. The patient's ileum 103 has grown into the implant 1, helping to secure the implant 1 in place. A lid 10 according to an embodiment of the invention is attached to the exterior section 4 of the implant 1. This allows the patient's bodily waste to be held in an internal reservoir 100 until the lid 10 is removed from the implant 1. The internal reservoir 100 forms in the patient's ileum after regular wearing of the lid 10 has started.

(39) FIGS. 4(a)-(d) show an implant 1 with a lid 10 attached thereto. For the purposes of this illustration, the implant 1 is not implanted into a patient in these figures. This is merely to illustrate more clearly where, on the implant 1, the lid 10 is attached. However, in use, of course, the implant 1 would be implanted into a patient as described above with reference to FIG. 3.

(40) As shown in FIGS. 4(a)-(d), the lid 10 is attached to the exterior section 4 of the implant 1. More specifically, the lid 10 is attached to the groove 6 around the exterior circumference of the exterior section 4. This groove 6 is not visible in FIGS. 4(a)-(d) as it is covered by the lid 10.

(41) The lid 10 has a hatch 11 which may be opened and closed whilst the lid 10 is attached to the implant 1. FIGS. 4(a) and (b) show the lid 10 with the hatch 11 in a closed configuration. FIGS. 4(c) and (d) show the lid 10 with the hatch 11 in an open configuration.

(42) As can be seen particularly in FIGS. 4(b) and (d), although the lid 10 is circular (when viewed from above or below), it is attached to the implant 1 such that its axial centreline is not collinear with the axial centreline of the generally tubular implant 1. The lid 10 overhangs the implant 1 more on one side than on its opposite side.

(43) FIG. 5 shows the lid 10 with the hatch 11 in a closed configuration. FIG. 6 shows the lid 10 with the hatch 11 in an open configuration.

(44) The lid 10 is made of three main components: the hatch 11, a slider 12 and a base 13. Sliding the slider 12 along a first path allows the lid 10 to be attached to/removed from an implant. Sliding the slider 12 along a second path opens/closes the hatch 11. These processes will be described in more detail below.

(45) The lid 10 has a first side 42a and a second side 42b, the first and second sides 42a, 42b being on opposite sides of the first and second sliding paths of the slider 12.

(46) The hatch 11 is illustrated in FIGS. 19 and 20. The hatch 11 has a pivoting end 29 and an opening end 41. The pivoting end 29 is arranged to pivot within the lid 10, causing the opening end 41 to open upwardly from the rest of the lid 10 in an arc about the pivoting end 29. The hatch 11 is formed of a top part 31 and a bottom part 32, which are joined together at the opening end 41, with a recess 24 provided between the top part 31 and the bottom part 32. At the pivoting end 29 of the bottom part 32 there is an axel 30 and a projection 20. When the hatch 11 is closed, the projection 20 projects upwardly. When the hatch 11 is open the projection 20 projects more radially outwardly from the lid 10 (but still slightly upwardly). The axel 30 extends horizontally and defines the axis about which the hatch 11 opens.

(47) The slider 12 is illustrated in FIGS. 16, 17 and 18. The slider 12 has a top part 33 and a tongue 19 which projects radially inwardly, away from a radial edge 34 of the slider, from underneath the top part 33. The tongue 19 has at or near its radially inner (or projecting) end an engagement part (e.g. a hook) 28. A gripping part 40 is provided on an upper surface of the top part 33. The gripping part 40 comprises raised and/or lowered parts to assist a user in gripping and sliding the slider 12. Two ridges 21 are provided along opposite edges of the slider 12. The ridges 21 extend in a sliding direction in parallel with the tongue 19. Each ridge 21 has, at its radially inward end, a hook 26. On a lower surface of the top part 33 at its radial edge 34 end is provided a pair of angled members 17. The angled members 17 extend from the radial edge 34 of the slider 12 radially inwardly and towards each other.

(48) An embodiment of the base 13 is illustrated in FIGS. 13, 14 and 15. The base is formed of three parts: an upper part 13a, a middle part 13b and a lower part 13c. The upper and lower parts 13a and 13c are formed from a relatively rigid (but still slightly flexible) plastic whereas the middle part 13b is formed from a soft and more flexible plastic or rubber material.

