Ostomy appliances for directing effluent output

[0001] The subject of the present invention is the field of ostomy appliances for mounting and sealing inside and around the stoma of the stoma to direct the outflow of content, and more specifically to extend the stoma, according to the preamble of claim 1. The term "stoma" is intended to include at least a colostomy, ileostomy and urostomy.

BACKGROUND OF THE INVENTION [0002] Effective directing or otherwise controlling the outflow of content is essential for ostomy appliances designed to protect the skin in the vicinity of the excreta area. Creating a seal around a person's stoma so that the seal is reliable, non-burdensome and beneficial to body tissues is important for the functioning of ostomy appliances. After this seal has been made, the device may use one or more of a variety of techniques to control ostomy discharge. The creation of such a seal remains an area of ​​continuous improvement and development, since the efficiency and convenience of sealing are essential to customer acceptance. The essential feature of such an ostomy appliance is the protection of the outer periostomy tissue in which normal skin is in contact with the stoma tissue. Periostomy tissue can be extremely sensitive. Irritation may occur if periostomy tissue is exposed to body excretions or repeated application and removal of glue or other sealants.

[0003] Ideally, the stoma should protrude from the abdomen's abdominal surface a distance of 0.5cm to 2.5cm. This projection creates a spout from which the content can be output directly to the bag. In many cases, however, the stoma protrudes less or not at all. For example, "flat stoma" is a condition in which the stoma reaches only the abdomen; "Depression" is a condition in which the stoma does not even reach the abdominal surface, and the skin around the stoma is drawn into the funnel-like cavity between the stoma and the abdominal surface. There are many potential causes for these conditions. These include the surgeon's improper creation of the stoma; and gaining weight after the surgery. Gaining weight after surgery causes the abdominal area of ​​the stoma to expand in circumference and the length of the intestine attached to the abdomen remains constant, which causes the stoma to be pulled in this direction, and ultimately below the abdominal surface.

[0004] Flat and recessed stomas can be difficult to control because some content entering from the stoma may tend to accumulate around the stoma rather than being fully discharged into the bag. Stool stuck in such a way may have a negative effect on the area of ​​connection of the element stuck to the body and skin around the stoma. Such a negative effect reduces the adhesion of the body-adhesive element to the skin, thereby reducing the device's effectiveness and service life. Stool can also cause irritation and deterioration of the skin itself around the stoma. Stool coming out of the stoma may contain digestive juices from the body, and such juices may attack the skin around the stoma, causing skin defects. To date, no single device is known to control the varying distances between the stoma and the skin level.

[0005] Some known devices use a single expandable balloon or member within the stoma to form a seal on the inner wall of the opening, and a permanent blockage or surface outside the body. However, such devices must be carefully designed to avoid the risk of damage to sensitive internal tissue. In such constructions, tissues under the stoma can be affected by a relatively high force intensity, affecting the blood circulation in the area under pressure, and as a result, leading to tissue necrosis over time.

[0006] For example, US Publication No. 2003/0220621 describes a valve ostomy device comprising a hollow discharge tube and anchoring means for anchoring the tube in the stoma. Anchoring means include an inflatable balloon cuff inserted into the stoma to anchor the tube on the wall of the stoma and a threaded screw clamp as the outer locking surface. Although the threaded screw clamp has a formable washer, the anchoring means bear the entire weight of the ostomy appliance and any collection devices attached to it. Thus, the joining force must be balanced taking into account the clamping force limits that can be delivered by periostomy tissue without causing discomfort or tissue damage and the inflation pressure of the balloon cuff without causing internal damage to the lumen of the stoma. In addition, the device has a very small or zero range of adaptation to the varying distance between the bottom of the fascia and the skin, limiting the use to people whose distance between the fascia and skin is within the scope of the device. Also, the means for inflating the device requires an additional mechanism, such as a syringe or pump, to inflate it. It would be inconvenient for the user to wear an additional element, and the inflating mechanism may not have the means to control the amount of fluid to be pumped into the device, which involves the risk of insufficient or excessive inflation of the device.

[0007] EP 0168967, EP 1346711 and US Patent No. 4,950,223 describe ostomy ports comprising a single inflatable balloon inserted into the stoma and an external adhesive plate for attaching the device to the skin around the stoma. Such constructions are primarily concerned with creating a seal inside the lumen of the stoma. Periostomy tissue is either unprotected or is protected by an adhesive plate, which leaves the possibility of exposing the periostomy tissue to the usual problem of irritation and pain resulting from stool exposure or repeated application and removal of glue. As in the previous recalled device, there are also no significant solutions for changing the distance between the fascia and skin or for the fact that an additional element is necessary for inflation.

[0008] US 6 984 221 B1 discloses a device for providing fluid communication with a hollow organ on a skin surface. The aforementioned device, which includes an integral tube at its ends with supportive peritoneal (8) and skin (6) sleeves, is characterized in that the tube consists of two parts (2,4) integrated with a suitable sleeve (6, 8) movably mounted in the axial orientation for their relative, but not spontaneously reversible displacement, the part of the tube (4) integrated with the peritoneal sleeve (8) includes external locking means (10, 12, 26), enabling the physician to modify said length based on the total thickness of the patient's walls through which it passes.

[0009] US 2003 220 621 A1 discloses a valve stoma drainage device comprising a primary channel that can be inserted into a colostomy or ileostomy. After insertion, the cuff or balloon collar is inflated on the inside of the canal, which holds the canal in place in the stoma. The channel is anchored on the patient's outer surface through a soft, plastic ring that acts as an elastic insert seal and an anchor flange that is mounted at the exposed end of the channel by pressing the ring against the patient's abdomen. With such a flange mounted, the remaining exposed end of the channel is adapted for sealing by detachably mounting a rigid sealing element on it, such as a threaded cap or other closing means. A flexible one-way valve mounted in the duct prevents pusses such as intestinal contents or stool from being pushed through the duct until the cap is removed and the resulting one-way valve opens through the secondary duct inserted into the primary duct and pushed onto the one-way valve to open the valve.

[0010] US 5 524 644 A discloses a device subject to step regulation and a method of its use for protecting an incision wound from exposure to bacteria and other harmful contaminants. A pair of O-ring flexible sealing rings are connected to the opposite ends of the impervious flexible sleeve. One of the O-rings is formed to contact the inside of the wound with a portion of the sleeve above the wound that can be wound onto the other ring to pull off the remainder of the sleeve with the edges of the wound. Flat surfaces on the second ring provide a grip surface for rotating the ring about its annular axis.

[0011] US 2004/049009 A1 discloses a surgical wound retractor adapted to extend the wound under extension to the desired diameter. The retractor includes a first ring with a diameter larger than the desired wound diameter and adapted to be positioned within the wound. The second ring has a diameter greater than the desired wound diameter and adapted to be positioned outside the wound. A plurality of retraction elements are arranged in a generally cylindrical relationship between the first ring and the second ring. These elements run through the wound to exert a radial retractive force on the wound, which is dependent on the distance separating the first ring from the second ring. The retraction elements, both expandable and non-expandable, are designed with appropriate fasteners on the rings to take account of changes in retraction force. With a suitable retraction sleeve, a third ring forming a peripheral retainer can be provided to vary the retraction force. The rings can also be inflatable or self-expanding to change the retraction force. The related method includes the step of winding the second ring circumferentially with respect to the third ring to form a peripheral retainer.

[0012] WO 2008/157172 A1, which is the prior art according to A54 (3) EPC, discloses an ostomy adapter that is particularly suitable for recessed or flat ostomy. The ostomy adapter effectively expands the exit from the stoma, protects the periosteal skin and creates a bridge at the interface between the stoma and the stoma device. The ostomy adapter includes a substantially free path exit, at least as far as the contents flowing in the direction of discharge. The ostomy adapter includes a seal for sealing the intestinal wall. The ostomy adapter has foldable, extended, flexible and reinforced constructions.

[0013] GB1492946 discloses a personal sanitary container for collecting faecal excretions of sick persons comprising an open tubular elastomeric member C for insertion into the human anus, each end of the member ending in a resilient ring 1, 3 and the central part of the member being led out where is to pass through the anal sphincter 2, and one ring 3 is adapted to receive and hold a removable faecal bag A and has a built-in outlet 4 for air or gases from the bag. The sack is made of plastic and its open end is detachably attached to the ring 3 by means of tape 3a. The transfer ring 1 has a flattened cross section, assuming a partially conical shape.

BRIEF DESCRIPTION OF THE INVENTION [0014] In general, the present invention provides a stoma extension as defined in independent claim 1, comprising a first end for insertion into the stoma for directing the stoma to the extension of the stoma before the content from the stoma, the other end for remaining outside the stoma for providing outputs for stoma content output, and a flexible duct portion joined between the first and second ends to convey ostomy contents by extension of the stoma, at least one of the first and second ends comprising an O-ring, characterized in that the length of the duct portion is stable adjustable to distance between the fascia and skin to allow the stoma extension to be adapted to the individual's stoma, wherein the O-ring and at least a portion of the channel part adjacent to the O-ring is configured to allow at least partial rolling of the channel part along its axis to reduce the length and / or at least partially unwinding of the rolled channel part along its axis to increase the length.

[0015] Optional aspects of the invention are defined in the dependent claims and include (i) a first end seal, the seal comprising a plurality of elastic projections and an elastic mesh extending at least between parts of these projections; (ii) a first end seal, said seal comprising material configured to extend upon contact with moisture; (iii) a complex configuration of the first end and, optionally, portions of the tubular member or channel portion, said complex configuration being secured by a water-soluble and / or water-dispersible adhesive or coating such as gelatin; (iv) an inflating fluid reservoir built into the stoma extension to inflate the seal at the first end, which avoids that the user will have to wear additional inflation equipment; and / or (v) a sliding flange on the tubular member and is selectively attached by a selective coupling device. The selective coupling device can be operated manually or can react depending on the direction.

[0016] These concepts can be used independently or two or more concepts can be used in combination. The invention uniquely covers all such possible combinations and permutations.

[0017] There are many embodiments of the invention. They present the above and other aspects: a means for sealing against the intestinal wall; the ability to adapt to changes in the distance between the fascia and skin and to provide a flexible range of possible movement; the channel part may be coiled from the second end to allow length adjustment after the first end has been inserted into the stoma; elements of insertion and removal from the stoma; and a "self-inflating" element by internal fluid pressure maintenance for starting and / or activating the device. Each embodiment may include one or more of these aspects.

[0018] At least the channel part is configured to allow at least one of the following: at least partially folding the channel part along its axis to reduce the length and / or at least partially unfolding the folded channel part along its axis to increase the length , preferably wherein the channel part can be folded from the second end to allow length adjustment after the first end has been inserted into the stoma.

[0019] Other aspects of the present invention and additional features that may be used in conjunction with the above include:

(a) the first end of the stoma extension may include a seal for sealing against the intestinal wall, preferably said seal is selected from: an inflatable seal and / or a seal comprising elastic projections and / or a seal containing material that expands upon contact with moisture ostomy content.

(b) the sealing may include part of an inflatable sealing chamber relative to the inner wall of the stoma. The inflatable chamber has a toroidal shape and is tightly attached to a tubular straight, conical or "trumpet" central channel formed of thin flexible material.

(c) The seal may include a first portion of an inflatable sealing chamber relative to the inner wall of the stoma and a second portion of an inflatable chamber for sealing outside the stoma.

(d) The seal may be located in the opening of the adhesive member. The seal may include part of an inflatable chamber and a carrier. The carrier may form the basis of part of the inflatable chamber. A portion of the inflatable chamber may allow the carrier to float securely relative to the adhesive member.