(49) The upper part 13a forms a “C” shape around a circular opening 15. Gripping parts 22 (e.g. grooves and/or ridges or other raised/lowered parts) are provided on the upper surface of the upper part 13a around its edge. The upper part 13a has two opposing radially inner projecting parts 37 which form the upper surfaces of grooves 25 through which the ridges 21 of the slider 12 can slide. The lower surfaces of the grooves 25 are formed from the lower part 13c.

(50) The middle part 13b is formed of an upper middle part 13ba and a lower middle part 13bb. The upper middle part 13ba is located between the upper and lower parts 13a and 13c. The lower middle part 13bb is located beneath the upper part 13a and partly fills a circumferential gap 39 in the lower part 13c (described below). The middle part 13b is formed of a soft, flexible and slightly stretchy plastic or rubber material. A circular opening 15 is formed in the upper middle part 13ba which is delimited by an inner circular edge part 38 of the middle part 13b.

(51) The bottom part 13c has a generally ring-like shape but with a gap 39 in it breaking its circumference. The gap 39 can be seen in FIG. 11, for example. The opening 15 continues through the bottom part 13c. The bottom part 13c contains a pair of grooves 36 which are located beneath the projecting parts 37 of the upper part 13a, thereby forming the grooves 25 through which the ridges 21 of the slider 12 can slide. Recesses 27 (as shown in FIG. 8) are located at ends of each groove 36 to help hold the hatch 11 open (this is described in more detail below). A further groove 35 is provided on either side of (across) the gap 39 for the axel 30 of the hatch 11 to rest and rotate in. A pair of angled members 18 is provided on the bottom part 13c on either side of the gap 39. These angled members 18 of the bottom part 13c. The angled members 18 are located and positioned such that the angled members 17 of the slider 12 abut against them when the slider 12 is in a closed configuration, as can be seen in FIG. 8.

(52) When the upper, middle and lower parts 13a-c of the base 13 are assembled, the opening 15 is delimited by the soft flexible edge part 38 of the middle part 13b and it is the edge part 38 which sits in and engages with the groove 6 on the implant 1 when the lid 10 is connected to the implant 1.

(53) A groove 14 is provided around the exterior circumference of the base 13 in its lower part 13c and lower middle part 13bb. This groove 14 allows other devices (such as connectors, evacuation sleeves, bags, catheters etc.) to be connected to the lid 10, e.g. while it is attached to the implant 1. A projection 43 is provided around the lid 10 on the lower side of the groove 14. This projection 43 can help to prevent any device connected to the groove 14 from sliding down the lid 10. The hatch 11 can be opened and closed while such other devices are connected to the lid 10 to allow evacuation of waste from the patient.

(54) FIGS. 33 and 34 show alternative embodiments of the base 13′ and 13″. In these bases 13′ and 13″, the upper and bottom parts 13a and 13c are the same as those in base 13. However, the middle parts 13b′ and 13b″ are slightly different. Specifically, the shapes of their respective edge parts 38′ and 38″, delimiting the opening 15, are slightly different to that of the edge 38 of middle part 13b.

(55) The operation of the lid 10 will now be described.

(56) There are two main operations of the lid 10: (i) attaching/detaching the lid 10 to/from an implant 1; and (ii) opening/closing the hatch 11 of the lid 10 (whilst attached to an implant 1).

(57) First, the attaching/detaching of the lid 10 to/from an implant 1 will be described.

(58) In order to attach the lid 10 to an implant 1, the lid 10 must start in the closed relaxed configuration illustrated in FIG. 12. A user must then squeeze the lid 10 by pushing down the hatch 11 and, at the same time, pushing the radial edge 34 of the slider 12 radially inwardly, such that the ridges 21 move through/along the grooves 25. This causes the top part 33 of the slider 12 to move over the top part 31 of the hatch 11. The top part 31 of the hatch 11 then extends partly between the top part 33 and tongue 19 of the slider 12.

(59) The recess 23 between the top part 31 and bottom part 32 of the hatch 11 allows the top part 31 to be pressed downwards in this way. This is illustrated in FIGS. 9 and 10, which show a “stressed” configuration of the lid 10. It can be seen that the recess 23 is smaller in FIG. 10 (in the stressed configuration) than in FIG. 12 (in the closed relaxed configuration).

(60) By pushing the slider 12 radially inwards in this way, this causes the angled parts 17 of the slider 12 to push against the angled parts 18 of the base 13. This pushes the angled parts 18 of the base 13 apart, increasing the distance between the opposing halves of the top and bottom parts 13a and 13c, stretching the middle part 13b, and thereby increasing the size of the opening 15. This is illustrated in FIGS. 11(a) and (b), which show how the size of the gap 39 in the bottom part 13c of the base 13, is larger in the stressed configuration (b) than in the relaxed configuration (a).

(61) Increasing the size of the opening 15 in this way allows the user to then place the lid 10 over the end of the implant 1.

(62) The user then relaxes their grip on the lid 10 such that they are no longer squeezing the slider 12 radially inwardly. This causes the slider 12 to move back towards (but not fully into) the relaxed configuration of FIG. 12.

(63) The user then squeezes the lid 10 at its first and second sides 42a and 42b (e.g. with the gripping parts 22), perpendicularly to the sliding motion of the slider 12, which causes the slider 12 to move back fully into the relaxed configuration of FIG. 12. At this point, the opening 15 returns to its normal or relaxed size, whereby the edge part 38 of the middle part 13b of the base 13 is positioned in the groove 6 on the exterior part 4 of the implant 1. A “click” sound may be heard at this point, indicating to the user that the lid 10 is properly attached onto the implant 1. The lid 10 is then attached to and located on the implant 1.

(64) As the middle part 13b, in particular its edge part 38, is made from a flexible and soft material, this creates a seal with the implant 1 and the lid 10 is therefore in sealing engagement with the implant 1.

(65) In order to remove the lid 10 from the implant 1, the same steps are performed in reverse. The lid 10 is squeezed by pushing the radial edge 34 of the slider 12 radially inwardly to increase the size of the opening 15. The lid 10 can then be removed from the implant 1. The user then relaxes their grip on the lid 10 such that they are no longer squeezing the slider 12 radially inwardly, thereby causing the lid 10 to return to its normal or relaxed configuration.

(66) The opening/closing of the hatch 11 of the lid 10 will now be described. This is performed when the lid 10 is attached to an implant 1 to allow the evacuation of waste from the ileum.

(67) As described above, two ridges 21 are provided on opposite sides of the slider 12. The ridges 21 can slide along/within the pair of grooves 25 which are provided in the base 13 of the lid 10. A hooking part 26 is provided at the end of each ridge 21.

(68) In order to open the hatch 11, the slider 12 is slid radially outwardly from the rest of the lid 10 such that the ridges 21 move along through the grooves 25. This process is described in more detail with reference to FIGS. 7 and 12.

(69) FIG. 7 is a cross-sectional side view of the lid 10 with the hatch 11 in an open configuration and FIG. 12 is a cross-sectional side view of the lid 10 with the hatch 11 in a closed configuration.

(70) When the slider 12 is slid radially outwardly from the rest of the lid 10, the engagement part 28 (e.g. a hook) on the tongue 19 slides along to and engages with the projection 20 on the hatch 11, pressing on the projection 20 and thereby causing the hatch 11 to pivot about the axel 30 at its pivoting end 29 and open upwardly.

(71) When the slider 12 is slid out and the hatch 11 is open, the hooks 26 on the end of each ridge 21 of the slider 12 are located in the recesses 27 in the base 13.

(72) In this state, the hatch 11 is held open because the shape and material (plastic) of the tongue 19, combined with the shape of the base 13, cause the tongue 19 to function like a spring, exerting a spring force on the hatch 11. If a user tries to close the hatch 11 with a force (or a force accidentally presses on the hatch 11), while the slider 12 is slid out from the rest of the lid 10, the hatch 11 will close but it will spring back open again when the force is removed due to the spring force of the tongue 19 acting on the hatch 11.

(73) In order to close the hatch 11, the slider 12 is pushed radially inwardly back into/over the rest of the lid 10. This causes the spring force of the tongue 19 acting on the hatch 11 to stop, as the engagement part 28 of the tongue 19 is slid away from the projection 20 and over the bottom part 32 of the hatch 11, thereby pressing down on the bottom part 32 of the hatch 11 and causing it to close.