(e) The seal may include a portion of the inflatable chamber that is located in the opening of the adhesive member and is configured to seal outside the stoma, substantially without clogging the stoma. The tubular member or passage may optionally extend through the outside of the inflatable chamber for discharging the body's excretions. The inflatable seal can allow the body to discharge without removing the inflatable seal from the stoma.

(f) A seal comprising an inner portion to seal against the inner wall of the stoma may be constructed of an un-inflated toroidal member, i.e. an O-ring. The member is connected to and / or associated with a substantially tubular flexible member, or forms with it a continuously formed shape that extends through the stoma opening to form a passage outside the body.

(g) The seal comprising the inner sealing portion on the inner wall of the stoma can be constructed in an activated state of an inflatable funnel-like member having finger-like projections, more or less similar to the umbrella carrier members, but facing in the opposite direction of activation. These projections are continuous with an annular element at the base that provides support for supporting the central opening, especially if there is a radial force to cause the projections to close. This funnel member is constructed of a flexible and / or flexible material so as to be rigid enough to hold the shape, and at the same time flexible enough and soft enough to easily close the projections to affect a somewhat cylindrical shape. The end of the protrusions is rounded inwardly around such a radius that prevents the force at the ends of the protrusions from coming into contact with the intestinal wall. Above this funnel member, a thin, very flexible cover is attached / tied or otherwise constructed in a continuous manner, forming a mesh between the projections and the sealed central passage from the end of the annular support element. The central tube passage runs through the stoma opening outside the body. The central pipe passage may have a straight, conical or "trumpet" shape. In another embodiment, the annular support member may extend through the stoma and out of the body. A pipe-shaped insertion tool can be used to engage the bent ends of the projections in a closed state. After the distal end of the device is inside the stoma, the tool is removed and the funnel-shaped member memory activates the device. It may happen that the highly elastic lid is overmolding, in which the protrusions, initially formed in a preloaded state, remain stretched during the overmolding process, so that when the finished device is activated, the highly elastic lid maintains a stretched state to maintain sealing against intestinal walls.

(h) A seal comprising an internally inflated chamber portion may be constructed of a single chamber or two chambers connected to each other, attached and / or connected or constructed from a single molded shape, with a tubular, more solid or rigid central member. The proximal end of this assembly or component may be attached to another more flexible tubular member, or the central member itself extends further out of the body to provide passage through the device. For embodiments having another more flexible tubular member, the shape may be straight, tapered or "trumpet" tubular. An assembly or component comprising single or double chambers and a more robust central tubular member are intended for full fascia and inflation, while the proximal end of the central member or the more flexible tubular straight, conical or "trumpet" shaped member remains outside the stoma. This assembly configuration may allow easy insertion into the stoma without the need for an insertion device.

(i) The sealing member on the outside of the stoma can be constructed of a thicker toroidal flexible material or O-ring such that when the inner member is activated inside the stoma, the outer member can be manually "retracted" by the user using a toroidal latch and elastic recoil connecting the tubular member or passage to conform to the changing length between the fascia and the skin. The connecting tubular member may include a range of properties from thinness and a high level of flexibility to being constructed of a stiffer material and may have a tubular conical shape.

(j) The sealing member outside the stoma may not only be constructed of thicker flexible toroidal shape material or an O-ring to manually adjust the peripheral latch to the distance between the fascia and skin, but may also include a chamber under pressure, i.e. inflatable O-ring. In this chamber, the vacuum is to be created by the fluid at the production stage or for some time before use, so that the contained pressure after release can be used to transfer, by flexible action of the fluid component through interconnected passages to the inner chamber, so that the inner chamber can be activated when it is in the body, thus eliminating the need for an additional component to inflate the device. An opening or other fluid restriction or valve may be used at the entrance, exit, or along connected passages to delay activation of the device to give the user enough time to insert the device. The inner chamber may be restricted, e.g., bent, curled and / or twisted, into a thin, long shape to facilitate insertion into the stoma before activating the device without the need for an insertion tool. Gelatin or other coating on the restricted inner chamber can facilitate insertion by maintaining the restriction until gelatin contacts or enters the wet interior of the stoma. The addition of an overlay over the inner chamber may also assist in keeping the chamber restricted before use.

(k) The member outside the stoma may not include the outer seal, but may only rest or attach and have "drains" to allow fluid to drain if the intestinal seal is damaged. Drainage can prevent the stoma opening from clogging in the event of a seal failure. The discharge of content may also indicate that the device needs to be replaced.

(l) A member outside the stoma, in embodiments where the central tubular member is stronger, may consist of a stiffer material, namely the flange, and may have elements along the contact surface with the central member such that the flange can be manually positioned over the central member and easily inserted into it, but it will meet with more resistance when moving the central member up.

This can be accomplished through inclined, bendable projections with sharp ends extending radially inward and in contact with the central member so that movement in one direction (down or distal) is facilitated, while movement in the opposite direction (up or proximal) is limited. Limited movement in the proximal direction of the collar may not be full, but measured to prevent tissue damage in the event of excessive or unexpected body movement. Another embodiment may use a locking element within the flange, whereas when the flange is already above the central tubular member, the second flange component interacts by pressing on the central tubular member firmly enough to hold the flange in place on the member.

(m) Successful packaging of device embodiments having a pressurized outer chamber or inflatable O-ring (see "and" above) can be achieved by using a container with a vacuum created using the same fluid and for the same pressure as the device in inactive state. This can reduce the problem of the device losing pressure over time due to the permeability of the device materials. The packaging container may be constructed of barrier films or it may be a hard polymer or aluminum (e.g., a beverage can) or other container that will maintain fluid pressure over time for which the device will be needed.

(n) A seal comprising an inner portion to seal against the inner wall of the stoma may be constructed of a rigid tubular member with a hemispherical bulge at the distal end. The proximal end of the tubular member includes an element having substantially the shape of a collar outside the body so that it does not contact the stoma and attaches to the outer plate or component. A series of holes pass through the protrusion. A cover of expandable foam material is placed on the outer region of the tubular member, which can be substantially thicker over the bulge at the distal end. This foam material expands significantly in the presence of moisture. When the device is inserted, moisture and liquid contents in the stoma pass through the holes in the bulge and above the foam surface, causing the foam to expand and form a seal on the intestinal wall.

[0020] The second end of the stoma extension may include a member or portion that is stiffer than the channel portion extending to the second end, preferably the second end includes an inflating fluid source for the first end. The stoma extension may further include glue for securing the other end, whereby the adapted length of the channel part is stably maintained.

[0021] As used herein, the term "inflatable" means a portion of the chamber that is configured to expand by inflating the chamber using a positive inflation pressure (e.g., inflation pressure greater than external pressure).

[0022] Features and advantages of the invention may include: providing a stoma seal that is convenient and effective without creating high pressure increases inside or outside, and which can provide a convenient perostomy seal; the ability to adapt to changes in the distance between the fascia and skin, and to provide a flexible range of possible movement; elements of insertion and removal from the stoma; and a "self-inflating" element by internally maintaining fluid pressure to activate and / or activate the device.

[0023] Although certain elements have been highlighted above and in the appended claims, the Applicant may seek protection of the claims with respect to any feature and / or inventive concept described and / or described herein, regardless of whether they have been highlighted.

BRIEF DESCRIPTION OF THE DRAWINGS [0024]

Fig. 1 is a schematic perspective view of the first embodiment of the invention in the "expanded state" having the features described in "e" and "h" above.

Fig. 2 is a schematic perspective view of a second embodiment of the invention in the "expanded state" having the features described in "e" and "h" above.

Fig. 3 is a schematic cross-sectional view showing the first embodiment of the invention in the "expanded" state.

Fig. 4 is a schematic perspective view of the first embodiment of the invention in the "expanded" state, showing the cable for removing the device. Fig. 5 is a schematic cross-sectional view of the third embodiment in the "expanded" and activated state having the features described in "f" and "h" above.

Fig. 6 is a schematic cross-section of a fourth embodiment of the invention having the features described in "m" above.

Fig. 7a is a schematic perspective view of a fifth embodiment of the invention in the "expanded" and inflated state, having the features described in "g" and "h" above.

Fig. 7b is a perspective view complementary to Fig. 7a showing the fifth embodiment of the invention in the "expanded" and inflated state, having the features described in "g" and "h" above.

Fig. 8 is a schematic cross section showing the fifth embodiment of the invention in the "expanded" and inflated state.

Fig. 9 is a schematic cross-sectional view of a sixth embodiment of the invention in an inflated state having the features described in "b" and "g" above.

Fig. 10 is a schematic perspective view showing a seventh embodiment of the invention in an inflated state having the features described in "g", "j" and "k" above.

Fig. 11 is a schematic perspective view showing an eighth embodiment of the invention in an inflated state having the features described in "g", "j" and "k" above.

Fig. 12a is a schematic perspective view of a ninth embodiment of the invention in the "expanded" and inflated state, having the features described in "a" and "h" above.

Fig. 12b is a perspective view complementary to Fig. 12a showing the ninth embodiment of the invention in the "expanded" and inflated state, having the features described in "a" and "h" above.

Fig. 13 is a schematic cross section showing the ninth embodiment of the invention in the "expanded" and inflated state.

Fig. 14a is a schematic perspective view showing an embodiment that does not belong to the invention, in an inactivated state, having the features described in "a" and "i" above (but cannot be rolled up).

Fig. 14a is a schematic perspective view supplementary to Fig. 14a, showing an embodiment that does not belong to the invention, in an inactivated state, having the features described in "a" and "i" above (but cannot be rolled up). Fig. 15 is a schematic perspective view showing a tenth embodiment of the invention with the restrictive cap removed.

Fig. 16 is a schematic perspective view showing a tenth embodiment of the invention inserted into the stoma through a two-part stoma plate.

Fig. 17 is a schematic perspective view showing a tenth embodiment of the invention, inserted into the stoma through a two-part stoma plate, but not yet activated.

Fig. 18 is a schematic cross-sectional view showing the tenth embodiment of the invention, inserted into the stoma through a two-part stoma plate, but not yet activated.

Fig. 19 is a schematic cross-sectional view showing the tenth embodiment of the invention, inserted into the stoma through the two-part stoma plate and activated. Fig. 20 is a schematic front perspective view showing a tenth embodiment of the invention inserted into the stoma through the two-part ostomy plate and activated.

Fig. 21 is a schematic perspective view of an eleventh embodiment of the invention in the "expanded" and inflated state, having the features described in "a" and "i" above (which can be rolled up).

Fig. 22 is a schematic cross section showing the eleventh embodiment of the invention in the "expanded" and inflated state.

Fig. 23 is a schematic perspective view showing an exemplary dipping tool for forming the eleventh embodiment of the invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0025] Referring to Figs. 1-4 showing the first and second embodiments in which the ostomy appliance 10 may include a seal for sealing around the stoma. This seal may generally include an O-ring or similar portion 11 for insertion into the stoma and a seal on the inner wall of the stoma lumen and a second O-ring or similar portion 12 for sealing and / or restraining against external tissue (skin) ) or adhesive component around the stoma. These two O-rings are attached or continuous with the channel part or tubular member 13 so as to form a central channel 14 for conducting ostomy contents. The inner O-ring 11 is inserted into the stoma using an insertion tool (not shown) and placed just outside the abdominal wall (fascia). The outer O-ring 12 is then gripped and gently pulled out to seat the inner O-ring 11 on the fascia. The second outer O-ring 12 is then manually "rolled" or twisted with your fingers to roll up the excess length of the tubular member 13 to conform to a certain distance between the fascia and the skin. The winding operation takes place abruptly with the use of a natural O-ring 12 peripheral pawl. After obtaining a sufficient length, the resistance of the peripheral pawl acts by maintaining the rolled length position. In addition, the resilient rebound of the tubular member 13 provides a flexible range of possible body movement when wearing the ostomy appliance 10. The addition of glue on the skin or adhesive component in which the O-ring 12 is in contact with the skin can help fix the ostomy appliance 10. In the first embodiment (Fig. 1, 3 and 4) the shape of the tubular member 13 is structured to precisely match the diameter reduction resulting from the accumulation of material during roll-up adjustments, giving the tubular member 13 a slightly conical shape and a fairly large diameter reduction near the distal end. This will allow a wide range of adaptation between fascia and skin and material flexibility.