(74) The slider 12 has two “spring” bumps 44 (see FIG. 18) on its lower side and on either side of the tongue 19. The spring bumps 44 slide over two corresponding bumps 45 located on either side inside the base 13 (see FIG. 13). The slider 12 is held in a closed position by its spring bumps 44 being held in place (prevented from sliding) by the bumps 45 on each side of the base 13. The slider 12 has to be pushed with sufficient force that its spring bumps 44 can overcome the resistance from, and move over, the bumps 45 in the base 13.

(75) When the slider 12 is in the closed position, the tongue 19 presses downwards on the bottom part 32 of the hatch 11, thereby pressing the hatch 11 down against the base 13, specifically, its middle part 13b, whereby the hatch 11 is closed in sealing engagement with the base 13.

(76) The lid 10 is made of plastics materials. The slider 12 is made of POM: Medical grade copolymer granules of PolyOxyMethylene.

(77) The hatch 11 is made of PBT: Medical grade copolymer granules of PolyButyleneTerephthalate (polyester).

(78) The top and bottom parts 13a and 13c of the base 13 are made of PP (polypropylene). In an alternative embodiment, the top and bottom parts 13a and 13c of the base 13 are made of ABS: Medical grade copolymer granules of AcrylonitrileButadieneStyrene. The middle part 13b of the base 13 is made of Mediprene®: Medical grade elastomer granules of StyreneEthyleneButyleneStyrene.

(79) The slider 12, hatch 11 and top, middle and bottom parts 13a-c of the base 13 are injection moulded, assembled and packed in a controlled process and environment, which is clean but not (necessarily) sterile.

(80) The base 13 is manufactured by first injection moulding the top and bottom parts 13a, 13c from PP, in separate first and second tools. These parts 13a, 13c are then inserted into a third tool, where Mediprene® is injected to both form the middle part 13b and join the top and bottom parts 13a, 13c (via the middle part 13b), thereby creating a complete base 13. This process is often referred to as 2K injection moulding.

(81) The lid 10 is reusable but should be replaced on a weekly basis.

(82) In order to clean the lid 10, it is recommended to rinse it in tap water. However, the lid 10 will withstand soap, household detergents and boiling water. It can also be soaked in 70% alcohol. After such cleaning it should always be rinsed carefully afterwards.

(83) A connector can be attached to the lid 10 in, or partly in, the groove 14.

(84) A preferred embodiment of a connector 50 is shown in FIGS. 21 to 23. FIG. 24 shows the connector 50 attached to a lid 10.

(85) The connector 50 provides a flat surface to which further devices such as evacuation sleeves, catheters or bags may be attached (e.g. with adhesive). Alternatively, such further devices may be provided with a connector 50 already attached, for attachment to a lid 10.

(86) The connector 50 is a circular disc with an opening 51 in the middle. The diameter of the opening 51 is sized such that the inner edge 52 of the connector 50 fits around the lid 10 just above the groove 14.

(87) In alternative embodiments, the connector 50 is sized slightly smaller such that its inner edge 52 fits around the implant 1 just above the groove 6. The connector 50 may then be attached directly to the implant 1.

(88) The connector 50 has a top side 50a and a bottom or skin side 50b. The top side 50a provides the flat surface to which further devices may be attached (e.g. with adhesive).

(89) The connector 50 is made of two main parts: an outer ring 53 and an inner ring 54.

(90) The outer ring 53 is made of a relatively hard or stiff plastic (e.g. polypropylene) and the inner ring 54 is made of a soft rubbery material such as Mediprene®. Forming the inner ring 54 from a soft material allows it to sealingly engage with the lid 10 (or the implant 1), thereby preventing leaks. Forming the outer ring 53 from a stiffer material allows it to form a rigid base, e.g. to which a further device may be attached, and makes it easier to position and attach the connector 50 to the lid 10 (or implant 1).

(91) The stiff outer ring 53 of the connector 50 has a number of tongues 55 (seven tongues are provided in the embodiment shown). The tongues 55 extend from the rest of the outer ring 53 through the inner ring 54 towards, but not quite as far as, the inner edge 52 of the connector 50. The tongues 55 are provided on the skin side 50b of the connector 50.

(92) The inner diameter of the inner tips (ends) of the tongues 55 matches, or nearly matches, the diameter of the groove 14 provided around the lid 10 (i.e. it is slightly smaller than or slightly larger than or the same as the diameter at the bottom of the groove 14, depending on how tight a fit is desired for the connector 50 on the lid 10). The inner diameter of the inner ring 54 is smaller than the inner diameter of the tips (ends) of the tongues 55 and smaller than the outer diameter of the lid 10, thereby creating a snug and sealing fit of the inner ring 54 against the lid 10.