[0026] In a second embodiment (Fig. 2), the shape of the tubular member 13 is a more "trumpet-shaped" shape. This design limits the concentration of the material of the tubular member 13 in the stoma, but when rolled up, it will add radial force to the outer O-ring 12, so that the range of adaptation between the fascia and the skin can be reduced. This can be compensated by increasing the rigidity of the outer O-ring 12 and / or reducing the diameter of the O-ring 12 and / or increasing the elasticity of the material of the tubular member 13. The complexity of this shape will depend on the specific range of distance between the fascia and the skin for a given ostomy appliance size 10. Once the ostomy appliance 10 is in place, the ostomy contents pass through the central channel 14 and out of the body. If a two-part ostomy bag system is used in conjunction with the ostomy appliance, it is likely to significantly reduce the risk of leakage.

[0027] For easy removal of the ostomy appliance 10, a removal cable 15 is specially attached to the inner O-ring 11 (Fig. 4). The removal cable 15 made of nylon, silk or other suitable material is passed through the O-ring 11 and attached to it from the front (distal side), and exits from the back. The stripping cable 15 is then looped around the central canal 14 and passes through it where its proper adhesion to the skin or ostomy plate above the central canal opening 14 is provided by the adhesive tape 16. When the user wants to remove the ostomy appliance 10, the removal cable 15 is gently pulled. This twists the inner O-ring seal 11 so that the shape of the O-ring seal is assembled and allows the O-ring seal 11 to more easily pass through the stoma opening and out.

[0028] In a third embodiment of the ostomy appliance 10, referring to Fig. 5, the ostomy appliance 10 may include a seal for sealing around the stoma, such that the seal, including an inner portion for sealing on the inner wall of the stoma lumen, consists of a funnel-like member 18 having finger-like projections 17. These protrusions 17 are continuous with an annular member 19 at the base that provides support to hold the central channel opening 14 through the funnel member 18. The dimensions of the protrusions 17 in combination with the flexible and / or flexible properties of the funnel member 18 are selected so that the member 18 is rigid enough to hold the shape, but flexible and soft enough to bend the projections 17 together to give a cylindrical shape to the member 18. The ends 20 of the projections 17 are bent inwardly with a radius that prevents the force 20 from concentrating on the ends 20 when it contacts the intestinal wall. A thin, continuous, highly flexible cover 21 is formed outside the funnel member 18, forming a foldable and extensible mesh between the projections 17 and the sealed central channel 14 from the end of the annular element 19. The flexible cover 21 is bonded or otherwise attached to the funnel member 18. It may be that the flexible cover 21 is overmolding, the protrusions 17 being formed prior to overmoulding in a preloaded state, so that during the overmoulding the protrusions 17 remain strained. so that when the finished ostomy appliance 10 is activated in situ, a portion of the flexible cover mesh 21 maintains a stretched state to maintain sealing against the intestinal wall. The flexible cover 21, which forms the central channel 14, extends through the stoma opening and out of the body when the ostomy appliance 10 is in place. The shape of the flexible cover 21 that forms the central channel 14 is similar to the proximal part of the tubular member 13 of the second embodiment above (Fig. 2), where the shape of the flexible cover 21 is "trumpet" and attached to the outer O-ring 12, so that it works like adapting to many different distances between the fascia and the skin.

[0029] In another embodiment, the shape of the flexible cover 21 that forms the central channel 14 may also have a tubular conical shape attached to the outer O-ring 12, as in the first embodiment above (Figs. 1, 3 and 4 ).

[0030] In yet another embodiment, the annular support member 19 may extend in a straight tubular shape through the passage of the stoma and out of the body. [0031] The means for inserting the ostomy appliance 10 into the stoma may include using a tubular-shaped insertion tool (not shown). The tool is positioned through the central passage 14 from the proximal end of the ostomy appliance 10, passes through the annular element 19, and the end of the tool engages with the curved ends of the protrusions 17 when they are co-curved into a cylindrical shape. The tool can be held in place with adhesive and / or coupling elements at the end of the tool. The projections 17 may also have adhesive and / or coupling elements. The tool can be held in place by means of an element that maintains alignment with the annular element 19 and / or the proximal end of the tool and ostomy appliance 10. The insertion tool can be fixed in place at the manufacturing stage and packaged to facilitate user input.

[0032] A third embodiment of the ostomy appliance 10 is introduced into the stoma opening by means of an insertion tool, and then the tool is detached and removed, allowing the funnel-shaped member 18 memory to activate the ostomy device 10 and form a seal on the intestinal wall. As in the first and long embodiment, the outer O-ring 12 is then gripped and manually "rolled" or twisted with your fingers to roll up the excess length of the flexible cover 21, which forms the central channel 14 so as to adapt to a certain distance between fascia and skin. The resilient bounce of the flexible cover 21 that forms the central channel 14 also provides a flexible range of possible body movement when wearing the ostomy appliance 10. The addition of glue on the skin or on the adhesive component at the contact point of the outer O-ring 12 can help fix the ostomy appliance 10.

[0033] Memory of the funnel-like member 18 is measured so that the force required to easily pull the ostomy appliance 10 out of the stoma does not cause tissue damage and is comfortable for the user.