(93) The tongues 55 are made of the same stiff material as the rest of the outer ring 53. These tongues 55 will flex slightly and, when the connector 50 is connected to a lid 10 (or implant 1) will click into the groove 14 in the lid 10 (or the groove 6 in the implant 1) thereby fixing the connector 50 to the lid 10 (or implant 1), as shown in FIGS. 25 and 26.

(94) The soft rubbery inner ring 54 forms a very thin, smooth inner circle, whose inner diameter is slightly smaller than the outer diameter of the lid 10 just above the groove 14. This means that the inner ring 54 can seal tightly against the lid 10 just above the groove 14, as shown in FIGS. 25 and 26.

(95) Thus, the tongues 55 engage with the lid 10 in the groove 14, and the inner ring 54 seals with the lid 10 just above the groove 14. Together, the tongues 55 and the inner ring 54 function to connect and seal the connector 50 to the lid 10. However, this only works correctly if the connector 50 is placed with the correct side facing upwards, i.e. with the tongues 55 on the lower (or skin) side 50b.

(96) In an alternative embodiment, the two sides of the connector are the same and so it can be used either way up.

(97) As described above, the projection 43 around the lid 10 at the lower side of the groove 14 helps to prevent the connector 50, when connected to the lid 10, from being pushed down the lid 10, e.g. to between the lid 10 and the patient's skin.

(98) The connector 50 is manufactured using injection moulding. First, the outer ring 53 (with its tongues 55) is formed by injection moulding it in a first tool. The outer ring 53 (with its tongues 55) is then placed in a second tool and the inner ring 54 is injection moulded onto the outer ring 53 in the second tool, thereby joining the two ring parts 53, 54 together.

(99) Alternative connectors are shown in FIGS. 27 to 32.

(100) FIGS. 27 and 28 show a connector 60 in closed and open configurations, respectively. The connector 60 is substantially ring-shaped and is formed of two relatively planar halves 64a and 64b. Each half 64a, 64b, has a joined end 64a′, 64b′ and a connecting end 64a″ and 64b″.

(101) A device such as a sleeve, catheter or bag may be adhered to the upper surface of these halves 64a 64b.

(102) A connecting edge 62 is provided around an inner circumference of the two halves 64a 64b. The connecting edge 62 is formed of a soft rubbery material and is sized and dimensioned so as to fit in and seal with the groove 14 in the lid (or in the groove 6 in an implant 1).

(103) The two halves 64a, 64b are joined at their joined ends 64a′, 64b′ by a pair of relatively thin and flexible bending member 63a, 63b.

(104) At the connecting ends 64a″, 64b″, radially outwardly projecting gripping parts 61a and 61b are provided, which can be connected together (thereby closing the connector 60) by means of a hook 66b provided on the second gripping part 61b and a hooking member 66a provided on the first gripping part 61a, around which the hook 66b can hook when a compression part 65 provided on the second gripping part 61b is compressed and then released.

(105) A pair of opening arms 67a and 67b are also provided at the connecting ends 64a″ and 64b″ of the halves 64a, 64b. Specifically, an opening arm 67b is provided at the connecting end 64a″, which passes under a retaining member 68b provided on the other connecting end 64b″. Similarly, an opening arm 67a is provided at the connecting end 64b″, which passes under a retaining member 68a provided on the other connecting end 64a″. Hooks 69a and 69b are provided at the end of each opening arm 67a, 67b which, when the connector 60 is opened to its fullest extent, hook against the retaining members 68a and 68b, thereby preventing the connector 60 from being opened too far.

(106) The same soft rubbery material that is provided along the connecting edge 62 is also provided along the joining edges of the connector 60 at the joined ends 64a′, 64b′ and connecting ends 64a″, 64b″ so that, when the connector 60 is closed, the two halves 64a, 64b are in sealing connection with each other.

(107) The connector 60 is provided in a closed state as illustrated in FIG. 27. In order to attach the connector 60 to a lid 10, the connector 60 is opened by pressing on the compression part 65 to release the hook 66b from the hooking member 66a. The two halves 64a, 64b of the connector 60 can then be opened. The connector 60 is then placed around the groove 14 in the lid 10 (or around the groove 6 in an implant 1) and the two halves 64a, 64b of the connector 60 are then moved back together so that the hook 66b hooks onto the hooking member 66a again and the connecting edge 62 is located in the groove 14 in the lid (on in the groove 6 in an implant 1), thereby holding the connector 60 in place.

(108) In order to remove the connector 60 from a lid 10 or implant 1, the same procedure is performed again except that the connector 60 is removed from the lid 10 or implant 1, rather than being placed around it.

(109) The connector 60 is manufactured by injection moulding. The two halves 64a, 64b of the connector 60 are injection moulded together in a first tool. Then they are placed in a second tool and the soft rubbery material is injection moulded on to them along the connecting edge 62 and joining edges between the two halves 64a, 64b.

(110) The two halves 64a, 64b of the connector 60 are then connected together at their connecting ends 64a″, 64b″ by inserting the opening arms 67a and 67b under their respective retaining members 68a, 68b, so that the connector 60 is ready for use.

(111) FIGS. 29 and 30 show a connector 70 in closed and open configurations, respectively. The connector 70 is substantially ring-shaped and is formed of two relatively planar halves 74a and 74b. Each half 74a, 74b, has a joined end 74a′, 74b′ and a connecting end 74a″ and 74b″.

(112) A device such as a sleeve, catheter or bag may be adhered to the upper surface of these halves 74a 74b.

(113) A connecting edge 72 is provided around an inner circumference of the two halves 74a 74b. The connecting edge 72 is formed of a soft rubbery material and is sized and dimensioned so as to fit in and seal with the groove 14 in the lid (or in the groove 6 in an implant 1).

(114) The two halves 74a, 74b are joined at their joined ends 74a′, 74b′ by a pair of relatively thin and flexible bending member 73a, 73b.

(115) At each connecting end 74a″, 74b″, a squeezing member 71a, 71b is provided, which, when squeezed together, cause the connecting ends 74a″, 74b″ to move apart and the connector 70 to open. The squeezing members 71a and 71b slightly overlap the connecting ends 74b″, 74a″ to which they are not attached. In addition, a retaining member 77a, 77b is provided at each connecting end 74a″, 74b″, which also overlaps the other connecting end 74b″, 74a″. These overlapping features act to keep the two halves 74a, 74b in the same plane.

(116) A further member 76a, 76b, is provided at each connecting end 74a″, 74b′. These further members 76a, 76b project out of the plane of the connector 70 and have a flattened end part such that one or more elastic bands (not shown) can be placed around the further members 76a, 76b. The elastic bands are sized such that they act to keep the connector 70 in a closed position.

(117) The same soft rubbery material that is provided along the connecting edge 72 is also provided along the joining edges of the connector 70 at the joined ends 74a′, 74b′ and connecting ends 74a″, 74b″ so that, when the connector 70 is closed, the two halves 74a, 74b are in sealing connection with each other.

(118) The connector 70 is provided in a closed state as illustrated in FIG. 29. In order to attach the connector 70 to a lid 10, the connector 70 is opened by squeezing the squeezing members 71a, 71b together. This stretches the elastic band(s) and the two halves 74a, 74b of the connector 70 are opened (as shown in FIG. 30). The connector 70 is then placed around the groove 14 in the lid 10 (or around the groove 6 in an implant 1) and pressure on the squeezing members 71a, 71b is released such that the two halves 74a, 74b of the connector 70 are pulled back together by the elastic band(s) so that the connecting edge 72 is located in the groove 14 in the lid (on in the groove 6 in an implant 1), thereby holding the connector 70 in place.

(119) In order to remove the connector 70 from a lid 10 or implant 1, the same procedure is performed again except that the connector 70 is removed from the lid 10 or implant 1, rather than being placed around it.

(120) The connector 70 is manufactured by injection moulding. The two halves 74a, 74b of the connector 70 are injection moulded together in a first tool. Then they are placed in a second tool and the soft rubbery material is injection moulded on to them along the connecting edge 72 and joining edges between the two halves 74a, 74b.

(121) The two halves 74a, 74b of the connector 70 are then connected together at their connecting ends 74a″, 74b″ by positioning the connecting end 74a″, 74b″ (partly) under their respective retaining members 77a, 77b. One or more elastic bands are then placed around the members 76a, 76b so that the connector 70 is ready for use.