[0034] In a fourth embodiment of the ostomy appliance 10, referring to Fig. 6, the ostomy appliance 10 may include a seal for sealing around the stoma, such that the seal including the inner portion for sealing on the inner wall of the stoma light consists of expandable foam material 22. This foam material 22 covers the outer portion of the stiffer central support 23 having a generally tubular shape, but having a hemispherical bulge 24 at the distal end and a flange-like element 25 at the proximal end. The foam material 22 may have different thicknesses within different parts of the central support 23, e.g., may be thicker within the hemispherical bulge 24. The foam material 22 expands significantly in the presence of moisture. Within the outer foam material 22 there may be a cover or cover made of a very thin flexible sealing film 27. The flange element 25 remains outside the body when the ostomy appliance 10 is in place so that it does not come into contact with the stoma and can attach the outer plate to the skin or other component. The flange member 25 may be substantially flat, convex, concave or a combination of the above. A series of holes 26 extend through the hemispheric bulge 24 to allow moisture to pass through the central support 23. At other points along the central support 23 may be additional holes 26.

[0035] The ostomy appliance 10 can be inserted manually through the opening of the two-part ostomy plate and into the stoma, and then the flange member 25 can attach to the plate.

Moisture and liquid contents in the stoma pass into the central channel 14 and through holes 26 in the central support 23 and into the foam material 22, causing the foam material 22 to expand, the sealing film 27 to stretch, and forming a seal on the intestinal wall.

[0036] The ostomy appliance 10 is removed manually by disconnecting the ostomy appliance 10 from the ostomy plate, then pulling it out of the stoma and discarding it.

[0037] In a fifth embodiment of the ostomy appliance 10, referring to Fig. 7 and 8, the ostomy appliance 10 may include a seal for sealing around the stoma, such that the seal comprising an inner portion for sealing on the inner wall of the stoma lumen consists of an internally inflated chamber portion 28, which can be constructed of two interconnected chambers 29, attached and / or bonded or constructed from a single molded shape, with a more robust or rigid central member 30. Part of the inflatable chamber 28 may be attached to another more flexible tubular member 31, similar to the proximal part of the tubular member 13 of the second embodiment above (Fig. 2), where the shape of the flexible tubular member 31 is "trumpet" and attached to an outer sealing ring of the type The O-ring 12 so that it works just like adjusting to many different distances between the fascia and skin. In another embodiment, the shape of the flexible tubular member 31, which also forms part of the central channel 14, may also have a tubular conical shape attached to the outer O-ring 12, as in the first embodiment above (Figs. 1, 3 and 4 ).

[0038] The inflated chamber part 28 of the fifth embodiment of the ostomy appliance 10 is fully inserted behind the fascia. The proximal end of the ostomy appliance 10, which includes a portion of the flexible tubular member 31 and the attached O-ring 12 remains outside the stoma. The two connected chambers 29 are then inflated by an inflating tube 32 which has a check valve and an inflating device such as a syringe. After inflating, as in the previous embodiments, the outer O-ring 12 is then gripped and gently pulled out to seat the furthest of the two chambers 29 connected to each other on the fascia. The outer O-ring 12 is then manually rolled up to adapt to the specific distance between the fascia and the skin. The robustness of the outer O-ring 12 acts to maintain the rolled length, and the resilient rebound of the tubular member 31 provides a flexible range of possible body movement when wearing an ostomy appliance

10. In addition, as with previous embodiments, the addition of glue on the skin or adhesive component 33 at the point of contact of the O-ring O-ring 12 may help attach the ostomy appliance 10. This assembly configuration may allow easy insertion into the ostomy opening without input device needs.

[0039] The ostomy appliance 10 is removed by deflating the interconnected chambers 29, and then pulling the ostomy appliance 10 out of the body and throwing it away.

[0040] In a sixth embodiment of the ostomy appliance 10, referring to Fig. 9, the ostomy appliance 10 may include a seal for sealing around the stoma, such that the seal comprising an inner portion for sealing on the inner wall of the stoma lumen consists of an inner inflated chamber 34 and an outer portion for holding against external tissues consisting of an external inflatable chamber 35, which they can be connected to each other smoothly and fixed and / or bound or constructed from one formed shape, with a more solid or rigid central member 36.

[0041] The inner chamber 34 and part of the central member 36 to the position just before the outer chamber 35 of the ostomy appliance 10 are introduced into the stoma. The chambers 34, 35 connected to each other are then inflated through an inflating tube 32 which has a check valve and an inflating device.

[0042] The ostomy appliance 10 is removed by deflating the interconnected chambers 34, 35 and then pulling the ostomy appliance 10 out of the body and throwing it away.

[0043] In a seventh embodiment of the ostomy appliance 10 referring to Fig. 10, the ostomy appliance 10 may include a seal for sealing around the stoma, such that the seal including the inner portion for sealing on the inner wall of the stoma light consists of an inner inflatable chamber 34 attached and / or bonded or constructed from one molded shape, with a tubular more robust or rigid central member 36. The central member 36 extends further out of the body so as to provide passage through the ostomy device 10. The member outside the stoma may consist of a stiffer material, namely the collar 37, and may have elements along the contact surface with the central member 36, so that the collar 37 can be manually position it over the central member 36 and easily slide into it, but it will meet with greater resistance when moving the central member 36 up. This can be accomplished through inclined, bendable protrusions 38 with sharp ends extending radially inward and in contact with the central member 36 so that movement in one direction (down or distal) is facilitated, while movement in the opposite direction (up or down proximal) is limited. The restricted movement in the proximal direction of the collar 37 may not be stiffly stopped, but measured to prevent tissue damage in the event of excessive or unexpected body movement. Another embodiment may utilize a locking element (not shown) within the flange 37, while when the flange 37 is already above the central member 36, the second flange component 37 interacts by pushing the central member 36 firmly enough to hold the flange 37 in place on the central member 36. The shape of the collar 37 is such that it does not come into contact with the stoma and can attach an outer plate or other component to the skin. The collar 37 may have a substantially flat, convex, concave or combined shape. The collar 37 may not include the outer seal, but may only rest or attach and have "drains" to allow fluid to exit in the event of damage to the internal seal of the intestine. Drainage can prevent the stoma opening from clogging in the event of a seal failure. The discharge of content may also indicate that the device needs to be replaced.