(122) FIGS. 31 and 32 show a connector 80 in closed and open configurations, respectively. The connector 80 is substantially ring-shaped and is formed of first and second relatively planar, overlapping, interlocking ring parts 84a and 84b.

(123) A device such as a sleeve, catheter or bag may be adhered to the upper surface of these ring parts 84a, 84b.

(124) The first ring part 84a is formed of an outer ring part 84a′ and an inner ring part 84a″. Similarly, the second ring part 84b is formed of an outer ring part 84b′ and an inner ring part 84b″. The two inner ring parts 84a″ and 84b″ are the same in size and shape and form the inner circumference of the connector 80. The two outer ring parts 84a′ and 84b′ form the outer circumference of the connector 80, with the outer ring part 84a′ being larger and forming a greater part of that circumference than the outer ring part 84b′.

(125) The inner and outer ring parts 84a′, 84b′, 84a″, 84b″ are interlocking in that that inner ring part 84a′ of the first ring part 84a is located above the outer ring part 84b″ of the second ring part 84b, and the inner ring part 84b′ of the second ring part 84b is located above the outer ring part 84a″ of the first ring part 84a. This interlocking feature helps to keep the two ring parts 84a, 84b together.

(126) The inner ring parts 84a″ and 84b″ each have a retaining member 81a, 81b, respectively, around their inner circumference, around which an elastic band (not shown) is positioned. The elastic band acts to pull the ring parts 84a and 84b together across the diameter of the connector 80, and thereby keeps the connector 80 in a closed configuration, as shown in FIG. 31.

(127) An inner groove (not visible in the figures) is provided on each side between the outer and inner ring parts 84a′, 84a″ of the first ring part 84a. Similarly, corresponding ridges (not visible in the figures) are provided on the inner surfaces of the inner ring part 84b″ of the second ring part 84b. The ridges can move along inside the grooves and this allows the two ring parts 84a and 84b to move towards/away from each other. Similarly, the grooves and ridges also act to hold the two ring parts 84a, 84b together.

(128) Connecting edges 85a, 85b are provided around the inner edges of the two inner ring parts 84a″ and 84b″. The connecting edges 85a, 85b are formed of a soft rubbery material and are sized and dimensioned so as to fit in and seal with the groove 14 in the lid (or in the groove 6 in an implant 1).

(129) The same soft rubbery material that is provided along the connecting edges 85a, 85b is also provided along the joining edges of the interlocking ring parts 84a and 84b so that, when the connector 80 is closed, the two ring parts 84a and 84b are in sealing connection with each other.

(130) The connector 80 is provided in a closed state as illustrated in FIG. 31. In order to attach the connector 80 to a lid 10, the connector 80 is opened by squeezing the two outer ring parts 84a″, 84b″ together. This causes the ridges to move along inside the grooves, stretches the elastic band, the inner ring parts 84a′, 84b′ move away from each other and the connector 80 is opened (as shown in FIG. 32).

(131) The connector 80 is then placed around the groove 14 in the lid 10 (or around the groove 6 in an implant 1) and pressure on the two outer ring parts 84a″, 84b″ is relaxed or reduced such that the inner ring parts 84a′, 84b′ of the connector 80 are pulled back together by the elastic band so that their inner edges are located in the groove 14 in the lid (on in the groove 6 in an implant 1), thereby holding the connector 80 in place.

(132) In order to remove the connector 80 from a lid 10 or implant 1, the same procedure is performed again except that the connector 80 is removed from the lid 10 or implant 1, rather than being placed around it.

(133) The connector 80 is manufactured by injection moulding. The two interlocking ring parts 84a and 84b are injection moulded separately in their own first tools. Then they are each placed in their own second tools and the soft rubbery material is injection moulded on to them along the connecting edges 85a, 85b and the joining edges of the interlocking ring parts 84a and 84b.

(134) The two interlocking ring parts 84a and 84b of the connector 80 are then slotted together and one or more elastic bands are then placed around the retaining members 81a, 81b so that the connector 80 is ready for use.

(135) The connectors 60, 70, 80 are made of plastic, specifically polypropylene, with Mediprene® being used as the soft rubbery material. In any of the connectors 50, 60, 70, 80, instead of polypropylene, acrylonitrile butadiene styrene (ABS), polybutylene terephthalate (PBT) or polyoxymethylene (POM) could be used for increased rigidity.