[0044] The inner chamber 34 and part of the central member 36 of the ostomy appliance 10 are inserted into the stoma, and fully behind the fascia, and inflated through an inflating tube 32 that has a check valve and an inflating device. The central member 36 is then gently pulled out in the distal direction to seat the inner chamber 34 on the fascia. Then the collar 37 is placed on the central member 36 and slid in so that it rests on the skin, the outer plate or other component, then locked in place as needed. The central member 36 may have an excess length shortened to reduce the profile of the ostomy appliance 10.

[0045] The ostomy appliance 10 is removed by deflating the internal chamber 34, then pulling the ostomy appliance 10 out of the body and throwing it away.

[0046] The eighth embodiment of the ostomy appliance 10, referring to Fig. 11, has the same elements and function as the seventh, except that there are two connected chambers 29 similar to the fifth embodiment.

[0047] In a ninth embodiment of the ostomy appliance 10, referring to Fig. 12 and 13, the ostomy appliance 10 may include a seal for sealing around the stoma, such that the seal comprising an inner portion for sealing on the inner wall of the stoma light consists of an inflatable chamber 39 with a toroidal shape that can be sealed to a tubular conical or "trumpet" central channel 40 constructed of thin flexible material. The conical channel 40 may be attached to another flexible tubular member 31, similar to the proximal part of the tubular member 13 of the second embodiment above (Fig. 2), where the shape of the flexible tubular member 31 is "trumpet" and attached to an O-ring outer seal ring 12 so that it works just like adjusting to many different distances between the fascia and skin. In another embodiment, the shape of the flexible tubular member 31, which also forms part of the central channel 14, may also have a tubular conical shape attached to the outer O-ring 12 as in the first embodiment above (Figs. 1, 3 and 4) . The distal end of the ostomy appliance 10, including the inflatable chamber 39, the distal end of the inflating tube 32 and the conical channel 40 with part of the flexible tubular member 31 may be limited, e.g. bent, curled and / or twisted into a thin, long shape to facilitate insertion into the stoma without the need for an insertion tool. Gelatin or other coating on restricted members may facilitate insertion by maintaining the restriction until gelatin contacts or enters the wet interior of the stoma. The addition of an overlay over the inner chamber may also assist in keeping the chamber restricted before use.

[0048] The limited distal end of the ninth embodiment of the ostomy appliance 10 is fully inserted into the stoma, such that the end is behind the fascia. The proximal end of the ostomy appliance 10, which includes a portion of the flexible tubular member 31 and the attached O-ring 12 remains outside the stoma. After the boundary coating has dissolved, the inflatable chamber 39 is then inflated through an inflating tube 32 that has a check valve and an inflating device such as a syringe. After inflating, as in the previous embodiments, the outer O-ring 12 is then gripped and gently pulled out (in the distal direction) to seat the inflatable chamber 39 on the fascia. The outer O-ring 12 is then manually rolled up to adapt to the specific distance between the fascia and the skin. The solidity of the outer O-ring 12 acts to maintain the rolled length, and the resilient rebound of the tubular member 31 and the conical channel 40 provides a flexible range of possible body movement when wearing the ostomy device 10. In addition, as with previous embodiments, the addition of glue on the skin or adhesive component at the point of contact of the outer O-ring 12 can help attach the ostomy device 10.

[0049] The ostomy appliance 10 is removed by deflating the inflatable chamber 39, then pulling the ostomy appliance 10 out of the body and throwing it away.

[0050] In the tenth embodiment of the ostomy appliance 10, referring to Fig. 14, 15, 16, 17, 18, 19 and 20, the ostomy appliance 10 may include a seal for sealing around the stoma 41, such that the seal including the inner portion for sealing on the inner wall of the stoma light consists of an inflatable inner chamber 39 with a toroidal shape, which can be tightly attached to a tubular conical or "trumpet" central channel 40 constructed of thin flexible material. The conical channel 40 may also be continuous with another external inflatable chamber 42 with a thicker and / or stronger (less soft) flexible material. There are fluid passageways 43 connected to each other between the inner chamber 39 and the outer chamber 42. An opening or other fluid restriction or valve may be provided at the entrance, exit or along the fluid passage 43 to delay and / or control the start of fluid transfer from outer chamber 42 to internal chamber 39. In the outer chamber 42, the underpressure is to be created by the fluid during manufacture or for some time before use, so that the contained pressure after release can be used to transfer, by the flexible action of the fluid component from the outer chamber 42 through the fluid passages 43 to the inner chamber 39, yes so that the inner chamber 39 can be activated inside the body, without the need for an additional component to inflate the ostomy appliance 10. The inner chamber 39 and the conical channel 40 can be limited, e.g., bent, rolled and / or twisted, into a thin, long shape to facilitate insertion into the stoma 41 without the need for an insertion tool. Gelatin or other coating 50 on the restricted members may facilitate insertion by maintaining the restriction until gelatin contacts or enters the wet interior of the stoma 41. The addition of a cap 46 over the inner chamber 39 and the restricted members may also assist in keeping the inner chamber 39 limited before use. The limitation of the inner chamber 39 can also prevent premature fluid transfer from the outer chamber under pressure 42. A cover member 44 of the cover 44 is connected to the outer chamber 42. The function of the cover member 44 is to provide means for easy handling, attachment / removal and deflation of the ostomy appliance 10 and is constructed of a relatively rigid polymer material. At the bottom of the cover member 44 along the outer flange there is an annular region 48 that after activation of the ostomy appliance 10 will contact the surface around the stoma 41 on the two-piece ostomy plate 47. The annular circuit 48 has alternate shallow leads 51 or spaced around the circumference to allow content and / or gas to be discharged from behind around the inner seal in the event of a seal failure. This annular region 48 may be covered with adhesive between leads 51 and / or the ostomy plate 47 may have adhesive for attaching the ostomy appliance 10. In addition, within the cover member 44 there is a detachable deflector 45 used to deflate the ostomy appliance 10. The deflector 45 is a tear-off element of the cover member 44 because the attachment or bonding of the material of the outer chamber 42 to the connecting member 44 overlaps the perforation of the deflector 45 in such a way that when the deflector 45 is broken, the sealing of the outer chamber 42 is leveled, resulting in the deflation of the ostomy appliance 10. Successful packaging of the ostomy appliance 10 can be achieved by using a vacuum container created using the same fluid and to the same pressure as the outer chamber 42 in the unactivated state. This can reduce the problem of pressure buildup by the ostomy appliance 10 over time due to the material permeability of the ostomy appliance 10. The packaging container may be constructed of barrier films or may be a hard polymer or aluminum (e.g., a can of beverage) or other container that will maintain fluid pressure over time for the period during which the ostomy appliance will be needed.

[0051] A tenth embodiment of the ostomy appliance 10 is removed from its container, the cap 46 is removed (Fig. 15), and the ostomy appliance 10 is fully inserted into the stoma 41 (Figures 16, 17 and 18) so that the end of the the parts were located behind fascia 49. The restraining coating 50 dissolves and fluid transfer from the outer chamber 42 to the inner chamber 39 begins. Manually pressing down on the cover member 44 can also start and / or accelerate fluid transfer.

The inner chamber 39 is then inflated and the outer chamber 42 is deflated, allowing the annular area 48 to contact the surface of the stoma plate 47 and attach the ostomy appliance 10. The ostomy contents can then freely flow through the ostomy appliance 10 and out into the bag without contact with other tissues.

[0052] The ostomy appliance 10 is removed by pulling the deflector tab 45, deflating the ostomy appliance 10, and then pulling the ostomy appliance 10 out of the ostomy plate 47 and out of the body and discarding. [0053] In the eleventh embodiment of the ostomy appliance 10, referring to Fig. 21 and 22, has the same elements and functionality as the tenth, except that there is no attachable cover member 44, but rests on the outer inflatable chamber 42 to provide means for easy handling, attachment / removal and deflation of the ostomy appliance 10. As with the tenth embodiment, fluid passageways 43 are provided between the inner chamber 39 and the outer chamber 42, which include an opening 52 or other fluid restriction or valve to delay and / or control the start of fluid transfer from the outer chamber 42 to the inner chamber 39 As with the tenth embodiment, pressure in the outer chamber 42 is to be maintained through the fluid during the production phase or for some time before use. Contained fluid under pressure, after releasing, can transfer, by elastic action, the fluid from the outer chamber 42 through the opening (s) 52 and fluid passages 43 to the inner chamber 39 so that the inner chamber 39 can activate inside the body without the need for a separate device for inflation. The inner chamber 39 and the conical channel 40 can also be restricted and held by means of the coating 50, as in the case of the tenth embodiment, in a thin, long shape to facilitate insertion into the stoma 41. A cap can be placed over the inner chamber 39 and the restricted members. In addition, when the ostomy appliance 10 is in place and the outer chamber 42 has transferred fluid to the inner chamber 39 to activate the ostomy appliance 10, then an outer chamber with deflated air 42 can be used, which is similar to an O-ring outer seal this time. 12 in the ninth embodiment (Figures 12 and 13) to act as a fitting for many different distances between the fascia and skin by circumferentially rolling the conical channel 40. Successful packaging of the ostomy appliance 10 can be achieved, as in the tenth embodiment, by using a container with a vacuum created using the same fluid and to the same pressure as the outer chamber 42 in the unactivated state.

[0054] The ostomy appliance 10 may be partially manufactured in a dipping molding process. Fig. 23 illustrates examples of possible cylindrical tools for dipping. First, the tool can be dipped in a suitable material component up to the AA line and allowed to cure to form a thin, soft film with a high level of flexibility to form the inner chamber 39 and the conical channel 40. This marks the first dipping area 53. The tool can then be dipped in a suitable material component up to the BB line and allowed to cure to form a thick, strong, flexible film to form the outer chamber 42. This designates a second dipping area 54. The second dipping area 54 may require subsequent dipping to achieve the desired thickness. After curing the molding materials by dipping, additional assembly steps will be required to finish the ostomy appliance 10.

[0055] The eleventh embodiment of the ostomy appliance 10, very similar to the tenth, is removed from its container, the cap on the restricted members is removed, and the ostomy appliance 10 is fully inserted into the stoma 41, so that the end of the restricted part is located behind the fascia 49 The restrictive coating dissolves and fluid transfer from the outer chamber 42 to the inner chamber 39 begins. The inner chamber 39 is then inflated and the outer chamber 42 is deflated, which allows the use of the de-aerated outer chamber 42 as an outer O-ring 12 as in the previous embodiments. The outer O-ring 42 is gripped and gently pulled out (proximal) to seat the inflatable chamber 39 relative to fascia 49. The outer chamber 42 is then manually "rolled up" to conform to a certain distance between the fascia and the skin. The solidity of the outer chamber with deflated air 42 acts to maintain the coiled length, and the springy rebound of the conical channel 40 provides a flexible range of possible body movement when wearing the ostomy appliance 10. The adhesive on the surface of the ostomy plate 47 in contact with the bottom of the outer chamber 42 helps to attach the ostomy device 10. Ostomy contents can then flow freely through the ostomy appliance 10 and out into the bag without contact with other tissues.

[0056] The ostomy appliance 10 is removed by pulling the tongue 51 for deflating the air, deflating the ostomy device 10, and then pulling the ostomy device 10 out of the ostomy plate 47 and out of the body and discarding.

[0057] It should be noted that the above description includes preferred embodiments of the invention and that many modifications, improvements and equivalents fall within the scope of the claimed invention.