(136) When a connector 50, 60, 70, 80 is connected to a lid 10, the lid 10 cannot accidentally be removed from the implant 1, because the presence of the connector 50, 60, 70, 80 around the lid 10 will prevent the base 13 of the lid 10 from being stretched or bent into the widened state (with an enlarged opening 15) which is required for removal of the lid 10 from (or mounting of the lid 10 to) the implant 1.

(137) The lid 10 and connectors 50, 60, 70, 80 are intended for ambulatory care and can be applied by either healthcare professionals or patients themselves.

(138) The system consisting of the implant 1, lid 10 and connector 50, 60, 70, 80, together with a further device such as a sleeve, catheter or bag, prevents seepage and is intended to eliminate the need for constantly wearing an external appliance (e.g. pouch/bag) on the abdomen for collection of intestinal content.

(139) After an implant 1 has been implanted into a patient, patients will typically have to use standard ostomy bags for an initial period of time before they can start using the lid 10. However, once the tissue is healed and fully integrated with the implant 1, the exterior end of the implant 1 can be closed with a lid 10.

(140) Use of the lid 10 should be gradually introduced by momentary use over an acclimatisation period, the length of which may vary from patient to patient. During this acclimatisation phase, the lid 10 may be used for short periods, which are gradually increased in duration and frequency. Between lid uses, it is recommended to use ostomy bags. The lid 10 should not be used permanently before lid acclimatisation is completed.

(141) As the lid 10 is used, the intestine gradually develops a natural reservoir 100 behind the implant 1. The development of this reservoir 100 means that the intestinal contents do not need to be emptied as often.

(142) Once the acclimatisation phase has been completed, use of the lid 10 means that a patient usually no longer needs to use an ostomy bag during the daytime. However, it is in some cases still preferable to use an ostomy bag at night.

(143) The length of time between emptying of the intestine varies from person to person, but the intestine normally needs to be emptied two to ten times a day.

(144) The process for emptying the intestine is described below.

(145) First, a connector 50, 60, 70, 80 is connected to the lid 10 and an irrigation sleeve is affixed to the connector 50, 60, 70, 80. The open (i.e. not affixed to the connector 50, 60, 70, 80) end of the irrigation sleeve is positioned over a toilet.

(146) The hatch 12 of the lid 10 is then opened inside the sleeve. The opening of the lid 10 is performed from outside the sleeve to avoid soiling, i.e. the patent operates the lid 10 through the sleeve without directly touching the lid 10.

(147) When the hatch 12 has been opened, the intestine can be emptied. In order to do this, the patient bends slightly forwards to empty all the contents of the intestine through the irrigation sleeve.

(148) When emptying is completed, the hatch 12 is closed, the sleeve is then removed and disposed of, and the connector 50, 60, 70, 80 is removed and either rinsed for further use or also disposed of.

(149) It can be convenient at this stage for a patient to replace the lid 10 with a second lid 10, and to rinse the first lid 10 ready for the next emptying.

(150) The patient's skin, stoma and external surface of the implant 1 should be wiped clean, preferably with lukewarm running water, if available, before replacing the lid 10. Disinfectants should be avoided.

(151) Should the emptying procedure require more length period of time, rather than an irrigation sleeve, an ostomy bag could be temporarily used on the skin around the implant 1, after removal of the irrigation sleeve and connector 50, 60, 70, 80, and possibly also the lid 10. Alternatively, an ostomy bag, rather than an irrigation sleeve, could be affixed to the connector 50, 60, 70, 80. In either case, when emptying is completed, the lid 10 should be closed from outside the bag before the bag is removed.

(152) Once the lid 10 is in continuous use, it should be replaced every week for hygienic reasons. The connector 50, 60, 70, 80 should be replaced every day. Alternative embodiments of the lid and/or connector may require more or less frequent replacement.

(153) Throughout this specification terms such as top/bottom/side/upper/lower are used. These are used for clarity and refer merely to the way in which the implant, lid and/or connector are typically viewed or considered (as shown in the figures unless otherwise indicated), i.e. with the external end of the implant at the top and the hatch of the lid opening upwards. However, of course, in use, the implant (and so therefore also the lid) may have different orientations and so parts referred to as top/bottom/side/upper/lower may of course have a different relative location.